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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
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Networking Opportunity
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Ticketed Event
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Student Focus

Mark Levi, PhD

Director of Regulatory Affairs
RTI
RTP, North Carolina

Dr. Mark Levi has more than 20 years of experience as a pharmacology/toxicology researcher, chemist, and regulatory affairs professional. He was trained in 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 blood products and vaccines), devices and 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 has U.S. Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER) application review experience, 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 has also managed all types of regulatory submissions and meeting types both as an FDA reviewer and a Regulatory Project Manager. Dr. Levi led the preparation and submission of IMPD and IND applications, USA 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. He currently advises clients on regulatory strategy and harmonisation.

Presentation(s):

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