Medical Affairs Unscripted

• It Doesn't Take Months: How an Expert CMO Builds a TPP That Drives Success - With Jeff Humphrey, MD

  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 patient-first KOLs and reminds listeners that poorly planned development can waste years of people's lives and millions of dollars.

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• From First Patient Enrolled to First Script: Medical Affairs as the Throughline

  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 a lean team can bring to BioTech, and the importance of evidence plans that support physician and market access needs.  The podcast emphasizes Medical Affairs as a continuous link from development to commercialization.

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• Podcast Bytes - Bridging Science and Strategy: The Power of Medical-Commercial Collaboration

  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 practical insights for anyone involved in bringing new therapies to market — and shows how collaboration can turn complex challenges into opportunities for impact.

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• The Intersection between New Product Planning and Medical Affairs with Cathy Symonds, PhD

  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 strategy is essential for successful development and market entry. They discuss various frameworks and best practices, including the creation of a Target Product Profile (TPP), which helps align the team on what success looks like and guides the development process from early stages through to commercialization. The conversation delves into the critical partnerships between new product planning and other functions such as Medical Affairs, clinical development, and market access. They highlight how these collaborations are essential for gathering comprehensive insights from healthcare professionals, patients, and the broader market landscape. They share their experiences and perspectives on the importance of strategic narratives that communicate the value of new products effectively to both internal teams and external stakeholders, including investors. Throughout the discussion, they underscore the necessity of continuous planning and adaptation to ensure that products not only meet regulatory requirements but also achieve commercial success and ultimately improve patient outcomes.

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• Rare Insights: Navigating Medical Affairs in Rare Disease Launches with Eva Gallagher, PhD, CNMAP

  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 field offer a blueprint for how Medical Affairs can drive impactful change and enhance patient outcomes.   The discussion delves into the significance of starting Medical Affairs efforts early—sometimes as much as five to seven years before a product launch. Eva explains the critical need for educating healthcare practitioners about rare diseases, especially when those conditions are often not well-known. The episode also highlights the role of medical strategy, publication planning, and patient advocacy in creating a comprehensive approach to rare disease management. With practical examples and real-world insights, this episode provides a detailed roadmap for navigating the complexities of launching therapies in rare disease markets.

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