Jeffrey P. Kittrelle, M.D.
Jeff Kittrelle is the founder and President of SPCI. Over the past 25 years, he has served his clients as scientific advisor and medical monitor for over 500 clinical trials - spanning disease indications in oncology, central nervous system disease, gene therapies, obesity, pain, infectious disease, gout, fibromyalgia, PTSD and headache, and has been instrumental in the preparation and success of numerous regulatory submissions in the U.S. and abroad, including numerous IND and Biologics Licensing and New Drug Applications. Many of the programs Dr. Kittrelle has consulted for culminated in FDA marketing approval, including for Vectibix®, Silenor®, Potiga®, Contrave®, Zurampic®, Sivextro®, Nuplazid®, Spinraza® and most recently Zynrelef®).
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Dr. Kittrelle is board certified in internal medicine and has over a decade of clinical practice experience in internal and emergency medicine. He received his medical degree in 1984 from the University of California, San Diego. After completing residency in internal medicine, Dr. Kittrelle joined Scripps Clinic and Research Foundation in La Jolla, California in 1990, where he was in clinical practice for ten years. He is a member of the American College of Physicians. Prior to starting SPCI in 2000, Dr. Kittrelle was also Director of Medical Services for Quintiles in San Diego.
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In addition to strategic planning, program development and preparation of regulatory submissions, Dr. Kittrelle directs SPCI's medical monitoring services. He co-authored the Integrated Summary of Safety for a successful Biologics Licensing application and 7 New Drug Applications, as well as the NDA Special Reports analyzing effects of several candidate molecules on cardiac repolarization (QTc). These applications included the NDA and QTc Special Report for Somaxon Pharmaceuticals' hypnotic agent, Silenor®, approved for marketing by the U.S. Food and Drug Administration in March 2010.