Podcasts about Drug development

“Pandemics are a political choice. We will not be able to prevent every disease outbreak or epidemic but we can prevent an epidemic from becoming a pandemic,” says Dr. Joanne Liu, the former International President of Médecins Sans Frontières/Doctors Without Borders and a professor in the School of Population and Global Health at McGill University. You are in for a lot of that sort of frank and clear-eyed analysis in this episode of Raise the Line from Dr. Liu, whose perspective is rooted in decades of experience providing medical care on the frontlines of major humanitarian and health crises across the globe, as well as wrangling with world leaders to produce more effective responses to those crises and to stop attacks on medical facilities and aid workers in conflict zones. Firsthand accounts from the bedside to the halls of power are captured in her new book Ebola, Bombs and Migrants, which focuses on the most significant issues during her tenure leading MSF from 2013-2019.  The book also contains insights about the geopolitical realities that hamper this work, including lax enforcement of international humanitarian law, and a focus on national security that erodes global solidarity. Join host Lindsey Smith as she interviews this leading voice on our preparedness to meet the needs of those impacted by violent conflict, forced migration, natural disasters, disease outbreaks and other grave challenges. If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

In this episode, former FDA leader and current SVP of Regulatory and Quality at Ariana Data Intelligence, Dr. Frederico Goodsaid, shares cutting-edge insights on how artificial intelligence (AI) is reshaping the landscape of drug discovery and development — particularly in the treatment of rare and orphan diseases.From breaking down the FDA's new guidance on AI to explaining why credibility now matters more than explainability, this conversation offers essential takeaways for professionals in biotech, pharma, regulatory affairs, clinical trials, and digital health.In This Episode, You'll Learn:How the FDA defines and regulates AI tools in drug developmentThe evolving concept of “credibility” in machine learning modelsWhy AI is essential for rare disease research with small patient populationsChallenges with black-box algorithms and how to overcome themHow real-world evidence and genomic data are driving drug repurposingThe FDA's stance on continuous learning AI systemsStrategic advice for pharma companies adopting AI under regulatory scrutinyAbout the Podcast:AI for Pharma Growth is a podcast focused on exploring how artificial intelligence can revolutionise healthcare by addressing disparities and creating equitable systems. Join us as we unpack groundbreaking technologies, real-world applications, and expert insights to inspire a healthier, more equitable future.This show brings together leading experts and changemakers to demystify AI and show how it's being used to transform healthcare. Whether you're in the medical field, technology sector, or just curious about AI's role in social good, this podcast offers valuable insights.AI For Pharma Growth is the podcast from pioneering Pharma Artificial Intelligence entrepreneur Dr. Andree Bates created to help organisations understand how the use of AI based technologies can easily save them time and grow their brands and business. This show blends deep experience in the sector with demystifying AI for all pharma people, from start up biotech right through to Big Pharma. In this podcast Dr Andree will teach you the tried and true secrets to building a pharma company using AI that anyone can use, at any budget. As the author of many peer-reviewed journals and having addressed over 500 industry conferences across the globe, Dr Andree Bates uses her obsession with all things AI and futuretech to help you to navigate through the, sometimes confusing but, magical world of AI powered tools to grow pharma businesses. This podcast features many experts who have developed powerful AI powered tools that are the secret behind some time saving and supercharged revenue generating business results. Those who share their stories and expertise show how AI can be applied to sales, marketing, production, social media, psychology, customer insights and so much more. Dr. Andree Bates LinkedIn | Facebook | Twitter

In this week's episode of the BroadEYE Podcast, hosts Dr. Shawn Maloney and Dr. Carlos Quezada-Ruiz sit down with Dr. Wiley Chambers, recently retired Deputy Director of the Division of Ophthalmology at the U.S. Food and Drug Administration (FDA). With over 36 years at the FDA, Dr. Chambers offers a rare insider's perspective on regulatory science, ophthalmic drug development, and the evolution of clinical trial oversight. This episode explores: How ophthalmology regulation has changed over the decades Common pitfalls in pre-IND meetings and what smart innovators do differently Lessons learned from reviewing countless drug and biologic applications The future of FDA guidance in areas like rare disease, gene therapy, and digital endpoints Dr. Chambers also shares personal reflections on mentorship, scientific integrity, and his transition out of federal service after a distinguished career. About Our Guest Dr. Wiley Chambers served as a lead ophthalmic reviewer at the U.S. FDA from 1987 until his retirement in 2023. As Deputy Director of the Division of Ophthal

Send us a text00:00 - Surf's Up, Season 6 Episode 8The conversation addresses three issues that are distinct, yet each is pivotal to the future of MASLD and MASH therapies. The first, from the Global Think-Tank on Steatotic Liver Disease, considers how personal and digital approaches can be combined to form the most effective strategy for patient management. In the second, Global Liver Institute President and CEO Larry Holden joins Roger Green to discuss the new challenges in Washington stemming from the Trump Administration and RFK Jr. The final section is the conclusion of our recent drug development roundtable, examining drug classes we did not previously discuss, along with a thought on where combination therapy is likely to lead. 00:04:57 - Global Think-Tank on SLD Roundtable, Part 2Behavior consultant Dr. Kristina Curtis joins Jörn Schattenberg, Louise Campbell and Roger Green to discuss issues related to patient-centered care. This discussion focuses on the elements of successful behavior change and the importance of real-time, actionable feedback. The group discusses the interplay of diagnostic test feedback, real-time personal exchanges and AI-based algorithms in what Kristina terms a "hybrid therapy."00:18:39 - Newsmaker: Larry HoldenGLI President and CEO Larry Holden addresses two issues related to current goings-on in Washington. First, he acknowledges that we are in for "dark times" under the current administration, and describes some of the decisions and challenges we face. Second, he suggests what individuals and organizations can do to create the best possible situation -- and even some "wins" -- for people living with liver disease. These suggestions reflect his experiences during a 30-year career on Capitol Hill, prior to his joining GLI.00:46:15 - Drug Development Roundtable, Part 4Sven Francque joins Jörn, Louise and Roger to share an up-to-date look at drug development. This discussion focuses on PPARs, genetic medicines, and other emerging drug classes. Sven uses the example of the pan-PPAR lanifibranor to explore the idea that drug therapies can have an impact on the liver independent of their effect on fibrosis regression. The group proceeds to discuss other emerging drugs in development and their modes of action. One theme: over time, we may see prescribers consider using different therapies to address metabolic vs. liver-specific effects, often in combination.01:00:47 - Business ReportThanks to our listeners, Jörn's vacation, Welcome Regeneron

Send us a textThis conversation is the third segment of SurfingMASH's April discussion of drug development in memory of Stephen A. Harrison. In addition to co-hosts Jörn Schattenberg, Louise Campbell and Roger Green, panelists include hepatologists and key opinion leaders Sven Francque and Naim Alkhouri. Louise starts the discussion by asking when a patient is metabolically and hepatically healthy instead of merely driving weight loss. She notes that basing therapy entirely on weight loss goals will breed failure and frustration while failing to address the actual pivotal goal of metabolic health. Sven agrees and notes how important this point is. Roger suggests that the benefit of weight loss is likely to become limited over time, which is why there is such excitement about GLP-glucagon combination therapies. Again, Sven concurs, noting that such knowledge and increasing drug class diversity will allow researchers to look at true, basic differences between agents instead of "small numerical differences."Jörn notes the importance of NITs in addressing these kinds of issues. Scanning is an effective method for measuring changes in liver fat; however, the academic community has developed surrogate NITs for specific physiological activities. As Sven notes, there is still a great deal of work to do here. That said, Jörn cites examples of large, NIT-based projects like the VCTE Study Group that have sufficient sample size to start building definitions around kilopascal levels. Louise shares her strong concern that many TE operators are not trained adequately to appreciate subtle clues that would tell an expert how an individual scan was providing misleading results. She notes that the increased demand for scanning, in this case TE, is going to drive a watering down of the qualifications and the skill of the user and the supervision level..." The discussion winds down with Sven agreeing with Louise and stating the need for sequential testing and Jörn citing EASL guidelines in stating that practices should provide and manage high-quality care to the best of their abilities. 

“As parents dedicated to getting a treatment for our children in their lifetimes, we have turned the rare disease drug development landscape upside down and created a new model,” says Nicole Johnson, co-founder and executive director of the FOXG1 Research Foundation.  That's not an exaggeration, as the foundation is on track to make history as it begins patient clinical trials on a gene replacement therapy next year. The former TV news producer and media executive unexpectedly entered the world of patient advocacy and drug research after her daughter, Josie, was born with FOXG1, a genetic disorder which causes severe seizures and impedes normal movement, speech, and sleep among other problems. Johnson is also making an impact in another important dimension of the rare disease space in her efforts to educate parents, teachers, and students about disability inclusion through her Joyfully Josie book series and “Live Joyfully” education programs. Tune-in to this fascinating Year of the Zebra conversation with host Lindsey Smith to find out how the foundation is aiming to bring a drug to market in less than half the time and at a fraction of the cost than the industry standard, and how this model might impact research on other rare disorders. Mentioned in this episode:FOXG1 Research FoundationJoyfully Josie Book If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

In this episode, Eunice Wang, MD and Eytan Stein, MD explore the latest key clinical updates on menin inhibitors in AML. This episode unpacks evolving treatment strategies and what these developments mean for patient care.Presenters:Eytan M. Stein, MDChief, Leukemia ServiceDirector, Program for Drug Development in LeukemiaAssociate Attending PhysicianLeukemia Service, Department of MedicineMemorial Sloan Kettering Cancer CenterNew York, New YorkEunice S. Wang, MDChief, Leukemia ServiceProfessor of OncologyDepartment of MedicineRoswell Park Comprehensive Cancer CenterBuffalo, New YorkLink to full program: https://bit.ly/4f4an0O

On this episode of Chit Chat Stocks, we speak with Leandro from the Best Anchor Stocks newsletter on a biopharma stock he recently researched. We discussed:(00:00) Introduction and history(04:31) Understanding the Pharmaceutical Supply Chain(07:30) Exploring Business Segments(12:06) High Value Products vs. Bulk Products(14:24) The Impact of AI on Drug Development(17:17) Current Industry Cycles and Demand Dynamics(21:24) CapEx Expansion and Future Capacity(24:04) Drivers of Demand for Products(26:33) The Impact of GLP-1s on Business Dynamics(29:27) Navigating Tariff Impacts in the Pharmaceutical Supply Chain(32:21) Understanding Competition in the Pharmaceutical Packaging Industry(36:45) The Advantages of Vertical Integration(41:41) Valuation Insights and Market Perception(47:38) Identifying Risks and Challenges Ahead(51:54) Exploring Best Anchor Stocks and Investment StrategiesLeandro's Twitter: https://x.com/InvesquotesBest Anchor Stocks: https://www.bestanchorstocks.com/*****************************************************JOIN OUR NEWSLETTER AND FREE CHAT COMMUNITY: https://chitchatstocks.substack.com/ *********************************************************************Chit Chat Stocks is presented by TSOH Investing Research. Long-term equity research with 100% portfolio transparency. Subscribe Today: https://thescienceofhitting.com/ *********************************************************************Chit Chat Stocks is presented by Interactive Brokers. Get professional pricing, global access, and premier technology with the best brokerage for investors today: https://www.interactivebrokers.com/ Interactive Brokers is a member of SIPC. *********************************************************************Fiscal.ai is building the future of financial data.With custom charts, AI-generated research reports, and endless analytical tools, you can get up to speed on any stock around the globe. All for a reasonable price. Use our LINK and get 15% off any premium plan: ⁠https://fiscal.ai/chitchat *********************************************************************Disclosure: Chit Chat Stocks hosts and guests are not financial advisors, and nothing they say on this show is formal advice or a recommendation.

Today on Raise the Line, we bring you the unlikely and inspiring story of a woman who was afraid of blood as a child but became an accomplished nurse; who struggled with learning disabilities but became an effective educator; and who, despite lacking business experience or knowledge of graphics, built a successful company that produces visually rich educational materials for nurses and other providers. “I think the theme of my life has been I have struggled with learning, and I didn't want other people to struggle,” says Jennifer Zahourek, RN, the founder and CEO of RekMed which has developed a sequential, interactive learning system that includes illustrated planners, books, and videos used by millions of students and providers. The initial focus was to provide nurses with everything they needed to know from “the basics to the bedside” but RekMed now offers content for medics, respiratory therapists, medical assistants, and veterinarians as well. Driven by her belief in the power of visual learning and her “just freakin' do it” attitude, Jennifer overcame her fear of launching a business and quickly realized just how well nursing had prepared her for the hard work and unpredictability of entrepreneurship. “Nursing teaches you how to just be resilient, to pivot, to delegate, to work on a team and to handle high stress. I think nurses could literally be some of the best entrepreneurs on the planet,” she tells host Lindsey Smith. Tune in to this lively and valuable conversation as Jennifer shares lessons from bootstrapping a publishing company, insights on the evolving landscape of healthcare education, and advice on embracing change in nursing, especially with the expanding role of AI. Mentioned in this episode:RekMed If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

00:00:00 - Surf's Up: Season 6 Episode 7Host Roger Green explains our recent vacation from publishing episodes, assures the audience that the podcast will continue weekly for months and years ahead, and discusses the episode's sections, covering the Global Think-Tank on Steatotic Liver Disease (SLD), the EASL patient screening activity and the increasing role of NITs in drug development. While introducing roundtable guests, he introduces first-time Surfer Dr. Kristina Curtis of the UK-based consultancy, Applied Behaviour Change.00:09:11 - Roundtable I: From the Global Think-Tank on SLDThis discussion starts with co-host Jörn Schattenberg discussing the history and evolution of the first four Global Think-Tanks as the focus shifts from educating medical professionals about liver disease to incorporating a broader group of stakeholders, including politicians and non-hepatologist MDs, to break down siloes and create wider awareness. Co-host Louise Campbell describes the breadth of stakeholders necessary to address this pandemic fully. She explains how her work with transient elastography and the MyLife365.me app constitutes a form of behavioral therapy. Jörn describes the test as a diagnostic and comments that the treatment is what health professionals do with the results. Kristina says that the behavioral change that results comes from well-delivered feedback. She describes "hybrid interventions, digital interventions with a human in the loop." Louise discusses results from the EASL late-breaker that support these findings and goes on to discuss the role AI can play in medical practices.00:23:50 - Newsmaker: Jose Willemse, Dutch Liver Patients Association This discussion covers two primary topics: (1) the Amsterdam screening activity that took place during EASL. Jose describes the phenomenal level of interest in this activity, in which hepatologists and APPs scanned 400 people per day for MASLD and MASH. Boosted by significant mass publicity in Amsterdam, the number of people seeking screening exceeded the 400/day quota, with some arriving in line hours before the scheduled start time and others traveling for hours to reach the site. Jose believes that with adequate publicity, efforts like these could be replicated around the world, but that the healthcare system lacks the necessary resources to do so. In terms of patient care, Jose emphasized the importance of sensitive yet frank conversations and helping patients appreciate the successes they are achieving. 00:53:45 - Roundtable II: NITs Increasing Role in Drug Development Sven Francque and Naim Alhouri joined Louise, Jörn and Roger for this roundtable, although Naim had dropped off by this time. The conversation starts with Louise noting that the goal of therapy is not simply to treat MASLD, but to achieve overall metabolic health, of which MASLD is a key component. Jörn states that we are on the path toward conducting clinical trials entirely with NITs as disease markers, which he describes as a "game changer" and Louise terms "exciting." She asks whether NITs can serve as the only trial surrogate. Jörn and Sven agree that we are not at that point yet, but we are headed in that direction. Jörn asserts that "nothing" will replace outcomes as the prerequisite for full approval and mentions the VCTE study group as demonstrating that a large NIT-based trial can prove effects on disease. Louise cautions that operator competency is a key, if overlooked, criterion for this kind of activity. Sven concurs and states that repeat measures are crucial in managing disease. Jörn notes that practices can serve as centers of care, but will need support from nutritionists and other professionals. 01:06:08 - Business ReportRoger highlights special September programming, indicates that new sponsors are on the way, and asks how many listeners find SurfingMASH on YouTube. 

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Takeda has taken the lead in the race for a narcolepsy treatment with back-to-back phase III wins for their drug Oveporexton. Investors are eagerly awaiting breakthroughs in using psychedelics to treat depression. Ultragenyx faced a setback as the FDA rejected their gene therapy for Sanfilippo syndrome, citing manufacturing issues. The FDA is considering speeding up reviews for companies that promise to lower drug costs. Market reaction to recent readouts from Compass Pathways and Beckley Psytech/Atai in treatment-resistant depression shows the challenges psychedelic therapies must overcome for commercial viability. Rainin Micropro offers a solution to streamline NGS preparation with their 96-channel pipettor. The industry is also focused on precision diagnostics to support precision therapeutics in the future. AstraZeneca's Baxdrostat showed promising results in lowering blood pressure in a phase III trial. The ADA revealed R&D priorities for potential blockbuster obesity treatments. Relmada has abandoned development of a depression drug after three failed attempts.The challenges faced by psychedelic therapies in the treatment of depression are discussed, as recent readouts from Compass Pathways and Beckley Psytech/Atai in treatment-resistant depression have left investors wanting more. The market reaction highlights the hurdles psychedelic therapies must overcome to prove their commercial viability. Additionally, the importance of precision diagnostics in the development of next-generation precision oncology therapies is emphasized, stating that only with the adoption of digital imaging and AI-powered analysis will these therapies reach their full potential. The FDA has several important decisions lined up, including applications in lymphoma, rare diseases, and hormone deficiency, while the American Diabetes Association's annual meeting reveals R&D priorities for weight loss medicines. Topics discussed include Capricor's FDA rejection of a DMD cell therapy, the ALS community petitioning the FDA to reconsider Brainstorm's Nurown, and updates on COVID-19 vaccines and Alzheimer's drugs. Upcoming webinars and job opportunities in the biopharma industry are also included.

In the latest episode of Conversations in Drug Development, Dr Katherine Bowen and Dr Eric Hardter discuss the ever-changing US regulatory landscape under the new administration, including new leadership and staff turnover, and their impact on drug development. They examine the FDA's cautious approach to AI, efforts to reduce animal testing, and the new National Priority Voucher Program aimed at expediting drug approvals. Tune in for an in-depth discussion that offers timely updates and expert perspectives on what might be in store for drug development stakeholders.

“Very often, doctors try to suppress what they feel or don't even have the vocabulary to describe their emotions,” says Professor Alicja Galazka of the University of Silesia, an observation based on decades of work with physicians to enhance their emotional intelligence and resilience. Galazka, a psychotherapist, psychologist, lecturer and coach, believes this deficit is rooted in part in a lack of instruction in the internal and external psychological dimensions of being a medical provider. “There is not enough space created in medical school for teaching and training students about how to deal with their own stress and all of the skills connected to building relationships with patients,” she tells host Michael Carrese. Those same skills are also critical to working effectively as a member of a care team, which is an increasingly common arrangement in hospitals and clinics. Galazka employs simulations, dramatic role-playing, mindfulness, Acceptance and Commitment Therapy and other methods in her work with an eye on increasing the emotional agility and sensitivity of her trainees and clients. Tune in to this thoughtful episode of Raise the Line to hear Galazka's ideas on how to reshape medical training, why she is a proponent of narrative medicine, and the merits of embedding psychologists on care teams as a resource for both patients and providers. Mentioned in this episode:University of SilesiaInternational Association of Coaching Institutes If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

Lisata Therapeutics Inc CEO Dr David Mazzo and GATC Health chief business officer Tyrone Lam talked with Proactive's Stephen Gunnion about the companies' collaboration to advance a novel treatment for opioid use disorder. Mazzo explained that combining Lisata's regulatory and clinical expertise with GATC's MAT artificial intelligence platform allows the team to significantly reduce the trial-and-error typical in early drug development. “The reason that we've expanded the partnership is that we see a real symbiotic relationship between the two organizations,” Mazzo said. He highlighted that the AI platform has enabled the identification of promising candidates much faster than conventional approaches. This first program targets opioid abuse, which Mazzo described as a large unmet medical need and a significant social issue in the United States. He noted the market potential could be valued in the billions of dollars, creating both commercial and social opportunities. Mazzo also discussed how the partnership model could lead to either independent commercialization or licensing deals with larger pharmaceutical companies. Throughout the discussion, both Mazzo and Lam emphasized that the combination of AI and biotech expertise may serve as a model for future drug development collaborations. Visit Proactive's YouTube channel for more videos. Don't forget to give this video a like, subscribe to the channel, and enable notifications for future content. #LisataTherapeutics #GATCHealth #OpioidCrisis #DrugDiscovery #ArtificialIntelligence #BiotechInnovation #MATPlatform #OpioidUseDisorder #ClinicalTrials #NonOpioidTreatment

In this episode, host Zac Lloyd engages with expert in the field Colleen Johnson to discuss critical considerations in designing in vivo nonclinical programs for dermal and topical products. Through this conversation we aim to enhance understanding of key aspects in this specialized area of toxicology.  This podcast is designed to offer listeners an introduction to dermal product drug development.

Dr. Diwakar Davar and Dr. Jason Luke discuss novel agents in melanoma and other promising new data in the field of immunotherapy that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Diwakar Davar: Hello. My name is Diwakar Davar, and I am welcoming you to the ASCO Daily News Podcast. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. Today, I'm joined by my colleague and good friend, Dr. Jason Luke. Dr. Luke is a professor of medicine. He is also the associate director of clinical research and the director of the Phase 1 IDDC Program at the University of Pittsburgh's Hillman Cancer Center. He and I are going to be discussing some key advancements in melanoma and skin cancers that were presented at the 2025 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode.  Jason, it is great to have you back on the podcast. Dr. Jason Luke: Thanks again so much for the opportunity, and I'm really looking forward to it. Dr. Diwakar Davar: Perfect. So we will go ahead and start talking a little bit about a couple of key abstracts in both the drug development immunotherapy space and the melanoma space. The first couple of abstracts, the first two, will cover melanoma. So, the first is LBA9500, which was essentially the primary results of RELATIVITY-098. RELATIVITY-098 was a phase 3 trial that compared nivolumab plus relatlimab in a fixed-dose combination against nivolumab alone for the adjuvant treatment of resected high-risk disease. Jason, do you want to maybe give us a brief context of what this is? Dr. Jason Luke: Yeah, it's great, thanks. So as almost all listeners, of course, will be aware, the use of anti–PD-1 immunotherapies really revolutionized melanoma oncology over the last 10 to 15 years. And it has become a standard of care in the adjuvant setting as well. But to review, in patients with stage III melanoma, treatment can be targeted towards BRAF with BRAF and MEK combination therapy, where that's relevant, or anti–PD-1 with nivolumab or pembrolizumab are a standard of care. And more recently, we've had the development of neoadjuvant approaches for palpable stage III disease. And in that space, if patients present, based on two different studies, either pembrolizumab or nivolumab plus ipilimumab can be given prior to surgery for somewhere in the 6- to 9-week range. And so all of these therapies have improved time-to-event endpoints, such as relapse-free or event-free survival. It's worth noting, however, that despite those advances, we've had a couple different trials now that have actually failed in this adjuvant setting, most high profile being the CheckMate-915 study, which looked at nivolumab plus ipilimumab and unfortunately was a negative study. So, with RELATIVITY-047, which was the trial of nivolumab plus relatlimab that showed an improvement in progression-free survival for metastatic disease, there's a lot of interest, and we've been awaiting these data for a long time for RELATIVITY-098, which, of course, is this adjuvant trial of LAG-3 blockade with relatlimab plus nivolumab. Dr. Diwakar Davar: Great. So with that, let's briefly discuss the trial design and the results. So this was a randomized, phase 3, blinded study, so double-blinded, so neither the investigators knew what the patients were getting, nor did the patients know what they were getting. The treatment investigational arm was nivolumab plus relatlimab in the fixed-dose combination. So that's the nivolumab standard fixed dose with relatlimab that was FDA approved in RELATIVITY-047. And the control arm was nivolumab by itself. The duration of treatment was 1 year. The patient population consisted of resected high-risk stage III or IV patients. The primary endpoint was investigator-assessed RFS. Stage and geography were the standard stratifying factors, and they were included, and most of the criteria were balanced across both arms. What we know at this point is that the 2-year RFS rate was 64% and 62% in the nivolumab and nivolumab-combination arms, respectively. The 2-year DMFS rate was similarly equivalent: 76% with nivolumab monotherapy, 73% with the combination. And similar to what you had talked about with CheckMate 915, unfortunately, the addition of LAG-3 did not appear to improve the RFS or DMFS compared to control in this patient population. So, tell us a little bit about your take on this and what do you think might be the reasons why this trial was negative? Dr. Jason Luke: It's really unfortunate that we have this negative phase 3 trial. There had been a lot of hope that the combination of nivolumab with relatlimab would be a better tolerated combination that increased the efficacy. So in the metastatic setting, we do have 047, the study that demonstrated nivolumab plus relatlimab, but now we have this negative trial in the adjuvant setting. And so as to why exactly, I think is a complicated scenario. You know, when we look at the hazard ratios for relapse-free survival, the primary endpoint, as well as the secondary endpoints for distant metastasis-free survival, we see that the hazard ratio is approximately 1. So there's basically no difference. And that really suggests that relatlimab in this setting had no impact whatsoever on therapeutic outcomes in terms of efficacy. Now, it's worth noting that there was a biomarker subanalysis that was presented in conjunction with these data that looked at some immunophenotyping, both from circulating T cells, CD8 T cells, as well as from the tumor microenvironment from patients who were treated, both in the previous metastatic trial, the RELATIVITY-047 study, and now in this adjuvant study in the RELATIVITY-098 study. And to briefly summarize those, what was identified was that T cells in advanced melanoma seemed to have higher expression levels of LAG-3 relative to T cells that are circulating in patients that are in the adjuvant setting. In addition to that, there was a suggestion that the magnitude of increase is greater in the advanced setting versus adjuvant. And the overall summary of this is that the suggested rationale for why this was a negative trial may have been that the target of LAG-3 is not expressed as highly in the adjuvant setting as it is in the metastatic setting. And so while the data that were presented, I think, support this kind of an idea, I am a little bit cautious that this is actually the reason for why the trial was negative, however. I would say we're not really sure yet as to why the trial was negative, but the fact that the hazard ratios for the major endpoints were essentially 1 suggests that there was no impact whatsoever from relatlimab. And this really makes one wonder whether or not building on anti–PD-1 in the adjuvant setting is feasible because anti–PD-1 works so well. You would think that even if the levels of LAG-3 expression were slightly different, you would have seen a trend in one direction or another by adding a second drug, relatlimab, in this scenario. So overall, I think it's an unfortunate circumstance that the trial is negative. Clearly there's going to be no role for relatlimab in the adjuvant setting. I think this really makes one wonder about the utility of LAG-3 blockade and how powerful it really can be. I think it's probably worth pointing out there's another adjuvant trial ongoing now of a different PD-1 and LAG-3 combination, and that's cemiplimab plus fianlimab, a LAG-3 antibody that's being dosed from another trial sponsor at a much higher dose, and perhaps that may make some level of difference. But certainly, these are unfortunate results that will not advance the field beyond where we were at already. Dr. Diwakar Davar: And to your point about third-generation checkpoint factors that were negative, I guess it's probably worth noting that a trial that you were involved with, KeyVibe-010, that evaluated the PD-1 TIGIT co-formulation of vibostolimab, MK-4280A, was also, unfortunately, similarly negative. So, to your point, it's not clear that all these third-generation receptors are necessarily going to have the same impact in the adjuvant setting, even if they, you know, for example, like TIGIT, and they sometimes may not even have an effect at all in the advanced cancer setting. So, we'll see what the HARMONY phase 3 trial, that's the Regeneron cemiplimab/fianlimab versus pembrolizumab control with cemiplimab with fianlimab at two different doses, we'll see how that reads out. But certainly, as you've said, LAG-3 does not, unfortunately, appear to have an impact in the adjuvant setting. So let's move on to LBA9501. This is the primary analysis of EORTC-2139-MG or the Columbus-AD trial. This was a randomized trial of encorafenib and binimetinib, which we will abbreviate as enco-bini going forward, compared to placebo in high-risk stage II setting in melanoma in patients with BRAF V600E or K mutant disease. So Jason, you know, you happen to know one or two things about the resected stage II setting, so maybe contextualize the stage II setting for us based on the trials that you've led, KEYNOTE-716, as well as CheckMate-76K, set us up to talk about Columbus-AD. Dr. Jason Luke: Thanks for that introduction, and certainly stage II disease has been something I've worked a lot on. The rationale for that has been that building off of the activity of anti–PD-1 in metastatic melanoma and then seeing the activity in stage III, like we just talked about, it was a curious circumstance that dating back about 7 to 8 years ago, there was no availability to use anti–PD-1 for high-risk stage II patients, even though the risk of recurrence and death from melanoma in the context of stage IIB and IIC melanoma is in fact similar or actually higher than in stage IIIA or IIIB, where anti–PD-1 was approved. And in that context, a couple of different trials that you alluded to, the Keynote-716 study that I led, as well as the CheckMate 76K trial, evaluated pembrolizumab and nivolumab, respectively, showing an improvement in relapse-free and distant metastasis-free survival, and both of those agents have subsequently been approved for use in the adjuvant setting by the US FDA as well as the European Medicines Agency.  So bringing then to this abstract, throughout melanoma oncology, we've seen that the impact of anti–PD-1 immunotherapy versus BRAF and MEK-targeted therapy have had very similar outcomes on a sort of comparison basis, both in frontline metastatic and then in adjuvant setting. So it was a totally reasonable question to ask: Could we use adjuvant BRAF and MEK inhibitor therapy? And I think all of us expected the answer would be yes. As we get into the discussion of the trial, I think the unfortunate circumstance was that the timing of this clinical trial being delayed somewhat, unfortunately, made it very difficult to accrue the trial, and so we're going to have to try to read through the tea leaves sort of, based on only a partially complete data set. Dr. Diwakar Davar: So, in terms of the results, they wanted to enroll 815 patients, they only enrolled 110. The RFS and DMFS were marginally improved in the treatment arm but certainly not significantly, which is not surprising because the trial had only accrued 16% to 18% of its complete accrual. As such, we really can't abstract from the stage III COMBI-AD data to stage II patients. And certainly in this setting, one would argue that the primary treatment options certainly remain either anti–PD-1 monotherapy, either with pembrolizumab or nivolumab, based on 716 or 76K, or potentially active surveillance for the patients who are not inclined to get treated.  Can you tell us a little bit about how you foresee drug development going forward in this space because, you know, for example, with HARMONY, certainly IIC disease is a part of HARMONY. We will know at least a little bit about that in this space. So what do you think about the stage IIB/C patient population? Is this a patient population in which future combinations are going to be helpful, and how would you think about where we can go forward from here? Dr. Jason Luke: It is an unfortunate circumstance that this trial could not be accrued at the pace that was necessary. I think all of us believe that the results would have been positive if they'd been able to accrue the trial. In the preliminary data set that they did disclose of that 110 patients, you know, it's clear there is a difference at a, you know, a landmark at a year. They showed a 16% difference, and that would be in line with what has been seen in stage III. And so, you know, I think it's really kind of too bad. There's really going to be no regulatory approach for this consideration. So using BRAF and MEK inhibition in stage II is not going to be part of standard practice moving into the future. To your point, though, about where will the field go? I think what we're already realizing is that in the adjuvant setting, we're really overtreating the total population. And so beyond merely staging by AJCC criteria, we need to move to biomarker selection to help inform which patients truly need the treatment. And in that regard, I don't think we've crystallized together as a field as yet, but the kinds of things that people are thinking about are the integration of molecular biomarkers like ctDNA. When it's positive, it can be very helpful, but in melanoma, we found that, unfortunately, the rates are quite low, you know, in the 10% to 15% range in the adjuvant setting. So then another consideration would be factors in the primary tumor, such as gene expression profiling or other considerations.  And so I think the future of adjuvant clinical trials will be an integration of both the standard AJCC staging system as well as some kind of overlaid molecular biomarker that helps to enrich for a higher-risk population of patients because on a high level, when you abstract out, it's just clearly the case that we're rather substantially overtreating the totality of the population, especially given that in all of our adjuvant studies to date for anti–PD-1, we have not yet shown that there's an overall survival advantage. And so some are even arguing perhaps we should even reserve treatment until patients progress. I think that's a complicated subject, and standard of care at this point is to offer adjuvant therapy, but certainly a lot more to do because many patients, you know, unfortunately, still do progress and move on to metastatic disease. Dr. Diwakar Davar: Let's transition to Abstract 2508. So we're moving on from the melanoma to the novel immunotherapy abstracts. And this is a very, very, very fascinating drug. It's IMA203. So Abstract 2508 is a phase 1 clinical update of IMA203. IMA203 is an autologous TCR-T construct targeting PRAME in patients with heavily pretreated PD-1-refractory metastatic melanoma. So Jason, in the PD-1 and CTLA-4-refractory settings, treatment options are either autologous TIL, response rate, you know, ballpark 29% to 31%, oncolytic viral therapy, RP1 with nivolumab, ORR about 30-ish percent. So new options are needed. Can you tell us a little bit about IMA203? Perhaps tell us for the audience, what is the difference between a TCR-T and traditional autologous TIL? And a little bit about this drug, IMA203, and how it distinguishes itself from the competing TIL products in the landscape. Dr. Jason Luke: I'm extremely enthusiastic about IMA203. I think that it really has transformative potential based on these results and hopefully from the phase 3 trial that's open to accrual now. So, what is IMA203? We said it's a TCR-T cell product. So what that means is that T cells are removed from a patient, and then they can be transduced through various technologies, but inserted into those T cells, we can then add a T-cell receptor that's very specific to a single antigen, and in this case, it's PRAME. So that then is contrasted quite a bit from the TIL process, which includes a surgical resection of a tumor where T cells are removed, but they're not specific necessarily to the cancer, and they're grown up in the lab and then given to the patient. They're both adoptive cell transfer products, but they're very different. One is genetically modified, and the other one is not. And so the process for generating a TCR-T cell is that patients are required to have a new biomarker that some may not be familiar with, which is HLA profiling. So the T-cell receptor requires matching to the concomitant HLA for which the peptide is bound in. And so the classic one that is used in most oncology practices is A*02:01 because approximately 48% of Caucasians have A*02:01, and the frequency of HLA in other ethnicities starts to become highly variable. But in patients who are identified to have A*02:01 genotype, we can then remove blood via leukapheresis or an apheresis product, and then insert via lentiviral transduction this T-cell receptor targeting PRAME. Patients are then brought back to the hospital where they can receive lymphodepleting chemotherapy and then receive the reinfusion of the TCR-T cells. Again, in contrast with the TIL process, however, these T cells are extremely potent, and we do not need to give high-dose interleukin-2, which is administered in the context of TIL. Given that process, we have this clinical trial in front of us now, and at ASCO, the update was from the phase 1 study, which was looking at IMA203 in an efficacy population of melanoma patients who were refractory at checkpoint blockade and actually multiple lines of therapy. So here, there were 33 patients and a response rate of approximately 50% was observed in this population of patients, notably with a duration of response approximately a year in that treatment group. And I realize that these were heavily pretreated patients who had a range of very high-risk features. And approximately half the population had uveal melanoma, which people may be aware is a generally speaking more difficult-to-treat subtype of melanoma that metastasizes to the liver, which again has been a site of resistance to cancer immunotherapy. So these results are extremely promising. To summarize them from what I said, it's easier to make TCR-T cells because we can remove blood from the patient to transduce the T cells, and we don't have to put them through surgery. We can then infuse them, and based on these results, it looks like the response rate to IMA203 is a little bit more than double what we expect from lifileucel. And then, whereas with lifileucel or TILs, we have to give high-dose IL-2, here we do not have to give high-dose IL-2. And so that's pretty promising. And a clinical trial is ongoing now called the SUPREME phase 3 clinical trial, which is hoping to validate these results in a randomized global study. Dr. Diwakar Davar: Now, one thing that I wanted to go over with you, because you know this trial particularly well, is what you think of the likelihood of success, and then we'll talk a little bit about the trial design. But in your mind, do you think that this is a trial that has got a reasonable likelihood of success, maybe even a high likelihood of success? And maybe let's contextualize that to say an alternative trial, such as, for example, the TebeAM trial, which is essentially a T-cell bispecific targeting GP100. It's being compared against SOC, investigator's choice control, also in a similarly heavily pretreated patient population. Dr. Jason Luke: So both trials, I think, have a strong chance of success. They are very different kinds of agents. And so the CD3 bispecific that you referred to, tebentafusp, likely has an effect of delaying progression, which in patients with advanced disease could have a value that might manifest as overall survival. With TCR-T cells, by contrast, we see a very high response rate with some of the patients going into very durable long-term benefit. And so I do think that the SUPREME clinical trial has a very high chance of success. It will be the first clinical trial in solid tumor oncology randomizing patients to receive a cell therapy as compared with a standard of care. And within that standard of care control arm, TILs are allowed as a treatment. And so it will also be the first study that will compare TCR-T cells against TILs in a randomized phase 3. But going back to the data that we've seen in the phase 1 trial, what we observe is that the duration of response is really connected to the quality of the response, meaning if you have more than a 50% tumor shrinkage, those patients do very, very well. But even in patients who have less than 50% tumor shrinkage, the median progression-free survival right now is about 4.5 months. And again, as we think about trial design, standard of care options for patients who are in this situation are unfortunately very bad. And the progression-free survival in that population is probably more like 2 months. So this is a trial that has a very high likelihood of being positive because the possibility of long-term response is there, but even for patients who don't get a durable response, they're likely going to benefit more than they would have based on standard chemotherapy or retreatment with an anti–PD-1 agent. Dr. Diwakar Davar: Really, a very important trial to enroll, a trial that is first in many ways. First of a new generation of TCR-T agents, first trial to look at cell therapy in the control arm, a new standard of efficacy, but potentially also if this trial is successful, it will also be a new standard of trial conduct, a new kind of trial, of a set of trials that will be done in the second-line immunotherapy-refractory space. So let's pivot to the last trial that we were going to discuss, which was Abstract 2501. Abstract 2501 is a first-in-human phase 1/2 trial evaluating BNT142, which is the first-in-class mRNA-encoded bispecific targeting Claudin-6 and CD3 in patients with Claudin-positive tumors. We'll talk a little bit about this, but maybe let's start by talking a little bit about Claudin-6. So Claudin-6 is a very interesting new target. It's a target that's highly expressed in GI and ovarian tumors. There are a whole plethora of Claudin-6-targeting agents, including T-cell bispecifics and Claudin-6-directed CAR-Ts that are being developed. But BNT142 is novel. It's a novel lipid nanoparticle LNP-encapsulated mRNA. The mRNA encodes an anti–Claudin-6 CD3 bispecific termed RiboMAB-021. And it then is administered to the patient. The BNT142-encoding mRNA LNPs are taken up by the liver and translated into the active drug. So Jason, tell us a little bit about this agent. Why you think it's novel, if you think it's novel, and let's talk a little bit then about the results. Dr. Jason Luke: So I certainly think this is a novel agent, and I think this is just the first of what will probably become a new paradigm in oncology drug development. And so you alluded to this, but just to rehash it quickly, the drug is encoded as genetic information that's placed in the lipid nanoparticle and then is infused into the patient. And after the lipid nanoparticles are taken up by the liver, which is the most common place that LNPs are usually taken up, that genetic material in the mRNA starts to be translated into the actual protein, and that protein is the drug. So this is in vivo generation, so the patient is making their own drug inside their body. I think it's a really, really interesting approach. So for any drug that could be encoded as a genetic sequence, and in this case, it's a bispecific, as you mentioned, CD3-Claudin-6 engager, this could have a tremendous impact on how we think about pharmacology and novel drug development moving into the future in oncology. So I think it's an extremely interesting drug, the like of which we'll probably see only more moving forward. Dr. Diwakar Davar: Let's maybe briefly talk about the results. You know, the patient population was heavily pretreated, 65 or so patients, mostly ovarian cancer. Two-thirds of the patients were ovarian cancer, the rest were germ cell and lung cancer patients. But let's talk a little bit about the efficacy. The disease control rate was about 58% in the phase 1 population as a whole, but 75% in the ovarian patient population. Now tell us a little bit about the interesting things about the drug in terms of the pharmacokinetics, and also then maybe we can pivot to the clinical activity by dose level. Dr. Jason Luke: Well, so they did present in their presentation at ASCO a proportionality showing that as higher doses were administered, that greater amounts of the drug were being made inside the patient. And so that's an interesting observation, and it's an important one, right? Suggesting that the pharmacology that we classically think of by administering drugs by IV, for example, would still be in play. And that did translate into some level of efficacy, particularly at the higher dose levels. Now, the caveat that I'll make a note of is that disease control rate is an endpoint that I think we have to be careful about because what that really means is sometimes a little bit unclear. Sometimes patients have slowly growing tumors and so on and so forth. And the clinical relevance of disease control, if it doesn't last at least 6 months, I think is probably pretty questionable. So I think these are extremely interesting data, and there's some preliminary sense that getting the dose up is going to matter because the treatment responses were mostly observed at the highest dose levels. There's also a caveat, however, that across the field of CD3 bispecific molecules like this, there's been quite a bit of heterogeneity in terms of the response rate, with some of them only really generating stable disease responses and other ones having more robust responses. And so I think this is a really interesting initial foray into this space. My best understanding is this molecule is not moving forward further after this, but I think that this really does set it up to be able to chase after multiple different drug targets on a CD3 bispecific backbone, both in ovarian cancer, but then basically across all of oncology. Dr. Diwakar Davar: Perfect. This is a very new sort of exciting arena where we're going to be looking at, in many ways, these programmable constructs, whether we're looking at in vivo-generated, in this case, a T-cell bispecific, but we've also got newer drugs where we are essentially giving drugs where people are generating in vivo CAR T, and also potentially even in vivo TCR-T. But certainly lots of new excitement around this entire class of drugs. And so, what we'd like to do at this point in time is switch to essentially the fact that we've got a very, very exciting set of data at ASCO 2025. You've heard from Dr. Luke regarding the advances in both early drug development but also in advanced cutaneous melanoma. And Jason, as always, thank you so much for sharing your very valuable and great, fantastic insights with us on the ASCO Daily News Podcast. Dr. Jason Luke: Well, thanks again for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for taking your time to listen today. You will find the links to the abstracts that we discussed today in the transcript of this episode. And finally, if you value the insights that you hear on 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. Diwakar Davar    @diwakardavar    Dr. Jason Luke @jasonlukemd Follow ASCO on social media:     @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn   Disclosures:     Dr. Diwakar Davar:      Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences     Consulting or Advisory Role: Instil Bio, Vedanta Biosciences     Consulting or Advisory Role (Immediate family member): Shionogi     Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences     Research Funding (Inst.): Zucero Therapeutics     Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy     Dr. Jason Luke:     Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX     Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine     Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure     Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)     Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

"Older adults have this special clarity about who they are and what they want, which is incredibly inspiring," says Dr. Julia Hiner, explaining, in part, why she loves her work as a geriatrician in Houston, Texas. She also enjoys the challenge of the medical complexity these patients present and the opportunity it creates to see the patient as a whole person. In fact, as you'll hear in this upbeat conversation with Raise the Line host Lindsey Smith, there's almost nothing about geriatrics that Dr. Hiner does not enjoy, which explains her passion for teaching the subject at McGovern Medical School at the University of Texas Health Science Center in Houston and trying to convince more students to pursue it as their specialty.  The need is great, given that there are only 8,000 geriatricians in the US despite a rapidly growing senior population. Tune in to learn why Dr. Hiner thinks clinicians avoid the field and the steps that can be taken to improve the situation, including requiring courses in geriatrics. You'll also learn about the importance of capacity assessments, the troubling, and under-reported, problem of elder mistreatment, ageism among health professionals and much more in this super informative episode. Mentioned in this episode:University of Texas Health Science Center at Houston McGovern Medical School  If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

In this episode, we speak with Jean-Philippe Therrien, a senior director of R&D, to discuss critical considerations in designing nonclinical programs for dermal and topical products. Through this conversation, we aim to enhance understanding of key aspects in this specialized area of toxicology. This podcast offers listeners an introduction to dermal product drug development.

LINK TO ACRO'S RBQM SUMMARY REPORT: https://www.acrohealth.org/rbqm-summary-report/In this episode, ACRO RBQM Working Group members Lauren Garson (Veeva), Cris McDavid (Parexel), and Jennifer Stewart (Premier Research) joined ACRO's Good Clinical Podcast to discuss key takeaways from ACRO's annual RBM/RBQM Landscape Survey. Since 2019, ACRO's RBQM survey has dug into trial-level data on industry adoption of RBM and RBQM components. Informed by conversations with FDA, the aim of the survey is to evaluate ACRO member companies' adoption of risk-based monitoring to better understand how the larger framework of risk-based quality management (RBQM) are being adopted across the clinical trial industry.  

In this episode of Idea Collider, host Mike Rea interviews Paul Peter Tak, CEO of Candel Therapeutics, discussing his remarkable journey from a clinician in Amsterdam to leading cutting-edge biotech companies. Paul shares pivotal moments in his career, the challenges of transitioning from academia to big pharma, and the innovative principles he applied. He dives deep into Candel's promising work in viral immunotherapies for cancers and the unique leadership and management philosophies that have guided his journey. Additionally, Paul Peter touches on his passion for leveraging collective intelligence and his unconventional hobbies that keep him grounded and creative. 00:00 Introduction and Guest Welcome00:59 Early Career and Passion for Medicine02:09 Transition to Industry and GSK Experience04:50 Building Successful Organizations07:42 Innovative Models in Pharma19:03 Joining Candel Therapeutics and Vision for the Future25:15 Transforming Cancer Treatment27:24 Challenges in Biotech Market28:45 Strategic Decisions and Prioritization31:39 Collaborations and External Partnerships33:07 Innovative Approaches and Future Prospects44:23 Leadership and Personal Insights Don't forget to Like, Share, Subscribe, Rate, and Review! Keep up with Paul Peter Tak;LinkedIn: https://www.linkedin.com/in/paul-peter-tak-md-phd-fmedsci-1b44749/ Follow Mike Rea On;Website: https://www.ideapharma.com/X: https://x.com/ideapharmaLinkedIn: https://www.linkedin.com/in/bigidea/ Listen to more fantastic podcast episodes: https://podcast.ideapharma.com/

Just about the hottest thing in longevity science right now is partial reprogramming - using Yamanaka factors to rewind the biological clock in our cells. Billion-dollar giants like Altos, Retro and New Limit are betting on it.But in this episode a far smaller player, Shift Bioscience, argues that the field may be looking in the wrong place. CEO Daniel Ives explains how his team used AI-powered virtual cells to uncover a single gene that seems to match OSK-level rejuvenation without the tumor risk that haunts classical reprogramming - and why their just-released data could change the game for aging research.

In 2024, ACRO announced its D&I Site Resource Grants Program. Designed to support an innovative 12-month pilot project, the site resource grants act as a platform to incubate innovative strategies for improving representative enrollment in clinical research.  On this episode, site grantee representatives Dr. Ammara Mushtaq, MD (Brooklyn Clinical Research), Dr. Lovie Negrin, APRN (Randomize Now), and Sandra Carmona Torres, BSN (K2 Medical Research) join the podcast to discuss the lessons learned through implementing their pilot projects so far. They dive deeper into how sites can address barriers to participation, the need for consistent investment in building trust and engaging local community members, and the state of clinical research from a site perspective.

My guest today is Dinakar Singh. Dinakar is the founder and CEO of Axon, the family office successor to TPG-Axon, which was a successful global long-short hedge fund. We wanted to share his story on Father's Day to honor the person and the dad that Dinakar is. He shares one of the most extraordinary stories at the intersection of finance and medicine I've ever encountered. This conversation explores the highest-stakes investment themes—timing, concentrated conviction, exceptional team building, and deploying resources toward outcomes that matter most. I will let him tell you his story. Please enjoy my conversation with Dinakar Singh.  For the full show notes, transcript, and links to mentioned content, check out the episode page⁠⁠⁠ here.⁠⁠⁠ ----- This episode is brought to you by⁠⁠⁠ Ramp⁠⁠⁠. Ramp's mission is to help companies manage their spend in a way that reduces expenses and frees up time for teams to work on more valuable projects. Go to⁠⁠⁠ Ramp.com/invest⁠⁠⁠ to sign up for free and get a $250 welcome bonus. – This episode is brought to you by⁠⁠⁠ Ridgeline⁠⁠⁠. Ridgeline has built a complete, real-time, modern operating system for investment managers. It handles trading, portfolio management, compliance, customer reporting, and much more through an all-in-one real-time cloud platform. Head to⁠⁠⁠ ridgelineapps.com⁠⁠⁠ to learn more about the platform. – This episode is brought to you by⁠⁠⁠ AlphaSense⁠⁠⁠. AlphaSense has completely transformed the research process with cutting-edge AI technology and a vast collection of top-tier, reliable business content. Invest Like the Best listeners can get a free trial now at⁠⁠⁠ Alpha-Sense.com/Invest⁠⁠⁠ and experience firsthand how AlphaSense and Tegus help you make smarter decisions faster. ----- Editing and post-production work for this episode was provided by The Podcast Consultant (⁠⁠⁠https://thepodcastconsultant.com⁠⁠⁠). Show Notes: (00:00:00) Welcome to Invest Like the Best (00:06:17) The Diagnosis and Initial Reactions (00:07:29) Understanding SMA and the Scientific Challenge (00:09:15) The Drive to Fund Research and Find a Cure (00:14:10) Building a Virtual Company for Drug Development (00:19:02) Breakthroughs and the First Approved Drugs (00:24:16) Personal Reflections and the Impact of the Journey (00:40:25) Challenges in the Biotech Industry and Future Hopes (00:46:43) The Kindest Thing Anyone Has Ever Done For Dinakar

"It was pretty apparent to me that something was going on with him," says Kristi Levine, describing the realization that, based on her experience as a Montessori teacher, her infant son, Trey, was missing developmental milestones. Unfortunately, Kristi's hunch turned out to be correct and Trey was later diagnosed with a rare genetic mutation called CACNA1A which is impacting his motor skills, balance, coordination and speech. Kristi and her husband, Eric, join host Michael Carrese on this installment in our Year of the Zebraseries to help us understand the disorder and its implications for Trey and their family, which includes Trey's older sister Stella.  “There's a lot of guilt involved in being a parent of a child who has a disability because you never feel like you're doing enough,” shares Eric, even though they both work full time and have becoming experts at juggling work, caregiving, advocating, and volunteering with the CACNA1A Foundation. In this candid interview, Eric and Kristi discuss the challenges of parenting a child with complex medical needs, the importance of community support, the ongoing search for treatment options, and share some advice for clinicians caring for patients and families living with rare disorders. “We just want medical professionals to respect and understand what we're dealing with on a day-to-day basis and to see our kids holistically, and not just try to fix the problem medically. Understand that for us, the biggest thing that we want for our kids is just their quality of life.”Mentioned in this episode:CACNA1A Foundation If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

In this episode, Jonathan Norman (Director, Localisation Services, YPrime) and Laura Russell (Senior Vice President, Head of Data and AI Product Development, Advarra) join the podcast to discuss how artificial intelligence is transforming today's clinical operations. They dive deeper into how AI can be used to improve protocol design, drive efficiency in localization processes, and modernize clinical operations to expand access to trials and get treatments to patients sooner. 

Today's guest is Damion Nero, Head of Data Science at Takeda Pharmaceuticals. With over 15 years of experience applying AI, machine learning, and real-world data to drug development and precision medicine, Damion joins Emerj Managing Editor Matthew DeMello to explore the evolving role of AI in drug development and supply chain management. He breaks down how AI is currently streamlining administrative and regulatory tasks, improving efficiency across clinical trials, and saving valuable time for healthcare professionals. Damion also discusses why broader, transformative supply chain efficiencies are still on the horizon, as AI continues to evolve and scale in the pharmaceutical industry. This episode is sponsored by Arkestro. Learn more about Arkestro's upcoming Advisory Council event here. Find out more about sponsored content and how to engage with the Emerj audience at emerj.com/ad1.

The Children's Tumor Foundation has been effective in working with drug developers to advance new therapies for neurofibromatosis, a group of rare, genetic conditions that cause tumors to grow on nerves throughout the body. Part of its success has been its ability to get biopharmaceutical companies to reposition assets once in development for other conditions as potential treatments for neurofibromatosis. We spoke to Annette Bakker, CEO of the Children's Tumor Foundation, about the complexities of neurofibromatosis, the foundation's role in advancing research and drug development, and what other patient organizations can learn from its strategic approach.

Rafael Fonseca is a distinguished Haematologist at Mayo Clinic, specialising in multiple myeloma and related plasma cell disorders. He earned his medical degree at Universidad Anáhuac in Mexico, and went on to complete his residency in Internal Medicine at the University of Miami, Florida, USA followed by a Hematology and Oncology fellowship at Mayo Clinic in Rochester, Minnesota, USA.     Timestamps  01:44 – Quickfire questions  07:25 – CAR-T cell therapy  10:48 – Anti-CD38 antibodies  13:31 – Minimal residual disease  14:30 – Bispecific antibodies  15:31 – Antibody-drug conjugates  19:04 – ASCO 2025  21:24 – Genetic discoveries  26:28 – Fonseca's three wishes 

What happens when cutting-edge science meets compassion? In this episode of Sounds of Science, host Mary Parker sits down with two pioneers reshaping the future of research: Elizabeth Nunamaker, Executive Director of Global Animal Welfare and Training at Charles River, and Dr. Megan LaFollette, Executive Director of the 3Rs Collaborative. From digital biomarkers to environmental health monitoring, they reveal how innovation and collaboration are redefining what's possible in animal welfare — and raising the bar for ethical, high-quality research. Tune in to explore the tools, strategies, and bold ideas driving meaningful change across the scientific community.Show NotesAdvancing Alternatives | Charles RiverEvolving Animal Welfare: Science, Ethics, and Innovation | Sounds of Science Can You Practice High-quality Science and 3Rs? | Eureka BlogAnimals in Research | Charles RiverResearch Models & Services | Charles River

In the latest collaboration between ACRO and TransCelerate BioPharma, Cris McDavid (Senior Director, Global Clinical Operations, Parexel) and Tashan Mistree (Senior Director, Business Operations, Office of Chief Medical Officer, GSK) join this week's episode to discuss the impact of ICH E6(R3) from their different vantage points in the clinical research industry. They dive deeper into their experiences implementing the new guidance at their respective companies, the new opportunities that R3 has created in the partnership between CROs and sponsors, and how they envision the future state of R3 once industry has fully embraced the guidance. FIND ACRO & TRANSCELERATE'S ICH E6(R3) TOOLS & RESOURCES HERE: https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/ 

We have a special guest on today's episode whose voice will be familiar to regular listeners. Last year at this time, Dr. Raven Baxter occupied the Raise the Line host chair for a special ten-part series we produced in collaboration with the Cohen Center for Recovery from Complex Chronic Illness (CoRe) at Mount Sinai in New York City, where she serves as the Director of Science Communication. The series explored the latest understandings of post-acute infection syndromes -- such as Chronic Lyme and Long COVID -- with an array of experts from the Center and other researchers and providers. In this episode, we check-in with Dr. Baxter to get an update on the work of the Cohen Center, especially with regard to its mission to educate providers. “We're building programs so that clinicians can earn credit for learning about chronic illnesses that are infection associated, and we've also developed a 200-page provider manual. I really think that we will be able to shift the narrative that currently exists,” Dr. Baxter tells host Michael Carrese. That narrative includes lingering skepticism among providers of some infection-associated illnesses, which Dr. Baxter witnessed herself as a Long COVID patient, an experience that has added meaningful perspective to her work. Dr. Baxter is also working on her own time to advance knowledge and combat misinformation through a robust social media presence as “The Science Maven” and helps other scientists and clinicians to do the same. "If we're not there to fill in that void, other people will fill it for us and the narrative may not be consistent with the truth or facts." This is a great opportunity to learn about the art and science of communications that can reach clinicians and patients alike.Mentioned in this episode:Cohen Center for Recovery from Complex Chronic IllnessThe Science Maven If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

In this episode, Dr Neil Fish and Dr Ami Patel dive into the real-world challenges of drug development - from early-stage planning to regulatory hurdles and everything in between. Drawing on decades of experience, they share personal stories and expert insights that reveal why a solid strategy and the ability to pivot are essential for success. They explore the value of strategic flexibility, the importance of engaging with regulators early, and how to approach patent protection and manufacturing for advanced therapies. Whether you're preparing an IND or planning scale-up, this episode delivers clear, actionable guidance grounded in industry know-how. A must-listen for biotech teams, clinical leads, and anyone involved in the drug development process.

In December 2017, the FDA approved a new injectable drug to treat type 2 diabetes called semaglutide, which you likely know by its brand name: Ozempic. A few years later, during the pandemic, Wegovy, a drug with a higher dose of the same active ingredient, was approved specifically for chronic weight management. Soon after, people taking Ozempic started reporting a dramatic, even “life-changing” weight loss. Ozempic is now a bona fide blockbuster. So what's the science behind these “wonder drugs” that apparently 1 in 10 of us could end up using? They have the potential to have so many positive effects on our lives, from treating Alzheimer's disease and addiction to changing our relationship with consumption but, like with most things, they also come with risks.Send us your science facts, news, or other stories for a chance to be featured on an upcoming Tiny Show and Tell Us bonus episode. And, while you're at it, subscribe to our newsletter!Links to the Tiny Show and Tell stories are here and here. All Tiny Matters transcripts and references are available here.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

The uncertainty surrounding changes at the FDA and other market dynamics is reshaping the global drug development landscape. In this webinar, CRO regulatory leaders will summarize the collective experience of the biotech companies we've spoken to recently. We will explore: • The impact of the FDA leadership changes, staffing cuts, and return to office mandates in reshaping regulatory priorities. • Trends we're observing from biotech sponsors on the decision of whether or not to keep trials in the US. • The broader implications for industry investment, pipeline prioritization strategies, and international responses. This episode is part 1 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we'll continue exploring the key forces shaping the future of clinical trials.

Malaikannan Sankarasubbu (Chief Technology & AI Officer, Saama) and Jonathan Shough (Chief Information Officer, Parexel) join this week's episode to discuss how the strategic use of AI technologies is transforming clinical development. They dive deeper into which advancements in generative AI have the potential to improve the clinical trial workflow, the integration of AI and predictive analytics in risk assessment processes, and the importance of strong change management strategies when implementing new AI technologies.

In this episode of The Clinical Research Coach, host Leanne Woehlke sits down with trailblazer Nasha Fitter—tech entrepreneur, rare disease advocate, and co-founder of both the FOXG1 Research Foundation and Citizen Health.After Nasha's daughter was diagnosed with FOXG1 syndrome, an ultra-rare neurological disorder, her world shifted. Instead of accepting the limitations of the current research landscape, she took action- building a foundation, galvanizing the scientific community, and redefining what's possible for families facing rare disease.What began as a grassroots foundation now drives innovative drug development, redefines data collection, and challenges the status quo in drug development.In this conversation, Nasha shares:How a small, determined parent community raised $10M and launched a gene therapy programWhy traditional research models fail rare disease patients—and how to fix themThe power of patient-owned data and how platforms like Citizen Health are transforming access and insightsHow to build empathy for families navigating special needsWhat pharma gets wrong (and right) in working with advocacy groupsHer vision for a precision medicine future—starting with ultra-rareThis is a story about courage, creativity, and a more inclusive, patient-driven future of medicine. Nasha's bold vision and action oriented approach will leave you inspired and hopeful.To Find Out More:Nasha Fitterhttps://www.linkedin.com/in/nashafitter/FOXG1 Research Foundation: https://www.foxg1research.org/Citizen Health:https://www.citizen.health/

Dr. Doug Thamm discusses the development and use of Tanovea, a drug for treating lymphoma in dogs. He explains the drug's origins, initially researched as a human cancer therapeutic in collaboration with Gilead Sciences, and its transition to veterinary use.   Dr. Thamm provides insights into Tanovea's application, dosage, and effectiveness compared to the CHOP protocol, as well as its potential side effects and other possible uses in different cancer types like multiple myeloma. The episode also delves into related immunotherapy research and personal reflections from Dr. Thamm, a double cancer survivor, on his career choice in veterinary oncology. Your Voice Matters!   If you have a question for our team, or if you want to share your own hopeful dog cancer story, we want to hear from you! Go to https://www.dogcancer.com/ask to submit your question or story, or call our Listener Line at +1 808-868-3200 to leave a question. Related Videos:  https://www.youtube.com/watch?v=G0iRyKshzq8  Related Links:  Our article on lymphoma: https://www.dogcancer.com/articles/types-of-dog-cancer/lymphoma-in-dogs/  Our article on Tanovea: https://www.dogcancer.com/articles/drugs/tanovea-rabacfosadine-chemotherapy/  Get the facts on dog cancer remission: https://www.dogcancer.com/articles/stats-and-facts/dog-cancer-remission/  Chapters:  00:00 Introduction  00:13 Interview with Dr. Doug Thamm  00:26 The Early Involvement with Tanovea  00:41 Challenges and Discoveries in Drug Development  02:16 Transition from Human to Veterinary Use  02:48 Clinical Trials and Dosage Experiments  06:45 FDA Approval and Practical Use  08:05 Comparing Tanovea and CHOP Protocol  15:23 Exploring Alternative Treatments: Laverdia  18:43 Off-Label Uses and Future Research  23:46 Exploring Tanovea's Effectiveness in Blood Cancers  25:14 Cost Comparison: Tanovea vs. CHOP  26:15 Side Effects of Tanovea  28:47 Pulmonary Fibrosis and Breed-Specific Risks  32:52 Personal Cancer Journeys: Dr. Doug and His Wife  38:23 Debunking Myths About Dog Cancer Treatment  42:24 The Future of Cancer Treatment: Immunotherapy  45:23 Conclusion and Resources    Get to know Dr. Doug Thamm: https://www.dogcancer.com/people/doug-Thammm-v-m-d-diplomate-acvim-oncology/   For more details, articles, podcast episodes, and quality education, go to the episode page: https://www.dogcancer.com/podcast/   Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of Idea Collider, we sit down with Susan Galbraith from AstraZeneca, a leading figure in oncology R&D. Susan shares her journey from medical training in Manchester and Cambridge to spearheading transformative cancer treatments at AstraZeneca. She discusses pivotal moments in her career, AstraZeneca's vision for eliminating cancer as a cause of death, the role of patient stories in motivating R&D efforts, and the integration of emerging technologies like AI and digital health tools.  With a focus on collaboration and continuous learning, Susan provides insights into how successful oncology drugs are developed and the importance of equitable representation in clinical trials. Stay tuned for an engaging conversation that highlights the future of personalized cancer therapies and the collaborative efforts driving innovations in oncology.Chapter Summaries;00:00 Introduction and Guest Welcome00:27 Susan Galbraith's Career Journey02:37 Defining Success in Oncology R&D05:01 Early Phase Drug Development07:09 Digital Health and Patient Experience12:37 Global Collaboration and Innovation15:05 AI and Future of Oncology28:08 Diversity and Inclusion in Clinical Trials33:46 Mentorship and Career Advice37:45 Challenges and Future Outlook in Oncology42:06 Closing Remarks and Call to Action Don't forget to Like, Share, Subscribe, Rate, and Review! Keep up with Susan Gabraith;LinkedIn: https://www.linkedin.com/in/susan-galbraith-584a195/?originalSubdomain=uk Follow Mike Rea On;Website: https://www.ideapharma.com/X: https://x.com/ideapharmaLinkedIn: https://www.linkedin.com/in/bigidea/ Listen to more fantastic podcast episodes: https://podcast.ideapharma.com/

On this episode, Tania Simoncelli (Vice President, Translational Impact and Engagement, Chan Zuckerberg Initiative) and Nasha Fitter (Co-founder & CBO, Citizen Health and Co-founder & CEO, FOXG1 Research Foundation) join forces to discuss how rare disease patient advocacy has transformed over time and how the biopharmaceutical industry should adapt to better meet the needs of today's patients. They dive deeper into the evolution of rare disease patient advocacy groups, why industry must move beyond the hyperfocus on “blockbuster drugs” to make progress in rare disease research, and how advancements in rare disease treatments can benefit the clinical research ecosystem for all.

Analyzing Trump's plan to roll back soaring drug prices for Americans; Sports bras eliminate bounce but may take a toll on women's backs; RFK Jr. targets the chemicals in our food; Do Americans really eat more animal protein than any other of the world's nations? Causes and treatments for pulmonary hypertension.

Stéphane Budel, founding partner at DeciBio, joins the Talking Precision Medicine Podcast to explore the future of the field. He unpacks how liquid biopsy, multi-omics, and AI are opening new doors for personalized care, why the diagnostics business model is holding innovation back, and what it will take to make complex tech usable for clinicians and patients alike.⁠TPM E46 highlights >⁠⁠⁠⁠⁠⁠⁠⁠Episode 46 links:DeciBioStephane Budel on LinkedInDeciBio's White Paper on AI in Drug Development (with contributions from Rafael Rosengarten)

On this episode of “Raise the Line” we welcome Dr. Sheldon Fields, a trailblazer in the nursing field and the president of the National Black Nurses Association. In a candid conversation, Dr. Fields shares his inspiring journey from the bedside to becoming a prominent figure in nursing, HIV/AIDS prevention and academia and also shares the challenges he faced as a Black man in a predominantly white and female field. "I fell in love with a profession that has not always loved me back," he tells host Kelsey Lafayette. Dr. Fields brings over thirty years of experience as an educator, researcher, clinician, administrator, consultant, health policy specialist, and entrepreneur to his current role at NBNA, and as the inaugural associate dean for equity and inclusion at the College of Nursing at Penn State University, where he also serves as a research professor. Listeners will find Dr. Fields' insights on navigating a career in healthcare particularly valuable, as he stresses the importance of resilience, continuing education, and mentorship. It's a compelling listen for anyone interested in the intersection of health, policy, and social justice.Mentioned in this episode:National Black Nurses Association If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

Over the last 200 years or so, vaccines have come a long way, for a number of viruses. We've made so much progress, in fact, that in 2017 scientists began the early stages of vaccine development for some virus families they believed could pose a future pandemic threat. One of those families was Coronaviridae: coronaviruses. Not many people know that before SARS-CoV-2 started making its way into people in 2019, there was already a project underway in the U.S. to create a vaccine for a looming coronavirus (we didn't!), but even that would not have been possible without the decades of vaccine and drug research that came before it, particularly for HIV. Send us your science facts, news, or other stories for a chance to be featured on an upcoming Tiny Show and Tell Us bonus episode. And, while you're at it, subscribe to our newsletter!Link to the Tiny Show & Tell stories are here and here. All Tiny Matters transcripts and references are available here.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this episode, Logan is joined by Zach Weinberg (Co-Founder/CEO @ Curie.Bio) and Derek Thompson (writer at The Atlantic) for a candid discussion on the state of U.S. healthcare and scientific progress. They unpack what went right, and wrong, with COVID vaccine policy, the public backlash against mRNA technology, and the ripple effects on trust in science. The conversation also dives into the real reasons behind NIH budget cuts, the economics of drug discovery, and the business incentives in medical R&D. It's a sharp, thought-provoking look at the intersection of policy, innovation, and public perception. (00:00) Introduction to Drug Pricing in the US (00:23) Broad Healthcare Topics and Open-Ended Discussion (02:37) COVID-19 Vaccines: Successes and Public Perception (06:21) The Evolution of COVID-19 and Vaccine Efficacy (07:59) Public Policy and Vaccine Mandates (13:10) Impact of School Closures and Public Sentiment (19:23) NIH Funding and the Importance of Basic Research (25:04) Challenges in Science Funding and Public Perception (35:19) Government vs. Private Investment in Science (36:40) Operation Warp Speed: A Case Study (39:07) Antibiotic Resistance Crisis (43:22) The Drug Pricing Debate (44:05) Challenges in Drug Discovery (54:06) Regulatory Hurdles in Medical R&D (58:06) The Future of Drug Development (01:04:19) Concluding Thoughts Executive Producer: Rashad Assir Producer: Leah Clapper Mixing and editing: Justin Hrabovsky Check out Unsupervised Learning, Redpoint's AI Podcast: https://www.youtube.com/@UCUl-s_Vp-Kkk_XVyDylNwLA

Today's guest is Patricio La Rosa, Head of End-to-End Decision Science at Seed Production Innovation in Bayer Crop Science. With over 20 years of experience developing AI and data science solutions across healthcare and agriculture, Patricio joins Emerj Managing Editor Matthew DeMello to explore how machine learning can drive better outcomes across the drug development lifecycle, from research design to clinical deployment. Patricio discusses how AI is optimizing early trial planning, improving participant engagement, and supporting ethical, human-centered decisions at scale. Drawing lessons from both agriculture and life sciences, he emphasizes the importance of connecting technical models with real-world workflows. The conversation also delves into key barriers to AI adoption in clinical settings, including behavioral friction, model transparency, and challenges in orchestrating decision-making across global teams. Patricio offers a grounded perspective on what it takes to move from experimentation to enterprise impact in AI-driven R&D. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on Emerj's flagship ‘AI in Business' podcast!

What does clinical trial monitoring have in common with growing a field of corn? Amy Kroeplin (PPD™ clinical research business of Thermo Fisher Scientific), Shailesh Madel (ICON plc), and Nicole Stansbury (Premier Research) join the podcast to discuss the importance of risk-based quality management, centralized monitoring, and strategic SDV/SDR sampling strategies. They dive deeper into the unique roles of SDV and SDR, different methods of implementing SDV/SDR sampling strategies, and the industry imperative to increase centralized monitoring adoption.

On this week's episode, Lisa Moneymaker (SVP, Head of Strategic Customer Engagement, Medidata Solutions) and Adam Aten (Legislative & Regulatory Policy Lead, Verily) join the podcast to discuss how the clinical research industry must use insights from the past to better prepare our AI models and other technologies to meet the needs of patients in the present and future. They dive deeper into the role that collaboration between technologists and clinical scientists can play in helping to reduce bias in our AI models, what legislators and regulators should be keeping top of mind as they write new rules of the road for AI and ML, and ACRO's ongoing efforts to promote the responsible use of AI in clinical research.

We're honored to continue our global tour of medical education today with Professor Katarzyna Taran, MD, PhD, a pioneering interdisciplinary researcher of tumor cell biology, an award winning educator noted for her focus on student engagement, and -- in a first for a Raise the Line guest -- a shooting sports certified coach and referee. As Professor Taran explains to host Michael Carrese, these seemingly disparate professional activities require the same underlying attributes: patience, the ability to overcome barriers, openness and adaptation. She believes those last qualities are especially important for today's medical students to acquire given the accelerated pace of change in healthcare. “They need to be equipped with the ability for critical thinking, to analyze and synthesize, and to search for unconventional solutions.” Professor Taran tries to impart these skills, in addition to the medical and scientific knowledge students must know, through a high level of engagement. “Teaching is relational, so try to be familiar with students' concerns. Talk to them, listen to them and you will become someone they trust.” In this wide-ranging and engaging conversation, Professor Taran also discusses her work as the head of the Laboratory of Isotopic Fractionation in Pathological Processes in Chair of Oncology, the use of neurodidactics in teaching, and the connection between the science of pathology and the future of humans in space. Mentioned in this episode:Medical University of Lodz If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

Part 2 of our series dives deeper into the explosion of ADC clinical drug development in China

We like to think of Osmosis from Elsevier as a global community of millions of learners, connected by a desire to serve humanity and an inclination to use a diverse mix of educational resources to help them become excellent healthcare practitioners. On today's episode of Raise the Line, we're going to learn how Osmosis has created an opportunity for hundreds of those students from sixty countries to actually solidify those connections through the Osmosis Health Leadership Initiative (OHLI). Our guide to this effort is Osmosis Community Specialist Alfred Collins, who brings a keen interest in developing tech solutions to power the future of human communication to his work with OHLI.“Technology collapses barriers to communication and to understanding the nuances behind culture, behind global perspectives,” he tells host Lindsey Smith. One example he cites is how OHLI members learn about variations in the way different cultures approach collaboration, an important insight to gain as they head into team-based healthcare environments. OHLI members convene regularly over video sessions to hear from leaders in healthcare and learn about hosting successful on-campus events, among other enriching content.  They also have an opportunity to provide feedback on improving the Osmosis learning platform, and this year they're participating in a “hackathon” aimed at improving the future of healthcare. Tune in to find out more about what the OHLI program offers, how to apply, and how Alfred thinks virtual reality and AI technologies will impact the future of community building. Mentioned in this episode:Osmosis Health Leadership Initiative If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast