CARY, N.C., 12/8/2021 – CATO SMS, a global provider of specialized clinical research solutions, announced today that it has appointed Marcus S. Delatte, Ph.D. as vice president of nonclinical regulatory strategy. Dr. Delatte brings to CATO SMS 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 as vice president of technical and as a principal consultant.
About CATO SMS
CATO SMS is a global provider of clinical research solutions, including strategic consulting, full-service clinical trial operations, biometrics, and clinical pharmacology. With more than 30 years of experience focusing on the needs of small and emerging biopharmaceutical companies, CATO SMS effectively designs and executes studies — from strategy to approval — in complex indications and modalities across a variety of therapeutic areas with a proven center of excellence in oncology. CATO SMS’ regulatory, therapeutic and operational expertise enables the company to meet goals and exceed expectations. Visit CATO-SMS.com for more information.