It has been and big year for gene therapy.  In the past 12 months, three gene therapy products received approval from FDA, and 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.

Featured Speakers

David Shoemaker, Ph.D.

Senior Vice President, R&D

Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development.  He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with products at all stages of the development process. Dr. Shoemaker has managed the regulatory strategy for programs involving multiple therapeutic areas, including hematology, oncology, cardiology, pulmonology, infectious diseases, genetic enzyme deficiencies, antitoxins, and anti-bioterrorism agents.

Jamison Chang, MD

Medical Officer

Jamison Chang, MD, medical officer, is a board-certified internist with over 15 years of clinical experience with a broad range of disease entities in both the ambulatory and hospital settings. After completing his residency and chief residency at UNC Chapel Hill, he obtained additional training in nephrology as well as a master’s degree in clinical research (MS-CR). These experiences allow Dr. Chang to meld clinical pragmatism with scientific rigor to help plan and conduct high quality clinical trials.

Dana Minnick, Ph.D.

Senior Research Scientist

Dana Minnick, PhD, DABT, RAC, is a board certified toxicologist and general regulatory affairs professional with 20 years’ experience leading and supporting drug and biologics programs throughout the development lifecycle.  Dr. Minnick has extensive experience in leading multi-disciplinary drug development teams to successful regulatory filings.  She has led and contributed to many marketing authorization applications.

Scott Burian, Ph.D.

Senior Research Scientist

Scott Burian, Senior Regulatory Scientist, is a broadly-experienced regulatory affairs professional specializing in pharmaceutical development, regulatory strategy, and chemistry, manufacturing, and controls (CMC).  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 gene therapy products. 


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