From Innovation To Collaboration: How Project Optimus Is Influencing Emerging Biopharma And Biotech

By Matt Simmons, Senior Director, Oncology Strategy, IQVIA Biotech

The U.S. Food and Drug Administration (FDA) has introduced draft guidelines under Project Optimus, proposing that clinical trials assess multiple dosages of drugs for treating oncologic diseases. This new dose optimization paradigm poses challenges for biotech sponsors, including increased patient enrollment, trial complexity, and rising costs. To address these challenges, efforts are underway to expand Phase 1 studies to a wider range of investigator sites and adopt a patient-centric approach in study design.

Support for implementing tools such as electronic patient-reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA) to evaluate dose levels and ensure comprehensive trial safety assessments is emphasized. While dose optimization cohorts may increase trial costs, they can generate additional value for smaller companies seeking partnerships or additional funding for later phases. Navigating this new paradigm involves considering endpoints that demonstrate value and communicating this information clearly to stakeholders.

Dedication to achieving successful trial outcomes while prioritizing patient safety and trial integrity is paramount. Emphasis on dose optimization early in development strategies aims for a better balance of efficacy and tolerability. With expertise in the evolving clinical trial landscape and solutions tailored to individual needs, navigating the challenges of oncology drug development is manageable.