Kendle

Timothy Forsey, Ph.D. has been appointed principal regulatory affairs consultant at Kendle, specializing in providing regulatory affairs guidance to biotechnology customers. He will be based in the Ely, Cambridgeshire office in England and will work with customers to gain regulatory approval for marketing authorizations. Dr. Forsey will provide customers with advice on strategy and regulatory approaches to development and assist them with dossier preparation.

“As biotechnology’s overall contribution to the healthcare arena continues to grow, so will the demand for outsourcing services, as new therapies move from preclinical to the clinical phases of drug development,” said Melanie Bruno, Ph.D., vice president global regulatory affairs and quality. “Tim Forsey’s experience with this customer group and in the regulatory environment will be a tremendous asset to our biotech and pharmaceutical customers seeking to move their new compounds from discovery to market approval,” she added.

Dr. Forsey previously served as head of biologicals and the biotechnology unit for The Medicines and Healthcare products Regulatory Agency (MHRA), where he represented the UK on the Biologics Working Party of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA). He also worked as senior director, head of European regulatory affairs for Shire Human Genetic Therapies, Ltd. Prior to that, he worked for Pharmacia, Amgen, the National Institute for Biological Standards and Control and the University of London. He brings more than 30 years of pharmaceutical, governmental and research experience to his new role at Kendle.