The Division of Monoclonal Antibodies. Kathleen A. Clouse, Ph.D., Director CTGTAC - July 26, 2007 . Mission of the DMA. … to ensure that safe, efficacious, and high quality
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Kathleen A. Clouse, Ph.D., Director
CTGTAC - July 26, 2007
… to ensure that safe, efficacious, and high quality
monoclonal antibody and related products are available to the American people to diagnose, prevent and treat the illnesses that afflict them.
… to maintain and retain a diverse, knowledgeable,
scientifically based and dedicated staff actively
involved in research and regulatory review
“Monoclonal antibodies now comprise the majority of recombinant proteins currently in the clinic, with more than 150 products in studies sponsored by companies located worldwide.”
Janice Reichert, Tufts University Center for the Study of Drug Development
Nature Biotechnology, September 2005
Research Program Objectives
Research Program Milestones