Optimizing Tomorrow’s Drug Development with Project Optimus: Precision Dosing IS Precision Oncology
Project Optimus, spearheaded by the US FDA’s Oncology Center of Excellence, represents a paradigm shift in the approach to oncologic drug development.1-3 The guidance emphasizes the crucial need to identify optimal dosages early in the drug development process and an initiative designed to revolutionize the clinical development of prescription drugs for oncologic diseases. With a primary focus on optimizing dosage to maximize therapeutic benefits while minimizing toxicity, Project Optimus introduces key recommendations for sponsors and drug developers.
