ARTICLE | Product Development

Navigating dose optimization requirements as a small biotech

FDA’s dose optimization push presents a burden for some small biotechs, and an opportunity for others

February 1, 2023 3:53 PM UTC

There’s no doubt that FDA’s Project Optimus and newly issued dose optimization guidance will benefit patients, but with added resource requirements in the earliest stages of clinical development, it’s also creating new challenges for some smaller biotechs.

For any targeted cancer companies that haven’t been following Project Optimus, now is the time to take notice and align with FDA on its new dose-finding expectations...