Joseph Randall, Ph.D.

Director of Toxicology

Joseph C. Randall, Ph.D., is the Director of Toxicology. Dr. Randall brings more than 20 years of drug development experience in the design, conduction and reporting of regulated toxicology studies in support of IND and NDA applications for pharmaceutical and biotechnology companies. His doctoral and postdoctoral research in neurotoxicology was conductedat the University of Michigan. He and has worked at multiple small and mid-sized pharmaceutical companies in Boston and the San Francisco area.

His expertise includes lead selection, lead optimization, in-vitro and in-vivo toxicology studies, safety pharmacology, genetictoxicology, and carcinogenicity assessment in rodents. Dr. Randall has detailed knowledge of FDA, ICH, and OECDguidance’s that pertain to the design and conduct of general and specialized toxicology studies. His areas of therapeutic expertise include the safety assessment of antivirals and drugs to treat neurodegenerative diseases, cancer, and ocularindications. He has more than 10 years of project team experience and has managed many outsourced bioanalytical, pharmacokinetic, and GLP toxicology studies in support of Phase 1 and 2 clinical trials. He has also co-authored 5 successful NDAs and 10 INDs using the common technical document format for regulatory submissions.

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