Dr. Kramer obtained his medical degree from Columbia University and has more than 30 years of experience in drug development including regulatory affairs, pharmacovigilance, management, and domestic and international drug control and abuse liability evaluation. He has advanced the clinical development of addiction treatment medicines, opioid and non-opioid analgesics, and cancer chemotherapy in large and small pharmaceutical companies. Dr. Kramer has experience in all phases of development from pre-IND to Phase 3. He was previously a Medical Officer for the FDA Center for Drug Evaluation and Research Division of Anesthetic, Critical Care, and Addiction Drug Products. During his time with the FDA, he reviewed INDs and NDAs for analgesics in development (including NSAID, opioid, and combination products in both immediate-release and controlled-release dosage forms), the treatment of substance use disorders (including nicotine, opioid, stimulant dependence, and alcoholism) and requests for INDs for human administration of drugs of abuse.
Vice President, Clinical and Regulatory Affairs