Clinical Pharmacology Podcast with Nathan Teuscher

Project Optimus (Ep. 21)

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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


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    Clinical Pharmacology Podcast with Nathan TeuscherBy Nathan Teuscher
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