Why direct-to-patient is the future of pharma access (Sponsored)

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.   To learn more about the topics in this episode:   ASCO: Revolution Medicines confident in RAS leadership as rivals square up  ASCO: Lilly exec points to ‘nutty’ 100% response rate for in vivo CAR-T as justifying Kelonia buyout  ASCO preview: With expectations jacked up, Akeso's ivonescimab to face scrutiny in high-stakes plenary  See omnystudio.com/listener for privacy information.

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 complete response with CR in 60% in treatment‑naïve high‑risk MDS, along with strong efficacy and encouraging safety signals in AML, with over 80% composite CR, and with potent activity in TP53 mutant, as well as zero death within 30 or 60 days and rapid cytopenia recovery.Listeners will hear how mesutoclax’s potency, selectivity, and pharmacokinetic profile may overcome key limitations of existing BCL‑2 inhibitors, and what these results could mean for future frontline treatment strategies.See omnystudio.com/listener for privacy information.

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 what the industry can learn from China's rapid innovation model, why investors and pharma companies have shifted toward clinically validated assets and whether biotech needs a fundamentally new operating model to accelerate drug development and bring breakthrough science to patients. To learn more about the topics in this episode:  After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep up As calls for COINS Act expansion grow, will new rules sweep up China biotech licensing? From drug development to M&A, Big Pharmas showcase AI’s ‘measurable impact’ See omnystudio.com/listener for privacy information.

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 platform can support medications across therapeutic areas and price points. With experience guiding more than 7 million patients through their prescription journeys, Richardson discusses what manufacturers truly need from a DTP partner, how technology can accelerate time to therapy and why ease and transparency are becoming nonnegotiable expectations. He also looks ahead to where the prescription journey is headed - and what pharma commercial leaders must do now to keep pace.See omnystudio.com/listener for privacy information.

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 conversation also explores why pharma companies are paying closer attention to aging and exercise biology, how GLP-1 drugs are reshaping conversations around prevention and what the future of aging-related medicine could look like. To learn more about the topics in this episode:  BioAge CEO has big plans for 'multi-disease impact' of NLRP3 drug across cardio, ocular and CNS Novartis, BioAge take on age-related diseases in $550M pact What can we learn from 2024’s biotech IPOs? See omnystudio.com/listener for privacy information.

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 integration, and relying on fragmented point solutions. Raelin and Krishna explain why strong data foundations, governance, and interoperability are prerequisites for. and how agentic AI—when built on that foundation—can close the gap between insight and action in real commercial workflows. Listeners will also hear a framework for scaling platforms over time, guidance on what effective implementation looks like in the first 60 to 90 days, and examples of connected workflows across commercial, medical, and patient functions. The episode closes with a compelling case for why the agentic roadmap is the most important strategic asset a first-launch company builds before its second product—and how getting it right converts a single launch into a portfolio intelligence engine.See omnystudio.com/listener for privacy information.

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 survey on investor sentiment. Focusing on health companies, Hunzinger explains how many innovative drugmakers have managed to capitalize on the shifting environment. Still, he warns that a more uncertain landscape for U.S. innovation and continued tariff pressures on sectors such as medtech could pose challenges down the line. To learn more about the topics in this episode:  AstraZeneca CEO's conservative MFN model excludes reference markets from forecast As Johnson & Johnson navigates changing tariff landscape, execs lay out their expectations Trump eyes 100% tariff rate for companies that have not struck MFN deals: Bloomberg See omnystudio.com/listener for privacy information.

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 potential 100% tariff on imported drugs. Young explains how the policy could affect smaller drugmakers that haven’t inked high-profile pricing deals with the government and shares best practices for navigating the rapidly evolving U.S. trade environment. To learn more about the topics in this episode:  An update on the pharma industry’s reshoring effort Trump eyes 100% tariff rate for companies that have not struck MFN deals: Bloomberg Trump's tariff threats, measured by manufacturing UK signs off on US pharma deal, ensuring tariff reprieve as Britain aims to reattract investments See omnystudio.com/listener for privacy information.

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 developers to eliminate redundant testing, streamline submissions and move more quickly into clinical fill.  The discussion highlights the benefits of single supplier accountability, improved supply security and reduced risk across development and commercialization. Designed for biologics and modern vaccines, West Synchrony sets a new standard in prefillable syringe systems.See omnystudio.com/listener for privacy information.

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 settings, new challenges are emerging. Workforce shortages, training needs and the importance of standardized practices are key considerations for scaling safely. Patterson shares how industry collaboration can help address these gaps while maintaining high standards of care.   He also outlines a future defined by greater access, reduced travel burdens and a more seamless patient experience. Listen to the full episode to learn how Curium is working to make theranostics more accessible across the United States.See omnystudio.com/listener for privacy information.