Medical Affairs Unscripted

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 engagement is no longer optional even for resource-constrained biotech companies. Instead, it is a critical lever for improving clinical, regulatory, and commercial outcomes. They explore three core pillars of medical affairs impact: De-risking clinical development by shaping the Target Product Profile (TPP) with real-world clinical and stakeholder insight Accelerating regulatory approval through early investigator engagement, site selection, and improved trial enrollment Enabling market access and adoption by building an evidence strategy aligned with payer, provider, and patient needs As scientific innovation accelerates across cell therapies, gene therapies, and complex biologics biotech companies must move beyond a narrow focus on regulatory approval and design development programs for real-world adoption and value demonstration. This episode is essential for biotech executives, medical affairs leaders, and cross-functional teams looking to integrate medical strategy earlier in clinical development and strengthen the probability of successful commercialization.

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 Affairs leaders can increase their strategic impact across pharma and biopharma organizations. Drawing on experience across commercial, quality, and Medical Affairs functions, Carpenter outlines why broader career paths, business acumen, and accountability are essential to creating Medical Affairs value. The conversation examines how Medical Affairs can move beyond data delivery to translate medical insights into strategy, strengthen cross-functional collaboration, and better support physicians and patients. The episode concludes with a practical discussion on AI in Medical Affairs, including how AI is being used today to improve insights, content development, and efficiency—while reinforcing the importance of human judgment and leadership.

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.

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.

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 healthcare professionals and patients can reveal critical insights for pharmaceutical companies. They delve into the usage of platforms like Twitter, Bluesky, and Threads, emphasizing the need for agility in adapting communication strategies to meet evolving digital trends.

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 dedicated congress leadership, the role of external engagement in shaping scientific communications, and how integrated approaches drive better stakeholder interactions. A key focus of the conversation is the increasing emphasis on patient inclusion, highlighting initiatives such as patient-authored scientific publications and the role of Medical Affairs in ensuring patients have a voice in clinical research and education. As companies evolve to meet new industry trends, this episode offers practical strategies for creating synergies across Medical Affairs and strengthening its impact on HCPs, KOLs, and patients alike.

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 for Medical Affairs teams working alongside clinical development, the ideal timing for their involvement, and how their role should progress over time. They also discuss the necessary skills and qualities that Medical Affairs team members need to collaborate effectively with Clinical Development, as well as the additional training that could be advantageous. Lastly, they cover what defines success in this emerging trend.

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 publication processes and reduce biases, ultimately impacting patient care positively. The conversation highlights AI as a tool to augment, not replace, the expertise of medical professionals. The episode concludes with reflections on the importance of strategic medical affairs planning and optimizing access to medical innovations.

In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, and Jodi Smith, PhD, the Global Medical Strategy Lead in Thoracic Oncology at Pfizer, discuss the value of Medical Affairs. While they agree that there's a cost associated with bringing Medical Affairs into the early development of a drug, they see a clear and measurable benefit, from accelerated enrollment to having a solid foundation for commercialization. Through their many years in different roles within Medical Affairs, they know that to achieve these benefits, organizations need to have the right team members in the right roles with the agility to work in an ever-changing landscape as well as provide strategic thinking, a diversity of audience, and continuity throughout the product lifecycle - from clinical development through commercialization and beyond.

Now, more than ever, the patient voice is being heard by the pharmaceutical industry. In this episode, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, and Len Lichtenfeld, MD, MACP meet to discuss the ways patients are providing advisement in drug development and valuation. After hearing about Len's extensive experience, they delve into the new regulatory changes coming to pharma and biotech that will require the patient experience to be taken into consideration during the drug development process. They conclude by discussing how the patient experience is having an impact on the valuation of new drugs.

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 Christian Dimaano, PhD, MPH. As the VP, Head of Medical Affairs at Kinnate Biopharma, 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 to the industry.

A thoughtfully and carefully built Medical Affairs team, and in particular, a Field Medical team can enhance study enrollment and serve as a foundation for future commercialization. In this episode, Peg and Christian Dimaano, PhD, MPH, VP, Head of Medical Affairs at Kinnate Biopharma, discuss the differences between building a Medical Affairs team in the US compared to building teams in the EU or Asia PAC, and the ideal timing for bringing field medical onboard. They review the pros and cons of outsourcing a field team versus building internally and highlight the different skill sets needed for teams at different stages of the product lifecycle.

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 second episode of our short form podcast series, we discuss this topic with Dr. John Yee. As the former CMO at Sobi, Dr. Yee has a wealth of Medical Affairs experience and insights. This conversation brings us further along in trying to understand the changes that are coming to the industry.