Parexel

Parexel Consulting, a business unit of Parexel International has appointed five new consulting experts to support its growth. The consultants are based in Parexel’s new Washington, D.C.-area office, in Bethesda, MD. The team of consultants is led by Carolyn Finkle, vice president of Parexel Consulting.

“Our clients require a fusion of scientific, regulatory and business expertise to help them develop products for worldwide bio/pharmaceutical markets,” said Alberto Grignolo, Ph.D., Corporate Vice President and General Manager of Parexel Consulting. “Our expanding team of consultants in Washington, D.C., many of whom have in-depth experience as former regulators, will assist our clients in gaining regulatory approval for important products.”

Ms. Finkle has more than 24 years of experience in drug development, regulatory affairs, GMP, pharmacology, drug product safety evaluation, clinical development, post-approval requirements, and scientific research. She is responsible for management of the product development and regulatory consulting team in North America, focused on helping clients optimize all aspects of the development process for drugs, biologics, devices and combination products. Prior to joining the company, Ms. Finkle was vice president of regulatory affairs at Celsion Corp.

Lawrence Grylack, M.D., was appointed principal consultant. Prior to joining the company, Dr. Grylack served as medical officer in the Division of Pediatric Drug Development in the Office of Counterterrorism and Pediatric Drug Development, and the Division of Pulmonary and Allergy Drug Products at the FDA Center for Drug Evaluation and Research (CDER). In this role, he handled reviews of adverse event reports, INDs and NDAs, and performed consultations for other CDER Divisions and other FDA Centers.

David Morse, Ph.D., has been appointed as a principal consultant. Dr. Morse has more than 20 years of experience in pharmacology and toxicology. Prior to joining the company, he worked as a supervisory pharmacologist for CDER, where he provided strategic regulatory oversight for all phases of product development and safety testing for new therapeutics.

Sally Hargus, Ph.D., was appointed senior consultant. Dr. Hargus has more than 15 years of combined research, industry, and regulatory experience in pharmacology and toxicology aspects of drug development. Prior to joining the company she held senior positions in toxicology, including with 3M Pharmaceuticals and with the FDA’s Center for Biologics Evaluation and Research (CBER), where she reviewed pharmacology and toxicology sections of IND, pre-IND, and BLA submissions for vaccines and allergenic products.

Patrick Guinn has been appointed manager. Prior to joining the company, Mr. Guinn served as Consumer Safety Officer/Regulatory Health Project Manager at the FDA’s CDER. He has more than 10 years of FDA experience, including preparation and facilitation of regulatory meetings and negotiations, coordination of activities for multi-disciplinary review teams, management of the drug review process, and development of several regulatory Guidance documents for the industry.