The BioCentury Show

Tigermed, the largest clinical CRO in China, has expanded into more than 50 countries and is growing its North American operations, offering full-service support from preclinical through Phase IV. On this sponsored edition of The BioCentury Show, Britney Winterberger, Tigermed’s VP and head of North America clinical operations, tells BioCentury Executive Editor Jeff Cranmer how the CRO helps U.S. sponsors run trials in China and Chinese sponsors run trials in the U.S. — and why combining both in a single protocol can de-risk FDA acceptance while capturing China’s enrollment speed. Winterberger also discusses investigator-initiated trials in China, China’...

Arrowhead Pharmaceuticals can now deliver siRNA to seven cell types, and new data showing subcutaneous delivery to the brain could push RNAi therapies well beyond the liver. On this edition of The BioCentury Show, Arrowhead Chairman, President, and CEO Chris Anzalone joins BioCentury’s Stephen Hansen to discuss where siRNA has the edge over ASOs, what the Phase III miss for Novartis’ pelacarsen means for olpasiran, the Lp(a) therapy Arrowhead partnered with Amgen, and the growth outlook for plozasiran in severe hypertriglyceridemia. Anzalone also describes Arrowhead’s obesity programs targeting INHBE and ALK7, and a dimer molecule that silenc...

Untapped multibillion-dollar markets are hiding in plain sight where patients endure mediocre generic standards of care, according to Canaan General Partner Julie Grant, co-founder and first CEO of Day One, which Servier acquired for $2.5 billion this year. In an interview with BioCentury's Lindsay Martin, Grant discussed white spaces in women's health such as migraine and anemia, and why mid-tier acquirers like Jazz, Ipsen and Servier make smaller markets viable. She also explained why the last private round can understate value by 10-20X, how Canaan builds management teams around a key individual who sets the tone and why biotech...

On this edition of The BioCentury Show, Nick Galakatos, Global Head of Life Sciences at Blackstone, joins Editor in Chief Simone Fishburn to discuss the path from Clarus to Blackstone's new $6.3 billion fund, and the goal of game-changing bets.
Galakatos discusses Blackstone's thesis for addressing the late-stage financing gap, as Phase III programs costing more than $1 billion drive demand for large, product-based capital. He also addresses structured capital as an alternative to acquisition, noting deals such as Blackstone's with Alnylam and Apogee can reduce dilution and extend runway.

View full story: https://www.biocentury.com/article/660824<...

On This Edition of The BioCentury Show, Gonçalo Abecasis, SVP and Chief Genomics and Data Sciences Officer at the Regeneron Genetics Center, joins BioCentury’s Tierney Baum to discuss genetics as a scalable drug discovery platform and the practical use of AI in genomics.

View full story: https://www.biocentury.com/article/660697

#Genomics #DrugDiscovery #AI #GeneticMedicines #ClinicalTrials 

0:00 - Introduction
1:14 - Regeneron Genetics Center
10:29 - Acting on Genetic Signals
16:57 - Getting to Drug Development
21:51 - Best AI Use Cases

The Critical Path Institute’s One to Millions Initiative is using individualized rare disease therapies as the starting point for a development framework that could eventually extend across all genetically defined diseases. The initiative seeks to bring form to FDA’s Plausible Mechanism Framework by standardizing how evidence and methods can be reused across therapies and patients.
In conversation with Biopharma Analyst Dr. Tierney Baum on The BioCentury Show, C-Path CEO and CSO Klaus Romero discusses how the principal bottleneck is no longer the ability to design therapies for individual patients but rather the absence of a standardized regu...

Throughout his career, which has included serving as president and CEO of Teva, chair of BIO, and a leader or senior executive of large and small biopharma companies, Jeremy Levin has challenged the industry to live up to its ideals. In an interview with BioCentury Washington Editor Steve Usdin, Levin discussed why he believes industry leaders should speak out, and why many remain silent, about critical issues. He described concerns about the strength of the pillars that support the U.S. biotech industry, and why he is optimistic about the future of biotech.

View full story: https...

As AI becomes increasingly commoditized, Initiate Ventures' Jessica Owens argues healthcare and life sciences companies need to use it to solve historically intractable problems, not just streamline workflows. On The BioCentury Show, Owens breaks down how she evaluates founders, when Initiate chooses to fund versus co-found a company, and why she believes proprietary data now matters more than any proprietary model.
Owens also discusses gaps in evidence generation for diagnostics, and closes with a look at MASH, arguing that better non-invasive fibrosis staging will become increasingly critical as more GLP-1 combination therapies reach patients.

View full...

Roivant CEO Matt Gline calls the company’s move beyond spinning out subsidiary “vants” to concentrating on late-stage programs and commercial launches less a pivot than an evolution toward an original goal, which could soon be realized with the approval and launch of brepocitinib this year.
In conversation with Lindsay Martin on The BioCentury Show, Gline discussed how Roivant’s initial hub-and-spoke approach has provided the foundation needed for the company to develop and commercialize its portfolio now, including lead program JAK-1/TYK2 inhibitor brepocitinib. Gline also discussed how he views AI at Roivant and more broadly in biopharm...

Launched in the 1970s as a generics company, Hengrui has become China’s leading innovator in R&D and dealmaking, with more than 100 NMEs in the pipeline and broad alliances with GSK and BMS. Under the leadership of Frank Jiang, EVP and chief strategy officer, Hengrui is engaging in a range of dealmaking and using its partnerships as stepping stones toward its goal of becoming one of the top biopharma companies in the world.
In conversation with Executive Editor Jeff Cranmer on The BioCentury Show, Jiang describes the evolution of China’s biotech ecosystem — and Hengrui's — toward first-order innovati...

Chris Arendt, CSO of Takeda, likens the AI overhaul at the pharma to gutting and rebuilding an old house, from the plumbing and electrical up, while you’re still living there. In a Fireside Chat at Grand Rounds U.S. in Seattle, Arendt sat down with Editor in Chief Simone Fishburn to discuss how Takeda is integrating AI across R&D, in and beyond the science, while still executing on the active programs in drug development.

View full story: https://www.biocentury.com/article/659807

#ArtificialIntelligence #PharmaInnovation #DrugDevelopment #DigitalTransformation #ResearchAndDevelopment

00:00 - Introduction
02:07 - Re...

ALS drug development has long been hampered by heterogeneity, but Angela Genge — neurologist at McGill University and CMO of AL-S Pharma — argues the field is getting closer to making that heterogeneity tractable. On The BioCentury Show, Genge discusses progress in pathway prioritization, progression-rate prediction, and endpoint standardization with BioCentury's Selina Koch.
On the biology side, Genge expects the field to converge on a small number of high-priority pathways. SOD1 is the first validated example, and AL-S Pharma is now testing whether misfolded SOD1 marks a treatable subset of sporadic ALS. On biomarkers, she's optimistic a TDP-43 marker could arri...

Richard Pops has lived the biotech roller coaster over three decades as CEO of Alkermes: an IPO, M&A, near-death events for his company, FDA setbacks, battles with an activist investor, and the satisfaction of knowing that millions of patients have benefited from the company’s medicines. He has led PDUFA reauthorization negotiations for industry, chaired BIO, and advocated for the interests of mid-sized biotechs.
As Pops prepares to retire as CEO (he will remain chairman), he spoke with BioCentury Washington Editor Steve Usdin about the ways policy and economics shape the development of medicines. Pops discussed the im...

Karen Knudsen, CEO of the Parker Institute for Cancer Immunotherapy, believes the central problem in cancer drug development is not discovery, but a broken “translational middle.”
In a wide-ranging interview on The BioCentury Show with BioCentury Washington Editor Steve Usdin, Knudsen discussed the Parker Institute’s focus on accelerating the path from scientific breakthrough to medical impact.
As it approaches its tenth anniversary, the institute has deployed about $400 million, catalyzing roughly $4 billion in follow-on investment across 17 companies.

View full story: https://www.biocentury.com/article/659476

#CancerImmunotherapy #TranslationalScience #DrugDevelopment #Biopharma #CancerResearch

00:00 - Introd...

A paradigm shift in research tools, combined with large-scale unbiased screening, has positioned the biopharma industry not only to rethink target discovery, but also to execute more faithfully on causal biology, according to Syncona CEO Chris Hollowood.
Hollowood spoke on The BioCentury Show with Editor in Chief Simone Fishburn about how discovery is evolving, why causal biology has been stuck in a loop of circularity, and where the U.K. investor is headed. He also discussed the firm’s approach to gene therapy investments, how it is surmounting the field’s challenges and Syncona’s pivot last year, with a...

The European biotech ecosystem has gone through a substantial maturation process over the past 20 years, as VC funds such as Forbion have experienced exponential growth to fund the region’s innovation. But Forbion co-founder and managing director Sander Slootweg says there’s still more that can be done to fund future European innovations and improve Europe’s competitiveness globally.
“We’ve observed in Europe that although we see great science, and we’ve been able to build great companies, in terms of the absolute magnitude of the ecosystem, we’re still lagging behind the U.S., and also China is comin...

The U.K. is excellent at invention and science, and creating institutions to further innovation, but poor at capturing their economic value, says Daniel Mahony, a problem that various forces in the U.K. are now putting serious efforts into solving.
Mahony, one of the major influential figures in U.K. biotech, is a senior partner in growth investments at Novo Holdings, and was until December chair of the U.K.’s BioIndustry Association (BIA). In conversation with BioCentury Editor in Chief Simone Fishburn on The BioCentury Show, Mahony discussed the future of U.K. and European biotech, an...

As AI spreads across biopharma, what will matter most is not who has the flashiest tools, but who can use them to make better medicines. In this episode of The BioCentury Show, Recursion CEO Najat Khan discusses where AI is showing measurable value now, how public techbio companies are being pushed toward proof points, and what comes next — from out-of-domain prediction to stronger data foundations and precompetitive collaboration.

View full story: https://www.biocentury.com/article/658829

#ArtificialIntelligence #DrugDevelopment #AgenticAI #ClinicalProof #BiopharmaInnovation

00:00 - Introduction
01:41 - AI Hype to Proof
04:52 - Where AI Ad...

There is a real opportunity for artificial intelligence to dramatically transform the speed, cost and efficiency of drug development over the long term, but the uptake of AI tools across biopharma has been much slower relative to the broader healthcare environment, SoftBank’s Jacqueline Fok said on The BioCentury Show.
In conversation with BioCentury's Stephen Hansen, Fok, who is investment director, Life Sciences & Health Tech at SoftBank Investment Advisers, also detailed SoftBank’s investment strategy in life sciences and the opportunity the U.K. has to stand out as a globally competitive player, with SoftBank’s obesity portfolio compan...

Caution: This episode of The BioCentury Show contains strong language.

In a candid interview with BioCentury, RA Capital Managing Partner Peter Kolchinsky warns that staffing losses and growing conservatism at FDA are slowing drug development and pushing companies to launch early-stage trials outside the U.S.
In conversation with BioCentury Washington Editor Steve Usdin, Kolchinsky also discusses U.S. policy headwinds, including most-favored-nation (MFN) pricing proposals and the Inflation Reduction Act’s “pill penalty,” and why he’s concerned that the biopharma sector is too “genteel” in its advocacy. Kolchinsky explains his decision to speak publicly about regula...

With disease biology still murky and trials notoriously noisy, psychiatry R&D is advancing fastest where teams can solve engineering problems. Delivery, selectivity and tolerability fixes are turning long-standing hypotheses into usable medicines, says veteran CNS drug developer Steven Paul. Few drug developers have had a closer view of the field’s false starts — and occasional breakthroughs — than Paul, who has moved from NIH to pharma R&D leadership and now to company building at Karuna, acquired by BMS for $14 billion, and Seaport.
In conversation with The BioCentury Show's Selina Koch, Paul explains why serendipity still plays a dispro...

Why does great science so often stall before it becomes a medicine? Astellas Pharma CEO Naoki Okamura argues the bottleneck isn’t capital — it’s translation: a shortage of people, processes and platforms that can move ideas across the boundaries of biology, manufacturing, regulation and commercialization. That theme threaded through his conversation on The BioCentury Show with Executive Editor Selina Koch, surfacing most clearly in his diagnosis of what Japan’s biotech ecosystem lacks — and in his rationale for why Astellas is doubling down on cell and gene therapy as other multinational pharmas pull back. The discussion also touches on Astella...

Private equity’s expanding role in biopharma as a growth equity investor reflects both the maturation of the life sciences sector and the rising need for large-scale capital, alongside PE firms’ increasing ability to conduct the technical diligence required for investments once considered too risky for their models.
In conversation with The BioCentury Show's Stephen Hansen, Bain Capital’s Adam Koppel discussed the evolution of private equity's interest in biotech, Bain’s prioritization scheme for scaled investments and his outlook for the capital markets in the year ahead.

View full story: https://www.biocentury.com/article/657997

In historical terms, this is not a bear market, says Stelios Papadopoulos. There’s volatility, which is unnerving, and major issues to reckon with, but the level of anxiety in biotech doesn’t reflect the “extraordinary science, the likes of which we’ve never seen — and it’s getting better,” said Papadopoulos on The BioCentury Show.
Papadopoulos is one of the long-term leading voices of biopharma, recognized for his influence in shaping the industry. Former chair of Biogen and current chair of Exelixis, with roles on several boards, and a background of nearly two decades as an investment banker, he bri...

When Bill Hinshaw looks back across the arc of his career — from his early days helping to commercialize Gleevec to his present role leading Fore Biotherapeutics — he sees a precision oncology field transformed by technological ambition, yet still grappling with many of the structural challenges that defined its beginnings, now compounded by the difficulty of positioning therapies within an ever more complex treatment landscape.
Gleevec proved the power of targeting a genomic driver, but the healthcare system around it was far from ready. “We weren’t able to fulfill the promise as fast as we wanted to until that sca...

This is a previously recorded episode of The BioCentury Show from September 5, 2025. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

If you could redesign FDA from the ground up, what would it look like? That’s the fundamental question underlying the 2025 BioCentury Back to School essay, authored by BioCentury Washington Editor Steve Usdin, who has been a leading voice on regulation and policy for over two decades. The topic is especially meaningful in this era of FDA turmoil, when regulatory risk has piled on top of...

Elias Zerhouni personifies the American dream. He arrived in the U.S. from Algeria as a young man with a couple of hundred dollars in his pocket. Talent, ambition and hard work propelled him into a successful academic career. In 2002, he was nominated and confirmed as NIH director, and later he served in senior positions in the biopharma industry. That trajectory “would be almost impossible” today, he told BioCentury Washington Editor Steve Usdin on The BioCentury Show.
Anti-immigration policies, underfunding of basic research, and attacks on philanthropy have made the U.S. an unattractive destination for anyone hoping to f...

It took Sophie Kornowski under four years as CEO of Boston Pharma to bring it from a pipeline full of in-licensed assets to an acquisition by GSK for about $2 billion in total deal value for a single MASH program. Though her first gig as a biotech CEO, Kornowski’s success was built on her years of experience as head of partnering at Roche. She discussed that pivot and the value of rolling your sleeves up on the latest episode of The BioCentury Show.

View full story: https://www.biocentury.com/article/657446

#BiotechLeadership #DrugDevelopment #PharmaDeals #BiotechCEO #St...

Kymera Therapeutics has a clear mission: to transform immunology with targeted protein degraders that enable “oral drugs with biologics-like activity,” CEO Nello Mainolfi told The BioCentury Show. A pioneer in one of biopharma’s most closely watched new therapeutic modalities, Kymera is now over nine years into its story, with multiple pharma partnerships and a wholly owned pipeline, including a STAT6 degrader that produced promising data in June.
In conversation with BioCentury’s Selina Koch, Mainolfi discusses the appeal of degraders, the rationale for choosing glues or heterobifunctional degraders and how to prove a new modality on a new targ...

The frenzy among Western companies to access China’s biotechnology innovation is remaking the landscape for cross-border dealmaking, with assets becoming more expensive and partnerships earlier and broader than ever before. That’s being driven by exceptional capital efficiency, access to patients and speed of development, said Frazier Life Sciences’ James Li on The BioCentury Show podcast.
Among multinational companies, “every company has an army on the ground hunting for assets,” said Li, who has more than 30 years of biotech experience, as an investor, company builder and executive at an MNC and a biotech.

View full story: htt...

President Donald Trump’s demands for “most favored nation” drug pricing presents the biopharma industry with an immense public policy challenge. Drug companies are convinced that meeting the president’s demand to reduce U.S. prices to levels below those of other industrialized countries would decimate the industry. On this episode of The BioCentury Show, Fritz Bittenbender, SVP of Roche's Genentech unit and chairman of BIO, discusses the industry’s responses to the MFN challenge, and some of the under-appreciated nuances of policy options. He notes that reducing or eliminating payments to PBMs would lead to higher insurance premiums. While drug...

If you could redesign FDA from the ground up, what would it look like? That’s the fundamental question underlying the 2025 BioCentury Back to School essay, authored by BioCentury Washington Editor Steve Usdin, who has been a leading voice on regulation and policy for over two decades. The topic is especially meaningful in this era of FDA turmoil, when regulatory risk has piled on top of the market pullback, making biotech appear an unusually hazardous domain for investors. But while the current landscape has underscored the need, FDA reform has been on the table long before this administration came in...

A new head at MHRA, a streamlined government life sciences strategy, and a more sophisticated innovation ecosystem have Annalisa Jenkins optimistic about the future of U.K. biotech — and its potential to carve out a stronger global role.
On The BioCentury Show, Annalisa Jenkins, chair of Gemma Biotherapeutics, discussed the evolving landscape of biotech in the U.K. and the critical hurdles it faces as it implements the latest strategy. Jenkins, who was president and CEO of Dimension Therapeutics, is a committee member on the Science Board to FDA, a board member of Genomics England and Faster Cures, an...

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. 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 n...

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 from the ground up. Speaking on The BioCentury Show in conversation with Editor in Chief Simone Fishburn, Lepore discussed how he approaches partnering, how he manages the need to both build a platform and ge...

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 Price Negotiation Program has undermined the economic rationale for investing in biosimilars. President Donald Trump’s proposals for most favored nation pricing would “kill” the industry, Woollett s...

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 Stephen Hansen, Steensberg goes behind the scenes of Zealand’s deal with Roche and also shares his vision for how the obesity treatment paradigm will evolve over...

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 know the Korean biopharma industry, and what’s next for Orum’s pipeline. This episode of The BioCentu...

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.
Jalkanen also discusses the Phase I/II data Faron presented for bexmarilimab in myelodysplastic syndrome at the American Society of Clinical Oncology...

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 China, and three areas of innovation he’s focused on -- aging, women's health and the...