The BioCentury Show

This is a previously recorded episode of The BioCentury Show from March 19, 2025. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes. 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. Wh...

In an environment where everybody hurts, it helps for biotech CEOs to understand the pressures driving pharmas, investors and other key players if they want to secure deals and financings that will help them succeed. That’s how John Lepore, CEO of Profound Therapeutics and former head of research at GSK, is navigating his early stage company through this capital-constrained era as he builds it fro...

Gillian Woollett, head of regulatory strategy and policy at Samsung Bioepis, discusses how FDA can deliver on its promise to “massively streamline” the regulation of biosimilars. Eliminating unnecessary clinical trial requirements could halve the time and cost of developing a biosimilar, according to Woollett. While regulators around the world are converging on ideas that will slash development ti...

Mounting clinical evidence suggests amylin agonists could supplant GLP-1 molecules as the foundational backbone of future obesity therapy, says Zealand Pharma CEO Adam Steensberg on The BioCentury Show . One of the leading cardiometabolic biotechs, Zealand received the largest-ever upfront payment in a biotech licensing deal when it partnered its petrelintide with Roche for nearly $2 billion. The...

Globalizing quickly and gaining a first-mover advantage are the winning strategies for South Korean biotechs as they look to compete on the world stage, says Orum Therapeutics founder and CEO SJ Lee in conversation with BioCentury Executive Editor Jeff Cranmer on The BioCentury Show . Lee’s company, a leader in degrader-antibody conjugates, provides an example of how to run that playbook. Lee also...

The macrophage field has seen its share of setbacks, but Faron believes bexmarilimab, its humanized mAb that binds to immune checkpoint target Clever-1, has what it takes to get across the goal line at FDA. On a special sponsored edition of The BioCentury Show , Juho Jalkanen, founder and CEO of Faron Pharmaceuticals, explains how the Finnish biotech landed on Clever-1, and why the target might mo...

Notwithstanding the bad start that the Trump administration got off to on FDA, Tim Opler is optimistic that the agency will serve drug developers well, and sees enough good signals that the direction the agency is headed will not bring the difficult regulatory era that many in the industry feared. Opler, a managing director at Stifel, spoke to Editor in Chief Simone Fishburn on The BioCentury Show...

As CEO of a vintage 2021 biotech, Jorge Santos Da Silva has had his leadership mettle tested by a pandemic, rising interest rates, a bear market, and a tumultuous U.S. policy environment — all while building the case for Moonlake’s lead program to become a top therapy for hidradenitis suppurativa and, eventually, a “pipeline-in-a-product.” The key for Santos Da Silva as founder and CEO of  Moonlak...

Europe did not ask for this opportunity, says VIB’s Jérôme van Biervliet, but with FDA and the U.S. research funding situation headed into uncertain territory, it needs to use this moment to capitalize on its strengths in research, and address the shortcomings of its business and regulatory systems that have made it hard for biotech to fulfill its potential there. Van Biervliet is managing directo...

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 Washingto...

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 efficient...

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...

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 drivi...

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 cre...

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 pr...

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 stand...

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 T...

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...

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 Br...

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 , Da...

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 lesso...

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 a...

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...

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 Fi...

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 i...