The BioCentury Show

Tigermed, the largest clinical CRO in China, has expanded into more than 50 countries and is growing its North American operations, offering full-service support from preclinical through Phase IV. On this sponsored edition of The BioCentury Show, Britney Winterberger, Tigermed’s VP and head of North America clinical operations, tells BioCentury Executive Editor Jeff Cranmer how the CRO helps U.S. sponsors run trials in China and Chinese sponsors run trials in the U.S. — and why combining both in a single protocol can de-risk FDA acceptance while capturing China’s enrollment speed. Winterberger also discusses investigator-initiated trials in China, China’s new IIT regulations, and trial trends spanning bispecifics, ADCs, cell and gene therapies, and radiopharmaceuticals.
This episode of The BioCentury Show is brought to you by Tigermed.

View full story: https://www.biocentury.com/article/661260

#GlobalClinicalTrials #IITs #Oncology #ADCs #CRO

0:00 Introduction
1:17 Tigermed's Global Capabilities
2:59 Running Trials in China
7:05 Chinese Sponsors in the U.S.
16:42 IITs
22:28 Trends in Trial Design

Arrowhead Pharmaceuticals can now deliver siRNA to seven cell types, and new data showing subcutaneous delivery to the brain could push RNAi therapies well beyond the liver. On this edition of The BioCentury Show, Arrowhead Chairman, President, and CEO Chris Anzalone joins BioCentury’s Stephen Hansen to discuss where siRNA has the edge over ASOs, what the Phase III miss for Novartis’ pelacarsen means for olpasiran, the Lp(a) therapy Arrowhead partnered with Amgen, and the growth outlook for plozasiran in severe hypertriglyceridemia. Anzalone also describes Arrowhead’s obesity programs targeting INHBE and ALK7, and a dimer molecule that silences two genes at once.

View full story: https://www.biocentury.com/article/661194

#RNAi #siRNA #DrugDelivery #DrugDevelopment #Biotech

0:00 Introduction
1:09 Arrowhead's siRNA Platform
9:05 Solving for Extra-Hepatic Delivery
23:43 Redemplo's Future Growth
27:00 Obesity and Bispecific siRNA

Untapped multibillion-dollar markets are hiding in plain sight where patients endure mediocre generic standards of care, according to Canaan General Partner Julie Grant, co-founder and first CEO of Day One, which Servier acquired for $2.5 billion this year. In an interview with BioCentury's Lindsay Martin, Grant discussed white spaces in women's health such as migraine and anemia, and why mid-tier acquirers like Jazz, Ipsen and Servier make smaller markets viable. She also explained why the last private round can understate value by 10-20X, how Canaan builds management teams around a key individual who sets the tone and why biotech needs scientific heroes as AI captures most venture dollars.

View full story: https://www.biocentury.com/article/660963

#VentureCapital #Biotech #WomensHealth #DrugDevelopment #BiotechMA

0:00 Introduction
1:19 Canaan's Strategy
11:34 Team Building
21:57 White Space
28:00 New Biotech Buyers
34:15 Biotech Founders

On this edition of The BioCentury Show, Nick Galakatos, Global Head of Life Sciences at Blackstone, joins Editor in Chief Simone Fishburn to discuss the path from Clarus to Blackstone's new $6.3 billion fund, and the goal of game-changing bets.
Galakatos discusses Blackstone's thesis for addressing the late-stage financing gap, as Phase III programs costing more than $1 billion drive demand for large, product-based capital. He also addresses structured capital as an alternative to acquisition, noting deals such as Blackstone's with Alnylam and Apogee can reduce dilution and extend runway.

View full story: https://www.biocentury.com/article/660824

#Biotech #PrivateEquity #DrugDevelopment #LifeSciences #ClinicalTrials

0:00 Introduction
1:22 New Fund & Founding
10:30 Alnylam Deal
17:14 Working with Big Caps
25:54 Biotech Risk
29:13 China

On This Edition of The BioCentury Show, Gonçalo Abecasis, SVP and Chief Genomics and Data Sciences Officer at the Regeneron Genetics Center, joins BioCentury’s Tierney Baum to discuss genetics as a scalable drug discovery platform and the practical use of AI in genomics.

View full story: https://www.biocentury.com/article/660697

#Genomics #DrugDiscovery #AI #GeneticMedicines #ClinicalTrials 

0:00 - Introduction
1:14 - Regeneron Genetics Center
10:29 - Acting on Genetic Signals
16:57 - Getting to Drug Development
21:51 - Best AI Use Cases

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