The BioCentury Show

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 #BiopharmaStrategy

00:00 - Introduction
00:42 - Roivant’s Evolution
09:19 - AI in R&D
17:48 - Lead Asset Brepocitinib
28:23 - Anti-FcRN mAb Imeroprubart
32:23 - China
37:55 - 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 #GlobalBiotech

00:00 - Introduction
01:32 - Evolution of China Biotech
08:43 - China Deals
17:23 - Hengrui’s Evolution
24:43 - Shareholder Base
26:42 - 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 #ResearchAndDevelopment

00:00 - Introduction
02:07 - Revamping Takeda for AI
19:03 - Teams & Talent
26:43 - Alliances
32:50 - 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 #ALSResearch

00:00 - Introduction
02:03 - ALS Mechanistic Diversity
06:13 - Trial Design Challenges
16:52 - Biomarker Toolkit Update
24:20 - 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 #DrugDevelopment

00:00 - Introduction
01:40 - Alkermes’ Evolution
05:12 - PBMs, Pricing & Access
10:54 - IRA
18:14 - MFN
24:36 - PDUFA Negotiations
28:05 - FDA Staffing
31:40 - China & U.S. Policy