Service

FDA Project Optimus

The goal of Project Optimus is to educate, innovate, and collaborate with companies, academia, professional societies, international regulatory authorities, and patients to move forward with a dose-finding and dose optimization paradigm across oncology that emphasizes selection of a dose or doses that maximizes not only the efficacy of a drug but the safety and tolerability as well.
Specific goals include:

  • Communicate expectations for dose-finding and dose optimization, through guidance, workshops, and other public meetings
  • Provide opportunities for and encourage drug developers to meet with FDA Oncology Review Divisions early in their development programs, well before conducting trials intended for registration, to discuss dose-finding and dose optimization.
  • Develop strategies for dose finding and dose optimization that leverages nonclinical and clinical data in dose selection, including randomized evaluations of a range of doses in trials. An emphasis of such strategies will be placed on performing these studies as early as possible in the development program and as efficiently as possible to bring promising new therapies to patients.

— From the FDA Project Optimus page

The FDA has a clear goal of reducing unneeded therapies — let us help you get there.

Partnering with us

Our team can work alongside you to evaluate your preclinical efficacy data (TGI or in-vitro) and your toxicology and DMPK data. Based on this analysis, we can assist you in identifying the most appropriate human start dose and dose escalation strategy (Phase Ia), including guidance on sample collection. Using the dose escalation data, we will collaborate with you to select 2-3 doses (including MTD and Optimal Biologic Dose) for the study's dose-expansion (Phase Ib) stage while also helping with other key design elements such as sample collection and endpoint selection. We can advise whether a randomized or sequential design would be more appropriate for your study. Upon completion of Phase Ia and Phase Ib, we will conduct all necessary categorical and exposure-response analyses to identify the recommended Phase II dose (RP2D) and establish a company position. We can assist in preparing the FDA Briefing Document and attend the FDA Type D meeting with you to discuss and defend the RP2D, allowing you to move forward with the pivotal part of your Development Plan.