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

Differentiating on tolerability, raising the bar for efficacy and concentrating small molecule development on indications with minimal IRA exposure are all pieces of Novartis CEO Vasant Narasimhan’s strategy to break into the top pharmas by U.S. sales. Two data readouts this week — one for CML drug Scemblix at ASCO and one for inflammatory disease therapy remibrutinib at the EAACI Congress — may tee up two launches to advance that goal through a strategy focused on prioritizing blockbuster-bound programs. Narasimhan discusses the readouts with Editor in Chief Simone Fishburn on a Special Edition of The BioCentury Show.

View full story: https://www.biocentury.com/article/652562

#biotech #biopharma #pharma #lifescience

00:00 - Intro
01:12 - CML Data
09:34 - Endpoints, Approval Pathway
13:00 – Remibrutinib
24:07 – IRA, Radioligands

“The bar has gotten higher because science has gotten so much better,” John Maraganore says on the latest BioCentury Show. Reflecting on the capital markets and the state of innovation, the founder and former CEO of Alnylam painted a picture of a robust ecosystem fueled by sprawling innovation, where the higher scrutiny by investors will serve the industry well. In a broad-ranging conversation with Editor in Chief Simone Fishburn, Maraganore gives his views on the innovation and funding landscape, geopolitical issues facing the industry and the outlook for the next generation of leaders.

View full story: https://www.biocentury.com/article/652517

#biotech #biopharma #pharma #lifescience #investment #innovation

00:00 Intro
01:50 Innovation Today
09:00 Obesity
12:23 Building, Mentoring Biotechs
16:38 Capital & Competition
24:10 Industry Overhangs

“I’m a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about why he hopes and believes the Supreme Court will rule for FDA in litigation over the abortion drug mifepristone; and explained his view that approval of Aduhelm to treat Alzheimer’s disease was one of FDA’s worst decisions

View full story: https://www.biocentury.com/article/652427

#biotech #biopharma #pharma #lifescience #DrugDiscovery

00:00 - Intro 
01:04 - Lowe’s Blog
04:42 - Biosecure Act
09:04 - AI & Drug Discovery
16:46 - FDA, The Abortion Drug, & Aduhelm

It sounds obvious, but still needs saying, says Ysios Capital's Karen Wagner. “How do you rise above the noise? By having the most spectacular data.” In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Wagner discussed the theme of the upcoming Bio€quity Europe conference — rising above the noise: in a sea of competition where companies vie for attention among investors and pharmas, what are the characteristics that allow them to differentiate? Wagner explains what she and her team looks for in a biotech before investing, and also discusses the role of ESG policies, including diversity, in companies. “We have absolute certainty that ESG is important."

View full story: https://www.biocentury.com/article/652294

#biotech #biopharma #pharma #lifescience #finance

00:00 - Intro
01:36 - Spain’s Biotech Ecosystem
09:30 - Investment Criteria
14:27 - ESG, Diversity
27:53 - AI in Drug Development

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

Within the framework of target, modality and path to clinic, causal biology is the axis along which Head of Research Robert Plenge is building and prosecuting research at Bristol Myers. It maps from late-stage decisions the company has made, such as the Karuna acquisition, to strategies in early R&D, such as how to innovate in ADCs and extend the modality to new applications.
In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Plenge outlined his view of causal biology as a principal axiom for building an R&D engine to maximize probability of success. It is the foundation for step one — picking the right target — and sets the basis for the second and third tenets of his framework, finding the right therapeutic modality for a mechanism of action, and establishing a clear path to clinical proof of concept.

View full story: https://www.biocentury.com/article/652135

#biotech #biopharma #pharma #lifescience

00:00 - Intro
01:53 - BMS's Framework for Research
12:38 - First vs. Best in Class
16:09 - Modalities & Manufacturing
19:48 - CAR Ts & Autoimmunity
24:34 - ADCs

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

BIO CEO John Crowley believes that biotech is part of a “great global rivalry” between the U.S. and China. The role of biotech in determining the outcome of this rivalry, and a belief in the need for reducing U.S. reliance on Chinese biotech companies, led BIO to reverse its opposition to the Biosecure Act. Crowley acknowledges concerns that the enactment of the bill in its current form would create serious disruptions in drug development. By accepting its overall goals and engaging with Congress, BIO will have opportunities to persuade negotiate changes that will mitigate its negative consequences for biopharma companies and patients, Crowley told BioCentury Washington Editor Steve Usdin in this episode of #TheBioCenturyShow.

View full story: https://www.biocentury.com/article/651990

#biotech #biopharma #pharma #biosecureact #lifescience

00:00 - Intro
03:57 - Decoupling from China
11:33 - Biosecure Act
15:48 - Rare Diseases at FDA
25:02 - Fly-outs and Big Ideas
28:05 - Changing the Narrative

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

Atlas Venture’s Bruce Booth believes the belt-tightening by biotechs in the past few years will presage a better financing outlook for companies, but the ripple effects will be felt for some time to come. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, the longtime biotech VC said that there are clear positive signs for biotech, with the XBI ETF bouncing back from its lows in the 60s, February’s robust follow-on financing market and a stream of M&A deals. “Everybody did belt-tightening the last few years,” said Booth. “So, you’re coming from a good place in terms of overall burn rates, and companies, I think, are in a good place to be financed by the next wave of investors.”

View full story: https://www.biocentury.com/article/651821

#biotech #pharma #biopharma #lifescience #TheBioCenturyShow 

00:00 - Intro
01:54 - Capital Markets
07:19 - How to Pitch a VC
12:12 - Obesity 
16:30 - New Modalities
22:28 - Industry Efficiency, AI