Timothy Forsey, former head of the Biologicals and the Biotechnology Unit for The Medicines and Healthcare Products Regulatory Agency (MHRA) in England, just accepted a position at contract research organization (CRO) Kendle International providing regulatory affairs guidance to the company’s biotechnology customers.

Based in Kendle’s Ely, Cambridgeshire, England, office, Forsey will work with customers to gain regulatory approval for new marketing authorizations and changes to existing marketing authorizations, said the company in a release. He will provide advice on strategy and regulatory approaches to development, interact on customers’ behalf with regulatory agencies and assist them with dossier preparation.

Biotech Burst

Forsey is the latest member of a team of pharmaceutical, clinical and non-clinical biotechnology professionals Kendle has assembled with backgrounds in regulatory agencies on three continents.

At the MHRA, Forsey was involved with licensing and scientific issues, and represented the United Kingdom 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. Prior to that, Forsey worked for Pharmacia, Amgen, the National Institute for Biological Standards and Control and the University of London.

He earned a doctorate in microbiology from the University of London and a Bachelor of Science in microbiology from the University of Surrey, England.

Revenues Up, Income Flat

Kendle (Nasdaq: KNDL), is the fourth-largest provider of Phase II-IV clinical development services worldwide. The company recently reported record net service revenues for the second quarter of 2007: $97.8 million, an increase of 58 percent over net service revenues of $62.1 million for second quarter 2006.
Net income stayed flat, though. The company reported net income of approximately $4.3 million in both the second quarter of 2007 and 2006.

—by Suz Redfearn