The BioCentury Show

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 r...

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 ha...

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...

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...

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.
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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 ...

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 U...

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...

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 are...

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 ...

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, discus...

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...

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 Sho...

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 t...

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 discu...

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...

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 abou...

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 port...

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...