Published on PharmaPhorum March 2023
The US Food and Drug Administration’s (FDA) Oncology Center of Excellence officially announced its Project Optimus initiative draft guidance in January 2023, and pharmaceutical and biotechnology companies are taking heed. The guidance aims to help clinical trial sponsors identify the optimal dosage(s) for oncology treatments in early-stage trials, instead of focusing on maximum tolerated dose as has been traditionally done for many years. Oncology trial sponsors, whether large pharmaceuticals or smaller biotechs, are having to navigate new ways of planning and operating early phase oncology trials. As consultative partners, we are seeing firsthand what business-impacting questions and concerns these companies are working through, while recognizing the importance of this patient-centered approach.
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