Live From BIO 2010: Hamburg discusses advancing regulatory science
CHICAGO - FDA Commissioner Margaret Hamburg addressed attendees at the BIO 2010 conference, where she emphasized the need to strengthen regulatory science to evaluate the safety and efficacy of products more quickly to get them to the people. Without strengthening regulatory science, many promising technologies may be abandoned because there wasn't the know-how to see their potential.
She added that she wants the FDA to serve as a gateway, not a barrier, for allowing products to get to the market. She urged companies to work with academia and other institutions to ensure that regulatory science advances.
Barry Gertz, SVP global clinical development and regulatory affairs at Merck, agreed that improving regulatory science is important. He emphasized that industry must collaborate with other stakeholders--including academia, government and patient groups--to advance this science. He also stressed the need for effective communication on the part of companies in discussing the risks and benefits of drugs they develop.
Gertz said Merck has been deploying the latest technologies to increase the efficiency of drug development, as well as working to maximize its collaborations. He cited Merck's work with other companies--such as its oncology collaboration with AstraZeneca--and government--including its membership in the Foundation for the National Institutes of Health Biomarkers Consortium--as partnerships geared toward improving regulatory science.