The Top Line

Uncertainty reigned early this year with the inauguration of President Donald Trump and his threats to impose tariffs and slash prescription drug prices. But as players in the biopharma industry have gotten a better handle on the impact of these measures and the overall investment landscape, valuations have become more predictable and dealmakers have focused on larger, lower-risk acquisitions. The recent trends bode well for the business development landscape in 2026 and beyond. In this week’s episode of “The Top Line,” Arda Ural, EY Americas life sciences sector leader, joins Fierce Pharma’s Kevin Dunleavy to discuss the dealmaking landscape in the biopharma industry. They dig into the Federal Trade Commission’s scrutiny of M&A transactions, revitalized therapeutic areas, artificial intelligence investment and the emergence of China as an innovation powerhouse. To learn more about the topics in this episode: 2025 M&A up in value and deal count after year of 'conservatism and recovery': Leerink PartnersAfter a 'reset' year for M&A, expect bigger deals in 2025: reportsSee omnystudio.com/listener for privacy information.

GCI Health, Fersen and Fierce Pharma, hosts Ryan Kurzman and 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—and explains why access to reliable insurance remains one of the most urgent challenges. As she notes, even with groundbreaking innovation, patients still struggle with affordability, systemic barriers and an overwhelming amount of information that is not always credible or tailored to their specific diagnosis. 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. She also highlights two top priorities for U.S. cancer policy by 2030: reducing out-of-pocket costs and improving nationwide screening rates. 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.

Bayer is reshaping its pharmaceutical business with a new operating model designed to enhance collaboration and bring research & development and commercialization closer together. In a recent episode of The Top Line podcast, Bayer executives Christine Roth, Executive Vice President and Head of Global Product Strategy and Commercialization, and Dr. Yesmean Wahdan, Head of Medical Affairs for the United States and North America, discussed how the company’s Dynamic Shared Ownership framework is driving faster innovation and helping accelerate the development of new therapies for patients. The model removes traditional hierarchies, empowers cross-functional teams and encourages real-time collaboration across departments. Roth and Wahdan said the approach has already shortened regulatory timelines, reduced resource use and helped deliver treatments to patients sooner. By embedding commercial insights early in the research process, Bayer teams can anticipate market needs and focus on the greatest areas of unmet medical demand. The leaders said the company’s collaborative culture keeps patient benefit at the center of decision-making. To learn more about how Bayer’s model is transforming its pipeline, listen to the full episode of The Top Line. See more from Bayer’s Christine Roth and Dr. Yesmean Wahdan on their LinkedIn profiles below: Christine: https://www.linkedin.com/in/christine-roth-34b07b18/ Yesmean: https://www.linkedin.com/in/yesmean-h-wahdan-md-71409b199/ See omnystudio.com/listener for privacy information.

In this episode of The Top Line, Fierce’s Chris Hayden speaks with Foresight Diagnostics co-founders Dr. Jake Chabon and Dr. Max Diehn about how their company is delivering the next generation of minimal residual disease (MRD) detection in cancer care. Born from research at Stanford University, Foresight’s PhasED-Seq technology delivers ultra-sensitive detection—down to parts per ten million—enabling clinicians to identify microscopic traces of cancer that traditional imaging misses. The discussion explores how Foresight’s MRD platform, CLARITY, can have the ability to support more confident decision-making, from determining curative success in early-stage cancers to guiding consolidation treatment in lymphoma. Chabon and Diehn highlight the company’s biopharma collaborations, clinical trial integration, and evidence-driven approach to guideline inclusion. They also look ahead to a future where MRD testing becomes central to oncology surveillance, accelerating therapy approvals and complementing genomic and digital pathology tools to advance precision medicine. See omnystudio.com/listener for privacy information.

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 Q27 top pharmas posted revenue declines in Q1. The common thread? All are US firmsSeveral 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 ingredientsFDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturingAmid pharma's US investment spree, FDA unveils new program to streamline domestic plant build-outsTrump signs executive order to boost US drug manufacturing amid threat of tariffsSee omnystudio.com/listener for privacy information.

The healthcare marketing landscape is evolving fast — shaped by regulatory shifts, patient empowerment, and the rise of digital health marketplaces. In this episode of The Top Line, sponsored by Havas Media Network, host Chris Hayden sits down with Holly Dunn, Managing Partner of Performance at Havas Media Network, to explore how pharma brands can redefine patient engagement for a more connected, equitable future. Dunn explains how first-party data, AI-driven intent signals, and curated health marketplaces are enabling more compliant, transparent, and human-centered campaigns. She also discusses the growing role of healthcare creators, the fight against misinformation, and strategies to ensure high-quality, privacy-safe engagement across the patient journey. If you’re in pharma or biotech marketing, this conversation offers critical insight into how leading brands are building trust and equity in an increasingly complex environment. See omnystudio.com/listener for privacy information.

Welcome to the Fierce Biotech Graveyard, our annual ritual remembering the biotechs we lost in 2025 and those on the brink. In this episode, Fierce Biotech’s Darren Incorvaia and Gabrielle Masson came together to chat about themes from this year’s graveyard, including a cell therapy mausoleum, some mad science, and Darren’s incredibly dated reference to a novelty song from 1958. To learn more about the topics in this episode: The 2025 Biotech GraveyardSee omnystudio.com/listener for privacy information.

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 15Fierce Biotech's 2023 Fierce 15See 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.

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.

With a new president of U.S. pharma at the helm—and two key FDA approvals now in the books—Boehringer Ingelheim is sharpening its focus on the lucrative American market. In this week’s episode of “The Top Line,” we dive into Boehringer Ingelheim’s latest regulatory successes, two crucial launches, and the German company’s expanding commercialization push in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Brian Hilberdink—who joined Boehringer as president of U.S. human pharma in February—to discuss his game plan to further unlock the American market and capitalize on key BI green lights in idiopathic pulmonary fibrosis and lung cancer. To learn more about the topics in this episode: Boehringer Ingelheim breaks into oncology with FDA approval for lung cancer med HernexeosBoehringer Ingelheim breathes new life into lung fibrosis field with FDA approval for Jascayd'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipelineChutes & Ladders—Boehringer snatches up LEO exec for US pharma teamSee omnystudio.com/listener for privacy information.

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 holdNIH research grinds to a halt as government shuts downPfizer offers price concessions, $70B US outlay in Trump's 'most favored nation' pushTrump's pharma tariffs on hold amid administration's effort to secure pricing concessions, industry investment: StatGSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke MielsSee 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 15See 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: surveyPharma's reputation is stable-ish. Will that survive Trump 2.0?ABPI finds familiarity breeds trust, supporting push for industry-healthcare collaborationsDoctor Mike calls on healthcare, pharma leaders to lean into social media to rebuild trust with patientsSee 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.