Never Stop Bioteching

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.