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Succeed within a new oncology drug development paradigm

Oncology drug development is a complex and time-consuming process, which will be further complicated by the FDA’s new dose optimization initiative: Project Optimus.

While specific guidelines for Project Optimus have not yet been released, the FDA has announced they are no longer accepting a maximum tolerated dose (MTD) approach for investigational oncology drugs. As a result, you will need to redesign your oncology drug development program to ensure you have adequate time and resources to optimize your dosing regimen, support regulatory submissions and avoid costly delays.

38% of oncology drug developers fear the FDA’s Project Optimus will increase development timelines and costs1

Get your oncology dose right the first time

With the introduction of the FDA’s new dose optimization initiative, Project Optimus, it’s critical to reevaluate your dosing strategy to avoid costly delays. From dosing and study design to regulatory strategy and submission, Certara can help you get your dose right the first time.

Set your oncology program up for success

Under the FDA’s Project Optimus, the success of your oncology program will be rooted in readiness. Our team will partner with you to assess and strengthen your oncology program’s readiness—empowering future decisions and regulatory engagement.

Optimize your dosing strategy with a model-informed approach

Help lower the risk of toxicity for cancer patients while strengthening therapeutic response through a model-informed approach to oncology drug development. Our accomplished team of experts follow a quantitative approach to help predict drug exposure and response, determine first-in-human (FIH) dosing, and optimize clinical trial designs—so you get your dosing strategy right the first time.

Navigate a rapidly changing regulatory landscape with confidence

Since FDA feedback can take up to 75 days from the initial meeting request, properly planning for regulatory interactions is essential. Strengthen your oncology drug’s chance of approval, while avoiding costly delays, with regulatory guidance from a former-FDA Reviewer. From regulatory strategy and engagement to writing and submissions, our team of seasoned regulatory experts will help you navigate this Project Optimus every step of the way.

Empower well-informed decisions faster with cutting-edge technology

Optimize your oncology dose selection with drug performance predictions from virtual populations. The Simcyp™ PBPK Simulator can help you determine first-in-human (FIH) dosing, while our Immuno-oncology QSP Simulator helps predict clinical results for novel combinations and biologics.

Visit our Project Optimus Resource Portal