What To Know
- managed Investigational New Drug (IND) and New Drug Applications (NDA) as a senior pharmacology/toxicology reviewer at the FDA’s CEDR Division of Anesthesia, Analgesia, and Addiction Products (DAAAP).
- Delatte joins CATO SMS from Parexel International where he held the role of vice president of technical and as a principal consultant.
CATO SMS: Marcus S. Delatte PhD. has more than 10 years of experience as a senior pharmacology/toxicology reviewer and regulatory scientist with the U.S. Food and Drug Administration (FDA).
Dr. Delatte will provide nonclinical and regulatory strategic consulting to CATO SMS’ growing base of small and mid-size biopharmaceutical clients to advance their complex development programs. Prior to joining CATO SMS, Dr. Delatte:
- managed Investigational New Drug (IND) and New Drug Applications (NDA) as a senior pharmacology/toxicology reviewer at the FDA’s CEDR Division of Anesthesia, Analgesia, and Addiction Products (DAAAP)
- served as a member of the FDA Biologics Subcommittee, Pharm/Tox Recruitment Committee and Cannabis Working group
- provided strategic guidance to clients on the nonclinical aspects of drug development in biologics, biosimilars, small molecules and drug-device products
- worked in multiple therapeutic areas including oncology, inflammation, cardiovascular, pain, infectious disease, neuroscience, and rare disease
“Dr. Delatte is an industry veteran with extensive expertise leading project teams in preparing and reviewing a comprehensive range of regulatory submissions,” said Mark A. Goldberg, M.D., chairman and ceo, CATO SMS. “His experience with the FDA has enabled him to create realistic and effective product development strategies that have helped accelerate the delivery of products to patients who need them. Dr. Delatte further strengthens our considerable expertise in regulatory affairs and deepens our scientific knowledge.”
Dr. Delatte joins CATO SMS from Parexel International where he held the role of vice president of technical and as a principal consultant.