RE: Project Optimus27 Jul 2024 23:47
I find this bit of more interest
initiatives such as the FDA’s Project Optimus were prominently discussed at the two-day conference.
Previously, developmental paradigm for cytotoxic agents correlated higher doses with increased probability of tumor burden reduction. However, more is not necessarily better, said Jim Eamma, Executive Director, Therapeutic Strategy Lead, Oncology & Hematology at Worldwide Clinical Trials. This project essentially flips the traditional developmental paradigm on its head, he added.
Project Optimus was launched in 2021 with the intent to reform dose optimisation and dose selection for oncology candidates. The impact of the initiative will be demonstrated in the [reduced] time it takes to increase dose escalation levels, employ backfill cohorts, and ultimately take a product to market, Eamma explained.