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, 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.

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 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.

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.

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, focusing on advisory board meetings, strategy, budgeting, and analysis and communication of actionable insights. Furthermore, they examine the qualities of effective leadership in Medical Affairs and outline the steps to build a high-performing Medical Operations team. The episode concludes with an exploration of the latest technologies and tools that drive efficiency and effectiveness within the team.

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 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 privacy, and the need for transparency and accountability. They also explore the future impact of Generative AI on medical communication agencies and their relationships with journals. Although Generative AI can accelerate the delivery of data to patients and healthcare providers, it will still require the careful oversight of trained professionals to ensure ethical and appropriate use.

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.