The Top Line

Fraiser Kansteiner, Fierce Pharma reporter who covered Lilly’s retatrutide data, and Kevin Dunleavy, Fierce Pharma industry reporter, discuss Lilly’s recent HSBC downgrade and market fallout. They dive into retatrutide’s diabetes and weight-loss data, tolerability questions, competitive risks from Novo and generics, and what the regulatory and commercial timeline might mean for GLP-1 positioning.

Olive McCormick, Director of Quality and Qualified Person at Almac Clinical Services with deep IMP and regulatory experience. She discusses the new UK Clinical Trial Regulation and what it means for trials. Short takes cover transitional rules, labeling and imported inventory timing. Practical de-risking steps and how to engage sponsors, CROs and sites are highlighted.

Since Xaira’s eye-popping $1 billion fundraise in 2024, the company has said relatively little in public. That’s made it one of biotech’s more closely watched black boxes: a company with enormous backing, enormous ambition and, until recently, few clues about what it has actually been building. In this week’s episode of “The Top Line,” Fierce Biotech’s Gabrielle Masson speaks with Xaira Chief Operating Officer Jeff Jonker about what the AI company is uncovering. Jonker discusses Xaira’s strategy as a next-generation biotech, the modalities and disease areas it is exploring, what he expects the industry to look like over the next five years and why Xaira is going after the “high-hanging fruit.” To learn more about the topics in this episode:  Xaira exec divulges R&D focus, how $1B fundraise fuels AI-driven hunt for what the 'industry is hungriest for' New AI drug discovery powerhouse Xaira rises with $1B in funding Biotech's top money raisers of 2024 See omnystudio.com/listener for privacy information.

Kevin Dunleavy, a pharma journalist and analyst at Fierce Pharma, breaks down Q4 2025 results and what they signal for 2026. He highlights widespread conservative guidance, looming patent cliffs and losses of exclusivity, surprising sales declines like Novo Nordisk's, and the intensifying GLP-1 rivalry between Eli Lilly and Novo Nordisk.

Ryley Poblete, Gensler’s global sciences practice leader who advises on lab and workplace design, discusses how AI, automation and new data-driven workflows are forcing a rethink of research spaces. He outlines the Next Next lab concept, balancing deep focus for computational teams with collaborative zones. Topics include automation’s impact on experimentation, digital pathology, infrastructure needs and future-proofing labs.

Sue Bodine, a professor at Oklahoma Medical Research Foundation and president-elect of the American Physiological Society, discusses how physiology links genes to whole-body function. She talks about its role in drug discovery, making wearable data meaningful, and why AI needs biological context. She also highlights efforts to raise physiology’s profile amid funding risks.

Harpreet Singh, Chief Medical Officer at Precision for Medicine and former FDA oncology division director, discusses CAR-T moving into autoimmune diseases. He unpacks the FDA’s cautious, case-by-case regulatory stance. Topics include long-term safety and follow-up, evolving clinical endpoints, reproductive and pediatric concerns, and which autoimmune settings may be best suited for CAR-T.

Denis Johnson, CEO of Grand River Aseptic Manufacturing with 25+ years in GMP sterile fill operations. He talks about a U.S. sterile manufacturing capacity crunch and why companies are reshoring. He covers the industry shift to isolator technology driven by Annex 1 and why segmentation and specialization matter. He also outlines GRAM’s investments in new facilities, high-volume syringe and cartridge capabilities.

Brady McKinney, a pharmaceuticals risk underwriter covering the Americas at Atradius, explains recent shifts in pharma manufacturing after tariff threats. He outlines the 2025 production surge, regional differences, why 2026 should normalize, and how reshoring, contract manufacturing and tariff flare-ups shape future investment and supply-chain strategies.

Biopharmaceutical innovation is advancing at an unprecedented pace, yet many patients still face barriers to accessing new medicines. In this episode of Health Matters, John O’Brien, president and CEO of the National Pharmaceutical Council, speaks with Kristin Cahill about why policy, pricing and benefit design are increasingly shaping whether innovation reaches patients. O’Brien shares insights from his career spanning pharmaceutical companies, health plans and government, including his time as a senior drug pricing advisor during the first Trump administration. He explains why prescription drugs remain a focal point in cost debates, what policymakers often misunderstand about value, and how middlemen and misaligned incentives affect what patients pay at the pharmacy counter. The conversation also examines emerging approaches such as direct-to-patient models, most-favored-nation pricing and the early effects of the Inflation Reduction Act, highlighting potential benefits as well as risks to access and future innovation. For healthcare professionals, payers and marketers seeking clarity in a complex policy environment, this episode offers a grounded perspective on how to ensure medical breakthroughs translate into meaningful patient benefit. Listen to the full interview.See omnystudio.com/listener for privacy information.