Julie Bullock

Dr. Bullock is currently a Senior Vice President in the Integrated Drug Development (Consulting) Division of Certara. She has over 20 years of drug development experience and is a recognized drug development scientist with scientific and regulatory expertise focused in the therapeutic areas of oncology/hematology and coagulation. Julie has extensive experience in all development phases including regulatory interactions with major global health authorities (FDA, EMA, PMDA), due diligence, design of clinical development plans, pediatrics, dose-finding strategy and streamlining development for breakthrough therapies and accelerated approval. Julie is a Key Opinion Leader on the FDA’s Project Optimus (oncology dose finding) initiative and has provided risk-assessment and tactical dose justification support for over 80 early and late-stage oncology assets since the launch of Project Optimus in 2022.

In her current role, Dr. Bullock supports a global team of clinical pharmacologists with regulatory strategy and drug development experience who provide program level and strategic support to Biotech and Pharma company portfolio programs.

Prior to her role at Certara Dr. Bullock was a 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 filing applications, multiple supplemental NDA/BLA applications and countless IND related submissions submitted to the hematology/oncology division. Dr. Bullock received her Doctor of Pharmacy from Drake University and completed a drug development fellowship with the State University of New York at Buffalo and Novartis Pharmaceuticals.
Speaking In
4:15 PM - 5:15 PM
Wednesday, June 7
FDA’s Oncology Center of Excellence launched “Project Optimus” in 2021, to encourage sponsors to…
Session Room 254A