Marc K. Walton, MD, PhD is the Associate Director for Translational Medicine in the Office of Translational Sciences at the Center for Drug Evaluation and Research, FDA.
Dr. Walton received his graduate degrees from the University of Chicago. Following a neurology residency at the University of Rochester, Rochester NY, he moved to the National Institute of Neurological Disorders and Stroke, NIH researching neurotransmitter responses in embryonic spinal cord.
Dr. Walton joined the Center for Biologics Evaluation and Research (CBER) at FDA in 1993 as a Medical Officer working on clinical trials of biological products for neurological disorders. Oversight of several additional clinical areas was added upon his appointment as Branch Chief in the Division of Clinical Trial Design and Analysis. Dr. Walton became the Division Director with clinical oversight for all non-oncology uses of biological proteins during with the transfer of jurisdiction for biological protein products from CBER to CDER. A subsequent move to the Office of Policy in the Office of the Commissioner gave involvement in a broad range of agency-wide issues. His position in the Office of Translational Sciences in CDER focuses on fostering both internal and external science and policies to support innovative approaches to therapeutic development, and includes biomarkers, clinical study design and analysis methods, liaison to external consortia and other agencies, and rare diseases.