Adam Runkle
Adam Runkle is a seasoned professional in regulatory affairs with extensive experience in the pharmaceutical industry. Currently, he serves as Associate Director of Regulatory Affairs at Daiichi Sankyo, Inc., a position he has held since February 2024 developing regulatory strategies for late-phase assets moving toward marketing applications. Prior to this, he was in similar roles at Kite Pharma and Tmunity Therapeutics, as a regulatory strategist in early-phase programs primarily focusing on expedited pathways.
From March 2014 to March 2024, Adam was the owner of keV Pharma Consulting, LLC, where he provided consulting services to the radiopharmaceutical industry including quality control and quality assurance best practices, quality-by-design (QbD), and radiopharmaceutical facility design.
Adam has also worked at the University of Pennsylvania School of Medicine as a Scientific Program Manager, supporting translational and regulatory aspects for clinical phase novel CAR T assets. Throughout his career, Adam has demonstrated strong leadership and management capabilities in regulatory affairs and product development.