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The BioCentury Show

BioCentury

39 episodes

4 days ago

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 times, commercial challenges, especially in the U.S., are far more challenging. The Medicare Drug P...

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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 times, commercial challenges, especially in the U.S., are far more challenging. The Medicare Drug P...

Show more...

Episodes (20/39)

The BioCentury Show

Ep. 89 - Delivering on the biosimilars promise, a conversation with Gillian Woollett

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 times, commercial challenges, especially in the U.S., are far more challenging. The Medicare Drug P...

1 week ago

31 minutes

The BioCentury Show

Ep. 88 – From Satiety to Muscle: Zealand CEO Steensberg on Amylin’s Edge in Obesity

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 deal helped make amylin arguably the hottest target in obesity. In conversation with BioCentury’s ...

3 weeks ago

30 minutes

The BioCentury Show

Ep. 87 – Korea’s Biotech Playbook: Orum CEO SJ Lee on Going Global and Creating Novel Therapies

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 East Asia’s life sciences scene, how Western players can get to k...

1 month ago

27 minutes

The BioCentury Show

Ep. 86 – Macrophages, ASCO & Clever-1: Faron CEO Juho Jalkanen on Bexmarilimab’s Promise

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 macrophages than therapies against other macrophage checkpoints. Jalkane...

1 month ago

10 minutes

The BioCentury Show

Ep. 85 - Stifel’s Opler on Trump 2.0's FDA & the Capital Markets

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 about FDA, what he sees ahead for capital markets, competition in Chin...

1 month ago

32 minutes

The BioCentury Show

Ep. 84 – Leadership Amid Turmoil: Moonlake CEO Jorge Santos Da Silva

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 down the noise and focus on the key choices in front of you....

2 months ago

29 minutes

The BioCentury Show

Ep. 83 – Europe’s Biotech Moment: Jérôme van Biervliet on Turning Uncertainty into Opportunity

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 Biotechnology (VIB), a key player in the Belgian biotech landscape th...

2 months ago

31 minutes

The BioCentury Show

Ep. 82 – Act Now or Fall Behind: Michelle Rozo on Biotech’s National Security Stakes

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 report's recommendations and warnings with the commission’s vic...

3 months ago

31 minutes

The BioCentury Show

Ep. 81 - Data-Driven Growth: Immunocore CEO Bahija Jallal on Expanding TCR Therapies

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 has informed how the company will take its TCR technology into e...

3 months ago

30 minutes

The BioCentury Show

Ep. 80 - Vertex’s Winning Formula: Altshuler on Choosing the Next Breakthroughs

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 Vertex expands to pain, renal disease, Type I diabetes, and m...

4 months ago

32 minutes

The BioCentury Show

Ep. 79 - BNP Paribas’ Moneer on Biotech’s Bull Case: M&A, PE, and Market Recovery

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 M&A activity. In the interview, he also also highlights the g...

4 months ago

29 minutes

The BioCentury Show

Ep. 78 - Biotech’s New Normal: SR One’s Simeon George on Adapting to Market Constraints

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. George, who co-founded SR One management in 2020 following its spin...

4 months ago

31 minutes

The BioCentury Show

Ep. 77 - AI’s Next Leap: Foresite Labs’ Vik Bajaj on Predictive Biology

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 and biological discovery technologies. Bajaj, who serves as in...

5 months ago

35 minutes

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...

5 months 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...

6 months 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...

6 months 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...

7 months 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 ...

8 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 ...

8 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...

9 months ago

33 minutes