Today’s episode was about Project Optimus, the FDA initiative to improve dose selection and optimization for oncology products. Julie Bullock was a guest on this episode and shared her expertise as a former oncology clinical pharmacology reviewer at the FDA and as a current consultant in the pharmaceutical industry.

Links discussed in the show:


Project Optimus FDA
List of FDA guidances and publications for Project Optimus
May 2022 FDA-ASCO workshop: Getting the Dose Right: Optimizing Dose Selection Strategies in Oncology
Sept 2023 Second Annual FDA ASCO WORKSHOP on Getting the Dosage Right (this one focused on combinations)
Feb 2024 FDA/AACR Public Workshop: Optimizing Dosages for Oncology Drugs
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