The Top Line

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 information and help reduce operational bottlenecks. The episode explores where sponsors can find the greatest opportunities for improvement, what it takes to move from pilots to enterprise-scale adoption, and how clinical roles may evolve as routine work becomes increasingly automated. The discussion also addresses the importance of data connectivity, governance and organizational readiness in building trusted AI programs. Listen now for a forward-looking conversation about how people, processes and intelligent systems could redefine the future of clinical trial execution. See omnystudio.com/listener for privacy information.

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 the topics in this episode: FDA greenlights Revolution Medicines' pancreatic cancer gamechanger As RevMed preps for ‘historic’ pancreatic cancer launch, questions linger on the ground ASCO: Revolution Medicines confident in RAS leadership as rivals square up AACR: Revolution sees pancreatic cancer win as 'tip of the iceberg' as RAS wave rises Fierce 50 of 2026: Breakthrough honoree Verastem Oncology Fierce 50 of 2026: Breakthrough honoree Revolution Medicines See omnystudio.com/listener for privacy information.

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 Fitzpatrick, M.D., Hip Hop Public Health, Eric Topol, M.D., and Mary Owen, M.D., and the problems they have chosen to keep working on. See omnystudio.com/listener for privacy information.

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 into better treatment decisions. The guests discuss increasing healthcare complexity, expanding biomarker requirements and the challenges clinicians face when making treatment decisions under time pressure. See omnystudio.com/listener for privacy information.

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 AI to work, pharma’s return to the winner’s circle at Cannes and why Novo Nordisk built a maze along the River Thames in London this summer. The conversation comes as Fierce Pharma Week approaches Sept. 14-17 in Philadelphia. To learn more about the topics in this episode: YouTuber MrBeast welcomes Amgen to the channel, kicking off pediatric cancer funding effort Inside agency view: Real Chemistry’s Frank Mazzola on audience nuance and rewarding creativity Snapchat creates ad format to support pharma disclosure needs Novo Nordisk asks public to ‘Meet Me in the Middle’ in new obesity experience installation Women’s ‘new health ecosystem’ takes shape on Reddit: report See omnystudio.com/listener for privacy information.

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 Fierce editors discuss how several new CEOs are finding their footing, which drugs appear poised to cross the $1 billion sales threshold in 2026 and more. To learn more about the topics in this episode: Biopharma saw a Q2 sales boom led by Lilly, Sanofi, Regeneron and Astellas Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues Novo CEO has 'no doubt' on eventual share price recovery as Wegovy pill continues to wow Sarepta’s new CEO Michael Severino faces critical milestones to prove growth See omnystudio.com/listener for privacy information.

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 health awareness and clinical diagnosis, the role of wellness tools and health data, and why some patients delay or avoid care altogether. The guests also discuss opportunities for pharma brands to rethink disease awareness, improve navigation to diagnosis and treatment, and borrow engagement strategies from successful consumer platforms that encourage long-term behavior change. Listen to hear practical insights on how brand teams can adapt their commercial strategies, identify hidden friction points and better meet the needs of today's healthcare consumer. See omnystudio.com/listener for privacy information.

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 Center, to discuss the role RGC plays in the larger Regeneron model, as well as where the center could be headed as drug development pushes into new technological frontiers. Aside from the data interpretation advantage RGC believes it holds in the AI era, Deubler also discusses how the unit’s ongoing genetic research has helped deliver recent breakthroughs like the hearing loss gene therapy Otarmeni. To learn more about the topics in this episode: Regeneron ushers in new genetic medicine era with groundbreaking gene therapy approval J. Craig Venter launches genomics startup designed to boost diagnostic insights Genomics inks partnership deal with Greywolf to assess gene datasets How a new tool for large-scale gene editing could power novel genetic medicines In global life sciences, insight isn’t the problem—execution is. Disconnected dashboards, siloed teams and fragmented workflows make it harder to act—consistently, compliantly and at scale. ZAIDYN by ZS closes that gap. ZAIDYN is the Life Sciences Intelligence Platform that embeds intelligence in the flow of work, based on domain expertise and agentic AI across commercial, medical, patient and content work. Trusted by more than 150 life sciences organizations across over 100 countries, ZAIDYN is built for global scale, regulatory compliance and trusted AI—so teams act together across brands, markets and channels. ZAIDYN. Move beyond reporting to intelligent action. Learn more at ZAIDYN.ai See omnystudio.com/listener for privacy information.

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 and compliance in patient engagement. As organizations invest in new technologies, the speakers contend that success will depend on creating connected data foundations that can deliver timely, actionable insights across the patient journey. Listeners will hear practical guidance on structuring data for actionability, building AI-ready capabilities and designing governance models that support both innovation and accountability. The discussion closes with a look at where patient services may be headed next and why organizations that prepare now will be better positioned to improve patient experiences and outcomes in the years ahead. See omnystudio.com/listener for privacy information.

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 optimistic” about CagriSema despite recent setbacks. To learn more about the topics in this episode: Novo CEO accepts ‘couple of setbacks’ in R&D as CagriSema posts more mixed data Novo CEO has 'no doubt' on eventual share price recovery as Wegovy pill continues to wow ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO See omnystudio.com/listener for privacy information.

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 work in self-administration support, Shain discusses the importance of incorporating patient insights into program design, the evolving complexity of at-home treatment models, and the industry's growing focus on adherence and long-term treatment success. See omnystudio.com/listener for privacy information.

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 learn more about the topics in this episode: ‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics UPDATE: Peptides favored on 1st day of closely watched FDA compounding adcomm Peptide adcomm Day 2: Emideltide voted down in panel's 1st pushback Novo Nordisk files lawsuit accusing rival Eli Lilly of running ‘false and misleading’ GLP-1 ads Novo escalates Lilly false advertising suit with planned bid to halt comparative ads See omnystudio.com/listener for privacy information.

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 Fierce Biotech staff writer, and a reflection on why human judgment, curiosity and original reporting matter more than ever. To learn more about the topics in this episode: GSK secures first lung cancer approval as FDA clears Jideytro in quick payoff from Nuvalent deal ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong House passes bill directing FDA to update animal testing rules See omnystudio.com/listener for privacy information.

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 study performance, and why organizations can no longer afford to treat finance as a disconnected administrative process. The conversation also highlights key indicators of readiness for transformation, from cross-functional alignment to executive sponsorship, and outlines the common pain points study teams face today. Ultimately, success depends on moving toward a connected, transparent and predictable financial model that reduces friction, improves collaboration and supports faster, more reliable clinical trials. See omnystudio.com/listener for privacy information.

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 As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’ British biotech VC funding shows ‘signs of recovery,’ but IPO rebound yet to materialize Could Basel be the next Boston? How the Swiss biotech hub is quietly raising its game This week's episode is sponsored by IQVIA Biotech. Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com See omnystudio.com/listener for privacy information.

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 to demonstrate value. The episode examines the structural challenges that continue to hold organizations back, including fragmented data systems, limited visibility into insights and the difficulty of translating engagement into measurable outcomes. It also looks at how artificial intelligence (AI) is reshaping workflows by helping teams generate insights faster, identify trends and inform next best actions. The discussion also considers the capabilities, operating models and cultural shifts medical affairs teams will need to keep pace with science and influence clinical practice. The central takeaway is clear: Future success will depend less on access to more data and more on the ability to turn intelligence into coordinated action. See omnystudio.com/listener for privacy information.

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. With more than 20 years of experience in healthcare and human sciences, Masterson shares perspective on how companies can align teams, processes and strategies to unlock AI’s value without becoming overwhelmed by the volume of available information. For leaders navigating new technologies, competing priorities and higher expectations for speed, this conversation offers a practical reframing of where AI value is created. Learn why decision readiness may be the next true advantage. See omnystudio.com/listener for privacy information.

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 American Diabetes Association’s 2026 Scientific Sessions with Fierce Pharma Marketing’s Zoey Becker. For years, ADA has focused heavily on its eponymous indication, but this year’s meeting made clear how much the conversation is evolving, with obesity data from drugmakers of all stripes taking up more of the spotlight. Topics include the biggest data sets from the meeting, what it was like to sit down with Novo Nordisk’s new CEO for the first time and the latest from Insulet’s Marvel collaboration on a line of comics about an Omnipod-wearing superheroine. To learn more about the topics in this episode: Vertex, in its largest-ever deal, acquires endocrine disease specialist Crinetics for $10B As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’ ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO ADA: Lilly pulls back curtain on impressive triple-G efficacy in patients with obesity, diabetes ADA: Amgen highlights Repatha perks, GLP-1 pitfalls in push to boost cardiometabolic pedigree With ADA in the books, analyst says Lilly is ‘widening its lead’ in the obesity race ADA: Novo's Wegovy pill reaches new GLP-1 patients with impressive 3M prescription milestone ADA: Tolerability ‘not to be underappreciated’ in Roche, Zealand’s amylin obesity prospect ADA: Boehringer execs claim survodutide tolerability 'consistent' with class despite phase 3 update ADA: Lilly posts oral semaglutide-topping data as Foundayo speeds toward 2nd potential nod in diabetes This week's episode is sponsored by IQVIA Biotech. Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com See omnystudio.com/listener for privacy information.

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 China’s growing role in licensing and the long relationship-building that often happens before a deal gets done. To learn more about the topics in this episode: March M&A surge triggers high expectations for 2026 'Biopharma ecosystem is back to full health,' fueled by M&A: PwC Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep up After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst Was Big Pharma’s ‘unusually aggressive’ M&A spree to blame for March IPO drought? This week's episode is sponsored by IQVIA Biotech. Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com See omnystudio.com/listener for privacy information.

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 determine whether sponsors are ready to pursue these designations, from building a credible data package to designing trials with clinically meaningful endpoints and keeping manufacturing readiness aligned with development timelines. Once a designation is granted, closer collaboration with the FDA can help sponsors navigate development with more dynamic feedback. But as Plant emphasizes, these pathways deliver the greatest value when they are part of a disciplined regulatory strategy. Listen now to learn how sponsors can approach expedited pathways with greater clarity and position oncology programs for meaningful acceleration. See omnystudio.com/listener for privacy information.