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 #ClinicalTrials

00:00 - Introduction
01:44 - Current Framework
07:01 - Process-based Regulation
13:57 - Overcoming Bottlenecks
20:28 - Use of AI
25:25 - 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 #Innovation

00:00 - Introduction
03:24 - Biotech Under Threat
10:38 - CEO Compensation
15:39 - Competing with China
22:08 - U.S. Policy Prescriptions
30:00 - 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 #DrugDevelopment

00:00 - Introduction
01:15 - Initiate Ventures' Thesis
07:04 - What Makes Founders Fundable
17:36 - Defining AI Native Healthcare
23:20 - Diagnostics & Evidence Generation
36:44 - 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 #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