The Top Line

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.

As the prospect of import tariffs and drug price reform marshals billions of biopharma investment dollars into the U.S., the feasibility of rapid domestic manufacturing buildouts could hinge on a new program cooking at the FDA. How that program, dubbed PreCheck, will work in practice—and on what timeline—are key questions as the U.S. looks to bolster its local pharmaceutical production base. This week on “The Top Line,” we dive into comments from a recent public meeting on the industry’s hopes for PreCheck, which is being designed to streamline the process by which new biopharma manufacturing facilities are built in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Christopher Shilling, chief regulatory officer at gene therapy CDMO Forge Biologics—who attended the meeting—to offer an on-the-ground perspective and explore the aspects of the plan that could have the biggest impact on manufacturers. Shilling also outlines what he sees as FDA’s next steps, plus regulatory considerations that could most benefit CDMOs and the broader industry. To learn more about the topics in this episode:  Amid tariff-fueled onshoring push, Trump signs order to boost US stockpiling of certain drug ingredients FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing Amid pharma's US investment spree, FDA unveils new program to streamline domestic plant build-outs Trump signs executive order to boost US drug manufacturing amid threat of tariffs See omnystudio.com/listener for privacy information.

Holly Dunn, Managing Partner of Performance at Havas Media Network, shares her expertise in healthcare marketing and privacy-safe strategies for pharma. She discusses the rapid evolution of health market dynamics driven by technology and regulatory changes. Dunn highlights the importance of first-party data and AI signals for transparent campaigns. She emphasizes health equity, addressing underserved patients through curated marketplaces, and the role of healthcare creators in combating misinformation. Her insights provide a roadmap for building trust and connection in an increasingly complex landscape.

Darren Incorvaia, an experienced biotech reporter and analyst, dives into the haunting tales of the 2025 Biotech Graveyard. He discusses the shocking rise in cell therapy failures, spotlighting the chaotic saga of Charisma and the remarkable comeback of Vorbio. The conversation reveals insights on macro headwinds affecting biotech, innovative 'mad science' startups, and the ongoing struggle for funding in a post-COVID landscape. Through a mix of humor and analysis, Darren sheds light on the industry's uncertain future and the strategies being employed to navigate these turbulent waters.

This week's episode of "The Top Line" features a discussion about what’s working now in biotech and what isn't.  Recorded Oct. 7 at Fierce Biotech Week, this panel featuring leaders from past Fierce 15 winners digs into timelines, partnerships, what's hype, what's signal and how teams are pressure-testing their models in today's market.  You'll hear from Generate Biomedicines CEO Mike Nally, Arbor Biotechnologies Chief Scientific Officer John Murphy, Epicrispr Biotechnologies CEO Amber Salzman, Ph.D., and Parabilis Medicines Chief Business Officer Greg Miller. The conversation was moderated by Fierce Biotech's Gabrielle Masson.  To learn more about the topics in this episode:  Fierce Biotech's 2022 Fierce 15 Fierce Biotech's 2023 Fierce 15 See omnystudio.com/listener for privacy information.

Life sciences organizations are facing both intense pressure and extraordinary opportunity, according to Mark Sullivan, president of regulated industries at Salesforce. In a conversation with The Top Line’s Chris Hayden, Sullivan said companies too often operate in “survival mode,” focused on defending margins rather than leading innovation. But with the rise of AI and agentic technologies, he said, the industry is poised for a transformation that could reshape how drugs are developed, trials conducted and patient data used — all at greater speed and lower cost. Sullivan emphasized that this new era requires rethinking how companies engage with stakeholders. Instead of distant, one-way interactions, he said, agentic AI enables dynamic, conversational relationships that improve satisfaction and generate actionable insights. Salesforce, he noted, is expanding beyond its CRM roots to help life science enterprises become “agentic” organizations — integrating secure, compliant AI systems across finance, HR and supply chains. With data security and trust at the core, Sullivan called on leaders to look beyond software replacement and pursue true digital transformation for the good of patients and the industry alike.See omnystudio.com/listener for privacy information.

The FDA made waves in early September when it announced a plan to publicly release complete response letters (CRLs) at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical transparency.” At the same time, the FDA released 89 new CRLs, adding to the more than 200 that were previously made public in July and shedding more light on the agency’s often opaque review process. That earlier document dump, though, only included rejection letters for drugs that were eventually approved. Now, for the first time, the agency is releasing CRLs for unapproved drug candidates—including recent high-profile rejections such as Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug.  Publicly airing the rationale for rejecting drug candidates is a significant shift for the FDA and a potential cause for concern for the biopharma industry. To unpack what the new policy means for drug developers, Fierce Biotech’s Darren Incorvaia sat down with Torrey Cope, a lawyer with Sidley Austin who represents and advises life sciences companies on issues related to the FDA. To learn more about the topics in this episode:  FDA releases ‘initial batch’ of more than 200 drug rejection letters  FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub  FDA misinterpreted efficacy data that prompted DMD rejection, Capricor claims  ‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process  'Several concerning observations': FDA sheds more light on reasons it rejected drugs  See omnystudio.com/listener for privacy information.