The Oncology Center of Excellence (OCE) Project Optimus aims to refine dose optimisation in oncology by focusing on the safety and tolerability of a drug and not just efficacy.

The goals for Project Optimus include the undertaking to “Develop strategies for dose finding and dose optimization that leverages nonclinical and clinical data in dose selection, including randomized evaluations of a range of doses in trials. An emphasis of such strategies will be placed on performing these studies as early as possible in the development program and as efficiently as possible to bring promising new therapies to patients”.¹

During this complimentary seminar, you will gain insight on:

• How Project Optimus will affect Clinical Development Plans
• Considerations for Statistical Designs
• Operationalising Project Optimus: A Case Study

The event will close with a short networking session with the presenters and your industry colleagues

¹ https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus Accessed May 1, 2024