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Luman is a regulatory lead for cell, tissue, and gene therapy programs with over 25 years’ experience as a regulatory nonclinical professional in pharmaceutical research and development. Clients benefit from his expertise in cell and gene therapy, biologics and small molecule regulatory consulting including IND, BLA and NDA applications and Meeting Briefing Documents.
As a program manager for antibody-drug conjugates, CAR-T therapy, monoclonal antibody, gene therapy and therapeutic protein programs for high-visibility clients, Luman has helped clients develop and implement successful regulatory strategies, especially small-sized companies with limited experience in drug development.
Luman has authored scientific and regulatory reports requiring expert regulatory and nonclinical comprehension, writing ability, and organizational skills. He has managed multiple projects and set priorities in an environment of constant change based on the demands of regulations and the needs of sponsors.
Prior to joining Parexel, Luman was a GLP compliance auditor for 20 years. Previous experience also includes the management, oversight, nonclinical GAP analyses and the development of nonclinical program strategies and study designs for small molecule, large molecule, and cell therapy programs.
Luman holds a Ph.D. in Biochemistry and Medical Science of the University of Aberdeen, Scotland, UK and a B.A. in Cell and Molecular Biology of the San Francisco State University.
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