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