Regulatory Affairs and Biostatistics Advisor
Cleveland Clinic Florida - Weston
Dr. Bittman has served as a senior advisor to Cleveland BioLabs since 2010. He has more than 25 years of experience in clinical trial design, clinical development and strategies, and US and international regulatory interactions. Since 2003, Dr. Bittman has consulted with companies on NDA, BLA and PMA advisory committees and dispute resolution preparation, protocol development, randomization plans, statistical analysis plans, modeling of trial outcomes, meta-analysis, staff recruitment and selection, evaluation of bids and proposals and statistical method development. Between 1984 and 2003, Dr. Bittman held positions of increasing responsibility at Searle, Monsanto, Pharmacia and then Pfizer. As Director of Cardiovascular Statistics he was responsible for statistics for a global program of 15 Phase 3 hypertension trials and a cardiovascular mortality/morbidity trial of 6,600 patients. He served on the pediatric, regulatory submissions, NDA and package insert teams and on the joint R&D-commercial publications working group. Dr. Bittman holds Masters and Ph.D. degrees from the University of Wisconsin.