The Top Line

Patient digital twins give life sciences teams a framework for evaluating how an individual patient’s health trajectory could change under different treatments or scenarios. In this sponsored episode of The Top Line, host Kelly Hogan speaks with Nadea Leavitt, a clinical statistician and AI researcher at IQVIA, about the role of digital twins in clinical development and evidence generation.

Leavitt explains the patient-specific connection that defines a digital twin, how the approach differs from external control arms, and how modeled predictions can complement observed comparator data. She reviews the spectrum of supporting analytics, from mechanistic and data-driven models to hybrid approaches that combine AI with biological knowledge and clinical constraints. The discussion also examines how IQVIA Life Science Models apply longitudinal real-world data, biomedical and clinical trial knowledge graphs, and multimodal patient information to simulate potential trajectories. Listen to the full podcast to learn more about the validation, transparency, scientific rigor and clinical plausibility required to build trust in model-generated evidence.

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For nearly three decades, Jigar Raythatha has helped build biotech companies and bring new medicines to patients. But in 2023, the Third Rock Ventures partner found himself on the other side of drug development when he was diagnosed with a rare form of brain cancer.

In a remarkable coincidence, the same day Raythatha underwent the MRI that would lead to his diagnosis, Servier announced positive phase 3 results for a drug targeting his type of cancer. The treatment, now approved as Voranigo, was originally developed by Agios Pharmaceuticals, one of the first companies backed by Third Rock. Today, Raythatha takes that very drug.

In this episode of "The Top Line," Will Maddox speaks with Raythatha about his diagnosis, how his experience as a patient has changed his perspective on drug development and the advantages his industry knowledge and connections gave him in navigating treatment.

They also discuss the importance of early-stage biotech investment, the risks involved in developing new medicines and why Raythatha believes taking chances on promising science remains essential.

To learn more about the topics in this episode:

• Servier snags FDA approval for Voranigo, the first targeted therapy for a common type of brain tumor
• Nuvation cancels plans to test brain cancer drug directly against Voranigo on FDA's advice
• Servier to widen rare cancer offerings with $2.5B buyout of Day One and glioma drug Ojemda
• FDA greenlights Revolution Medicines' pancreatic cancer gamechanger

Thank you, IQVIA Digital, for sponsoring today's episode.

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Life science field teams are a major source of customer insight, but growing complexity, limited HCP access and expanding omnichannel demands can make it difficult to turn every interaction into action. In this sponsored episode of The Top Line, host Kelly Hogan speaks with Nick Syndercombe, STEM AI lead program director at Inizio Ignite, about how AI can help connect real-world field conversations to coaching, strategic insights and stronger execution.

Syndercombe explains how STEM AI was developed to let field teams record customer conversations for analysis by an LLM AI, producing rapid, individualized coaching feedback. For managers and leadership teams, the solution provides aggregated real-time KPI and trend analysis, along with customer sentiment on messages delivered in the field and the impact of strategy. He also discusses the importance of field-team adoption, change management, data security and moving beyond simply reporting what is happening to understanding why.

Their conversation explores how STEM AI aims to turn HCP interactions into personalized coaching, actionable insights and strategic reporting for continuous improvement and long-term commercial impact.

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Broad chronic kidney disease labels can obscure distinct biology, complicating patient selection, progression assumptions and treatment-signal interpretation. In this sponsored episode of The Top Line, Will Hurth speaks with Dr. Ronen Schneider, medical director of renal genetics at Natera, about the business and development implications of moving toward genotype-defined kidney disease.

Schneider explains how RenasightIQ connects genetic test results with clinical intake data, longitudinal laboratory measures and claims data from more than 300,000 patients. He discusses findings across FSGS and genetically defined glomerular disease, including differences in progression to end-stage kidney disease.

The conversation translates those insights into considerations for drug-development teams: natural-history modeling, endpoint selection, prognostic enrichment, background therapy and patient recruitment. Schneider also outlines questions teams can apply to completed studies, ongoing trials and screening populations to evaluate genetic causes, placebo-arm progression and potential variation in treatment effect. Listen to the podcast to learn how real-world genetic data can help expose hidden heterogeneity and strengthen clinical development strategy.

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In this week's episode of "The Top Line," we're covering a pair of FDA approvals for GSK, an antibody-drug conjugate pact worth up to $15 billion and the growing role of point-of-care advertising in pharmaceutical marketing.

First, we look at GSK's big week, which included FDA approval for Jemperli in certain patients with rectal cancer, offering the possibility of avoiding chemotherapy, radiation and surgery. The company also secured a landmark approval for Hibsago, a chronic hepatitis B treatment that could deliver a functional cure for some patients. We also discuss Roche's expanded partnership with China's Hansoh Pharmaceutical, an antibody-drug conjugate deal featuring up to $15 billion in potential milestone payments.

Then, Fierce Pharma's Zoey Becker sits down with Nicole Divinagracia, president of the Point of Care Marketing Association, to discuss the rapid growth of point-of-care advertising. Divinagracia explains what's driving that momentum, how the channel is evolving and why marketers should incorporate point of care earlier in their planning. They also explore efforts to establish more consistent measurement standards and best practices for reaching patients and healthcare professionals at critical moments in the care journey.

To learn more about the topics in this episode:

• GSK’s Jemperli scores FDA approval in rectal cancer, backed by high complete response rate
• GSK brings promise of 'functional cure' to hepatitis B finish line with FDA nod for Hibsago
• Roche returns to China’s ADC powerhouse Hansoh for $15B biobucks pact
• Point-of-care pharma marketing spending passes $1B milestone

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In this week's episode of "The Top Line," we're looking at two companies building on recent successes and pursuing new opportunities in the pharmaceutical industry. From Teva's growing portfolio of innovative medicines to Novo's expanding reach in the GLP-1 market, both companies are looking to build on their momentum as they prepare for the next phase of growth.

First, Fierce Pharma's Fraiser Kansteiner speaks with Christine Fox, Teva's executive vice president of U.S. commercial and head of its innovative medicines franchise, and Eric Hughes, M.D., Ph.D., executive vice president of global R&D and chief medical officer. They discuss the FDA's recent approval of Weltruza, a once-monthly injectable treatment for schizophrenia, lessons learned from the company's earlier rollout of Uzedy and how its growing portfolio of innovative medicines fits into its broader strategy. They also explain how Weltruza's formulation could help address unmet needs in schizophrenia treatment.

Then, we turn to Novo and the expanding market for GLP-1 drugs. At Fierce Pharma Week in Philadelphia, Fierce Pharma's Zoey Becker sat down with Kevin Donahoe, Novo's vice president and head of diabetes therapy area marketing and patient solutions, to discuss how the popularity of GLP-1s is creating new opportunities to reach and educate patients. Their conversation covers Novo's evolving marketing strategy, lessons from the Wegovy pill launch and the company's outlook on the future of obesity treatment as more medicines enter the market.

To learn more about the topics in this episode:

• Teva debuts Weltruza in schizophrenia as much-hyped FDA nod for long-acting olanzapine arrives
• Teva saddles up as stalking horse bidder for bankrupt BioXcel’s neuroscience portfolio
• With Austedo at helm, Teva's impressive innovative drug sales signal company's successful metamorpho…
• No more Nordisk as Novo goes it alone amid rebranding push
• The Oral GLP-1 Tracker: Prescriptions edge down for Novo, Lilly
• How drugmakers are tapping into the GLP-1 frenzy's unprecedented 'consumer overlay'

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Clinical AI is moving from systems that predict and summarize toward agents that can help execute parts of a workflow. In this sponsored episode of The Top Line, Will Hurth speaks with Saama’s Ari Srinivasan, chief customer success and growth officer, and Yatesh Midha, associate vice president of product management, about what that evolution could mean for clinical development.

The conversation places Agent OS, Saama’s orchestration and governance layer, within a broader shift from disconnected AI tools to coordinated clinical workflows. A practical example explores how an agentic data manager could support SAE reconciliation by retrieving records from EDC and safety systems, comparing fields and presenting important mismatches with supporting evidence.

The interview also considers what trusted use requires in a regulated environment: task-appropriate models, grounding, provenance, permission controls, transparency, auditability and human oversight. The central argument is not that agents replace clinical experts, but that they take on repetitive information-gathering and comparison work so experts can focus on complex cases and consequential decisions. Listen to the full interview to learn more about the role governed, connected agents could play in the next phase of AI-enabled trials.

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What if clinical development teams could evaluate potential trial outcomes before a study reaches patients? In this sponsored episode of The Top Line, host Irena Luo speaks with Raja Shankar, vice president for machine learning within AI and technology solutions at IQVIA, about a foundation model designed specifically for life sciences. Shankar explains why general-purpose models may overlook important relationships in patient and clinical trial data and how post-training on life sciences data can make AI more relevant to predictive decision-making. He explores how the model represents patients, diseases, treatments and endpoints, then applies those relationships to anticipate events across a patient journey. The conversation also examines the strategic role of study simulation, including how teams can compare scenarios, challenge assumptions and refine protocol decisions before a trial begins. Shankar addresses the evidence, transparency and expert oversight needed to build confidence in model outputs. Listen to the podcast to learn how simulation could help reduce uncertainty and improve clinical development planning.

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What does it mean to be a Fierce 15 biotech in 2026? With this year’s list unveiled, the Fierce Biotech team gets together to discuss what the winners tell us about the state of the sector.

In this week’s episode of "The Top Line," the Fierce Biotech editorial team reflects on the process of distilling more than 150 high-quality entries into the final Fierce 15 list. The team discusses how the ambitions of these companies are higher than ever and looks back on some of its conversations with the winners, covering everything from cutting-edge antibody research and novel fertility treatments to innovative ways to source radioisotopes.

To learn more about the topics in this episode:

• Introducing Fierce Biotech's 2026 Fierce 15
• Regeneron backs $75M series A for antibody upstart Infinimmune
• Sanofi-backed Expedition uses $115M series B to advance COPD drug on phase 2 journey
• Beacon lights path to FDA approval with pivotal trial win for rare vision loss gene therapy
• Fierce Biotech at London Life Sciences Week: Learn more and register
• Learn more about the Fierce Vanguard Awards Gala

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With GLP-1s paving the way, a consumer shift is happening across markets for certain branded pharmaceuticals. Now, the CEO of a buzzy pattern-hair-loss biotech is eyeing opportunities in an evolving market that could expand well beyond his own company.

In this week’s episode of "The Top Line," Fierce’s Fraiser Kansteiner chats with Reid Waldman, co-founder and CEO of hair loss-focused biotech Veradermics. With impressive data on its reformulated minoxidil candidate and an upsized IPO earlier this year, Veradermics has generated significant interest in its approach. The company now hopes to tap into an increasingly consumer-minded market for certain drugs, a shift Waldman says could carry over to a range of indications and products.

To learn more about the topics in this episode:

• A cut above: Veradermics locks in $256M IPO and shares spike
• Buzzy Veradermics shows its oral minoxidil can tackle female pattern hair loss, too
• Contraline and its male birth control candidate rally $92.5M amid push into 'massive white space' of…
• ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordi…

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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 creative approaches companies are using to reach patients and healthcare professionals.

To learn more about the topics in this episode:

• ‘People like the sincerity of it’: comedian Damon Wayans on humor, relatability and DME awareness in…
• Standout pharma marketing takes the stage at the 2026 Fierce Pharma Marketing Awards
• Panthers and zebras and meerkats, oh my: A peek behind the curtain at Fierce Pharma Week 2026
• Former 'Real Housewives' star Jenn Fessler and CineHealth’s Tracey Yaw break down authentic healthca…
• 'The growth driver of our organization'; Genentech CMO Zoë Lazarre on experimental marketing, AI and…
• Journalist and menopause advocate Tamsen Fadal shines a light on overlooked women’s health topics

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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 companies should be doing now to reduce their risk.

To learn more about the topics in this episode:

• Betting on biotech: Prediction markets set sights on clinical trials

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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.

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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

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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.

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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.

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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

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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

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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.

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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

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