Whitepaper Overview
Project Optimus is revolutionising oncology drug development. Learn more about the challenges this brings and solutions for successful implementation.
In 2021, the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) launched Project Optimus, an initiative aiming to revolutionise dose optimisation and selection in early-phase oncology drug development.
Shifting away from the maximum tolerated dose (MTD) and other traditional methods, Project Optimus prioritises a thorough evaluation of safety, tolerability and efficacy to pinpoint optimal therapeutic doses of oncology drug products before approval.
Sign up to access our resource
Thanks for signing up
Please click the download link below to access your requested resource
Download resource