The BioCentury Show

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

Rep. Jake Auchincloss (D-Mass.), an influential voice in Congress on life sciences issues, gained stature last week when he was appointed to serve on the Energy & Commerce Committee, giving him a seat at the table for debates over legislation affecting FDA, CMS and NIH and a host of issues of critical importance to the biopharma industry.
In an interview with Washington Editor Steve Usdin on The BioCentury Show, Auchincloss outlined his priorities for the 119th Congress, from pushing “muscular” PBM reform over the congressional finish line to finding bipartisan support for refining the IRA's orphan drug exemption and advancing methods to evaluate the social value of medicines.

View full story: https://www.biocentury.com/article/654659

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

00:00 - Introduction
01:08 - New Congress & RFK Jr.
10:09 - China & Biotech
16:36 - Assessing Drugs’ Value

Specialist public investors are doing their best to hold up the sector, but biotech still has to wash out many of the lower quality companies that were funded during the boom and ended up driving the generalists away, said MPM Bioimpact's Chris Bardon on The BioCentury Show. Bardon said the market hasn’t yet found the footing that will see an opening of the IPO window and a swing of positive sentiment. But although markets aren’t yet out of the woods, she said M&A will remain robust for years, fueled by obesity drug revenues.

View full story: https://www.biocentury.com/article/654649

#biotech #biopharma #pharma #lifescience #financing #investing

00:00 - Introduction
01:30 - Market Sentiment
06:19 - IPO Window
12:04 - M&A Outlook
19:51 - The Obesity Landscape

Leading biotech companies through the turbulence of the past few years and the uncertainty of the next ones takes not just resilience, but an ability to grapple with the CEO’s paradox, according to Climb Bio CEO Aoife Brennan. This paradox requires preparing for repeated setbacks while planning optimistically, a duality that has been the story of biotech since the outbreak of the pandemic, said Brennan. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Brennan discusses how CEOs are managing through uncertainty, and why "boring" naked mAbs are the smart move in one field.

View full story: https://www.biocentury.com/article/654451

#biotech #biopharma #pharma #lifescience

00:00 - Introduction
00:59 - State of Play for Biotech
04:34 - How to Choose a CEO Job
18:49 - New Era of Discipline
26:51 - Building a Team

With new governments both side of the pond, capital markets picking up, and some geopolitical overhang, there’s a mixed feast for biotech, with a net trend to the positive, says Sidley Austin’s Robert Darwin, who specializes in global M&A and private equity for life sciences and healthcare companies and investors. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Darwin, who is based in London, discussed the consequences for biotech of the changing forces as we enter 2025: the new Labour government’s recently announced budget, the incoming Trump administration, the improving outlook for the markets, and the ongoing — if not mounting — tensions between the U.S. and China. Across each of these is a considerable amount of uncertainty, but the pluses and minuses add up to net positive outlook, he believes.
This episode of The BioCentury Show was sponsored by Cytiva.

View full story: https://www.biocentury.com/article/654182

#biotech #biopharma #pharma #lifescience #deals

00:00 – Introduction
01:49 – U.K.’s Place in Global Biotech
09:41 – Trump & Biotech
17:32 – Deals in 2025
31:57 – Private Equity in Biotech

Richard Pazdur, director of FDA’s Oncology Center of Excellence, joined FDA in 1999. Looking back on his 25th anniversary, he draws a line between unpopular decisions at the start of his tenure and a surge in cancer drug development over the last 20 years. He believes this and other lessons from the regulation of oncology can be applied broadly across FDA. The BioCentury Show discussed these lessons, as well as Pazdur’s views about advisory committees, pragmatic trials, dose optimization and more.
This episode of The BioCentury Show was sponsored by Cytiva.

View full story: https://www.biocentury.com/article/654032

#biotech #biopharma #pharma #lifescience #RandD #drugapproval #regulation

00:00 - Introduction
01:55 - Rejecting the ineffective
10:56 - Creating Consensus
16:43 - Fire From the Dragon’s Mouth
24:30 - Three Reasons for Trial Equity
29:28 - Dose Optimization

With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard’s data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape.

View full story: https://www.biocentury.com/article/653858

#biotech #biopharma #pharma #lifescience #IPO #capitalmarkets #deals

00:00 - Introduction
02:17 - Capital Markets Outlook
05:18 - M&A
14:37 - Breaking Down Deals
23:44 - Asia

CMS’s controversial decision to restrict access to Alzheimer’s mAb treatments, including Aduhelm, approved under FDA’s accelerated pathway was a unique case that is unlikely to set a precedent, former CMS CMO Lee Fleisher told BioCentury. “I do not think this will be repeated,” he said. In an interview with The BioCentury Show's Steve Usdin, Fleisher gives a behind-the-scenes account of the decision-making process, including the role of accelerated approval. He also discusses the opportunities and risks for healthcare posed by AI, and the scientific and legislative steps that will be needed to make real the promise of blood-based multicancer detection technologies.

View full story: https://www.biocentury.com/article/653749

#biotech #biopharma #pharma #lifescience #policy

00:00 - Introduction
01:31 - Behind the Aduhelm Decision
08:01 - Questioning CMS
17:19 - Accelerated Approval
26:34 - AI in Medicine

Few CEOs have built a $20 billion biotech in under 15 years, as John Oyler has with BeiGene, managing to stay in that market cap band even through the downmarket. His strategy, to own clinical trials and manufacturing early on, looks particularly prescient in light of the cost and supply constraints threatening many biotechs today. On this episode of The BioCentury Show, Editor in Chief Simone Fishburn sits down with Oyler to discuss the early strategies that are now paying off for the global oncology company.

View full story: https://www.biocentury.com/article/653597

#biotech #biopharma #pharma #lifescience #drugdevelopment 

00:00 - Introduction
11:20 – In-house Manufacturing
15:51 – BeiGene’s Pipeline
23:45 – Partnering Plans
27:00 – Building a High Value Biotech

There is good news in this year’s Association for Accessible Medicines report on savings from biosimilars, including a 30% increase over the last year in savings attributed to biosimilars. The report also explores the economic, policy and regulatory headwinds that are preventing the industry from generating savings at a level that would have a dramatic effect on the U.S. healthcare system.
In an interview with Washington Editor Steve Usdin on The BioCentury Show, Craig Burton, executive director of AAM’s Biosimilars Council, calls out business practices and government policies that are holding the industry back and discusses the ways a robust biosimilars market could promote biomedical innovation.

View full story: https://www.biocentury.com/article/653459

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

00:00 - Introduction
03:45 - IRA
13:38 - Humira
20:44 - Biosimilars Pipeline

This is a previously recorded episode of The BioCentury Show from February 22, 2024. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

In a wide-ranging conversation with BioCentury, Bob Nelsen, co-founder and managing director of Arch Venture Partners, said he is excited by the potential for AI to “create a language of biology,” is cautious about investing in China given increasing geopolitical tensions, and is convinced that the U.S. healthcare system could do a far better job of delivering on the promise of rapidly progressing science.
Nelsen, who has helped finance and create more than 150 companies, including 47 that have reached valuations exceeding $1 billion, discussed his conviction that focusing on creating transformational medicines, rather than looking for short-term gains, is a key to success in the life sciences.

View full story: https://www.biocentury.com/article/651502

#biotech #pharma #biopharma #TheBioCenturyShow 

0:00 - Introduction
01:59 - The Promise of AI
08:35 - The Inflation Reduction Act
15:38 - China
25:58 - Building Companies Around Big challenges

As Jane Grogan anticipates the unmet needs in patients five years from now, she’s harnessing a wave of interest in targeting B cells as a key driver of an immunology expansion at Biogen. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Grogan, who became EVP and head of research of Biogen in October, discusses how she’s approaching the mission to build diversity and balance the risk in the company’s portfolio, extending further into disease areas beyond neurology.

View full story: https://www.biocentury.com/article/653208

#RandD #DrugDevelopment #neurology #immunology #nephrology #celltherapy #bcells #CD28 #CD38

00:00 - Intro
01:05 – Expanding Research
08:22 – Integrating Hi-Bio
11:30 – Targeting B Cells
16:35 – Growing the Modality Toolbox

As Astellas prepares to launch four products in parallel, Chief Commercial Officer Claus Zieler is balancing the complexity of this multi-faceted enterprise with a simple guiding principle: it has to work at a local level, and that will change with geography, circumstance and time. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Zieler discusses how to factor local differences in patient behavior, payer systems and regulatory environments into a global launch strategy. He also advocates for a seamless integration of R&D and commercial efforts throughout the lifecycle of each product, from early development to loss of exclusivity, and he discusses what small companies need to know when deciding whether to commercialize a therapy on their own.

View full story: https://www.biocentury.com/article/653047

#biotech #biopharma #pharma #lifescience #RandD #deals #licensing #partnerships

00:00 - Intro
01:26 - Focus Area Approach
04:55 - Continuous Teams
09:00 - Building Partnerships
15:24 - Omni Channel Launches
28:40 - Future Pipeline

Ignorance about the path from scientific discovery to approved drugs, high out-of-pocket costs, and a byzantine healthcare system that obscures net prices while inflating list prices have fueled policies that threaten biomedical progress, John O’Brien, CEO of think tank National Pharmaceutical Council, told BioCentury.
In an interview with The BioCentury Show's Steve Usdin, O’Brien, who led efforts to reduce drug prices as an HHS official during the Trump administration, said that whoever wins the White House in November will step into a political atmosphere that is hostile to biopharma companies. While it is difficult to predict what drug pricing policies Trump would pursue if he is re-elected, “Beltway chatter” suggests he would undercut the Inflation Reduction Act’s Medicare drug price negotiation program and attempt to revive international reference pricing proposals, O’Brien said.

View full story: https://www.biocentury.com/article/652931

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

00:00 - Intro
01:15 - Drug Pricing Policy Overview
09:30 - Inflation Reduction Act
16:20 - A Byzantine Healthcare System

Pediatric cancer drug development is difficult: it requires high levels of safety, involves parents as well as the patients, and has small populations that can make it difficult to achieve the revenues that reward the investment. Squaring that circle, according to Day One Biopharmaceuticals CEO Jeremy Bender, is not impossible, but takes a dedicated strategy that considers both pediatric and adult development paths from the get-go, and pursues them with equal intensity. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Bender discussed the rapid rise of Day One, and how it is building a pipeline and evolving a strategy that allows it to keep pediatric drug development central to its philosophy.

View full story: https://www.biocentury.com/article/652807

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

00:00 - Intro
02:25 - Origins & What’s Next
07:57 - Commercialization & Capital
15:28 - Precision Pediatric Strategy
21:00 - First v. Best, ADCs
30:00 - Life as a CEO

The U.S. is experiencing events that are either the first stages of a widespread avian influenza outbreak or a fire drill that will show how well the nation is prepared for an outbreak. The U.S. has not stepped up to meet the challenge, Rick Bright, the former director of BARDA, told BioCentury.
In an interview with The BioCentury Show's Steve Usdin, Bright said there are opportunities for biotech companies to help fill voids in surveillance, point-of-care diagnostics, vaccines and therapeutics. The federal government must provide leadership and funding to unleash industry, but it has acted slowly and hasn’t taken the necessary initiative, Bright said.

View full story: https://www.biocentury.com/article/652676

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

00:00 - Intro
01:56 - H5N1: State of Play
10:14 - Rebuilding Trust, Vaccines
20:50 - Creating Better Therapeutics
25:34 - BARDA, Barriers to Preparedness
32:50 – Urgent Next Steps