Syneos Health Podcast | Project Optimus Series

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?

Scroll down to listen to all the episodes in this series, which will dive deeper into the regulatory, statistical, clinical, and operational implications of this evolving regulatory framework.

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

Episode 1: Navigating the Realities of 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.

Episode 2: The Regulatory Implications of Project Optimus

In this episode, Dr. Harb shifts into the host role and is joined by Zohra Lomri, Executive Director, Regulatory Affairs at Syneos Health, to discuss how this initiative is transforming dose optimization strategies and reshaping the clinical trial landscape.

The conversation delves into the FDA’s emphasis on balancing efficacy and tolerability, the shift away from maximum tolerated doses, and the integration of patient-reported outcomes. Zohra provides valuable insights on the regulatory expectations for dose-ranging studies, the importance of leveraging non-clinical data, and the role of pharmacokinetics (PK) and pharmacodynamics (PD) modeling in optimizing trial designs.