FDA Project Optimus and Dose Optimization: Putting Guidance into Practice in Oncology Trials

Fierce Biotech Interview with Alex MacDonald, PhD, MSc, VP of Model Informed Drug Development at Allucent

FDA’s Project Optimus is transforming oncology drug development by moving beyond maximum tolerated dose (MTD) toward identifying the optimal biological dose (OBD). In this 15-minute expert interview, Dr. Alex MacDonald, PhD, MSc, explains what this shift means for sponsors in practice. He discusses the FDA’s evolving expectations, the role of pharmacometrics and model-informed strategies, and how proactive engagement can streamline early-phase trial design. Watch the conversation to learn how to align your oncology program with Project Optimus while keeping patient outcomes and regulatory success at the center of development.