The BioCentury Show

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 spoke about where Korea fits in...

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 more effectively repolarize macrop...

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 about why he’s optimistic abou...

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  Moonlake Immunotherapeutics is to dial...

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 director of Flanders Institute for Biotech...

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.
G...

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...