Judith Kramer, MD, MS, has been appointed to the newly created position of Executive Director of the Clinical Trials Transformation Initiative (CTTI), the recently announced FDA-Duke Public-Private Partnership. Dr. Kramer brings over two decades of leadership experience in the field of clinical research as well as the perspective of someone who has worked across multiple sectors including private medical practice, the medical products industry, and academia. She also brings experience in leading another major public-private partnership and serving in an advisory capacity to regulatory authorities.

Dr. Kramer is an Associate Professor of Medicine in the Division of General Internal Medicine at the Duke University School of Medicine. She received her MD from the University of North Carolina, Chapel Hill, in addition to a BS and MS in Pharmacy. She completed her internship and residency at Massachusetts General Hospital. She is board certified in internal medicine and practiced internal medicine in the community for 5 years. For the past 22 years, she has been involved in clinical research. She worked for ten years at Burroughs Wellcome Co., where she was Vice President, Medical and U.S. Director of 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 seven full original NDAs and 14 INDs.

From 1997 to 2006, Dr. Kramer served as the Chief Medical Officer of the DCRI and in that role she provided guidance and consultation on the formation of the regulatory services, regulatory compliance and quality assurance functions. Dr. Kramer previously served as Professor of Pharmaceutical Sciences and Director of Clinical Research Programs at Campbell University where she was responsible for developing the initial curriculum for the BS and MS degrees in Clinical Research. She also served as the Principal Investigator of the Agency for Healthcare Research and Quality (AHRQ) sponsored Duke Center for Education and Research on Therapeutics, focused on cardiovascular drugs and devices. She currently serves as a member of several national panels related to regulatory reform and policy development. In 2004 she served as a member of the FDA’s Medical Product Surveillance Network (MedSun) Expert Working Group with the Center for Devices and Radiological Health and since 2006 she has served as a member of the FDA’s Drug Safety and Risk Management Advisory Committee.

She is a reviewer for JAMA, Circulation, the American Heart Journal, the American Journal of Public Health, and the American Journal of Managed Care. She has published over 30 manuscripts in the peer-reviewed literature and two book chapters.

In her new role as Executive Director of CTTI, Dr. Kramer will oversee 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.

Dr. Kramer is located in Room #7024 in the North Pavilion on the Duke University Medical Center campus and may be reached at (919) 668-8501 or judith.kramer@duke.edu.