Medical Affairs Unscripted

39:28

Rethinking Global Medical Affairs: Co-Led Brand...

Medical Affairs Unscripted ·

2026/09/30

How can Medical Affairs teams move faster, align global brand strategy, and use artificial intelligence (AI) while keeping patients first? Emad Siddiqui, Senior Vice President, Head of Medical Affairs Global Brand Strategy at Astellas Pharma, joins host Peg Crowley-Nowick on Medical Affairs Unscripted. A surgeon by training, Emad describes his move from clinical practice into Medical Affairs and his belief in putting patients and science first. He explains the Astellas "Brand at the Center" model,

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42:43

One Size Does Not Fit All: Leading Medical Affairs...

Medical Affairs Unscripted ·

2026/08/25

What happens when one Medical Affairs leader is responsible for oncology, neurology, immunology, fertility, HIV, and rare disease, all at the same time? The answer is not a bigger playbook. It is an entirely different way of thinking. Host Peg Crowley sits down with Lori Lebson, Senior Vice President of Global Medical Affairs at CalVista Pharmaceuticals, to dig into one of the most underestimated challenges in the field: leading Medical Affairs strategy across a truly diverse portfolio. Lori has

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48:13

Proactive vs. Reactive: How the SIUU Guidance is...

Medical Affairs Unscripted ·

2026/07/28

The FDA finalized its guidance on Scientific Information on Unapproved Uses (SIUU) in January 2025, giving pharmaceutical and biotech companies a framework for proactive off-label communication with healthcare providers. Yet many medical affairs organizations are still navigating what it means in practice. In this episode, Peg Crowley-Nowick, PhD, MBA talks with Josh Bryson, PhD, Head of U.S. Medical Affairs and Evidence Generation at Argenx, about the real-world implications for medical affairs

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51:21

The Launch Starts Now: A CMO's Approach to Early...

Medical Affairs Unscripted ·

2026/05/15

In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick speaks with Nick Sarlis, MD, PhD, FACP, Chief Medical Officer at Clara Biotech, about why successful biotech launches begin years before approval. Drawing on experience across six product launches and nine indications, Nick shares a practical CMO perspective on building medical affairs capabilities early, aligning scientific strategy across functions, and preparing organizations for launch success in today's biotech environment.

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43:33

Medical Affairs as a Strategic Engine: De-Risking...

Medical Affairs Unscripted ·

2026/04/10

What if the decisions that determine your drug's commercial success are already being made and medical affairs isn't in the room? In this episode of Medical Affairs Unscripted, Peg Crowley speaks with Nick Sen, SVP and Practice Lead at Lumanity Medical Affairs Consulting, about the evolving role of medical affairs as a strategic driver in biotech and pharmaceutical development. Drawing on experience across academia, commercial strategy, and market access, Nick explains why early medical

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47:26

Building the CMO Playbook: From Pre-IND to Launch in...

Medical Affairs Unscripted ·

2026/02/19

In this episode, Peg Crowley-Nowick speaks with Joseph Elassal, MD, MBA, Chief Medical Officer of Ankyra Therapeutics, about the strategic, operational, and financial realities of leading clinical development from pre-IND through proof of concept and toward commercialization. Drawing on experience across large pharma, biotech partnerships, and early-phase oncology, Joe shares a practical roadmap for new and aspiring CMOs. They discuss how to prioritize essential capabilities, including clinical

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44:00

Medical Affairs Leadership: From Support Function to...

Medical Affairs Unscripted ·

2026/02/03

How Medical Affairs leaders can move their organizations from a supporting role to a strategic driver—through accountability, insight translation, and the smart use of AI. In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick speaks with Greg Carpenter, Global Medical Strategy Leader in General Medicine at Sanofi, for a candid conversation on how Medical Affairs must evolve to remain relevant—and indispensable—in a rapidly changing industry. The discussion focuses on how Medical

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51:26

It Doesn't Take Months: How an Expert CMO Builds a...

Medical Affairs Unscripted ·

2025/11/20

Medical Affairs Unscripted welcomes Dr. Jeff Humphrey—an experienced CMO with three decades across Bristol Myers Squibb, Pfizer, Bayer, Kyowa Kirin, and multiple biotechs—to discuss why the Target Product Profile (TPP) is the foundation of effective drug development. He shares a clear framework for "starting with the end in mind," from scientific fit and standards of care to regulatory precedent, investor expectations, and the smart use of AI. Humphrey also underscores the importance of working with

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42:40

From First Patient Enrolled to First Script: Medical...

Medical Affairs Unscripted ·

2025/10/29

Medical Affairs isn't a downstream function—it's the throughline connecting science, story, and strategy from development through commercialization. This episode features Howard Rutman, MD, MBA, Chief Medical Officer at Xalud Therapeutics and Peg Crowley-Nowick, PhD, MBA discussing the critical role of early Medical Affairs engagement. Key topics include how early Medical Affairs involvement speeds patient enrollment and data generation, qualities to seek in the first Medical Affairs hire, the value

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35:39

Podcast Bytes - Bridging Science and Strategy: The...

Medical Affairs Unscripted ·

2025/10/09

In this episode of Medical Affairs Unscripted, host Peg Crowley-Nowick talks with Shera Gruen, SVP of Strategy Consulting at Lumanity, about the power of collaboration between medical and commercial teams in pharma. Drawing on her 20 years of industry experience leading commercial teams, Shera shares lessons on aligning science with strategy, preparing for launch success, and managing uncertainty. From cross-functional teamwork to scenario planning and external partnerships, this conversation offers

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50:35

The Intersection between New Product Planning and...

Medical Affairs Unscripted ·

2025/06/25

In this episode of Medical Affairs unscripted, Peg Crowley-Nowick, PhD, MBA, Senior Advisor, Medical Affairs Consulting at Lumanity, and Cathy Symonds, PhD, Program Lead and Head of New Product Planning at Arbor Biotechnologies, engage in an insightful discussion about the evolving role of new product planning and its intersection with Medical Affairs. Peg and Cathy explore the strategic importance of new product planning in the lifecycle of medical products, emphasizing how early commercial

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44:43

Rare Insights: Navigating Medical Affairs in Rare...

Medical Affairs Unscripted ·

2025/05/27

In the latest episode of Medical Affairs unscripted, Peg Crowley-Nowick, PhD and Senior Advisor, Medical Affairs Consulting at Lumanity, engages in a compelling conversation with Eva Gallagher, PhD, CNMAP, VP, Head of Medical Affairs at Agios Pharmaceuticals. They explore the strategic role of Medical Affairs in the rare disease space, discussing best practices for building effective teams, engaging diverse stakeholders, and leveraging digital tools for education. Eva’s journey and success in the

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30:33

Podcast Bytes - From Tweets to Trends: Leveraging...

Medical Affairs Unscripted ·

2025/04/18

In this episode of Medical Affairs unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, discusses the critical role of social media listening in healthcare with Jamie Doggett, Associate Director of Social Media Insights and Analytics at Lumanity. They explore the insights obtained from Jamie's whitepaper, Transforming Scientific Conversations: Adapting to a New Era of Healthcare Social Media. Jamie highlights how unprompted online conversations among

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45:13

Realizing Value through Effective Medical Affairs...

Medical Affairs Unscripted ·

2025/03/27

Join Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, in this episode of Medical Affairs Unscripted as she engages with Keith Poole, Executive Director and Head of Medical Excellence & Impact Enhancement at Merck KGaA, Darmstadt, Germany. They delve into the critical role of Medical Operations in fostering a high-performance culture within organizations. The discussion covers the strategic collaboration between medical operations teams and Medical Directors,

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43:51

Creating Synergies by Integrating Across Medical...

Medical Affairs Unscripted ·

2025/03/06

In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, speaks with Caroline Ojaimi, PhD, Head of Global Scientific Communications, Congresses, and External Engagement at Takeda Oncology. Dr. Ojaimi shares her passion for Medical Affairs and provides insights into strategically redesigning organizational structures to enhance agility, efficiency, and cross-functional collaboration. Their discussion covers the importance of

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25:09

Podcast Bytes - Use of GenAI in Medical Publications...

Medical Affairs Unscripted ·

2025/02/24

In this Medical Affairs unscripted Podcast Byte, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, discusses the recently released insights report: Expert Perspectives on the Use of Generative AI in Medical Publication with her colleague, Tim Becker, PharmD, RPh, EVP, Creative Scientific Solutions at Lumanity. Their discussion sheds light on the safe and proper use of Generative AI in medical publications, addressing key concerns such as hallucinations, data

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42:20

Establishing Strategic Connections to Accelerate...

Medical Affairs Unscripted ·

2025/01/31

In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, engages in an enlightening discussion with Smitha Sivaraman, PhD, MBA, Vice President of Medical Affairs at Verastem Oncology. Their discussion highlights the growing trend of integrating Medical Affairs into the Clinical Development process, and how this integration can streamline development when executed properly. Dr. Sivaraman shares her insights on the expectations

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47:01

Insights for Building a Rockstar MSL Team with Cathy...

Medical Affairs Unscripted ·

2024/11/27

In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, welcomes Cathy Andorfer, PhD, the national Director of Field Medical for Tourmaline Bio, and author of "The Art of Excellence: Build a Rockstar Career as a Medical Science Liaison and Beyond." Their conversation explores the vital role of medical affairs, emphasizing the importance of strategic vision, continuous learning, and effective communication within the team

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39:25

Generative AI Unleashed: Revolutionizing Innovation...

Medical Affairs Unscripted ·

2024/07/23

In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, welcomes Jane Carroll, MS, BSN, Vice President of Global Strategy and Operations at Moderna. They discuss the evolving role of medical affairs and the impact of generative AI, specifically ChatGPT, on the field. Jane shares her experiences leveraging AI as a copilot to enhance efficiency and innovation in medical affairs. They delve into the potential of AI to speed up

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08:36

Podcast Bytes - The Digital Transformation of Medical...

Medical Affairs Unscripted ·

2024/05/28

Medical Affairs is going through a digital transformation. What this means, what it will look like, and what value it will bring to pharmaceutical and biotech companies is still unknown. In this third episode of our short form podcast series, we discuss this topic with Dan Hennessy, PhD. As the Vice President of Medical Affairs at Merus N.V., he has a wealth of Medical Affairs experience and insights. This conversation brings us further along in trying to understand the changes that are coming

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