Medical Affairs Unscripted

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.

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.

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.

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.

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.