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.

Biomarkers are playing an increasingly critical role in shaping the future of oncology trials—and the pace of innovation is accelerating. In this sponsored episode of The Top Line, host Stephanie Butler sits down with Dr. Danielly Vicente, Associate Medical Director of Oncology and Hematology at Allucent, to explore how advanced biomarker strategies are transforming clinical development.

From improving patient selection in early-phase trials to enabling adaptive study designs, biomarkers are helping researchers identify the right patients, optimize outcomes, and reduce development risks. Dr. Vicente discusses how approaches like comprehensive genomic profiling, basket and umbrella trials, and real-time monitoring are driving more efficient and successful oncology programs.

The episode also tackles the challenges of integrating genomic testing and biomarker screening into trials, including operational complexity and data coordination. Plus, learn how emerging technologies such as circulating tumor DNA (ctDNA) and multiomic strategies are set to redefine trial design and accelerate precision medicine.

Tune in to hear how biomarker-driven innovation is advancing oncology research—and what it means for the future of patient care.

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.