Skip to main content
RAPS 2024 Global Regulatory Strategy Conference Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back

Mark Levi, PhD

Director of Regulatory Affairs
RTI
Washington, District of Columbia, United States

Dr. Mark Levi has more than 20 years of experience as a pharmacology/toxicology researcher, chemist, and regulatory affairs professional. Trained in small molecule medicinal chemistry and pharmacology/toxicology he has worked as a consultant on all aspects of regulatory strategy across multiple therapeutic areas encompassing both biologics (including vaccines) and biologic-device combination products with subject matter expertise in hematology, oncology, neuropharmacology, neurotoxicology, drug discovery, vaccines, cell and gene therapy, data integrity, and biologic-device combination products, as well as significant expertise with novel biologics, biosimilars, and blood products. Dr. Levi was at U.S. Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER) application review, focusing on chemistry, manufacturing and controls (CMC)-lot release, and fully accredited quality laboratory experience in the Office of Compliance and Biologics Quality (OCBQ). He also managed all types of regulatory submissions and meeting types both as an FDA reviewer and a Regulatory Project Manager in the Office of Blood Research and Review (OBRR) and Office of Tissues and Advanced Therapies (OTAT). After positions in regulatory strategy at both a consulting firm and small biotech company, he is now a Director of Regulatory Affairs where he leads 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.

Disclosure information not submitted.

Presentation(s):