The BioCentury Show

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. To gain more insights into therapeutic advances and biopharma sustainability, read the report now available on cytiva.com.

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