Are you prepared for Project Optimus?
Project Optimus is revolutionising oncology drug development.
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.
How can oncology drug developers successfully implement Project Optimus?
Project Optimus aims to significantly change how early-phase oncology drug development and clinical trials are conducted, with this shift promising to enhance patient well-being by minimising side effects, improving treatment adherence and ensuring accurate drug dosing.
However, oncology drug developers face several challenges when implementing Project Optimus, including varying awareness and more complex clinical trial designs.
Our latest whitepaper explores Project Optimus in more detail, including:
- How contract research organisations (CROs) can support developers implementing Project Optimus.
- The reasons for refining dose optimisation in oncology drug development.
- The impact of Project Optimus on both patients and oncology drug developers.
- Challenges when implementing Project Optimus and solutions for overcoming them.
