Project Optimus

Project Optimus is a strategic initiative spearheaded by the US FDA aimed at modernizing and streamlining the regulatory review process for new drug applications & biologics license applications. Its objectives include enhancing efficiency, consistency, and predictability through the utilization of advanced data analytics, automation, and collaborative tools. 

Project Optimus is geared towards optimizing resources, refining regulatory decision-making, and expediting the approval of groundbreaking therapies while upholding stringent safety and efficacy standards.

We are committed to assisting you in the evaluation of preclinical pharmacology/toxicology data as well as DMPK data, and in determining the appropriate starting dose and dose escalation strategy for Phase I. Leveraging insights from the dose escalation phase, we will assist in selecting the most suitable doses for the expansion phase, while also providing guidance on study design. Following the completion of Phase I, comprehensive data analyses, including exposure-response analyses for efficacy and safety, will be conducted to identify the recommended Phase 2 dose (RP2D).

Our team will support you in preparing for regulatory meetings where justification for the RP2D will be thoroughly articulated, facilitating smooth progression to the pivotal phase of your drug development journey.