Podcasts about Genentech

For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/courses/the-evolving-role-of-antibody-drug-conjugates-in-metastatic-triple-negative-breast-cancer-10800SummaryThis CME/CE-certified podcast will provide multidisciplinary clinicians with an evidence-based update on the evolving role of TROP2-directed antibody-drug conjugates (ADCs) in the frontline treatment of metastatic triple-negative breast cancer. A medical and an ocular oncology specialist review the latest efficacy and safety data from pivotal clinical trials evaluating ADCs, their integration into contemporary treatment algorithms, and guideline recommendations based on PD-L1 status, BRCA mutation status, and immunotherapy eligibility. Learners will explore key factors influencing treatment selection, compare the benefits and limitations of more established therapeutic options, and examine practical strategies for preventing, recognizing, and managing ADC-associated toxicities. Special emphasis will be placed on multidisciplinary approaches to the management of ocular adverse events and other clinically significant toxicities to optimize patient outcomes and support safe implementation of these therapies in clinical practice.Learning ObjectivesEvaluate the current and emerging clinical evidence surrounding the use of trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugates (ADCs) in the first-line treatment of metastatic triple-negative breast cancer (TNBC)Integrate TROP2-directed ADCs into frontline treatment regimens for metastatic TNBC based on the latest clinical evidence, guidelines, and patient- and tumor-specific factorsApply multidisciplinary and patient-centric strategies for the prevention, recognition, and management of toxicities associated with the use of TROP2-directed ADCs in patients with metastatic TNBCThis activity is accredited for CME/CE CreditThe National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.50 contact hours (which includes 0.50 hours of pharmacology). For additional information about the accreditation of this program, please contact NACE at info@naceonline.com.Faculty and Moderator Aditya Bardia, MDProgram Director, Breast Medical Oncology, UCLAProfessor of Medicine, UCLALos Angeles, CADr. Bardia has disclosed the following financial relationships:Consultant: Alyssum, AstraZeneca/Daiichi, BMS, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, Pfizer, VyomeAdvisor/Advisory Board: Alyssum, AstraZeneca/Daiichi, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, Pfizer, VyomeContracted Research: AstraZeneca/Daiichi, Eli Lilly, Genentech, Gilead, Menarini, Merck, Novartis, PfizerStock options: Vyome (immuno-inflammatory and rare diseases)All of his consultant, advisor/advisory board, and contracted research disclosures are related to cancer.Maura Di Nicola, MDAssistant Professor of OphthalmologyBascom Palmer Eye InstituteMedical Director of Imaging and EchographyBascom Palmer Eye InstituteMiami, FLDr. Di Nicola has disclosed the following financial relationships:Consultant: AbbVie (ophthalmology), SpringWorks Therapeutics (oncology)Advisor/Advisory Board: AbbVie (ophthalmology)Research Grant: Castle Biosciences (ocular oncology)Please review additional planner disclosures here.Disclosure of Commercial SupportThis educational activity is supported by a medical education grant from AstraZeneca Pharmaceuticals and a medical education grant from Daiichi Sankyo, Inc.Please visit  http://naceonline.com to engage in more live and on demand CME/CE content.

Let Babies Eat: New Guidelines to Prevent Food Allergies FACULTY: David Stukus, MD is a Professor of Clinical Pediatrics and the Director of the Food Allergy Treatment Center at Nationwide Children's Hospital and the Ohio State University College of Medicine.   OVERVIEW: In this grand rounds episode of Pediatrics Now, host Holly Wayment brings us cutting-edge approaches to infant food introduction and allergy prevention, featuring Nationwide Children's Hospital's Dr. David Stukus .   Dr. Stukus delves into the history of infant feeding guidelines, the evolving scientific evidence, and practical strategies for pediatric practitioners. Listeners will gain insights into the confusion caused by changing guidelines, the landmark LEAP trial's impact on peanut allergy prevention, and the importance of introducing allergenic foods early, based on evidence rather than outdated practices. The episode provides evidence-based recommendations to support parents, addressing common misconceptions and fears about food allergies.   Join the discussion to better understand the relationship between eczema and food allergies, how to effectively reassure and guide families during clinics, and strategies to help pediatric patients achieve diverse diets that minimize allergy risks. Learn how pediatricians play a crucial role in educating families and preventing unnecessary dietary restrictions that can lead to food allergies. This episode is a must-listen for any healthcare professional looking to navigate the complexities of infant nutrition and allergy prevention with clarity and confidence.   OVERALL LEARNING OBJECTIVE: Increased awareness and education for pediatric providers DISCLOSURE TO LEARNERS: David Stukus, MD has disclosed he is a researcher for DBV Technologies and was a consultant to ARS Pharmaceutical and Genentech. The relevant financial relationships noted for Dr. Stukus have been mitigated.   The Pediatric Grand Rounds Planning Committee (Deepak Kamat, MD, PhD, Steven Seidner, MD, Daniel Ranch, MD and Elizabeth Hanson, MD) has no financial relationships with ineligible companies to disclose. The UT Health Science Center San Antonio and Deepak Kamat, MD course director and content reviewer for the activity, have reviewed all financial disclosure information for all speakers, facilitators, and planning committee members; and determined and resolved all conflicts of interests. CONTINUING MEDICAL EDUCATION STATEMENTS: The UT Health Science Center San Antonio is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The UT Health Science Center San Antonio designates this live activity up to a maximum of 0.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Successful completion of this CME activity, which includes participation in the activity, with individual assessments of the participant and feedback to the participant, enables the participant to earn 0.75 MOC point in the American Board of Pediatrics' (ABP) Maintenance of Certification (MOC) program. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABP MOC credit. CERTIFICATE OF ATTENDANCE: Healthcare professionals will receive a certificate of attendance and are asked to consult with their licensing board for information on applicability and acceptance. Credit may be obtained upon successful completion of the activity's evaluation. RELEASE DATE: 2/5/2025 EXPIRATION DATE: 8/31/2027        

In this episode of Mind the Meds, Erica Marini, PharmD, highlights information from the European Stroke Organization Conference include encouraging data on asundexian(Bayer), a factor XIa inhibitor showing reduced recurrent ischemic stroke risk without increased bleeding, as well as positive results from three trials of tirofiban in acute ischemic stroke settings. On the multiple sclerosis (MS) front, Marini covers the FDA approval of ocrelizumab (Ocrevus; Genentech) for pediatric relapsing-remitting MS in children 10 and older, a new study supporting early use of high-efficacy agents in pediatric MS, and 2 Lancet publications on ocrelizumab — one examining higher weight-adjusted dosing (which did not improve disability progression) and one confirming benefit in a broader primary progressive MS population. She also briefly discusses PADOVA (NCT04777331), a phase 2b trial of prasinezumab in early Parkinson's disease, which failed to meet its primary end point.The bulk of the episode is a discussion with guest Millad Sobhanian, PharmD, BCPS, clinical pharmacy specialist in neurology at the University of Maryland, focused on Alzheimer disease. They cover dextromethorphan/bupropion (Auvelity; Axsome Therapeutics), newly approved in April 2026 for agitation associated with Alzheimer dementia. Sobhanian walks through key safety considerations—including additive NMDA antagonism if combined with memantine, cardiovascular risks from the bupropion component, and the ever-present black box warning on antipsychotics in dementia patients—while both note that the efficacy data, though statistically significant, shows modest clinical effect sizes compared to the threshold for meaningful within-patient change.The conversation then turns to lecanemab's subcutaneous initiation formulation (Leqembi Iqlik; Eisai, Biogen), whose FDA decision has been delayed to about August 2026 as regulators seek more data on bioavailability and ARIA monitoring in the at-home setting. Sobhanian shares his real-world perspective on anti-amyloid therapy, describing a patient population that is typically early-stage, high-functioning, and has a mean age of about 60 to 70 years, and emphasizing the pharmacist's role in expectation-setting around the modest but potentially cumulative slowing of cognitive decline. The episode closes with a thorough discussion of the April 2026 Cochrane review on amyloid-targeting monoclonal antibodies, which both Marini and Sobhanian find overly broad in its conclusions. They note limitations such as the inclusion of withdrawn agents like aducanumab (Aduhelm; Biogen), heterogeneous inclusion criteria across trials, and an 18-month study horizon that may be too short to capture the full benefit suggested by longer-term open-label extension data.Key Takeaways:1. New options for Alzheimer's agitation exist, but fit carefully into the treatment algorithm. Dextromethorphan/bupropion offers a novel NMDA-based mechanism for treating agitation in Alzheimer dementia, but its clinical effect size is modest, and it carries meaningful safety considerations—particularly around the bupropion component in elderly patients. Like all pharmacologic options in this space, it remains a later-line choice after nonpharmacologic interventions have been exhausted, and medication reconciliation is critical given its interaction potential with memantine and CYP2D6 inhibitors.2. Anti-amyloid therapies are imperfect but not ready to be written off. The April 2026 Cochrane review drew significant attention with its conclusion that anti-amyloid monoclonal antibodies produce only trivial cognitive benefits, but its findings are limited by the inclusion of older, withdrawn agents, heterogeneous trial populations, and an 18-month time horizon that may be too short to capture the full trajectory of benefit.3. The pharmacist's role in anti-amyloid therapy goes well beyond dispensing. As illustrated by Sobhanian's practice at the University of Maryland, clinical pharmacists embedded in neurology clinics play a critical role in patient selection, expectation-setting, ARIA counseling, and informed decision-making for patients considering anti-amyloid therapy—a complex, high-stakes treatment decision that these patients and their caregivers should never be navigating alone.

In this special Investor Spotlight edition of Raising Biotech, Surani sits down with Dr. Jakob Dupont, Executive Partner at Sofinnova Investments, to explore one of the most unusual career trajectories in biotech. Before becoming a venture investor, Dupont spent decades as a physician, cancer researcher, biotech executive, and drug developer, helping bring therapies from the laboratory all the way to patients. From Memorial Sloan Kettering to Genentech, Roche, OncoMed, Gossamer Bio and Atara Biotherapeutics, his career spans nearly every corner of the drug development ecosystem. The conversation explores what investors are really looking for when evaluating biotech companies, why unmet need and clinical strategy matter as much as the science itself, and how Sofinnova approaches investing in clinical-stage therapeutics. Dupont also shares examples from Sofinnova's portfolio, including Avenzo Therapeutics and Capstan Therapeutics, before discussing the future of biotech, the rise of new therapeutic modalities, AI-enabled drug development, and why the industry's next challenge may be developing medicines quickly enough to keep pace with innovation. Timestamps 00:00 — Introduction: Why this Investor Spotlight is different 02:00 — Growing up in a family of doctors and finding a passion for cancer research 04:00 — Leaving academia for Genentech and the transition into industry 05:00 — A career across Genentech, Roche, OncoMed, Gossamer Bio and Atara 06:00 — Why venture investing felt like a natural next step 10:00 — Sofinnova Investments: strategy, structure, and investing in clinical-stage biotech 15:00 — What investors really look for: unmet need, science, clinical strategy, and teams 19:00 — Avenzo Therapeutics: backing experienced operators and oncology innovation 22:00 — Capstan Therapeutics: betting on in vivo CAR-T before the market caught on 24:00 — The future of biotech, AI, and the challenge of accelerating drug development For any comments, questions or feedback you can connect directly with Surani Fernando on LinkedIn or email: raisingbiotech@gmail.com Title music composed by: Yurii Semchyshyn (Coma Media)

Kevin Mack, the new president of Via Licensing Alliance, joins Eli for the Clause 8 season finale.Kevin talks about Via's plans to build its next patent pools around "de facto" standards — technology the market adopted on its own, with no standards body behind it — which would push collaborative licensing into territory it has never touched. Mack also takes a hard look at the royalty-free models spreading through tech and AI, from AV1 to the new Shared AI License Foundation (SAIL), argues that "free" rarely stays free, and explains why he's optimistic about where the patent system is heading.Kevin and Eli also discuss:*Via's model and the "tipping point" that turns a pool from a few licensors into thousands of licensees*"De facto" standards: pooling patents for technology no standards body ever blessed*Leadership turnover at Via, the HEVC pool's move to Access Advance, and a new strategy-and-growth group*The push into semiconductors, including a new DRAM memory program*AV1, SAIL, and why Mack thinks royalty-free rarely stays free*Whether AI patents are as "foundational" as advertised — and why "AI is not new"*Efficient infringement, patents as property rights, and why companies ultimately take a license*The mood out of Via's Rome summit and a US patent system tilting back toward ownersNotable names, companies & standardsPeople: Kevin Mack (president, Via Licensing Alliance); Heath Hoglund (former Via president); John Amster (Jamster Capital; RPX co-founder)Organizations: Via Licensing Alliance (Via LA), MPEG LA, Dolby, Access Advance, Alliance for Open Media, Shared AI License Foundation (SAIL), WIPO (PatentScope), DOJ, USPTOSAIL founders / board (public): Anthropic, Genentech, IBM, Meta, Microsoft; board observers eBay and TD Bank Group; members include Block and FigmaStandards & technologies: AAC, AVC (H.264), HEVC (H.265), AV1, MPEG-2, Qi wireless charging, DRAM memory, SEP / FRANDDisclaimer This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.voiceofip.com

Purti Kanodia Talks Real-World AI Applications. On this episode of OWA Talks, Purti shares a practical, no-hype approach to building AI fluency. Join us as we get beyond the ‘theory' and talk implementation. If you're curious about AI but overwhelmed, this one's for you.About the guest:Purti Kanodia is a fractional AI transformation leader and founder of Clarity Prompts, an AI consulting firm and weekly newsletter that helps executives and senior leaders build AI fluency and lead practical, responsible AI adoption across their organizations.With nearly two decades of experience across optical retail, employer healthcare, management consulting, and biopharma, Purti has worked with companies including National Vision, Crossover Health, Slalom Consulting, and Genentech, always at the intersection of technology, business strategy, and human change. At National Vision, she led the launch of Toku BioAge, the first AI-based retinal imaging wellness product in US optical retail. Earlier at Slalom Consulting, she spent two years in Ophthalmology designing product strategy for AI/ML clinical decision support tools.What sets Purti apart is her whole-picture lens on technology adoption. She starts with the problem, not the technology, and believes that testing without measurement rarely survives the pilot. Getting to real scale means thinking through people, process, and organizational readiness together, not as an afterthought.She has mentored startups through Singularity University Labs, the UCSF Entrepreneurship Center, and HealthTech Capital. Purti holds a Master of Science in Biotechnology from Georgetown University and is based in the San Francisco Bay Area.Like this episode? Please subscribe and share!iTunes | Spotify | Overcast | iHeartRadio | AmazonConnect with the OWA:Website | LinkedIn | Instagram | Facebook

Kortney and Dr. Payel Gupta are joined by Tamara Hubbard, MA, LCPC, a licensed clinical professional counselor and food-allergy parent. Together, they dig into what food allergy anxiety actually looks like in teenagers, why some teens take more risks as they get older, and what parents can do to support their teens without making things worse. What we cover in this episode is about food allergy anxiety in teens: What makes teenagers a high-risk group for food allergy reactions. Independence is increasing at the exact same time parental oversight is decreasing, and that combination creates real safety concerns. What food allergy risk-taking actually looks like. It is not always what parents expect, and some of it is just teens figuring out how to belong. Food allergy social anxiety is its own distinct experience. The fear of looking different, being a burden, or standing out can drive behavior just as much as the fear of a reaction. Why parental anxiety matters more than most parents realize. The way parents talk about food allergies often directly affects how teens handle them. How to build confidence and ownership in your teen. What to do when a teen is either too anxious or not anxious enough. *********** Made in partnership with The Allergy & Asthma Network. Thanks to Genentech and Kaléo 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.

How CD38, PARP, and Leaky Gut Are Destroying Your NAD Levels | Dr. Andrew Salzman Your NAD is being drained by two hidden enzymes, your gut may be the starting point of every aging process in your body, and creatine does something to your mitochondria that has nothing to do with muscle. This episode rewrites what you thought you knew about longevity, anti-aging biology, and how your body actually produces and delivers energy at the cellular level. -Watch this episode on YouTube for the full video experience: https://www.youtube.com/@DaveAspreyBPR -Explore all of Wonderfeel's products at: getwonderfeel.com/dave They are gifting a complimentary 7-day Youngr™ supply (mini pouch) with every order across any of their products. The code will be DAVE, and the campaign will be active through June 6th. Host Dave Asprey sits down with Dr. Andrew Salzman, a physician, inventor, and biomedical entrepreneur with more than 30 years of experience in drug discovery and development. An alumnus of Harvard Medical School, Yale University, and Columbia University, Dr. Salzman has authored more than 170 scientific publications and holds 50 patents. He invented the original clinical-stage PARP-1 inhibitor, leading to the world's first clinical treatment for raising NAD levels and fighting cancers caused by the BRCA1 and BRCA2 genes. Genentech licensed his breakthrough technology for $600 million. His research into gastrointestinal microbiota, autoimmune disease, oxidative stress, and mitochondrial ATP production now forms the foundation of how millions of patients get treated worldwide. Dr. Salzman names the two biggest NAD drains in your body, CD38 and PARP, and explains why taking NMN or NR alone is like filling a bathtub with the drain wide open. He breaks down the formulation science behind pairing NAD precursors with CD38 blockers like hydroxytyrosol alongside PARP-reducing antioxidants like ergothioneine, and delivers a paradigm-shifting explanation of creatine as an energy distribution network inside your cells. Rather than a simple muscle supplement, creatine acts as a high-speed ATP shuttle that carries energy from your mitochondria to the precise location and moment your brain, gut, and heart need it most. You'll Learn: Why NAD declines with age and which two enzymes are primarily responsible for draining it How CD38 rises with inflammation rather than NAD levels, and what that means for your supplement strategy Why creatine is one of the most underrated anti-aging and brain optimization supplements available How creatine functions as a spatial and temporal energy delivery network for your brain, gut, and heart Why the gut may be the origin point of the entire aging process and how that cascade unfolds decade by decade How leaky gut drives systemic inflammation, crashes NAD, and accelerates biological aging throughout the body What controls tight junction integrity and how ATP, butyrate, creatine, and fasting all play a role Why most creatine supplements fail to absorb properly and what to look for in a high-quality source How to rebuild your microbiome in three to four weeks through diet alone, without antibiotics Why walking immediately after a meal may be doing more harm than good to your gut lining Thank you to our sponsors! - Screenfit | Get your at-home eye training program for 40% off using code DAVE at https://www.screenfit.com/dave. - KILLSwitch | If you're ready for the best sleep of your life, order now at https://www.switchsupplements.com/and use code DAVE for 20% off - Pique | Go to Piquelife.com/dave for 20% off. - iRestore | Reverse hair loss at www.irestore.com/DAVE and get exclusive savings on the iRestore Elite, use code DAVE Dave Asprey is a four-time New York Times bestselling author, founder of Bulletproof Coffee, and the father of biohacking. With over 1,000 interviews and 1 million monthly listeners, The Human Upgrade brings you the knowledge to take control of your biology, extend your longevity, and optimize every system in your body and mind. Each episode delivers cutting-edge insights inhealth, performance, neuroscience, supplements, nutrition, biohacking, emotional intelligence, and conscious living. New episodes are released every Tuesday, Thursday, Friday, and Sunday (BONUS). Dave asks the questions no one else will and gives you real tools to become stronger, smarter, and more resilient. Keywords: Dr. Andrew Salzman, NAD depletion, CD38 inhibition, PARP inhibition, NMN supplements, creatine ATP shuttle, leaky gut aging, tight junction integrity, inflammaging, lipopolysaccharide gut, flagellin toxin, butyrate gut healing, ergothioneine, hydroxytyrosol, peroxynitrite, superoxide mitochondria, creatine energy distribution, gut origin of aging, NAD bathtub analogy, BRCA PARP inhibitor, Wonderfeel, creatine monohydrate, intestinal permeability, microbiome butyrate, selective digestive decontamination, TMAO nitric oxide Resources: • Explore all of Wonderfeel's products at: getwonderfeel.com/dave • Order Youngr™: getwonderfeel.com/dave• Order ChocoCreatin™: getwonderfeel.com/dave• Get My 2026 Clean Nicotine Roadmap | Enroll for free at https://daveasprey.com/2026-clean-nicotine-roadmap/ • Dave Asprey's Latest News | Go to https://daveasprey.com/ to join Inside Track today. • Danger Coffee: https://dangercoffee.com/discount/dave15 • My Daily Supplements: SuppGrade Labs (15% Off) • Favorite Blue Light Blocking Glasses: TrueDark (15% Off) • Dave Asprey's BEYOND Conference: https://beyondconference.com • Dave Asprey's New Book – Heavily Meditated: https://daveasprey.com/heavily-meditated • Join My Substack (Live Access To Podcast Recordings): https://substack.daveasprey.com/ • Upgrade Labs: https://upgradelabs.com Timestamps: 00:00 – Trailer 01:12 – Introduction & BRCA Background 02:19 – DNA Damage & PARP 04:38 – Free Radicals & Oxidative Stress 11:37 – NAD & Antioxidant Defense 12:34 – CD38 & NAD Depletion 23:31 – The Gut-Aging Hypothesis 30:05 – ATP, Creatine & Energy Distribution 36:41 – Creatine as Energy Shuttle 51:09 – Microbiome & Gut Repair 59:21 – TMAO & Nitric Oxide Interference 1:03:52 – Flagellin & Gut Inflammation Research 1:09:45 – FDA & Pharmaceutical Incentives 1:16:05 – Closing See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Quita Highsmith is the VP of population health at Genentech, but more importantly, she's a friend of The MM+M Podcast. In her third appearance on the show, she discusses Genentech's All Eyes on DME campaign featuring comedian Damon Wayans. Launched this spring, All Eyes on DME is the drugmaker's pop culture-focused way to talk about a condition in diabetic macular edema that is both often overlooked and disproportionately impacts patients of color.  Additionally, Highsmith reflects on her decades working in healthcare and why the work doesn't stop for her or Genentech.  And for our Trends segment, we're talking with our editor-at-large Steve Madden about his time in Las Vegas covering the Enhanced Games and what it means for medical marketers. Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Fredric Marshall spent decades helping companies including Apple, Pfizer, and Genentech solve problems in sales effectiveness, product launches, and organizational change. In this discussion, he explains why he views sales and leadership primarily as change management challenges: helping people move from where they are to where they want to be. The conversation centers on several practical ideas that shape long-term performance. Marshall argues that strong systems reduce stress because "the system is carrying the load, not you as a person or the team." He explains why high-performing people consistently invest in infrastructure, technology, and environments that remove friction and preserve attention for higher-value work. The episode also explores Marshall's "Super Eight" framework, which includes the neural net, biological health, relationships, systems, assets, and contribution. One of the central themes is that attention shapes outcomes. "Whatever you feed [neural nets], they get better at," he explains, arguing for greater discipline around information intake, habits, and social environments. Other insights from the discussion include: • Why emotionally intelligent and externally focused people often elevate entire organizations • How successful professionals balance initiative with responsiveness rather than operating in constant reaction mode • Why many entrepreneurs underestimate the value of their own time and capabilities • How journaling, repetition, and evidence gathering can gradually replace limiting beliefs • Why wealth creation often depends on investing simultaneously in productive assets and personal capability Marshall also shares research from his work studying top performers, identifying three recurring characteristics: action orientation, external focus, and the ability to question assumptions others accept too easily. The discussion is ultimately about building a life and career intentionally: curating what enters your attention, surrounding yourself with the right people, and constructing systems that support the future you are trying to create. Get Fredric's book, Thrive: The Antidote to Future Shock, here: https://tinyurl.com/smn4u5ts Claim your free gift: Free gift #1 McKinsey & BCG winning resume www.FIRMSconsulting.com/resumePDF Free gift #2 Breakthrough Decisions Guide with 25 AI Prompts www.FIRMSconsulting.com/decisions Free gift #3 Five Reasons Why People Ignore Somebody www.FIRMSconsulting.com/owntheroom Free gift #4 Access episode 1 from Build a Consulting Firm, Level 1 www.FIRMSconsulting.com/build Free gift #5 The Overall Approach used in well-managed strategy studies www.FIRMSconsulting.com/OverallApproach Free gift #6 Get a copy of Nine Leaders in Action, a book we co-authored with some of our clients: www.FIRMSconsulting.com/gift

Sponsored by Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation. Intended for US Audiences. This information is for general purposes only and is not a substitute for consulting your healthcare provider about food allergy treatment. Dr. Ari Zelig has been financially compensated by Genentech and Novartis for his participation in this episode. Today, I'm joined by Dr. Ari Zelig, a board-certified allergist and immunologist to unpack what's really happening when it comes to food allergies - and why so many more people are dealing with them today. If you are navigating food allergies, or if you've ever wondered if what you're experiencing might be more than just a sensitivity, this episode features an informative discussion on these topics! In this episode, we dive into the reality of living with food allergies, from the day-to-day challenges that families carry to the misconceptions that still exist around what an allergic reaction to food actually looks like. Dr. Zelig breaks down IgE-mediated food allergies, what's happening in the body during a reaction, and why early exposure guidelines for kids have changed. Plus, we discuss a treatment option, XOLAIR (omalizumab), an FDA-approved prescription medication for subcutaneous use that can help reduce allergic reactions to multiple foods that may occur after accidental exposure in people with IgE-mediated food allergies one year of age and up. While taking XOLAIR you should continue to avoid all foods to which you are allergic. If you or a loved one has been diagnosed with food allergies, talk to your allergist and ask about XOLAIR. You can also find more information at XOLAIR.com. XOLAIR is one of several available treatment options for IgE-mediated food allergy and it may not be appropriate for all patients. What is XOLAIR?XOLAIR®(omalizumab) for subcutaneous use is an injectable prescription medicine used to treat food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age. XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. What is the most important information I should know about XOLAIR?Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:· wheezing, shortness of breath, cough, chest tightness, or trouble breathing· low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”· flushing, itching, hives, or feeling warm· swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction. Please listen to the Important Safety Information throughout and stay tuned for additional safety information at the end of this podcast. See full Prescribing Information, including Medication Guide, at bit.ly/XOLPI. This episode may contain paid endorsements and advertisements for products and services. Individuals on the show may have a direct, or indirect financial interest in products, or services referred to in this episode. Produced by Dear Media M-US-00032583(v1.0) 5/26See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Some of the most powerful shifts in leadership come from seeing something that's been there all along, but never fully acted on.   On this episode of The Unlock Moment, I am joined by Christine Barnes, executive coach, UC Berkeley lecturer, and author of Inclusionable: Transform How You Lead and Elevate Your Team's Performance ... and her story is a brilliant example of exactly that.   Christine has spent her career inside some of the world's most complex organisations, from IBM to Oracle, Roche to Genentech, helping leaders navigate change and build capability. But it was her doctoral research - begun at an age when most of her peers were thinking about retirement - that crystallised what she had been observing for decades: that despite billions spent on diversity hiring, too many people still look up in their organisations and see nobody like them.   In this conversation, we explore why most leaders can't actually distinguish between diversity and inclusion, how Christine's own biases showed up in the middle of a research interview, and why outsourcing inclusion to DEI experts, however essential they are, lets leaders off the hook.   This is a conversation about self-awareness, accountability, and the simple but transformative idea that inclusion isn't a nice-to-have. It's your most underused leadership strategy. The Unlock Moment is hosted by Dr Gary Crotaz, PhD — master interviewer, executive coach and author. Downloaded in over 140 countries. Sign up to The Unlock Moment newsletter at https://tinyurl.com/ywhdaazp Find out more at https://garycrotaz.com and https://theunlockmoment.com Also discover his other podcasts, The Box of Keys and Unlock Your Leadership. Follow, subscribe and leave a review wherever you get your podcasts — and connect with Dr Gary on LinkedIn for more leadership insights. Part of The Unlock Moment podcast family.

Food allergy anxiety in kids is real, and it does not always look like fear. It can show up as tantrums, clinginess, control-seeking behaviors, or a child who refuses to eat at a restaurant. Child life specialist and therapist Kelsey Mora joins Kortney and Dr. Payel Gupta to unpack what is really going on.  What we cover in our episode about managing anxiety in kids Food allergy anxiety does not always look like anxiety. Tantrums, clinginess, and control-seeking behaviors can all be signs that a child is struggling. Language matters from the start. How parents explain food allergies to young children can build confidence or quietly reinforce fear. Separation anxiety and food allergies are connected. Dependence on parents can make it harder for kids to navigate school, parties, and social situations on their own. Practicing independence at home builds real-world skills. Exposure to allergens in a safe home environment teaches confidence and communication skills kids need everywhere else. Passing parental anxiety onto kids. Co-regulation starts with the caregiver, when parents are anxious, kids have a harder time calming down. Helpful resources Food allergy anxiety information from Allergy & Asthma Network Kelsey's practice and services: childlifetherapist.com  Kelsey's workbooks and resources: themethodworkbooks.com  *********** Made in partnership with The Allergy & Asthma Network. Thanks to Genentech and Kaléo 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.

It's In The News, where we bring you the top diabetes stories and headlines happening now. Top stories this week: Dexcom shares details of its next generation CGM, T1D and GLP-1 studies, weight loss management on GLP-1 medications updates, all-in-one CGM and pump, and more! Announcing Community Commericals! Learn how to get your message on the show here. Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Omnipod - Simplify Life All about Dexcom  All about VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Episode transcript: XX Dexcom announces some features of it's next generation CGM – the G8. We've been talking about this with CEO Jake Leach for a while now – it will be a 50% smaller with what they're calling advanced sensing capabilities. According to Leach, G8 will adapt to the physiologic variability of each user. It has additional technology built in, based on a new silicon chip design and algorithm. 15 day wear is now the baseline for all Dexcom sensors moving forward. At launch the G8 will only measure glucose but the plan is for a multi-analyte version to follow. That would measure ketones and potassium. Ketones we know – but potassium is very important for people with kidney and possible for people taking some diabetes meds. It's an interesting space to watch.. btw, analyte is just a medical word for the specific thing you're measuring – the target of the test you're running. we're going to hear that word a lot I think..   Looks like an FDA submission for the G8 next year.. with an outside the US launch the following year. https://www.drugdeliverybusiness.com/dexcom-unveils-next-gen-g8-cgm/ XX Glucotrack has submitted its implantable continuous blood glucose monitor (CBGM) for FDA IDE, that's investigational device exemption and would enable the company to initiate a U.S. clinical study for the fully implantable technology. Rutherford, New Jersey-based Glucotrack's device features no on-body external component. The company aims to offer it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution. Unlike traditional CGMs that measure glucose in interstitial fluid, the CBGM measures glucose levels directly from the blood. The implant goes five centimeters within the subclavian vein. Glucotrack's active implantable device has a small battery and some electronics that go just under the skin in the pectoral region. The location of the implant is not in a major vessel, but the implant can measure real-time glucose levels as pulsatile blood flows over the tip of the sensor. https://www.drugdeliverybusiness.com/glucotrack-submits-long-term-implantable-cbgm-fda-ide/ XX PharmaSens today announced the publication of data from the first clinical study evaluating its all-in-one insulin patch pump offering. The all-in-one pump pairs the Niaa Essential insulin patch pump with the SynerG continuous glucose monitor (CGM) sensor developed by Pacific Diabetes Technologies. However, this system would be one device that features both the pump and CGM technology.   PharmaSens and SiBionics also have a collaboration aimed at developing the all-in-one solution. They are jointly developing the next-generation Niia insulin patch pump with a SiBionics CGM. PharmaSens expects a second feasibility study in the second quarter to evaluate the next-generation pump with SiBionics' CGM.   PharmaSens says the clinical feasibility study of Niia demonstrated for the first time ever that the combined offering is, in fact, feasible. It believes its device addresses the need for alternatives to multi-device diabetes management. systems.   Aggregated MARD for the investigational device came in at 11.6%. A MARD target of less than 10% is considered ideal for CGM devices, but PharmaSens said that, in the context of the early feasibility study, the results were encouraging and provide evidence supporting the development of an all-in-one system. https://www.drugdeliverybusiness.com/pharmasens-efs-insulin-patch-pump-cgm/ XX   XX ViCentra launches the newest version of the Kaleido pump system in Europe. This is that small colorful pump, with Diabeloops algorithm and the Dexcom G7. It'll be in Germany and the Netherlands later this summer. https://hellokaleido.com/vicentra-announces-commercial-launch-of-new-smartphone-controlled-kaleido-automated-insulin-delivery-patch-pump-system/--   XX Diabeloop just got CE Mark approval for DBLG2 integrations – it's latest AID platform the company has kicked off the gradual European launch of the technology. It currently offers DBLG2 as a smartphone application on Android, with iOS integration coming soon. As you just heard, it's integrated with kaleido and the company says it plans to make additional configuration for DBLG2 with alternative pumps "available soon." Running on a user's smartphone, DBLG2 works as a self-learning algorithm. It continuously analyzes glucose data, calculates insulin needs in real time and automatically adjusts delivery. https://www.drugdeliverybusiness.com/diabeloop-fda-next-gen-algorithm-g7/   XX Among adults with type 1 diabetes (T1D), the initiation of GLP-1-based therapy was associated with a lower risk for all-cause death, several cardiovascular outcomes, all-cause hospitalisations, and hypoglycaemia, without a higher risk for diabetic ketoacidosis.   METHODOLOGY: Researchers in Greece conducted a retrospective cohort study utilising real-world data from a global health research network to evaluate the association between GLP-1-based therapy and cardiovascular and renal outcomes in adults with T1D. A total of 4088 patients receiving GLP-1-based therapies (median age, 43 years; 34.3% men) were propensity score matched with an equal number of patients not receiving the treatment. The risk for hypoglycaemia was lower with GLP-1-based therapy (hazard ratio, 0.72; P = .021); however, the risk for diabetic ketoacidosis did not differ significantly between the two groups. https://www.medscape.com/viewarticle/glp-1-drugs-tied-cardiovascular-benefits-t1d-2026a1000fbx   XX Eli Lilly and Company (NYSE: LLY) today announced detailed results from two late-phase trials showing that people with obesity maintained their weight loss long term with either Foundayo or lower-dose Zepbound after switching from higher doses of injectable incretin therapy. The findings from SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN, were presented at the 33rd European Congress on Obesity (ECO) and published in The Lancet and Nature Medicine, respectively.   "Weight regain remains one of the biggest challenges in obesity care, and is often the result of treatment interruptions that cause biology to work against patients, undoing the progress they've made," said Louis J. Aronne, M.D., FACP, DABOM, founder and Chair Emeritus of the American Board of Obesity Medicine, former president of The Obesity Society, Fellow of the American College of Physicians, world-renowned obesity specialist and Lilly consultant. "These medicines can be used for long-term maintenance today, and results from SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN provide additional evidence of their potential when switching from higher doses of injectable incretin therapy." https://investor.lilly.com/news-releases/news-release-details/lillys-foundayo-and-lower-dose-zepbound-helped-people-maintain XX Scientists in Sweden have developed a more reliable way to create insulin-producing cells from human stem cells. These lab-grown cells not only respond strongly to glucose but were also able to restore blood sugar control when transplanted into diabetic mice. When transplanted into diabetic mice, the cells gradually restored the animals' ability to regulate blood sugar. Long way to go, as we say with most of these mice studies. https://www.sciencedaily.com/releases/2026/05/260505234620.htm XX Interesting look at how the body controls sugar storage – apparently this finding challenges long-standing biology concepts and could open new directions for disease treatment. Published in Nature, the study describes a potential method for directly reducing glycogen, the stored form of sugar in the body. These scientists discovered that glycogen can be directly regulated by ubiquitin, a protein best known for marking damaged proteins for recycling or removal. The study is the first to show that ubiquitin can regulate glycogen in humans, overturning more than 50 years of scientific understanding. Excess glycogen is also associated with more common health problems, including diabetes, obesity, liver disease, and heart disease.       https://scitechdaily.com/scientists-just-rewrote-biology-hidden-mechanism-could-transform-diabetes-treatment/ XX A new Oklahoma law will give parents the option to have their children screened for Type 1 Diabetes.   The measure passed with overwhelming bipartisan support in the Legislature and takes effect Nov 1. Oklahoma consistently ranks among the states with the highest rates of diabetes and diabetes-related deaths. The law gives parents access to antibody testing that can detect risk years before symptoms develop, helping families take preventive action and avoid emergency room visits. https://journalrecord.com/2026/05/11/oklahoma-law-expands-access-type-1-diabetes-screening/ XX More to come including a new study trying to figure out why some people are more likely to develop diabetes, a look at cannabis and preventing metabolic disorders, and XX   A National Institutes of Health (NIH)-funded study has identified key differences in human pancreatic islet cells that may help explain why some people are more likely to develop diabetes. Researchers found that the mix of hormone-producing cells in the pancreas varies widely from person to person, and that variation plays a central role in how the body regulates blood sugar. The study involved a deep dive into islet cell function that is linked to donor traits associated with observable characteristics, or phenotype, such as sex, race and ethnicity, as well as genetic information, or genotype, including predicted ancestry and genetic risk for both type 1 and type 2 diabetes. The findings highlight that islet cell composition, rather than the physical size and shape of islets, is a key factor in regulating hormone release. The team found that the makeup of pancreatic islets plays a major role in how effectively they release insulin and glucagon — key hormones that regulate blood glucose. Islets with a higher proportion of insulin-producing beta cells showed stronger insulin secretion in response to various stimuli, while higher levels of alpha and delta cells were generally linked to reduced insulin output. In addition, the researchers found that islet hormone secretion is affected by donor traits, such as sex, race and ethnicity and their genetic makeup, including ancestry predicted from genetic testing and genetic risk for type 2 diabetes. Combined, the findings of the study have significant implications for understanding the factors that may predispose people to diabetes. "This study is the tip of the iceberg," said Dr. Evans-Molina. "We hope this dataset becomes useful to the entire diabetes research community and that researchers use it to answer questions about the genotype-phenotype correlation within these data."   https://www.nih.gov/news-events/news-releases/nih-funded-study-maps-human-pancreatic-islet-cells-offering-new-clues-diabetes-risk XX XX XX Research published recently in JAMA Network Open offers illuminating evidence suggesting there is a positive association between GLP-1 agonists—drugs commonly used to treat obesity and diabetes—and better outcomes among breast cancer patients.   "This study suggests that GLP-1 drugs may offer protective benefits potentially improving survival and recurrence risk in some female patients with breast cancer – whether this is related to weight control, improve cardiovascular health or other mechanisms remains to be studied," said study senior author Bernard F. Fuemmeler, Ph.D., MPH, associate director for population sciences and the Gordon D. Ginder, M.D., Chair in Cancer Research at VCU Massey Comprehensive Cancer Center.   Breast cancer patients who are also obese or have type 2 diabetes experience more aggressive cancer growth and worse outcomes. Prior studies have shown that weight loss treatment and surgery following a breast cancer diagnosis are associated with improved heart health and increased survival.   What are GLP-1 drugs? Glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Approved to treat type 2 diabetes in 2005 and weight management in 2021. Impacts on breast cancer survival and recurrence are still unclear. Since 2020, the use of these drugs has increased dramatically, where approximately 12% of Americans have used GLP-1s for weight loss, according to a RAND report.   The research findings Through a retrospective cohort study examining the electronic health records of more than 840,000 breast cancer patients who were diagnosed between 2006 and 2023, the results suggest there is a potential link between GLP-1 RAs and improved outcomes among breast cancer patients who are also obese or have type 2 diabetes.   GLP-1 RA use was associated with an overall lower risk of death from any cause over a 10-year follow-up period among breast cancer patients. Additionally, breast cancer survivors who used GLP1-RAs for diabetes or obesity had a significantly lower risk of their cancer returning over 10 years following their initial treatment.   "Our findings align with emerging preclinical research and contribute to a growing body of literature related to GLP-1 RA use in oncology settings," said study lead author Kristina L. Tatum, PsyD, MS, of the VCU School of Public Health.   What's next? Further studies are needed to understand the biological mechanisms, if any, between GLP-1 RAs and breast cancer outcomes. The research team intends to further evaluate these correlations through randomized clinical trials.   "Our study underscores the potential of GLP-1 RAs as an adjunct strategy for improving cancer-related outcomes among patients with breast cancer, although clinical trials are needed to inform effective therapeutic approaches and clinical decision making," Fuemmeler said. https://www.oncology-central.com/could-glp-1-receptor-agonists-improve-outcomes-for-breast-cancer-patients-with-obesity-or-with-type-2-diabetes/ XX Researchers at UC Riverside gave cannabis to obese mice and found that not only did the rodents lose weight, but when given a concentrated cannabis oil, the mice also saw striking benefits in their metabolic function. DiPatrizio said his team studied the issue to better understand why cannabis users show significant reductions in weight and risk for diabetes compared with nonusers. "We would think that chronic cannabis users would be eating more and weigh more, but it's just the opposite," DiPatrizio said. Scientists are increasingly examining the possibility that cannabis compounds could fight obesity or metabolic disorders like diabetes. Cannabinoids interact with the body's endocannabinoid system, which partially controls nearly every aspect of our physiology, including metabolism and appetite. That creates the possibility that targeting this widespread system could unlock new therapies for these conditions. https://www.sfgate.com/cannabis/article/cannabis-weight-loss-california-study-22255328.php XX A new campaign launched by diaTribe and Genentech aims to empower and educate people about diabetes-related eye disease. Here's what you can do today to protect your eye health. To help address these barriers, diaTribe and Genentech partnered to launch All Eyes on DME, a new campaign that aims to spread awareness and educate people at-risk for or living with diabetes-related eye conditions like DME. Also partnering in the campaign is actor and comedian Damon Wayans, who wanted to share his journey (and, of course, a joke or two) with type 2 diabetes to open up the conversation about what is often a stigmatized or less talked about topic: eye health and diabetes.   One of these important conversations happened recently at the All Eyes on DME launch in New York City, where Wayans joined a panel of experts, advocates, and people living with DME to talk about diabetes-related eye disease and how to help prevent it. https://www.alleyesondme.com/dme-in-the-spotlight.html https://diatribe.org/diabetes-complications/all-eyes-dme-new-campaign-spotlights-eye-health-and-diabetes

Some people with chronic lymphocytic leukemia (CLL) may feel well day to day, but that doesn't mean life stays the same. In this episode, we hear from Annette Holloway, a clinical psychologist living with CLL, as she shares how her diagnosis, treatment decisions, and side effects have shaped her daily life. Also joining us is Elise Curry, RN, OCN, a Clinical Trial Nurse Navigator at Blood Cancer United's Clinical Trial Support Center, who helps break down treatment options, side effects, and the importance of communication with your care team. DOWNLOAD TRANSCRIPT CLICK HERE to participate in our episode survey. Mentioned on this episode: Chronic lymphocytic leukemia (CLL) Clinical Trial Support Center Minimal/measurable residual disease (MRD) Patti Robinson Kaufmann First Connection ® program Online Chat Patient Community Support groups Caregiver support Lessons in Blood Cancer Video: CLL Shared Decision Making in Chronic Leukemias interactive program CLL Society Patient Power Additional Blood Cancer United Support Resources: Information Specialists Financial support Free Nutrition Consultations Free telephone/web patient programs Free booklets Caregiver Workbook Young Adult Resources Survivorship Workbook Advocacy and Public Policy Mental Health Resources Episode supported by AbbVie Inc.; BeOne Medicines; and Genentech, A Member of the Roche Group.The post Chronic Lymphocytic Leukemia (CLL): Managing Treatment and Finding Balance first appeared on The Bloodline with Blood Cancer United Podcast.

Mia Silverman, food allergy advocate, joins us to talk about the real emotional and practical side of dating with food allergies. From what the research says about kissing risks to setting boundaries to why your allergies might actually be the best filter you have. What we cover in this episode about dating with food allergies When to tell someone about your food allergies. Mia shares why she brings up her allergies early and how she works it into her dating app profile without making it a big deal. Fear of rejection. Mia opens up about being ghosted and bullied, and how she learned to reframe rejection as a filter rather than a failure. The risks of kissing with food allergies. Dr. Gupta breaks down what the research actually says about allergens in saliva and what your partner can do to reduce the risk. Intimacy beyond kissing. From latex-free condoms to body fluids, Dr. Gupta covers what food allergy patients need to know about being safely intimate with a partner. Date ideas and setting boundaries. Mia shares practical tips for early dates, setting food-allergy rules, and keeping the conversation open without making it feel overwhelming. *********** Made in partnership with The Allergy & Asthma Network. Thanks to Genentech and Kaléo 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, Greg Voisen sits down with Dr. Sheila Gujrathi, a powerhouse physician and biotech entrepreneur who reached the top of the corporate ladder only to find an "inner glass ceiling" made of fear. Despite an elite career at McKinsey and Genentech, Sheila realized her greatest battles were internal. In this episode, she breaks down the roadmap from her book, The Mirror Effect: A Transformative Approach to Growth for the Next Generation of Female Leaders, revealing how high-achievers can dismantle the hidden fears that sabotage their success. If you've ever felt like an impostor while winning, this conversation will show you how to finally flip the script.

In this episode, Michele Lamoureux sits down with Fredric Marshall, a leading expert in change management, human behavior, and helping people navigate uncertainty with confidence. Over the course of his career, Fred has worked with organizations like Apple, Pfizer, and Genentech, helping teams adapt, grow, and lead through change. But this conversation goes beyond corporate performance. Fred shares why the tools for resilience, adaptability, and growth are not reserved for high achievers or executives—they're essential skills for anyone facing change, uncertainty, overwhelm, or anxiety about the future. Drawing from decades of research and experience training more than 130,000 people across fourteen countries, Fred explains how people can move from fear and overwhelm to clarity, agency, and momentum in a rapidly changing world. We also dive into his book, THRIVE: The Antidote to Future Shock, and explore practical ways people can stay grounded and hopeful during times of disruption.   RESOURCES MENTIONED Join The Newsletter Subscribe on YouTube Follow on APPLE PODCASTS Follow on SPOTIFY PODCASTS Book: Thrive: The Antidote to Future Shock Website: https://thrivefutureyou.com/     *The Good Life with Michele Lamoureux podcast and content provided by Michele Lamoureux is for educational and entertainment purposes only. It does NOT constitute medical, mental health, professional, personal, or any kind of advice or serve as a substitute for such advice. The use of information on this podcast or materials linked from this podcast or website is at the user's own risk. Always consult a qualified healthcare or trusted provider for any decisions regarding your health and wellbeing. This episode may contain affiliate links.

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/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies 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 an educational grant from Genentech, a member of the Roche Group.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/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies 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 an educational grant from Genentech, a member of the Roche Group.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/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies 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 an educational grant from Genentech, a member of the Roche Group.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/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies 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 an educational grant from Genentech, a member of the Roche Group.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/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies 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 an educational grant from Genentech, a member of the Roche Group.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/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies 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 an educational grant from Genentech, a member of the Roche Group.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/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies 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 an educational grant from Genentech, a member of the Roche Group.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/COPE information, and to apply for credit, please visit us at PeerView.com/PVU865. CME/COPE credit will be available until April 26, 2027.Reimagining Retinal Treatment: The Promise of Novel Delivery Mechanisms for Anti-VEGF Therapies 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 an educational grant from Genentech, a member of the Roche Group.Disclosure information is available at the beginning of the video presentation.

In this podcast, Greg Voisen sits down with Dr. Sheila Gujrathi, a powerhouse physician and biotech entrepreneur who reached the top of the corporate ladder only to find an "inner glass ceiling" made of fear. Despite an elite career at McKinsey and Genentech, Sheila realized her greatest battles were internal. In this episode, she breaks down the roadmap from her book, The Mirror Effect: A Transformative Approach to Growth for the Next Generation of Female Leaders, revealing how high-achievers can dismantle the hidden fears that sabotage their success. If you've ever felt like an impostor while winning, this conversation will show you how to finally flip the script.

On this week's Tech Nation, we celebrate the 50th anniversary of the first biotech company to go public, Genentech. Moira speaks with CEO Ashley Magargee about the company's journey since its founding 50 years ago, and where they're going next. Then, we remember the life of the late Dr. Craig Venter, whose efforts catalysed the race to decode the first human genome.

Fred Marshall is a pioneer in identifying the behavioral patterns of top performers and scaling them across global organizations. Having worked with companies like Apple, Pfizer, and Genentech, Fred has trained over 130,000 professionals in 14+ countries and helped launch dozens of biopharma brands generating billions in revenue. In this episode, he shares how entrepreneurs can think strategically about growth, innovation, and building businesses that actually work. On this episode we talk about: Fred's early entrepreneurial experiments and what they taught him about scaling Why combining fun and work leads to better long-term success The “Uncle Bill strategy” for gaining experience before starting a business How unit economics determine whether a business succeeds or fails Leveraging AI, delegation, and systems to scale beyond yourself Top 3 Takeaways If your unit economics don't work, your business doesn't work—no matter how great the product is. Work for others strategically to learn the model, then improve and build your own version. The key to scaling is shifting from “How can I do this?” to “How can this get done?” Notable Quotes “Instead of asking how can I do this, ask how can this get done.” “If you're not enjoying your work, you should rethink what you're doing—this is most of your life.” “Every bit of knowledge is useful—you just never know when it will pay off.” Connect with Fred Marshall: LinkedIn: https://www.linkedin.com/in/fredric-marshall-1984bb/ Instagram: https://www.instagram.com/officialfredricmarshall/ Other: https://thrivefutureyou.com  Travis Makes Money is made possible by High Level – the All-In-One Sales & Marketing Platform built for agencies, by an agency.  Capture leads, nurture them, and close more deals—all from one powerful platform.  Get an extended free trial at gohighlevel.com/travis Learn more about your ad choices. Visit megaphone.fm/adchoices

When a child is diagnosed with a food allergy, one of the first things many parents wonder is, "Did I do something wrong?" and "Did I cause my child's food allergy?" You question if it was something you ate or didn't eat during pregnancy, whether you breastfed long enough, or if you introduced foods too late. The guilt is real, and it is incredibly common. Kortney and Dr. Payel Gupta sit down with Dr. Joanne Moreau, a board-certified allergist and immunologist, to unpack exactly how food allergies develop, and why no parent should carry the weight of blame. What we cover in this episode about food allergy development and parent guilt How food allergies develop. The immune system, genetics, and environment all play a role, and science is still uncovering why. Food allergy genetics and family history. A parent with asthma, eczema, or hay fever raises a child's risk, even without a food allergy themselves. Pregnancy diet, breastfeeding, and food allergy. No conclusive evidence links what a mother eats during pregnancy, or whether she breastfeeds, to whether a child develops food allergies. Eczema and food allergy. Cracked or inflamed skin lets food proteins in before the gut can build tolerance, which can trigger sensitization. Early allergen introduction. Introducing allergenic foods between 4 and 6 months of age, and keeping them in the diet consistently, is one of the best tools we have. *********** Made in partnership with The Allergy & Asthma Network. Thanks to Genentech and Kaléo 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.  

Shashi Shankar, CEO of Novellia,  focuses on enabling patients with serious medical conditions to consolidate their medical history into a single record using a free app.  The business model provides anonymized real-world data to pharmaceutical companies for research, clinical trial recruitment, and the acceleration of new therapy development. Artificial intelligence is used to help patients make sense of their fragmented medical records, identify clinical trials, and better understand drug safety profiles and therapeutic effectiveness.  Shashi explains, "In a nutshell, what we do is we help folks living with serious and complex medical conditions find access to and then collect all of their medical records going back 20 plus years across different physicians, sites of care, labs, and insurance into one always continuously updated record that then helps them manage and navigate their course of care." "I actually spent months of my career working at Genentech and Roche, working on a number of different cancer therapeutics, and it was an amazing opportunity, and you get to meet so many different patient communities. But one of the most difficult parts, I think, for anybody who's working on developing new medications and new therapies, is that you need to really understand the communities that you hope to serve one day. And unfortunately, a lot of data that exists right now doesn't actually capture the true patient journey. And it's not very representative of the communities that are dealing with and trying to navigate all of these different conditions." "The benefit of being able to share this data with researchers in a way that's anonymous and de- identified, so patient data is always totally secure and always held private by Novellia. The benefit of this is that researchers are able to finally understand the full journey of patients and think through how their therapies can actually help those who are trying to navigate their care."  #Novellia#HealthcareInnovation #PatientEmpowerment #DigitalHealth #HealthTech #MedicalRecords #AIinHealthcare #PatientCenteredCare #HealthcareData #ClinicalTrials #Oncology #PharmaceuticalResearch #HealthIT Novellia.com Listen to the podcast here

Shashi Shankar, CEO of Novellia,  focuses on enabling patients with serious medical conditions to consolidate their medical history into a single record using a free app.  The business model provides anonymized real-world data to pharmaceutical companies for research, clinical trial recruitment, and the acceleration of new therapy development. Artificial intelligence is used to help patients make sense of their fragmented medical records, identify clinical trials, and better understand drug safety profiles and therapeutic effectiveness.  Shashi explains, "In a nutshell, what we do is we help folks living with serious and complex medical conditions find access to and then collect all of their medical records going back 20 plus years across different physicians, sites of care, labs, and insurance into one always continuously updated record that then helps them manage and navigate their course of care." "I actually spent months of my career working at Genentech and Roche, working on a number of different cancer therapeutics, and it was an amazing opportunity, and you get to meet so many different patient communities. But one of the most difficult parts, I think, for anybody who's working on developing new medications and new therapies, is that you need to really understand the communities that you hope to serve one day. And unfortunately, a lot of data that exists right now doesn't actually capture the true patient journey. And it's not very representative of the communities that are dealing with and trying to navigate all of these different conditions." "The benefit of being able to share this data with researchers in a way that's anonymous and de- identified, so patient data is always totally secure and always held private by Novellia. The benefit of this is that researchers are able to finally understand the full journey of patients and think through how their therapies can actually help those who are trying to navigate their care."  #Novellia#HealthcareInnovation #PatientEmpowerment #DigitalHealth #HealthTech #MedicalRecords #AIinHealthcare #PatientCenteredCare #HealthcareData #ClinicalTrials #Oncology #PharmaceuticalResearch #HealthIT Novellia.com Download the transcript here

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of pivotal advancements and strategic moves that are reshaping the landscape of drug development and patient care. In vaccine development, Sanofi has recently reported promising results from a comparative trial of its protein-based COVID-19 vaccine, Nuvaxovid, against Moderna's latest mRNA vaccine, MNEXspike. The focus here was primarily on tolerability, and Sanofi's candidate demonstrated a superior safety profile. This marks a significant moment in the ongoing evolution of vaccine technology, underscoring the importance of diversifying vaccine platforms to effectively address global public health challenges. Shifting to regulatory landscapes, the U.S. Food and Drug Administration has been tasked with expediting the review process for psychedelic drugs under a directive from former President Donald Trump. This move aims to enhance access to novel treatments for serious mental health conditions, reflecting a broader trend in medicine towards exploring therapeutic avenues beyond traditional pharmaceuticals. It highlights an increasing openness to alternative therapies that could potentially transform mental health care. Strategic acquisitions continue to fuel innovation within the sector. Eli Lilly's acquisition of Kelonia Therapeutics for up to $7 billion is particularly noteworthy. This investment marks Lilly's second venture into in vivo CAR-T technology this year, emphasizing its commitment to advancing cell-based therapies. Kelonia's work on phase 1-stage myeloma therapy showcases the potential of CAR-T modalities in treating complex diseases, promising expanded treatment options for patients. Globally, infrastructure development is gaining momentum with Biovac securing a $108 million finance package to establish Africa's first fully integrated vaccine production facility. This initiative is crucial for enhancing regional healthcare autonomy by addressing local health needs and reducing reliance on external supply chains—a step forward in building resilient healthcare systems. In oncology, Merck & Co. has unveiled clinical data for its PD-1xVEGF bispecific antibody in non-small cell lung cancer (NSCLC). The results reveal similar efficacy and safety profiles compared to existing treatments, suggesting promising prospects for this bispecific approach in oncology therapeutics. Bispecific antibodies are engineered to engage two different targets simultaneously, potentially enhancing anti-tumor efficacy by not only stimulating immune responses but also disrupting angiogenesis. This innovation represents a continued focus on targeted cancer therapies that enhance treatment precision. Similarly, AstraZeneca's IL-33 inhibitor has achieved another phase 3 success in treating chronic obstructive pulmonary disease (COPD). This reinforces the therapeutic potential of targeting interleukin pathways in inflammatory diseases and reflects AstraZeneca's strategic focus on respiratory conditions. Such successes highlight the promise of precision medicine in improving patient outcomes. On the topic of market expansion, GlaxoSmithKline's multiple myeloma treatment Blenrep has entered the Chinese market. This move exemplifies the growing importance of global market access strategies, ensuring that patients worldwide can benefit from cutting-edge therapies. Now let's turn our attention to some intriguing scientific developments. A former Genentech leader has launched a synthetic design lab focused on adaptive "smart" antibody-drug conjugates (ADCs) for cancer therapy. ADCs represent a significant leap forward in precision medicine by offering targeted cancer treatments that minimize damage to healthy cells. These "smart" ADCs could provide more effective and less toxic options for cancer patients. Support the show

Rebecca Olin, MD, MSCE Acute myeloid leukemia (AML) is a complex diagnosis, and it can be difficult to know what to expect in those early conversations after diagnosis. In this episode, we speak with Dr. Rebecca Olin from the University of California, San Francisco (UCSF), who helps explain what AML is and how care is approached today. Dr. Olin walks us through how doctors evaluate AML, what factors influence treatment decisions, and how therapies – including targeted treatments, stem cell transplant, and clinical trials – are helping improve outcomes and quality of life. We also discuss the importance of supportive care and ongoing research, offering listeners a clearer picture of how AML is treated now and where progress continues to be made. DOWNLOAD TRANSCRIPT CLICK HERE to participate in our episode survey. Mentioned on this episode: Acute myeloid leukemia Allogeneic stem cell transplantation Clinical Trial Support Center Beat AML® Master Clinical Trial Beat AML® press release – January 2026 Additional Blood Cancer United Support Resources: Information Specialists Financial support Online Chat Free Nutrition Consultations Free telephone/web patient programs Free booklets Support groups Caregiver support Caregiver Workbook Young Adult Resources Survivorship Workbook Advocacy and Public Policy Patient Community Mental Health Resources Episode supported by Astellas Pharma US Inc.; Daiichi Sankyo Inc.; Debiopharm; Genentech, A Member of the Roche Group; and Kura Oncology, Inc. The post Acute Myeloid Leukemia (AML): New Approaches For A Complex Diagnosis first appeared on The Bloodline with Blood Cancer United Podcast.

Food allergy bullying is more common than most parents realize, and most kids never bring it up on their own. Research shows it affects up to 1 in 3 children with food allergies, and the signs can be easy to miss: a lunchbox that keeps coming home full, a sudden reluctance to go to school, or quietly backing off from safe food habits to avoid standing out. In this episode, psychologist Dr. Amanda Whitehouse joins Kortney and Dr. Payel Gupta to talk about what food allergy bullying actually looks like, how to start a conversation with your child without shutting them down, and when and how to bring the school into it. What we cover in this episode about food allergy bullying What food allergy bullying looks like. From verbal teasing and social exclusion to threats involving allergens, and how it differs from everyday teasing. Signs your child may be being bullied. Behavioral shifts to watch for include school avoidance, changes in eating habits, and withdrawal from activities they used to love. How to start the conversation. Why open-ended questions and connection before action are key to getting your child to open up. When and how to involve the school. How to approach teachers and administrators, know your child's rights, and document what's happening. Building resilience after bullying. How involving your child in the solution, rather than swooping in to fix it, helps them feel empowered rather than powerless. *********** Made in partnership with The Allergy & Asthma Network. Thanks to Genentech and Kaléo 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 episode of The Builders Club Podcast, host Sohail Khan sits down with Ahmad Fattahi, Executive Director of Generative AI at Genentech, to explore the massive shift from AI experimentation to real-world enterprise transformation.With over two decades of experience in data science and analytics—spanning roles at Cisco, Spotfire, and OSIsoft—Ahmed provides a masterclass on how organizations can move beyond the "chat" interface to build scalable, high-impact AI products. He breaks down the economic shift caused by the "decreasing cost of intelligence" and how specialized industries like Life Sciences are leading the charge.Key Insights from Ahmed Fatahi:1. The Continuum of Automation: Why the "ChatGP moment" is a significant jump in a decades-long journey of humans delegating decision-making power to machines [07:34].2. The "Steam Engine" Analogy: Why the biggest gains in AI won't come from just replacing old tools, but from reimagining entire business processes from the ground up [14:24].3. Life Sciences at the Forefront: How AI is tackling unstructured data—from FDA regulations to doctor's notes—to accelerate drug discovery and personalized medicine [20:46].4. The Human-AI Interface: A look at "Vibe Coding" and how natural language is becoming the ultimate programming language, lowering the barrier for builders everywhere [28:00].5. Tools for the Modern Builder: Ahmed shares his top recommendations, including NotebookLM for data synthesis and CrewAI for building autonomous multi-agent systems [47:57].6. The Future of Longevity: A bold prediction on whether AI will help humans live to 200 years and beyond [51:16].7. Whether you are an enterprise leader, a software developer, or an AI enthusiast, this conversation offers deep strategic insights into the next phase of the AI revolution.Watch the full episode here: https://youtu.be/lzQOGV1QCZo#GenerativeAI #GenAI #TheBuildersClub #LifeSciences #TechLeadership #EnterpriseAI #DigitalTransformation #AhmedFatahi

Dr. Monty Pal speaks with internationally acclaimed hematologists Dr. Vincent Rajkumar and Dr. Saad Usmani about the AQUILA trial in high-risk smoldering multiple myeloma, as well as advances in CAR-T and other evolving treatment strategies in the myeloma space. TRANSCRIPT Dr. Monty Pal: Hello everyone and welcome to the ASCO Daily News Podcast. I'm your host, Monty Pal. I'm a medical oncologist, underline medical oncologist, a professor, and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. You're going to understand why I underlined "medical oncologist" there. I'm actually on the line today with two amazing hematologists. Today, we're going to actually explore treatments for high-risk smoldering multiple myeloma following the FDA's approval last year of daratumumab for the first-ever treatment of this indication. Now, this is based on the AQUILA trial, and this represents a huge shift in our traditional watch-and-wait approach to active disease interception. We're going to consider whether this landmark trial published in The New England Journal translates to day-to-day practice. I think it does, and we'll certainly make an argument for that. And I'm so fortunate today to have two internationally acclaimed experts here in the conversation: Dr. Vincent Rajkumar, senior author on the manuscript, and Dr. Saad Usmani, also an expert in his own right in myeloma. Dr. Rajkumar is the lead investigator of the AQUILA study. He's a professor of medicine and consultant in the divisions of hematology and hematopathology at the Mayo Clinic in Rochester, Minnesota. He actually chairs the Myeloma, Amyloidosis, Dysproteinemia Program. He is also editor-in-chief of the Blood Cancer Journal. Dr. Usmani, he and I actually go way, way back. We actually did the AACR Molecular Biology in Clinical Oncology course, I want to say in 2006, so this is our 20-year anniversary, Saad. He's the chief of the myeloma service at the MSK Cancer Center and a professor of medicine at the Weill Cornell Medical College in New York.  Saad, Vincent, welcome. Dr. Saad Usmani: Thank you so much for having me, Monty. Dr. Vincent Rajkumar: Yeah, thanks, Monty. A pleasure to be here. Dr. Monty Pal: Thanks. And just a quick note for our listeners, all of our disclosures are available in the transcript of this episode. First off, Saad, did I get that right? Was it 2006 when we did that course together? Dr. Saad Usmani: Yeah, 20 years. We are coming up to our 20-year anniversary. It's remarkable to have seen our careers move the way they have, Monty. Dr. Monty Pal: Oh my gosh. And for all the fellows who are on the line, that AACR Molecular Biology and Clinical Oncology course, it's sometimes overlooked. Wonderful primer on translational science. Okay, now we're going to get to the heart of the matter here, the AQUILA trial. So this was a study, Vincent, that you led. I wonder if you'd walk us through the primary endpoints in the study. What are we looking at in the AQUILA trial specifically? Dr. Vincent Rajkumar: Thanks so much. Again, as you mentioned, smoldering multiple myeloma has just been a condition that we watch and wait. And the first thing that I want to clarify here is that the AQUILA trial is looking at only a subset of smoldering multiple myeloma. That is the high-risk smoldering multiple myeloma. It was defined the way high-risk smoldering myeloma was defined at the time the trial was designed. It randomized 390 patients. One arm got daratumumab single agent in an attempt to delay progression to active myeloma and possibly prolong survival. And the other arm was the traditional observation. The primary endpoint, therefore, was time to active multiple myeloma. Other endpoints included time to when patients needed to start therapy for active multiple myeloma, which can vary based on physician judgment, and overall survival. Of course, response rate, complete response rate, and others were also endpoints. Dr. Monty Pal: That's interesting. And you know, I wanted you to riff a little bit on this definition of high-risk smoldering myeloma. Can you tell our audience how that's sort of evolved over the years? Dr. Vincent Rajkumar: Yes. I mean, if you step back, monoclonal gammopathy of undetermined significance has only a 1% per year risk of progression. Smoldering multiple myeloma, all comers have a 10% per year risk of progression. And over the years, trials have been done in the whole population, and then more recently, we felt we should really focus on the people with high-risk smoldering, defined as a 50-50 risk of progression in 2 years. That's like a 25% per year risk of progression in the first 2 years, which is a very high risk for the patient and something that would justify prophylactic intervention. And that definition initially was based on just high levels of monoclonal protein like more than 3 grams, the IgA subtype of myeloma, the suppression of uninvolved immunoglobulins. Others have used bone marrow flow cytometry markers, cytogenetics. Those combinations of factors were available at the time the AQUILA trial was designed, and a select combination was used. Later on, we found that we could match almost all of that in a very simple risk stratification using just the percentage of bone marrow plasma cells, the level of the M-spike, and the free light chain ratio, all three of which are available to all patients with smoldering at the time of diagnosis. So you don't need any special testing. So more than 20% plasma cells, more than 20 for the light chain ratio, and more than 2 grams for the M-spike. If someone has any two of the three, that is high-risk smoldering multiple myeloma according to the IMWG, but that definition, of course, came in 2020 after the AQUILA trial completed accrual. Dr. Monty Pal: That's interesting because this sort of flips the traditional paradigm where biomarkers get more and more complex as time goes on. Am I right in saying this sort of simplifies things a little bit? It uses standard laboratory or clinical parameters to gauge this category? Dr. Vincent Rajkumar: Absolutely. People were using suppression of uninvolved immunoglobulins, and those levels are not standardized, often vary by race. Also, the other aspect was the abnormal plasma cells on flow cytometry. Again, labs define it differently. So this makes it much more simple. But the IMWG also did a separate exploratory cohort within that paper where we added cytogenetics and we added scoring systems to improve on this further. So it simplified it for regular clinical practice and for like trials. But if you have a patient in front of you, the IMWG paper also has more complex scoring systems where you can take more than 20; 21 is more than 20, so is 51. And so, you can use the actual numbers that a patient has, additional variables like cytogenetics, and get a more refined estimate of what is the true risk of progression. Dr. Monty Pal: That's really helpful. Now, you told us about the primary endpoints, you've helped us define high-risk smoldering myeloma. Can you give us a sense of the top-line results from AQUILA? Dr. Vincent Rajkumar: Yes, I think the most important one was the primary endpoint, time to multiple myeloma, was at 5 years, the progression-free survival was 63% in the daratumumab arm compared to 41% in the observation arm. So, you know, approximately 60% of patients in the observation arm had already progressed by 5 years. And that number was about 40% for the daratumumab arm. We also looked at time to starting myeloma therapy, which is clinically actually quite meaningful because, you know, myeloma therapy means patients get a quadruplet for induction, they get stem cell transplant, they get endless maintenance, they get ongoing therapy virtually for the entire duration. So, preventing the need for myeloma therapy is in and of itself, I think, a major endpoint. And that at 3 years, 40% of people in the observation arm required full myeloma therapy compared to only 20% in the daratumumab arm. So there's a significant reduction in the risk of developing active myeloma as well as the need for myeloma therapy by using a time-limited 3 years of daratumumab single agent. Dr. Monty Pal: Perfect summary of the results. And maybe, Saad, I'm going to bring you into the conversation now. How does this sort of influence your day-to-day practice for smoldering myeloma? Is this something that you've incorporated for that high-risk subset? Dr. Saad Usmani: Thank you, Monty, and I agree. I think that's a really nice summary from Vincent. This study is very important for several reasons. It's actually the third clinical trial that has demonstrated that patients who are in the high-risk smoldering myeloma category benefit from an early intervention that delays the progression to active myeloma or to end-organ damage. And so having a nuanced discussion with our patients in the clinic becomes very important. Having this discussion around as an option becomes very important. And like Vincent said, when we look at that high-risk smoldering myeloma patient population, someone who has 22, 23% plasma cells versus, you know, 45, 50, you know, it's going to be a different discussion each time. But I think it's a very important first step. And I think this sets up the stage for us to design clinical trials where we can ask other questions on what would be better than daratumumab alone in terms of delaying progression in these patients. The other thing that I do want to highlight, and Vincent touched upon this a little bit, that the treatment in this clinical trial was for a fixed duration of treatment. So it was not forever treatment. This is maybe something that Vincent, you can even comment on a little bit more because the question we get after having this discussion is, "Okay, what do we do with patients who are going to be progressing to active myeloma?" Whether we can utilize anti-CD38 therapies for those. So Vincent, I would love your take on this too. Dr. Vincent Rajkumar: Yeah, I think, you know, the main philosophical change for me was previously, the thing was 'don't treat', and now for high-risk smoldering multiple myeloma, the question is, is daratumumab the best treatment or can we do something better? And those trials are thankfully ongoing. One of them has already completed accrual, isatuximab-len-dex versus len-dex. And another one is ongoing in ECOG, almost close to finishing accrual. And in the future, we'll be trying to see if we can use early intervention to even cure and prevent progression altogether.  So we are in this phase where we have one approved regimen, one approved drug, and we are not sure whether we can improve on that. The question is, "is a myeloma-like therapy better than monotherapy" would be the next question, and then what would we do further beyond that? In this context, whenever we have patients like this, one of the questions that comes up, as Saad mentioned, is how does this affect newly diagnosed myeloma therapy if somebody has been treated for smoldering and things like that? How will they be considered for clinical trials? Would they be considered as relapse myeloma or still newly diagnosed myeloma? And those are important discussions for clinical trialists to keep in mind, but I think for clinical practice, your duty is to the patient in front of you. If they have high-risk smoldering myeloma and there's data that there's treatments that can delay progression significantly, delay the need for myeloma therapy significantly, that's the highest priority. We'll cross that bridge.   There are so few patients going on clinical trials right now that if such a patient were to later on progress and wants to enter in a newly diagnosed myeloma trial later, years later, we can figure that out later. I feel like the most important discussion is what to do for that patient today. I still prefer a clinical trial if one was available. If one was not available, I'd prefer early intervention, but have an informed discussion with the patient because some of them may wish to delay therapy still. Some of them may have very borderline numbers that you want to watch them closely. Some of them may be having other comorbidities that prevent need for therapy. Some of them maybe have had the smoldering for a long time and you already know it's stable. So a lot of factors go in, and I think it's not a one-size-fits-all. Dr. Monty Pal: This is a terrific discussion, and you know, it sort of segues into maybe a question around biology. And this is something I was going to get to a little bit later, but Saad, I'm glad you brought it up. I'll liken it to the only thing I know, which is kidney cancer. So, you know, in kidney cancer, we use checkpoint inhibitors as adjuvant therapy. And there's this question of whether or not it breeds some resistance in the localized setting to ultimately what the patient might potentially be exposed to in the metastatic setting. Tell me your thoughts on this, Vincent, then maybe Saad separately. If you treat a patient with daratumumab in this high-risk smoldering setting, could it theoretically sort of limit options in the refractory setting now that we have regimens like DRBD that are kind of being utilized, or daratumumab with teclistamab? Vincent, I'll throw that to you first. Dr. Vincent Rajkumar: This is a great question, and it's usually asked when we've done the lenalidomide trials actually. We try to put the question back. If that was your concern, how would you actually solve it? Is it really biology that's going to answer that? Or is it a randomized trial? So the experiment has been done three times now where early intervention has been given. And if there was some detriment because of that, that would be reflected in the overall survival. In all three trials, there's no such detriment seen. In the first lenalidomide-dex trial, there was an improvement in overall survival. In the AQUILA trial again, the confidence interval doesn't cross one, and patients had better long-term survival on AQUILA, but certainly not less. We've also examined PFS2 data, and that doesn't seem to be affected. So yes, there is a theoretical concern, and that concern cannot be allayed for new treatments which we have not even tried, like tec-dara, and whether that effect would be there or not. But so far, I don't see it. And I think the onus is on proof of that in order to prevent people from getting early therapy. Dr. Monty Pal: Yeah. Saad, your thoughts on that? And before you jump in, I'll mention, we're kind of taking the same approach in kidney cancer, we're trying to really do studies to see whether or not, you know, immunotherapy rechallenge in these contexts, you know, really lends any substantial benefit. So far, the results have been interesting. I don't think we have enough numbers as yet to capture the impact of adjuvant therapy as it translates to metastatic, but I see so many similarities between the scenarios that you're facing in myeloma and what we're facing in RCC. Saad, your thoughts? Dr. Saad Usmani: Thanks, Monty. I'll go back to something that Vincent alluded to a few minutes ago about the way that we risk-stratify patients within smoldering myeloma. Right now, we are relying more on a disease burden-based stratification looking at the percentage of plasma cells in the bone marrow, the monoclonal protein, as well as the involved light chain versus the uninvolved light chain ratio. However, there are efforts underway to actually incorporate genomics into that schema and try to refine that definition of high-risk smoldering. And there have been two papers that came out in the latter half of last year. In fact. Dr. Rajkumar and I are co-senior authors on one effort where we can identify genomic myeloma in patients in precursor conditions. One of the key things that came out of that effort was that within the high-risk smoldering myeloma category, about 90% of the patients are genomically myeloma. So this whole debate of whether we need to intervene for those patients, I think, you know, we have sufficient biologic evidence that yes, we need to intervene for those patients.  I think that the next real step, like Vincent stated, is how do we intervene in those patients? And those clinical trials kind of are ongoing. We will probably need to have more validation of those genomic models being incorporated, but that's what I see in the future. I wouldn't be concerned for the patients being seen today with that query about the disease biology evolving because if I'm seeing a patient today in March of the first quarter of 2026 and offering them monotherapy daratumumab in their high-risk smoldering situation for the next 3 years and then they progress to myeloma after another couple of years, we are talking about what would be the treatment options for them in 2031, 2032. So I think the field is moving so fast, we have a lot of novel therapies coming into that frontline setting rapidly, so our options at that time would be very different. So, you know, I just wanted to kind of set up the stage for saying, you know, our tools are getting better in delineating which patients will need that intervention. And then eventually, I think, you know, we'll have much better options for newly diagnosed myeloma patients at the time when they need it in the future. Dr. Monty Pal: Just absolutely brilliant, absolutely brilliant. I love that summary. I think that you're absolutely right in saying that, you know, you've got to think about what you're going to do for that patient sort of in the moment, what's going to optimize their outcome and agree that the landscape is evolving very rapidly.  I'd be remiss, Saad, if I didn't ask you about something that I've been following in terms of your career trajectory. You've developed quite a reputation for your leadership in trials looking at CAR T-cell therapies for myeloma. Can you give us a sense of where that stands in broad terms? Dr. Saad Usmani: Certainly, Monty. I think the CAR Ts have slowly made their way from late relapse to early relapse. And now we have clinical trials that have completed accrual in the frontline setting comparing them to standard-of-care treatment for both older myeloma patients or transplant-ineligible patients, as well as younger transplant-eligible patients where we're actually trying to replace transplants with BCMA-directed CAR T-cell therapies. The nuance there would be we want to equal or better the survival outcomes that we've accomplished without compromising on the safety side of things for patients. Those therapies are moving into earlier lines. And more excitingly, you know, that's just the first wave of CARs. The next wave of CAR technology is coming, and it's going to be in vivo CARs where we may not need lymphodepleting chemotherapy, we may not even need as stringent regulatory nuances that we do for cellular therapies today. So, you know, I think the field is moving rapidly, and it's going to be a very interesting landscape to see over the next 5 to 6 years. Dr. Monty Pal: Yeah, you know, it's so interesting. I know in the solid tumor space, we're trying to replicate the success that you've had with CAR T and bispecifics, and I do see some light at the end of the tunnel. I'm seeing some really promising agents being developed, but clearly, we have so much to learn from our colleagues in hematology. Well, I have to tell you, this has just been a phenomenal conversation. Vincent, congratulations on your leadership of the AQUILA trial. Clearly, a big paradigm shift in the field. Saad, thank you for offering your expert insights and really giving us also a glimpse at the future of myeloma. Really appreciate having you both on the podcast today. Dr. Vincent Rajkumar: Thank you, Monty. Dr. Saad Usmani: Thank you so much. Dr. Monty Pal: And thank you so much to our listeners for your time today. Finally, if you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to 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. Follow today's speakers:      Dr. Monty Pal    @montypal   Dr. Vincent Rajkumar @VincentRK Dr. Saad Z. Usmani @szusmani   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. Vincent Rajkumar: Honoraria: Research to Practice, Medscape Patents, Royalties, Other Intellectual Property: Authorship Royalties from Up To Date Dr. Saad Usmani: Consulting or Advisory Role: Janssen Oncology, GlaxoSmithKline, Abbvie, Bristol-Myers Squibb/Celgene, Regeneron, AstraZeneca, Sanofi Research Funding: Janssen Oncology, Bristol-Myers Squibb, K36 Therapeutics, Abbvie, Regeneron  

Dr. Monty Pal and Dr. Vamsi Velcheti discuss the evolving treatment landscape in EGFR-mutated non-small cell lung cancer, including landmark trials like FLAURA2, novel drug therapies, and the growing importance of ctDNA and MRD testing. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist and professor and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, I'm truly delighted to introduce Dr. Vamsi Velcheti, who's a professor of medicine and the chief of hematology-oncology at the Mayo Clinic in Jacksonville, Florida. We'll be discussing the expanding treatment landscape in EGFR-positive lung cancer and how to navigate the challenges of balancing treatment efficacy, toxicity, and patient quality of life in the EGFR-positive space.  Just FYI, our full disclosures are available in the transcript of this episode.  Vamsi, it's so great to have you on the podcast. Thank you so much for being here. Dr. Vamsi Velcheti: Thank you, Monty. It's a pleasure to be here with you. It's a really exciting topic and there are a lot of updates in the EGFR space. Dr. Monty Pal: So, I'm going to need your help with this because I'll be honest with you, I see very little lung cancer, if any, in my practice. I'm pretty much exclusively kidney cancer these days. I'm coming on 20 years at City of Hope now, and I still remember when trials like ECOG 1599 were presented with, you know, platinum doublets. And, of course, the field has changed a lot since then. But tell us a little bit about the first-line landscape, and I think just for the sake of time, we're going to stick with EGFR-positive disease here. What does it look like these days? Dr. Vamsi Velcheti: Monty, the foundation of care remains the third-generation EGFR inhibitors. These are selective EGFR inhibitors, like osimertinib. We've had an evolution of the development of these TKIs. Like, you know, we had the first-generation, second-generation, not-so-selective EGFR inhibitors. Now we have mutant-selective EGFR inhibitors in the clinic, and they're doing a really good job. And these are quite effective in patients who have classical activating mutations. But the reality is that these have not been transformative. These agents have fundamentally changed the response patterns, excellent CNS penetration, and very good tolerability profile. However, we don't see a lot of durability in terms of the response. So, what's different today is now there have been several trials in combination with these third-generation EGFR inhibitors that have really laid the foundation of how we kind of think about EGFR-positive disease. At the high level, there are a lot of challenges to selecting the patients for these combination-based modalities. I'm assuming we'll be talking more about these different trials and different approaches. Some of these combination-based strategies have really moved the needle in terms of improving overall survival and really improving long-term outcomes and durability in our patients. Dr. Monty Pal: And we are going to get into the weeds on this in just a moment. But I did kick off this podcast talking about chemotherapy, ECOG 1599. It does seem as though chemotherapy is still a component of management in advanced non-small cell lung cancer. So, can you tell us about, perhaps first, you mentioned osimertinib, you know, some of these next-generation EGFR inhibitors. Tell us about the role of chemo plus osimertinib. Dr. Vamsi Velcheti: That's exactly where I was going with the combination-based strategies. You know, we first started off with our earlier trials in the EGFR space evaluating the question of, are targeted therapies, are these highly effective, third-generation, EGFR-selective inhibitors, superior to platinum-doublet chemotherapy? And we've had multiple trials demonstrating that, like the FLAURA trial and in the past with second-generation EGFR inhibitors like erlotinib and gefitinib and afatinib. So, we know that these TKIs actually perform better than platinum-doublet chemotherapy. Now, we have a large, global, phase 3 trial data from the FLAURA2 trial, which looks at the question, "Hey, you know, osimertinib is better than chemotherapy, platinum-doublet chemotherapy. Can we do even better by combining osimertinib with platinum-doublet chemotherapy?" So, FLAURA2 answered that question. This is a large, phase 3 trial, and it's a positive trial with improved durability of disease control and improving overall survival with combination with chemotherapy. So, it's a very important and landmark trial, and essentially combining osimertinib with a platinum-based chemotherapy improved responses, deepened responses, and improved overall survival and really changing the disease trajectory. And this strategy is definitely compelling, especially in patients who have certain clinical high-risk features like, you know, patients who have high disease burden or patients who are sometimes having rapid disease progression early on osimertinib, especially with patients who have a lot of visceral disease burden. So, intensifying treatments up front could alter the natural trajectory of the disease. Dr. Monty Pal: So, you sort of alluded to this in that last part there, but is that kind of how you in clinical practice select? Is it based on, you know, visceral involvement? Is it based on rapidity of disease where you think about adding chemotherapy to osimertinib? Maybe you can give us the corollary. Which patients do you just use osimertinib alone in, for instance? Dr. Vamsi Velcheti: Definitely, there are some patients who have low disease burden and they have the classical mutations, like an exon 19 deletion. And these patients, especially if they don't have a lot of disease burden, they don't have CNS involvement, there may be a subset of patients who could just do fine on osimertinib of course, with close monitoring of the disease. I guess we'll get into that later, how do we do that with either ctDNA or like closer imaging or both. So, there may be some opportunity to kind of escalate patients' treatments based on certain clinical characteristics or radiographic characteristics or certain biological characteristics informed by ctDNA or other approaches. Dr. Monty Pal: No, that's interesting. And you're right, we will chat about ctDNA in just a bit. But before we get there, I think one of the big agents that has really sort of come to the fore in advanced non-small cell lung cancer is amivantamab. I've heard a lot about this in the context of even kidney cancer because in certain subsets, I'm interested in MET-directed therapies and so forth, right? So maybe tell us a little bit about the mechanism of amivantamab first, and then maybe tell us about this pivotal MARIPOSA trial where it's combined with lazertinib. Dr. Vamsi Velcheti: So, the MARIPOSA trial compared lazertinib alone with amivantamab plus lazertinib. And this trial demonstrated overall survival advantage, and there were key differences in terms of tolerability and the safety of amivantamab, which is an EGFR and MET bispecific, and there were certain kind of unique toxicity profiles that make it a little different than the intensification approach with chemotherapy through the FLAURA2 trial. So, there's a trade-off in terms of the toxicity profile. It's a different agent and a different management protocol in terms of dermatological toxicity management that clinicians need to be comfortable with. And also, there are certain unique issues in terms of amivantamab; there's a higher rate of infusion-related reactions, there's an increased risk for edema and VTEs because of amivantamab. Certainly a different toxicity profile, different management paradigm there in terms of longitudinal care of these patients requiring dermatological care and like, you know, close monitoring and prophylaxis VTEs. But having said that, definitely it's a different strategy, and it kind of changes the biology and the natural history of the cancers, and we do see some durability of responses that we see with the MARIPOSA. So, it's certainly a great alternative, at least for some patients. Dr. Monty Pal: That was a great overview of MARIPOSA. Now comes the really difficult question, which is, how do you choose between the two? You have these two great options, right, for EGFR-positive patients. You've already highlighted some of the distinctions in terms of toxicity. I think the audience is well aware of the side effects of chemo-doublet, perhaps even the EGFR-based therapies. Amivantamab is quite new. Give us a sense of how you in clinical practice decide between the two potential options here. Dr. Vamsi Velcheti: Yeah, I think that's the big challenge. I think these are two independent strategies that have evolved through the phase 3, and both of them have demonstrated overall survival benefit. So, the way I think about this is in three dimensions, right? Like, the disease biology, the patient priorities, and feasibility of care delivery. So, when I talk about the disease biology, you know, the mechanism is very different, and MET is a very dominant driver of disease in EGFR-altered patients and it's a significant mechanism of resistance, acquired resistance to TKIs. So, certainly I think there's a patient population that could benefit from a MET-directed therapy up front. However, we don't have great data to kind of really demonstrate how using amivantamab in the front line is going to change that. And are there like perhaps like some patients who we could identify who would benefit from such a strategy? Very recently, there have been some approvals in the second-line setting in lung cancer, not in the EGFR space, but like in generally in lung cancer, with the MET ADCs, and those drugs are approved with a companion diagnostic, which requires MET IHC testing. So, what has happened, at least in large academic practices and also I think in the community now, they have been checking for MET IHC expression more routinely in lung cancer. What we have been doing in our institution is we have been doing MET IHC as a reflex for all patients with EGFR, not just EGFR, but all non-small cell lung cancer patients. What that has done is now, like, we have been increasingly testing patients with EGFR for MET. And there's clearly a subset of patients who have de novo MET expression and a high MET expression. And those patients, I've been kind of like preferentially treating them with the MARIPOSA regimen. But again, I have to caution the audience that we still don't have data that MET IHC is going to help us make those decisions, whether it's better than like a FLAURA2 regimen. But however, in the second-line setting in the CHRYSALIS trial, we know that MET is a very powerful predictor of response to amivantamab. We really need more data there, but that's what I have been doing in my practice. But also, there's a lot of patient preference here. Like, there are some patients who don't want chemotherapy, and they want a non-chemotherapy approach. So, certainly there are some patients who prefer to have amivantamab. And now with the amivantamab, the subcutaneous version, the infusion reactions and the logistics of actual administration of amivantamab are more favorable with the subcutaneous approval. So, those are some of the elements that we need to take into account. Dr. Monty Pal: Well, I want to hone in on that because this subcutaneous administration route has been a big debate that I've seen on social media. Tell us, how much easier does it actually make the amivantamab experience? Does it cut down on the rash? Is it just infusion reactions? What's been your clinical experience? Vamsi Velcheti, MD: So, the subcutaneous administration of amivantamab has definitely improved the infusion reaction issue. Very rarely patients have infusion reaction now with the subcutaneous injections. And also, the infusion time is much, much shorter. Like we don't need a lot of infusion time, which is sometimes a challenge in busy infusion clinics. We need to take that into account. As far as the impact of the subcutaneous formulation on dermatological toxicity, we haven't really seen significant difference in terms of the intensity or rates of dermatological toxicity with subcutaneous. The benefits are really with the infusion reaction, the ease of administration. And interestingly, in the PALOMA trial, it also seems to be, even though this was not the primary endpoint of the study, there seems to be some suggestion that the subcutaneous amivantamab seems to have improved OS compared to the IV amivantamab. We don't really understand why, but that's a finding from the trial that's very intriguing. Dr. Monty Pal: That is really fascinating. I'm kind of curious to see how that's going to pan out. I'm going to shift gears a little bit here. And, you know, as we sort of close, I wanted to talk a little bit about biomarkers. I mean, this is obviously not a lung cancer-specific issue. It's something we think about across the board. But what I will say is that there are certain commonalities, and in bladder cancer, we think a lot now about ctDNA. But you've been way ahead of the game in lung cancer. Tell us how you guys use ctDNA, maybe both from the standpoint of monitoring for mutational status, but if you can, maybe offer some insights into some of these new MRD tests that are available too. Dr. Vamsi Velcheti: Yeah, it's rapidly evolving. Certainly, I think in the lung cancer space, you know, this has really kicked off in the lung cancer space with incorporating ctDNA into the workflow. Of course, you know, like baseline evaluation, we still kind of heavily rely on tissue genomic sequencing. But as you know, with targeted therapy, a lot of these patients have disease that evolves over time, and changes in terms of mutational pattern driving acquired resistance is a major issue across different molecular subtypes. And especially so in EGFR, when there are certain actionable opportunities associated with that transformation. So, we need to kind of have like a longitudinal snapshot of how we monitor these patients. So, the ctDNA has come to be like a tool that has now come to the forefront of clinical workflow, and almost all my patients who are having disease progression have ctDNA for kind of evaluating for resistance and informing treatment decisions, especially in EGFR. But having said that, there are a lot of challenges in terms of using ctDNA as a tool for monitoring. There are a lot of different types of assays and different platforms, and being able to use this as a quantitative tool that would be used along with the CT scans that we routinely use in clinical practice has been a challenge. And I think I would love to hear your perspectives as well, Monty, about how you're thinking about that in bladder and other disease contexts. But having said that, I think there's a lot of opportunity to incorporate ctDNA and MRD assays into clinical decision-making. Right now, in terms of clinical trials and clinical development, there have been some very interesting trials that are currently ongoing, especially in the EGFR space. We know that patients who clear ctDNA, based on some retrospective data and also like some retrospective-prospective data from trials that have already read out, that patients who clear ctDNA early with target therapy tend to do much better. They have a longer durability of response. There may be a subset of patients who have, even though they're having radiographic response, they have persistent ctDNA after a certain time point of initiation of targeted therapy. Those patients may require escalation of therapy. We don't yet know. I can't recommend that as a standard right now because we don't have clinical evidence to support that. But however, some of the clinical trials, like the ELIOS trial that's being done right now, that's actually completed enrollment, we'll hopefully see the results very soon. So, there is an emerging thought that instead of intensifying treatment for all patients with EGFR, there may be a population that may be just fine with frontline osimertinib monotherapy and introducing the intensification strategy at the time of emergence of MRD or progression on ctDNA before radiographic progression. So, there are a lot of adaptive molecular response criteria that we are kind of exploring in clinical trials that could inform how the future is going to look like for EGFR and other perhaps targeted therapies as well. So, it's fascinating, and I think there's a lot of opportunity there. Dr. Monty Pal: You know, you asked for my perspective. I actually think that what you highlighted there is the most interesting opportunity for ctDNA: the ability to de-escalate therapy. In terms of drug development, we've done so much to bring new therapies to patients, and now it's a bit of an embarrassment of riches, but the downside is that I feel like we tend to overtreat a lot of patients in the clinic. So, I definitely view MRD, you know, some of these other ctDNA techniques with methylation and so forth that may not be sort of tumor-dependent or bespoke could be incredibly, incredibly helpful. You touched on sort of the future, right, in this last section here with biomarkers. But give us a sense now in terms of novel drug therapies in the EGFR space. What are you most excited about moving forward in 2026 and beyond? Dr. Vamsi Velcheti: Yeah, I think there's a lot going on in this space, and not just this space, but across lung cancer and others as well. Like looking at the next generation of targets for ADCs. And I think a lot of these have to do with…so far in the drug development space, as you know, the improvements in clinical outcomes has been very incremental. So, we really need to make that big leap. And I think the big leap is not going to come from, in my opinion, from the next ADC, but it's going to come from how we tailor treatments and how we monitor disease better and how do we kind of incorporate the next treatment earlier and not wait for the radiographic progression. So, there's a lot of opportunity there to integrate biomarkers and dynamic biomarkers into clinical trial design and incorporating the recent advances in terms of drug design. You know, we have a lot of assets in the EGFR space, the next-generation EGFR inhibitors that are kind of designed with resistance in mind and rational combination, knowing when to introduce those combinations is also equally important. So, there's a lot going on, really exciting times to be in drug development. The one thing that I really hope will come to the forefront in drug development, not just for lung cancer, but all disease groups, is to kind of really be thoughtful about how we incorporate these really cool molecular monitoring tools and creating a composite score with imaging to be able to like really design the next generation of clinical trials. Dr. Monty Pal: You're so spot-on with that. I definitely think that we're getting to this point where, you know, we could think about the next BiTE, the next CAR-T, the next ADC. But, you know, maybe it's time for us to start really honing in on appropriate applications of these drugs, honing in on the right dose and what have you, because I definitely see some issues there.  Vamsi, this has just been terrific. I really want to thank you so much for sharing your fantastic insights with us today on the ASCO Daily News Podcast, and I really appreciate all your efforts to move the field of lung cancer forward. Dr. Vamsi Velcheti: Thanks, Monty. I really enjoyed the conversation. Dr. Monty Pal: Yeah, this was terrific.  And thanks to our listeners as well. If you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to 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. Follow today's speakers:     Dr. Monty Pal   @montypal  Dr. Vamsi Velcheti @VamsiVelcheti 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. Vamsi Velcheti:   Honoraria: Galvanize Therapeutics  Consulting or Advisory Role: Bristol-Myers Squibb, Merck, AstraZeneca/MedImmune, GSK, Amgen, Taiho Oncology, Novocure, Regeneron, Takeda, Janssen Oncology, Picture Health Research Funding (Inst.): Genentech, Trovagene, Eisai, OncoPlex Diagnostics, Alkermes, NantOmics, Genoptix, Altor BioScience, Merck, Bristol-Myers Squibb, Atreca, Heat Biologics, Leap Therapeutics, RSIP Vision, GlaxoSmithKline

Why haven't we cured cancer yet? A Genentech scientist explains the real reason.In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Bob Liu, Senior Principal Scientist at Genentech Roche, to unpack one of the most important and misunderstood questions in modern medicine.This is a rigorous, scientifically grounded conversation on cancer biology, immunotherapy, and the real constraints shaping oncology drug development today.Dr. Liu brings over a decade of experience across antibody drug conjugates (ADCs), bispecific antibodies, and CAR-T therapies, offering a rare, insider perspective on why a universal cure remains elusive and where meaningful progress is actually being made.Thanks to our Founding Sponsor: LEUCENTRA: Helping teams evaluate, implement, and get real value from IT solutions that support innovation, not slow it down. https://leucentra.com/ What You'll LearnWhy cancer is not one disease, but more than 200 biologically distinct conditionsWhat “curing cancer” actually means in clinical oncologyHow immunotherapies like checkpoint inhibitors and CAR-T are changing outcomesThe biological limits of eliminating every cancer cellHow tumors evade immune detection and adapt over timeWhy only about 20% of patients respond to immuno-oncology therapiesThe role of biomarkers, molecular profiling, and precision medicineWhy early detection remains one of the biggest unsolved challengesThe economic and regulatory pressures shaping next-generation therapiesKey InsightCancer is not simply something to eliminate.It is a dynamic, adaptive system evolving within the human body. The future of oncology is not just eradication, but control, personalization, and intelligent engagement of the immune system.Notable Quotes“Cancer is a collection of more than 200 diseases, each requiring its own specific approach.”“The cure for some cancers is within reach, but for many others, early detection remains the critical challenge.”“Our immune system is constantly surveilling. The key is learning how to harness it effectively.”Timestamps00:00 – Introduction02:42 – Bob's passion - AACR04:28 – Why we haven't cured cancer07:09 – Defining a cancer cure10:26 – Cancer classification and molecular signatures14:16 – Methylation profiling in diagnosis17:22 – Patient resources and navigation21:14 – FDA shifts toward randomized trials for CAR-T24:15 – Cost and access challenges26:33 – Cancer vs cardiovascular disease progress33:39 – The challenge of early detection37:48 – Biomarker limitations39:14 – Immune system dynamics in cancer45:19 – Bioanalytical challenges in modern therapies51:08 – Progress and future outlookAbout the GuestDr. Bob Liu is a Senior Principal Scientist at Genentech Roche specializing in bioanalytical sciences and immunogenicity assessment for advanced oncology therapies, including T-cell bispecifics and CAR-T.Resources & LinksFDA to tighten approval requirements for CAR-T therapieshttps://www.raps.org/news-and-articles/news-articles/2025/12/fda-to-tighten-approval-requirements-for-car-t-celAmerican Association for Cancer Research (AACR)https://www.aacr.org/National Cancer Institute – Molecular diagnostics and biomarkershttps://www.cancer.gov/about-cancer/diagnosis-staging/diagnosisPattern recognition technologies in diagnosticshttps://toby.healthConnectDr. Bob Liuhttps://www.linkedin.com/in/bob-liu-42b8b278/Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/Final ThoughtThe path to curing cancer is not a single breakthrough. It is a long, complex progression of scientific advances, better diagnostics, and deeper biological understanding.The progress is real.But the work is far from finished.

Dr. Kyunghyun Cho is a leading AI researcher best known for co-authoring a landmark 2014 paper that introduced neural machine translation. In this episode, he discusses his wide-ranging career spanning fundamental AI research, co-founding Prescient Design (acquired by Genentech), and driving applications of AI in health care. For clinicians, Cho's core message is pragmatic: AI should help health care run better. After years of work at NYU Langone, he reframed AI in medicine from solving rare diagnostic puzzles to improving operational prediction at scale. Cho emphasizes purpose‑built data, careful fine‑tuning, and regulatory accountability. His perspective connects technical rigor with system stewardship—and insists that patient voices must be present in AI governance. Transcript. 

Andrew Yee, MD Multiple myeloma can feel unfamiliar and overwhelming at first, but today's advances tell a much brighter story. In this episode, Dr. Andrew Yee of Massachusetts General Hospital explains what myeloma is, how it's diagnosed, and why new treatment options, from four-drug regimens to CAR T-cell therapy and bispecific antibodies, are transforming patient outcomes. With enthusiasm and relatable analogies, he highlights how patients may progress from periods of significant challenges to reaching a level of stability and well‑being that allows them to live fully. This conversation offers clarity, confidence, and real optimism for anyone navigating myeloma. DOWNLOAD TRANSCRIPT CLICK HERE to participate in our episode survey. Mentioned on this episode: Multiple myeloma Amyloidosis Autologous stem cell transplantation CAR T-cell therapy Immunotherapy fact sheet Clinical Trial Support Center Additional Blood Cancer United Support Resources: Information Specialists Financial support Online Chat Free Nutrition Consultations 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 Episode supported by AbbVie Inc.; Bristol Myers Squibb; Genentech, A Member of the Roche Group; GSK plc.; Johnson & Johnson. The post Facing Multiple Myeloma: A Guide to Choices, Care, and Confidence first appeared on The Bloodline with Blood Cancer United Podcast.

In this episode of NP Pulse: The Voice of the Nurse Practitioner®️, Drs. Erin Sinnaeve and Julianne Doucette discuss immunoglobulin E (IgE)-mediated food allergies, current prevention strategies, diagnostic best-practices and evolving treatment options — including early allergen introduction, oral immunotherapy and biologic therapies — to support safe, evidence-based care.   Upon successful completion of this podcast, you will be able to:  Review the pathophysiology and subsequent patient journey associated with IgE-mediated food allergies.    Evaluate the trial data and practice-changing potential of monoclonal antibodies in a new era of food allergy management.    Develop evidence-driven care plans focused on mitigating patient and caregiver burden, and safely and effectively reducing IgE-mediated reactions in patients with food allergies.    A participation code will be provided at the END of the podcast — make sure to write this code down. Once you have listened to the podcast and have the participation code, return to this activity in the AANP CE Center and follow these steps:  Register for this activity.  Click on the "Next Steps" button.  Enter the participation code that was provided.  Complete the activity evaluation.  This will award your continuing education (CE) credit and certificate of completion.  1.25 CE will be available through March 31, 2027.  Listeners are encouraged to explore the accompanying food allergy point-of-care tool to support clinical decision-making.   The Hidden Burden: Understanding Food Allergies and Their Impact This podcast is supported by an education grant from Genentech, a member of the Roche Group. 

Synopsis: This episode is proudly sponsored by Quartzy. Physician-scientist, biotech founder, and leadership advocate Sheila Gujrathi, MD joins Rahul Chaturvedi on the Biotech 2050 Podcast for a powerful conversation at the intersection of biotech innovation, leadership, and personal transformation. Sheila shares the unconventional journey that led her from academic medicine to the forefront of biotechnology—spanning roles at Genentech and Bristol Myers Squibb, founding companies, serving on boards, and recently helping guide Ventus Therapeutics through its acquisition by Lilly. Along the way, she reflects on the lessons she learned building drugs, scaling companies, and navigating the evolving biotech deal environment. The discussion then turns deeply personal as Sheila explores the ideas behind her book “The Mirror Effect,” revealing how self-awareness, supportive networks, and authentic leadership can transform careers—especially for women and underrepresented leaders in science. From overcoming imposter syndrome to building the “CEO Sisterhood” network of women biotech leaders, Sheila shares hard-earned insights on navigating power, culture, and identity in high-stakes industries. For founders, investors, and leaders alike, this episode blends biotech strategy with deeply human lessons on resilience, purpose, and the power of believing in yourself. Biography: SHEILA GUJRATHI, MD, 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.

Dr. Monty Pal and Dr. Andrea Apolo discuss practice-changing studies and other novel approaches in bladder, kidney, and prostate cancers that were presented at the 2026 ASCO Genitourinary Cancers Symposium. TRANSCRIPT Dr. Monty Pal: Hello 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 academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles.  And today is super exciting, we're highlighting key abstracts that were presented at the 2026 ASCO GU Cancers Symposium, and I'm just delighted to be joined by the chair of this year's meeting, who is also a dear friend, Dr. Andrea Apolo. Dr. Apolo serves within the Center for Cancer Research at the NCI as head of the Bladder Cancer Section, and she is also acting deputy chief of the Genitourinary Malignancies Branch.  Welcome, Andrea, it is so great to have you on the podcast. Dr. Andrea Apolo: Oh, thank you so much for having me. What a great ASCO that we had, it is really exciting, lots of really great data. So I look forward to chatting about it. Dr. Monty Pal: Excellent. And you know, our full disclosures are available in the transcript of this episode in case our listeners want to have a peek.  The theme of this year's GU meeting was "Patient-Centered Care: From Discovery to Delivery." I love that theme. And really, this is one of the most competitive meetings out there, more than 850 abstracts being presented on high-impact science. Andrea, I just wanted to get right into it and dive into what I think we both felt were some of the most exciting abstracts of the meeting.  And the first of those is one that I know is near and dear to your heart, being a bladder cancer expert yourself, and that is the KEYNOTE-B15 study presented by Matt Galsky. Can you give us a flavor for what that study entailed and some of the key results? Dr. Andrea Apolo: Yeah, I think this was kind of the missing study that we have been waiting for since we saw the EV-302 data in metastatic disease in the frontline setting. We wanted to know how well this combination would work in muscle-invasive bladder cancer patients. And we saw half of that puzzle, you can say half of the piece of the puzzle, when we saw the data at ESMO, the EV-303 data in patients that were cisplatin-ineligible. And then now we are getting the full story with patients that are platinum-eligible, cisplatin-eligible, with the EV-304 data. So that study randomized patients to receive chemotherapy, so different than the EV-303 where the patients were randomized just to receive the radical cystectomy. These patients were randomized to receive neoadjuvant EV plus pembro and then adjuvant EV plus pembro versus neoadjuvant gemcitabine and cisplatin with no adjuvant component to the control arm. So I think this is a really, really important study. Dr. Monty Pal: And share with us some of the results because this in my mind is definitely practice-changing. This is one of those studies that I think you walked into the office on Monday and you are like, "Okay, this is what I am doing now," right? Dr. Andrea Apolo: Yeah. So the study was positive. The primary endpoint was event-free survival, and it met the primary endpoint. The secondary endpoint of overall survival was also met. So really, really great results. Consistent with what we saw with EV-303, the median event-free survival was not reached for the EV plus pembro arm, and it was 48 months for the patients receiving gem-cis. And then looking at the 24-month estimated event-free survival, it was 79% for the EV plus pembro and 66% for the chemo, the gem-cis arm. And that was a hazard ratio of 0.5. So that is really exciting. That is the event-free survival. And then the overall survival, the medians were not reached for either arm, but when you look at the 24-month estimated overall survival, it was 87% for the EV plus pembro versus 81% for the gem-cis, and that was a hazard ratio of 0.65. So very positive study.  And then another question that we had was the pathologic CR rate. Very consistent with what we saw with the EV-303, the pathologic response rate was about 56% for the patients that received EV plus pembro and about 32%, 33% for the patients that received gem-cis. So very consistent with the findings that we have been kind of seeing in phase 2 studies, and this is a pT0N0, so that is important. Dr. Monty Pal: So Andrea, you know, I think that the big question in folks' minds is at this point, we see the data from NIAGARA, cis-gem-durva, we have now seen this data. Put it into context for us. Is there a patient in this day and age who maybe shouldn't get IO altogether, who should maybe get the NIAGARA regimen as opposed to EV-pembro in this context? What are your thoughts there? Dr. Andrea Apolo: Now, that is a great question. I would say with this data, it is very enticing to give EV pembro to our patients in the perioperative setting, and for that to be the new standard of care for all patients, regardless of cisplatin eligibility. So similar to what we saw with EV-302 really changing the standard of care in the frontline setting, I think these two studies, the EV-303 and the EV-304, change the standard of care for patients with muscle-invasive bladder cancer in the perioperative setting, and this should be the new standard of care if the patients don't have a restriction to receiving an immunotherapy. Dr. Monty Pal: I totally agree with that assessment. It is great to hear it from the expert's mouth as well. Thanks a lot for that, Andrea.  The next abstract I wanted to tackle is one that is, I would say, near and dear to my heart because I know these folks really well. It is led by the SWOG group, and this is SWOG S1602. The number there for the audience gives you a sense of how long the study has been running for. The 16 prefix means it is something that we kicked off back in 2016. So this study is really 10 years in the making, right? So Rob Svatek presented this data. It is interesting, right, because it addresses this issue of the BCG (Bacille Calmette-Guérin) shortage, right, where we have needed to sort of rely potentially on other alternative sources or regimens and so forth. Tell us about this trial, Andrea. Dr. Andrea Apolo: This is one of my favorite studies. We talked about putting it in the main oral abstracts, but we put it in one of the educational sessions that talked about non-muscle-invasive bladder cancer because we thought that would be the best audience for it. But it doesn't take away from how important this abstract is, and the tremendous effort that went into the study. Almost a thousand patients enrolled. I think 984 were eligible to enroll in this study. So it is a very high enrolling, randomized, cooperative group study in high-grade non-muscle-invasive bladder cancer. And really the study was designed to address two questions. One is the BCG shortage and can we use a different strain, Tokyo versus TICE? And whether there is a priming effect if you gave intradermal BCG to patients with non-muscle-invasive bladder cancer, can that enhance the effect if you gave it a little bit earlier? I think the study is really important, and it met its primary endpoint, which was it is not inferior to TICE. The findings were really terrific in terms of the outcomes. Numerically. When you look at the endpoint, it looked like the Tokyo strain was as good, if not maybe a little bit better, but not statistically significant than the TICE. And then they broke it down by carcinoma in situ, they broke it down by papillary tumors, and the Tokyo strain was non-inferior in both of those instances. But interestingly, the intradermal BCG did not change outcomes. There was really no priming effect, which was really backed up by pre-clinical data that there would be, but there wasn't a priming effect when the intradermal BCG was given in the Tokyo strain. So that was a really, really interesting finding. But a great study, really important outcomes in the field for non-muscle-invasive bladder cancer. Dr. Monty Pal: Totally. And it just seems like we can't get away from BCG, right? You know, as hard as we try, I mean, I appreciate the studies that sort of build on it that are emerging right now, but it seems like BCG at least for the foreseeable future is kind of here to stay, right? Dr. Andrea Apolo: It works. It is one of the most effective treatments we have for non-muscle-invasive bladder cancer. So, you know, I think it is here to stay and, you know, we need to find alternatives in terms of strains so we don't deal with this shortage that we have been dealing with for so many years now. Dr. Monty Pal: Yeah, indeed. Moving on to some of the other highlighted studies from the meeting, you had mentioned the EV-303 data, so we probably don't need to rehash that study design in much detail. But there was also a rapid oral abstract presented by Dr. Ullén that I think is of interest here, right, that really hones in on pathologic outcomes and DFS from that trial. Do you mind just outlining that for our listenership? Dr. Andrea Apolo: This is the KEYNOTE-905, also known as the EV-303 study. This is a follow-up to the EV-303 data looking at the pathologic response rates, looking at the downstaging effect, looking at the surgical margins after treatment with the neoadjuvant EV plus pembro in the 303. Now, remember in the 303, patients got three cycles of neoadjuvant EV plus pembro and then six cycles in the adjuvant setting. A little bit different than the 304, where they got four cycles, which is really kind of the standard in the neoadjuvant setting, and then five cycles in the adjuvant setting. So still a total of nine cycles. But in the 303, the treatment arm had no systemic therapy, so it was just radical cystectomy. And they looked at the negative margins that you get with the EV plus pembro treatment, which was 92.6% versus 79% with patients receiving just the surgery alone. And then the pathologic CR rate, there was more follow-up on that, it was 57% for the patients receiving EV plus pembro, and as we would expect, about 9% for the patients that just went on to surgery alone because you can achieve a pathologic response rate with TURBT alone. Then they looked at the pathologic downstaging, so anything less than a pT2, and that was 66% in the patients that received the EV plus pembro. So very interesting findings, and it is also really just nice to have now the EV-304 data, like I was saying, there were two pieces of it, the cisplatin-eligible and the cisplatin-ineligible, and just to have those contemporary controls are really important. How did the cisplatin-ineligible do versus the cisplatin-eligible patient in terms of the event-free survival and in terms of the overall survival? So I feel like now we have all of this data that we can kind of put together in the perioperative setting and we can really inform our patients a little bit more about their outcomes depending on whether they are cisplatin-eligible or not, which you know cisplatin-ineligible patients often just, they are sicker, they may have obstruction, their tumors may be larger, they just tend to be a more delicate population than the cisplatin-eligible patients. So not surprisingly, you know, we see that in the EV-303 the disease-free survival for the patients is pretty poor. So the disease-free survival that was reported for this follow-up of the specific abstract was 23.6 months for the patients that just got surgery, and it was not reached for the patients that had the EV plus pembro, and that was a hazard ratio of 0.37. Dr. Monty Pal: Excellent, excellent distillation. So Andrea, in the interest of time, I mean, we could probably talk about bladder cancer forever, but I am going to move us on to the subject of kidney cancer. We have two late-breaking abstracts, LITESPARK-011, which looked at lenvatinib and belzutifan versus cabozantinib in the advanced setting, and then we have an adjuvant study, LITESPARK-022, that looked at pembrolizumab with or without belzutifan in the adjuvant setting. Both studies positive. One for progression-free survival, the other for disease-free survival. Both I think making a big dent in how we treat kidney cancer. Can you tell us a little bit about that? Dr. Andrea Apolo: Yeah, we have been waiting for these trials for a long time. So one of the things that we have been talking about at GU ASCO is to have plenary sessions. And if we would have had a plenary session, these two abstracts would have been part of it because they are important data, really big studies where we are trying to improve the outcomes of our patients with kidney cancer. So the first one, the LITESPARK-011, like you said, this is for advanced renal cell carcinoma, clear cell renal cell carcinoma, where we really don't have a standard of care after IO therapy, right? So we give IO-IO, we give VEGF-IO, but we don't really have a good standard of care. We usually give monotherapy TKIs. So the combination of belzutifan and lenvatinib versus what a standard of care is, cabozantinib, is really an important question to ask. And you know, this is a pretty large study, about 750 patients were randomized. And belzutifan plus lenvatinib demonstrated an improvement in progression-free survival and overall survival versus cabozantinib, but not overall survival, at least not yet, is what the authors are saying. So for the progression-free survival, the hazard ratio was 0.7 and it was 14.8 months for the combination, belzutifan plus lenvatinib arm versus cabozantinib, which was 10.7 months. So I think that is significant. And for the overall survival, it did favor the combination again with a hazard ratio of 0.85. The median was 35 months versus 28 months for the monotherapy cabozantinib, but it did not reach statistical significance. And the authors said that this will be further tested at a final analysis, these were the interim results.  And for the overall survival, the overall survival was 53% for the combination versus 40%. This is significant. And the CR rates were lowish for both of them, it was like 5% for the combo and 1% for cabo monotherapy. So I think that the findings are important because we don't have a standard of care. And although there is no survival benefit, there was a trend. So I think this could be considered in patients that are fit, a treatment option for these patients in the later line settings. Dr. Monty Pal: Great points. I mean lots of great discussion around toxicity as well as efficacy. I mean certainly this is a regimen that may not be suitable for every patient in my portfolio, but certainly one to consider.  Now Andrea, let's shift focus to LITESPARK-022, the adjuvant trial that I mentioned previously. So this is again looking at pembrolizumab with or without belzutifan, met the primary endpoint of disease-free survival. What are your impressions there of the data? Dr. Andrea Apolo: Yeah, the data looks great. And this was a really large study, 1,800 patients were randomized, and the study met the primary endpoint of disease-free survival, benefiting the combination of pembro plus belzutifan. And that is really terrific. The medians were not reached for either arm. And in terms of the overall survival results, also the medians were not reached, but the hazard ratio was 0.78 and did not reach a statistical significance. So there was again a statistically significant improvement in disease-free survival for the combination of pembrolizumab plus belzutifan, but not an overall survival benefit.  So I guess, Monty, you know, we can kind of talk about what that means. There was a lot of discussion about belzutifan and some of the side effects, specifically anemia and managing anemia in this setting and requirements for transfusions. Generally, the authors said it was well tolerated, but we know that combination studies do have more toxicity. So it may be a select group of patients again, similar to the advanced setting, where we opt for a combination, possibly until we see more follow-up data in terms of the overall survival. Dr. Monty Pal: I have to agree with you. You know, in my group, we have been talking about a lot of pembrolizumab-based studies that are running right now, some through the NCI, some, you know, our own sort of homegrown investigator-sponsored trials, and you know, I think for the foreseeable future we are comfortable just maintaining pembrolizumab. Things might change if, for instance, we ultimately see a survival advantage emerge, but I just have my own personal doubts around that, that will be interesting.  Okay, so now we are going to move to the last disease category that we are going to cover, which is prostate cancer. So there, we have the long-awaited results from the PEACE-3 study. These are the final OS results from this trial looking at enzalutamide with or without radium-223 in metastatic castration-resistant prostate cancer. So Andrea, would love to get your perspectives on this. Dr. Andrea Apolo: Yeah, so this study had been presented before and we had seen positive results for the combination of enzalutamide and radium with some interim overall survival results also showing a benefit. But like you said, these are the final results with a median follow-up of 58 months. So it was really nice to see the final results. And with the combination of enzalutamide and six cycles of radium, it did show an improvement in overall survival with a hazard ratio of 0.76. The median overall survival increased from 32.6 months to 38.2 months with the combination. So that is really great. There was some crossing over of the overall survival curves around 18 months was still seen. And again, there was also an improvement in the rPFS with a hazard ratio of 0.71, and the median rPFS improved from 16.4 to 19 months with the combination. So, you know, we have been awaiting the final results, but we kind of knew a lot about the benefits of the combination. And it is something that is kind of slowly trickling into the community in terms of adapting it and using it. There is more buzz now about it and I think these overall survival results will hopefully shift the community into incorporating the combination in these patients. Dr. Monty Pal: Brilliant. So well said. I mean, Andrea, congratulations on a terrific meeting. You have really done it again. Incredible, incredible output from this year's ASCO GU. I just want to thank you for joining us on the program today. Dr. Andrea Apolo: Oh, thank you so much for having me, Monty. It was really a joy to work with the ASCO team and with all the investigators and the Education Committee and the Scientific Committee. Everyone was really outstanding. So to me it was an honor to be part of this meeting, and I am so happy that it was so successful and really presented some amazing data that I think will be practice-changing to our patients. Dr. Monty Pal: Oh, thanks a ton. And also a huge thanks to our listeners. If you enjoyed the content of today's podcast, please don't forget to like and subscribe to our channel wherever you listen to podcasts. Thanks 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. Follow today's speakers:     Dr. Monty Pal   @montypal  Dr. Andrea Apolo @apolo_andrea  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. Andrea Apolo: No disclosures to report.

Your favorite science podcast is back! To kick off season seven of Two Scientists Walk Into a Bar, hosts Maria Wilson and Danielle Mandikian sit down to celebrate a decade of the podcast and look back at our previous season on unmet medical needs. But what's next? Get ready for a season that's going bigger than ever before. To mark the 50th anniversary of Genentech, Maria and Danielle will draw a thread from the seminal breakthroughs of the last 50 years in biotechnology to the incredible innovations that will shape the next decade and beyond. Read the full text transcript at www.gene.com/stories/season-seven-teaser

What if leadership isn't just shaped by strategy, structure, or individual capability but by the energetic field we are participating in together?In this deeply spacious episode of the Sacred Changemakers Podcast, I'm joined by Alan Briskin and Mary Gelinas, longtime practitioners and teachers whose work bridges collective wisdom, neuroscience, spirituality, and conscious social change.Together, we explore the reality that space is not empty, that it is alive with information, relationships, and potential. Drawing on insights from their book Space Is Not Empty, Alan and Mary invite us to sense leadership as a relational, emergent practice rather than a position or role. This conversation moves beyond concepts into a felt, lived experience. We speak about field awareness, language, shared power, polarization, and what becomes possible when leaders learn to listen not just to words, but to the space between us.This episode is an invitation to slow down, to feel, and to experience leadership differently, not as control, but as participation in something wiser than any one of us.About Today's Guests:Alan Briskin, PhD is an award-winning author, leadership consultant, and a pioneer in the field of collective wisdom. For over four decades, he has worked with nonprofits and mission-driven organizations, including Kaiser Permanente, Sutter Health, and the George Lucas Educational Foundation. Alan is a co-founder of the Collective Wisdom Initiative, a Noted Humanist Scholar at Saybrook University, and has served as Senior Advisor to the Institute of Noetic Sciences, the Goi Peace Foundation in Tokyo, and the One Humanity Institute in Poland.Mary Gelinas, EdD is a managing director of Gelinas James, Inc., and an author, consultant, educator, and executive coach devoted to conscious social change. She is the author of Talk Matters! Saving the World One Word at a Time and brings decades of experience in organizational change, neuroscience, and embodied leadership. For 20 years, she co-led the Cascadia Center for Leadership, graduating over 500 leaders across sectors, and has worked with organizations including Genentech, California State Polytechnic University Humboldt, and public-sector institutions.Learn More About Today's GuestsSpace Is Not Empty website →www.spaceisnotempty.netAlan's website ****→ www.alanbriskin.comMary's website → www.gelinasjames.comSpace Is Not Empty on LinkedIn →https://www.linkedin.com/company/space-is-not-empty/about/Alan on LinkedIn →https://www.linkedin.com/in/alan-briskin-a9637b6/

In this episode of the GSD Presents Silicon Valley AI & Tech series, we sit down with the visionary founders of Matrix Edge Therapeutics, Elaine Phan and Andreas Taylor.We dive deep into how they are building the "Signal → Cure → Longevity" AI infrastructure to revolutionize drug discovery and patient stratification. Learn how continuous patient signals and agentic AI are being used to reduce clinical trial-and-error, speed up cure development, and ultimately extend human healthspan.Key Topics Covered:The shift from reactive medicine to AI-driven Precision Medicine.How "Continuous Patient Signals" improve subtyping and stratification.The role of AI in streamlining the lifecycle from drug discovery to post-market management.The future of longevity and bio-tech innovation.About the Guests:Elaine Phan: Founder of Matrix Edge Therapeutics, Biopharma leader (20+ years), NIH AI strategist, and UC Berkeley/Stanford/Georgia Tech alumna.Andreas Taylor: Co-Founder & CTO, Genentech veteran, Data Scientist, and expert in agentic AI applications and drug delivery.Connect with GSD Venture Studios: gsdvs.com#PrecisionMedicine #AIinHealthcare #Longevity #DrugDiscovery #Biotech #GSDVS #TopGlobalStartups #HealthTech #BioPharma

Dr. Monty Pal and Dr. Ari Rosenberg discuss the evolution of treatment strategies in head and neck cancers, including the challenges of treating both HPV-positive and HPV-negative disease and the emergence of blood-based biomarkers to advance personalized therapy across different subtypes. TRANSCRIPT Dr. Monty Pal: Hello 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 academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, we're going to explore the evolving landscape of treatment strategies in head and neck cancer management, including locoregionally advanced head and neck squamous cell carcinoma, which happens to be on the rise in United States, in part due to spike in HPV-mediated oropharyngeal cancers. We're also going to discuss the emerging strategies of using blood-based biomarkers to really advance personalized therapy. Joining me for this discussion is Dr. Ari Rosenberg. He's a medical oncologist focused on head and neck cancer, and he's an associate professor – congratulations on the recent promotion – at the University of Chicago. The University of Chicago has really produced luminaries in this field, Dr. Rosenberg included. I've had the pleasure of getting to know Dr. Ezra Cohen over the years, who really had his grounding there, and of course Everett Vokes, former ASCO President. I'm really looking forward to this conversation, Ari. Thanks so much for joining us. Dr. Ari Rosenberg: Thanks, Monty. Thanks for the invitation. Dr. Monty Pal: You got it. And just a quick note for our listeners, our full disclosures are going to be in the transcript at the end of this episode. So let's start with the basics, if you don't mind. So, head and neck cancers are very diverse and they're challenging, right? In the sense that they're near vital organs, the treatments, you know, as we all saw during fellowship, if not now in clinical practice. They can really have such a major impact on vital organ function, speech, swallowing, et cetera. Can you just comment on head and neck cancers that are on the rise in the U.S.? I alluded to this briefly. Particularly, we've heard this in the context of colorectal cancer and so forth. Are you actually seeing younger adults being affected by this? Dr. Ari Rosenberg: Yeah, thanks for that. The vast majority of head and neck cancers are head and neck squamous cell carcinomas, as I'm sure many of the listeners recall as well from fellowship or their current training. And as you alluded to, the organ function, long-term and functional quality of life outcomes are quite important, particularly in the context that these develop in high value real estate, parts of our head and neck area that we use for speaking, swallowing, all sorts of other essential functions as well. As you also alluded to, we think of this in two different particular subtypes of head and neck cancer. The historical head and neck cancer from 50, 60 years ago was almost exclusively related to carcinogen exposure, tobacco, alcohol use, and that subtype of carcinogen-induced head and neck cancer has been slowly declining. However, over the last now several decades, we've been seeing an increase in primary oropharyngeal squamous cell carcinoma, mostly tonsil, base of tongue. These are attributable to HPV, human papillomavirus exposure. And that's now the majority of the head and neck cancers that we tend to see in our clinic. As you also alluded to, these have very different prognoses as well. HPV-related head and neck cancer has a much more favorable prognosis where much of the interest has been in can we de-intensify to optimize long-term function? But then the non-HPV-related head and neck cancer, or what we call HPV-negative head and neck cancer, continue to be very, very challenging. We only managed to cure about half of these folks, with many of these patients developing the current disease. These patients, in addition to being difficult to treat, also have major impacts both in terms of the treatments they undergo as well as their disease that can impact their function and quality of life. And you hinted at this a little bit, but we have been seeing an increase in younger patients with HPV-negative head and neck cancer as well, which is quite concerning. Younger patients, oftentimes never smokers, never drinkers, who are developing non-HPV-negative head and neck cancer. And that's been a little bit of a more recent trend that we've been seeing as well. So, definitely a lot of work to be done to optimize and improve outcomes across all of these different head and neck cancer subtypes. Dr. Monty Pal: I mean, I'm just curious, you know, in the context of colorectal cancer, one of the things that we talk about is the potential role of the microbiome driving some of these young-onset cancers with, you know, perhaps there being an impact on, for instance, inflammation and the gut and what have you. Tell me about head and neck cancer. Is this anything known as to why younger patients might be getting diagnosed with non-HPV type cancers? It's odd to me. Dr. Ari Rosenberg: Yeah, it's a great question. A lot of people are working on it. I think we folks have hypotheses, but it hasn't totally panned out exactly what's going on there. It does have a little bit more of a tendency towards women, whereas historically head and neck cancer is much more common in men than it is in women. But lots of people working on that, whether it's related to chronic inflammation, whether it's related to the microbiome. Whether it's related to dental exposure, dental work. So, a lot of folks trying to parse that out because I agree with you, it needs to be identified alongside improving treatment paradigms for these patients, the young ones and the older patients as well. Dr. Monty Pal: Interesting, interesting. You know, one of the phenomena that was sort of coming around when I was in training 25 years ago was this role of sort of induction therapy for head and neck cancers. And of course, it's really come full circle now to include checkpoint inhibitors and so forth. Tell me a little bit about this and how you apply it, maybe in an HPV-mediated context, maybe in a non-HPV context. Dr. Ari Rosenberg: Yeah, absolutely. Induction chemotherapy, as you alluded to, or neoadjuvant chemotherapy, depending on what the locoregional treatment approach is. Similar to other cancer types where systemic control early on has many potential advantages in this setting. Now, in head and neck cancer, even though induction chemotherapy is quite active in head and neck cancer, both HPV-positive and HPV-negative with pretty good response rates. A survival advantage for all comers with local regionally advanced disease remains unproven. There's been two randomized trials, both underpowered, but essentially did not show a survival advantage, showing that induction chemotherapy for all patients with locoregionally advanced and neck cancer can't be justified for a survival advantage. That being said though, there remains a number of potential advantages of giving induction or neoadjuvant chemotherapy, of course, improving systemic control and debulking the disease early on has potential advantages, and predicting the responsiveness to subsequent radiation treatment. We know for some time in head and neck cancer that the percentage of shrinkage or the response to induction chemotherapy actually predicts outcome related to radiation as a dynamic biomarker where response can be used to select patients, for example, for de-escalated radiation has been an area of active investigation, active research. And it also remains a key opportunity to evaluate predictive biomarkers and understanding pre and post treatment to better understand the biology. I'll just add to your question that recently over this past year, we also saw phase 3 data for neoadjuvant immunotherapy for a subset of head and neck cancer that is surgically resectable. And so that's reintroducing the potential benefit in the immunotherapy era of incorporating immunotherapy in the neoadjuvant or the induction setting as part of the evolving treatment paradigm for these diseases. Dr. Monty Pal: That's really interesting. And you kind of alluded to already several topics that I plan to hit on, you know, for instance, the role of immune checkpoint inhibitors, induction, chemotherapy, and so forth. And you started to touch on biomarkers. And of course, I think that's something near and dear to many of us in academic oncology. One thing that we've started talking a lot about in the context of colorectal cancer is circulating tumor DNA. How do you think this might fit in the context of head and neck cancer? Can you give us a flavor for that? Dr. Ari Rosenberg: Yeah, absolutely. In head and neck cancer, the current landscape is most developed for circulating tumor DNA for HPV-related head and neck cancer. The advantage of HPV-related head neck cancer is that you have a distinctive HPV DNA that does tend to spill out into the peripheral blood and can be detected using various different blood-based assays. And because of that advantage as a tissue agnostic approach, it turns out that a number of HPV DNA plasma assays are actually quite sensitive and quite specific. And a number of them have indeed been commercialized. Of course, not only for detecting a baseline, but also grading responsiveness during treatment and probably most importantly in the post-treatment surveillance setting, the detection of HPV DNA in the plasma remains a very important and substantial predictor of developing recurrent disease. There's been a number of trials that have been emerging looking at ctDNA and HPV-related head and neck cancer, using it, for example, as a strategy to deescalate patients. That was something we saw this past ASCO from the Dana-Farber group, and also using it to early detect recurrence and potentially intervene earlier for patients with minimal residual disease positivity. So, that remains evolving and as many folks are, I think, already using it in the clinic. But ctDNA also has a lot of potential for HPV-negative head and neck cancer. This is actually a bit more challenging to develop because you don't have that HPV DNA that you can track predictably because the tumor is an HPV- negative disease are much more heterogeneous, but there are a number of data that are coming out both for personalized assays such as Signatera or some of the other assays that require tumor. Unlike colon cancer, which you referenced, where most patients get surgery upfront, in head and neck cancer, many of the patients receive non-surgical pre-chemoradiation. So sometimes the amount of tumor available to generate a personalized assay is more limited and can be one of the challenges that we see in head neck cancer. But certainly that also seems to be emerging. And there's also further assays that are being developed for HPV-negative head neck cancers, such as methylomic signatures and others that may be tissue informed or tissue agnostic. And these are also emerging, particularly in the post-treatment surveillance setting as strong predictors of recurrent disease. So while we're certainly behind some of these other more common tumor types, colon cancer, lung cancer, we're right there with them and more and more trials are going report out, including a number of trials in our upcoming [University of Chicago] Head and Neck Cancer Symposium where I'll be presenting some data and others in the field will be presenting some data looking at ctDNA both for HPV-positive and for HPV- negative to try to improve outcomes for these patients. Dr. Monty Pal: That's so interesting. I've got to tell you that in kidney cancer, what I deal with day to day is a very low shedding disease, right? So techniques as opposed to ctDNA looking for tumor-informed information, that might be less preferred to something like methylomics where you might not necessarily be so contingent on what's happening in the primary tumor. I'm really interested in you mentioning that. Just a point of clarification, this is something I'm trying to wrap my head around. You'd mentioned circulating tumor HPV DNA, right? I assume this is markedly different from just looking for HPV titers in the patient, right? So is this actually incorporated elements of HPV within, you know, essentially host genome, if you will? Dr. Ari Rosenberg: Yeah, correct. This is circulating tumor HPV DNA. And we think of it biologically as a plasma-based tumor DNA biomarker that's specific for HPV-related head and neck cancers. Dr. Monty Pal: Got it, got it. It makes me wonder whether or not this might be applicable to diseases like cervical cancer and so forth where there's also extensively, you know, biology driven by HPV. Is that fair? Dr. Ari Rosenberg: Yes, definitely. And in the head and neck cancer field, much of this ctDNA actually was derived from a different viral mediated head neck cancer, is less common in the U.S., but nasopharyngeal cancer, which is oftentimes associated with EBV. That has been a biomarker for quite some time in nasopharyngeal cancer. Of course, in places where EBV-associated nasopharyngeal cancer, is endemic, such as East Asia, this has been around for quite some time, but we've been using that in the U.S., and there's been trials that have used EBV DNA plasma to predict recurrence and stratify for adjuvant treatment, for example. And so now with HPV, it's much more applicable to our US population because the vast majority of our head and neck cancer patients that we see in the US that are viral mediated in the US tend to be HPV-related. So having assays that we can use to improve outcomes for that biological subset remains of particular interest for us. Dr. Monty Pal: Yeah, that's fascinating. By the way, for the fellows listening, there's tons of boards pearls here that Dr. Rosenberg shared, EBV-associated cancers, the role of HPV and treatment association. So if you're recertifying anytime soon, I definitely think there's notes to take from this conversation indeed. I wanted to shift gears a little bit. And obviously, you're a prolific researcher. I don't think anyone goes through their fellowship in medical oncology without recounting these experiences of our head and neck patients really suffering from treatment-related toxicities. It's a real challenge. And I'm just wondering, I know a big body of work that you're focused on is really using multimodality treatment paradigms to perhaps reduce the cumulative treatment burden of patients with head and neck cancers. Can you talk about that a little bit? Dr. Ari Rosenberg: Yeah, definitely. Thanks for the question. And before I start going into some of the strategies, I'll just say that head and neck cancer, this is particularly for the fellows that are listening as well, just in reference to your prior comment, that this is really a multidisciplinary disease. At our center, all head and neck cancer patients are seen upfront at that first visit by all three specialties, med onc, rad onc, and surgery, because the choice and sequencing of modalities to optimize not only survival, but also functional quality of life outcome is so critical. And I think that's probably the biggest takeaway for anyone who treats a lot of head and neck cancer or will be treating a lot of head and neck cancer in the clinic. But in terms of more specific attempts at trying to optimize some of those parameters that you described, we really think about these separately in terms of HPV-positive and HPV-negative head and neck cancer. For HPV-positive head and neck cancer, the cure rates are quite high with chemo radiation, although not for everyone. There's still about 15, 10 to 15 % of folks that will develop a recurrence. But for the vast majority of patients, standard chemoradiation is quite a cure to therapy, but the toxicity associated with that can be quite substantial. And so there's been a number of attempts to try to deescalate treatment. It turns out that deescalating everyone with locoregionally advanced HPV-positive head and neck cancer is not a good strategy because it's not able to select out the patients that really do need full dose treatment. And we have seen some negative trials that show inferior outcomes when everyone is deescalated. But what does remain promising is again, trying to select out who the best candidates are for deescalated treatment. The folks at MSK have hypoxia imaging that they're using in trials that looks quite promising to select for the more favorable deescalatable biology. At our center, we've been interested in using induction chemotherapy to stratify response and select patients for deescalated treatment with excellent survival outcomes and reduce toxicity with deescalated treatment. And more recently, ctDNA that us and other groups, such as the Dana-Farber group, is using. And that also looks quite promising. Again, how do you select the patient who will do well with less radiation versus the ones that really need the full doses and volumes of radiation? And then for HPV-negative head and neck cancer, this is a much trickier disease because already the survival outcomes are not like we want it to be. Trying to figure out how to improve survival outcomes remains an important thing. Using immunotherapy seems to be one of the key cornerstones to that. But these are patients that also suffer from a lot of toxicity related to their treatment. We completed a trial not too long ago that we published this past year where we, in HPV-negative head and neck cancer patients, de-intensified the radiation for responders to neoadjuvant chemoimmunotherapy. And those patients did similar, if not even a little bit better, than the non-responders who got full dose treatment. So something that does warrant further investigation as well. How do we not only improve survival for those patients, but also reduce some of the long-term toxicities? Dr. Monty Pal: This is brilliant. I'm taking so many notes as you were mentioning these items. There are so many areas where I think the research crosses over. I already mentioned, know, ctDNA, for instance, and metabolomics and the places where that might apply to kidney cancer. The hypoxia imaging really caught my ear too. Obviously, kidney cancer is disease highly predicated on hypoxia. So thank you for all of this. We've got about a minute or so. So, I'm going to ask you for a really tall task here. Can you tell us what you foresee being some of the biggest challenges that sort of lie ahead and head and neck cancer. You've already kind of alluded to it with ongoing research, but if you had to pick maybe 2, 3 problems, the very most that we really need to get to and head and neck cancer, what would that be? Dr. Ari Rosenberg: Yeah, that's a great question. Obviously, lots of things to be done, but if I'm going to limit it to just a couple, I would say number one is really trying to improve the survival for HPV negative local regionally advanced head and neck cancer. We talked early on about how we are seeing, you know, of course we see many of these people that were smokers and drinkers, but also seeing these in younger patients, in patients without a history of tobacco use. Some of these are very biologically aggressive and we need better treatments beyond surgery, beyond chemo radiation, beyond immunotherapy to improve outcomes for these patients and cure more of them. So, I would say that's one big area. And the other is, which we didn't speak about so much in this talk, but remains one of the biggest challenges that we see in the clinic is the recurrent metastatic head and neck cancer patients. This is an incredibly challenging disease to treat, not only with poor survival, but also with substantial impacts on quality of life and function. mean, these are bad recurrences that cause a lot of pain, functional deficits, really impacts quality of life as well. So developing novel therapies, many of which are currently in clinical trials and many of which are currently continuing to be developed, remains so critical. How do we develop better systemic therapies, better targeted therapies, better biomarkers for recurrent metastatic head neck cancer to improve their survival and quality of life and functional outcomes. Those are the two big areas that require the most work at this time within the head and neck cancer field. Dr. Monty Pal: That's brilliant. I mean, I have to tell you I could probably talk to you all day about this, such a fascinating topic. It's a very exciting time in the field. Thank you, Dr. Rosenberg, for all your incredible contributions and thanks for sharing with us your insights on the ASCO Daily News Podcast. Dr. Ari Rosenberg: Yeah, and thanks for the introduction. Hope to do it again soon. Dr. Monty Pal: And many thanks to our listeners for your time today. If you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. More on today's speakers:      Dr. Monty Pal   @montypal  Dr. Ari Rosenberg @AriRosenbergMD 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. Ari Rosenberg:     Stock and Other Ownership Interests: Privo Technologies Consulting or Advisory Role: Nanobiotix, EMD Serono, Vaccitech, Novartis, Eisai, Astellas Pharma, Regeneron, RAPT Therapeutics, Geovax Labs, Janssen, Summit Therapeutics Speakers' Bureau: Coherus Biosciences Research Funding (Inst.): Hookipa Biotech, EMD Serono, Purple Biotech, Bristol-Myers Squibb/Celgene, BeiGene, Abbvie, Astellas Pharma, Pfizer, Janux Therapeutics

Dr. Monty Pal and Dr. Atul Batra discuss the PLANeT study from India, which evaluated low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer, and its place among a growing body of international research on improving efficacy while reducing costs and toxicity with lower doses of immunotherapy. TRANSCRIPT Dr. Monty Pal: Hello 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 academic affairs at the City of Hope Comprehensive Cancer Center, Los Angeles. My guest today, I think, is going to be a really riveting one. It's Dr. Atul Batra, who is an additional professor of medical oncology at the All India Institute of Medical Sciences, or AIIMS, in New Delhi. And he's also the senior author of the PLANeT study. It's a very compelling study that evaluated low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer. And it's really a big part of a growing body of research that's showing balanced efficacy when we use lower doses of immunotherapy instead of standard doses to reduce cost, as well as potentially toxicity. I think this has huge implications for our global audience, and I'm so thrilled to have you on the podcast today, Dr. Atul Batra, welcome. Dr. Atul Batra: Thank you, Dr. Pal. Dr. Monty Pal: And we'll just take it with first names from here since we're both friends. I have to give the audience some context. Atul, I had the great honor of visiting AIIMS New Delhi. For those that don't know, this is really, you know, the Harvard Medical School of India. It's the most competitive institution for medical training. And on the back end of that, there's also incredible resources when it comes to clinical trials and infrastructure. I just wanted to have you give the audience sort of a scope of the types of trials that you've been able to do at AIIMS New Delhi. Dr. Atul Batra: Thank you, Monty. So, I work at the All India Institute of Medical Sciences, and we had the honor and pleasure of having Monty here this month. And people are still in awe of his lectures that he delivered there. Coming back to our institute, so it's kind of a medical college. It's one of the oldest ones, it was built in 1956. We are lucky enough that we get the best of the residents and fellows because they have to go through an exam, a competitive exam, and mostly it's them who come to us and we're able to do some good work out here. Regarding the trials that we have conducted, we do conduct some investigator-initiated studies, and we try to answer the questions where we can help our own patients. Like, for example, this PLANeT study. Every other patient in the clinic was almost not able to afford Keytruda at the full dose, pembrolizumab, and we had a lot of evidence creeping in that a lower dose might be helpful. And that's how we planned this study. Before that, there are certain cancers that are peculiar to India, like gallbladder cancer, head and neck cancers. These are much more common in India as compared to the U.S., and there are some good studies that have been conducted from our own institute by our senior colleagues which have been presented at ASCO and published in the JCO. We also did the capecitabine hand-foot syndrome study that was known as the D-ToRCH study: 1% diclofenac gel that became the standard of care to prevent hand-foot syndrome.  So, that's kind of a brief overview of investigator-initiated studies. India is slowly and steadily becoming a partner of the global registration trials. And it's more recently, the last five years or so, we have seen that the number of phase 2 and phase 3 trials are increasing and we are able to offer now these trials as well to our patients. Dr. Monty Pal: That was a terrific overview. I just want to highlight for the audience, as we go through some of your discussions today around specific trials, the speed at which this can be done. Just for context, for me to accrue a clinical trial of 30 patients – I think many people have probably come across some of the work that I've done in the microbiome space – at a single institution, 30 patients, right, takes me about a year and a half, two years. We're going to go through some trials today where Dr. Batra and his team have actually, in fact, accrued close to 200 patients over a span of just a year, which is just remarkable by, I would say, any American standard. So, I see a real need for partnership and Atul, I'll kind of get back to that at the end. But without further ado, the focus of this podcast today, I think, is really this terrific presentation you gave in an oral session at ESMO and subsequently published in Annals of Oncology related to the PLANeT study. Would you give the listeners some context around what the study entailed and population and so forth? Dr. Atul Batra: So, we know the KEYNOTE-522 became the standard of care for triple-negative breast cancer, where Keytruda, when added at 200 mg, the standard dose every three weeks with neoadjuvant, increases the pCR from around 51% to 64% by a magnitude of around 13%. However, in India and other low-middle income countries, less than 5% of the patients actually have access to this dose of pembrolizumab. So, our standard of care was actually just chemotherapy till now. And this kind of led us to design this trial. There are data that come from previous trials conducted in India, from the Tata Memorial, done in head and neck space, some other studies done in Hodgkin's lymphoma, that a much lower dose, probably around one-tenth of the dose, works well in these cancers. So, that's where we designed the PLANeT study, where we gave the standard neoadjuvant chemotherapy in the control arm, and in the experimental arm we added 50 mg of pembrolizumab. This was given every six weeks for three doses. So, that's a total of 150 mg over the neoadjuvant period as compared to 1,600 mg that was given in the KEYNOTE-522 study. So, this was almost one-tenth of the study. Dr. Monty Pal: So, a tenth of the dose, which is just remarkable. I mean, that's just such an interesting concept. Dr. Atul Batra: And the results, when we – the primary outcome, this was a phase 2 study. We just wanted to see, is there a signal of activity? And to even our surprise, when we looked at the pathological complete response rates, in the control arm this was 40.5%, and in the experimental arm this was 53.8%. So, a difference came to around 13.3%; it was numerically, I mean, so much similar to what KEYNOTE-522 had with just these many doses. So, this was around 160 patients randomized over one year. We could randomize them in one year because of the load that we see. And the primary endpoint was met, and we could see that the path complete response did show a remarkable increase. We are still following these patients to see whether there is a difference in event-free survival at a longer follow-up. Until now, it's a small follow-up, so the number of events absolute, are different: four events in the experimental arm and 11 events in the control arm. So, we are seeing some signal even in this much short follow-up period as well. But we need to see more of what happens in the longer term. Dr. Monty Pal: That's so impressive. I wonder, with this lower dose, do you attenuate toxicity at all as far as you can gather? Dr. Atul Batra: So, although we shouldn't be doing kind of cross-trial comparisons, but if you look at thyroid dysfunction, we saw that around 10% of our patients had this thyroid dysfunction. This was compared to 15% in the KEYNOTE-522, that was a larger sample size though. But we're seeing that all the toxicities are somewhat less as compared to those in the standard dose. So, the exposure is less, but I mean, I can't really commit definitely on this. For this we would need much more data to say this with more confidence. Dr. Monty Pal: Yeah. I'm going to ask you a really tough question to follow up, and this is probably something that's on everyone's mind after reading a study like this. Is this something that is disease-specific that needs to be replicated across other histologies? The reason I ask this is, you know, you think about paradigms like, for instance, in the States we're toying between intravenous versus subcutaneous delivery of checkpoint inhibitors, and we have studies focused in specific histologies that might justify use across all histologies. With this particular phenomenon, do you think we need to do dedicated studies in renal cell or in colon cancer and other places where, you know, in selected settings we might use checkpoint inhibitors and then decide whether or not there's this dose equivalence, if you will? Dr. Atul Batra: That's a real tough one, though. But I'm happy to share that there are several ongoing studies within India currently. At our institute, my colleagues are leading studies in lung cancer space, cervical cancer. There was already a publication from Tata Memorial Hospital in head and neck cancers and we see that the signal has been consistent throughout. Regarding renal cancer, there was one study that was presented for sure at ASCO from CMC Vellore, that's again a center in South India. That was in RCC at a much lower dose. And for patients who cannot take the full dose, we actually are offering lower dose nivolumab in such patients and we are seeing responses. I mean, we haven't done those randomized trials again because the numbers are much lower in kidney cancers, we know. We could do this trial in triple-negative ones because we had support and we had numbers to conduct this trial. But I'm sure this should be a class effect. I mean, when we can get tumor-agnostic approvals, then some real-world data has come up in almost all tumors, we have seen that consistent effect across tumors. And as we speak of today, I'm also delighted to share that in India, yesterday, we had the first biosimilar of nivolumab and that's now available at a much, much lower price than the original patent product. There was a long ongoing lawsuit that was there, that's over now, and from yesterday onwards, I'm so happy to share here that we would have the first biosimilar of nivolumab that's available. That's going to bring the cost to almost like one-tenth already. Dr. Monty Pal: Wow. That's huge.  I'm going to be very selfish here for a second and focus on a study that is in the renal cell space that your group has done. You know, when it came out, I was really sort of intrigued by this study as well and it reflects sort of a different capability, I think, of AIIMS New Delhi, and that's in the, what I'm going to call, biomarker space. This, for the audience, was a prospective effort to characterize germline variants in patients with advanced kidney cancer. And it's something that we talk about a lot in the kidney cancer literature, whether or not we're missing a lot of these so-called hereditary patterns of RCC. Can you tell us a little bit about that study too? Dr. Atul Batra: Yeah, so that was led by one of our fellows, Chitrakshi Nagpal, and she's just completed her fellowship. And two years back we published that. So, that was done in almost 160 consecutive patients that we recruited over the span of just one year and we saw, apart from the common known mutations in RCC, that was around 5% or so, but a lot of other mutations were also seen that we don't generally see in kidney cancers and we see in other cancers like BRCA1, BRCA2 and others. We are still, I mean, doing those analyses to see whether we get more things out of there in the somatic: is there a loss of heterozygosity or was it just present and in there? Dr. Monty Pal: I thought it was a terrific study and again, I was just so blown away at the pace. I mean, as I look at 140 patients accrued over a span of one year, this is something that would take us perhaps three times as long at City of Hope, and that's with a very sort of, what I consider to be large and dedicated kidney cancer program. So, it really underscores, I think, the need for collaboration. And ever since I came back from my visit to you at AIIMS Delhi, I think I've just been sort of transformed in the sense of trying to think of better ways for us to collaborate. One tangible thing that I'm going to get cracking on is seeing whether or not perhaps we can form some partnerships through SWOG or what we call the NCTN, the National Clinical Trials Network here within the U.S. Talk to me about collaboration. I mean, you've been really terrific at this. How do you sort of envision collaboration enhancing the global landscape of oncology? Dr. Atul Batra: That's really amazing, Monty. That's what we need. We have the infrastructure, we have the manpower, we have patients. I mean, these are all high-volume centers. Unfortunately, we are a little less in numbers, so we are more clinically occupied as well. So, sometimes it's kind of tougher, but again, when it comes to helping out the patients, global collaboration, we need to kind of take you guys along with us and have our patients finish trials earlier. This is a win-win situation for patients, one, because they also get exposure or an option to participate in the clinical trials, and second, we can answer all these scientific questions that we have at a much faster pace. All those things can be done within a much shorter span of time for sure. We are so happy to hear that, and with open hands we are ready to collaborate for all these efforts. Dr. Monty Pal: That's awesome. You know, I came back thinking, gosh, this would be so ideal for some of these rare subtypes of kidney cancer. Prospective clinical trials that I'm running in that space where really we're threatened with closure all the time. And if we just sort of extended a hand to, you know, our partners in India and other countries, you know, I'm sure we could get this research done in a meaningful way and that's got to be a win for patients. Atul, I had such a terrific time chatting with you today. I'm looking forward to seeing lots more productivity from your group there. By the way, for our viewership here, take a look and see what AIIMS New Delhi is doing under the leadership of Dr. Batra and others. It is just a real powerhouse and I think that after doing so, you'll be enticed to collaborate as well.  I'm hoping this is the first of many times that we have you on the podcast. Thank you so much for joining. Dr. Atul Batra: Thank you so much for having me here, Monty. It was a pleasure as always speaking to you. And thank you again. Dr. Monty Pal: You got it.  Well, and thanks to our listeners. I encourage you to check out Dr. Batra's paper. We'll actually have a link to the 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. 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. Monty Pal   @montypal Dr. Atul Batra @batraatulonc 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. Atul Batra: Stock and Other Ownership Interests: Zydus Pharmaceuticals, Glenmark, Caplin Point Laboratories, Laurus Research Funding: AstraZeneca, Astellas Pharma, Alkem Laboratories

The cultivated meat industry has captured headlines and struggled with economics. Meanwhile, plant cell biomanufacturing is quietly solving the cost equation and approaching commercial launch. The question isn't whether cellular agriculture can work at scale. It's which applications will get there first, and what bioprocessing innovations will make it possible.In Part 2, we dive into the commercialization challenges that separate laboratory curiosity from market-ready products. Steven Lang tackles the hard questions: How do you replicate chocolate's complex flavor profile without traditional fermentation? What analytical infrastructure ensures product consistency and safety? And how do you build the right team and data foundation to navigate the journey from premium launch to commodity-scale production?Steven's background spanning Johnson & Johnson, Genentech, and Upside Foods gives him a unique perspective on what works and what doesn't when translating biopharma rigor to food applications. At California Cultured, he's applying those lessons to launch high-flavanol cocoa powder in 2026, with a clear roadmap to commodity cocoa and coffee thereafter.In this episode:The challenge of replicating chocolate's taste and fermentation in the lab (02:39)How plant cell culture differs from conventional farming and its advantages for safety and scalability (03:03)Analytical methods and equipment needed for consistent, safe, and high-quality cultured cocoa products (05:05)The potential for cell-based food to minimize heavy metals and other contaminants in chocolate (06:09)Environmental implications: tackling climate change, deforestation, and the realistic timeline for widespread adoption of lab-grown foods (06:50)Emerging opportunities beyond cocoa and coffee—saffron, ginseng, echinacea, and even lab-grown wood (08:40)Key advice for scientists and entrepreneurs interested in entering the cellular agriculture field (10:12)Building successful teams and robust data foundations in biotech startups (11:43)Key takeaway:Cellular agriculture's future isn't a single technology replacing conventional food production. It's multiple parallel approaches creating resilience in global food systems. The opportunity is clear: the technical principles you've mastered in biopharma translate directly to food applications, but the faster commercialization timelines and novel business models require rethinking what "stage-appropriate development" means.The question for bioprocess leaders is whether you'll help build the solutions to bridge the food production gap, or watch from the sidelines as food security becomes the defining challenge of our generation.Here is the previous conversation with Steven Lang:Episodes 55-56: Cultivated Meat: A Promising Future or an Inevitable Bubble? with Steven LangConnect with Steven Lang:LinkedIn: www.linkedin.com/in/steven-lang-b003406California Cultured Inc.: www.cacultured.comNext step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show