Roivant’s CEO thinks China is a ‘red herring’

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.

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.

The wait is over. Fierce Biotech has released its annual ranking of the top 10 pharma R&D budgets of 2025—offering a clear look at which companies are spending the most on innovation and how those investments are shifting year over year. In this week’s episode of "The Top Line," Darren Incorvaia and Eric Sagonowsky break down the new report, digging into who claimed the top spot, which companies moved up or down the rankings and whether any newcomers broke into the top 10. The conversation also explores the broader trends behind the budgets—what increased R&D investment signals about pipeline priorities, where companies may be pulling back and whether this year’s list reflects continued momentum or a plateau after several years of elevated spending. Listen to the full episode for a closer look at how the industry’s biggest players are allocating their R&D budgets—and what it could mean for the next wave of drug development. To learn more about the topics in this episode:  The top 10 pharma R&D budgets of 2025  Biopharma R&D pipeline shrinks for 1st time in 30 years: report  See omnystudio.com/listener for privacy information.

After a wave of high-profile pledges to bring pharmaceutical manufacturing back to the United States, a clearer picture of what reshoring actually looks like is starting to emerge. Tens of billions of dollars have been committed to new U.S. plants, but those investments are unlikely to translate into immediate gains in domestic production. In this week’s episode of "The Top Line," Fierce’s Eric Sagonowsky sits down with Rosemary Coates, executive director of the Reshoring Institute, to unpack where the trend stands today and what comes next. Coates explains why the pharma industry is uniquely positioned to bring supply chains back to the U.S., and the challenges companies face as they try to do it. To learn more about the topics in this episode:  UCB unveils plan to build $2B biologics plant near its US headquarters in Atlanta  Pharmas have promised $370B in US investments amid 2025's onshoring boom: DPR  Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report  See omnystudio.com/listener for privacy information.

While Lilly’s position in the obesity market and wider GLP-1 space has remained largely unshakeable in recent months, a crack in the company’s armor may be forming, according to at least one analyst. As that assessment dealt a blow to the company’s stock price in recent weeks, Lilly is plowing forward all the same with more details on its next wave of potential incretin drugs.   In this week’s episode of "The Top Line," the Fierce Pharma team breaks down Lilly’s recent HSBC downgrade, what it signals for the GLP-1 and obesity markets, and the data shaping the company’s next wave of diabetes and weight loss products. Fierce’s Eric Sagonowsky is joined by Kevin Dunleavy and Fraiser Kansteiner to unpack the latest and assess the commercial narrative around GLP-1s so far. To learn more about the topics in this episode:  With downgrade, HSBC casts doubt about Lilly's 'stairway to heaven' trajectory Lilly's triple-G bet lowers blood sugar, prompts 16.8% weight loss in phase 3 diabetes trial Lilly's obesity triple threat smashes efficacy expectations in phase 3 but proves intolerable for some Novo’s CagriSema tops semaglutide in ph. 3 diabetes study See omnystudio.com/listener for privacy information.

In this episode of The Top Line, host Chris Hayden speaks with Olive McCormick, Head of Quality and Qualified Person at Almac Clinical Services about why late‑breaking issues in clinical trials pose such significant risk — and what teams can do to prevent them. McCormick explains that operational misalignment, delayed communication, overlooked regulatory steps or misinterpretation of requirements under the new UK Clinical Trial Regulation can snowball quickly, putting both patient safety and organizational credibility at stake. She and Hayden discuss how sponsors, CROs and site teams can keep trials on track by establishing strong communication channels and maintaining a unified understanding of responsibilities as studies reach key milestones. McCormick stresses the value of proactive engagement and early insight into potential challenges, noting that waiting too long to identify or resolve issues increases the likelihood of disruptions. The episode calls on clinical research professionals to prioritize transparency, coordination and shared accountability. Whether you’re leading a trial or supporting one, the discussion offers practical guidance to help teams avoid the preventable setbacks that so often arise near the finish line.See omnystudio.com/listener for privacy information.