Catalyze Annual Meeting 2023 - Alternatives to Animal Testing: Leveraging the Modernization Act 2.0

Meeting description

Presented by Dr. Mark Levi, Director of Regulatory Affairs, RTI International

Dr. Mark Levi has more than 20 years of experience as a pharmacology/toxicology researcher, chemist, and regulatory affairs professional. He was trained in small molecule medicinal chemistry and pharmacology/toxicology and has worked as a consultant on all aspects of regulatory strategy across multiple therapeutic areas encompassing both biologics (including vaccines) and combination products.

Dr. Levi worked at FDA in the Center for Biologics Evaluation and Research (CBER) application review, focusing on chemistry, manufacturing and controls (CMC)-lot release, and in a fully accredited quality laboratory. He also managed all types of regulatory submissions and meeting types both as an FDA reviewer and a Regulatory Project Manager and led preparation and submission of foreign and FDA investigational new drug (IND) applications, biologics license applications (BLAs), and requests for expedited designations (including regenerative medicine advanced therapy [RMAT], breakthrough, and fast-track), specifically driving strategy for and data integrity within these submissions.

This meeting was recorded on September 21st, 2023.

This video is provided for educational purposes only.

This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.