Biotechnology Heritage Award
Randall Garnick Photography.
The Biotechnology Heritage Award honors extraordinary individuals whose work in biotechnology, whether it be through discovery, innovation, commercialization, or public understanding, is helping to heal, fuel, and feed the world.
First bestowed in 1999, the award is given yearly during the BIO Annual International Convention. The Science History Institute is proud to present this award alongside the Biotechnology Innovation Organization, which represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations.
Janet Woodcock, the director of the Center for Drug Evaluation and Research at the Food and Drug Administration, will receive the 2019 Biotechnology Heritage Award. The award will be presented on June 3 at the BIO International Convention, hosted by the Biotechnology Innovation Organization (BIO).
Since joining the U.S. Food and Drug Administration (FDA) in 1986, Janet Woodcock has served in multiple senior leadership roles, including as deputy commissioner, as chief medical officer, and most significantly, as director of the FDA’s Center for Drug Evaluation and Research (CDER). Under her management the CDER staff works to foster advances in science and research with the goal of ensuring that safe, effective medical products are available to improve public health.
In 1994 Woodcock initiated a period of unprecedented change for CDER and has been instrumental in the success of many of the FDA’s modernization initiatives. Under her innovative leadership, in the 1990s the FDA built a new safety monitoring system for organizing and analyzing reports of potential adverse reactions to marketed drugs. She introduced the concept of risk management in 2000 as a new approach to drug safety, and an electronic repository for all drug reviews and approvals was created under her direction. Further, she oversaw CDER’s implementation of multiple user fee programs.
Over the years Woodcock has steered the launch of numerous FDA initiatives, including Pharmaceutical Quality for the 21st Century, the FDA’s highly successful effort to modernize drug manufacturing and regulation. She conceived and led the Critical Path Initiative, designed to move medical discoveries from the laboratory to patients more efficiently. In 2007 she launched the Safe Use/Safety First initiative in CDER, which implements a life-cycle approach to drug safety oversight. Then beginning in 2012 she oversaw a major reorganization of the generic drug program and CDER’s regulation of pharmaceutical quality, which led to the first generic drug user fee program. More recent accomplishments include development of the FDA’s Sentinel System, oversight of CDER’s New Drugs Regulatory Program modernization effort, and participation in and implementation of the 21st Century Cures Act.
She received a BS in chemistry from Bucknell University and an MD degree from Northwestern University Medical School.
The Biotechnology Innovation Organization (BIO) is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative health-care, agricultural, industrial, and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.