The Top Line

Fierce Pharma Week brought thousands of people to Philadelphia for four days of conversations about pharma marketing, commercialization, medical affairs and communications.

In this episode of "The Top Line," Fierce editors share the conversations, trends and moments that stood out from the event. Topics include Genentech’s use of humor and celebrity storytelling to raise awareness of diabetic macular edema, how Novo is navigating the extraordinary attention around GLP-1 drugs, and the growing role of AI in pharma marketing. The team also looks at some of the campaigns honored at the Fierce Pharma Marketing Awards and the cr...

Prediction markets are opening up new ways to bet on biopharma events, from clinical trial readouts to FDA approvals. But they also create a new set of risks for an industry where employees, researchers, contractors and others may have access to confidential information that could give them an edge.

In this episode of “The Top Line,” Fierce Biotech’s Will Maddox talks with David Oliwenstein, a partner at Pillsbury Winthrop Shaw Pittman and former SEC enforcement attorney, about how regulators may approach misuse of nonpublic information in prediction markets, why biopharma could face heightened scrutiny and what compan...

Clinical development organizations are facing mounting pressure to do more with increasingly complex protocols, larger data sets and tighter timelines. While automation has improved individual processes, many of the industry's most persistent delays continue to occur between tasks, systems and teams.

In this sponsored episode of The Top Line, host Lauren Ledger sits down with Greg Lever, director of AI and Technology Solutions at IQVIA, to discuss why agentic AI is gaining attention across clinical operations. Lever explains how the conversation is shifting from task automation to workflow orchestration, with AI systems designed to coordinate activities, connect...

Revolution Medicines recently made history with the approval of its RAS inhibitor Rasonque for advanced pancreatic cancer. But behind RevMed is an entire field of biotechs working to broaden the reach of RAS-targeting drugs.

In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia sits down with Verastem Oncology CEO Dan Paterson and Chief Scientific Officer Jonathan Pachter, Ph.D., to discuss the significance of Revolution Medicines’ recent pancreatic cancer approval, Verastem’s work in the RAS-targeting space and how the company is trying to improve on existing approaches.

To learn more about t...

The 2026 Fierce 50 includes people and organizations working on very different problems across biopharma and healthcare, from designing new proteins and developing cancer medicines to protecting vaccine science, improving health literacy and expanding representation in medicine.

In this episode of “The Top Line,” Fierce Editor-in-Chief Ayla Ellison looks at the stories behind several of this year’s honorees, including Revolution Medicines’ work targeting RAS, the protein-design research of David Baker, Ph.D., and Michael Osterholm, Ph.D.’s, decision to put plans to step back from public health on hold. The episode also explores the work of Lisa Fitzpatric...

The promise of precision medicine depends on more than scientific innovation. It also depends on whether eligible patients can be identified, tested and connected to the most appropriate treatment. In this episode of The Top Line, host Kelly Hogan is joined by Susanne Munksted, chief growth officer at Diaceutics, and Jordan Clark, chief customer officer, to discuss why many diagnostic-driven therapies still fail to reach their full potential.

Drawing on findings from Diaceutics' practice gap studies, the conversation explores where patients are being lost across the diagnostic pathway and why improvements in testing have not always translated...

As Fierce Pharma Week approaches, the Fierce Pharma Marketing team is taking stock of some of the biggest trends reshaping how drugmakers and healthcare agencies reach audiences.

In this week’s episode of “The Top Line,” Fierce’s Ben Adams and Zoey Becker discuss how pharma marketing is evolving across social media, creative work and agency strategy. They dig into the changing approach to HIV marketing, pharma’s experiments with platforms including Snapchat, and what a collaboration with MrBeast says about the industry’s efforts to reach new audiences.

They also examine how healthcare agencies are putting...

Earnings calls are a chance to catch up with the latest developments across Big Pharma and beyond, and last quarter was no different. From the rollout of AI to the oral GLP-1 battle between Novo Nordisk and Eli Lilly and new leadership at Sarepta and Sanofi, it feels like the opportunities and challenges for biopharma have never been greater.

In this week’s episode of "The Top Line," Fierce Pharma Senior Editor Fraiser Kansteiner and Fierce Biotech Senior Editor James Waldron share their takeaways from another whirlwind season of earnings calls. Alongside a Q2 scorecard breakdown, the Fi...

Consumerization is changing how patients engage with healthcare, and pharma companies may need to rethink how they approach awareness, diagnosis and commercialization.

In this sponsored episode of The Top Line, host Irena Luo is joined by Rachel Stoll, Managing Partner, Growth & Innovation at Princeton10, and Kevin Nalty, Vice President of Strategy at Princeton10, to discuss how evolving patient behaviors are reshaping the healthcare journey. Together, they explore the impact of GLP-1s, telemedicine, AI, wellness technologies and other low-friction healthcare experiences that are raising expectations for convenience and accessibility.

The conversation examines emerging gaps between...

Having spent 14 years building out its capacity, Regeneron Genetics Center—the genomic research branch of the Tarrytown, New York-based pharma—is a pro when it comes to the sort of target validation work central to the field today. Now, as RGC continues the massive expansion of its genetic database, the center’s unique ability to interpret that trove of data could give it an edge in the age of AI-powered drug development.

In this week’s episode of "The Top Line," Fierce’s Fraiser Kansteiner sits down with Andy Deubler, chief business and administrative officer at Regeneron Genetics C...

The future of patient support may depend less on how much data organizations collect and more on how effectively they connect, govern and activate it. In this sponsored episode of The Top Line, host Stephanie Butler speaks with ZS principals Asheesh Shukla and Kirti Prakash about the changing role of patient data in life sciences and what it will take to support more personalized engagement at scale.

The conversation examines several shifts reshaping the industry, including the move from reactive care to proactive intervention, the growing role of AI-powered experiences and the increasing importance of trust, consent...

Novo Nordisk’s second-quarter earnings results this week were closely watched by analysts and investors eager to see whether the rollout of oral Wegovy could neutralize concerns about the pharma’s pipeline.

Fierce spoke to Novo’s chief financial officer, Karsten Munk Knudsen, to dig into the figures, including the reasons behind the company’s decision to raise its full-year guidance and the launch of oral Wegovy across Europe.

In the candid conversation, Knudsen also reflected on Novo’s “rollercoaster” journey in obesity, his approach to pursuing long-term growth for the company and why he’s “still optimis...

The continued shift toward self-administered therapies is changing how pharmaceutical companies think about patient support. While access and affordability remain priorities, a growing share of industry attention is focused on the patient experience itself, particularly during the critical transition from prescription to successful treatment initiation.

In this episode of The Top Line, Adam Shain, Vice President and Head of Business Transformation and Growth and Government Affairs Lead at Noble, an Aptar Pharma company, examines why patient onboarding, device training, and engagement strategies are increasingly being viewed as interconnected components of a broader patient experience. Drawing from Noble's...

Is biotech taking a trip to the world of psychedelic drugs? Why is Novo Nordisk going after Eli Lilly’s Zepbound ads? And what are peptides? 

This week on "The Top Line," Fierce's Zoey Becker, Will Maddox and Kevin Dunleavy chat about some of the biggest recent stories. From a psychedelics acquisition that could spark more movement in the emerging field to an advisory committee meeting on peptides shrouded in political controversy to a lawsuit between the two major obesity drugmakers, we’ll catch you up on the latest developments shaking up the biopharma world.

To le...

This week on "The Top Line," Fierce Healthcare and Life Sciences' editor-in-chief steps behind the microphone for a solo episode highlighting several of the biggest stories in biopharma.

The episode covers GSK’s first lung cancer approval following its acquisition of Nuvalent, Axiom Biosciences’ unusual plan to list first in Hong Kong before pursuing a Nasdaq co-listing amid a resurgent biotech IPO market, and the U.S. House’s passage of legislation directing the FDA to update its animal testing rules.

The episode also includes an update from the Fierce newsroom, including the arrival of a new...

Clinical trial success depends on more than scientific rigor and operational execution. It also depends on the financial systems that support every stage of a study. In this episode of The Top Line, Zahiah “Zee Zee” Gueddar, senior director of commercial strategy for the Clinical Trial Financial Suite at IQVIA Technologies, discusses why modernizing clinical trial finance has become a strategic priority for sponsors.

As trials become more complex, fragmented systems and manual workflows are creating bottlenecks that limit visibility, delay payments and introduce unnecessary risk. Gueddar explains how these challenges affect site relationships, operational efficiency and stud...

Boston. San Francisco. Beijing? The global biotech industry has long been concentrated in a handful of cities. But which emerging hubs could become dominant forces in biotech in the decades ahead?

In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia and Will Maddox discuss a new Fierce special report identifying five cities with the potential to become major forces in the global biotech industry. Did your favorite city make the cut? Listen to find out. 

To learn more about the topics in this episode: 

Top emerging biotech hubs in 2026 <...

Medical affairs is at an inflection point. As science advances and healthcare professionals gain access to information in real time, medical teams face a mandate to deliver insight with greater speed, relevance and impact.

In this episode of The Top Line, Josh Schwartz, Vice President of Medical Affairs, North America at BeOne Medicines, and Jalpa Shah, who leads the medical and evidence practice at ZS Pharma discuss what a modern medical affairs model requires. The conversation explores how the function is becoming a more strategic business driver and why traditional measures of activity are no longer enough...

AI is reshaping how organizations compete, but more data and more tools do not automatically lead to better decisions. In this episode of The Top Line, Justin Masterson, senior vice president of human sciences at The Directions Group, challenges leaders to look beyond AI adoption and focus on the discipline required to act on intelligence.

Masterson argues that the defining issue for many organizations is not a data problem, but a decision readiness problem. As information ecosystems become more complex, the ability to translate insight into timely, confident action is emerging as a critical business differentiator.

This week on "The Top Line," we’re covering some of the biggest stories across biopharma before turning to one of the industry’s major scientific meetings of the summer.

First, we discuss Vertex’s $10 billion acquisition of Crinetics Pharmaceuticals, the company’s largest deal to date, and what it says about Vertex’s push beyond its historic strength in cystic fibrosis. We also cover growing scrutiny from U.S. lawmakers over the industry’s use of clinical trials in China.

Then, Fierce Pharma Senior Editor Fraiser Kansteiner recounts his recent trip to New Orleans for the Amer...

Big Pharma dealmaking has picked up, but the biotech path to a signed agreement is still anything but simple.

In this episode, recorded at Fierce Biotech Week, Senior Editor James Waldron leads a discussion on the evolving BD&L landscape across pharma and biotech.

He is joined by Kaleem Chowdhury, Ph.D., CEO of Haiku Biosciences; Liz Leveille, who leads the Boston Innovation Hub and discovery transactions at Merck; and Abbas Kazemi, CEO of Nimbus Therapeutics.

The panel digs into the realities behind the headlines, from investor scrutiny and platform company pressure to...

In this sponsored episode of The Top Line, host Stephanie Butler is joined by Sheila Plant, vice president of regulatory affairs at Allucent, to examine how FDA Breakthrough Therapy and RMAT designations can support more strategic oncology development. 

Although both pathways are intended to speed development, they are not interchangeable. Plant outlines the key distinctions, noting that Breakthrough Therapy requires evidence of substantial improvement over existing treatments, while RMAT is available for regenerative medicine therapies and centers on preliminary clinical evidence indicating the potential to address unmet medical needs. 

The conversation also explores the strategic choices that de...

In this episode of “The Top Line,” recorded on site at Fierce Biotech Week in Boston, Fierce’s Ayla Ellison sits down with Christelle Huguet, Ph.D., executive vice president and head of R&D at Ipsen, to discuss how the company is building its pipeline through external innovation while maintaining internal scientific accountability.

Huguet explains Ipsen’s approach to partnering, describing the company as an “accelerator” that helps move promising science from academic labs and biotech partners toward patients. She also discusses how Ipsen evaluates which programs move forward, why transparency with partners is essential from the start an...

In this sponsored episode of The Top Line, experts from Myriad Genetics join host Stephanie Butler to examine how tumor-informed molecular residual disease, or MRD, testing is beginning to redefine what early insight can mean in oncology drug development. As biomarker-driven therapies become more precise, the ability to understand response earlier and more clearly is increasingly being viewed as foundational to smarter development strategy.

The discussion looks at how ultrasensitive, tumor-informed MRD assays can help track response over time, potentially surface deeper signals earlier and inform decisions that shape trial design, patient selection and regulatory direction. It...

Each year, the global oncology community flocks to Chicago to convene at the American Society of Clinical Oncology’s annual meeting for a weekend of buzzy data drops, practice-changing posters and insightful sessions.  

In this week’s episode of "The Top Line," Fierce Biotech and Fierce Pharma’s Darren Incorvaia, Zoey Becker and Angus Liu break down the biggest takeaways from their weekend of reporting live from the Windy City. From “nutty” in vivo CAR-T data to a historic first for a Chinese biotech asset, ASCO 2026 reflected new and continuing trends within the evolving state of cancer care today. ...

High‑risk MDS and AML continue to challenge clinicians, with limited durable responses and few options for older or treatment‑refractory patients. In this sponsored episode of The Top Line, host Stephanie Butler is joined by Dr. Amer Zeidan, Professor of Internal Medicine at Yale School of Medicine, to unpack new ASCO 2026 data that are drawing attention across the myeloid malignancies field.

The discussion focuses on mesutoclax, a novel oral BCL‑2 inhibitor evaluated in combination with azacitidine. Dr. Zeidan breaks down early findings showing a 100% objective response rate with CR rate of 40% per IWG 2006 criteria and 90% composite comple...

Boston remains biotech's most influential hub, but the questions facing the region are increasingly global.

Recorded live at Fierce Biotech Week in Boston, this panel discussion brings together Uli Stilz, senior advisor at Flagship Pioneering; Bruce Beutel, CEO and co-founder of PassKey; and Ben Bradford, head of external affairs at MassBio, for a conversation about the future of biotech innovation. Moderated by Senior Writer Darren Incorvaia, the discussion explores everything from funding pressures and talent trends to AI, clinical development and growing competition from biotech ecosystems around the world.

Along the way, the panelists debate...

Direct-to-patient models are no longer an experiment - they're becoming a critical part of the modern prescription journey. In this sponsored episode of The Top Line, host Kelly Hogan talks with Jeremy Richardson, chief commercial officer at GiftHealth, about how DTP is redefining access, transparency and speed in pharma commercialization.

Richardson shares insights from more than a decade in specialty pharmacy and explains where the traditional model breaks down for patients and providers. He addresses common misconceptions about DTP, including the belief that it only works for cash-pay or consumer-driven drugs, and outlines how a single, seamless...

Recorded last week at Fierce Biotech Week in Boston, this episode of “The Top Line” features a conversation with Kristen Fortney, Ph.D., co-founder and CEO of BioAge Labs.

In a conversation with Ayla Ellison, editor-in-chief of Fierce Healthcare and Life Sciences, Fortney discusses the company’s decade-long effort to use human aging data to identify drug targets tied to longevity and age-related disease. She also breaks down BioAge’s oral NLRP3 inhibitor, BGE-102, which the company believes could have applications across cardiovascular, ocular and CNS diseases by targeting inflammation linked to aging biology.

The conversa...

Emerging pharma organizations face unique technology challenges as they prepare for launch. Expectations for AI-enabled decision-making continue to rise, even as teams remain small and operate in highly regulated environments. In this sponsored episode of The Top Line, Fierce Biotech host Kelly Hogan speaks with JR Raelin, executive director of analytics and insight at SynOx Therapeutics and Krishna GS, business technology solutions manager at ZS, about how first-launch and emerging companies can design an agentic future-ready technology road map.

The conversation examines common pitfalls, including chasing new technology and AI trends before establishing data readiness, underinvesting in...

Despite a prolonged period of policy uncertainty in the U.S.—and the ripple effects across the global life sciences and healthcare industries—executives at health companies are still seeing opportunities amid the tumult. In many cases, they’re finding that the resilient business models they built through disruptions like the pandemic have positioned their companies not just to survive, but to thrive in a new normal for the industry.

In this episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner chats with Glenn Hunzinger, PwC’s U.S. health industries leader, about results from the firm’s recent...

After months of mixed messaging from the White House, the pharmaceutical industry has gained more clarity on the second Trump administration’s import tariff policy for drugs. While many of the industry’s biggest firms have navigated the trade threat through investment pledges and drug pricing deals, the current landscape remains murkier for small- and mid-sized drugmakers.

In this episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner sits down with Chris Young, a principal in KPMG’s trade and customs practice, to discuss the pharma tariff landscape following President Donald Trump’s announcement in early April of a pot...

In this sponsored episode of The Top Line, host Kelly Hogan speaks with Dr. Bettine Boltres, director of scientific affairs, integrated systems at West Pharmaceutical Services, about the development of the West Synchrony prefillable syringe system. As drug pipelines grow and regulatory expectations increase, pharma and biotech companies face mounting pressure to reduce complexity while accelerating development timelines. 

Dr. Boltres explains how West Synchrony addresses these challenges by offering a fully integrated system rather than a collection of individual components. By providing complete design verification data, system level specifications and a single global regulatory package, West enables dev...

Theranostics is transforming cancer care, but scaling these treatments requires overcoming operational and workforce challenges. In this episode of The Top Line, Curium’s Mike Patterson discusses how access, safety and trust are shaping the next phase of growth for targeted radiopharmaceutical therapies.

Patterson explains why strong coordination across ordering, manufacturing and distribution is essential to delivering therapies on time. He also explores how building trust with physicians, care teams and patients requires education, consistent communication and reliable support at every stage of the treatment process.

As theranostics expands into community sett...

It’s a pivotal year for RNA therapeutics pioneer Ionis Pharmaceuticals. 

After transitioning from a partnering model to a full-ownership strategy following the 2024 approval of Tryngolza, the company is expecting an FDA decision to expand the drug into severe hypertriglyceridemia as its first non-rare-disease indication for a wholly owned product. Meanwhile, potentially game-changing phase 3 readouts are expected from Ionis’ Novartis-partnered lipoprotein(a) candidate and AstraZeneca-partnered ATTR cardiomyopathy program.

In this week’s episode of "The Top Line," Fierce’s Angus Liu interviews Ionis CEO Brett Monia, Ph.D. He discusses the science of antisense oligonucleotides, the signi...

Speed, precision, and visibility are critical to clinical trial success, and logistics plays a central role in delivering all three. In this interview, Manishaa O’Brien, director of commercial operations at Marken UPS Healthcare Precision Logistics, shares how the Laboratory Advantage service line is helping central labs and sponsors accelerate timelines while maintaining sample integrity and compliance.

O’Brien discusses how Marken’s global network, combined with its air and ground fleet, connects clinical sites worldwide and expands access to diverse patient populations. She explains how enhanced tracking, integrated data systems and a 99.5% on-time performance rate support reliab...

President Donald Trump has struck a deal with the UK that exempts prescription drugs imported to the United States from tariffs for three years. In exchange, Britain’s National Health Service will pay 25% more for new drugs. The question now is: Can the U.S. negotiate similar deals with other countries?

In this week’s episode of "The Top Line," we examine the drug pricing agreement between the UK and the U.S. Fierce Pharma’s Kevin Dunleavy explores the issue with Jeffrey Gerrish, who served as deputy U.S. trade representative for Asia, Europe and the Middle...

Biomarkers are playing an increasingly critical role in shaping the future of oncology trials—and the pace of innovation is accelerating. In this sponsored episode of The Top Line, host Stephanie Butler sits down with Dr. Danielly Vicente, Associate Medical Director of Oncology and Hematology at Allucent, to explore how advanced biomarker strategies are transforming clinical development.

From improving patient selection in early-phase trials to enabling adaptive study designs, biomarkers are helping researchers identify the right patients, optimize outcomes, and reduce development risks. Dr. Vicente discusses how approaches like comprehensive genomic profiling, basket and umbrella trials, and re...

Spray-dried dispersions are widely used, but they do not always deliver expected results. In this sponsored episode of The Top Line, host Stephanie Butler speaks with AustinPx Chief Scientific Officer Dr. Dave Miller about how drug developers can recover from suboptimal formulations and manufacturing challenges.

Miller outlines common issues, including poor bioperformance, inefficient scale-up, intellectual property limitations and high pill burden. He explains how next-generation amorphous solid dispersion technologies, such as KinetiSol, expand formulation design space, remove solvent constraints and support more efficient, scalable manufacturing.

The conversation also covers how to introduce improved formulations into...

Artificial intelligence is increasingly shaping how pharma companies approach content strategy and decision-making. In this episode of The Top Line, Kristen Pilkiewicz, EVP and executive creative director at Sound Healthcare Communications, examines how AI is being applied in real-world marketing workflows.

Rather than positioning AI as a standalone solution, Sound has integrated it into core processes to support faster content development, more rigorous strategy testing and improved alignment with regulatory expectations. Pilkiewicz outlines how the company is building tools tailored to pharma and training teams to use AI as a partner in decision-making.

The discussion...