The Top Line

Hosted by Fierce Life Sciences

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Episodes

100

Latest episode

Nov 2026

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EN-US

About the show

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning.

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60 recent

November 16, 202620 min

Digital Twins: Advancing Clinical Evidence Strategy (Sponsored)

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. See omnystudio.com/listener for privacy information.

November 9, 202615 min

Use Kidney Genetics to Strengthen Clinical Trial Design (Sponsored)

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. See omnystudio.com/listener for privacy information.

November 6, 202617 min

When China Fits a Global Clinical Development Strategy (Sponsored)

China can play several roles in a global clinical development program, from supporting a capital-efficient proof-of-concept study to contributing evidence within a multiregional clinical trial. In this sponsored episode of The Top Line, Caidya Chief Operating Officer Mike Clay and Vice President of Business Development Jinye Shen join Fierce Life Sciences’ Will Herth to discuss how sponsors can decide when and how to include China. The conversation examines China-only, multiregional and sequenced development approaches, and how the intended use of China-generated evidence should shape the strategy. They also explain why a large patient population does not automatically equal recruitable patients, highlighting the importance of site-level feasibility, investigator networks, local treatment practices, competing trials and referral pathways. Additionally, they discuss the risks of considering China too late, including protocol redesign, duplicated work, delayed trial starts and reduced regulatory flexibility. This conversation assesses practical perspectives on regulatory planning, bridging-study questions, operational execution, governance, data quality and the balance between local expertise and global accountability. See omnystudio.com/listener for privacy information.

November 6, 202616 min

There's more than one way to build a biotech

As biotech companies continue to navigate a challenging funding environment, Axiom Biosciences is taking an unconventional approach to raising capital and developing new therapies. The company is pursuing a public listing in Hong Kong, with ambitions to eventually list on the Nasdaq. Meanwhile, it's developing several drug delivery platforms, including a stem cell therapy approach that doesn't rely on genetic modification. In this episode of "The Top Line," Fierce Biotech's Marissa Russo speaks with Axiom founder and CEO Remo Moomiaie-Qajar about the company's financing strategy, its approach to drug development and what's next for its clinical pipeline. To learn more about the topics in this episode: ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong Why Axiom hopes it’s ‘solved 2 major potholes’ that have hurt other stem cell biotechs See omnystudio.com/listener for privacy information.

October 30, 202628 min

When drug development gets personal

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. See omnystudio.com/listener for privacy information.

October 28, 202616 min

How AI turns field conversations into actionable insights (Sponsored)

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. See omnystudio.com/listener for privacy information.

October 23, 202615 min

GSK's double FDA win, Roche's $15B deal and the rise of point-of-care marketing

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 See omnystudio.com/listener for privacy information.

October 16, 202625 min

Inside Teva's Weltruza launch and Novo's GLP-1 strategy

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' See omnystudio.com/listener for privacy information.

October 15, 202632 min

The Next Chapter for AI in Clinical Trials [Sponsored]

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 AgentOS, 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. See omnystudio.com/listener for privacy information.

October 12, 202622 min

How AI could improve clinical trial decision-making (Sponsored)

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. See omnystudio.com/listener for privacy information.