Madhu Siluveru

Madhu Siluveru is a Director at Merck in Global Regulatory Affairs CMC, focusing on Cell and Gene Therapy Products and biologics. He has been the Regulatory CMC product lead for two oncolytic virus products (wild type and genetically modified) and two mRNA therapeutic vaccines. He has successfully led global IND/CTAs submission for these products in over 20 countries. He also led the interactions with global health authorities (FDA/PMDA/CDE) to define the best development strategy for gene therapy products.

Madhu has over 20 years of experience in analytical R&D, quality, and manufacturing operations. Prior to joining Merck, Madhu spent most of his career with Wyeth/Pfizer. He started his career in small molecules working with early and late stage molecules and subsequently moved into Biologics, specifically working with Antibody Drug Conjugates (ADCs). He was part of the ADC programs from IND to BLA submission and post-approval phases. Madhu Siluveru has a BS in Pharmacy and a Ph.D in Analytical Chemistry from University of Georgia.