Project Optimus Podcast, Series #2
This series explores Project Optimus: what it is, what’s its advantages are, the real-world shift to optimized doses in oncology drugs, and how it is implemented in study design.
It offers expertise from Fortrea’s oncology team on regulatory strategy, clinical trial design, and data-driven approaches to dose optimization.
Each episode will provide practical insights, expert perspectives, and actionable strategies to help sponsors navigate the evolving oncology development landscape.
Episode 1: Project Optimus: Rethinking Dose Optimization in Oncology
Topics: Rethinking Dose Optimization in Oncology
What is Project Optimus, and why is it reshaping the future of oncology drug development? In this kickoff episode, we unpack the FDA’s initiative to modernize dose optimization in cancer trials. Join host Abigail Beanie as she speaks with Audrey Finesso, Senior Director of Clinical Regulatory Strategy, and Luca Cantini, Medical Director of Oncology at Fortrea. Together, they explore the implications for sponsors, regulators, and—most importantly—patients.
Participants:
- Host: Abigail Beanie Global Data reporter for Clinical Trials Arena
- Audrey Finesso, Senior Director of Clinical Regulatory Strategy, Fortrea
- Luca Cantini, Medical Director, Oncology, Fortrea
Episode 2: Operationalizing Project Optimus: Practical Strategies for Smarter Trial Design
Topics: Practical Strategies for Smarter Trial Design
How do you bring Project Optimus from concept to clinic? In this episode, Dr. Shanthi Sundaramoorthy, Senior Director of Fortrea’s Strategic Growth and Delivery Team in Oncology, shares actionable insights on how sponsors can adapt early-phase trial designs to align with the FDA’s evolving expectations. Learn how smarter dosing strategies can lead to better outcomes and more efficient development.
Participants:
- Dr. Shanthi Sundaramoorthy, Senior Director of Fortrea's Strategic Growth and Delivery Team in Oncology, Fortrea
Episode 3: Implementing Project Optimus: A Deeper Dive into Modeling, Simulation & Study Design
Topics: A Deeper Dive into Modeling, Simulation & Study Design
Behind every optimized dose is a robust framework of modeling, simulation, and thoughtful study design. Host Abigail Beanie returns to guide listeners through the technical backbone of Project Optimus. This episode explores how data-driven tools are transforming oncology trials and enabling more precise, patient-centric dosing decisions.
Participants:
- Host: Abigail Beanie
- Dr. Mark Lovern, Executive Director of Medical Science Services, Fortrea
- Dr. Richard McNally, Director of Biostatistics, Fortrea