Implications for Oncology Development Strategy
Initially drafted in January 2023 and finalized in August 2024, the US Food and Drug Administration (FDA) released guidance tied to Project Optimus, titled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.”
The Project Optimus initiative recommends oncology drug developers move away from traditional approaches of determining the maximum tolerated dose to building dose optimization strategies into clinical development plans that balance safety, tolerability and efficacy.
Since the release of the guidance, early-phase oncology drug development has shifted dramatically, including new dose escalation designs (a 3+3 is no more), larger sample sizes, real-time PK/PD sampling, randomization between doses and global reach for patient access.
While the new guidance has led to larger sample sizes, larger global footprints and higher study costs, Project Optimus aims to ensure a more robust safety and efficacy profile early in the development cycle. This can result in streamlined later-phase studies and a more comprehensive understanding of the asset, enhancing the probability of registrational success.
In this webinar, the expert speakers will provide tangible examples and case studies of how drug development has played out in the Project Optimus era. By reviewing case studies and their experiences, they will uncover lessons learned and best practices in interpreting the guidance, in addition to exploring the changing regulatory landscape.
The panel:
- Andrew Zupnick, PhD, Vice President, Oncology Drug Development, Catalyst Oncology (Moderator)
- Meredith Manuel, Executive Director, Consulting, Catalyst Oncology
- Gilles Gallant, BPharm, PhD, FOPQ, Chief Development Officer, Mythic Therapeutics
- Joe Shan, VP ClinOps, Adcentrx Therapeutics
