The Top Line

After a turbulent 2025, the biopharma industry is heading into the new year with major questions still unresolved. A tough biotech investing environment, aggressive direct-to-consumer drug marketing and sweeping U.S. policy changes reshaped the landscape last year. Many of those pressures are expected to persist into 2026, even as early signs point to a thaw in venture capital. At the same time, the industry is testing whether DTC drug sales can meaningfully affect pricing for patients and whether broad manufacturing onshoring goals can realistically apply to advanced therapies like cell and gene treatments and radiopharmaceuticals. In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner sits down with three biopharma CEOs to unpack what defined 2025 and what comes next. He’s joined by Thijs Spoor, CEO of Perspective Therapeutics; Brian Culley, CEO of Lineage Cell Therapeutics; and Rich Daly, CEO of Catalyst Pharmaceuticals. Together, they tackle issues from DTC sales and onshore manufacturing to drug pricing, regulatory uncertainty at the FDA and the broader innovations the leaders are most excited about this year. To learn more about the topics in this episode:  2026 forecast: After a surge of M&A in Q4, will the trend continue? Editor's Corner: Fierce Biotech's 10 most-read stories of 2025 What a year: Here are the stories that captivated our audience in 2025 Editor's Corner: The top 10 Fierce Pharma Marketing stories of 2025 2026 forecast: Pharma clicks with patients as direct sales model shifts marketing strategies See omnystudio.com/listener for privacy information.

This discussion features Darren Incorvaia, a Staff writer at Fierce Biotech, who sheds light on how NIH funding cuts impact drug discovery. Fraser Kansteiner, a reporter/editor at Fierce Pharma, dives into the shifting dynamics within FDA vaccine policies. Angus Liu and Eric Sagonowsky provide insights on FDA leadership changes and their implications. The panel also evaluates the cautious optimism seen at the Jefferies Healthcare Conference, while Heather Landi and Paige Minemyer analyze the challenges providers face and the evolving role of AI in healthcare.

Deepak Kuletha, leader of data analytics for biopharma services at Walgreens, shares invaluable insights into how the company leverages its vast daily interactions to generate data that informs pharmaceutical strategies. He discusses how Walgreens helps partners optimize drug launches by uncovering patient behavior trends and addressing access barriers. Deepak highlights the role of machine learning and AI in predicting adherence risks and the importance of maintaining patient privacy while delivering actionable insights. This collaboration is shaping the future of evidence generation in healthcare.

Arda Ural, EY's Americas life sciences leader and dealmaking expert, shares insights on the evolving biopharma landscape. He discusses the shift towards larger, low-risk acquisitions post-pandemic and highlights revitalized therapeutic areas driving deals, such as oncology and neurology. Ural addresses the Federal Trade Commission's scrutiny of mergers and the long-term impacts of NIH funding cuts on innovation. He also emphasizes the rapid rise of AI in biopharma R&D and China's emergence as an innovation powerhouse, shaping future dealmaking.

In this episode of Health Matters, GCI Health’s Ryan Kuresman and Health@WPP’s Wendy Lund explore the fast-shifting landscape of cancer care with Pam Traxel of the American Cancer Society Cancer Action Network. Traxel outlines the growing complexity facing patients—from navigating an expanding range of treatment options to managing rising costs. The conversation also examines the evolving role of patient advocacy and the partnerships needed to drive meaningful change. Traxel emphasizes the importance of integrating lived experiences into policy, improving the credibility of patient-facing communication and strengthening early, ongoing collaboration between biopharma, policymakers and advocacy organizations. For healthcare and life sciences professionals seeking deeper insight into how access, innovation and policy must intersect to improve patient outcomes, this is a must-listen episode.See omnystudio.com/listener for privacy information.

Research shows that women remain woefully underrepresented at the highest levels of leadership in the life sciences industry. Those who have broken through that glass ceiling, however, are not only doing groundbreaking work in pharma, biotech, medtech and beyond but also reframing what it means to be a leader in the sector—as evidenced by the often-unconventional career paths and management philosophies of the 10 women featured in this year’s Fiercest Women in Life Sciences report. In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, highlighting several honorees’ paradigm-busting approaches to leadership, mentorship and building inclusive teams. To learn more about the topics in this episode: 2025's Fiercest Women in Life Sciences 4 reasons life sciences still fail women at the top, despite a female-majority workforce: report GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels Merck KGaA, grappling with geopolitical tensions, ⁠reveals CEO transition Takeda taps Julie Kim to take over for retiring CEO Christophe Weber  See omnystudio.com/listener for privacy information.

Christine Roth, Executive Vice President at Bayer Pharmaceuticals, teams up with Dr. Yesmean Wahdan, Senior VP of Medical Affairs, to discuss Bayer's revolutionary Dynamic Shared Ownership model. They highlight how breaking down hierarchies enhances collaboration between R&D and commercialization, speeding up innovation. Their approach has notably shortened regulatory timelines and ensured patient needs are prioritized. With real-world evidence and early market insights, Bayer is transforming drug development to deliver treatments faster and more efficiently.

In this engaging conversation, Jake Chabon, Co-founder and CEO of Foresight Diagnostics, and Dr. Max Diehn, Scientific Advisor and Stanford professor, dive into the groundbreaking world of minimal residual disease (MRD) detection. They unveil Foresight's PhasED-Seq technology, which can identify cancer traces down to parts per ten million, and discuss its potential to transform cancer monitoring. The duo explores biopharma collaborations and the future of MRD testing in precision medicine. Expect fascinating insights on how MRD could redefine oncology surveillance!

In this week’s episode of "The Top Line," we take a deep dive into the top-line performance of the biopharma industry in the third quarter.  After a slow start to the year, U.S. drugmakers in particular have recovered, led by Eli Lilly. We examine which companies are hot and which are not. We also look at trends that emerged in the third quarter, such as the shortfall in vaccine sales, especially in the U.S., and companies’ sales projections for the rest of the year. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss their observations from the third quarter and put the industry’s performance in perspective compared with previous quarters. They also examine the biopharma outlook for the fourth quarter.  To learn more about the topics in this episode:  Q1 biopharma layoff trends, plus expectations for Q2 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year   See omnystudio.com/listener for privacy information.

Christopher Schilling, Chief Regulatory Officer at Forge Biologics, shares insights from his extensive experience in gene therapy and manufacturing. He discusses the FDA's PreCheck initiative aimed at streamlining U.S. biopharma facility buildouts. Key topics include the program’s goals for partnership and predictability, expected timelines, and the need for clear guidance on regulatory processes. Schilling highlights the importance of early engagement and the role of CDMOs in scaling complex therapies, advocating for more transparency from the FDA.