Stephane Avella

Stephane Avella, M.S., is the Sr. Director of CMC Regulatory Affairs Biologics at Merck, bringing 19 years of global experience in CMC regulatory affairs for biologics. Stephane has a proven track record of developing regulatory strategies throughout the lifecycle of biologic products, from clinical development to post-approval. With a strong background in process development and a deep understanding of the biologic drug substance and product development processes, Stephane has successfully engaged in numerous interactions with regulatory agencies, including the FDA. Additionally, Stephane is committed to fostering diversity and inclusion in the workplace.