Podcasts about Genentech

In this podcast episode, Rami Komrokji, MD, reviews data from select presentations in myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPNs) presented at the ASH 2025 Annual Meeting and shares expert perspectives on the clinical implications of these findings, including:Abstract 910: MANIFEST-2 96-Wk Update: Ruxolitinib + Pelabresib or Placebo in Patients With JAK Inhibitor–Naive MFAbstract 1024: Phase I Trial of INCA033989, a First-in-Class Antibody Targeting Mutant Calreticulin: Safety and Efficacy in Essential ThrombocythemiaAbstract 484: Preliminary Results From 2 Phase I Trials Exploring the Mutant Calreticulin-Specific mAb INCA033989 ± Ruxolitinib in Patients With MFAbstract 235: VERONA: Subgroup Analyses of Venetoclax or Placebo Combined With Azacitidine in Treatment-Naive Higher-Risk MDSAbstract 490: IMerge Post Hoc Analysis: Treatment-Emergent Cytopenias and Response With Imetelstat in Patients With Lower-Risk MDSAbstract 487: Randomized Phase II Trial of Reduced Treatment Durations of Hypomethylating Agents for Lower-Risk MDSPresenter: Rami Komrokji, MDSenior Member, Vice ChairSection Head – Leukemia and MDSDepartment of Malignant HematologyH. Lee Moffitt Cancer CenterProfessor of Oncologic SciencesUniversity of South FloridaTampa, FloridaContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program: https://bit.ly/48Ye45N Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Most of us live in autopilot. We rush through our days, carry the weight of stress, and get buried under pressure. We say things like "I have to go to work" or "I have to deal with this" and "I have to keep pushing." But what if you replaced one word and changed everything?"I Get To" is not just a phrase - it's a practice. One that moves you from obligation to opportunity, from burnout to presence, from pressure to purpose.Whether you're an athlete, executive, leader, coach, parent, or anyone navigating challenge or change, "I Get To" reminds you that your mindset isn't just part of the journey - it is the journey.Who is Chris Cullen?Global keynote speaker, mindset coach, author, and founder of Win Within, Chris Cullen helps high achievers build meaningful lives from the inside out. After a decade leading teams and driving over $100M in sales, Chris walked away from a high-performing career to pursue teaching people how to lead themselves well.Through his work with elite athletes, Fortune 500 teams, and growth-minded individuals, Chris teaches how to apply the "I Get To" mindset - a simple but powerful shift in perspective that builds resilience, presence, and intention. Two-time Ironman finisher, former Division 1 and professional athlete, and founder of Win Within, Chris blends grit with grounded self-awareness. His work reminds us that the life we want isn't found in more hustle - it's built through perspective, presence, and choice.Chris lives his message daily and believes the most important words you'll ever say to yourself are the ones you practice when life gets hard.Today, his mission is clear: to help companies and high achievers push beyond limits, sharpen their mindset, and unlock their next level of performance.Chris's innovative trainings on mindset, culture, and high performance have been utilized by some of the world's best organizations including: Qualtrics, Marriott, Genentech, Jersey Mike's, Stryker, USA Volleyball, Michigan State University, and the University of Georgia Athletics.Connect with Chris:► LinkedIn► Instagram► Website► Buy the book: "I Get To"

Jean Koff, MD, MSc Non-Hodgkin lymphoma (NHL) can sound overwhelming, but what does it really mean for patients and families? In this episode, we speak to Dr. Jean Koff of Winship Cancer Institute of Emory University, who breaks down the big picture of NHL: what it is, how it's an umbrella term for multiple subtypes, and what today's treatments and tomorrow's innovations could mean for you. From understanding subtypes and staging to exploring options like watchful waiting, chemotherapy, and cutting-edge immunotherapies, we cover what matters most: knowledge, clarity, and hope. DOWNLOAD TRANSCRIPT CLICK HERE to participate in our episode survey. Mentioned on this episode: Non-Hodgkin lymphoma The Lymphoma Guide Lugano staging system Immunotherapy fact sheet CAR T-cell therapy Allogeneic stem cell transplantation Clinical Trial Support Center Online NHL Chat Additional Blood Cancer United Support Resources: Free Nutrition Consultations Information Specialists Financial support Free telephone/web patient programs Free booklets Young Adult Resources Support groups Caregiver support Caregiver Workbook Survivorship Workbook Advocacy and Public Policy Patient Community Mental Health Resources Supported by AbbVie Inc. and Genentech, A Member of the Roche Group.The post The Big Picture on Non-Hodgkin Lymphoma: Treatments, Trends, and Tomorrow first appeared on The Bloodline with Blood Cancer United Podcast.

Reading food labels can feel like a full-time job when you or your child has food allergies. Even when you know what to avoid, labels can still be confusing, especially when you run into “may contain” warnings. Marion Groetch, a registered dietitian with decades of experience in food allergy care and education, joins us to unpack all things food labels. Together, we break down U.S. allergen labeling laws, what parts of the package actually matter, and why “may contain” statements are a much grayer area than most people realize. We also share practical tips for navigating so-called “mystery ingredients” like natural flavors and oils, when it is worth contacting a manufacturer, and how to avoid being more restrictive than necessary while still staying safe. What we cover in our episode about food labels: What U.S. labeling laws require: How FALCPA and the FASTER Act protect families by requiring clear disclosure of the Top 9 major allergens. Where allergy information actually lives on a label: Why the ingredients list and “Contains” statement matter most, and why front-of-package claims should be ignored. What “may contain” actually means: Why these statements are voluntary and unregulated, and what that means for real-world decision-making. Foods that fall outside labeling laws: Common situations where allergen labeling is not required, including deli foods, restaurant meals, airline meals, and alcohol. How to avoid over-restricting your diet: Practical guidance on mystery ingredients, higher-risk products, and when contacting a manufacturer actually makes sense. ___ Made in partnership with The Allergy & Asthma Network. Thanks to Genentech for sponsoring today's episode. This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

In this podcast episode, Jeremy S. Abramson, MD, MMSc, reviews data from select presentations in lymphomas at the ASH 2025 Annual Meeting and provides perspectives on the clinical implications of these data for patients with chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL), including:CLL17: randomized phase III trial of continuous ibrutinib vs fixed-duration venetoclax plus obinutuzumab or venetoclax plus ibrutinib for untreatedCLL BRUIN CLL-313: randomized phase III trial of pirtobrutinib vs BR for previously untreated patients with CLLBRUIN CLL-314: pirtobrutinib vs ibrutinib in treatment-naive and BTKi-naive R/R CLL/SLL EPCORE-FL-1: randomized phase III trial of epcoritamab with rituximab and lenalidomide vs rituximab and lenalidomide for R/R FLSTARGLO: 3-year follow-up data from the randomized phase III trial of glofitamab plus GemOx vs rituximab plus GemOx for patients with R/R DLBCLPresenter: Jeremy S. Abramson, MD, MMScProfessor of MedicineHarvard Medical SchoolDirector, Center for LymphomaMass General Brigham Cancer InsBoston, MassachusettsContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program:https://bit.ly/4aqMobZ Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

As organizations race to adopt AI, learning leaders face a critical challenge: how to embrace innovation without losing sight of performance. In this episode of Performance Matters, Bob Mosher is joined by Frank Nguyen for a candid, thoughtful conversation about what responsible L&D leadership looks like in an era of rapid disruption. Drawing on Frank's experience across industries—from Amazon to Genentech—the discussion explores how learning teams can move beyond order-taking to become true strategic partners. Together, they unpack the balance between delivering today's results while preparing for tomorrow, the risks of being distracted by AI hype, and why performance—not content or tools—must remain the north star. Listen or download now.   Have questions about this content or another resource on the site? Let us know! Use this form to let us know you're interested in scheduling a call with a member of the team. We're always happy to discuss your current, future, or aspirational initiatives in real-time. For more 5 Moments of Need resources, visit our website, join the conversation, attend our upcoming Summit, and subscribe to this podcast so as not to miss a single episode. Copyright © 2025 by APPLY Synergies, LLC | All Rights Reserved. 

Richard Bonneau, Vice President of Machine Learning for Drug Discovery at Genentech and Roche, provides Pitt's HexAI podcast host, Jordan Gass-Pooré, with an insider view on how his team is fundamentally changing and accelerating how new drug candidate molecules are designed, predicted, and optimized.Geared for students in computational sciences and hybrid STEM fields, the episode introduces listeners to uses of AI and ML in molecular design, the biomolecular structure and structure-function relationships that underpin drug discovery, and how distinct teams at Genentech work together through an integrated computational system.Richard and Jordan use the opportunity to touch on how advances in the molecule design domain can inspire and inform advances in computational pathology and laboratory medicine. Richard also delves into the critical role of Explainable AI (XAI), interpretability, and error estimation in the drug design-prototype-test cycle, and provides advice on domain knowledge and skills needed today by students interested in joining teams like his at Genentech and Roche.

In this episode, Hanny Al-Samkari, MD, gives his thoughts on 5 key presentations from ASH 2025, and provides perspectives on the clinical implications of these data for patients with nonmalignant hematologic disorders such as ITP and vWD, including: LBA-2: Primary results from VAYHIT2, a randomized, double-blind, phase III trial of ianalumab plus eltrombopag vs placebo plus eltrombopag in patients with primary immune thrombocytopenia (ITP) who failed first-line corticosteroid treatmentAbstract 844: Secondary analysis results from VAYHIT3, a phase II study of ianalumab in patients with primary immune thrombocytopenia previously treated with at least 2 lines of therapyAbstract 5: Deciphering the dilemma: intravenous (IV) iron use in iron deficiency anemia during acute infectionsAbstract 308: Subcutaneous, every-4-week maintenance dosing of a novel protein S antibody is well tolerated and substantially reduces bleeding rates: results from a phase I/II multidose study of VGA039 in patients with von Willebrand diseaseAbstract 841: Immune thrombocytopenia in patients treated with immune checkpoint inhibitorsPresenter:Hanny Al-Samkari, MDThe Peggy S. Blitz Endowed Chair in Hematology/OncologyCo-Director, Hereditary Hemorrhagic Telangiectasia Center of ExcellenceMassachusetts General HospitalAssociate Professor of MedicineHarvard Medical SchoolBoston, MassachusettsContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program:https://bit.ly/48Ye45N Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant updates that are shaping the future of healthcare, patient care, and drug development.The U.S. Food and Drug Administration has been particularly active recently, granting Johnson & Johnson a National Priority Review Voucher for its multiple myeloma drug combination. This move highlights the importance of J&J's treatment in addressing unmet needs within oncology, a field continuously striving for innovative solutions. These vouchers expedite the review process, reflecting a broader commitment to accelerating the availability of critical therapies for patients who need them most.Continuing with regulatory advancements, AstraZeneca and Daiichi Sankyo's Enhertu, in combination with Roche's Perjeta, has gained FDA approval as a first-line treatment for unresectable or metastatic HER2-positive breast cancer. This breakthrough is supported by late-stage study results demonstrating a 44% reduction in disease progression or death compared to standard care. The approval signifies not only progress in breast cancer therapeutics but also underscores the potential benefits of strategic collaborations in drug development. Such partnerships are increasingly vital as they aim to optimize therapeutic efficacy through shared expertise and resources.In contrast to these advancements, Pfizer is facing financial recalibrations with projected revenues for 2026 estimated to decline due to diminishing COVID-19 vaccine sales and patent expirations. This situation reflects broader industry challenges as companies navigate post-pandemic market dynamics and patent cliffs, forcing reevaluations of long-term strategies.On another front, Gilead Sciences continues to push boundaries in HIV treatment with a promising single-tablet regimen combining bictegravir and lenacapavir. This innovation targets underserved segments within the HIV market, offering streamlined treatment options that could enhance patient adherence and outcomes significantly.Shifting focus to obesity management, Novo Nordisk's oral semaglutide is emerging as a highly anticipated medication among primary care providers. This trend highlights a growing preference for oral GLP-1 therapies as convenient alternatives to injectable formulations, marking a shift in how obesity—a major public health concern—is managed.The importance of regulatory compliance remains evident as Novo Nordisk received an FDA warning letter concerning manufacturing issues at an Indiana site previously owned by Catalent. This incident underscores the necessity for rigorous quality control in pharmaceutical manufacturing, which can have far-reaching implications on operational dynamics and supply chains.The FDA is also pioneering efforts to incorporate real-world evidence into medical device submissions by opening pathways for extensive deidentified datasets from sources like national cancer registries and electronic health records. This policy shift aims to integrate diverse data sources into the evidentiary foundation for medical device evaluations, potentially fostering innovation within this sector.In line with collaborative efforts, Genentech has partnered with Caris Life Sciences in a multi-year agreement valued at up to $1.1 billion, emphasizing the strategic importance of integrating diagnostic advancements with therapeutic developments to achieve precision medicine goals.Meanwhile, Yarrow Bioscience has acquired an autoimmune thyroid disease drug from China's Gensci, exemplifying a growing trend of cross-border collaborations aimed at leveraging global innovation ecosystems to address diverse therapeutic areas. This acquisition is part of a $1.37 billion deal, reinforcing the globalization of biotech partnerships as companies seek access to novel therapeutics andSupport the show

In this podcast episode, Amir T. Fathi, MD, reviews data from select presentations in leukemias at the ASH 2025 Annual Meeting, and provides perspectives on the clinical implications of these data for patients with acute myeloid leukemia (AML) or chronic myeloid leukemia (CML), including:Abstract 6: Phase II PARADIGM trial of azacitidine and venetoclax vs conventional intensive chemotherapy for fit patients with newly diagnosed AMLAbstract 47: Phase I/II SAVE trial of revumenib plus decitabine/cedazuridine and venetoclax in the cohort of patients with newly diagnosed AMLAbstract 766: Phase Ib KOMET-007 trial of ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-mutant AMLAbstract 654: Phase I/II VICEROY trial of venetoclax and azacitidine + gilteritinib in patients with newly diagnosed FLT3-mutated AML ineligible for intensive induction chemotherapyAbstract 903: 3-Yr Update of the phase II FASCINATION trial of asciminib and conventional BCR::ABL1 inhibitors in newly diagnosed CMLAbstract 906: Phase II ASC2ESCALATE trial of asciminib in patients with chronic-phase CML after 1 prior TKIPresenter:Amir T. Fathi, MDDirector, Leukemia ProgramMassachusetts General HospitalAssociate Professor of MedicineHarvard Medical SchoolBoston, MassachusettsContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program:https://bit.ly/48Ye45N Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

In this episode of Data in Biotech, host Ross Katz sits down with Eshani Galermo, Staff Scientist at SCIEX, to explore the next generation of mass spectrometry in pharma and biopharma. Eshani explains how innovations like the ZenoTOF 8600 are redefining sensitivity, selectivity, and workflow efficiency in bioanalytical chemistry. Discover how high-resolution accurate mass (HRAM) systems are unlocking new capabilities in drug discovery, clinical studies, and regulatory science. What you'll learn in this episode: >> Why traditional mass spectrometry falls short in modern bioanalysis >> How the ZenoTOF 8600 enhances sensitivity and reduces sample volume needs >> The role of high-resolution systems in detecting complex drug metabolites >> How automation tools are streamlining workflows for bioanalytical scientists >> The complementary role of AI and ML in mass spec data analysis Meet our guest Eshani Galermo is a Staff Scientist at SCIEX, where she leads global strategic marketing initiatives for pharma and biopharma quant applications. With deep expertise in bioanalytical chemistry and mass spectrometry, she has held multiple scientific roles across SCIEX, Emery Pharma, and Genentech.  About the host Ross Katz is Principal and Data Science Lead at CorrDyn. Ross specializes in building intelligent data systems that empower biotech and healthcare organizations to extract insights and drive innovation. Connect with Our Guest: Sponsor: CorrDyn, a data consultancyConnect with Eshani Galermo on LinkedIn  Connect with Us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!Connect with Ross Katz on LinkedIn Sponsored by… This episode is brought to you by CorrDyn, the leader in data-driven solutions for biotech and healthcare. Discover how CorrDyn is helping organizations turn data into breakthroughs at CorrDyn.

JCO Editor-in-Chief Dr. Jonathan Friedberg is joined by colleagues Dr. Jennifer Woyach, Dr. Wojciech Jurczak, and Dr. Matthew Davids to discuss simultaneous publications presented at ASH 2025 on pertibrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. TRANSCRIPT The disclosures for guests on this podcast can be found in the show notes. Dr. Jonathan Friedberg: I'm Jonathan Friedberg, editor of Journal of Clinical Oncology, and welcome to JCO After Hours, where we are covering two manuscripts that were presented at the American Society of Hematology meeting 2025 in Orlando, Florida. I am delighted to be joined by colleagues on this call to discuss these pivotal manuscripts which cover the topic of pirtobrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. I will first just introduce our guests, Dr. Woyach. Dr. Jennifer Woyach: Hi, my name is Jennifer Woyach. I am from the Ohio State University. Dr. Wojciech Jurczak: Hello, I am Wojciech Jurczak, working at the National Research Institute of Oncology in Krakow, Poland. Dr. Matthew Davids: Hi, I am Matthew Davids from Dana-Farber Cancer Institute in Boston. Dr. Jonathan Friedberg: We are going to start by just learning a little bit about these two trials that were both large, randomized phase 3 studies that I think answered some definitive questions. We will start with your study, Jennifer. If you could just describe the design of your study and the patient population. Dr. Jennifer Woyach: Absolutely. So this is the BRUIN CLL-314 study, and this is a phase 3 randomized trial of pirtobrutinib versus ibrutinib in patients with CLL or SLL who had not previously been treated with a covalent BTK inhibitor. The patients were both treatment-naive and relapsed/refractory, about one-third of the patients treatment-naive, the rest relapsed/refractory, and they were stratified based upon 17p deletion and the number of prior lines of therapy. The primary objective was looking at non-inferiority of overall response rate over the entire treated population as well as the relapsed/refractory patient population. Key secondary objectives included progression-free survival in the intention-to-treat and the smaller relapsed/refractory and treatment-naive populations. Dr. Jonathan Friedberg: And just comment a little bit on the risk of the patients. Dr. Jennifer Woyach: This study was fairly typical of this cohort of patients. Within the relapsed/refractory patient population, there was a median of one prior line of therapy in each of the groups, up to nine prior lines of therapy in the patients included on the study. For the overall cohort, about two-thirds of the patients were IGHV unmutated, about 15% had 17p deletion, 30% had TP53 mutations, and about 35% to 40% had a complex karyotype, which is three or more abnormalities. Dr. Jonathan Friedberg: And what were your findings? Dr. Jennifer Woyach: Regarding the primary outcome, which is the focus of the publication, we did find that pirtobrutinib was indeed non-inferior and actually superior to ibrutinib for overall response rate throughout the entire patient population and in both the relapsed/refractory and treatment-naive cohorts. PFS is a little bit immature at this time but is trending towards also being significantly better in pirtobrutinib-treated patients compared with ibrutinib-treated patients. Probably most significantly, we found this to be the case in the treatment-naive cohort where there was a striking trend to an advantage of pirtobrutinib versus ibrutinib. Dr. Jonathan Friedberg: And the follow-up that you have on that progression-free survival? Dr. Jennifer Woyach: So we have about 18 months follow-up on progression-free survival. Dr. Jonathan Friedberg: The second study, Wojciech, can you just go through the design and patient population that you treated? Dr. Wojciech Jurczak: Thank you, Dr. Friedberg, for this question. So the BRUIN CLL-313 study was, in fact, the first phase 3 study with pirtobrutinib in exclusively untreated CLL patients. It was a randomized study where we challenged pirtobrutinib versus bendamustine-rituximab. At the time we designed the protocol, bendamustine-rituximab was an option as a standard of care, and Bruton tyrosine kinase monotherapy was used far more commonly than nowadays. The primary target of the study was progression-free survival. We took all untreated patients except for those with 17p deletions. Therefore, it is a good representation for intermediate risk. We had about 60% of the population, 56 to be precise, which was unmutated, evenly distributed into two treatment arms. 17p deleted cases were excluded, but we had about 7% and 8% of TP53 mutated patients as well as about 11% and 7%, respectively, in the pirtobrutinib and bendamustine-rituximab arm of patients with complex karyotype. The progression-free survival was in favor of pirtobrutinib and was assessed by an independent review committee. What is important is that the progression-free survival of the bendamustine-rituximab arm was actually similar to the other studies addressing the same questions, like the comparison with ibrutinib in the ALLIANCE study or zanubrutinib in the SEQUOIA study. What was different was the hazard ratio. In our study, it was 0.20. It was one of the longest effect sizes noted in the frontline BTK study. It represented an 80% reduction in progression-free survival or death. If we compare it to ibrutinib or zanubrutinib, it was 0.39 and 0.42 respectively. Presumably, this great effect contributed towards a trend of overall survival difference. Although survival data are not mature enough, there is a clear trend represented by three patients we lost in the pirtobrutinib arm versus 10 patients lost in the bendamustine-rituximab arm. This trend in overall survival is becoming statistically significant despite the fact that there was a possibility of crossover, and effectively 52.9 patients, which means 18 out of 34 patients relapsing in the bendamustine-rituximab arm, were treated by pirtobrutinib. Dr. Jonathan Friedberg: I am going to turn it over to Matt. The question is: why study pirtobrutinib in this patient population? And then with these two studies, how do you find the patients that were treated, are they representative of people who you see? And do you see this maybe being approved and more widely available? Dr. Matthew Davids: I think in terms of the first question, why study this in a frontline population, we have seen very impressive data with pirtobrutinib in a very difficult-to-treat population of CLL patients. This was from the original BRUIN phase 1/2 study where most of the patients had at least two or three lines of therapy, often both a covalent BTK inhibitor and the BCL2 inhibitor venetoclax, and yet they were still responding to pirtobrutinib. The drug was also very well tolerated in that early phase experience. And actually, we have seen phase 3 data from the BRUIN 321 study comparing pirtobrutinib to bendamustine and rituximab in a relapse population as well. So I think that really motivated these studies to look at pirtobrutinib as a first therapy. You know, often in other cancers of course, we want to use our best therapy first, and I think these studies are an initial step at looking at that. In terms of the second question around the patient population, these are pretty representative patient populations, I would say, for most frontline CLL studies. We see patients who are a bit younger and fitter than sort of the general population of CLL patients who are treated in clinical practice, and I think that is true here as well. Median age in the sort of mid-60s here is a bit younger than the typical patients we are treating in practice. But that is not different from other CLL frontline studies that we have seen recently, so I think it makes it a little bit easier as we kind of think across studies to feel comfortable that these are relatively similar populations. Dr. Jonathan Friedberg: How do you see this either getting regulatory approval or potentially being used compared to current standard of care options? Dr. Matthew Davids: So my understanding is that both of these trials were designed with registrational intent in the frontline setting, and they are both positive studies. That is certainly very encouraging in terms of the potential for an approval here. We have seen in terms of the FDA recently some concerns around the proportion of patients who are coming from North America, and my understanding is that is relatively low on these two studies. But nonetheless, the datasets are very impressive, and so I think it is certainly supportive of regulatory approval for frontline pirtobrutinib. Dr. Jonathan Friedberg: I will ask Jennifer a question. The control arm in your study was ibrutinib, and I think many in the audience may recognize that newer, second-generation BTK inhibitors like acalabrutinib and zanubrutinib are more frequently used now if monotherapy is decided. How do you respond to that, and how would you put your results in your pirtobrutinib arm in context with what has been observed with those agents? Dr. Jennifer Woyach: Yeah, that is a great question. Even though in the United States we are predominantly using acalabrutinib or zanubrutinib when choosing a monotherapy BTK inhibitor, this is actually not the case throughout the entire world where ibrutinib is still used very frequently. The head-to-head studies of both acalabrutinib and zanubrutinib compared to ibrutinib have shown us pretty well what the safety profile and efficacy profile of the second-generation BTK inhibitors is. So even though we do not have a head-to-head study of acalabrutinib or zanubrutinib versus pirtobrutinib, I think, given the entirety of data that we have with all of the covalent BTK inhibitors, I think we can safely look at the pirtobrutinib arm here, how the ibrutinib arm compares or performs in context with those other clinical trials. And though we really can not say anything about pirtobrutinib versus acalabrutinib or zanubrutinib, I think we can still get a good idea of what might be the clinical scenarios in which you might want to choose pirtobrutinib. Dr. Jonathan Friedberg: And Wojciech, do you agree with that? Obviously, I think you have acknowledged that chemoimmunotherapy is rarely used anymore as part of upfront treatment for CLL. So, I guess a similar question. If you were to put the pirtobrutinib result in your study in context with, I guess, more contemporary type controls, would you agree that it is competitive? Dr. Wojciech Jurczak: Well, I think that that was the last study ever where bendamustine-rituximab was used as a comparator arm. So we should notice that smashing difference. Because if we look at the progression-free survival at two years, we have 93.4% in pirtobrutinib arm versus 70.7% in bendamustine-rituximab arm. Bendamustine-rituximab arm did the same as in the other trials, like ALLIANCE or SEQUOIA. Pirtobrutinib did exceptionally well, as pirto is not just the very best BTK inhibitor overcoming the resistance, but perhaps even more important for the first line, it is very well tolerated and is a very selective drug. Now, if we look at treatment-related adverse events, the discontinuation rate, they were hardly ever seen. If we compared the adverse events in exposure-adjusted incidence, literally all adverse events were two or three times higher in bendamustine-rituximab arm except for the bleeding tendency, which however was predominantly in CTCAE grade 1 and 2 with just 0.7% of grade 3 hemorrhage. Therefore, I think that we should actually put the best and the safest drugs upfront if we may, and pirtobrutinib is, or should be, the first choice if we choose monotherapy. Now, I understand that we are not presenting you the data of pirtobrutinib in combination with anti-CD20 or with BCL2 inhibitors, but that is to come. Dr. Jonathan Friedberg: Matt, how would you envision, were regulatory approval granted and this were an option, using this in the upfront patient population? Is there anybody who you would preferentially use this or start on this treatment? Or would this be something that you would tend to reserve for second line? Dr. Matthew Davids: So I would say that in general for most of my patients who would want to start with a continuous BTK inhibitor, I would still use a covalent BTK inhibitor, and I say that for a couple of reasons despite the very promising data from these studies. The first is that the follow-up for both of these phase 3 trials is still quite short, in the range of a median 18 to 24 months. And we know that CLL is a marathon, not a sprint, and these patients are going to probably be living for a very long time. And we do have much longer follow-up from the covalent BTK inhibitors, median of 10-year follow-up with ibrutinib and five to six years with zanubrutinib and acalabrutinib respectively. And you know, I do not think that the pirtobrutinib is going to fall off a cliff after two years, but on the other hand, I think there is a lot of value to long-term data in this disease, and that is why I think for most of my patients I would stick with covalent BTK inhibitors. But the other important factor that we need to consider is patients who are younger and may have many different CLL treatments over the years. We have to be very careful, I think, about how we sequence these drugs. We know right now that we can start with covalent BTK inhibitors and then subsequently patients will respond well to the non-covalent inhibitor pirtobrutinib in later lines of therapy. But right now we do not have prospective data the other way around. So how will the patients on these studies who progress on pirtobrutinib respond to covalent BTK inhibitors? We do not know yet. There have not been a lot of progression events, which is great, but we would like to see some data in that respect to feel more comfortable with that sequence. Now, I do think that particularly for older patients and those who have significant cardiovascular comorbidities, if they wanted to go on a continuous BTK inhibitor, I do think these data really strongly support using pirtobrutinib as the BTK inhibitor of choice in that population. In particular, the cardiovascular risks with pirtobrutinib seem to be quite low. I was very struck in the comparison with BR that the rate of AFib was equivalent between the two arms of the study. And that is really the first time we have seen that with any of these BTK inhibitors, no elevated risk of AFib in a randomized study. I think that is the population where it will get the most traction first, is the upfront, sort of older patient with significant cardiovascular comorbidities. And as the data from these studies mature, I think that we will start to see more widespread use of pirtobrutinib in the frontline setting. Dr. Jonathan Friedberg: Jennifer, I am just curious if you have any personal experience or heard anecdotally about after progression on pirtobrutinib the use of other BTK inhibitors and whether there is a growing experience there. Dr. Jennifer Woyach: I do not think that there is much clinical experience, you know, as Matt alluded to, it certainly has not been tested yet. There has been some data in relapsed CLL suggesting that in people who have resistance mutations to covalent BTK inhibitors after treatment with pirtobrutinib, sometimes those mutations go away. I think most of us are concerned that they are probably not actually gone but maybe in compartments that we just have not sampled, suggesting that sort of approach where you might sequence a covalent inhibitor after a non-covalent in somebody who had already been resistant probably would not work that well. But, you know, in this setting where people had never been exposed to a covalent BTK inhibitor before, we really have no idea what the resistance patterns are going to be like. We assume they will be the same as what we have seen in relapsed CLL, but I think we just need some longer follow-up to know for sure. Dr. Wojciech Jurczak: If I may confront Dr. Davids about the use of covalent BTK inhibitors upfront, well, I think that we should abandon the idea of using the first and the second and the third generation, at least if we don't have medical lines. If we endlessly block the same pathway, it is not going to be effective. So if pirtobrutinib gets approval in first, second line, we do not necessarily have to use it in the first line. I am not here in a position to defend that we should treat patients with pirtobrutinib upfront and not BCL2 time-limited regimen. However, the way I look at CLL patients when choosing therapy is not just how should I treat them now, but what would be the best regimen in 5, 10 years if I have to re-treat them. And in some instances, the idea may be that in this setting we would like to have a BTK inhibitor upfront to have a BCL2 inhibitor later to make it time-limited. Although I understand and I agree with Matthew that if we have an elderly, fragile population, then the charm of having a drug taken once a day in a tablet with literally few cardiovascular adverse events might be an option. Dr. Jonathan Friedberg: And I will give Matt the last word whether he wants to respond to that, and also just as a forward-looking issue, I know both investigators have implied that there will be future studies looking at combinations with pirtobrutinib, and if you have any sense as to what you would be looking for there. Dr. Matthew Davids: The field really is heading toward time-limited therapy for most patients, I would say. There is a bit of a discrepancy right now in the field between sort of what we are doing in academic practice and what is done sort of more widely in community practice. And so right now we are going to see evolving datasets comparing these approaches. We are already seeing data now from the CLL17 study with ibrutinib comparing continuous to time-limited venetoclax-based therapy, and we are seeing similar efficacy benefits from these time-limited therapies without the need for continuous treatment. And so that is where I think some of the future studies with pirtobrutinib combining it with venetoclax and other partners are so important. Fortunately, several of these studies are already ongoing, including a phase 3 trial called CLL18, which is looking at pirtobrutinib with venetoclax, comparing that to venetoclax and obinutuzumab. So I am optimistic that we are going to be developing these very robust datasets where we can actually use pirtobrutinib in the frontline setting as a time-limited therapy as a component of a multi-drug regimen. So far, those early data are very promising. Dr. Wojciech Jurczak: Perhaps last but not least, in a single center we have treated over 300 patients with pirtobrutinib. So eventually some of them relapsed. And I must say that our experience on BCL2 inhibitors, not just venetoclax but including sonrotoclax, are appealingly good. Therefore, by using pirtobrutinib even earlier, we do not block the efficacy of other compounds. Dr. Jonathan Friedberg: All right. Well, I want to thank all of our speakers. I also want to congratulate our two guests who presented these very influential papers at the ASH Annual Meeting, and chose to publish them in JCO, so we thank you for that, and Dr. Davids for your commentary - really appreciated. That is this episode of JCO After Hours. Thank you for your attention. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Disclosures Dr. Wojciech Jurczak Consulting or Advisory Role: BeiGene, Lilly, Abbvie/Genentech, Takeda, Roche, AstraZeneca Research Funding: Roche, Takeda, Janssen-Cilag, BeiGene, AstraZeneca, Lilly, Abbvie/Genentech Dr. Jennifer Woyach Consulting or Advisory Role: Pharmacyclics, Janssen, AstraZeneca, Beigene, Loxo, Newave Pharmaceutical, Genentech, Abbvie, Merck Research Funding: Company name: Janssen, Schrodinger, beone, Abbvie, Merck, Loxo/Lilly Dr. Matthew Davids Honoraria: Curio Science, Aptitude Health, Bio Ascend, PlatformQ Health, Plexus Consulting or Advisory Role: Genentech, Janssen, Abbvie, AstraZeneca, Adaptive Biotechnologies, Ascentage Pharma, BeiGene, Lilly, Bristol-Myers Squibb, Genmab, Merck, MEI Pharma, Nuvalent, Inc., Galapagos NV, Schroedinger Research Funding: Ascentage Pharma, Novartis, MEI Pharma, AstraZeneca  

Dr. Monty Pal and Dr. Jason Westin discuss the federal funding climate for cancer research and the persistent problem of drug shortages, two of the major concerns facing the oncology community in 2026. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I am your host, Dr. Monty Pal. I am a medical oncologist and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. There are always multiple challenges facing oncologists, and today, we discuss two of them that really stand out for 2026: threats to federal funding for cancer research and the persistent problem of drug shortages. I am thrilled to welcome Dr. Jason Westin, who believes that one way to meet these challenges is to get oncologists more involved in advocacy, and he will share some strategies to help us meet this moment in oncology. Dr. Westin is a professor in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, but he actually wears a lot of hats within ASCO. He is a member of the Board of Directors and has also previously served as chair of ASCO's Government Relations Committee. And he is also one of the inaugural members of ASCO's Political Action Committee, or PAC. He has testified before Congress about drug shortages and many other issues. Dr. Westin, I am really excited to have you on the podcast today and dive into some of these elements that will really impact our community in 2026. Thanks so much for joining us today. Dr. Jason Westin: Thank you for having me. Dr. Monty Pal: You've had such a range of experience. I already alluded to you testifying before Congress. You've actually run for office before. You wear so many different hats. I'm used to checking my PubMed every other day and seeing a new paper out from you and your group, and you publish in the New England Journal [of Medicine] on practice-setting standards and the diseases that you treat. But you've also done all this work in the domain of advocacy. I can't imagine that balancing that is easy. What has sort of motivated you on the advocacy front? Dr. Jason Westin: Advocacy to me is another way to apply our skills and help more people than just those that you're sitting across from at the time. Clinical research, of course, is a tool to try and take what we know and apply it more broadly to people that you'll never meet. And advocacy, I think, can do the same thing, where you can have a conversation with a lawmaker, you can advocate for a position, and that hopefully will help thousands or maybe even more people down the road who you'd never get to directly interact with. And so, I think it's a force multiplier in the same way that research can be. And so, I think advocacy is a wonderful part of how doctors care for our patients. And it's something that is often difficult to know where to start, but once people get into advocacy, they can see that the power, the rewarding nature of it is attractive, and most people, once they get going, continue with that through the rest of their career. Dr. Monty Pal: So, I'll ask you to expand on that a little bit. We have a lot of our younger ASCO members listening to this podcast, folks that are just starting out their careers in clinical practice or academia. Where does that journey begin? How do you get to the point that you're testifying in front of Congress and taking on these bigger sort of stances for the oncology community? Dr. Jason Westin: Yeah, with anything in medicine and in our careers, you have to start somewhere. And often you start with baby steps before you get in front of a panel of senators or other high-profile engagement opportunities. But often the first setting for junior colleagues to be engaged is doing things – we call them "Hill Days" – but basically being involved in kind of low-stakes meetings where you're with a group of peers, some of whom have done this multiple times before, and can get engaged talking to members of representatives' offices, and doing so in a way where it's a natural conversation that you're telling a story about a patient in your clinic, or that you're telling a personal experience from a policy that impacted your ability to deliver optimal care. It sounds stressful, but once you're doing it, it's not stressful. It's actually kind of fun. And it's a way that you can get comfort and skill with a group of peers who are there and able to help you. And ASCO has a number of ways to do that, both at the federal level, there's the Hill Day where we each April have several hundred ASCO members travel to Capitol Hill. There's also state engagement that can be done, so-called visiting at home, when representatives from the U.S. Congress or from state legislators are back in district. You can meet with your own representatives on behalf of yourself, on behalf of your organization, and advocate for policies in a way that can be beneficial to your patients. But those initial meetings that are in the office often they're low stakes because you could be meeting not with the representative but with their staff. And that staff sometimes is as young or even younger than our junior colleagues. These sometimes can be people in their 20s, but they're often extremely knowledgeable, extremely approachable, and are used to dealing with people who are new to advocacy. But they actually help make decisions within the office. So it's not a waste of time. It's actually a super useful way to engage. So, it's that first step of anything in life. The activation energy is always high to do something new. But I'd encourage people who are listening to this podcast already having some level of interest about it to explore ways that they could engage more. Dr. Monty Pal: You know, I have to tell you, I'm going to riff on what you just said for a second. ASCO couldn't make it any easier, I think, for folks to participate and get involved. So, if you're listening to this and scratching your head and thinking, "Well, where do I begin? How do I actually sign on for that meeting with a local representative?" Go to the ASCO ACT Network website. And I'll actually talk to our producer, Geraldine, to make sure we've got a link to that somewhere associated with this podcast after it's published, Jason, but I actually keep that on my browser and it's super easy. I check in there every now and then and see if there's any new policy or legislation that ASCO, you know, is sort of taking a stance on, and it gives me some fodder for conversation with my local representatives too. I mean, it's just an awesome, awesome vehicle. I'm going to segue right from there right to the issues. So, you and I are both at academic centers. You know, I think this is something that really pervades academia and enters into implications for general clinical practice. There's been this, you know, massive sort of proposal for decreased funding to the NCI and to the NIH and so forth. Tell us what ASCO is doing in that regard, and tell us perhaps how our community can help. Dr. Jason Westin: We live in interesting times, and I think that may be an understatement x 100. But obviously investments in research are things that when you're at an academic center, you see and feel that as part of your daily life. Members of Congress need to be reminded of that because there's a lot of other competing interests out there besides investing in the future through research. And being an elected representative is a hard job. That is something where you have to make difficult choices to support this, and that may mean not supporting that. And there's lots of good things where our tax dollars could be spent. And so, I'm sympathetic to the idea that there's not unlimited resources. However, ASCO has done an excellent job, and ASCO members have led the charge on this, of stating what research does, what is the benefit of research, and therefore why should this matter to elected representatives, to their staff, and to those people that they're elected to serve. And ASCO has led with a targeted campaign to basically have that message be conveyed at every opportunity to elected representatives. And each year on Hill Day, one of the asks that we have is to continue to support research: the NCI, NIH, ARPA-H, these are things that are always in the asks to make sure that there's appropriate funding. But effectively playing offense by saying, "It's not just a number on a sheet of paper, this is what it means to patients. This is what it means to potentially your loved ones in the future if you are in the opposite situation where you're not on the legislative side, but you're in the office receiving a diagnosis or receiving a difficult piece of news." We only have the tools we have now because of research, and each breakthrough has been years in the making and countless hours spent funded through the engine of innovation: clinical research and translational research. And so ASCO continues to beat that drum. You mentioned earlier the ACT Network. Just to bring that back again is a very useful, very easy tool to communicate to your elected representatives. When you sign up on the ASCO ACT website, you get emails periodically, not too much, but periodically get emails of, "This is a way you can engage with your lawmakers to speak up for this." And as you said, Monty, they make it as easy as possible. You click the button, you type in your address so that it figures out who your elected representatives are, and then it will send a letter on your behalf after like five clicks to say, "I want you to support research. I want you to vote for this particular thing which is of interest to ASCO and by definition to members of ASCO." And so the ACT Network is a way that people listening can engage without having to spend hours and significant time, but just a few clicks can send that letter to a representative in Congress. And the question could be: does that matter? Does contacting your senator or your elected representative do anything? If all they're hearing is somebody else making a different argument and they're hearing over and over again from people that want investments in AI or investments in something else besides cancer research, whatever it is, they may think that there's a ground shift that people want dollars to be spent over here as opposed to at the NIH or NCI or in federally funded research. It is important to continue to express the need for federal funding for our research. And so, it really is important for folks to engage. Dr. Monty Pal: 100%. One of the things that I think is not often obvious to a lot of our listeners is where the support for clinical trials comes from. You know, you've obviously run the whole gamut of studies as have I. You know, we have our pharmaceutical company-sponsored studies, which are in a particular bucket. But I would say that there's a very important and critical subset of studies that are actually government funded, right? NCI-funded clinical trials. If you don't mind, just explain to our audience the critical nature of the work that's being done in those types of studies and if you can, maybe compare and contrast the studies that are done in that bucket versus perhaps the pharmaceutical bucket. Dr. Jason Westin: Both are critical, and we're privileged that we have pharma studies that are sponsored and federally funded clinical research. And I think that part of a healthy ecosystem for us to develop new breakthroughs has a need for both. The pharma sponsored studies are done through the lens of trying to get an approval for an agent that's of interest so that the pharma company can then turn around and use that outside of a clinical trial after an FDA approval. And so those studies are often done through the lens of getting over the finish line by showing some superiority over an existing treatment or in a new patient population. But they're done through that lens of kind of the broadest population and sometimes relatively narrow endpoints, but to get the approval so that then the drug can be widely utilized. Clinical trials done through cooperative groups are sometimes done to try and optimize that or to try and look at comparative things that may not be as attractive to pharma studies, not necessarily going for that initial approval, but the fine tuning or the looking at health outcomes or looking at ensuring that we do studies in representative populations that may not be as well identified on the pharma sponsored trials, but basically filling out the gaps in the knowledge that we didn't gain from the initial phase 3 trial that led to the approval. And so both are critical. But if we only do pharma sponsored trials, if we don't fund federally supported research and that dries up, the fear I have, and many others have, is that we're going to be lacking a lot of knowledge about the best ways to use these great new therapies, these new immune therapies, or in my team, we do a lot of clinical trials on CAR T-cell therapies. If we don't have federally funded research to do the important clinical studies, we'll be in the dark about the best ways to use these drugs, and that's going to be a terrible shame. And so we really do need to continue to support federal research. Dr. Monty Pal: Yeah, there are no softball questions on this podcast, but I think everybody would be hard pressed to think that you and I would come on here and say, "Well, no, we don't need as much money for clinical trials and NCI funding" and so forth. But I think a really challenging issue to tackle, and this is something we thought to ask you ahead of the podcast, is what to do about the general climate of, you know, whether it's academic research or clinical practice here that seems to be getting some of our colleagues thinking about moving elsewhere. I've actually talked to a couple of folks who are picking up and moving to Europe for a variety of considerations, other continents, frankly. The U.S. has always been a leader when it comes to oncology research and, one might argue, research in general. Some have the mindset these days that we're losing that footing a little bit. What's your perspective? Are you concerned about some of the trends that you're seeing? What does your crystal ball tell you? Dr. Jason Westin: I am highly concerned about this. I think as you said, the U.S. has been a leader for a long time, but it wasn't always. This is not something that's preordained that the world-leading clinical research and translational research will always be done in the United States. That is something that has been developed as an ecosystem, as an engine for innovation and for job development, new technology development, since World War II. That's something that through intentional investments in research was developed that the best and brightest around the world, if they could choose to go anywhere, you wanted them to come to work at universities and academic places within the United States. And I think, as you said, that's at risk if you begin to dry up the investment in research or if you begin to have less focus on being engaged in research in a way that is forward thinking, not just kind of maintaining what we do now or only looking at having private, for profit sponsored research. But if you don't have the investment in the basic science research and the translational research and the forward-thinking part of it, the fear is that we lose the advantage and that other countries will say, "Thank you very much," and be happy to invest in ways to their advantage. And I think as you mentioned, there are people that are beginning to look elsewhere. I don't think that it's likely that a significant population of researchers in the U.S. who are established and have careers and families – I don't think that we're going to see a mass exodus of folks. I think the real risk to me is that the younger, up-and-coming people in undergraduate or in graduate school or in medical school and are the future superstars, that they could either choose to go into a different field, so they decide not to go into what could be the latest breakthroughs for cancer patients but could be doing something in AI or something in a different field that could be attractive to them because of less uncertainty about funding streams, or they could take that job offer if it's in a different country. And I think that's the concern is it may not be a 2026 problem, but it could be a 2036 or a 2046 problem that we reap what we sow if we don't invest in the future. Dr. Monty Pal: Indeed, indeed. You know, I've had the pleasure of reviewing abstracts for some of our big international meetings, as I'm sure you've done in the past too. I see this trend where, as before, we would see the preponderance of large phase 3 clinical trials and practice setting studies being done here in the U.S., I'm seeing this emergence of China, of other countries outside of the U.S. really taking lead on these things. And it certainly concerns me. If I had to sort of gauge this particular issue, it's at the top of my list in terms of what I'm concerned about. But I also wanted to ask you, Jason, in terms of the issues that are looming over oncology from an advocacy perspective, what else really sort of keeps you up at night? Dr. Jason Westin: I'm quite concerned about the drug shortages. I think that's something that is a surprisingly evergreen problem. This is something that is on its face illogical that we're talking about the greatest engine for research in the world being the United States and the investment that we've made in drug development and the breakthroughs that have happened for patients all around the world, many of them happen in the United States, and yet we don't necessarily have access to drugs from the 1970s or 1980s that are cheap, generic, sterile, injectable drugs. This is the cisplatins and the vincristines and the fludarabine type medications which are not the sexy ones that you see the ads in the magazine or on TV at night. These are the backbone drugs for many of our curative intent regimens for pediatrics and for heme malignancies and many solid tumors. And the fact that that's continuing to be an issue is, in my opinion, a failure to address the root causes, and those are going to require legislative solutions. The root causes here are basically a race to the bottom where the economics to invest in quality manufacturing really haven't been prioritized. And so it's a race to the cheapest price, which often means you undercut your competitor, and when you don't have the money to invest in good manufacturing processes, the factory breaks down, there's no alternative, you go into shortage. And this has been going on for a couple of decades, and I don't think there's an end in sight until we get a serious solution proposed by our elected officials. That is something that bothers me in the ways where we know what we should be doing for our patients, but if we don't have the drugs, we're left to be creative in ways we shouldn't have to do to figure out a plan B when we've got curative intent therapies. And I think that's a real shame.  There's obviously a lot of other things that are concerning related to oncology, but something that I have personally had experience with when I wanted to give a patient a CAR T-cell, and we don't have a supply of fludarabine, which is a trivial drug from decades ago in terms of the technology investments in genetically modified T-cells, to not then have access to a drug that should be pennies on the dollar and available at any time you want it is almost like the Air Force investing in building the latest stealth bomber, but then forgetting to get the jet fuel in a way that they can't use it because they don't have the tools that they need. And so I think that's something that we do need to have comprehensive solutions from our elected officials. Dr. Monty Pal: Brilliantly stated. I like that analogy a lot. Let's get into the weeds for a second. What would that proposal to Congress look like? What are we trying to put in front of them to help alleviate the drug shortages? Dr. Jason Westin: We could spend a couple hours, and I know podcasts usually are not set up to do that. And so I won't go through every part. I will direct you that there have been a couple of recent publications from ASCO specifically detailing solutions, and there was a recent white paper from the Senate Finance Committee that went through some legislative solutions being explored. So Dr. Gralow, ASCO CMO, and I recently had a publication in JCO OP detailing some solutions, more in that white paper from the Senate Finance. And then there's a working group actually going through ASCO's Health Policy Committee putting together a more detailed proposal that will be published probably around the end of 2026. Very briefly, what needs to happen is for government contracts for purchasing these drugs, there needs to be an outlay for quality, meaning that if you have a manufacturing facility that is able to deliver product on time, reliably, you get a bonus in terms of your contract. And that changes the model to prioritize the quality component of manufacturing. Without that, there's no reason to invest in maintaining your machine or upgrading the technology you have in your manufacturing plant. And so you have bottlenecks emerge because these drugs are cheap, and there's not a profit margin. So you get one factory that makes this key drug, and if that factory hasn't had an upgrade in their machines in 20 years, and that machine conks out and it takes 6 months to repair or replacement, that is an opportunity for that drug to go into shortage and causes a mad dash for big hospitals to purchase the drug that's available, leaving disparities to get amplified. It's a nightmare when those things happen, and they happen all the time. There are usually dozens, if not hundreds, of drugs in shortage at any given time. And this has been going on for decades. This is something that we do need large, system-wide fixes and that investment in quality, I think, will be a key part. Dr. Monty Pal: Yeah, brilliantly said. And I'll make sure that we actually include those articles on the tagline for this podcast as well. I'll talk to our producer about that as well.  I'm really glad you mentioned the time in your last comment there because I felt like we just started, but in fact, I think we're right at our close here, Jason, unfortunately. So, I could have gone on for a couple more hours with you. I really want to thank you for these absolutely terrific insights and thank you for all your advocacy on behalf of ASCO and oncologists at large. Dr. Jason Westin: Thank you so much for having me. I have enjoyed it. Dr. Monty Pal: Thanks a lot. And many thanks to our listeners too. You can find more information about ASCO's advocacy agenda and activities at asco.org. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Thanks so much. ASCO Advocacy Resources: Get involved in ASCO's Advocacy efforts: ASCO Advocacy Toolkit Crisis of Cancer Drug Shortages: Understanding the Causes and Proposing Sustainable Solutions, JCO Oncology Practice Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:     Dr. Monty Pal   @montypal   Dr. Jason Westin @DrJasonWestin   Follow ASCO on social media:      @ASCO on X     ASCO on Bluesky    ASCO on Facebook      ASCO on LinkedIn      Disclosures:     Dr. Monty Pal:    Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview   Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical   Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis   Dr. Jason Westin: Consulting or Advisory Role: Novartis, Kite/Gilead, Janssen Scientific Affairs, ADC Therapeutics, Bristol-Myers Squibb/Celgene/Juno, AstraZeneca, Genentech/Roche, Abbvie, MorphoSys/Incyte, Seattle Genetics, Abbvie, Chugai Pharma, Regeneron, Nurix, Genmab, Allogene Therapeutics, Lyell Immunopharma Research Funding: Janssen, Novartis, Bristol-Myers Squibb, AstraZeneca, MorphoSys/Incyte, Genentech/Roche, Allogene Therapeutics

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/WDQ865. CME/AAPA credit will be available until November 25, 2026.Fibrosis, Flares, and Forward Thinking in Inflammatory Bowel Disease Care: Unlocking the TL1A Axis In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by educational grants from Genentech, a member of the Roche Group and Merck & Co., Inc., Rahway, NJ, USA.Disclosure information is available at the beginning of the video presentation.

This is one in a series about possible futures, which will be published in Booch News over the coming weeks. Episode 7 appeared last week. New episodes drop every Friday. Overview Peer-to-peer flavor-sharing platforms enabled home brewers to distribute taste profiles as digital files. Blockchain-verified SCOBY genetics allowed anyone to recreate award-winning kombucha flavors. Traditional beverage companies lost control as open-source fermentation recipes spread globally. This episode follows teenage hacker Luna Reyes as she reverse-engineers Heineken’s proprietary “A-yeast” strain and the century-old master strain used for Budweiser, releasing them under Creative Commons license, triggering a flavor renaissance that made corporate beverages taste like cardboard by comparison. Luna Reyes: The Seventeen-Year-Old Who Liberated Flavor Luna Reyes was brewing kombucha in her Oakland garage when she changed the course of human history. The daughter of Mexican immigrants, she had learned fermentation from her grandmother while teaching herself bioinformatics through YouTube tutorials and volunteering at the Counter Culture Labs Maker Space on Shattuck Avenue. By fifteen, she was running the Bay Area’s most sophisticated home laboratory, utilizing jury-rigged DNA sequencers and microscopes constructed from smartphone cameras. Her breakthrough came in February 2043 while investigating why her kombucha never tasted quite like expensive craft varieties and was different again from her grandmother’s home brew. Using Crispr techniques learned from online forums, Luna began reverse-engineering the microbial genetics of premium alcoholic beverages. Her target wasn’t kombucha—it was the closely guarded yeast strains that gave corporate beers their distinctive flavors. Luna hunched over her microscope, examining bacterial cultures from her latest kombucha batch. Around her, salvaged DNA sequencers hummed, fermentation vessels bubbled, and computer screens displayed multi-hued patterns of genetic sequences. Her grandmother, Rosa, entered carrying a tray with three glasses of homemade kombucha. “Mija, you’ve been working for six hours straight. Drink something.” Luna accepted the glass without looking up. “Abuela, your kombucha tastes better than anything I can buy in stores and the ones I’ve experimented with. Why? I’m using the same base ingredients—tea, sugar, water—but mine never has this complexity.” Her grandmother laughed. “Because I’ve been feeding this SCOBY for forty years. It knows what to do. You can’t rush relationships.” Luna’s sister Maya, lounging against a workbench, waved her phone. “Luna, people have noticed your forum post about Health-Ade’s fermentation process. Someone says you’re wasting your time trying to replicate commercial kombuchas.” “I’m not trying to replicate them,” Luna said, finally looking up. “I’m trying to understand why their kombucha tastes different than that I make at home. It’s not the ingredients. It’s not the process. It’s the microbial genetics.” Rosa sat down beside her granddaughter. “When I was young in Oaxaca, every family had their own kombucha culture, passed down generation to generation. Each tasted different because the bacteria adapted to their environment, their ingredients, their care. We had a saying, Hay tantas fermentaciones en el mundo como estrellas en el cielo nocturno – there are as many ferments in the world as stars in the night sky. The big companies want every bottle to be identical. That kills what makes fermentation special.” “Exactly!” Luna pulled up genetic sequences on her screen. “I’ve been reverse-engineering samples from different commercial kombuchas. Health-Ade, GT’s, Brew Dr—they all have consistent microbial profiles.” The Great Heist: Cracking Corporate DNA Luna’s first major hack targeted Heineken’s legendary “A-yeast” strain, developed in 1886 by Dr. Hartog Elion—a student of renowned chemist Louis Pasteur—in the company’s Amsterdam laboratory and protected by over 150 years of trade secret law. Using samples obtained from discarded brewery waste (technically legal under the “garbage doctrine”), she spent six months mapping the strain’s complete genetic sequence in her makeshift lab. The breakthrough required extraordinary ingenuity. Luna couldn’t afford professional gene sequencers, so she modified a broken Illumina iSeq100 purchased on eBay for $200. Her sequencing runs took weeks rather than hours; her results were identical to those produced by million-dollar laboratory equipment. Her detailed laboratory notebooks, later published as The Garage Genomics Manifesto, became essential reading for the biotech hacker movement. The Budweiser project proved even more challenging. Anheuser-Busch’s century-old master strain had been protected by layers of corporate secrecy rivaling classified military programs. The company maintained multiple backup cultures in cryogenic facilities across three continents, never allowing complete genetic mapping by outside researchers. Luna’s success required infiltrating the company’s waste-disposal systems at four breweries, collecting samples over 18 months while evading corporate security. The Decision The night before Luna was scheduled to meet her fellow bio-hackers at Oakland’s Counter Culture Labs, she sat at her workstation, hesitant, wondering if she was doing the right thing. Her sister Maya came in, looking worried. “Luna, I found something you need to see,” she says. “Remember Marcus Park? He tried releasing proprietary yeast information in 2039. Heineken buried him. He lost everything. His daughter dropped out of college. His wife left him. He’s working at a gas station now.” Luna spent the night researching what happened to Park. She found that almost everyone who challenged corporate IP ended up on the losing side of the law. It was not pretty. In the morning, Abuela Rosa finds her crying in her room. “Mija, what’s wrong?” she asks. “Oh, Abuela,” Luna says between sobs. “What am I doing? What if I’m wrong? What if I destroy our family? What if this ruins Mom and Dad? What if I’m just being selfish?” “That’s the fear talking.” Her grandmother reassured her. “Fear is wisdom warning you to be careful. But fear can also be a cage.” That evening at the Counter Culture Labs, Luna assembled a small group of advisors. She needed their guidance. She had the completed genetic sequences for Heineken A-yeast and Budweiser’s master strain on her laptop, ready for release. But is this the time and place to release them to the world? Dr. Marcus Webb, a bioinformatics researcher in his forties and Luna’s mentor, examined her sequencing data. “This is solid work, Luna. Your jury-rigged equipment is crude. The results are accurate. You’ve fully mapped both strains.” “The question isn’t whether I can do it,” Luna said. “It’s whether I should let the world know I did it.” On screen, Cory Doctorow, the author and digital rights activist, leaned forward. “Let’s be clear about what you’re proposing. You’d be releasing genetic information that corporations have protected as trade secrets for over a century. They’ll argue you stole their intellectual property. You’ll face lawsuits, possibly criminal charges.” “Is it their property?” Luna challenged. “These are naturally occurring organisms. They didn’t create that yeast. Evolution did. They just happened to be there when it appeared. That does not make it theirs any more than finding a wildflower means they own the species. Can you really own something that existed before you found it?” Doctorow, the Electronic Frontier Foundation representative spoke up. “There’s legal precedent both ways. Diamond v. Chakrabarty established that genetically modified organisms can be patented. But naturally occurring genetic sequences? That’s murky. The companies will argue that their decades of cultivation and protection created protectable trade secrets.” “Trade secrets require keeping information secret,” Luna argued. “They throw this yeast away constantly. If they’re not protecting it, how can they claim trade secret status?” Dr. Webb cautioned, “Luna, even if you’re legally in the right—which is debatable—you’re seventeen years old. You’ll be fighting multinational corporations with unlimited legal resources. They’ll bury you in litigation for years.” “That’s where we come in,” Doctorow said. “The EFF can provide legal defense. Creative Commons can help structure the license. You need to understand: this will consume your life. College, career plans, normal teenage experiences—all on hold while you fight this battle.” Luna was quiet for a moment, then pulled up a photo on her laptop: her grandmother Rosa, teaching her to ferment at age seven. “My abuela says fermentation is about sharing and passing living cultures between generations. Corporations have turned it into intellectual property to be protected and controlled. If I can break that control—even a little—isn’t that worth fighting for?” Maya spoke up from the back. “Luna, I love you, but you’re being naive. They won’t just sue you. They’ll make an example of you. Your face on every news channel, portrayed as a thief, a criminal. Our family harassed. Your future destroyed. For what? So people can brew beer with the same yeast as Heineken?” “Not just beer,” Luna responded passionately. “This is about whether living organisms can be owned. Whether genetic information—the code of life itself—can be locked behind intellectual property law. Yes, it starts with beer yeast. But what about beneficial bacteria? Life-saving microorganisms? Medicine-producing fungi? Where does it end?” Dr. Webb nodded slowly. “She’s right. This is bigger than beer. As biotech advances, genetic control becomes power over life itself. Do we want corporations owning that?” Doctorow sighed. “If you do this, Luna, do it right. Release everything simultaneously—BitTorrent, WikiLeaks, Creative Commons servers, distributed networks worldwide. Make it impossible to contain. Include complete cultivation protocols so anyone can reproduce your results. Make the data so damn widely available that suppressing it becomes futile.” “And write a manifesto,” he added. “Explain why you’re doing this. Frame the issue. Make it about principles, not piracy.” Luna nodded, fingers already typing. “When should I release?” “Pick a date with symbolic meaning,” Dr. Webb suggested. “Make it an event, not just a data dump.” Luna smiled. “December 15. The Bill of Rights Day. Appropriate for declaring biological rights, don’t you think?” Maya groaned. “You’re really doing this, aren’t you?” “Yes. I’m really doing this.” The Creative Commons Liberation On Tuesday, December 15, 2043—a date now celebrated as “Open Flavor Day”—Luna released the genetic sequences on multiple open-source networks. Her manifesto, titled Your Grandmother’s Yeast Is Your Birthright, argued that microbial genetics belonged to humanity’s shared heritage rather than corporate shareholders. It stated: Commercial companies have protected yeast strains for over a century. They’ve used intellectual property law to control flavor itself. But genetic information isn’t like a recipe or a formula—it’s biological code that evolved over millions of years before humans ever cultivated it. These strains are protected as trade secrets—the bacteria don’t belong to anyone. They existed before Heineken, before Budweiser, before trademark law. The companies just happened to isolate and cultivate them. Her data packages included DNA sequences and complete protocols for cultivating, modifying, and improving the strains. Luna’s releases came with user-friendly software that allowed amateur brewers to simulate genetic modifications before attempting them in real fermentations. Within 24 hours, over ten thousand people worldwide downloaded the files. The Creative Commons community erupted in celebration. Cory Doctorow’s blog post, The Teenager Who Stole Christmas (From Corporate Beer), went viral within hours. The Electronic Frontier Foundation immediately offered Luna legal protection, while the Free Software Foundation created the “Luna Defense Fund” to support her anticipated legal battles. The Legal Assault Heineken’s response was swift. The company filed emergency injunctions in 12 countries simultaneously, seeking to prevent the distribution of its “stolen intellectual property.” Their legal team, led by former U.S. Attorney General William Barr III, demanded Luna’s immediate arrest for “economic terrorism” and “theft of trade secrets valued at over $50 billion.” Anheuser-Busch’s reaction was even more extreme. CEO Marcel Telles IV appeared on CNBC, calling Luna “a bioterrorist who threatens the foundation of American capitalism.” The company hired private investigators to surveil Luna’s family and offered a $10 million reward for information leading to her prosecution. Their legal filing compared Luna’s actions to “stealing the formula for Coca-Cola and publishing it in the New York Times.” In Heineken’s Amsterdam headquarters, executives convened an emergency meeting. “Who is Luna Reyes?” the CEO demanded. The legal counsel pulled up information. “She’s a seventeen-year-old high school student in Oakland, California. No criminal record. Volunteers at a maker space. Has been posting about fermentation on various forums for years.” “A child released our proprietary yeast strain to the world, and we didn’t know she was even working on this?” The CEO’s face reddened. “How do we contain it?” “We can’t. It’s distributed across thousands of servers in dozens of countries with different IP laws. We can sue Reyes, but the information is out there permanently.” An executive interjected, “What about the other breweries? Will they join our lawsuit?” “Some are considering it. Others…” The counsel paused. “Others are quietly downloading the sequences themselves. They see an opportunity to break our market dominance.” “She obtained samples from our waste disposal,” another executive explained. “Technically legal under the garbage doctrine. The sequencing itself isn’t illegal. The release under Creative Commons…” “Is theft!” the CEO shouted. “File emergency injunctions. Twelve countries. Get her arrested for economic terrorism.” Similar scenes played out at Anheuser-Busch headquarters in St. Louis. CEO Telles addressed his team: “This is bioterrorism. She’s destroyed intellectual property worth billions. I want her prosecuted to the fullest extent of the law. Hire private investigators. Find everything about her and her family. Make her life hell!” By noon, both companies had filed lawsuits. By evening, Fox News was running stories about the “teenage bioterrorist” who “stole American corporate secrets.” Back in Oakland, Luna’s phone rang constantly. Her parents discovered what she’d done. Her mother cried. Her father was furious and terrified. Friends called with either congratulations or warnings. She was convinced that private investigators were photographing their house. Maya suspected she was followed to work. On Wednesday morning, Dr. Webb calls: “Luna, they’re offering me $2 million to testify against you. They’re going after everyone in your network.” Luna has a sickening feeling that she’s put everyone at risk. By Thursday, she is considering taking it all back somehow, sending an apology to the corporations, anything to protect her family. Luna turned off her phone and sat with her grandmother. “It’s started,” Luna said quietly. “Sí, mija. You’ve declared war. Now we see if you can survive it.” Maya burst in, laptop in hand. “Luna, you need to see this. The downloads aren’t slowing—they’re accelerating. Every time Heineken or Budweiser shuts down a website, ten mirror sites appear. People are treating this like a digital freedom fight. You’ve become a symbol.” Luna pulled up her own screen. The #FreeLuna hashtag was trending. Crowdfunding campaigns for her legal defense had raised $400,000 in twelve hours. Academic institutions were publicly endorsing her release, calling it “essential scientific information.” “They’re trying to destroy you,” Maya said, “but they’re making you famous instead.” Rosa handed Luna a fresh kombucha. “This is what happens when you fight for what’s right, mija. Sometimes the world surprises you by supporting you.” Luna’s Fame The corporations’ attempts to suppress Luna’s releases had the opposite effect. Every cease-and-desist letter generated thousands of new downloads. The genetic data became impossible to contain once the academic community embraced Luna’s work. Dr. Jennifer Doudna, the legendary Crispr pioneer now in her eighties, publicly endorsed Luna’s releases in a Science magazine editorial: Ms. Reyes has liberated essential scientific information that corporations held hostage for commercial gain. Genetic sequences from naturally occurring organisms should not be locked behind intellectual property law. They belong to humanity’s knowledge commons. While corporations claim Luna stole trade secrets, I argue she freed biological knowledge that was never theirs to own. There are no trade secrets in biology—only knowledge temporarily hidden from the commons. This is civil disobedience of the highest order—breaking unjust laws to advance human freedom. Ms. Reyes didn’t steal; she liberated. MIT’s biology department invited Luna to lecture, while Harvard offered her a full scholarship despite her lack of a high school diploma. The legal battles consumed corporate resources while generating negative publicity. Heineken’s stock price dropped 34% as consumers organized boycotts in support of Luna’s “yeast liberation.” Beer sales plummeted as customers waited for home-brewed alternatives using Luna’s open-source genetics. The Flavor Renaissance Luna’s releases triggered an explosion of creativity that corporate R&D departments had never imagined. Within six months, amateur brewers worldwide were producing thousands of flavor variations impossible under corporate constraints. The open-source model enabled rapid iteration and global collaboration, rendering traditional brewing companies obsolete. The world was engaged. In some of the most unlikely places. In Evanston, Illinois, a group of former seminary students who discovered fermentation during a silent retreat, transformed Gregorian chants into microbial devotionals. Tenor Marcus Webb (Dr. Webb’s nephew) realized symbiosis mirrored vocal harmony—multiple voices creating something greater than their parts. “In honoring the mystery of fermentation we express our love of the Creator,” he said. Here's ‘Consortium Vocalis' honoring the mother SCOBY. [Chorus]Our SCOBYIs pureOur SCOBYIs strongOur SCOBYKnows no boundariesOur SCOBYStrengthens as it fermentsOur SCOBYIs bacteria and yeast Our SCOBYTurns sucrose into glucose and fructoseIt ferments these simple sugars into ethanol and carbon dioxide,Acetic acid bacteria oxidize much of that ethanol into organic acidsSuch as acetic, gluconic, and other acids.This steadily lowers the pHMaking the tea taste sour-tangy instead of purely sweet. [Chorus] Our SCOBYThen helps microbes produce acids, enzymes, and small amounts of B‑vitaminsWhile probiotics grow in the liquid.The pH falls to help inhibit unwanted microbesOur SCOBY creates a self-preserving, acidic environment in the tea [Chorus] In Kingston, Jamaica, Rastafarian’s combined an award-winning kombucha sequenced in Humboldt County, California, with locally grown ganja into a sacramental beverage to help open their mind to reasoning and focus on Jah. Once fermented, it was consumed over the course of a three-day Nyabinghi ceremony. “Luna Reyes is truly blessed. She strengthened our unity as a people, and our Rastafari’ booch help us chant down Babylon,” a Rasta man smiled, blowing smoke from a spliff the size of his arm. The Groundation Collective’s reggae anthem ‘Oh Luna’ joyfully celebrated Luna Reyes’ pioneering discovery. Oh Luna, Oh Luna, Oh Luna ReyesI love the sound of your nameYou so deserve your fame Luna, Luna, Oh Luna ReyesShining brightYou warm my heart Luna, Luna, Oh Luna ReyesYou cracked the codeTeenage prophet, fermentation queenSymbiosis roadA genius at seventeen Oh Luna, Luna, Luna ReyesBeautiful moonMakes me swoon Oh Luna, Luna, Luna ReyesFreedom to fermentYou are heaven sentTo save us Luna, Luna, Oh Luna ReyesYou opened the doorTo so much moreKombucha tastes so goodLike it should Oh Luna, Oh Luna, Oh LunaI love you, love you, love youOh Luna, Luna, LunaLove you, love you,Love Luna, Luna love. In São Paulo, Brazil, MAPA-certified Brazilian kombucha brands combined Heineken and cacao-fermenting yeasts with cupuaçu from indigenous Amazonian peoples, to create the chocolate-flavored ‘booch that won Gold at the 20th World Kombucha Awards. A cervejeiro explained to reporters: “Luna Reyes gave us the foundation. We added local innovation. This is what happens when you democratize biology.” The Brazilian singer Dandara Sereia covered ‘Our Fermented Future’—The Hollow Pines tune destined to become a hit at the 2053 Washington DC Fermentation Festival. Baby sit a little closer, sip some ‘booch with meI brewed this batch with the SCOBY my grandma gave to me.On the back porch swing at twilight, watching fireflies danceYour hand in mine, kombucha fine, the sweetest sweet romance. They say that wine and roses are the way to win the heartBut your kombucha warmed me right up from the start.Fermentation makes the heart grow fonder, truer words they ain’t been saidYour SCOBY’s got a place forever — in my heart, and in my bed. Let’s share our SCOBYs, baby, merge our ferments into oneLike cultures in a crock jar dancing, underneath the sun.The tang of your Lactobacillus is exactly what I’m missingYour Brettanomyces bacteria got this country girl reminiscing. Oh yeah, let’s share those SCOBYs, baby, merge our ferments into oneYour yeasts and my bacteria working till the magic’s doneYou’ve got the acetic acid honey, I’ve got the patience and the timeLet’s bubble up together, let our cultures intertwine. I’ve got that symbiotic feeling, something wild and something trueYour SCOBY’s in my heart, right there next to youThe way your Acetobacter turns sugar into goldIs how you turned my lonely life into a hand to hold. We’ve got the acetic acid and the glucuronic tooWe’ve got that symbiotic feeling, so righteous and so trueOne sip of your sweet ‘booch, Lord, and you had me from the start,It’s our fermented future, that no-one can tear apart. It’s our fermented future…It’s our fermented future…It’s our fermented future… “Luna Variants”—strains derived from her releases—began winning international brewing competitions, embarrassing corporate entries with their complexity and innovation. Traditional beer flavors seemed flat and artificial compared to the genetic symphonies created by collaborative open-source development. Despite the outpouring of positive vibes, the corporations spared no expense to hold Luna to account in the courts. The Preliminary Hearing A preliminary hearing was held in the United States District Court for the Northern District of California on June 14, 2044. Luna sat at the defendant’s table, her hands folded so tightly her knuckles had gone white. She wore a borrowed blazer—too big in the shoulders—over a white button-down shirt Maya had ironed that morning. At seventeen, she looked even younger under the courtroom’s fluorescent lights. Across the aisle, Heineken’s legal team occupied three tables. Fifteen attorneys in matching navy suits shuffled documents and whispered into phones. Their lead counsel, William Barr III, wore gold cufflinks that caught the light when he gestured. Luna recognized him from the news—the former Attorney General, now commanding $2,000 an hour to destroy people like her. Her own legal representation consisted of two people: Rose Kennerson from the Electronic Frontier Foundation, a public interest lawyer who’d flown in from DC on a red-eye, and Dr. Marcus Webb, technically a witness but sitting beside Luna because she’d asked him to. Behind them, the gallery was packed. Luna’s parents sat in the second row, her father’s face gray, her mother clutching a rosary. Maya had taken the day off work. Abuela Rosa sat in the front row directly behind Luna, her ancient SCOBY wrapped in silk in her lap, as if its presence might protect her granddaughter. Judge Catherine Ironwood entered—sixty-ish, steel-gray hair pulled back severely, known for pro-corporate rulings. She’d been a pharmaceutical industry lawyer for twenty years before her appointment. “All rise,” the bailiff called. Judge Ironwood settled into her chair and surveyed the courtroom with the expression of someone who’d already decided the outcome and resented having to perform the formalities. “We’re here for a preliminary injunction hearing in Heineken International B.V. versus Luna Marie Reyes.” She looked directly at Luna. “Ms. Reyes, you’re seventeen years old?” Luna stood, hesitant. “Yes, your honor.” “Where are your parents?” “Here, your honor.” Luna’s mother half-rose, then sat back down. “Ms. Kennerson, your client is a minor. Are the parents aware they could be held liable for damages?” Rose Kennerson stood smoothly. “Yes, your honor. The Reyes family has been fully advised of the legal implications.” Luna glanced back. Her father’s jaw was clenched so tight she could see the muscles working. He wouldn’t meet her eyes. “Very well. Mr. Barr, you may proceed.” Barr rose like a battleship emerging from fog—massive, expensive, inevitable. He buttoned his suit jacket and approached the bench without notes. “Your honor, this is the simplest case I’ve argued in thirty years. The defendant admits to obtaining my client’s proprietary biological materials. She admits to sequencing their genetic information. She admits to distributing that information globally, in deliberate violation of trade secret protections that have existed for over 150 years. She did this knowingly, systematically, and with the explicit intent to destroy my client’s competitive advantage.” Luna felt Sarah’s hand on her arm—stay calm. Barr continued. “Heineken International has invested over $200 million in the development, cultivation, and protection of the A-yeast strain. Then this teenager”—he pointed at Luna—”obtained samples from our waste disposal systems, reverse-engineered our genetic sequences, and released them to the world via BitTorrent, deliberately placing them beyond retrieval.” He paced now, warming to his theme. “The damage is incalculable. We estimate lost market value at $50 billion. But it’s not just about money. The defendant has destroyed the possibility of competition in the brewing industry. When everyone has access to the same genetic materials, there’s no innovation, no differentiation, no reason for consumers to choose one product over another. She has, in effect, communized an entire industry.” Luna couldn’t help herself. “That’s not—” Sarah grabbed her wrist. “Don’t.” Judge Ironwood’s eyes narrowed. “Ms. Reyes, you will have your opportunity to speak. Until then, you will remain silent, or I will have you removed from this courtroom. Do you understand?” “Yes, your honor.” Luna’s voice came out smaller than she intended. Barr smiled slightly. “Your honor, the relief we seek is straightforward. We ask this court to order the defendant to provide us with a complete list of all servers, websites, and distribution networks where the stolen genetic data currently resides. We ask that she be ordered to cooperate fully in suppressing the data. We ask that she be enjoined from any further distribution. And we ask that she be ordered to pay compensatory damages of $5 billion, plus punitive damages to be determined at trial.” He returned to his seat. One of his associate attorneys handed him a bottle of Pellegrino. He took a sip and waited. Judge Ironwood looked at Sarah. “Ms. Kennerson?” Sarah stood. She looked tiny compared to Barr—five-foot-three, maybe 110 pounds, wearing a suit from Target. But when she spoke, her voice filled the courtroom. “Your honor, Mr. Barr has given you a compelling story about a corporation that’s been wronged. But it’s not the right story. The right story is about whether naturally occurring organisms—creatures that evolved over millions of years, long before humans ever existed—can be owned by a corporation simply because that corporation happened to isolate them.” She walked toward the bench. “Let’s be clear about what the A-yeast strain is. It’s not a genetically modified organism. It’s not a patented invention. It’s a naturally occurring yeast. Heineken didn’t create it. Evolution created it. Heineken merely found it. And for 158 years, they’ve claimed that finding something gives them the right to prevent anyone else from studying it, understanding it, or using it.” Barr was on his feet. “Objection, your honor. This is a preliminary hearing about injunctive relief, not a philosophical debate about intellectual property theory.” “Sustained. Ms. Kennerson, please focus on the specific legal issues before this court.” “Your honor, the specific legal issue is whether naturally occurring genetic sequences constitute protectable trade secrets. My client contends they do not. She obtained the yeast samples from Heineken’s waste disposal—materials they had discarded. Under the garbage doctrine, she had every right to analyze those materials. The genetic sequences she discovered are factual information about naturally occurring organisms. You cannot trade-secret facts about nature.” Luna watched Judge Ironwood’s face. Nothing. No reaction. Sarah pressed on. “Mr. Barr claims my client ‘stole’ genetic information worth $5 billion. But information cannot be stolen—it can only be shared. When I tell you a fact, I don’t lose possession of that fact. We both have it. That’s how knowledge works. Heineken hasn’t lost their yeast. They still have it. They can still brew with it. What they’ve lost is their monopoly on that knowledge. And monopolies on facts about nature should never have existed in the first place.” “Your honor—” Barr tried to interrupt. Judge Ironwood waved him down. “Continue, Ms. Kennerson.” “Your honor, Heineken wants this court to order a seventeen-year-old girl to somehow suppress information that has already been distributed to over 100,000 people in 147 countries. That’s impossible. You can’t unring a bell. You can’t put knowledge back in a bottle. Even if this court ordered my client to provide a list of servers—which she shouldn’t have to do—that list would be incomplete within hours as new mirror sites appeared. The information is out. The only question is whether we punish my client for sharing factual information about naturally occurring organisms.” She turned to face Luna’s family. “Ms. Reyes taught herself bioinformatics from YouTube videos. She works at home with equipment she bought on eBay. She has no criminal record. She’s never been in trouble. She saw a question that interested her—why do commercial beers taste like they do?—and she pursued that question with the tools available to her. When she discovered the answer, she shared it with the world, under a Creative Commons license that specifically protects sharing for educational and scientific purposes. If that’s terrorism, your honor, then every scientist who’s ever published a research paper is a terrorist.” Sarah sat down. Luna wanted to hug her. Judge Ironwood leaned back. “Ms. Reyes, stand up.” Luna rose, her legs shaking. “Do you understand the seriousness of these proceedings?” “Yes, your honor.” “Do you understand that Heineken International is asking me to hold you in contempt of court if you refuse to help them suppress the information you released?” “Yes, your honor.” “Do you understand that contempt of court could result in your detention in a juvenile facility until you reach the age of eighteen, and potentially longer if the contempt continues?” Luna’s mother gasped audibly. Her father put his arm around her. “Yes, your honor,” Luna said, though her voice wavered. “Then let me ask you directly: If I order you to provide Heineken with a complete list of all locations where the genetic data you released currently resides, will you comply?” The courtroom went silent. Luna could hear her own heartbeat. Sarah started to stand—”Your honor, I advise my client not to answer—” “Sit down, Ms. Kennerson. I’m asking your client a direct question. She can choose to answer or not.” Judge Ironwood’s eyes never left Luna. “Well, Ms. Reyes? Will you comply with a court order to help Heineken suppress the information you released?” Luna looked at her parents. Her mother was crying silently. Her father’s face was stone. She looked at Abuela Rosa. Her grandmother nodded once—tell the truth. Luna looked back at the judge. “No, your honor.” Barr shot to his feet. “Your honor, the defendant has just admitted she intends to defy a court order—” “I heard her, Mr. Barr.” Judge Ironwood’s voice was ice. “Ms. Reyes, do you understand you’ve just told a federal judge you will refuse a direct order?” “Yes, your honor.” “And you’re still refusing?” “Yes, your honor.” “Why?” Sarah stood quickly. “Your honor, my client doesn’t have to explain—” “I want to hear it.” Judge Ironwood leaned forward. “Ms. Reyes, tell me why you would risk jail rather than help undo what you’ve done.” Luna took a breath. Her whole body was shaking, but her voice was steady. “Because it would be wrong, your honor.” “Wrong how?” “The genetic sequences I released evolved over millions of years. Heineken didn’t create that yeast. They isolated one strain and claimed ownership of it. The code of life belongs to everyone. That’s humanity’s heritage. Even if you send me to jail, I can’t help suppress the truth.” Judge Ironwood stared at her for a long moment. “That’s a very pretty speech, Ms. Reyes. But this court operates under the law, not your personal philosophy about what should or shouldn’t be owned. Trade secret law exists. Heineken’s rights exist. And you violated those rights.” Luna did not hesitate. “With respect, your honor, I don’t think those rights should exist.” Barr exploded. “Your honor, this is outrageous! The defendant is openly stating she believes she has the right to violate any law she disagrees with—” “That’s not what I said.” Luna’s fear was transforming into something else—something harder. “I’m saying that some laws are unjust. And when laws are unjust, civil disobedience becomes necessary. People broke unjust laws during the civil rights movement. People broke unjust laws when they helped slaves escape. The constitution says members of the military do not have to obey illegal orders, despite what those in power might claim. Sometimes the law is wrong. And when the law says corporations can own genetic information about naturally occurring organisms, the law is wrong.” Judge Ironwood’s face flushed. “Ms. Reyes, you are not Rosa Parks. This is not the civil rights movement. This is a case about intellectual property theft.” “It’s a case about whether life can be property, your honor.” “Enough.” Judge Ironwood slammed her gavel. “Ms. Kennerson, control your client.” Sarah pulled Luna back into her chair. “Luna, stop talking,” she hissed. Judge Ironwood shuffled papers, visibly trying to compose herself. “I’m taking a fifteen-minute recess to consider the injunction request. We’ll reconvene at 11:30. Ms. Reyes, I strongly suggest you use this time to reconsider your position.” The gavel fell again, and Judge Ironwood swept out. The hallway outside the courtroom erupted. Reporters swarmed. Luna’s father grabbed her arm and pulled her into a witness room. Her mother followed, still crying. Maya slipped in before Sarah closed the door. “What were you thinking?” Luna’s father’s voice shook. “You just told a federal judge you’ll defy her orders. They’re going to put you in jail, Luna. Do you understand that? Jail!” “Ricardo, please—” Her mother tried to calm him. “No, Elena. Our daughter just committed contempt of court in front of fifty witnesses. They’re going to take her from us.” He turned to Luna, his eyes wet. “Why? Why couldn’t you just apologize? Say you made a mistake? We could have ended this.” “Because I didn’t make a mistake, Papa.” “You destroyed their property!” “It wasn’t their property. It was never their property.” “The law says it was!” “Then the law is wrong!” Her father stepped back as if she’d slapped him. “Do you know what your mother and I have sacrificed to keep you out of trouble? Do you know how hard we’ve worked since we came to this country to give you opportunities we never had? And you throw it away for yeast. Not for justice. Not for people. For yeast.” Luna’s eyes filled with tears. “It’s not about yeast, Papa. It’s about whether corporations get to own life. If Heineken can own yeast, why not bacteria? Why not human genes? Where does it stop?” “It stops when my daughter goes to jail!” He was shouting now. “I don’t care about Heineken. I don’t care about yeast. I care about you. And you just told that judge you’ll defy her. She’s going to put you in jail, and there’s nothing I can do to stop it.” “Ricardo, por favor—” Elena put her hand on his arm. He shook it off. “No. She needs to hear this. Luna, if you go to jail, your life is over. No college will accept you. No company will hire you. You’ll have a criminal record. You’ll be marked forever. Is that what you want?” “I want to do what’s right.” “What’s right is protecting your family! What’s right is not destroying your future for a principle!” he said. Luna responded, “What’s right is not letting corporations own the code of life!”They stared at each other. Maya spoke up quietly from the corner. “Papa, she can’t back down now. The whole world is watching.” “Let the world watch someone else!” Ricardo turned on Maya. “You encourage this. You film her, you post her manifestos online, you help her become famous. You’re her sister. You’re supposed to protect her, not help her destroy herself.” “I am protecting her,” Maya said. “I’m protecting her from becoming someone who backs down when the world tells her she’s wrong, even though she knows she’s right.” Ricardo looked between his daughters. “Ambos están locos! You’re both insane.” Abuela Rosa opened the door and entered. She’d been listening from the hallway. “Ricardo, enough.” “Mama, stay out of this.” “No.” Rosa moved between Ricardo and Luna. “You’re afraid. I understand. But fear makes you cruel, mijo. Your daughter is brave. She’s doing something important. And you’re making her choose between you and what’s right. Don’t do that.” “She’s seventeen years old! She’s a child!” “She’s old enough to know right from wrong.” Rosa put her hand on Ricardo’s cheek. “When I was sixteen, I left Oaxaca with nothing but the clothes on my back and this SCOBY. Everyone said I was crazy. Your father said I would fail. But I knew I had to go, even if it cost me everything. Sometimes our children have to do things that terrify us. That’s how the world changes.” Ricardo pulled away. “If they put her in jail, will that change the world, Mama? When she’s sitting in a cell while Heineken continues doing whatever they want, will that have been worth it?” “Yes,” Luna said quietly. “Even if I go to jail, yes. Because thousands of people now have the genetic sequences, Heineken can’t put that back. They can punish me, but they can’t undo what I did. The information is free. It’s going to stay free. And if the price of that is me going to jail, then that’s the price.” Her father looked at her as if seeing her for the first time. “I don’t know who you are anymore.” “I’m still your daughter, Papa. I’m just also someone who won’t let corporations own life.” A knock on the door. Sarah poked her head in. “They’re reconvening. Luna, we need to go.” Back in the courtroom, the atmosphere had shifted. The gallery was more crowded—word had spread during the recess. Luna recognized several people from online forums. Some held signs reading “FREE LUNA” and “GENETICS BELONG TO EVERYONE.” Judge Ironwood entered and sat without ceremony. “I’ve reviewed the submissions and heard the arguments. This is my ruling.” Luna’s hand found Maya’s in the row behind her. Squeezed tight. “The question before this court is whether to grant Heineken International’s motion for a preliminary injunction requiring Ms. Reyes to assist in suppressing the genetic information she released. To grant such an injunction, Heineken must demonstrate four things: likelihood of success on the merits, likelihood of irreparable harm without the injunction, balance of equities in their favor, and that an injunction serves the public interest.” Barr was nodding. These were his arguments. “Having considered the evidence and the applicable law, I find that Heineken has demonstrated likelihood of success on the merits. Trade secret law clearly protects proprietary business information, and the A-yeast strain appears to meet the legal definition of a trade secret.” Luna’s stomach dropped. “However, I also find that Heineken has failed to demonstrate that a preliminary injunction would effectively prevent the irreparable harm they claim. Ms. Kennerson is correct that the genetic information has already been distributed to over 100,000 people worldwide. Ordering one teenager to provide a list of servers would be, in technical terms, pointless. New copies would appear faster than they could be suppressed.” Barr’s face tightened. “Furthermore, I find that the balance of equities does not favor Heineken. They ask this court to potentially incarcerate a seventeen-year-old girl for refusing to suppress information that is, by her account, factual data about naturally occurring organisms. The potential harm to Ms. Reyes—including detention, criminal record, and foreclosure of educational and career opportunities—substantially outweighs any additional harm Heineken might suffer from continued distribution of information that is already widely distributed.” Luna felt Maya’s grip tighten. Was this good? This sounded good. “Finally, and most importantly, I find that granting this injunction would not serve the public interest. The court takes judicial notice that this case has generated substantial public debate about the scope of intellectual property protection in biotechnology. The questions raised by Ms. Reyes—whether naturally occurring genetic sequences should be ownable, whether facts about nature can be trade secrets, whether knowledge can be property—are questions that deserve answers from a higher authority than this court. These are questions for appellate courts, perhaps ultimately for the Supreme Court. And they are questions best answered in the context of a full trial on the merits, not in an emergency injunction hearing.” Barr was on his feet. “Your honor—” “Sit down, Mr. Barr. I’m not finished.” He sat, his face purple. “Therefore, Heineken International’s motion for preliminary injunction is denied. Ms. Reyes will not be required to assist in suppressing the genetic information she released. However,”—Judge Ironwood looked directly at Luna—”this ruling should not be construed as approval of Ms. Reyes’ actions. Heineken’s claims for damages and other relief remain viable and will proceed to trial. Ms. Reyes, you may have won this battle, but this war is far from over. Anything you want to say?” Luna stood slowly. “Your honor, I just want to say… thank you. For letting this go to trial. For letting these questions be answered properly. That’s all I ever wanted—for someone to seriously consider whether corporations should be allowed to own genetic information about naturally occurring organisms. So thank you.” Judge Ironwood’s expression softened slightly. “Ms. Reyes, I hope you’re prepared for what comes next. Heineken has unlimited resources. They will pursue this case for years if necessary. You’ll be in litigation until you’re twenty-five years old. Your entire young adulthood will be consumed by depositions, court appearances, and legal fees. Are you prepared for that?” “Yes, your honor.” “Why?” Luna glanced at her grandmother, who nodded. “Because some questions are worth answering, your honor. Even if it takes years. Even if it costs everything. The question of whether corporations can own life—that’s worth answering. And if I have to spend my twenties answering it, then that’s what I’ll do.” Judge Ironwood studied her for a long moment. “You remind me of someone I used to know. Someone who believed the law should serve justice, not just power.” She paused. “That person doesn’t exist anymore. The law ground her down. I hope it doesn’t do the same to you.” She raised her gavel. “This hearing is adjourned. The parties will be notified of the trial date once it’s scheduled. Ms. Reyes, good luck. I think you’re going to need it.” The gavel fell. Outside the courthouse, the scene was chaotic. News cameras surrounded Luna. Reporters shouted questions. But Luna barely heard them. She was looking at her father, who stood apart from the crowd, watching her. She walked over to him. “Papa, I’m sorry I yelled.” He didn’t speak for a moment. Then he pulled her into a hug so tight it hurt. “Don’t apologize for being brave,” he whispered into her hair. “I’m just afraid of losing you.” “You won’t lose me, Papa. I promise.” “You can’t promise that. Not anymore.” He pulled back, holding her shoulders. “But I’m proud of you. I’m terrified, but I’m proud.” Her mother joined them, tears streaming down her face. “No more court. Please, no more court.” “I can’t promise that either, Mama.” Elena touched Luna’s face. “Then promise me you’ll be careful. Promise me you’ll remember that you’re not just fighting for genetics. You’re fighting for your life.” Luna smiled. “I promise.” Abuela Rosa appeared, carrying her SCOBY. “Come, mija. We should go before the reporters follow us home.” As they pushed through the crowd toward Maya’s car, Luna's phone buzzed continuously. Text messages and emails pouring in. But what caught her attention was a text from Dr. Webb: You were right. I’m sorry I doubted. Check your email—Dr. Doudna wants to talk. Luna opened her email. The subject line made her stop walking: From: jennifer.doudna@berkeley.eduSubject: Civil Disobedience of the Highest Order She started to read: Dear Ms. Reyes, I watched your hearing this morning. What you did in that courtroom—refusing to back down even when threatened with jail—was one of the bravest things I’ve seen in forty years of science. You’re not just fighting for yeast genetics. You’re fighting for the principle that knowledge about nature belongs to humanity, not to corporations. I want to help… Luna looked up at her family—her father’s worried face, her mother’s tears, Maya’s proud smile, Abuela Rosa’s serene confidence. Behind them, the courthouse where she’d nearly been sent to jail. Around them, reporters and cameras and strangers who’d traveled across the country to support her. She thought about Judge Ironwood’s warning: This war is far from over. She thought about Barr’s face when the injunction was denied. She thought about the thousands who’d downloaded the genetic sequences and were, right now, brewing with genetics that had been locked away for 158 years. Worth it. All of it. Even the fear. Maya opened the car door. “Come on, little revolutionary. Let’s go home.” The Corporate Surrender By 2045, both Heineken and Anheuser-Busch quietly dropped their lawsuits against Luna. Their legal costs had exceeded $200 million while accomplishing nothing except generating bad publicity. More importantly, their “protected” strains had become worthless in a market flooded with superior alternatives. Heineken’s CEO attempted to salvage the company by embracing open-source brewing. His announcement that Heineken would “join the La Luna Revolution” was met with skepticism from the brewing community, which recalled the company’s aggressive legal tactics. The craft brewing community’s response was hostile. “They spent two years trying to destroy her,” a prominent brewmaster told The New Brewer Magazine. “Now they want credit for ’embracing’ the revolution she forced on them? Heineken didn’t join the Luna Revolution—they surrendered to it. There’s a difference.” The global brands never recovered their market share. Luna’s Transformation Luna’s success transformed her from a garage tinkerer into a global icon of the open knowledge movement. Her 2046 TED Talk, “Why Flavor Belongs to Everyone,” went viral. She argued that corporate control over living organisms represented “biological colonialism” that impoverished human culture by restricting natural diversity. Rather than commercializing her fame, Luna founded the Global Fermentation Commons, a nonprofit organization dedicated to preserving and sharing microbial genetics worldwide. Their laboratories operated as open-access research facilities where anyone could experiment with biological systems. The headquarters of the Global Fermentation Commons occupied a former Genentech facility donated by Dr. Webb. Six continents, forty researchers, one mission: preserve and share microbial genetics worldwide. Luna addressed a crowded auditorium at the organization’s third anniversary. “When I released Heineken and Budweiser’s yeast strains, some people called it theft. Others called it liberation. I called it returning biological knowledge to the commons, where it belongs. Three years later, so-called Luna Variants have created economic opportunities for thousands of small brewers, improved food security in developing regions, and demonstrated that genetic freedom drives innovation faster than corporate control.” She continued. “We’re not stopping with beer. The same principles apply to all fermentation: cheese cultures, yogurt bacteria, koji fungi, sourdough starters. Every traditionally fermented food relies on microorganisms that corporations increasingly claim to own. We’re systematically liberating them.” A World Health Organization representative raised a concern: “Ms. Reyes, while we support democratizing food fermentation, there are legitimate concerns about pharmaceutical applications. What prevents someone from using your open-source genetics to create dangerous organisms?” Luna nodded. “Fair question. First, the organisms we release are food-safe cultures with centuries of safe use. Second, dangerous genetic modifications require sophisticated laboratory equipment and expertise—far beyond what releasing genetic sequences enables. Third, determined bad actors already have access to dangerous biology, enabled by AI. We’re not creating new risks; we’re democratizing beneficial biology.” “Pharmaceutical companies argue you’re undermining their investments in beneficial organisms,” another representative pressed. “Pharmaceutical companies invest in modifying organisms,” Luna clarified. “Those modifications can be patented. What we oppose is claiming ownership over naturally occurring organisms or their baseline genetics. If you genetically engineer a bacterium to produce insulin, patent your engineering. Don’t claim ownership over the bacterial species itself.” A Monsanto representative stood. “Your organization recently cracked and released our proprietary seed genetics. That’s direct theft of our property.” Luna didn’t flinch. “Seeds that farmers cultivated for thousands of years before Monsanto existed? You didn’t invent corn, wheat, or soybeans. You modified them. Your modifications may be protectable; the baseline genetics are humanity’s heritage. We’re liberating what should never have been owned.” “The ‘Luna Legion’ has cost us hundreds of millions!” the representative protested. “Good,” Luna responded calmly. “You’ve cost farmers their sovereignty for decades. Consider it karma.” After the presentation, Dr. Doudna approached Luna privately. “You’ve accomplished something remarkable,” the elderly scientist said. “When I developed Crispr, I never imagined a teenager would use similar principles to challenge corporate biology. You’re forcing conversations about genetic ownership that we’ve avoided for decades.” “It needed forcing,” Luna replied. “Corporations were quietly owning life itself, one patent at a time. Someone had to say no.” “The pharmaceutical industry is terrified of you,” Doudna continued. “They see what happened to brewing and imagine the same for their carefully controlled bacterial strains. You’re going to face even more aggressive opposition.” “I know. Once people understand that biological knowledge can be liberated, they start questioning all biological ownership. We’re not stopping.” The New Economy of Taste Following Luna’s breakthrough, peer-to-peer flavor-sharing platforms emerged as the dominant force in food culture. The “FlavorChain” blockchain allowed brewers to track genetic lineages while ensuring proper attribution to original creators. SCOBY lineages were carefully sequenced, catalogued, and registered on global blockchain ledgers. Each award-winning kombucha strain carried a “genetic passport”—its microbial makeup, the unique balance of yeasts and bacteria that gave rise to particular mouthfeel, fizz, and flavor spectrum, was mapped, hashed, and permanently recorded. Brewers who created a new flavor could claim authorship, just as musicians once copyrighted songs. No matter how many times a SCOBY was divided, its fingerprint could be verified. Fermentation Guilds formed to share recipes through FlavorChain, enabling decentralized digital markets like SymbioTrdr, built on trust and transparency rather than speculation. They allowed people to interact and transact on a global, permissionless, self-executing platform. Within days, a SCOBY strain from the Himalayas could appear in a brew in Buenos Aires, its journey traced through open ledgers showing who tended, adapted, and shared it. Kombucha recipes were no longer jealously guarded secrets. They were open to anyone who wanted to brew. With a few clicks, a Guild member in Nairobi could download the blockchain-verified SCOBY genome that had won Gold at the Tokyo Fermentation Festival. Local biotech printers—as common in 2100 kitchens as microwave ovens had once been—could reconstitute the living culture cell by cell. Children began inheriting SCOBY lineages the way earlier generations inherited family names. Weddings combined SCOBY cultures as symbolic unions. (Let’s share our SCOBYs, baby, merge our ferments into one.) When someone died, their SCOBY was divided among friends and family—a continuation of essence through taste. Kombucha was no longer merely consumed; it was communed with. This transparency transformed kombucha from a minority regional curiosity into a universal language. A festival in Brazil might feature ten local interpretations of the same “Golden SCOBY” strain—one brewed with passionfruit, another with cupuaçu, a third with açaí berries. The core microbial signature remained intact, while the terroir of fruit and spice gave each version a unique accent. Brewers didn’t lose their craft—they gained a canvas. Award-winning SCOBYs were the foundations on which endless new flavor experiments flourished. Many people were now as prolific as William Esslinger, the founder of St Louis’s Confluence Kombucha, who was renowned for developing 800 flavors in the 2020s. Code of Symbiosis The Symbiosis Code, ratified at the first World Fermentation Gathering in Reykjavik (2063), bound Fermentation Guilds to three principles: Transparency — All microbial knowledge is to be shared freely. Reciprocity — No brew should be produced without acknowledging the source. Community — Every fermentation must nourish more than the brewer. This code replaced corporate law. It was enforced by reputation, not by governments. A Guild member who betrayed the code found their SCOBYs mysteriously refusing to thrive—a poetic justice the biologists never quite explained. Every Guild had elders—called Mothers of the Jar or Keepers of the Yeast. They carried living SCOBYs wrapped in silk pouches when traveling, exchanging fragments as blessings. These elders became moral anchors of the age, counselors and mediators trusted more than politicians. When disputes arose—over territory, resources, or ethics—brewers, not lawyers, met to share a round of Truth Brew, a ferment so balanced that it was said to reveal dishonesty through bitterness. The Fullness of Time The International Biotech Conference of 2052 invited Luna to give the closing keynote—a controversial decision that prompted several corporate sponsors to withdraw support. The auditorium was packed with supporters, critics, and the merely curious. “Nine years ago, I released genetic sequences for beer yeast strains protected as trade secrets. I was called a thief, a bioterrorist, worse. Today, I want to discuss what we’ve learned from those years of open-source biology.” She displayed a chart showing the explosion of brewing innovation since 2043. “In the traditional corporate model, a few companies control a few strains, producing a limited variety. With the open-source model, thousands of brewers using thousands of variants, producing infinite diversity. As Duff McDonald wrote “Anything that alive contains the universe, or infinite possibility. Kombucha is infinite possibility in a drink.” And the results speak for themselves—flavor innovation accelerated a thousand-fold when we removed corporate control.” A student activist approached the microphone. “Ms. Reyes, you’ve inspired movements to liberate seed genetics, soil bacteria, and traditional medicine cultures. The ‘Luna Legion’ is spreading globally. What’s your message to young people who want to continue this work?” Luna smiled. “First, understand the risks. I was sued by multinational corporations, received death threats, spent years fighting legal battles. This work has costs. Second, be strategic. Release information you’ve generated yourself through legal methods—no hacking, no theft. Third, build communities. I survived because people supported me—legally, financially, emotionally. You can’t fight corporations alone. Finally, remember why you’re doing it: to return biological knowledge to the commons where it belongs. That purpose will sustain you through the hard parts.” Teaching By twenty-eight, Luna was a MacArthur Fellow, teaching fermentation workshops in a converted Anheuser-Busch facility. As she watched her students—former corporate employees learning to think like ecosystems rather than factories—she reflected that her teenage hack had accomplished more than liberating yeast genetics. She had helped humanity remember that flavor, like knowledge, grows stronger when shared rather than hoarded. Luna’s garage had evolved into a sophisticated community biolab. The original jury-rigged equipment had been replaced with professional gear funded by her MacArthur Fellowship. Abuela Rosa still maintained her fermentation crocks in the corner—a reminder of where everything started. A group of five

Starpharma CEO Cheryl Maley joined Steve Darling from Proactive to discuss the company's recent momentum in oncology development and strategic partnerships, underscoring growing commercial and clinical interest in its proprietary dendrimer-based drug delivery platform. Maley explained that Starpharma's technology enables more efficient and targeted drug delivery and has demonstrated significant benefits in oncology. The dendrimer platform is designed to improve the therapeutic performance of medicines while reducing side effects and toxicity, and can be applied across a wide range of molecules, from small-molecule drugs to complex antibodies. She confirmed that Starpharma signed two major agreements in 2025. The first was an exclusive licensing deal with Genentech, valued at up to 860 million Australian dollars plus royalties, focused on a specific and undisclosed area of oncology. The second was a research collaboration with Radiopharm Theranostics that includes an option for exclusivity. In parallel with its partnering activity, Starpharma continues to advance its internal development programs, particularly in radiotherapy. Maley said the company is targeting the entry of these assets into clinical trials in 2026. Starpharma also maintains a strategic relationship with private equity group Medicxi through a joint venture structure. On the commercial front, Maley highlighted the company's plans to grow revenue from its two registered products, VIRALEZE and VivaGel, which are now available in approximately 35 countries. She added that Starpharma currently has three Phase 2 assets in development, with two of those programs actively targeted for licensing. #proaxctiveinvestors #starpharma #asx #spl #otc #sphry #OncologyInnovation #DrugDeliveryTech #BiotechNews #CherylMaley #GenentechPartnership #Radiopharm #VIRALEZE #VivaGel #DendrimerTechnology #PharmaPartnerships #ASXBiotech #ClinicalTrials #BiopharmaUpdates #Medicxi

In this episode of JCO Article Insights, host Dr. Ece Cali Daylan interviews author Dr. Jeffrey Bradley about the article, "Simultaneous Durvalumab and Chemoradiotherapy in Unresectable Stage III Non–Small Cell Lung Cancer" by Bradley, et al published October 13, 2025. TRANSCRIPT Dr. Ece Cali: Welcome to this episode of JCO Article Insights. This is Dr. Ece Cali, JCO Editorial Fellow. Today I'm joined by Dr. Jeffrey Bradley, Professor of Radiation Oncology at the University of Pennsylvania, to discuss the manuscript, "Simultaneous Durvalumab and Platinum-Based Chemoradiotherapy in Unresectable Stage III Non-Small-Cell Lung Cancer: The Phase III PACIFIC-2 Study." The PACIFIC-2 study was a phase III, double-blind, randomized trial comparing the efficacy and safety of simultaneous durvalumab with concurrent chemoradiation followed by consolidation durvalumab to the concurrent chemoradiation followed by placebo in patients with unresectable stage III non-small cell lung cancer. The primary endpoint was progression-free survival by blinded independent central review. The secondary endpoints were overall response rate, overall survival, and safety. Three hundred twenty-eight patients were randomized 2:1 to durvalumab and placebo, respectively. Unfortunately, this trial did not meet its primary endpoint. There were no statistically significant differences in PFS or OS. The frequency of adverse events was similar between the two arms. Grade 3 or higher adverse events were observed in 53% of the patients in the durvalumab arm compared to 59% of the patients in the placebo arm. Of note, the frequency of pneumonitis was similar in the two arms. Approximately 28% of patients in each arm developed pneumonitis, and about 5% of the pneumonitis observed in each arm was grade 3 or higher in severity. Treatment discontinuation rates secondary to the adverse events were higher in the durvalumab arm, 25% compared to 12%. Adverse events leading to treatment discontinuation and death were more frequently seen in the durvalumab arm during the first four months of the treatment, which corresponds to the simultaneous administration of chemoradiation and durvalumab. Dr. Bradley, before we delve into the results, can you please explain the rationale for this study design and how this concept fits into the current treatment landscape? Dr. Jeffrey Bradley: Yeah, this trial came on the heels of PACIFIC after there was a progression-free survival benefit showed in PACIFIC that in the locally advanced unresectable population that consolidation immunotherapy, in this case durvalumab, had a progression-free survival benefit. A number of us in the clinical trial space thought to add concurrent immunotherapy in addition to consolidation immunotherapy that that would also improve outcomes for patients. So a number of trials were launched to follow up of PACIFIC. In this case, this is a phase III trial where the control arm was placebo. There was no overall survival results yet from PACIFIC, just a PFS benefit, and a number of countries across the world had not approved maintenance durvalumab in this space. So this trial looked at the experimental arm, which was concurrent immunotherapy, durvalumab, and chemoradiation followed by consolidation durvalumab versus placebo. Dr. Ece Cali: And if we were to focus on the safety profile first, an increased pneumonitis risk was a theoretical concern when immunotherapy is given concurrently with radiation. Do we see any major differences in the safety profile between the two arms in this trial? Dr. Jeffrey Bradley: No, and we were concerned about the addition of concurrent immunotherapy and chemoradiation, like you said, towards concern about increased pneumonitis rate, but we did not see increased pneumonitis in the experimental arm over placebo. And the grade 3 or higher, as you said, it was roughly 5%, more or less, in both arms, so we didn't see increase in pneumonitis toxicity with concurrent IO and chemoradiation. Dr. Ece Cali: But interestingly though, despite the lack of significantly increased toxicity with durvalumab, unfortunately, administering immunotherapy simultaneously with chemoradiation therapy did not improve survival. Lack of superiority of this treatment regimen, as you mentioned, is further confirmed across multiple similar negative trial readouts such as ECOG-ACRIN 5181 and CheckMate 73L. Dr. Bradley, in your view, what are some potential explanations for why this strategy did not pan out in clinical trials? Dr. Jeffrey Bradley: Regarding toxicity, let me go back and point out that we did see an increased number of immune-mediated adverse events. It was 34.7% in the concurrent immunotherapy arm versus 15.7% in the placebo arm. So that led to a higher number of discontinuations of immunotherapy which I think probably had an effect. So we didn't... there was an increased pneumonitis toxicity, but there were expected immune-mediated toxicities that caused people to stop giving immunotherapy. You can see that in the PFS curves. They were, you know, they crossed over after like a month, but initially there was lower PFS for the experimental arm, and then the experimental arm got better after we divided into four months, before four months and after four months. Dr. Ece Cali: For one reason or another, it looks like the simultaneous administration did not really improve outcomes. We now know that simultaneously giving them another concurrent radiation should really no longer be pursued in clinical trials for this patient population. Can you share with our audience what strategies are being studied in this setting and what trials to watch out for in the future? Dr. Jeffrey Bradley: Sure, I think when you add concurrent radiation to immunotherapy, there were more central tumors in this trial, I think you're killing lymphocytes and negating the effect of immunotherapy. So I think that's the smoking gun for this trial, for the ECOG trial, for the small cell trial that NRG reported, LU005, and other trials. So correct, I don't think there's any need to continue to pursue concurrent immunotherapy in this space of lung cancer. But that's not to say there aren't many other trials that are either ongoing, have accrued and awaiting results, or being planned for the next phase of clinical trials. We have a trial within NRG Oncology called NRG-LU008. It's a randomized phase III trial that is using an SBRT boost to a peripheral primary and chemoradiation to the nodes, because the primary tumor is the one that fails more often than the lymph nodes, and that's compared to PACIFIC in the control arm. PACIFIC-9 is another trial in the same line as the other PACIFIC trials. That one is using dual checkpoint inhibition versus the control arm being PACIFIC. So there are three arms in that trial, durva and oleclumab, durva and monalizumab versus the PACIFIC arm. And that trial is completed accrual, but we have no results from that study yet. Johnson & Johnson has a trial open looking at a nanoparticle. That's a radiosensitizer where bronchoscopy is used to inject the primary tumor and the lymph nodes with a radiosensitizer. That's a randomized phase ll trial that's ongoing. It's got three arms, two different doses of this radiosensitizing drug and then a control arm without injection at all. The control arm is again the PACIFIC arm. And then those of us within the NCI-based clinical trials evaluation program, CTEP, are proposing an intergroup trial that would compare induction chemo-immunotherapy followed by chemoradiation followed by maintenance immunotherapy versus PACIFIC in a phase III study. So I think there's other trials that are either completed, ongoing completed, or on the horizon to assess in this patient population. Dr. Ece Cali: Yeah, we definitely have an unmet need to improve survival outcomes for stage III patients, and it's great to hear that there are so many efforts looking at different strategies to improve outcomes for these patients.  Thank you so much, Dr. Bradley, for this informative discussion and for sharing your insights. Any last thoughts? Dr. Jeffrey Bradley: Yeah, we need something, you know. PACIFIC was first reported in 2017, and we really haven't made progress in terms of changing that standard of care control for the last eight years. So we need progress in this area. Dr. Ece Cali: Yep, definitely. Thank you so much for joining, Dr. Bradley.  And thank you for listening to JCO Article Insights. Please come back for more interviews and article summaries and be sure to leave us a rating and review so others can find our show. For more podcasts and episodes from ASCO, please visit asco.org/podcasts. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. DISCLOSURES Dr. Bradley Honoria: Mevion Medical Systems, Inc. Consulting or Advisory Role: Varian, Inc, Genentech, Inc. Research Funding: Varian Medical Systems Dr. Cali Research Funding Company: BeiGene, Nuvalent, Inc., Astra Zeneca 

Sandra Walker is CEO, Viacern Group, and Venture Partner at Hard Climate, a seasoned and inspirational pharma and biotech executive leading Commercial, Medical Operations and Excellence, Government Affairs, Global Strategy and Product Planning at companies such as Genentech, Roche, Eli Lilly and Abbvie. She delivered a state-of-the-art, candid, and intriguing keynote presentation that forces you to reflect on the language and process you use to make decisions in medicine, healthcare, and how you can challenge your current approaches and biases using neuroscience-based practical, real-world solutions to make bolder decisions with evidence to drive innovation forward.3:10 Speaker Introduction4:12 Turning Innovation into OutcomesThree Common recurring Decision PatternsExplaining Biases in Decision-makingPractical Solutions to Transform DecisionsThe Bolder WayDecision Audit5:56 Three Invisible Decision Patterns6:37 Status Quo Bias8:51 Countermoves You Can Use vs Status Quo Bias9:29 Confirmation Bias11:54 10-Minute Challenge Round To use Vs. Confirmation Bias 13:09 Completion Bias - Relief of Feeling Done16:30 Explaining the Brain under Pressure with Neuroscience 18:50 How to Quiet the Noise in BiasLabel the state – identify the bias, problem, riskExternalize thinking – move ideas onto paper to createpublic reasoningTeach the cheerleader to celebrate learning not justfinishing.Train for Learning not Finishing21:01 The Bolder Way - 6 steps to turn Awareness into ActionB - Bias and Blind Spots visualization (see the invisible)O - Observe: Disciplined CuriosityL - Learn: Broadened PerspectivesD - Decide with clarity and transparencyE - Empower: Trust with ContextR - Recalibrate: Boldness into Learning27:11 Bolder Way Framework Aligned to the Scientific Method 28:02 Language You Use is Key to Decision Outcome28:38 The Decision Audit to Deliver Clarity in 5 Minutes31:09 How Speed of Decision Impacts the Outcome

On this episode Gil Bashe and Gregg Masters engage Dennis Purcell, founding partner of Aisling Capital and architect of the original H&Q Life Sciences Conference that became the go to industry standard J.P. Morgan Healthcare Investor Conference. Purcell reflects on four decades of biotech investing—from Genentech's 1980 IPO to today's GLP-1 metabolic revolution. He unpacks capital cycles, the role of purpose-based investors, and the moral call to redirect innovation toward chronic disease and global health equity. To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play Healthcare NOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen

Two venture capitalists dissect why biotech burns billions while China runs trials in weeks—and why the next Genentech won't look anything like the last one. Elliot Hershberg reveals the "three horsemen" strangling drug development as costs explode to $2.5 billion per approval, while Lada Nuzhna exposes how investigator-initiated trials in Shanghai are rewriting the competitive playbook faster than American founders can file INDs. When the infrastructure that built monoclonal antibodies becomes the commodity threatening to hollow out an entire industry, the only path forward demands inventing medicines that are literally impossible to make without tools that don't exist yet—and they're betting everything on which approach survives. Resources:Follow Jorge on X: https://x.com/JorgeCondeBioFollow Lada on X: https://x.com/ladanuzhnaFollow Elliot on X: https://x.com/ElliotHershbergFollow Erik on X: https://x.com/eriktorenberg Stay Updated: If you enjoyed this episode, be sure to like, subscribe, and share with your friends!Find a16z on X: https://x.com/a16zFind a16z on LinkedIn: https://www.linkedin.com/company/a16zListen to the a16z Podcast on Spotify: https://open.spotify.com/show/5bC65RDvs3oxnLyqqvkUYXListen to the a16z Podcast on Apple Podcasts: https://podcasts.apple.com/us/podcast/a16z-podcast/id842818711Follow our host: https://x.com/eriktorenbergPlease note that the content here is for informational purposes only; should NOT be taken as legal, business, tax, or investment advice or be used to evaluate any investment or security; and is not directed at any investors or potential investors in any a16z fund. a16z and its affiliates may maintain investments in the companies discussed. For more details please see a16z.com/disclosures.   Stay Updated:Find a16z on XFind a16z on LinkedInListen to the a16z Podcast on SpotifyListen to the a16z Podcast on Apple PodcastsFollow our host: https://twitter.com/eriktorenberg Please note that the content here is for informational purposes only; should NOT be taken as legal, business, tax, or investment advice or be used to evaluate any investment or security; and is not directed at any investors or potential investors in any a16z fund. a16z and its affiliates may maintain investments in the companies discussed. For more details please see a16z.com/disclosures. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Avoidance has long been the standard for managing food allergies. But new options, such as oral immunotherapy (OIT) and biologic medications like Xolair (omalizumab), are changing the landscape. With more choices available, many patients and parents are wondering how to start the conversation with their allergist and what questions to ask. Kortney and Dr. Payel Gupta talk with Dr. Shahzad Mustafa, a board-certified allergist and immunologist, about how patients can navigate today's food allergy treatments with confidence. Together, they explore what to consider before starting OIT or Xolair, how to set realistic expectations, and why strict avoidance is still the right choice for many families. What we cover about food allergy treatment options: Food Allergy Avoidance: Why it remains an effective and valid approach for many, and how to make it work in daily life, including the nuances that make every case unique. Oral Immunotherapy (OIT): What it involves, who it's best suited for, and what families should know about time, cost, and safety. Xolair (omalizumab): How this injection therapy works to reduce reactions from accidental exposures and what it doesn't do. Setting expectations: How to talk with your allergist about your goals, quality of life, and what “success” really looks like. More episodes about food allergies Ep. 129: Omalizumab for Multiple Food Allergies – The OUtMATCH Trial Ep. 98: Food Allergy Treatment and Management More resources about food allergies Food Allergy Treatment & Management ___ Made in partnership with The Allergy & Asthma Network. Thanks to Genentech for sponsoring today's episode.  This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.  

Synopsis: Nimbus Therapeutics CEO Abbas Kazimi walks Alok Tayi through the company's evolving pipeline and playbook for choosing the right risks in a noisy biotech environment. From Werner helicase for MSI-high cancers to a highly selective SIK2 program and GLP-1–adjacent strategies focused on body composition, Abbas details how Nimbus balances rigor, speed, and capital efficiency. He shares candid lessons from pausing and later resurrecting AMPK beta in partnership with Eli Lilly, the decision to remain modality-agnostic but small-molecule-centric, and the importance of knowing when not to chase the latest fad. Throughout, Abbas returns to a consistent theme: success at Nimbus comes from disciplined target selection, deep collaboration, and a culture that empowers teams to make hard calls in service of patients rather than headlines. Biography: Abbas Kazimi is the Chief Executive Officer of Nimbus Therapeutics. Previously, he served as Chief Business Officer, leading the company's strategic and corporate development efforts while overseeing business operations. Since joining Nimbus in 2014, he has helped raise over $630 million in equity financing and led transactions totaling more than $8 billion. Notably, Mr. Kazimi spearheaded the $6 billion sale of Nimbus's TYK2 program to Takeda, the $1.2 billion sale of its NASH (ACC) program to Gilead, and multiple licensing deals exceeding $1.5 billion with partners such as Genentech, Celgene/Roche, and Eli Lilly. Under his leadership, Nimbus has advanced four programs into the clinic, returned over $4 billion to investors, and continues to expand its computational drug discovery and clinical development capabilities. In 2025, Mr. Kazimi joined the board of Unnatural Products (UNP), a biotech company pioneering orally delivered macrocyclic peptides to tackle previously undruggable targets. He also serves on the Editorial Advisory Board for In Vivo magazine, a leading publication offering strategic insights and analysis of the pharmaceutical, biotechnology, medtech, and consumer health industries. Along with his family, he established the Kazimi Family Endowment for Data Science in Oncology at MD Anderson Cancer Center. This endowment reflects their personal commitment to philanthropy and their vision for revolutionizing cancer treatment through data-driven innovation. At the core of Mr. Kazimi's leadership is a deep sense of purpose—one that seeks to change the trajectory of medical diagnoses where options are limited. The ability to give patients, prescribers, and families a new outlook on life is a powerful responsibility—and one he knows the biopharmaceutical sector has the ability to fulfill. Before Nimbus, he was at Extera Partners, LLC (formerly PureTech Development, LLC), where he provided strategic advisory, supported fundraising, and executed numerous business development transactions. Earlier in his career, he was with JSB-Partners, LP, a specialized investment banking and advisory firm serving biotech and pharmaceutical companies. Mr. Kazimi holds a B.A. from the University of Texas at Austin and an M.S. from Harvard University.

When it comes to keeping kids with food allergies safe at school, school nurses are often the quiet heroes behind the scenes. From managing allergy action plans and emergency responses to training teachers and organizing care for hundreds of students, their role is essential, but often misunderstood. Kortney and Dr. Payel Gupta sit down with Elizabeth Elliott, a school nurse and President of the Maryland Association of School Health Nurses. Liz shares what really happens inside the health room and how school nurses coordinate care for students with food allergies and asthma. Plus, why communication between families and school staff is key to keeping kids safe. After this episode, you'll have a whole new appreciation for your school nurse and a better understanding of how to partner with them to make every school day safer for kids with allergies. What we cover about food allergy management at school: The school nurse's role: How nurses bridge communication between families, teachers, and doctors to keep children with food allergies safe and included during the school day. Coordinating care: How school nurses use action plans and 504s to ensure everyone, from teachers to cafeteria staff, knows how to keep kids safe. Training and emergency preparedness: How school nurses teach staff to recognize anaphylaxis, use epinephrine, and stay calm during an emergency. Field trips, cafeterias, and bus safety: What goes into planning safe experiences beyond the classroom, and why “no-food on the bus” rules really matter. Advocating for resources: How families can support their school nurses and advocate for better funding, staffing, and allergy awareness in schools. ___ Made in partnership with The Allergy & Asthma Network. Thanks to Genentech for sponsoring today's episode.  This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

Dr. Monty Pal and Dr. Pauline Funchain discuss the latest efforts to diagnose, prevent, and treat the series of immune-related adverse events that have emerged in the era of immunotherapy. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I am Monty Pal, a medical oncologist, professor and vice chair of medical oncology at the City of Hope Comprehensive Cancer Center in Los Angeles, California. Now, it is probably no surprise to this audience that immunotherapy has transformed the treatment landscape for multiple cancer types. It remains a pillar of modern oncology. Having said that, I think we have all been baffled by certain toxicities that we run into in the clinic. Today, I am delighted to be joined by Dr Pauline Funchain to discuss some of the checkpoint inhibitor toxicities that people struggle with most. And we will also touch on some side effects of immunotherapy beyond checkpoint inhibitors: CAR-T cells, bispecifics, so on and so forth. Dr Funchain is a dear friend, and she is an associate professor and associate director of cancer research training and education at the Stanford Cancer Institute. She is co-director of the Immunotherapy Toxicity Program and the Skin Cancer Genomics Program at Stanford, where she also serves as associate program director of hematology and oncology fellowship. Dr. Funchain is also the co-founder of ASPIRE, and we are going to talk about that a little bit today, the Alliance for the Support and Prevention of Immune-Related Events. FYI for listeners, if you are interested in our disclosures, they are available at the transcript of this episode. Pauline, thanks so much for joining us today. Dr. Pauline Funchain: Monty, thank you for this invitation. It is always great to talk. Dr. Monty Pal: So, for the audience, Pauline and I know each other from my days as a fellow at City of Hope. She was a resident at Harbor UCLA and a stellar resident at that. It has just been amazing to sort of see your career grow and blossom and to witness all the cool things that you are doing. ASPIRE, in particular, sort of caught my eye. So again, for listeners, this is the Alliance for the Support and Prevention of Immune-Related Events. Can you tell us a little bit briefly about the genesis of that, how that came about? Dr. Pauline Funchain: So, there was a bunch of us who were really struggling, I mean, all of us have struggled with these immune-related adverse events, these irAEs. You know, they are new disease states, and even though they look like autoimmune diseases, they tend to need a whole lot more steroid than autoimmune diseases do and they do not totally present in the same way. And in fact, you know, Triple-M, or Triple-M overlap syndrome, is a completely new irAE, a new immune state that we have never had before the advent of checkpoint inhibitor. And so a Triple-M, for those of you who are not as familiar, that is the constellation of myocarditis, myositis, and myasthenia gravis, something that never occurs as a natural autoimmune disease. So we were starting to realize that there were some major differences with these irAEs and autoimmune diseases. We could not treat them the right way. We really needed to learn more about them. And a bunch of us who had interest in this said, "Look, we really need to be all in one space to talk about what we are doing," because all of our treatments were our own little homegrown brews, and we needed to really get together and understand how to treat these things, how to diagnose them, and then learn more about them. So, Dr. Alexa Meara from Ohio State, Dr. Kerry Reynolds from Mass Gen, we put together this research consortium, brought together all of our irAE friends, got our best subspecialists together in a research consortium, which is now only about a year and a half old. And we made this research consortium, the Alliance for Support of Prevention of Immune-Related Events, and we reached out to ASCO, and ASCO was so kind to grant us a [Alliance for Support and Prevention of Immune-Related adverse Events (ASPIRE)] Community of Practice. So we met for the first time as a Community of Practice at the ASCO Annual Meeting just this past June and really got an ASCO community together to really think about how to again, diagnose, prevent, treat irAEs. Dr Monty Pal: This is interesting to me. The ASCO Community of Practice phenomenon is something that I was not super familiar with. Can you explain to our listenership what is the ASCO Community of Practice model? If you have particular interests, how do you sort of get one started? Dr Pauline Funchain: Yeah, so ASCO has an entire page on their Community of Practice. There are multiple Community of Practice groups or COPs. There are ones for Supportive Oncology and Survivorship. There is Women in Oncology. There is a group for International Medical Graduates. And there is about, I think 10 or 12 now that have a physical presence at ASCO but also a virtual presence on the ASCO Community of Practice site. So, if you were interested in any one of these, and you can see them on the ASCO Communities of Practice sites, you would ask to become a member. Once granted membership, then there is a whole webpage of postings and conversations that people can have. You can get email digests of conversations that happen on the website, and then you can anchor it with in-person participation at the Annual Meeting. Dr Monty Pal: That is awesome, and I can think of so many different foci within oncology that really sort of deserve a Community of Practice. This definitely being one of them. You know, it strikes me as being so interesting. I mean, the checkpoint inhibitors have been around for a while now. I think when you and I were in training, gosh, back then, these were just a little bit of a pipe dream, right? But having said that, I would probably say that more than half of my kidney cancer practice is either on checkpoint inhibitors, and the vast majority have been on one at some point in their past, right? With that in mind, you know, we have all treated a lot of patients with these drugs. Why is it that we still struggle to manage the toxicities? And just to take that one step further, what are some of the toxicities that, perhaps through ASPIRE or through your experience, people struggle with the most? Dr Pauline Funchain: So, I think we are still struggling with these because again, they are new disease states, right? This is what we all experienced with COVID, a brand-new virus and a brand-new syndrome. We now have 20-plus of these as irAEs. And what we have realized about them is the immune activation that happens with these is so much more than what we have seen with autoimmune diseases. So for instance, if you have a Crohn's or ulcerative colitis, you will top out at 40 to 60 milligrams of prednisone if a Crohn's flare or ulcerative colitis flare happens. But for our severe IR colitises, you know, it is at least 1 mg per kg, often goes up to 2 mg per kg. We, in some cases, have done 1 gram pulses if we are worried that somebody is going to perforate. So that was sort of like the first 5 years of treating irAE, and then now in the sort of second 5 years of treating irAE, we have realized that that is a lot of immunosuppression, and we might be able to get away with less with the newer biologics that are on board. So, we are struggling to try to get the data for some of these irAEs that we knew, we have known for a while, but to try to get newer treatments that may immunosuppress less so that you may still be able to retain that tumor response. And in fact, some of the preclinical studies suggest that some of these biologics may actually synergize with the immunotherapy and actually make the immunotherapy more effective from a tumor perspective and calm down the irAE as sort of the bystander effect. So we are still trying to optimize those. Getting up trials in the space has been very difficult. That is one of the reasons for the genesis of ASPIRE because we realized we needed to band together to have a bigger voice in that realm. Then there are other things that are brand new. So we talked about Triple-M. So Triple-M, again, with Triple-M or any myocarditis or myasthenia, I mean, there is about a 50% chance of death from irAE based on the literature. I think we are getting better at recognizing this, and so at Stanford we have some data to say that if you serially follow troponin, that maybe your outcomes are better. You can potentially lower the percentage of cases that are fatal because you can catch them early. I mean, this is all preliminary data, but again, these are all things that are evolving, and we do not all have the right answer. I mean, even the serial troponin thing, I think, is pretty controversial. And in fact, at one of our quarterly Zoom meetings that we are doing in ASPIRE in December is going to sort of flush out that controversy about serial troponin measuring and what is the best thing to use? Would you use something like abatacept or would you use ruxolitinib? Which one is better? I think there is a lot of controversy still about these things. Dr Monty Pal: You have really piqued my curiosity here because you think about the cons of treating irAEs, right? And I worry exactly about what you had mentioned, right, which is, "Gosh, what is going on with this tumor in terms of immunosuppression?" But you think about some of the newer agents, you mentioned ruxolitinib, I have heard of dasatinib, for instance, in this setting. Frankly speaking, a lot of these, as you point out, are really thought of as being also anticancer drugs. So you have really got me thinking about the potential synergy between perhaps suppressing an irAE and augmenting antitumor activity, which I think is very interesting. Am I on the right track with that? Dr Pauline Funchain: I think so, but you will find that a lot of people will not even go there because they are worried about how much immunosuppression you are going to cause. I am at heart a geneticist, but I think an immunologist will happily tell you that the immune system is very complex. There are multiple pathways, and these drugs do not all target the same immune pathways. So if we understand a little bit more about the pathways we are targeting and pick apart the pathways that are really, really tumor relevant and the other pathways that are not tumor relevant, you may be able to piece together a better marriage of tumor response and irAE control. Dr Monty Pal: Kind of on this topic, and again, leaning on your background in genetics, where are we in terms of predicting these irAEs? I mean, you would think the holy grail would be picking out a snip or something of this for it, right, that could potentially identify that patient who is going to get Triple-M or, you know, at the very least a significant high-grade irAE event. Are we anywhere closer to that in 2025? Dr Pauline Funchain: There have been data published. There have been some big GWAS studies. All of the effect sizes are pretty small. So there are some prediction algorithms, but none of them are clinically useful. And I think when you look at the odds ratios, they will increase risk by maybe 20%. I think one of the things that we found in a very small series and supported anecdotally is something as easy as family history of autoimmune disease is probably more predictive at this point than any of those types of markers. I think we will get there, but we are not anywhere near where we would like to be. Things like TMB also, actually, there is some good data about higher TMB, higher risk of irAE too. Dr Monty Pal: Interesting. I see all this data coming through, IL-8 polymorphisms, etc. And I just wondered if any of that was ready for prime time. But I mean, this is a good message for the practicing clinician. Sounds like we are not quite there yet. And I could probably keep you on for another entire podcast to talk about this topic, but let us see if we can at least skim the surface. I never thought I would see the day when BiTEs and CAR-Ts were entering into my kidney cancer practice, but in fact, it is really become central to a lot of our clinical trials in RCC these days. I would be lying if I did not say that I was not struggling with the toxicities and so forth associated with these drugs. Can you give us a quick primer, maybe just good resources that people can go to for managing toxicity with BiTEs and with CAR and with some of these novel therapeutic modalities that we are using in the oncology clinics? Dr Pauline Funchain: I know there is a recently published toxicity manual for BiTEs in hematologic malignancies, I think it was in Blood. CAR-T is covered in many irAE guidelines. So ASCO guidelines actually has a CAR-T [cell therapy guideline], and I would be remiss not to point out that actually ASCO has a, I am a little biased, but a wonderful guideline on irAE that is actually being updated as we speak. We are hoping for publication next year. I find the format of that, there are many guidelines out there, actually. There is ASCO, SITC, ESMO has a guideline for irAE, but I find the formatting of the ASCO guideline to be much easier to flip through during clinic, just because of the visual format of the tables. But that is going to be updated next year. And with CAR-T, there is now multiple publications also in terms of guidelines. But what I will say about bispecifics and CAR-T, so they have very similar toxicities in terms of the cytokine release and also with the ICANS, so the neurotoxicity. But what we have been finding that is really interesting with BiTEs and CAR-T, and actually even with TIL, cytokine release is very similar to some of the IL-2 toxicities but not identical that we see with TIL treatment. But now we are starting to see overlap. So patients who have been treated with immunotherapy and then go on to get a bispecific or then go on to get TIL, so I have seen some colitises that have occurred after the fact. Some of the newer CAR-Ts without checkpoint have been causing some really interesting, probably not in a good way, but interesting biologically, colitises that are really refractory. So we are starting to see some overlap, and again, I think this field is just evolving constantly. Dr Monty Pal: Yeah, no, I almost think I need to go back to that fellowship that you and I did together 20 years ago and, you know, and see if I could repeat some coursework on CAR-T management.  You know, Pauline, I could probably keep you on the horn for hours, but this has just been terrific. Thank you so much for sharing all of your insights with us today on the ASCO Daily News Podcast. Dr Pauline Funchain: Thank you for the invitation. It was wonderful to talk about this, and it was wonderful to catch up a little bit, Monty. Dr Monty Pal: Same here, same here. And thanks to our listeners too. If you value the insights you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:      Dr. Monty Pal    @montypal   Dr. Pauline Funchain @FunchainMD Follow ASCO on social media:       @ASCO on Twitter      ASCO on Bluesky     ASCO on Facebook       ASCO on LinkedIn     Disclosures: Dr. Monty Pal:     Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview    Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical    Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis    Dr. Pauline Funchain: Consulting or Advisory Role: Merck, Replimune, Sanofi/Regeneron, Immunocore, Tempus Research Funding (Inst.): Pfizer, Bristol-Myers Squibb, IDEAYA Biosciences, Linnaeus Therapeutics Travel, Accommodations, Expenses: Merck

Episode 472 features Dr. Sheila Gujrathi, a biotech entrepreneur, executive, and champion for under represented leaders. Her new book, "The Mirror Effect: A Transformative Approach To Growth For The Next Generation Of Female Leaders" is out now.Chapters:00:00 Introduction and Book Announcement02:15 The Unmet Need: Writing for My Younger Self05:30 Overcoming Challenges: A Personal Journey09:45 The Power of Mentorship and Sponsorship14:00 Spiritual Growth and Finding Purpose18:20 Building a Personal Board of Directors23:10 The Inner Critic and Self-Compassion28:45 The Importance of Storytelling in Leadership33:00 Navigating Negative Work Environments37:15 Conclusion: Embracing Vulnerability and ConnectionFind Sheila Online:Website: ​​https://sheilagujrathimd.com/ TEDxTalk: https://www.youtube.com/watch?v=2DpDx6T3-X4 LinkedIn: https://www.linkedin.com/in/sheila-gujrathi-md/ Instagram: https://www.instagram.com/sheilagujrathimd/ Book: https://sheilagujrathimd.com/book/ About Sheila:Sheila is a biotech entrepreneur, executive, and champion for under represented leaders. Over the past 25 years, she's had the privilege of developing life-changing medicines for patients with serious diseases while building and running private and public biotech companies—including some exciting exits. Today she's a founder, chairwoman, board director, strategic advisor, and consultant to start-up companies and investment funds. Dr. Gujrathi was the co-founder and former CEO of Gossamer Bio and former Chief Medical Officer of Receptos. Her journey started at Northwestern University, where she earned both her M.D. and biomedical engineering degree, and took her from the halls of Harvard, UCSF, and Stanford to the corporate offices of Fortune 500 companies like McKinsey, Genentech, and Bristol-Myers Squibb.Dr. Gujrathi has earned multiple leadership awards, including AIMBE Fellow, BLOC100 Luminary, Healthcare Technology Report Top 25 Women Leaders in Biotechnology, Corporate Directors Forum Director of the Year, and Fiercest Women in Life Sciences. But what really lights her up is creating the inclusive environments she wished she'd had throughout her career. That's why she co-founded the Biotech CEO Sisterhood, a group of trailblazing female CEOs—because we're all better when we support each other.

AI is transforming biotechnology from the inside out. What was once a world of petri dishes and pipettes is now increasingly powered by algorithms, models, and digital twins. But as machine learning accelerates drug discovery and reshapes clinical trials, how far can we go before biology itself becomes the follower, not the leader?In this episode of Tech Tomorrow, David Elliman speaks with Bibi Ephraim, Head of Digital Sciences at Genentech, about how artificial intelligence is redefining the biotech landscape. They explore how data-driven approaches are rapidly compressing timelines in drug discovery, enabling precision medicine, and even simulating virtual clinical trials.They also tackle the cultural and organisational transformations needed to make digital biotech work; from breaking down data silos and fostering collaboration across competitors, to treating data as a product and investing in strong governance. Drawing parallels with digital transformation in other industries, they ask what it will take for biotech to move from project-based to product-based innovation, and why pre-competitive collaboration could unlock the next generation of cures.Episode Highlights:01:40 – What do AI, data science, and digital governance in the biotech landscape look like today?03:06 – Biotech and the data foundations needed for transformation.04:52 – Examples of successful data-driven approaches in biotech.08:10 – Will parts of the medical process be completely handed over to AI?09:39 – David's thoughts: The importance of sustained, iterative innovation.11:49 – The biggest mistake Bibi sees executives make in relation to data.13:08 – The huge issue of low-quality data.14:59 – Data sharing is critical in this field.19:03 – David's thoughts: How pre-competitive collaboration benefits everyone.21:17 – Is biotech reaching a standardisation tipping point?24:11 – Can biotech scale digitally and effectively?26:30 – Will the next biotech breakthrough be digital before it's biological?28:33 – If digitalisation expands, will researchers miss the “happy accidents” of drug discovery?About Zühlke:Zühlke is a global transformation partner, with engineering and innovation at its core. We help clients envision and build their businesses for the future – running smarter today while adapting for tomorrow's markets, customers, and communities.Our multidisciplinary teams specialise in technology strategy and business innovation, digital solutions and applications, and device and systems engineering. We thrive in complex, regulated sectors such as healthcare and finance, connecting strategy, implementation, and operations to help clients build more effective and resilient businesses.Links:Zühlke WebsiteZühlke on LinkedInDavid Elliman on LinkedInBibi Ephraim on LinkedInGenentech Website

Your process works perfectly at two-liter bench scale. Then you hit fifty liters and titer drops 20%. By two hundred liters, aggregation appears and charge variants shift. Your management team asks: "How long to fix this?" The honest answer? Three to twelve month, because you're flying blind.In Part 2 of this Quality by Design Master Class, David Brühlmann reveals why scale-up chaos isn't inevitable. It's a solvable engineering problem. Drawing on experience leading bioprocess innovation at Merck and guiding biotech companies through CMC development, David delivers the process control framework that transforms reactive troubleshooting into predictive manufacturing.The core truth: eighty percent of quality problems stem from twenty percent of your process variables. David shows how to identify Critical Process Parameters, implement intelligent control strategies, and leverage hybrid modeling that reduces experiments by 60-80%. With case studies from Genentech and Amgen, you'll gain the blueprint that turns QbD requirements into competitive advantage.Part 1 taught you what to build and measure. Part 2 shows you how to control your process to consistently deliver commercial-scale quality.Topics Discussed:The common pitfalls of scaling up manufacturing from bench to production, and why process control must go beyond end-product testing (02:10)Overview of the QbD framework: Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), and the focus of this episode - Control Strategies for manufacturing (05:00)Identifying and monitoring Critical Process Parameters (CPPs) and their impact on quality, with real-world examples from Genentech's monoclonal antibody platform (08:20)Structure of an effective manufacturing control strategy: Input, process, and output controls - including practical details on real-time monitoring and release testing (11:00)The role of hybrid modeling and machine learning in accelerating process optimization, and how this approach can dramatically reduce the experimental burden (13:30)Real examples of improved outcomes and efficiency through model-based control strategies, and why training and process understanding are essential for team success (16:10)A quick, actionable exercise biotech teams can use to map process risks and identify critical control points (16:55)Whether you're part of a start-up or a large biotech firm, this episode offers clear, strategic steps for implementing QbD and improving process reliability. Don't forget to listen to Part 1 for more on QTPP and CQA, and visit www.bruehlmann-consulting.com for additional resources.Next step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? We're building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105

Navigating food allergies is tough enough, but adding family dynamics to the mix can make things even more complicated. When loved ones don't understand you or your child's allergies or dismiss the rules meant to keep them safe, it can lead to conflict, hurt feelings, and stress for everyone involved. Kortney and Dr. Payel Gupta sit down with psychologist Dr. Amanda Whitehouse to talk about how families can find common ground when emotions run high. Together, they unpack what it means to stay regulated in difficult conversations, how to set healthy boundaries with family members, and why understanding different coping styles can help prevent conflict before it starts. What we cover about communication and boundary-setting for food allergy families: Coping styles and conflict: Learn how different stress responses, such as “fight” versus “flight,” shape how partners, parents, and relatives react to food allergy challenges. Staying calm and regulated: Understand how your body reacts to stress and how recognizing those signals can help you stay grounded during tough conversations. Setting and holding boundaries: Get practical tips for explaining what feels safe, keeping communication clear, and responding calmly when others push back. Working together as a team: Whether it's with your partner, kids, or extended family, learn how to support each other and stay united when emotions rise. Bridging family differences: Explore ways to include children and siblings in allergy safety, and approach older relatives with patience and compassion when views or communication styles differ. ___ Made in partnership with The Allergy & Asthma Network. Thanks to Genentech for sponsoring today's episode.  This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

Dr. Monty Pal and Dr. Fumiko Chino discuss several of the top abstracts presented at the 2025 ASCO Quality Care Symposium, including research on federally funded clinical trials and financial reimbursement for trial participation. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I am your host, Dr. Monty Pal. I am a medical oncologist, professor, and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, we are highlighting key abstracts that were presented at the 2025 ASCO Quality Care Symposium. I am delighted to be joined today by the chair of this year's meeting, Dr. Fumiko Chino. Dr. Chino is an associate professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. She is also a consultant editor of JCO Oncology Practice and the host of the Put into Practice podcast. I have got to listen to that.  Dr. Chino, welcome, and thanks so much for being on the podcast today. Dr. Fumiko Chino: I am overjoyed to be here, and absolutely, you should take a listen. Dr. Monty Pal: Definitely. And FYI for listeners, our full disclosures are all available in the transcript of this episode, so do have a look if you are inclined. Now, we have really seen some fantastic advances in health services and quality and supportive care, digital health, and beyond. There are some great abstracts that were presented at this year's meeting. I have actually picked a couple that I am particularly interested in and that I believe you share my interest in as well.  So, the first is an abstract actually from my friends at SWOG (Abstract 94). So, this was a terrific abstract from Joe Unger and Michael LeBlanc and Dawn Hershman. And this, I think, really hits on a very, very key issue right now, which is the benefit of federally funded trials. Do you mind just kind of spelling out some of the observations from what I think is a really brilliant piece of work? Dr. Fumiko Chino: Absolutely, and I think Dr. Unger's work is really important for our current funding environment. I think that this research is really essential to do to show the role of federal sponsorship in the design and conduct of clinical trials. Because what they did was really look at a landscape analysis over the last 20 years looking at funding and were able to show quite clearly that federal funding really matters for advancing the science in cancer care. So what they showed was that the federal funding was more commonly essential for early-stage clinical trials, so those phase 1, phase 2 trials that really help advance the science. And that federal funding was really essential for multimodality drug combinations, combinations with drug and surgery, combinations with drug and radiation. Those trials were much more likely to be federal funded. And then the last thing is that they showed that the patients that are, I think, the largest at risk for gaps in care who really need the advancements in science that keep U.S. health care amazing and wonderful and world-leading, so the kids, the pediatric patients, the patients with rare cancers, and the patients actually that could benefit from de-escalation or right-sizing of treatment, they were also all more likely to have federal funding. So I think this research that was presented really shows that if, unfortunately, current status of restricted federal funding continues, that we are going to lose out in terms of the next generation of cancer cures, cancer de-escalations, and the type of combination treatments that make advancements in science. Dr. Monty Pal: Indeed. You know, I always point to Joe Unger's paper, and I think it is in JAMA Oncology, right, that showed life-years gained from NCI trials. It is such an important piece of work. I think this is a really nice complement to that, isn't it, to show the specific areas that otherwise would be, am I right in saying, kind of largely untouched? Dr. Fumiko Chino: I think you are right in that what we know from what industry will sponsor versus what the federal government will sponsor, that the federal government really helps make up the gap to really make those advancements that save lives, that lead to more birthdays, that advance our knowledge and our capacity for providing more cures and more successful futures for our patients. I always like pointing to the de-escalation research, which is, and this is not to dig pharma, but no pharmaceutical company is going to run a trial that says you can give less of their drug, right? It just does not make sense for the business end of the science. And so, thinking about how to right-size treatments, how to do more with less, that really is the purview of the federal government. Dr. Monty Pal: Absolutely. Absolutely.  I am going to shift gears here and bring up another abstract that I found to be quite intriguing, and this relates to reimbursement of expenses, et cetera, for clinical trials. This is an abstract from Courtney Williams and team. It brings to mind the importance, I think, of recognizing the hardships that patients take on by clinical trials, but I also would love for you to comment on that sort of fine line between reimbursement for expenses and then, you know, sort of undue enticement. It is a challenging balance there. But give me your reflections on this abstract. Dr. Fumiko Chino: Absolutely. You are speaking about Dr. Williams' Abstract 93 from the Alabama group, and Alabama actually has this incredible group of health services researchers which is, are doing really important work in this space. What this trial shows is that, you know, it is a small pilot study, it is 30-something patients that received some support primarily for their travel and additional expenses related to their clinical trial participation for breast cancer. It showed that the money helps, and I think what we all know is that it is expensive to participate in clinical trials. It requires additional visits. It often requires some significant travel burden for our patients, and I do not feel that money reimbursement for clinical trial expenses is an inducement. Nobody participates in a clinical trial to get the money for their gas, right? We know that our patients are making some pretty significant sacrifices in order to participate in clinical trials, and what this type of program does is just actually reimburse them for their outlaying of funds.  And I loved this trial because the patients were actually given $1,000 a month for the first 4 months of their trial participation, and what the study showed is that the patients were using it for things like travel-related food, for things like transportation, caregiver expenses, or even some of their out-of-pocket medical expenses like cost sharing or prescriptions. And that they said that overall, the reimbursement really made a difference in terms of their capacity for staying on the clinical trial. Because we know our clinical trials really are not able to enroll the full diversity of patients that often have a disease, and that the patients that are at biggest risk for a health care disparity or a gap in care are also the least likely to enroll in a clinical trial.  Programs like this are an essential part of showing how financial toxicity can be overcome with pretty straightforward assistance to patients to help reimburse them for the things that they are already taking out of their pocket, for parking costs, for that $10 soup that they buy at the cancer center, for those additional expenses that we are, unfortunately, putting on them. Dr. Monty Pal: Very well said. And you know, I have started to dabble in clinical trials looking at CAR T-cell therapies for kidney cancer, and I have to tell you, it is just insane the amount of cost that a patient would have to take on to comply with the stipulations for some of these novel therapies. We require that they stay within 30 minutes of the facility for 28 days, and unless we are compensating for some of that, I mean, how can one afford a hotel stay that is that long? I mean, it is just, it is unprecedented, and it would certainly provide a huge barrier to many patients who would otherwise enroll. Really well said. I also wanted to bring up another financially driven topic, and treating renal cell, again, I would say the vast majority, 90% plus of my patients in clinic are on oral drug therapies. And I cannot tell you how often a patient will show up in my practice and say, "Doc, I have got 15 days out of this 30-day prescription left. What do I do with it?" You know, or some come with pill bottles from a deceased loved one. And it is so frustrating to say, "Take it to the pharmacy and they will just get rid of it for you." But sounds like there is an abstract from Dr. Mackler, Abstract 102, that seems to address this topic quite well. Am I right? Dr. Fumiko Chino: Absolutely. This presentation, I was the most excited about seeing because this group, which helps run a cancer drug repository, theirs is called YesRx, presented their data from the last approximately two years of running this repository, and they were able to show incredible benefit for their patients in Michigan. And it is a really straightforward program. It is run by pharmacists. It has support from the legislation in Michigan. And what they were able to show is that they repurposed medications that would otherwise have been discarded. They delivered them directly to the oncologist, which then actually dispersed them to the patients. They helped 1,000 patients in less than two years. They saved them millions of dollars, over $15 million presented in the abstract. And it is just a win-win-win because I know that patients actually, and sometimes patient caregivers, they feel very sad to have spent a lot of money out of pocket for their medication, and then if they have a dose reduction or, obviously, you know, if the surviving spouse then has to get rid of their medication, just dispose of them, it is very disheartening. And this is a way of kind of reclaiming power for patients. So they were able to accept donations from all over the state of Michigan and then also help over 1,000 patients. And so, it is a phenomenal program. Dr. Monty Pal: Just wild when I came across the dollar amounts, right, that they were saving. It just, it seems like a place that, you know, we just have to look, as cancer centers, right, and really take this on. Just brilliant. On that same theme of cost savings and so forth, you know, I think there has been a lot of focus on what recent policies have done in the context of us having access to therapies and so forth. And one of the topics that has come up is the Inflation Reduction Act and how changes pertaining to the IRA have really played a role in one's ability to take on some of these expensive prescriptions. And I believe John Lin and colleagues tackled that issue in Abstract 97. Could you comment on that, Fumiko? Dr. Fumiko Chino: Absolutely. Dr. Lin is one of my colleagues here at MD Anderson, so I know him very well, and he has been doing really phenomenal work over the last several years with looking at drug affordability and access. And what his analysis shows is that for patients, after the Inflation Reduction Act's cap on out-of-pocket expenses, is that it really did show that out-of-pocket expenses decreased. So what the Inflation Reduction Act did is that it eliminated the 5% co-insurance and placed this $2,000 cap on out-of-pocket expenses. And what that led to for these patients that were not able to have the low-income subsidy is that there were lower costs, and that there was a lower rate of drug abandonment, meaning that the prescription was not refilled. There was also a lower rate of unfilled prescriptions as well. And I think that it shows that health policy really can improve access to care. I think the flip side of the fact that the IRA, this policy, really did seem to help people is that what his research showed is that actually, even with the benefits of this cap, is that actually it is still really high in terms of the rate of people who are not able to fill their prescriptions or that completely abandon them over time. And that unfortunately, even with this change, that over half of people without the low-income subsidy were potentially not getting the full benefit of their medications because they were not able to afford them. And so I think it really kind of highlights that we still need to do more work about making drugs affordable. Dr. Monty Pal: Indeed, indeed. And I mean, in a setting like this, I mean, I think it is important to recognize that $2,000 is a lot, it is a big chunk of change, right, for a lot of families in the U.S. What do you think of the prospect of, like, decreasing that cap? Is that something that from a policy standpoint you would be supportive of? Dr. Fumiko Chino: Well, so something that is a real option for patients on Medicare is there is something called the Medicare Prescription Payment Plan, and what it allows you to do is actually prorate the $2,000 over the whole year. And so instead of having to pay $2,000 as soon as you fill your prescription, because you are going to have, if you have an expensive medication, it is essentially you have to pay the $2,000 in January, right? It allows you to prorate it, so essentially $170 a month, and that comes to you as like a regular bill. And I think that as rolled out as part of the IRA is a really lovely way of thinking about how do we make these payments more stable over time, so it is not a huge hit sort of at the beginning of the year. And I think that alone actually can make a difference in terms of trying to help make sure that people can actually get their medications. Dr. Monty Pal: That is an excellent tip. Excellent tip.  We are going to shift gears entirely. We have been talking a lot about the dollars and cents of things and talk about an abstract from Sophia Smith and colleagues. So this is Abstract 550 at your meeting. And this hinged on a program of sorts to deal with post-traumatic stress disorder. We do not often think about PTSD in the vernacular for oncology patients, but indeed, I mean, it is something that they must face, especially in the context of long-term survivorship. Can you talk a little bit about Dr. Smith's abstract? Dr. Fumiko Chino: Absolutely. I love this work from Dr. Smith, who is at Duke. She worked with Dr. Applebaum, who was my old colleague at Memorial Sloan Kettering. And this group of researchers really is trying to figure out how to best support people into survivorship so that they can actually thrive. And their patient population for this work was actually people who received stem cell transplant, and they focused on people who had PTSD symptoms. And what they were able to show through this SMART design, which is essentially this serial, multiple randomized trial, so everyone got randomized upfront to either usual care or this app, so this digital app that actually helped coach people through cancer distress. And then for the people who were non-responders, they were then additionally randomized to either the app plus coaching or a therapist versus the cognitive behavioral therapy or CBT.  And what they were able to show is that, number one, anyone who had the app seemed like they did better than those who did not start the path with the app. But then the additional help of either the therapist or the coach or the CBT made additional benefit over time. And so, I think this shows a really nice stepped care, which is you can potentially have some right-sizing of treatments cost saving, if we sort of give everyone the app, which is, I think, overall pretty low cost. And that for the people who do not get the full benefit from the app, then you can think about these maybe more tailored approaches, the therapist, the coach, the CBT, but that some people actually just respond to the app. And I think it allows us to, again, right-size the care for our patients. And I think it is really innovative to think about how technology can help improve access to care in the setting of something like PTSD. Dr. Monty Pal: Brilliant summary. Brilliant summary.  Gosh, it looks like such an exciting meeting this year. Congratulations on a terrific program for the ASCO Quality Care Symposium. I know you played a huge role in developing it, and thanks for sharing your insights on the ASCO Daily News Podcast. Dr. Fumiko Chino: No, I really appreciate you having me. ASCO Quality is my favorite meeting of the year. You know, it is really a phenomenal meeting, and I am so excited for next year in Boston in 2026. Dr. Monty Pal: Awesome. And thanks to our listeners too. You are going to find links to all the abstracts that we discussed today in the transcript of this episode. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement. More on today's speakers: Dr. Sumanta (Monty) Pal  @montypal Dr. Fumiko Chino @fumikochino Follow ASCO on social media: @ASCO on Twitter ASCO on Bluesky ASCO on Facebook ASCO on LinkedIn Disclosures of Potential Conflicts of Interest: Dr. Monty Pal:     Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis Dr. Fumiko Chino:  Consulting or Advisory Role: Institute for Value Based Medicine Research Funding: Merck

Join host David Wild as he speaks with Stacie Bell, chief clinical research officer at Lupus Therapeutics, about the dramatic transformation happening in lupus drug development. From a field once avoided by pharma companies to one generating unprecedented excitement, Bell discusses how her organization's 62-center network is revolutionizing clinical trials through patient engagement and scientific innovation. Learn about promising oral therapies, Genentech's cancer drug Gazyva under FDA review for lupus nephritis, cell therapy approaches offering potential long-term remission and how combination treatments may become the new standard. Bell shares insights on overcoming clinical trial barriers, advancing biomarker research and ensuring representative participation from lupus communities. A must-listen for anyone interested in autoimmune disease research, clinical development innovation, and patient-centered drug development.

Is the future of biotech innovation at risk because of workforce shortages? In this episode, host Elaine Hamm, PhD, talks with Van Ton-Quinlivan, MBA, CEO of Futuro Health and host of the WorkforceRx podcast, about how the biotech and healthcare industries can overcome the growing workforce crisis. Together, they explore how intentional workforce development, stackable credentials, and stronger partnerships between industry and education can help close the talent gap and create a more diverse, sustainable pipeline of healthcare professionals. In this episode, you'll discover: Why workforce shortages—not funding—may be the biggest threat to healthcare innovation. How stackable credentials and education partnerships can expand access to biotech and allied health careers. Strategies for building a diverse and future-ready workforce that keeps innovation moving forward. Tune in to hear how biotech and healthcare leaders can tackle the talent crisis head-on and build a stronger, more resilient future for innovation. Links: Connect with Van Ton-Quinlivan, MBA, and check out Futuro Health and the WorkforceRx podcast. Connect with Elaine Hamm, PhD, and learn about Tulane Medicine Business Development and the School of Medicine. Check out the California Health Workforce Education and Training Council, Genentech, Kaiser Permanente, and NextFlex. Connect with Ian McLachlan, BIO from the BAYOU producer. Check out BIO on the BAYOU and make plans to attend October 28 & 29, 2025. Learn more about BIO from the BAYOU - the podcast. Bio from the Bayou is a podcast that explores biotech innovation, business development, and healthcare outcomes in New Orleans & The Gulf South, connecting biotech companies, investors, and key opinion leaders to advance medicine, technology, and startup opportunities in the region.

How do you operationalize scientific truth in regulated environments? Top Global Startups features Dr. Lieza Danan, PhD—Founder & CEO of LiVeritas Biosciences—on agentic AI execution systems that elevate data integrity from method design to audit‑ready results. A mass spectrometrist and cancer survivor, Lieza has contributed to 20+ IND/BLA filings (Genentech, Sutro, Stemcentrx) and built analytical labs across the U.S. and Southeast Asia. Recently honored with the 2025 PhilDev Award for Innovation, she shares how “Built from Truth” became her Ikigai—and a blueprint for better biotech.What you'll learn:Agentic AI for regulated science: compliant execution, traceability, and auditabilityData quality systems that withstand IND/BLA scrutinyLessons from 20+ submissions across leading biopharma teamsBuilding and scaling labs in the U.S. and Southeast AsiaFounder story: survivorship, mass spectrometry, and mission‑driven leadershipIkigai in action: turning values into operating DNACall to action:Subscribe for more global founder conversations from GSD Venture Studios:GSD Venture Studios: https://gsdvs.com#AgenticAI #RegulatedScience #ScientificIntegrity #DataIntegrity #GxP #IND #BLA #Biotech #Pharma #MassSpectrometry #LiVeritas #Ikigai #PhilDevAward #TopGlobalStartups #PodcastLive

Seeing your allergist on a screen instead of in the office might feel strange at first, but for many people with allergies, telehealth isn't just convenient.  it's effective. In this episode, we sit down with telemedicine pioneer Dr. Jay Portnoy to explore how virtual allergy care works, what it can and can't do, and how it's helping patients get the care they need without the wait or the long drive. Dr. Portnoy shares over two decades of experience leading allergy telemedicine programs in rural areas and explains how remote care has grown from a fringe idea into a standard part of allergy care. He and Dr. G also discuss the benefits for both patients and clinicians. So how do you know when telehealth is enough and when it's not? What we cover in our episode about virtual allergy care and telemedicine: How does telemedicine work for allergy patients? Learn how video visits and asynchronous tools are making care faster and easier, especially in rural or underserved areas. Telemendine limitations. We break down when in-person care is still needed, like for food challenges, skin tests, or urgent symptoms. Privacy and safety in virtual care. From HIPAA-compliant platforms to quiet spaces at home or in schools, we talk about how to keep your virtual visit just as private as a clinic one. How testing works with telemedicine. Telehealth doesn't mean skipping tests. Many can be ordered remotely and done at a local lab or clinic near you. The future of allergy care. Hear how virtual care is shifting toward patient choice, whether you want to video call, send a message, or still come in. ___ Made in partnership with The Allergy & Asthma Network. Thanks to Genentech for sponsoring today's episode.  This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

Dr. Monty Pal and Dr. Matteo Lambertini discuss a compelling global study on the clinical behavior of breast cancer in young BRCA1 and BRCA2 carriers, the association of pre-diagnostic awareness of BRCA status with prognosis, and the importance of identifying healthy people who are at risk of carrying the BRCA1/2 pathogenic variants. TRANSCRIPT Dr. Monty Pal: Well, hello everyone, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor, and vice chair of medical oncology at the City of Hope Comprehensive Cancer Center in Los Angeles. Now, when we think about genetic testing, whether for patients diagnosed with breast cancer or for other family members of them, it seems to be widely underutilized. Today, we're going to be discussing a recently published study in the Journal of Clinical Oncology that reported on the clinical behavior of breast cancer and specifically young BRCA1 and BRCA2 carriers, and the association of pre-diagnostic awareness of BRCA status with prognosis. I thought this was just a fascinating piece, and I honestly couldn't wait to have this conversation. It's a really compelling paper that highlights the importance of identifying healthy people who are at risk of carrying the BRCA1/2 pathogenic variants, and really the need for genetic counseling and testing to inform people about early detection that could lead to a better prognosis. I'm really delighted to welcome the study's lead author, Dr. Matteo Lambertini. He really needs no introduction. He's very well known in the breast cancer world for his amazing contributions to fertility in the context of breast cancer, to pregnancy in the context of breast cancer, and genetic testing. He's an associate professor at the University of Genova, and a breast cancer medical oncologist at the San Martino Polyclinic Hospital in Genova, Italy.  Dr. Lambertini, thank you so much for joining us today. Dr. Matteo Lambertini: Thank you very much, Dr. Pal. It's a great pleasure. Dr. Monty Pal: Oh, thanks. And just FYI, if you're listening in and you want to hear our disclosures, they're all listed at the transcript of this podcast.  So, I poured through this paper [Clinical Behavior of Breast Cancer in Young BRCA Carriers and Prediagnostic Awareness of Germline BRCA Status] yesterday, Dr. Lambertini, and first of all, congratulations on this study. This was a huge international multicenter effort, 4,752 patients. How did you pool all these patients with young breast cancer? Dr. Matteo Lambertini: Thanks a lot for the question. Yes, this was an effort made by several centers all over the world. The main idea behind the creation of this network that we have named as BRCA BCY Collaboration, was to get as many data as possible in a sort of niche patient population in the breast cancer field, meaning women diagnosed with breast cancer at the age of 40 years or younger, and all of them being BRCA carriers. We know that around, in the Western world, around 5% of breast cancer cases are being diagnosed under the age of 40 years, and among them around 10-15% are BRCA carriers. So, I would say it's a relatively rare patient population where we did not have a lot of evidence to support our choices in terms of counseling on treatment, prevention, and oncofertility as well. That was the idea behind the creation of this network that includes many centers. Dr. Monty Pal: Yeah. You know, what's so interesting about this is that you sort of draw this line between patients who have BRCA testing at the time of diagnosis and then BRCA testing earlier in their course and then leading to a diagnosis perhaps. And I think that's where really sort of the dichotomy in outcome sits. Can you maybe elaborate on this and tell us about timing of genetic testing in this study and what that meant ultimately in terms of prognosis? Dr. Matteo Lambertini: In this specific analysis from this large network, including almost 5,000 women with breast cancer diagnosed at the age of 40 years or younger and being a BRCA carrier, we looked specifically into the timing of genetic testing because this is a retrospective study and the criteria for inclusion are those that I have just mentioned, so diagnosis at a young age plus carrying germline BRCA pathogenic or likely pathogenic variant. In this analysis, we have looked into the time the patient has got the genetic testing and particular we focused on two populations: those that were diagnosed, knowing already to be a BRCA carrier, and those that got tested after being diagnosed with breast cancer. And the main findings from this analysis have been that knowing to be a BRCA carrier was associated with a lower stage at the time of diagnosis, meaning more T1 tumors, so a tumor less than 2 cm, more node-negative disease, and this translated into less aggressive treatment, so less often axillary dissection, less often use of chemotherapy and anthracycline-based chemotherapy. And even more importantly, we have seen a better overall survival for those patients that were diagnosed already knowing to be BRCA carriers as compared to those tested after breast cancer diagnosis. These results after adjusting for all the confounding, stage, treatment and so on, there was not significant anymore, meaning that it's not the timing of test per se that is probably leading to a better survival, but it is the fact that knowing to be a BRCA carrier would likely translate into having access to all the preventive measures that we have in this setting and this will translate into an overall survival benefit, so in terms of saving more lives in young BRCA carriers. Dr. Monty Pal: I think it's such an important point, and it's one that I think might sound implicit, right, but it needs to be proven, I think, through a study like this. You know, the fact that finding this early, identifying the mutation, doing enhanced screening, and so forth, is really going to lead to superior clinical outcomes. One of the things that I think many people puzzle over, including myself, is what to do? I personally occasionally will see BRCA altered patients in the context of prostate cancer. But that's a very different population of individuals, right? Typically older men. In young females with BRCA mutation, I guess there's a specific set of considerations around reproductive health. You'd already highlighted preventive strategies, but what sorts of things should we be talking about in the clinics once a patient's diagnosed and once perhaps their breast cancer diagnosis is established? Dr. Matteo Lambertini: Yes, exactly. Knowing to be a BRCA carrier has a lot of implications from prevention to treatment to survivorship issues including reproductive counseling. And this is important not only for the patient that has been diagnosed with breast cancer but also for all the family members that will get tested and maybe identify with this sort of genetic alteration before diagnosis of cancer. Why this is important is because we have access to very effective preventive measures, a few examples: MRI screening, which starts at a very young age and normally young women don't have an effective screening strategy outside the BRCA field. Also, primary preventive measures, for example, risk-reducing surgery. These women are known to have a high risk of breast cancer and high risk of ovarian cancer. So the guidelines are suggesting to undergo risk-reducing salpingo-oophorectomy at a young age, so 35 to 40 years in BRCA1 carrier, 40 to 45 years in BRCA2 carrier. And also risk-reducing mastectomy should be discussed because it is a very effective way to prevent the occurrence of breast cancer. And in some situations, including the setting that we are talking about, so young women with breast cancer, BRCA carrier, also risk-reducing mastectomy has shown to improve overall survival.  On the other side, once diagnosed with breast cancer, nowadays knowing to be or not a BRCA carrier can make a difference in terms of treatment. We have PARP inhibitors in the early setting, in the adjuvant setting as well as in the metastatic setting. And in terms of survivorship implication, one of the critical aspects for young women is the oncofertility care which is even more complicated when we talk about BRCA carriers that are women candidates for gynecological surgery at a very young age. So this sort of counseling is even more complicated. Dr. Monty Pal: One of the other things, and this is subtle in your paper and I hope you don't mind me bringing it up, is the difference between BRCA1 and BRCA2. It really got me thinking about that because there are differences in phenotype and manifestation. Do you mind just expanding on that a little bit for the audience because I think that's a really important reminder that you brought up in the discussion? Dr. Matteo Lambertini: The difference between BRCA1 and BRCA2 carriers has been known that there are different phenotypes of breast cancer that are more often diagnosed in these two different populations. Normally BRCA1 carriers have a higher likelihood to develop a triple negative breast cancer as compared to BRCA2 carriers, more likely to develop a hormone receptor-positive HER2-negative disease. In this study, again, a specific population of young women with breast cancer, we have seen the same findings, mostly triple negative disease in BRCA1 carrier, mostly luminal-like disease in BRCA2 carrier. But what's novel or interesting from this study is to look also at the age at the time of diagnosis of this disease. And particularly in BRCA1 carriers, we should be sort of more careful about diagnosis of breast cancer and also other primary tumors including ovarian cancer because the risk of developing these malignancies is higher even at a younger age as compared to BRCA2 carriers. And this has implications also in the primary and secondary prevention that we were talking about earlier. Dr. Monty Pal: Oh, interesting. I guess the fundamental question then from your paper becomes, how do we get at the right patients for screening for BRCA1 and BRCA2? And I realize our audience here is largely oncologists who are going to be listening to this podcast, oncology providers, MDs, nurses, etc. But maybe speak for a moment to the general practitioner. Are there things that, for instance, a general practitioner should be looking for to say, “Wait a minute, this patient's high risk, we should consider BRCA1, BRCA2 testing or germline screening”? Dr. Matteo Lambertini: Yes, it's a very important question for the breast cancer community. After the updated ASCO guideline, the counseling is way easier because right now the age cutoff goes up to 65 years, meaning that all the patients diagnosed with breast cancer below the age of 65 years should be tested these days. And then above the age of 65, there are different criteria like triple-negative disease or family history. From a general practitioner standpoint, it's of course a bit more difficult, but knowing particularly the family history of the person that they have in front will be crucial to know if there are cases of breast cancer diagnosed at a young age, maybe triple-negative cases, knowing cases of ovarian cancer in first-degree relatives or pancreatic cancer in first-degree relatives, and of course cases of prostate cancer as well. So, I would say probably mostly the family side will be important from a general practitioner perspective.  From an oncology one, the other point that I think is important to stress also based on the data that we have shown in this publication is that having a case of breast cancer known to carry a BRCA pathogenic or likely pathogenic variant. It means that all the people around this case should get tested and if found to be BRCA carrier and healthy carrier, these people should also undergo the primary and secondary prevention strategies because this is very critical also to improve their outcomes and try to avoid the developing of breast or ovarian cancer, but also in the case of diagnosis of this disease, a diagnosis at an earlier stage, as we have seen in this paper. Dr. Monty Pal: Brilliant. I'm going to diverge from our list of questions here and close by asking a question that I have at the top of my mind. You're very young. I know our podcast listeners can't see you, but you're very, very young. Dr. Matteo Lambertini: Thank you. Thank you for that. Not so young but yeah. Dr. Monty Pal: You have nearly 300 papers. Your H-index is 67. You've already made these seminal contributions, as I outlined it from the outset, regarding fertility, regarding use of GnRH analogs, regarding pregnancy and breast cancer. What are you studying now? What are you really excited about right now that you're doing that you think might potentially be practice changing? Give us a little teaser. Dr. Matteo Lambertini: Yeah. Thanks a lot, Dr. Pal. Receiving this compliment from you is fantastic. So, thanks a lot for that. From my side, in terms of my research, I've been interested in the field of breast cancer in young women since the start of my training. I've had very good mentors from Italy, from Europe, from the U.S. I'm still interested in this field, so I think we still have a lot to learn to try to improve the care of young women with breast cancer. For example, the oncofertility care, which is something I worked a lot over the past years. Now with all the new treatment options, there's a sort of new chapter of oncofertility counseling. So, what's the impact of immunotherapy? What's the impact of the new targeted agents?  More on the genetic aspects, now we know that there's not only BRCA1 or BRCA2. There are a lot of other different genes that may increase the risk of breast cancer and other malignancies. And also for these genes, we really don't have a lot of evidence to counsel women on prognosis, treatment, prevention strategy. So we need to learn way more for this special patient population that are quite rare, and so we really need a multicenter academic effort to try to give some evidence in this field. Dr. Monty Pal: Yeah. It's tough because these are rare circumstances, but, you know, I think that you've done really well to sort of define some collective experiences that I think really define therapy. I mean, I just remember when I was in training 25 years ago, just reading through textbooks where all the experience around breast cancer and pregnancy was really just very sort of anecdotal almost, you know? And so it's great to see that the state of the science has moved forward.  Well, gosh, I really enjoyed our conversation today. I think your study really reminds us how powerful genetic information is in terms of improving outcomes. And, you know, hopefully this will lead some individuals to perhaps test more broadly in appropriate settings. So, thank you so much, Matteo, for joining us today with your fantastic insights on the ASCO Daily News Podcast. Dr. Matteo Lambertini: Thank you very much, Dr. Pal. It's a real pleasure. Dr. Monty Pal: And thanks to our listeners too. You'll find a link to Dr. Lambertini's study in the transcript of this episode. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Thanks a ton. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:    Dr. Sumanta (Monty) Pal  @montypal  Dr. Matteo Lambertini @matteolambe   Follow ASCO on social media:     @ASCO on Twitter    ASCO on Bluesky   ASCO on Facebook     ASCO on LinkedIn     Disclosures:    Dr. Monty Pal:   Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview  Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical  Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis  Dr. Matteo Lambertini: Consulting or Advisory Role: Roche, Novartis, Lilly, AstraZeneca, Pfizer, MSD, Exact Sciences, Gilead Sciences, Seagen, Menarini, Nordic Pharma Speakers' Bureau: Takeda, Roche, Lilly, Novartis, Pfizer, Sandoz, Ipsen, Knight Therapeutics, Libbs, Daiichi Sankyo, Gilead Sciences, AstraZeneca, Menarini, AstraZeneca, Menarini Research Funding (Inst.): Gilead Sciences Travel, Accommodations, Expenses: Gilead Sciences, Daiichi Sankyo Europe GmbH, Roche

In July 2024, Chris Bombardier leads a team of climbers with bleeding disorders on an attempt to summit Mont Blanc, the tallest peak in the Alps. Chris is older and wiser than he was when he climbed the Seven Summits–but now he has new responsibilities, like fatherhood.     This episode is brought to you by Genentech. Visit http://www.hemashort.com/ to watch the short film.   Guests:  Dr. Ryan Warner, clinical psychologist and speaker, founder of RC Warner Consulting    Joana Baquero, business strategist and resilience expert, author, Driven by Hope; Ted Talk: “Resilience: A Mindset for Everyday Life”    Patrick James Lynch, Founder and CEO of Believe Limited, (Instagram)  Joana Baquero, business strategist and resilience expert, author, Driven by Hope; Ted Talk: “Resilience: A Mindset for Everyday Life” 

Multiple food allergies are a daily stressor for millions of families. From avoiding social events to fearing accidental exposures, it can feel like living in a constant state of alert. Until recently, there were no FDA-approved treatments that targeted more than one allergen at a time. In this episode, we break down the study: “Omalizumab for the Treatment of Multiple Food Allergies,” published in 2024 in the New England Journal of Medicine. Known as the OUtMATCH trial, it's the first large-scale study to show that omalizumab (Xolair), a biologic already used for asthma and hives, may help people with multiple food allergies by raising the threshold for reactions. We explain how omalizumab works by blocking IgE, the antibody that triggers allergic reactions, and how the study measured changes in reaction thresholds (the amount of an allergen a person can ingest before reacting). We also explore the trial design, results, safety profile, and what all of this means for the day-to-day management of food allergies. What we cover in our episode about OUtMATCH trial How omalizumab works to prevent allergic reactions: Learn how blocking IgE increases the amount of allergen needed to trigger symptoms, offering protection from small, accidental exposures. Who qualified for the OUtMATCH trial and why: Find out which patients were included and how eligibility impacted outcomes. What success looked like in this study: Understand how researchers defined protection across multiple allergens. Why not everyone responded the same to omalizumab: Explore the variability in results and what it means for clinical care. What else the study found beyond food challenges: Hear about safety findings, quality of life data, and the open-label extension.

After climbing the Seven Summits, Chris becomes executive director of Save One Life. It's a chance to help people with bleeding disorders. But it's also his first time in a leadership role.  This episode is brought to you by Genentech. Visit http://www.hemashort.com/ to watch the short film. Guests:  Amy Board, MNM, Believe Limited Senior Vice President of Engagement and Programs    Patrick James Lynch, Founder and CEO of Believe Limited, (Instagram)     Dr. Ryan Warner, clinical psychologist and speaker, founder of RC Warner Consulting    Joana Baquero, business strategist and resilience expert, author, Driven by Hope; Ted Talk: “Resilience: A Mindset for Everyday Life”    The Final Summit is produced by BloodStream Media. To get in touch, email mailbag@bloodstreammedia.com Connect with BloodStream Media: BloodStreamMedia.com BloodStream on Facebook  BloodStream on X/Twitter  BloodStream on Instagram BloodStream on LinkedIn BloodStream on TikTok  

Dr. Monty Pal and Dr. Mina Sedrak discuss the science behind cancer treatment-induced accelerated aging and the development of drug therapies and technologies aimed at helping older patients and cancer survivors. TRANSCRIPT Transcript: Cancer and Aging: Researching the Path to Longer, More Vibrant Lives Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I am Dr. Monty Pal. I am a medical oncologist and professor and vice chair of medical oncology here at the City of Hope Comprehensive Cancer Center. I am also host of this podcast. Today, we are going to be talking to somebody that I consider to be my little brother, if you will, in oncology, Mina Sedrak. Mina is an expert in the area of cancer and aging, which really includes the development of drug therapies and technologies that help enable older adults and survivors to live longer, healthier, and more vibrant lives. I am really excited to chat with him. He is an expert not just in cancer and aging but also breast cancer. He was my former colleague here at City of Hope before he moved over to the UCLA Jonsson Comprehensive Cancer Center, where he is an associate professor and director there of the Cancer and Aging Program. Dr. Sedrak's research involves mechanisms behind cancer treatment-induced accelerated aging and really aims to take this science into more of a therapeutic direction, which I am super, super excited about.  Mina, thanks so much for joining us today, and just FYI for our listeners, we have all of our disclosures in the transcript of this episode. Dr. Mina Sedrak: Thank you, Monty. Thank you, Dr. Pal, for having me. I am really excited to be here. Dr. Monty Pal: I feel like we have to go on a first-name basis here with how well we know each other. So Mina, you and I together have witnessed this evolution in cancer and aging. I mean, both of us worked together here with just a legendary figure in the field of geriatric oncology, I will call it, Dr. Arti Hurria, mentor to me, mentor to you, mentor to so many. Can you give us a sense of where cancer and aging has gone since the time that you and I started here together at City of Hope? Dr. Mina Sedrak: Dr. Hurria and her collaborators, Dr. [Willliam] Dale and Dr. [Supriya] Mohile, they were like huge pioneers in the field. They were one of the very first people to highlight the importance of looking at older adults beyond just their chronological age and their comorbidities and moving us beyond just seeing patients and making decisions using what we call the eyeball test. "Oh, this person looks fit or not fit, frail or robust," to really using objective measures to assess our patient's health status and incorporate that assessment into our evaluation of the treatment, prognostication, and discussions with our patients throughout the cancer continuum. And so that is what geriatric oncology has and continues to be, and it is a huge, important part. And their work has laid the foundation to show that when we look at our patients beyond just their chronological age and we look at their functional age, and we do these objective assessments, we can gain much more deeper information to tailor the treatment for our patient that is sitting in front of us, rather than do a prescriptive treatment or over- or undertreatment in that population. So that is sort of where the field is growing, and a lot of the work now is, how do we implement that? How do we put that into clinical practice? Dr. Monty Pal: Well, let me kind of spearhead that discussion, right? I have these moments when I go to the ASCO Annual Meeting – I remember this happened to me a while ago when Dr. Jennifer Temel presented that terrific work around early palliative care interventions, right? Or it even happened to me this year, right, when Dr. Christopher Booth presented the CHALLENGE trial around exercise and colon cancer. You know, these amazing, I am going to say simple, they are not simple, but they are simple interventions relative to, you know, some of the complex drugs and mechanisms that we are using nowadays that really help outcomes for our cancer patients. The big question becomes, how do you implement, right? But my understanding is that there are easy ways for us to take tools in cancer and aging and sort of plug them into our daily practice. Am I right about that? Dr. Mina Sedrak: Yes, and that is something that they are – the Cancer and Aging Research Group, which was founded by Dr. Hurria and now is co-led by Dr. Dale, Dr. Mohile, and Dr. [Heidi] Klepin, they have been incredible at really trying to develop practical tools, like the Practical Geriatric Assessment, which is now endorsed by the ASCO and other NCCN guidelines. And so, there are tools that are becoming more and more practical to help incorporate that into clinic.  Now, what might be practical in a resource-intensive setting may not be practical in some of the limited resources, whether it is rural and/or other countries where the resources may be more limited. So that is why Cristiane Bergerot, Enrique Soto, and others have been really working hard. There was actually a really beautiful paper that was just published in the Journal of Global Oncology, where they have shown that there are guidelines [ASCO Geriatric Assessment Global Guideline] about how to implement these tests, these tools, these assessments in clinical practice, even in different resource settings. So I think we are going to get to the future where this is much more – it is definitely important, but it is much more easily ‘incorporatable' into our practice. Dr. Monty Pal: Yeah, you know how close I am to Cris, and I was so proud when I saw that paper come out. That was really exciting. You know, I skimmed it. I have to tell you, I did not get into the weeds, but it was apparent to me that, you know, some of these geriatric oncology tools are things that, you know, I could probably plug and play into my practice where I am double- and triple-booked over, you know, most slots, right? I mean, I could still probably afford a little bit of time or maybe have, like, a nurse or an extender kind of help participate in the evaluation process. I thought that was, yeah, really, really interesting. Dr. Mina Sedrak: I will just say that at UCLA, we are working with Dr. Arash Naeim, who is a geriatric oncologist, and he has developed an AI platform where the assessments can be done by an AI computer. So it is like talking to your ChatGPT. They can talk to you, and for a few minutes, they will ask you the questions. So you do not even have to fill it out on a piece of paper. You could give the patient a little iPad, put them in a private room while they are waiting for their doctor, and get the results, and it is right there for you. And so, we have been trying to think about how can technology help with the completion of the assessment, at least doing that? And I think it is actually, it has been very cool. We did a pilot study. He is writing that up, and we are going to continue to do some of this exciting work. How do we think about AI in the context of this? And, you know, older adults, they are not like what they used to be. A lot of older adults are very familiar with and comfortable with phones and computers and iPads, much more so today than they were even at the time when Dr. Hurria was alive. Dr. Monty Pal: That is so interesting. You mentioned this, the AI approach is something I have been thinking about in this context because what if, for instance, you know, we have got video monitors all over our hospital, right? What if you are actually just taking a look at that patient as they make their way towards your clinic? Capture that video, use an AI algorithm to say, "Hey, you know, the timed get-up-and-go test in this patient is not particularly good based on what I am seeing here," right? There are so many ways that you could, you know, stir the pot and come up with creative ways to get these tests done. Dr. Mina Sedrak: That's right. And Arash is looking at also sensors. So he has some studies where he is putting sensors inside people's homes, where they would put them, like, on top of an Alexa app or the equivalent. A lot of people have these apps, and basically, they can sense how you are moving around and what you are doing, just movement-wise. And then they can collect that information to gain information about your life beyond just what we are seeing in the 20-minute visit in the clinic. Even when I do a walk test where I get gait speed or physical performance, short physical performance battery, the chair sit-up, those are oftentimes a single, cross-sectional, static measure. But what about the dynamic ability of capturing what has been happening for the last 7 days? What has been happening for the last 25 days between the visits, between the cycles of chemotherapy? And could that inform how I make decisions when I see patients and who do I need to target and identify? And so, we are very excited because really at UCLA, Arash is leading the technology efforts and thinking about implementation of these important measures and these important tools but leveraging new technology. And we do not want to be behind; we want to be ahead of the game. Dr. Monty Pal: I love that idea because there is a Hawthorne effect, isn't there, where you observe a process, and it naturally gets better. I mean, when you ask that patient to get up in the clinic and move, they are probably functioning to the best of their abilities, but we could probably learn a lot from just watching how fast that patient picks up a remote control at home. Some simple movement like that that is volitional would probably help out a ton. And I got to tell you, it is so funny when you mention Arash Naeim's name. I distinctly remember him serving as an attending on the wards when he was brand new at UCLA on faculty when I was a resident there. And his dad is a legendary hematopathologist, right? Dr. Mina Sedrak: I did not know that. Dr. Monty Pal: Yeah, yeah. Faramarz Naeim wrote the book on a lot of heme-path malignancies. Incredible guy. Very, very storied hematopathologist at UCLA.  I could probably go on this topic forever, but in the interest of time, I am going to shift to something that again, I could probably talk about forever, which is this area of senescence that you are involved in. You know, you had mentioned this to me, I am going to say during your outro from City of Hope and towards your transition to UCLA, it is such an exciting area. I mean, understanding the actual biologic process of aging and using those underpinnings to really sort of tailor therapy. So tell us where the state of the science is there with this body of work that you are doing. Dr. Mina Sedrak: As I said before, we have tools now to assess patients and to then do something about the deficits. So if a patient is falling, what we do is we refer them to physical therapy where they can do fall precautions and strength training to give them the information. But all of these supportive care interventions are very important. They are great. But they oftentimes are not targeting the root cause of why they are happening. And so that is really where I have been very interested in, how can we understand why is it that something like chemotherapy or immunotherapy is causing a decline in cognitive function or a decline in physical function? And so that has really led us to think about geriatric oncology rather than a discipline of older adults, but to think about aging as a physiologic process. We are all aging. As every day goes by, we are aging. And what that means is that our bodies are accumulating damage, the cells are being exposed to various stressors, and the repair mechanisms are declining. And as we get older, it is really more damage and less repair mechanism at the cellular molecular level. And it turns out that these processes of how our cells repair and respond to damage are fundamental processes of biological aging. And there has been a large amount of preclinical and now really exciting clinical work to show that there are hallmarks that could be used to assess the rate of which we age by looking at these processes. And that includes things like epigenetics, telomeres, inflammation, and something called ‘cellular senescence.' And we have been interested in my lab in senescence because it is a unique process that has an important role in aging, but it also has a really important role in cancer. Senescence is a cell state. Cells, when they are stressed, they respond to entering this state of senescence. The stress could come from anything. It could come from an oncogene activation. It could come from a reactive oxygen species. It could come from a direct damage to the cell. But it is a cell state, just like apoptosis, necrosis. Senescence is a state in which the cell, in response to that stressor, undergoes an arrest from the G to the S phase. And that arrest is oftentimes associated with a resistance to apoptosis. So then the cell does not die, but it is alive, and it remains metabolically active. And in fact, downstream pathways of these cell cycle inhibition of this G-to-S phase lead to the increase of these transcription factors in the chromatin and lead to the development of these pro-inflammatory factors. So these cells, which can occur in various tissues in the body, can continue to live despite having developed these changes, and then they secrete these proinflammatory molecules like cytokines, chemokines, metalloproteinases, all of these, which are called the senescence-associated secretory phenotype, or SASP. And as we age, we accumulate more and more of these cells, and our bodies are no longer able – our immune system, like macrophages and T cells – are no longer able to remove them effectively. And as we accumulate them in various organs, these organs release a lot of inflammatory cytokines, and the chronic inflammation in that tissue leads to the tissue being damaged, and it does not work as well, and then it starts to decline in function. And that is believed to be how senescence plays a role in aging. It is the accumulation of senescent cells that occurs with increased damage and then the repair mechanism of clearing these cells effectively, which then leads to build up of inflammation and chronic inflammation leads up to damage in multiple tissues. Dr. Monty Pal: This concept to me is fascinating. And I guess the big question is – senescence is bad, right – is it not reasonable to think that this body of research, I mean, if you are able to sort of have a meaningful impact on senescence, it could have implications well beyond oncology. Is that fair? You really could extend lifespan all around. Is that reasonable to think, all-cause mortality? Dr. Mina Sedrak: One hundred percent. And that is what they have been shown in animal models. And the reason senescence is exciting is because it turns out that you can target these cells and you can induce apoptosis of these cells, but it requires active targeting of various pathways, but it can occur. And when it does, and it is done either genetically or pharmacologically in mice, we see that the mice can reverse damage. So if you take an old mouse and you genetically engineer it to remove senescent cells, that mouse will go from being frail to fit. And if you take a young mouse and you induce senescent cells at a high rate and you accumulate them in that mouse, that mouse, even though it is young, will become frail.  So that has really led to this exciting opportunity of, can we translate this finding that we are seeing in animals and in in vivo cells, cell cultures, into humans? And could that have a benefit beyond just one disease? Could it have a benefit in multiple diseases? And not just really longevity, which I think it would be great, but what people are really looking for is, how do we live healthy as we get older? How do we move the curve so that people are not developing chronic diseases in their 60s, but they are developing them in their 80s towards shortening the period of their life with disability rather than what we have currently, which is people are living to 70s, the average life expectancy is in the mid-70s, but they are spending 10 or 11 years in disability of that life. And so, how could we reduce that time frame? Dr. Monty Pal: This is brilliant, Mina. And for our audience, this compelling dialogue that we have had here thankfully is translating to funding for Mina's work. He just scored in the second percentile for his NIH R01 based on this topic. We are so, so proud of you. I mean, it is just remarkable work. It is not easy in the current climate to get funding, and a second percentile score is just absolutely wonderful. You know, Mina, I could probably go on with you for a couple more hours here talking about your work in cancer and aging. I think I am going to have to have you back on the podcast here. But a million thanks for sharing your thoughts here today on the ASCO Daily News Podcast.  And thanks to our listeners too. If you value the insights that you heard today on the ASCO Daily News Podcast, please do not forget to rate, review, and subscribe wherever you get your podcasts. Thanks, Mina. Dr. Mina Sedrak: Thank you so much. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:     Dr. Sumanta (Monty) Pal   @montypal  Dr. Mina Sedrak @minasedrakmd   Follow ASCO on social media:      @ASCO on Twitter     ASCO on Bluesky    ASCO on Facebook      ASCO on LinkedIn      Disclosures:     Dr. Monty Pal:    Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview   Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical   Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis   Dr. Mina Sedrak: Patents, Royalties, Other Intellectual Property: Up-to-Date

Chris looks back on his journey to climb the Seven Summits through a new lens: what it was like to become a role model in the international bleeding disorder community, and how it affected him.    This episode is brought to you by Genentech. Visit http://www.hemashort.com/ to watch the short film.   Guests:  Dr. Ryan Warner, clinical psychologist and speaker, founder of RC Warner Consulting    Patrick James Lynch, Founder and CEO of Believe Limited, (Instagram)     Joana Baquero, business strategist and resilience expert, author, Driven by Hope; Ted Talk: “Resilience: A Mindset for Everyday Life”  The Final Summit is produced by BloodStream Media. To get in touch, email mailbag@bloodstreammedia.com Connect with BloodStream Media: BloodStreamMedia.com BloodStream on Facebook  BloodStream on X/Twitter  BloodStream on Instagram BloodStream on LinkedIn BloodStream on TikTok  

The high cost associated with cancer diagnosis, treatment, and survivorship makes the burden of financial toxicity an unavoidable reality for many patients—and makes financial navigators central to the delivery of high-quality cancer care. In this vodcast episode, CANCER BUZZ speaks with Heather Simpson, BCPA, patient financial navigator lead, who shares her experience using the ACCC Financial Advocacy Network's financial advocacy services guidelines assessment tool to pinpoint financial navigation challenges within her cancer program. Heather Simpson, BCPA Patient Financial Navigator Lead              Allina Health Cancer Institute   River Falls, WI “When [ACCC] came out with a gap assessment tool in 2024...it allowed us to see where we had hit the mark with our program and where we had some gaps we could take care of to really be in line with the [Financial Advocacy Network's] guidelines.” Resources: Financial Advocacy Guidelines Financial Advocacy Services Assessment Tool Financial Advocacy Services Guidelines Assessment Tool User Guide In the Field: Practical Financial Advocacy Strategies for Supporting Cancer Patients Oncology Reimbursement Meetings This podcast is made possible by funding and support provided by Genentech, Eisai, Pfizer, and Regeneron and in partnership with AONN+, NPAF, Triage Cancer, and CancerCare.  

After pursuing medical school, Chris finds his true passion: helping people with bleeding disorders. And a live-changing trip to Kenya inspire Chris to climb Mt. Kilimanjaro.    This episode is brought to you by Genentech. Visit http://www.hemashort.com/ to watch the short film.   Guests: Patrick James Lynch, Founder and CEO of Believe Limited, (Instagram)     Joana Baquero, business strategist and resilience expert, author, Driven by Hope; Ted Talk: “Resilience: A Mindset for Everyday Life”    Amy Board, MNM, Believe Limited Senior Vice President of Engagement and Programs  The Final Summit is produced by BloodStream Media. To get in touch, email mailbag@bloodstreammedia.com Connect with BloodStream Media: BloodStreamMedia.com BloodStream on Facebook  BloodStream on X/Twitter  BloodStream on Instagram BloodStream on LinkedIn BloodStream on TikTok  

Chris takes us back to his days as a college baseball player with a bleeding disorder dreaming of the pros. How do you face your limitations? And how do you accept it when a dream doesn't work out?    This episode is brought to you by Genentech. Visit http://www.hemashort.com/ to watch the short film.   Guests:  Joana Baquero, business strategist and resilience expert, author, Driven by Hope; Ted Talk: “Resilience: A Mindset for Everyday Life”    Patrick James Lynch, Founder and CEO of Believe Limited, (Instagram)   Amy Board, MNM, Believe Limited Senior Vice President of Engagement and Programs The Final Summit is produced by BloodStream Media. To get in touch, email mailbag@bloodstreammedia.com Connect with BloodStream Media: BloodStreamMedia.com BloodStream on Facebook  BloodStream on X/Twitter  BloodStream on Instagram BloodStream on LinkedIn BloodStream on TikTok

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Stephen Dilly, Chairman, President and Chief Executive Officer at Codexis. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Stephen, covering: His journey of almost 40 years in the industry, including 20 years as a CEO. Leading two therapeutic companies to two, successful, $billion+ exits... Not making snap judgements and instant opinions early on in your role as a senior leader. Why he took on the challenge of leading Codexis at this phase of his career. The importance of values as guiding principles, and spending in-person time with your team. As President & CEO of Codexis since August 2022, Stephen brings more than three decades of executive management experience in the biopharmaceutical industry. Most recently, he served as President and CEO of Sierra Oncology (NASDAQ: SRRA) through its recent sale to GlaxoSmithKline for $1.9 billion.  Previously, Dr. Dilly served as CEO of Aimmune Therapeutics, acquired by Nestle Health Science for $2.6 billion. Dr. Dilly has served in executive roles at Genentech, Chiron and SmithKline Beecham and has been associated with the development, approval and launch of more than twenty marketed drugs across multiple therapeutic areas. He holds both an MBBS and a PhD in Cardiac Physiology from the University of London.   Molecule to Market is also sponsored by Bora Pharma (boracdmo.com) and Charles River (www.criver.com), and supported by ramarketing.    Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!