The BioCentury Show

Caution: This episode of The BioCentury Show contains strong language.

In a candid interview with BioCentury, RA Capital Managing Partner Peter Kolchinsky warns that staffing losses and growing conservatism at FDA are slowing drug development and pushing companies to launch early-stage trials outside the U.S.
In conversation with BioCentury Washington Editor Steve Usdin, Kolchinsky also discusses U.S. policy headwinds, including most-favored-nation (MFN) pricing proposals and the Inflation Reduction Act’s “pill penalty,” and why he’s concerned that the biopharma sector is too “genteel” in its advocacy. Kolchinsky explains his decision to speak publicly about regulatory and political issues, including immigration, and reflected on China’s expanding role in the global life sciences innovation ecosystem.

View full story: https://www.biocentury.com/article/658433

#BiotechPolicy #FDALeadership #DrugPricingPolicy #LifeSciencesInnovation #CapitalMarkets

00:00 - Introduction
00:37 - Impact of FDA Policy Changes
06:17 - MFN & Drug Pricing in Europe
20:16 - The Importance of Speaking Up
34:26 - China & Innovation

With disease biology still murky and trials notoriously noisy, psychiatry R&D is advancing fastest where teams can solve engineering problems. Delivery, selectivity and tolerability fixes are turning long-standing hypotheses into usable medicines, says veteran CNS drug developer Steven Paul. Few drug developers have had a closer view of the field’s false starts — and occasional breakthroughs — than Paul, who has moved from NIH to pharma R&D leadership and now to company building at Karuna, acquired by BMS for $14 billion, and Seaport.
In conversation with The BioCentury Show's Selina Koch, Paul explains why serendipity still plays a disproportionate role in psychiatric drug development and how critical it is for teams to engineer and execute their way from an unexpected signal to a usable medicine. He also discusses psychedelics, brain shuttles, Karuna’s muscarinic approach in schizophrenia, and the delivery and trial-design choices Seaport is using to revisit neuroactive steroid biology in depression.

View full story: https://www.biocentury.com/article/658314

#PsychiatryTherapeutics #CNSDrugDevelopment #BiotechEngineering #Psychedelics #NeuroScience

00:00 - Introduction
01:32 - Psychiatric Drug Discovery
06:56 - The Karuna Story
22:09 - What’s New in Depression
32:06 - Gene Therapies, Brain Shuttles
33:53 - Psychedelics

Why does great science so often stall before it becomes a medicine? Astellas Pharma CEO Naoki Okamura argues the bottleneck isn’t capital — it’s translation: a shortage of people, processes and platforms that can move ideas across the boundaries of biology, manufacturing, regulation and commercialization. That theme threaded through his conversation on The BioCentury Show with Executive Editor Selina Koch, surfacing most clearly in his diagnosis of what Japan’s biotech ecosystem lacks — and in his rationale for why Astellas is doubling down on cell and gene therapy as other multinational pharmas pull back. The discussion also touches on Astellas’ journey in commercializing a women’s health product, the company’s China strategy, and its plans for life after Xtandi’s patent cliff.

View full story: https://www.biocentury.com/article/658141

#BiotechTranslation #CellAndGeneTherapy #JapanBiotech #PharmaStrategy #DrugDevelopment

00:00 - Introduction
00:39 - Cell & Gene Therapy
07:22 - Women’s Health
13:00 - Japan’s Biotech Ecosystem
19:00 - Astellas’ China Strategy
22:45 - Astellas’ Near-Term Strategy

Private equity’s expanding role in biopharma as a growth equity investor reflects both the maturation of the life sciences sector and the rising need for large-scale capital, alongside PE firms’ increasing ability to conduct the technical diligence required for investments once considered too risky for their models.
In conversation with The BioCentury Show's Stephen Hansen, Bain Capital’s Adam Koppel discussed the evolution of private equity's interest in biotech, Bain’s prioritization scheme for scaled investments and his outlook for the capital markets in the year ahead.

View full story: https://www.biocentury.com/article/657997

#PrivateEquity #BiotechDeals #LifeSciencesInvesting #GrowthEquity #BiopharmaMarkets

00:00 - Introduction
01:57 - PE's Evolution in Biotech
06:58 - Bain's Priorities
11:24 - Structuring Deals
18:23 - Capital Market Conditions
24:03 - Environment for Private Companies
27:08 - IPO Outlook

In historical terms, this is not a bear market, says Stelios Papadopoulos. There’s volatility, which is unnerving, and major issues to reckon with, but the level of anxiety in biotech doesn’t reflect the “extraordinary science, the likes of which we’ve never seen — and it’s getting better,” said Papadopoulos on The BioCentury Show.
Papadopoulos is one of the long-term leading voices of biopharma, recognized for his influence in shaping the industry. Former chair of Biogen and current chair of Exelixis, with roles on several boards, and a background of nearly two decades as an investment banker, he brings a long view to how the industry has grown and the forces driving where it is headed. Tune in to hear his take on the financing environment for biotechs, company building, pricing pressure, innovation from China, and the future of big pharmas, in conversation with Editor in Chief Simone Fishburn.

View full story: https://www.biocentury.com/article/657910

#BiotechOutlook #DrugPricing #ChinaBiotech #BigPharma #BiopharmaStrategy

00:00 - Introduction
02:00 - Financing Environment
10:18 - Company Building
20:47 - Women in Biotech
25:38 - China, Korea & Europe
30:00 - Is Biotech Too Insular?