Julie Bullock, Pharm.D. is Senior Vice President and Head of Clinical Pharmacology & Translational Medicine at Certara. She has over 15 years of drug development experience and is a recognized drug development scientist with clinical pharmacology and regulatory experience focused in the therapeutic areas of hematology/oncology and coagulation. She has unique insight in pediatric development, oncology dose-finding strategy and streamlining development for breakthrough therapies and accelerated approval. Julie has extensive experience in all development phases of therapeutics including regulatory interactions with major global health authorities (FDA, EMA, PMDA), due diligence, and design of clinical development approaches behind multiple filings.
In her current role, Dr. Bullock supports a global team of clinical pharmacologists with broad regulatory strategy and drug development backgrounds who create value for clients across the drug development ecosystem and ultimately accelerate patients’ access to medicines.
Prior to her role at Certara Dr. Bullock was the Clinical Pharmacology Team Leader for the Hematology/Oncology review team in the Office of Clinical Pharmacology at the Center for Drug Evaluation and Research at the FDA. Julie’s FDA career spanned 10 years where she contributed to over 14 new molecular entity NDA/BLA applications, multiple supplemental NDA/BLA applications, and was involved in the review all IND-related submissions submitted to the hematology/oncology division. Dr. Bullock received her doctor of pharmacy from Drake University and completed a clinical pharmacology drug development fellowship with the State University of New York at Buffalo and Novartis Pharmaceuticals.
ADC Review, Journal of Antibody-drug Conjugates (ISSN 2327-0152) is an international peer-reviewed publication designed to serve the needs of a diverse community of individuals including academia, life sciences, pharma, research, clinicians and physicians. Along with regulatory affairs, we also cover government authorities and representatives from payers to policymakers.