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.
Register for this webinar today to explore the transformative impact of Project Optimus on oncology drug development.
Join experts Gilles Gallant, BPharm, PhD, FOPQ, Chief Development Officer, Mythic Therapeutics; Joe Shan, Vice President, Clinical Operations, Adcentrx Therapeutics, and from Catalyst Oncology: Andrew Zupnick, PhD, Vice President, Oncology Drug Development; and Meredith Manuel, Executive Director, Consulting; for the live webinar on Wednesday, September 25, 2024, at 1pm EDT (10am PDT).
For more information, or to register for this event, visit The New Era of Project Optimus: Implications for Oncology Development Strategy.
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