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Judith  M.  Kramer, MD, MS
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Judith M. Kramer, MD, MS

Senior Scientific Advisor, Clinical Trials Transformation Initiative (CTTI)

Box 3850 Med Ctr


Durham , NC 27710
Work: (919) 668-8501

Biography:

 

Dr. Kramer is trained in clinical pharmacy (BS, MS) and is board certified in general internal medicine, having practiced internal medicine in the community for 5 years. For the past 21 years, she has been involved in clinical research. She worked for 10 years at Burroughs Wellcome Co. where she was Vice-President and Director of U.S. Clinical Research. In that capacity, she oversaw 220 employees and was responsible for the scientific administration of antiviral, oncology, neurology/psychiatry, cardiovascular, and pulmonary/critical care clinical research. During that time she supervised the preparation of 7 full original new drug applications (NDAs) and 14 INDs.

From 1997 to 2006 Dr. Kramer was Chief Medical Officer at DCRI and in that role provided guidance and consultation on the formation of the regulatory affairs and quality assurance functions at DCRI.

Dr. Kramer is currently the Executive Director of a public–private partnership, the Clinical Trials Transformation Initiative (CTTI). She oversees all activities and operations of the partnership under the direction of the Chair and Co-Chair, Dr. Robert M. Califf, Vice Chancellor for Clinical Research at Duke University, and Dr. Rachel Behrman, Director of the FDA’s Office of Critical Path Programs. The goal of CTTI is to improve and modernize the operational performance of the clinical research enterprise by convening experts in the field and undertaking projects to identify existing issues related to current practice, design models for improvement, test the new procedures and compare them to previously existing systems, and develop recommendations to inform policy makers.