Lucas Kempf, M.D.

Lucas Kempf, M.D.

Lucas Kempf, M.D.

Vice President, Technical

Lucas has 15 years of pharmaceutical R&D in academia and government from basic research, translational sciences, design and conducting clinical trials to regulatory senior leadership management positions at the FDA. He was also the former Director of Rare Disease program Office of New drugs and former team lead for Psychiatric Products for the CDER Food and Drug Administration. 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 Director of 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 his 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.

Connect With Me

We are always available for a conversation.

*  

We are always available for a conversation.

Submitting...

Communication Preference

Communication Preference