The Top Line

Artificial intelligence is reshaping drug safety, but governance is just as critical as innovation, according to Marie Flanagan of IQVIA Safety Technologies. Speaking on The Top Line podcast, Flanagan said responsibility for AI in healthcare must be shared across compliance, technology, business teams and regulators. Strong governance, she said, ensures AI systems are ethically designed, technically validated, transparent and adaptable to continuous oversight. Organizations can prepare by grounding their strategies in guiding principles such as human oversight, fairness and accountability, Flanagan said. She emphasized the need to embed governance in AI design from the start, rather than adding controls later. Compliance teams, she added, can shift from being seen as barriers to acting as enablers of safe innovation. From constant monitoring to feedback loops, the conversation highlights practical steps for managing AI in life sciences. Hear the full episode of The Top Line for a deeper look at how companies can balance innovation and responsibility.See omnystudio.com/listener for privacy information.

Tariffs, drug pricing reform, a government shutdown and a major turnover at one of the world’s largest drugmakers all converged this week, leaving plenty to unpack for the industry as it heads into fall. Greater clarity on President Donald Trump’s tariff and pricing strategies has likely come as something of a relief for those companies operating in the U.S., but that news was tempered by a shutdown of the federal government on Wednesday. Meanwhile, big changes are likely on the way at GSK, whose longtime CEO Emma Walmsley is headed for the exit. In this week’s episode of "The Top Line," we break down some of the biggest stories across Fierce Pharma for the week—which may very well be some of the biggest stories of the year—touching on critical policy updates in the U.S., the furloughing of federal employees at agencies like the FDA and NIH and the imminent departure of GSK’s chief executive. Fierce Life Sciences’ Ben Adams sits down with Fierce Pharma's Fraiser Kansteiner to discuss the latest headlines and go over the key points from each major development that has played out. To learn more about the topics in this episode:  FDA avoids the worst amid government shutdown, but new applications put on hold NIH research grinds to a halt as government shuts down Pfizer offers price concessions, $70B US outlay in Trump's 'most favored nation' push Trump's pharma tariffs on hold amid administration's effort to secure pricing concessions, industry investment: Stat GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels See omnystudio.com/listener for privacy information.

Despite a challenging year, the biotech industry has continued to push boundaries, taking bold risks in pursuit of groundbreaking science. If anything, this year has only strengthened our conviction in the rising stars leading the next wave of innovation.   Fierce Biotech’s Fierce 15 class of 2025 is defined by their resilience, diversity in both strategy and leadership, and treatments that hold life-changing potential for underserved patients around the world.   In this week’s episode of "The Top Line," Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Andrea Park discuss what went into picking this year’s winners and some highlights from the special report.  To learn more about the topics in this episode:  Introducing Fierce Biotech's 2025 Fierce 15 See omnystudio.com/listener for privacy information.

Trust in pharma has always been fragile, and the rise of misinformation has made it even more precarious. In this episode of "The Top Line," recorded at Fierce Pharma Week in Philadelphia, Freda Lewis-Hall, M.D., joins us to share how she has worked to put a human face on the industry. A psychiatrist, longtime patient advocate and former Pfizer chief medical officer, she explains why listening must come before messaging, how AI and omnichannel outreach can help or harm patient trust and why rebuilding credibility starts one conversation at a time. To learn more about the topics in this episode:  TV ads close to overtaking doctors as consumers' primary source for learning about new meds: survey Pharma's reputation is stable-ish. Will that survive Trump 2.0? ABPI finds familiarity breeds trust, supporting push for industry-healthcare collaborations Doctor Mike calls on healthcare, pharma leaders to lean into social media to rebuild trust with patients See omnystudio.com/listener for privacy information.

Robert Abel, chief scientific officer at Schrödinger, says advanced computational tools are changing the pace and accuracy of drug discovery. In a recent episode of The Top Line podcast, Abel outlined three areas where AI and machine learning are making the greatest impact: understanding disease biology, predicting protein structures and designing drug molecules. Schrödinger’s platform uses physics-based simulations alongside AI to evaluate millions of molecules in days, compared with the thousands traditionally synthesized in a year. Abel pointed to real-world results, including a program that reached a clinical trial candidate in just 10 months — far faster than industry averages. He said the technology also helps overcome challenges such as improving drug selectivity and reducing the need for animal testing, aligning with FDA priorities. Abel will share more insights during his upcoming talk at AAPS PharmSci 360 in San Antonio this November. His session abstract is available here. To hear more about Schrödinger’s work in computational drug discovery, listen to the full interview.See omnystudio.com/listener for privacy information.

With Pfizer discontinuing Beqvez and BioMarin scaling back the commercial focus of Roctavian, the curative promise of hemophilia gene therapies is tempered by significant barriers that discourage widespread adoption. In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker speaks with Glenn Pierce, M.D., Ph.D., vice president of medical at the World Federation of Hemophilia, about the complexities behind these innovative therapies and the multifaceted reasons for their slow uptake. Pierce discusses the competitiveness of the current hemophilia gene therapy market, why Pfizer’s product couldn’t keep up, and the patient populations that risk being left behind. To learn more about the topics in this episode:   As Pfizer backs out of hemophilia gene therapy space, CSL hopes Hemgenix is here to stay  Pfizer discontinues hemophilia treatment Beqvez, emptying its gene therapy portfolio  BioMarin downsizes Roctavian efforts but keeps hemophilia gene therapy for 3 markets  See omnystudio.com/listener for privacy information.

Hope, when applied with purpose and action, can be a powerful force for driving change in healthcare. That’s the philosophy of Eugene Woods, CEO of Advocate Health and a 2025 Fierce 50 honoree, who joins Ayla Ellison, Editor-in-Chief of Fierce Life Sciences & Healthcare, to share how he puts “Applied Hope” into practice. Woods explains how this approach combines optimism with action and why it’s become a guiding strategy for one of the nation’s largest nonprofit health systems. In their conversation, Woods discusses leading through massive organizational change, cultural transformation and the rapid adoption of new technologies. He offers insights on improving quality and affordability, investing in both rural communities and urban neighborhoods and preparing for a future shaped by AI and more human-centered healthcare delivery. To learn more about the topics in this episode:  Fierce 50 of 2025 Eugene A. Woods—Fierce 50 Leadership Honoree See omnystudio.com/listener for privacy information.

In the latest episode of the Health Matters podcast, former Food and Drug Administration Commissioner Scott Gottlieb joins WPP’s Wendy Lund, GCI Health’s Ryan Kuresman and Burson’s Judy Stecker to discuss the forces reshaping U.S. health policy. Gottlieb warns that while new laws such as the Inflation Reduction Act may lower government spending on drugs, consumers are unlikely to see significant relief at the pharmacy counter. Insurers’ tighter formularies and higher cost-sharing requirements, he said, could continue to drive affordability challenges for patients. The discussion also covers the future of direct-to-consumer advertising, FDA’s role in combating health misinformation and the promise of cell and gene therapies. Gottlieb shares both caution and optimism — noting the risk of consumer frustration if policy changes fail to deliver savings, while pointing to breakthroughs that are transforming treatment and outcomes. To hear his full take on the challenges and opportunities facing health care leaders, listen to the full Health Matters episode.See omnystudio.com/listener for privacy information.

After many U.S. biopharma companies posted sales declines in the first quarter, the domestic pharma industry largely bounced back to growth in the second quarter.  In this episode of "The Top Line," Fierce Pharma's Eric Sagonowsky and Kevin Dunleavy break down the numbers behind the industry’s second-quarter performance. Among U.S. pharma heavyweights, J&J, AbbVie, Pfizer, Regeneron, Bristol Myers Squibb and Biogen each eked out gains this past quarter. Their results varied, with individual stories worth highlighting at each of these major companies. Beyond earnings, Sagonowsky and Dunleavy also discuss the growing competition in diabetes and obesity treatments between Eli Lilly and Novo Nordisk, as well as Merck’s rising financial reliance on its blockbuster cancer drug Keytruda, among other topics.  To learn more about the topics in this episode:  Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year The battle of the obesity drug heavyweights 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms Biopharma briefing: Q1 trends, gene therapy updates and ASCO preview  See omnystudio.com/listener for privacy information.

Fraiser Kansteiner, a journalist from Fierce Pharma, joins to unravel the fierce competition between Novo Nordisk and Eli Lilly in the obesity drug market. They discuss Novo's challenges, including product shortages and a recent pipeline clearout. Kansteiner highlights Lilly’s successful strategies amidst increasing sales and the implications of compounding pharmacies. The conversation also touches on Pfizer's exit from the obesity race and the potential emergence of smaller biotech firms, painting a vivid picture of the evolving landscape.