Development Advice for Gene Therapy Products
In July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy. The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products. This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development.
Scott Burian, Ph.D.
Senior Research Scientist
Dr. Burian has more than 15 years of experience in the pharmaceutical industry and has contributed to the development of a diverse range of small molecule, biologic, and nanoparticle-based products. He is a broadly-experienced regulatory affairs professional specializing in pharmaceutical development, regulatory strategy, and chemistry, manufacturing, and controls (CMC). Dr. Burian has supported the development of lingual spray, solid oral, topical, parenteral, and nasal spray dosage forms. Prior to joining Rho in early 2016, Dr. Burian served as the Director, Regulatory Affairs CMC at Mallinckrodt Pharmaceuticals. In this role, he provided input into drug substance and drug product development plans,…
Jamie Chang, M.D.
Melding clinical pragmatism with scientific rigor to better plan and conduct high-quality clinical trials, Dr. Jamison Chang is a board-certified internist with over 15 years of clinical experience. While his experience includes a broad range of disease entities (both ambulatory and hospital settings), a significant portion of Dr. Chang’s clinical practice has been focused in the treatment of infectious disease patients. Over the course of his clinical career, Dr. Chang has diagnosed and treated patients with pulmonary, soft-tissue, urinary tract, orthopedic, central nervous system, and bloodstream infections in both outpatient, acute, and critical care settings. Dr. Chang’s collective experience in…
David Shoemaker, Ph.D.
Senior Vice President, R&D
Dr. David Shoemaker has been a trusted regulatory advisor to international clientele for close to 30 years, providing regulatory and scientific expertise for integrated product development programs across a wide range of therapeutic areas. Dr. Shoemaker has extensive experience in all stages of investigational product development, has moderated dozens of regulatory authority meetings, and has managed and contributed to over one hundred INDs, over a dozen IMPDs, and dozens of successful marketing applications across the majority of reviewing divisions at FDA and several international regulatory authorities. At Rho, Dr. Shoemaker serves as an expert scientific and regulatory reviewer for documents…