Chris Sheth, PhD
Senior Consultant
Dr. Sheth served as a pharmacology/toxicology reviewer and supervisor at the FDA in CDER’s Office of Hematology and Oncology Products for nearly 7 years. He reviewed or oversaw over 250 pre-INDs, 1,000 INDs and 175 NDAs, BLAs and/or supplements. As a result, hundreds of compounds entered Phase 1 clinical trials and 40 new molecular entities and 4 biosimilars entered the market, including 21 with pediatric indications. He has extensive regulatory experience in all aspects of nonclinical toxicology and safety pharmacology assessments for small and large molecules, with an emphasis on the vast array of drugs and biologics indicated for the treatment of malignant and nonmalignant hematological conditions.
Prior to his position at Aclairo, Chris gained experience in GLP animal studies while working as a report coordinator and assistant toxicologist at Covance, then received PhD training in immunotoxicology at the Medical College of Virginia, and worked in the EPA’s IRIS Program writing the Toxicological Reviews that provide a foundation for setting air and water quality standards and clean-up levels for contaminated manufacturing facilities, processing plants, landfills, and mining sites.
At Aclairo, Dr. Sheth’s FDA experience will provide clients with insights on regulatory toxicology related to drug and biologic product development across the CDER divisions. His additional capabilities include design of complete safety assessment strategies including development and reproductive toxicity and carcinogenicity, reformulations, route of administration switches, and expert guidance on requests for waivers.
Prior to his position at Aclairo, Chris gained experience in GLP animal studies while working as a report coordinator and assistant toxicologist at Covance, then received PhD training in immunotoxicology at the Medical College of Virginia, and worked in the EPA’s IRIS Program writing the Toxicological Reviews that provide a foundation for setting air and water quality standards and clean-up levels for contaminated manufacturing facilities, processing plants, landfills, and mining sites.
At Aclairo, Dr. Sheth’s FDA experience will provide clients with insights on regulatory toxicology related to drug and biologic product development across the CDER divisions. His additional capabilities include design of complete safety assessment strategies including development and reproductive toxicity and carcinogenicity, reformulations, route of administration switches, and expert guidance on requests for waivers.