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The BioCentury Show

BioCentury

26 episodes

14 hours ago

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 ramif...

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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 ramif...

Show more...

Episodes (20/26)

The BioCentury Show

Ep. 76 - FDA Inflection Point: Steve Usdin on Biopharma during Trump 2.0

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 ramif...

1 week ago

34 minutes

The BioCentury Show

Ep. 75 - PBMs, IRA, RFK Jr: A Conversation With Rep. Jake Auchincloss

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 “musc...

3 weeks ago

36 minutes

The BioCentury Show

Ep. 74 - Chris Bardon on Biotech’s Recovery: Valuations, Obesity Drugs, and M&A

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 y...

3 weeks ago

34 minutes

The BioCentury Show

Ep. 73 - Resilience and the CEO’s Paradox: Aoife Brennan on Leading in Biotech

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 discu...

1 month ago

32 minutes

The BioCentury Show

Ep. 72 - Outlook for Biotech M&A and Financing: Sidley's Robert Darwin

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 ...

2 months ago

35 minutes

The BioCentury Show

Ep. 71 - Pazdur Unplugged: FDA Director Richard Pazdur on the Past, Future of Cancer Treatments

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 ...

3 months ago

41 minutes

The BioCentury Show

Ep. 70 - Trends in Global Biopharma Deals: Lazard’s Kingston and Raine

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-prec...

3 months ago

33 minutes

The BioCentury Show

Ep. 69 - Lee Fleisher: An Insider’s Account of CMS’s Alzheimer’s Coverage Decisions

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 opportunitie...

4 months ago

34 minutes

The BioCentury Show

Ep. 68 - Inside BeiGene: CEO John Oyler on Owning the Drug Development Process

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...

4 months ago

35 minutes

The BioCentury Show

Ep 67 - AAM's Craig Burton on Opportunities, Challenges of U.S. Biosimilars Market

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 direct...

5 months ago

28 minutes

The BioCentury Show

Popular Episode - Bob Nelsen on AI, China and the IRA

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 conv...

5 months ago

35 minutes

The BioCentury Show

Ep. 66 - Jane Grogan on Building Biogen’s Growth Engine

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.V...

6 months ago

32 minutes

The BioCentury Show

Ep. 65 - Astellas' Claus Zieler: Global Launches with Local Impact

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 stra...

6 months ago

32 minutes

The BioCentury Show

Ep. 64 - NPC CEO John O’Brien: Why America Needs an Honest Conversation About Drug Pricing

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...

6 months ago

33 minutes

The BioCentury Show

Ep. 63 - Day One's Jeremy Bender: Building Pediatric Oncology from the Ground Up

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 E...

7 months ago

32 minutes

The BioCentury Show

Ep. 62 - Rick Bright: Navigating the Avian Flu Threat

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 therapeutic...

7 months ago

40 minutes

The BioCentury Show

Ep. 61 - Vas Narasimhan: How New Data Fit Novartis’ Growth Plan

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-bo...

8 months ago

32 minutes

The BioCentury Show

Ep. 60 - JMM John Maraganore: A higher bar for investment is a credit to biotech

“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 lands...

8 months ago

36 minutes

The BioCentury Show

Ep. 59 - Derek Lowe Unplugged: AI; Biosecure; FDA, Abortion & SCOTUS; and more

“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 ...

8 months ago

32 minutes

The BioCentury Show

Ep. 58 - Ysios' Karen Wagner: How Europe's Biotechs Can Rise Above the Noise

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 sh...

9 months ago

30 minutes