The continued shift toward self-administered therapies is changing how pharmaceutical companies think about patient support. While access and affordability remain priorities, a growing share of industry attention is focused on the patient experience itself, particularly during the critical transition from prescription to successful treatment initiation.

In this episode of The Top Line, Adam Shain, Vice President and Head of Business Transformation and Growth and Government Affairs Lead at Noble, an Aptar Pharma company, examines why patient onboarding, device training, and engagement strategies are increasingly being viewed as interconnected components of a broader patient experience. Drawing from Noble's work in self-administration support, Shain discusses the importance of incorporating patient insights into program design, the evolving complexity of at-home treatment models, and the industry's growing focus on adherence and long-term treatment success.

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Is biotech taking a trip to the world of psychedelic drugs? Why is Novo Nordisk going after Eli Lilly’s Zepbound ads? And what are peptides? 

This week on "The Top Line," Fierce's Zoey Becker, Will Maddox and Kevin Dunleavy chat about some of the biggest recent stories. From a psychedelics acquisition that could spark more movement in the emerging field to an advisory committee meeting on peptides shrouded in political controversy to a lawsuit between the two major obesity drugmakers, we’ll catch you up on the latest developments shaking up the biopharma world.

To learn more about the topics in this episode: 

• ‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics 
• UPDATE: Peptides favored on 1st day of closely watched FDA compounding adcomm
• Peptide adcomm Day 2: Emideltide voted down in panel's 1st pushback
• Novo Nordisk files lawsuit accusing rival Eli Lilly of running ‘false and misleading’ GLP-1 ads 
• Novo escalates Lilly false advertising suit with planned bid to halt comparative ads 

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This week on "The Top Line," Fierce Healthcare and Life Sciences' editor-in-chief steps behind the microphone for a solo episode highlighting several of the biggest stories in biopharma.

The episode covers GSK’s first lung cancer approval following its acquisition of Nuvalent, Axiom Biosciences’ unusual plan to list first in Hong Kong before pursuing a Nasdaq co-listing amid a resurgent biotech IPO market, and the U.S. House’s passage of legislation directing the FDA to update its animal testing rules.

The episode also includes an update from the Fierce newsroom, including the arrival of a new Fierce Biotech staff writer, and a reflection on why human judgment, curiosity and original reporting matter more than ever.

To learn more about the topics in this episode: 

• GSK secures first lung cancer approval as FDA clears Jideytro in quick payoff from Nuvalent deal
• ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong
• House passes bill directing FDA to update animal testing rules

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Clinical trial success depends on more than scientific rigor and operational execution. It also depends on the financial systems that support every stage of a study. In this episode of The Top Line, Zahiah “Zee Zee” Gueddar, senior director of commercial strategy for the Clinical Trial Financial Suite at IQVIA Technologies, discusses why modernizing clinical trial finance has become a strategic priority for sponsors.

As trials become more complex, fragmented systems and manual workflows are creating bottlenecks that limit visibility, delay payments and introduce unnecessary risk. Gueddar explains how these challenges affect site relationships, operational efficiency and study performance, and why organizations can no longer afford to treat finance as a disconnected administrative process.

The conversation also highlights key indicators of readiness for transformation, from cross-functional alignment to executive sponsorship, and outlines the common pain points study teams face today. Ultimately, success depends on moving toward a connected, transparent and predictable financial model that reduces friction, improves collaboration and supports faster, more reliable clinical trials.

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Boston. San Francisco. Beijing? The global biotech industry has long been concentrated in a handful of cities. But which emerging hubs could become dominant forces in biotech in the decades ahead?

In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia and Will Maddox discuss a new Fierce special report identifying five cities with the potential to become major forces in the global biotech industry. Did your favorite city make the cut? Listen to find out. 

To learn more about the topics in this episode: 

• Top emerging biotech hubs in 2026 

• As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’ 

• British biotech VC funding shows ‘signs of recovery,’ but IPO rebound yet to materialize 

• Could Basel be the next Boston? How the Swiss biotech hub is quietly raising its game 

This week's episode is sponsored by IQVIA Biotech.

 
Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com

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Medical affairs is at an inflection point. As science advances and healthcare professionals gain access to information in real time, medical teams face a mandate to deliver insight with greater speed, relevance and impact.

In this episode of The Top Line, Josh Schwartz, Vice President of Medical Affairs, North America at BeOne Medicines, and Jalpa Shah, who leads the medical and evidence practice at ZS Pharma discuss what a modern medical affairs model requires. The conversation explores how the function is becoming a more strategic business driver and why traditional measures of activity are no longer enough to demonstrate value.

The episode examines the structural challenges that continue to hold organizations back, including fragmented data systems, limited visibility into insights and the difficulty of translating engagement into measurable outcomes. It also looks at how artificial intelligence (AI) is reshaping workflows by helping teams generate insights faster, identify trends and inform next best actions.

The discussion also considers the capabilities, operating models and cultural shifts medical affairs teams will need to keep pace with science and influence clinical practice. The central takeaway is clear: Future success will depend less on access to more data and more on the ability to turn intelligence into coordinated action.

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AI is reshaping how organizations compete, but more data and more tools do not automatically lead to better decisions. In this episode of The Top Line, Justin Masterson, senior vice president of human sciences at The Directions Group, challenges leaders to look beyond AI adoption and focus on the discipline required to act on intelligence.

Masterson argues that the defining issue for many organizations is not a data problem, but a decision readiness problem. As information ecosystems become more complex, the ability to translate insight into timely, confident action is emerging as a critical business differentiator.

With more than 20 years of experience in healthcare and human sciences, Masterson shares perspective on how companies can align teams, processes and strategies to unlock AI’s value without becoming overwhelmed by the volume of available information.

For leaders navigating new technologies, competing priorities and higher expectations for speed, this conversation offers a practical reframing of where AI value is created. Learn why decision readiness may be the next true advantage.

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This week on "The Top Line," we’re covering some of the biggest stories across biopharma before turning to one of the industry’s major scientific meetings of the summer.

First, we discuss Vertex’s $10 billion acquisition of Crinetics Pharmaceuticals, the company’s largest deal to date, and what it says about Vertex’s push beyond its historic strength in cystic fibrosis. We also cover growing scrutiny from U.S. lawmakers over the industry’s use of clinical trials in China.

Then, Fierce Pharma Senior Editor Fraiser Kansteiner recounts his recent trip to New Orleans for the American Diabetes Association’s 2026 Scientific Sessions with Fierce Pharma Marketing’s Zoey Becker. For years, ADA has focused heavily on its eponymous indication, but this year’s meeting made clear how much the conversation is evolving, with obesity data from drugmakers of all stripes taking up more of the spotlight. Topics include the biggest data sets from the meeting, what it was like to sit down with Novo Nordisk’s new CEO for the first time and the latest from Insulet’s Marvel collaboration on a line of comics about an Omnipod-wearing superheroine.

To learn more about the topics in this episode: 

• Vertex, in its largest-ever deal, acquires endocrine disease specialist Crinetics for $10B
• As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’
• ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO
• ADA: Lilly pulls back curtain on impressive triple-G efficacy in patients with obesity, diabetes
• ADA: Amgen highlights Repatha perks, GLP-1 pitfalls in push to boost cardiometabolic pedigree
• With ADA in the books, analyst says Lilly is ‘widening its lead’ in the obesity race
• ADA: Novo's Wegovy pill reaches new GLP-1 patients with impressive 3M prescription milestone
• ADA: Tolerability ‘not to be underappreciated’ in Roche, Zealand’s amylin obesity prospect
• ADA: Boehringer execs claim survodutide tolerability 'consistent' with class despite phase 3 update
• ADA: Lilly posts oral semaglutide-topping data as Foundayo speeds toward 2nd potential nod in diabetes

This week's episode is sponsored by IQVIA Biotech.

 
Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com

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Big Pharma dealmaking has picked up, but the biotech path to a signed agreement is still anything but simple.

In this episode, recorded at Fierce Biotech Week, Senior Editor James Waldron leads a discussion on the evolving BD&L landscape across pharma and biotech.

He is joined by Kaleem Chowdhury, Ph.D., CEO of Haiku Biosciences; Liz Leveille, who leads the Boston Innovation Hub and discovery transactions at Merck; and Abbas Kazemi, CEO of Nimbus Therapeutics.

The panel digs into the realities behind the headlines, from investor scrutiny and platform company pressure to China’s growing role in licensing and the long relationship-building that often happens before a deal gets done.

To learn more about the topics in this episode: 

• March M&A surge triggers high expectations for 2026
• 'Biopharma ecosystem is back to full health,' fueled by M&A: PwC
• Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep up
• After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst
• Was Big Pharma’s ‘unusually aggressive’ M&A spree to blame for March IPO drought?

This week's episode is sponsored by IQVIA Biotech.

 
Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com

See omnystudio.com/listener for privacy information.

In this sponsored episode of The Top Line, host Stephanie Butler is joined by Sheila Plant, vice president of regulatory affairs at Allucent, to examine how FDA Breakthrough Therapy and RMAT designations can support more strategic oncology development. 

Although both pathways are intended to speed development, they are not interchangeable. Plant outlines the key distinctions, noting that Breakthrough Therapy requires evidence of substantial improvement over existing treatments, while RMAT is available for regenerative medicine therapies and centers on preliminary clinical evidence indicating the potential to address unmet medical needs. 

The conversation also explores the strategic choices that determine whether sponsors are ready to pursue these designations, from building a credible data package to designing trials with clinically meaningful endpoints and keeping manufacturing readiness aligned with development timelines. 

Once a designation is granted, closer collaboration with the FDA can help sponsors navigate development with more dynamic feedback. But as Plant emphasizes, these pathways deliver the greatest value when they are part of a disciplined regulatory strategy. 

Listen now to learn how sponsors can approach expedited pathways with greater clarity and position oncology programs for meaningful acceleration. 

 

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