Description
In October 2022 the FDA provided Industry Guidance, Human
Gene Therapy for Neurodegenerative Diseases. The scope of the guidance
spans CMC, preclinical studies and considerations for clinical trial
design. Lovelace Biomedical is a nonclinical contract research laboratory
that specializes in Gene Therapy, including for neurological disorders.
On November 10, 2022 Dr. Jake McDonald and colleagues will provide a
synopsis of the FDA guidance and examples of how this guidance has and is put
into practice. This will include considerations for test article
characterization, study design, endpoints that are expected (i.e.
biodistribution, immune and neurological assessments). Particular
attention will be paid to examples of neurodegenerative diseases.
Contributors
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Jake McDonald, Ph.D.
Jake McDonald, Ph.D. is Vice President of Applied Sciences, with more than 13 years of experience in drug development and toxicology/pharmacology. He has more than 100 publications and 130 published abstracts, and he has given over 50 presentations at technical meetings.
Dr. McDonald has served on several National Academy of Science panels as well as numerous advisory and editorial boards for private industry, government and academia. His depth of experience includes pharmaceutics, drug development, risk assessment, environmental/occupational hazard assessment, medical countermeasure development and chemical-induced toxicity.
Dr. McDonald received a B.S. in biology/environmental chemistry from the University of La Verne in 1996 and a Ph.D. in aerosol chemistry and toxicology from the University of Nevada in 2000.