Project Optimus: Early-stage haste can lead to waste
The study designs and dose selection strategies that have supported decades of oncology drug development are now crumbling as the FDA’s Project Optimus takes full effect. The agency is now scrutinizing Phase 1 and 2 studies to see whether they pinpoint the dose that is biologically effective and maintains a truly acceptable safety profile. The added time and cost to achieve this objective will pay off in products with a defined risk-benefit profile, smoother regulatory path, better long-term patient adherence, and improved quality of life. In turn, this will sustain uptake and market share. In this webinar, we will share several techniques, which we’ve found in our work with clients that can help companies achieve this new standard, including:
- Using smarter, adaptive designs to conduct robust, randomized, and data-rich early dosing studies, combined with modeling techniques that integrate pharmacokinetics, safety, pharmacodynamics, and efficacy
- Complementing the evidence dossier with data on dynamic endpoints, such as tumor growth rate (TGR), tumor growth kinetics (TGK), and circulating tumor DNA (ctDNA)
- Gathering toxicity data directly from patients using tools such as the NCI’s Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
