Gillian Woollett, head of regulatory strategy and policy at Samsung Bioepis, discusses how FDA can deliver on its promise to “massively streamline” the regulation of biosimilars. Eliminating unnecessary clinical trial requirements could halve the time and cost of developing a biosimilar, according to Woollett.
While regulators around the world are converging on ideas that will slash development times, commercial challenges, especially in the U.S., are far more challenging. The Medicare Drug Price Negotiation Program has undermined the economic rationale for investing in biosimilars. President Donald Trump’s proposals for most favored nation pricing would “kill” the industry, Woollett said.

View full story: https://www.biocentury.com/article/656445

#biotech #biopharma #pharma #lifescience #DrugDevelopment #FDA

00:00 - Introduction
02:50 - Halving the Time and Cost
10:30 - Interchangeability
15:50 - The Importance of Market Share
22:08 - Most Favored Nation

Mounting clinical evidence suggests amylin agonists could supplant GLP-1 molecules as the foundational backbone of future obesity therapy, says Zealand Pharma CEO Adam Steensberg on The BioCentury Show.
One of the leading cardiometabolic biotechs, Zealand received the largest-ever upfront payment in a biotech licensing deal when it partnered its petrelintide with Roche for nearly $2 billion. The deal helped make amylin arguably the hottest target in obesity.
In conversation with BioCentury’s Stephen Hansen, Steensberg goes behind the scenes of Zealand’s deal with Roche and also shares his vision for how the obesity treatment paradigm will evolve over the next five years. This episode of The BioCentury Show was sponsored by Faron.

View full story: https://www.biocentury.com/article/656295

#biotech #biopharma #pharma #lifescience #DrugDevelopment #Amylin #GLP1

00:00 - Introduction
02:18 - The Case for Amylin
16:44 - Roche Deal
21:04 - What’s Next for Obesity Therapies

Globalizing quickly and gaining a first-mover advantage are the winning strategies for South Korean biotechs as they look to compete on the world stage, says Orum Therapeutics founder and CEO SJ Lee in conversation with BioCentury Executive Editor Jeff Cranmer on The BioCentury Show.
Lee’s company, a leader in degrader-antibody conjugates, provides an example of how to run that playbook. Lee also spoke about where Korea fits in East Asia’s life sciences scene, how Western players can get to know the Korean biopharma industry, and what’s next for Orum’s pipeline. This episode of The BioCentury Show was sponsored by Faron.

View full story: https://www.biocentury.com/article/656147

#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment

02:11 - Korea's Biotech Ecosystem
09:57 - Evolution of Korean Biotech
16:08 - Orum's Degrader Antibody Conjugates

The macrophage field has seen its share of setbacks, but Faron believes bexmarilimab, its humanized mAb that binds to immune checkpoint target Clever-1, has what it takes to get across the goal line at FDA.
On a special sponsored edition of The BioCentury Show, Juho Jalkanen, founder and CEO of Faron Pharmaceuticals, explains how the Finnish biotech landed on Clever-1, and why the target might more effectively repolarize macrophages than therapies against other macrophage checkpoints.
Jalkanen also discusses the Phase I/II data Faron presented for bexmarilimab in myelodysplastic syndrome at the American Society of Clinical Oncology (ASCO) in Chicago, and what’s next for the immunotherapy. This episode of The BioCentury Show was sponsored by Faron.

View full story: https://www.biocentury.com/article/656099

#biotech #biopharma #pharma #lifescience #ASCO #RandD #DrugDevelopment

Notwithstanding the bad start that the Trump administration got off to on FDA, Tim Opler is optimistic that the agency will serve drug developers well, and sees enough good signals that the direction the agency is headed will not bring the difficult regulatory era that many in the industry feared.
Opler, a managing director at Stifel, spoke to Editor in Chief Simone Fishburn on The BioCentury Show about why he’s optimistic about FDA, what he sees ahead for capital markets, competition in China, and three areas of innovation he’s focused on -- aging, women's health and the brain.

View full story: https://www.biocentury.com/article/656040

#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment #FDA

00:00 - Introduction
01:30 FDA under Trump 2.0
08:07 State of Capital Markets
13:13 China Competition
17:09 Innovation: Aging, Women’s Health & the Brain

As CEO of a vintage 2021 biotech, Jorge Santos Da Silva has had his leadership mettle tested by a pandemic, rising interest rates, a bear market, and a tumultuous U.S. policy environment — all while building the case for Moonlake’s lead program to become a top therapy for hidradenitis suppurativa and, eventually, a “pipeline-in-a-product.”
The key for Santos Da Silva as founder and CEO of  Moonlake Immunotherapeutics is to dial down the noise and focus on the key choices in front of you. “Moonlake has always existed in times of turmoil,” Santos Da Silva told Executive Editor Jeff Cranmer on The BioCentury Show, citing the recent M&A drought, high interest rates and political turmoil. “Understanding the situation from a cool perspective, being able to explain that to your people first, and then try to explain that to the Street and place the company in the right moment so that you have all the game in front of you" is his recipe for success as a CEO in biotech. Moonlake’s sonelokimab is expected to enter Phase III testing this year for HS; it's one of the most advanced multispecifics in the clinic for inflammation and immunology diseases.

View full story: https://www.biocentury.com/article/655903

#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment

00:00 - Introduction
01:48 - Landscape for HS Therapies
09:03 - Market Opportunity
19:40 - Next Steps for Moonlake

Europe did not ask for this opportunity, says VIB’s Jérôme van Biervliet, but with FDA and the U.S. research funding situation headed into uncertain territory, it needs to use this moment to capitalize on its strengths in research, and address the shortcomings of its business and regulatory systems that have made it hard for biotech to fulfill its potential there. Van Biervliet is managing director of Flanders Institute for Biotechnology (VIB), a key player in the Belgian biotech landscape that has both a research arm and an investment unit.  Ahead of BioCentury’s Bio€quity Europe conference in Bruges, which will discuss how Europe can meet the complexity of this moment, he talked to BioCentury Editor in Chief Simone Fishburn on The BioCentury Show about the landscape unfolding in Europe, as well as where he sees innovation headed.

View full story: https://www.biocentury.com/article/655818

#biotech #biopharma #pharma #LifeScience #ResearchFunding #EuropeanInnovation

00:00 - Introduction
02:03 - VIB’s Mission
07:52 - Europe’s Funding Opportunity
17:37 - Belgium’s Biotech Ecosystem
25:27 - Nanobodies’ Potential

The U.S. will cede its preeminence in biotechnology to China within three years unless the government acts urgently, an independent commission chartered by Congress warns. “Our window to act is closing,” the National Security Commission on Emerging Biotechnology said in a newly released report. “We need a two-track strategy: make America innovate faster, and slow China down.” BioCentury Washington Editor Steve Usdin discusses the report's recommendations and warnings with the commission’s vice chair, Michelle Rozo, on The BioCentury Show.

View full story: https://www.biocentury.com/article/655654

#biotech #biopharma #pharma #lifescience #politics #policy #law 

00:00 - Introduction
03:56 - China Closing the Innovation Gap
09:20 - Slowing China Down
17:20 - Bolstering U.S. Biotech

On the latest episode of The BioCentury Show, Editor in Chief Simone Fishburn speaks with Bahija Jallal, CEO of Immunocore and the former president of Medimmune. While some biotechs are circumspect about gathering data during clinical trials that might not support the product in question, Jallal sees it as part of the obligation to patients and the field to learn as much as possible, as efficiently as possible. And that strategy has informed how the company will take its TCR technology into earlier lines of treatment and new indications.

View full story: https://www.biocentury.com/article/655504

#biopharma #pharma #biotech #lifescience #RandD #DrugDevelopment #CEO

00:00 - Introduction
04:18 - Getting a New Modality to Market
17:15 - Infectious Pipeline
22:04 - Autoimmune Pipeline
27:24 - Leading in Challenging Times

Vertex’s approach to research, defined over a decade ago to beat the dismal odds of success in biotech, remains core to its strategy, even as the industry evolves and technologies expand. While that strategy, which EVP and CSO David Altshuler calls “serial innovation,” has seen the company launch eight drugs since 2011 and jump market cap tiers on the success of its cystic fibrosis portfolio, it’s now being tested in other areas as Vertex expands to pain, renal disease, Type I diabetes, and more. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Altshuler discussed the rising interest in causal biology and the role of AI, noting that the fundamentals of picking targets and programs have not changed.

View full story: https://www.biocentury.com/article/655408

#biotech #biopharma #pharma #lifescience
#RandD #DrugDevelopment #AI

00:00 - Introduction
02:12 - Causal Biology
08:48 - AI in R&D, at Vertex
16:35 - Academia-Industry Interface
22:00 - Cell Therapy for Diabetes
25:35 - Gene Therapy for DMD