Launched in 2021 by the FDA's Oncology Center of Excellence, Project Optimus seeks to reshape traditional oncology trial designs and dosing paradigms, shifting from maximum tolerated doses to precision dosing strategies. While the FDA's hope was that the added time and cost of collecting comprehensive dose and exposure response data would benefit both patients and sponsors, there is also concern and debate in the biotech community that, if the Optimus formula is closely followed, the additional time, cost, and patient needs may, in fact, be crippling to cash-strapped emerging companies. 

So what is the reality around Project Optimus? And how best can it be implemented and navigated?

Kicking off a new special series on Project Optimus, in this episode Nick Kenny, Chief Scientific Officer at Syneos Health, is joined by Dr. Wael Harb, Vice President on the Syneos Health Medical Oncology Team, to explore this transformative initiative, diving into the implications for biotech companies and discussing the balance between upfront investment and long-term benefits, the operational challenges of implementation, and the critical role of early planning.

Stay tuned for upcoming episodes in this series, which will dive deeper into the regulatory, statistical, clinical, and operational implications of this evolving regulatory framework.

For more insights from our oncology experts:

Syneos Health Podcast | A Site-Specific Approach to Optimizing Diversity in Oncology Trials

WEBINAR | Transforming Oncology Drug Development: Insights from Healthcare Providers on the Frontlines of Cancer Care

Syneos Health Podcast | Circulating Tumor DNA: Transforming Oncology Clinical Trials

Navigating Tumor-Agnostic Drug Development: Value, Challenges and Strategic Insights for Sponsors

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

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