Project Optimus –FDA’s “New” Dose Optimization & Selection Paradigm in Oncology Drug Development


Dr. Brian P. Booth and Dr. Hao Zhu from the Office of Clinical Pharmacology (OCP) at the FDA will present and discuss Project Optimus, an initiative from the Oncology Center of Excellence (OCE) to reform the dose optimization and dose selection paradigm in oncology drug development. Clinical pharmacology strategy and model-based approach supporting Project Optimus will be discussed with the following outline:
• Introduction-Project Optimus
• Why we need to optimize dose for oncology products
• Case studies
• Leveraging what we know
• The Role of Model-Informed Drug Development (MIDD) in Dose Optimization

Panelist(s): Dr. Brian P. Booth, Division of Cancer Pharmacology I and
Dr. Hao Zhu, Division of Pharmacometrics, FDA CDER/Office of Clinical Pharmacology

Moderator: Tom Sun, Vice President, Strategic Consulting Services, Simulations Plus

Host: Arlene Padron, Corporate Marketing Director, Simulations Plus

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