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

Since the annual J.P. Morgan Healthcare Conference in San Francisco in early January, biotech has seen a notable surge in enthusiasm, Zahid Moneer, senior managing director of investment banking at BNP Paribas, told The BioCentury Show.
Moneer, who is more upbeat than many in today’s biopharma sector, sees capital raises from million-dollar seed rounds to nine-digit series A, B, and C rounds driving significant growth alongside M&A activity. In the interview, he also also highlights the growing role of private equity firms in biopharma and the trend of pharmas engaging earlier with biotechs and investors looking to deploy capital into those companies

View full story: https://www.biocentury.com/article/655216

#biotech #biopharma #pharma #lifescience #financing #privateequity #IPO

00:00 - Introduction
00:37 - Investment Climate
05:06 - Pharma M&A Activity
15:25 - Private Equity's Role
21:44 - Biotech Financing

Biotechs need to get used to the new normal, says SR One CEO and Managing Partner Simeon George, and that will require significant adjustments to the business model. This new normal comes from an extended tough capital environment against a backdrop of political uncertainty, but while biotechs face a different set of factors than they have in the past, there are still first principles of value creation that should guide them.
George, who co-founded SR One management in 2020 following its spinout from GSK, spoke on The BioCentury Show with Editor in Chief Simone Fishburn about the challenges facing biotechs and how VCs are navigating through the complexity of the moment. He also discussed SR One’s strategy and philosophy of investing.

View full story: https://www.biocentury.com/article/655142

00:00 - Introduction
01:31 - Meeting the Moment
04:45 - Company Valuations
13:54 - China Strategy, NewCos
22:08 - Building Successful Biotechs

#biotech #biopharma #pharma #lifescience #CEO #financing #newco

Clinical trials will be launched in the next year or two to test predictions about causal biology made by artificial intelligence models, Vik Bajaj, co-founder and CEO of Foresite Labs and managing director of Foresite Capital Management, believes. Foresite teamed up with Arch Venture Partners last year on a $1 billion venture round to fund Xaira Therapeutics, which aims to reinvent the R&D process via AI-driven protein design and biological discovery technologies.
Bajaj, who serves as interim president of Xaira, discussed the potential for artificial intelligence to accelerate biomedical progress in an interview with Washington Editor Steve Usdin on The BioCentury Show.

View full story: https://www.biocentury.com/article/654977

#biotech #biopharma #pharma #lifescience #AI #RandD #drugdiscovery

00:00 - Introduction
01:18 - AI & Biotech
12:19 - Getting the Data Right
19:06 - Healthcare Delivery
30:47 - Making It Real

All presidential transitions with a change of party come with disruption and threats as well as opportunities. But this one, in particular with regard to the implications for FDA, is different from all those Steve Usdin has been covering in his 30-year tenure as Washington editor at BioCentury.
In particular, this is an inflection point for the agency that currently serves as the global gold standard for drug regulation, said Usdin on a special edition of The BioCentury Show covering the ramifications for the biopharma industry of the second Trump administration. Usdin has recently outlined the threats and opportunities that the new era presents, and he elaborated further on those in a discussion with Editor in Chief Simone Fishburn.

View full story: https://www.biocentury.com/article/654798

#biotech #biopharma #pharma #lifescience #politics #policy #fda #ftc #biosecure #ira

00:00 - Introduction
05:06 - Inflection Point at FDA
14:10 - Changes at the FTC
16:43 - China, Biosecure
21:30 - The IRA