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

0:00 Title Page 2:15 Speaker Introduction 5:15 Webinar Outline 6:05 Project Optimus Overview 8:05 List of approved oncology drugs 13:25 Dose Finding Schematic 21:33 Take Home Messages 22:25 Dose Optimization Strategies 25:48 MIDD for Oncological Product Development 32:08 MIDD Paired Meeting Program 38:50 Summary of Dose Finding/ Optimization 41:21 Trial Simulation for Alt Prime Dosing 41:50 Take Home Messages Dr. Brian P. Booth and Dr. Hao Zhu from the Office of Clinical Pharmacology (OCP) at the FDA 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. 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 For more information visit: https://www.simulations-plus.com/