The BioCentury Show

The Critical Path Institute’s One to Millions Initiative is using individualized rare disease therapies as the starting point for a development framework that could eventually extend across all genetically defined diseases. The initiative seeks to bring form to FDA’s Plausible Mechanism Framework by standardizing how evidence and methods can be reused across therapies and patients.In conversation with Biopharma Analyst Dr. Tierney Baum on The BioCentury Show, C-Path CEO and CSO Klaus Romero discusses how the principal bottleneck is no longer the ability to design therapies for individual patients but rather the absence of a standardized regulatory and development system that can translate one success into many. C-Path plans to bring companies, academics, patient groups, and regulators together to share data and address recurring development bottlenecks.View full story: https://www.biocentury.com/article/660583#GeneticMedicines #RareDisease #DrugDevelopment #RegulatoryScience #ClinicalTrials00:00 - Introduction01:44 - Current Framework07:01 - Process-based Regulation13:57 - Overcoming Bottlenecks20:28 - Use of AI25:25 - Beyond Rare Diseases

Throughout his career, which has included serving as president and CEO of Teva, chair of BIO, and a leader or senior executive of large and small biopharma companies, Jeremy Levin has challenged the industry to live up to its ideals. In an interview with BioCentury Washington Editor Steve Usdin, Levin discussed why he believes industry leaders should speak out, and why many remain silent, about critical issues. He described concerns about the strength of the pillars that support the U.S. biotech industry, and why he is optimistic about the future of biotech.View full story: https://www.biocentury.com/article/660408#Biotech #DrugPricing #BiopharmaPolicy #ChinaBiotech #Innovation00:00 - Introduction03:24 - Biotech Under Threat10:38 - CEO Compensation15:39 - Competing with China22:08 - U.S. Policy Prescriptions30:00 - Looking Ahead

As AI becomes increasingly commoditized, Initiate Ventures' Jessica Owens argues healthcare and life sciences companies need to use it to solve historically intractable problems, not just streamline workflows. On The BioCentury Show, Owens breaks down how she evaluates founders, when Initiate chooses to fund versus co-found a company, and why she believes proprietary data now matters more than any proprietary model.Owens also discusses gaps in evidence generation for diagnostics, and closes with a look at MASH, arguing that better non-invasive fibrosis staging will become increasingly critical as more GLP-1 combination therapies reach patients.View full story: https://www.biocentury.com/article/660203#AI #VentureCapital #Diagnostics #HealthTech #DrugDevelopment00:00 - Introduction01:15 - Initiate Ventures' Thesis07:04 - What Makes Founders Fundable17:36 - Defining AI Native Healthcare23:20 - Diagnostics & Evidence Generation36:44 - Non-Invasive Fibrosis Testing

Roivant CEO Matt Gline calls the company’s move beyond spinning out subsidiary “vants” to concentrating on late-stage programs and commercial launches less a pivot than an evolution toward an original goal, which could soon be realized with the approval and launch of brepocitinib this year.In conversation with Lindsay Martin on The BioCentury Show, Gline discussed how Roivant’s initial hub-and-spoke approach has provided the foundation needed for the company to develop and commercialize its portfolio now, including lead program JAK-1/TYK2 inhibitor brepocitinib. Gline also discussed how he views AI at Roivant and more broadly in biopharma R&D, the science behind Roivant’s next most advanced program, Phase III anti-FcRN mAb imeroprubart and the lessons he’s taking from a “graduating class” of biotechs that have launched programs, like Alnylam and Argenx S.E. View full story: https://www.biocentury.com/article/660059#DrugDevelopment #BiotechInnovation #Commercialization #ArtificialIntelligence #BiopharmaStrategy00:00 - Introduction00:42 - Roivant’s Evolution09:19 - AI in R&D17:48 - Lead Asset Brepocitinib28:23 - Anti-FcRN mAb Imeroprubart32:23 - China37:55 - What’s Next for Roivant

Launched in the 1970s as a generics company, Hengrui has become China’s leading innovator in R&D and dealmaking, with more than 100 NMEs in the pipeline and broad alliances with GSK and BMS. Under the leadership of Frank Jiang, EVP and chief strategy officer, Hengrui is engaging in a range of dealmaking and using its partnerships as stepping stones toward its goal of becoming one of the top biopharma companies in the world.In conversation with Executive Editor Jeff Cranmer on The BioCentury Show, Jiang describes the evolution of China’s biotech ecosystem — and Hengrui's — toward first-order innovation and the changing nature of deals in China, from straightforward licensing deals with “safe money” to NewCo deals and “co-co” partnerships.View full story: https://www.biocentury.com/article/659912#ChinaBiotech #BiopharmaInnovation #DrugDevelopment #StrategicPartnerships #GlobalBiotech00:00 - Introduction01:32 - Evolution of China Biotech08:43 - China Deals17:23 - Hengrui’s Evolution24:43 - Shareholder Base26:42 - Deals

Chris Arendt, CSO of Takeda, likens the AI overhaul at the pharma to gutting and rebuilding an old house, from the plumbing and electrical up, while you’re still living there. In a Fireside Chat at Grand Rounds U.S. in Seattle, Arendt sat down with Editor in Chief Simone Fishburn to discuss how Takeda is integrating AI across R&D, in and beyond the science, while still executing on the active programs in drug development.View full story: https://www.biocentury.com/article/659807#ArtificialIntelligence #PharmaInnovation #DrugDevelopment #DigitalTransformation #ResearchAndDevelopment00:00 - Introduction02:07 - Revamping Takeda for AI19:03 - Teams & Talent26:43 - Alliances32:50 - Q&A

ALS drug development has long been hampered by heterogeneity, but Angela Genge — neurologist at McGill University and CMO of AL-S Pharma — argues the field is getting closer to making that heterogeneity tractable. On The BioCentury Show, Genge discusses progress in pathway prioritization, progression-rate prediction, and endpoint standardization with BioCentury's Selina Koch.On the biology side, Genge expects the field to converge on a small number of high-priority pathways. SOD1 is the first validated example, and AL-S Pharma is now testing whether misfolded SOD1 marks a treatable subset of sporadic ALS. On biomarkers, she's optimistic a TDP-43 marker could arrive within two years.View full story: https://www.biocentury.com/article/659713 #ALS #DrugDevelopment #ClinicalTrials #Biomarkers #ALSResearch00:00 - Introduction02:03 - ALS Mechanistic Diversity06:13 - Trial Design Challenges16:52 - Biomarker Toolkit Update24:20 - ALS Pharma & SOD1

Richard Pops has lived the biotech roller coaster over three decades as CEO of Alkermes: an IPO, M&A, near-death events for his company, FDA setbacks, battles with an activist investor, and the satisfaction of knowing that millions of patients have benefited from the company’s medicines. He has led PDUFA reauthorization negotiations for industry, chaired BIO, and advocated for the interests of mid-sized biotechs.As Pops prepares to retire as CEO (he will remain chairman), he spoke with BioCentury Washington Editor Steve Usdin about the ways policy and economics shape the development of medicines. Pops discussed the impact of the Trump administration’s most favored nation (MFN) drug pricing policy and the Inflation Reduction Act (IRA), concerns about FDA’s loss of talent, and competition and collaboration with China’s life sciences sector.View full story: https://www.biocentury.com/article/659601#DrugPricing #BiotechLeadership #FDAPolicy #LifeSciencesPolicy #DrugDevelopment00:00 - Introduction01:40 - Alkermes’ Evolution05:12 - PBMs, Pricing & Access10:54 - IRA18:14 - MFN24:36 - PDUFA Negotiations28:05 - FDA Staffing31:40 - China & U.S. Policy

Karen Knudsen, CEO of the Parker Institute for Cancer Immunotherapy, believes the central problem in cancer drug development is not discovery, but a broken “translational middle.”In a wide-ranging interview on The BioCentury Show with BioCentury Washington Editor Steve Usdin, Knudsen discussed the Parker Institute’s focus on accelerating the path from scientific breakthrough to medical impact.As it approaches its tenth anniversary, the institute has deployed about $400 million, catalyzing roughly $4 billion in follow-on investment across 17 companies.View full story: https://www.biocentury.com/article/659476#CancerImmunotherapy #TranslationalScience #DrugDevelopment #Biopharma #CancerResearch00:00 - Introduction01:34 - Optimizing Translation07:42 - Training the Immune System16:33 - China’s Opportunity20:50 - Need for a Cancer Strategy24:40 - Enhancing Cancer Survivorship27:55 - Scientific Foundation Under Threat

A paradigm shift in research tools, combined with large-scale unbiased screening, has positioned the biopharma industry not only to rethink target discovery, but also to execute more faithfully on causal biology, according to Syncona CEO Chris Hollowood.Hollowood spoke on The BioCentury Show with Editor in Chief Simone Fishburn about how discovery is evolving, why causal biology has been stuck in a loop of circularity, and where the U.K. investor is headed. He also discussed the firm’s approach to gene therapy investments, how it is surmounting the field’s challenges and Syncona’s pivot last year, with a portfolio shift from 25% to over 85% clinical-stage companies.View full story: https://www.biocentury.com/article/659341#CausalBiology #GeneTherapy #BiotechInvesting #DrugDiscovery #ClinicalStage00:00 - Introduction01:06 - Rational Target Discovery16:48 - Gene Therapy23:15 - Syncona’s Strategy