A pivotal time for an RNA pioneer

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.

It’s a pivotal year for RNA therapeutics pioneer Ionis Pharmaceuticals.  After transitioning from a partnering model to a full-ownership strategy following the 2024 approval of Tryngolza, the company is expecting an FDA decision to expand the drug into severe hypertriglyceridemia as its first non-rare-disease indication for a wholly owned product. Meanwhile, potentially game-changing phase 3 readouts are expected from Ionis’ Novartis-partnered lipoprotein(a) candidate and AstraZeneca-partnered ATTR cardiomyopathy program. In this week’s episode of "The Top Line," Fierce’s Angus Liu interviews Ionis CEO Brett Monia, Ph.D. He discusses the science of antisense oligonucleotides, the significance of the two closely watched upcoming clinical readouts, and what it takes to turn a 30-year-old discovery platform into a full-fledged commercial biotech. To learn more about the topics in this episode:  Ionis slashes Tryngolza's price tag by 93% ahead of anticipated label expansion  'It’s going to be huge': The 'diabolical' molecule poised to become biotech's next gold rush  AstraZeneca sets sights on 25+ blockbusters by 2030 to fuel $80B revenue ambition  As questions swirl around ATTR competition, Alnylam plots path to market leadership for Amvuttra  Ionis exec shares method to the Madness after 2026 Drug Name Tournament win  Ionis plots FDA filing after rare neurological disease candidate posts phase 3 win  See omnystudio.com/listener for privacy information.

Speed, precision, and visibility are critical to clinical trial success, and logistics plays a central role in delivering all three. In this interview, Manishaa O’Brien, director of commercial operations at Marken UPS Healthcare Precision Logistics, shares how the Laboratory Advantage service line is helping central labs and sponsors accelerate timelines while maintaining sample integrity and compliance.O’Brien discusses how Marken’s global network, combined with its air and ground fleet, connects clinical sites worldwide and expands access to diverse patient populations. She explains how enhanced tracking, integrated data systems and a 99.5% on-time performance rate support reliable, end-to-end visibility for lab partners. Dedicated account management and tailored logistics solutions further strengthen collaboration and help ensure regulatory requirements are met.The conversation also explores key trends shaping the future of clinical trial logistics, including increasing complexity, the rise of AI-driven routing and the growing importance of sustainability. From automation to eco-friendly packaging innovations, Marken is building a more efficient and resilient supply chain. Watch the full interview to learn how these advancements are helping clinical trials move faster and smarter.See omnystudio.com/listener for privacy information.

President Donald Trump has struck a deal with the UK that exempts prescription drugs imported to the United States from tariffs for three years. In exchange, Britain’s National Health Service will pay 25% more for new drugs. The question now is: Can the U.S. negotiate similar deals with other countries? In this week’s episode of "The Top Line," we examine the drug pricing agreement between the UK and the U.S. Fierce Pharma’s Kevin Dunleavy explores the issue with Jeffrey Gerrish, who served as deputy U.S. trade representative for Asia, Europe and the Middle East during the first Trump administration.  They break down the specifics of the UK-U.S. partnership and whether the deal could be applied to other countries to bring drug prices more in line with those in the U.S. They also discuss Trump’s other attempts to use America’s economic power to secure drug pricing agreements. To learn more about the topics in this episode:  UK signs off on US pharma deal, ensuring tariff reprieve as Britain aims to reattract investments Merck executes its own Brexit, moving all R&D operations out of UK AstraZeneca's Soriot is considering move of stock listing to the US: Times See omnystudio.com/listener for privacy information.

Artificial intelligence is increasingly shaping how pharma companies approach content strategy and decision-making. In this episode of The Top Line, Kristen Pilkiewicz, EVP and executive creative director at Sound Healthcare Communications, examines how AI is being applied in real-world marketing workflows. Rather than positioning AI as a standalone solution, Sound has integrated it into core processes to support faster content development, more rigorous strategy testing and improved alignment with regulatory expectations. Pilkiewicz outlines how the company is building tools tailored to pharma and training teams to use AI as a partner in decision-making. The discussion also explores PerspectiveX, an AI-powered decision intelligence platform that simulates health care provider reactions to content before it reaches market research. By helping teams refine messaging earlier, the tool aims to reduce bias, improve research inputs and strengthen overall campaign performance. For health care marketers and industry stakeholders, the conversation offers a grounded perspective on how AI is evolving from experimentation to practical application across the communications landscape.See omnystudio.com/listener for privacy information.

Spray-dried dispersions are widely used, but they do not always deliver expected results. In this sponsored episode of The Top Line, host Stephanie Butler speaks with AustinPx Chief Scientific Officer Dr. Dave Miller about how drug developers can recover from suboptimal formulations and manufacturing challenges. Miller outlines common issues, including poor bioperformance, inefficient scale-up, intellectual property limitations and high pill burden. He explains how next-generation amorphous solid dispersion technologies, such as KinetiSol, expand formulation design space, remove solvent constraints and support more efficient, scalable manufacturing. The conversation also covers how to introduce improved formulations into late-stage clinical programs and navigate regulatory considerations. Miller shares how teams can accelerate timelines while maintaining product quality and performance. For developers looking to optimize assets or reduce risk, this episode delivers clear, expert insight. Listen to the full interview to learn how to overcome formulation challenges and advance drug development.See omnystudio.com/listener for privacy information.

China’s biotech rise has been a persistent concern for federal health leaders, Congress, and many biopharma executives. But to Roivant CEO Matt Gline, the country is nothing more than a red herring.  In this week’s episode of "The Top Line," Fierce Biotech’s Darren Incorvaia chats with Gline about China, artificial intelligence and the exciting year ahead for Roivant’s lead asset brepocitinib.  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  NIH grant cuts hit women, early-career scientists the hardest: analysis  Roche pumps $480M into South Korea biopharma industry to establish global trial 'ecosystem'  Lilly pledges $500M to South Korea biopharma industry, following Roche’s lead  Pfizer-backed Priovant scores again with fast-rising brepocitinib in midstage study   See omnystudio.com/listener for privacy information.