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