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Medical Affairs Unscripted

Lumanity Medical Affairs Consulting

In Medical Affairs Unscripted we explore a range of topics related to the strategic role of Medical Affairs from the perspective of industry experts. Through these conversations with our guests we will share first hand experience to provide the listener with insights and knowledge about the evolving role of Medical Affairs.

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  • 21 episodes
  • monthly
  • Avg 41 min
  • English
Counted on this page — what you have heard stays on this device, so it is not something the list can be paged by.
  • S6 · E6
    Tuesday · 42 min

    One Size Does Not Fit All: Leading Medical Affairs Across a Diverse Portfolio

    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 lived this challenge from the inside. From large pharma to biotech, she brings a rare perspective on how portfolio diversity changes everything, from scientific narrative and data generation strategy to team design, resource trade-offs, and global launch planning across the U.S., Europe, and beyond. Together, Peg and Lori explore why a lift and shift approach across therapeutic areas fails every time, and what Medical Affairs leaders must do instead. They dig into how oncology, neurology, and rare disease each demand a fundamentally different strategy, why the pace, the patient community, and the evidence generation priorities are worlds apart, and what that means for how Medical Affairs shows up at the enterprise level. They also get into the biotech reality, where diverse pipelines inside small organizations create compounding pressure, and why getting Medical Affairs to the table early is no longer optional. Running through it all is the belief that the patient is the true North Star, and that no drug has truly succeeded until it reaches the patient who needs it. If you lead across franchises, manage a diverse Medical Affairs portfolio, or are building your career and want to understand what it really takes to operate at this level, this episode is essential listening.

  • S6 · E5
    July 28 · 48 min

    Proactive vs. Reactive: How the SIUU Guidance is Reshaping Medical Affairs Strategy with Josh Bryson

    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 strategy. Josh and Peg examine what the FDA guidance permits, the data integrity and publication requirements that must be in place, and how the shift from reactive to proactive scientific exchange changes HCP engagement. They also discuss how SIUU raises the bar for evidence generation, driving companies to think more deliberately about data quality, study design, and publication strategy in order to meet the criteria the guidance requires. Medical Science Liaisons and Medical Affairs leaders will find this conversation directly relevant to how they approach both field engagement and evidence planning. A practical conversation for medical affairs professionals looking to understand how the FDA off-label communication guidance reshapes communications strategy and the evidence needed to support it.

  • S6 · E4
    May 15 · 51 min

    The Launch Starts Now: A CMO's Approach to Early Medical Affairs Strategy in Biotech with Nick Sarlis, MD, PhD, FACP

    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. Nick explains why "T-minus 30 months" is becoming the new standard for launch preparation and discusses the foundational role of medical affairs in shaping scientific narrative, publication strategy, KOL engagement, field medical deployment, and long-term evidence generation planning. The conversation also explores: • Early hiring strategy for medical affairs teams • Building experienced MSL and field medical capabilities • Aligning medical, commercial, and corporate communications • Publication planning and scientific congress engagement • Academic center and patient advocacy partnerships • Managing actionable MSL insights • Evidence generation planning beyond approval • Launch readiness in resource-constrained biotech organizations A practical, resource and strategy-focused discussion for biotech executives, CMOs, medical affairs leaders, MSLs, and clinical-stage companies considering commercialization.

  • S6 · E3
    April 10 · 43 min

    Medical Affairs as a Strategic Engine: De-Risking Biotech Development and Driving Commercial Success

    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.

  • S6 · E2
    February 19 · 47 min

    Building the CMO Playbook: From Pre-IND to Launch in Early-Stage Biotech

    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 operations, regulatory strategy, biostatistics, and pharmacovigilance, while determining the right time to introduce Medical Affairs. The conversation outlines how to scale teams at critical inflection points such as IND clearance, Phase 2 proof of concept, and advancement into Phase 3. The episode also examines investor and board expectations, CRO selection, capital efficiency, cash runway management, and the performance metrics CMOs are ultimately judged on—from disciplined milestone execution to generating meaningful clinical data. This episode offers actionable insight for biotech founders, clinical development leaders, medical affairs professionals, and emerging CMOs navigating the path from early development to launch.

  • S6 · E1
    February 3 · 44 min

    Medical Affairs Leadership: From Support Function to Strategic Lever

    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.

  • S5 · E10
    Nov 20, 2025 · 51 min

    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.

  • S5 · E9
    Oct 29, 2025 · 42 min

    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.

  • S5 · E8
    Oct 9, 2025 · 35 min

    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.

  • S5 · E7
    Jun 25, 2025 · 50 min

    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.

  • S5 · E6
    May 27, 2025 · 44 min

    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.

  • S5 · E5
    Apr 18, 2025 · 30 min

    Podcast Bytes - From Tweets to Trends: Leveraging Social Media for Medical Affairs Insights with Jamie Doggett

    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.

  • S5 · E4
    Mar 27, 2025 · 45 min

    Realizing Value through Effective Medical Affairs Operations with Keith Poole

    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.

  • S5 · E3
    Mar 6, 2025 · 43 min

    Creating Synergies by Integrating Across Medical Affairs with Caroline Ojaimi, PhD

    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.

  • S5 · E2
    Feb 24, 2025 · 25 min

    Podcast Bytes - Use of GenAI in Medical Publications with Tim Becker, PharmD, RPh

    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.

  • S5 · E1
    Jan 31, 2025 · 42 min

    Establishing Strategic Connections to Accelerate Clinical Trials with Smitha Sivaraman, PhD, MBA

    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.

  • S4 · E7
    Nov 27, 2024 · 47 min

    Insights for Building a Rockstar MSL Team with Cathy Andorfer, PhD

    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. Cathy shares her experiences and insights on leadership, stressing the necessity of repetition and clarity in setting objectives. She believes that consistent reminders and clear priorities are key to team success. Cathy also highlights the importance of training MSLs to interpret and contextualize insights, transforming them from simple observations into valuable strategic intelligence. The conversation touches on the need for ongoing refinement in training and the significance of fostering an environment where team members feel empowered to ask questions and engage in deep scientific discussions. Cathy underscores the value of learning from mistakes and continuously evolving to achieve better outcomes. Lastly, Peg and Cathy reflect on the broader impact of medical affairs on improving patient health by optimizing access to medical advances.

  • S4 · E6
    Jul 23, 2024 · 39 min

    Generative AI Unleashed: Revolutionizing Innovation and Efficiency in Medical Affairs with Jane Carroll, MS, BSN

    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.

  • S4 · E5
    May 28, 2024 · 8 min

    Podcast Bytes - The Digital Transformation of Medical Affairs with Dan Hennessy, PhD

    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 to the industry, and more specifically how it may affect clinical trial enrollment and engagement.

  • S4 · E4
    Apr 30, 2024 · 45 min

    The Value of Medical Affairs – Strategic Thinking and Continuity from Clinical Development to Commercialization and Beyond With Jodi Smith, PhD

    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.

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