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 You can connect with Julie on LinkedIn You can connect with me on LinkedIn and send me a message Send me a message Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved

Ask this episode

“What did the council decide on item 42?” — answered with the speaker and the moment.

Transcript

Related