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.