Lucas Kempf, M.D.

Lucas Kempf, M.D.

Lucas Kempf, M.D.

Vice President, Technical

Lucas has 8 years of experience in drug review, development, and regulatory experience at the U.S. Food and Drug Administration most recently in the role of Associate Director of Rare Diseases in CDER. He was responsible for all Divisions performing the scientific review and evaluation of rare disease therapeutic drugs and biologics subject to regulation by the CDER. He has strong knowledge of review and development of small molecules and biologics targeting the central nervous system.

Work Experience

Lucas has experience in managing, developing and implementing the multi-disciplinary reviews for marketing applications (NDAs & BLAs) within CDER. He managed an international regulatory program with outreach and program development with EMA, Health Canada, and other regulatory bodies. Lucas co-authored inter-center and intra-center draft and final Guidances to Industry on drug development for common issues for rare diseases drug development, natural history studies, pre-IND meetings, rare pediatric priority review voucher programs, and eligibility criteria among other specific rare disease guidances. He is a dynamic leader with demonstrated ability to strategically build and lead multidisciplinary teams and to manage and influence within a matrix organization around novel innovation.

Prior to joining Parexel, he held several other positions at the FDA including Acting Associate Director for Rare Diseases Program, Senior Medical Reviewer for Rare Diseases and Medical Genetics Division, and Team Leader and Senior Medical Reviewer within OND’s Division of Psychiatric Products. At the NIMH, he held several positions both in the intramural and extramural program in addition to serving on the strategic planning committee. 

Education

Lucas received her M.D. from University of Kansas School of Medicine in Kansas City, KS. He completed his Psychiatry residency at The Johns Hopkins Medical Institute Baltimore, MD. He was a Clinical Research Fellow at the National Institute of Mental Health in the National Institute of Health, Bethesda, MD. He is board certified with the American Board of Psychiatry and Neurology.

We are always available for a conversation.

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