Ravishankar Vadali
About Ravishankar Vadali
Ravishankar Vadali is a Director of CMC Process Development at Ocugen and a Senior Director at Aruvant, with significant experience in the biopharmaceutical sector. He has held various leadership roles and contributed to regulatory interactions and CMC sections of multiple INDs and BLAs.
Work at Ocugen
Ravishankar Vadali serves as the Director of CMC Process Development at Ocugen, a position he has held since 2022. Based in Malvern, Pennsylvania, he focuses on the development and management of Chemistry, Manufacturing, and Controls (CMC) processes. His role involves overseeing the technical aspects of product development and ensuring compliance with regulatory standards.
Current Roles and Committees
In addition to his role at Ocugen, Vadali is an active member of the ASGCT CMC Committee, a position he has held since 2022. He also serves as the Senior Director of CMC Gene Therapy at Aruvant, where he has been employed since 2022 in Philadelphia, Pennsylvania. His involvement in these organizations highlights his commitment to advancing gene and cell therapy development.
Professional Background
Vadali has an extensive background in the biopharmaceutical industry, with significant experience in CMC roles. He worked at The Janssen Pharmaceutical Companies of Johnson & Johnson as an Associate Director/Principal Scientist from 2013 to 2021. Prior to that, he held positions at GlaxoSmithKline Biopharm R&D and Eli Lilly and Company, contributing to various aspects of drug development and regulatory compliance.
Education and Expertise
Ravishankar Vadali earned his Ph.D. in Bioengineering from Rice University, completing his studies between 1998 and 2003. He also holds a Bachelor's degree in Chemical Engineering from the Indian Institute of Technology, Madras. Additionally, he obtained a Business Foundations Management Certificate from The Wharton School, enhancing his management skills within the biopharmaceutical sector.
Achievements in Biopharmaceuticals
Vadali is recognized as a CMC Subject Matter Expert in the biopharmaceutical industry. He has authored and consolidated CMC sections for multiple Investigational New Drug applications (INDs) and Biologics License Applications (BLAs) for various therapeutic assets. His expertise includes leading interactions with regulatory agencies such as the FDA and EMA, and he has contributed to numerous conference presentations, publications, and patents in his field.