Washington Editor

WASHINGTON - The Biotechnology Industry Organization said Friday it hired Gillian Woollett to head its newly established science and regulatory affairs department.

Woollett will resign her post as associate vice president for biologics and biotechnology at the Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA) Feb.17 to join BIO. Woollett will serve as BIO's vice president of regulatory affairs and as the internal and external scientific adviser.

"What Gillian does is elevate BIO's regulatory and scientific capabilities to a whole new level," Carl Feldbaum, BIO's president, told BioWorld Today. "The need here is for a regulatory affairs department that's deserving of the biotech industry."

The department will play a critical role in enabling the industry and government to work together effectively, BIO said in a prepared statement.

At PhRMA, Woollett was responsible for managing policy on research, development, manufacturing, regulatory and all related issues for biologic medicines, including therapeutic equivalence, cell and gene therapy, vaccines and challenges related to emergency biopreparedness. She also served as PhRMA's liaison to the FDA's Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research (on biologics issues).

Before joining PhRMA in 1996, Woollett was the deputy director, special science programs at the American Institute of Biological Sciences in Washington. She also was a research investigator at the Biomedical Research Institute in Rockville, Md. She holds a doctorate of philosophy in immunology from the University of Oxford and a master of arts from the University of Cambridge.

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations.