Back to Agenda
Session 7: Innovation for Dose Optimization - Updates from Project Optimus
Session Chair(s)
Mallorie Fiero, PHD
Master Mathematical Statistician, CDER, FDA, United States
Lisa Renee Bailey Iacona, PHD, MPH
Vice President, Oncology Biometrics, AstraZeneca Pharmaceuticals LP, United States
Oncology is going through a paradigm change. In the past, the Maximum Tolerated Dose was often used for Phase I dose decision-making, which led to therapies with higher toxicity without additional efficacy. Recently, there has been a reform to better characterize dose selection prior to initiating registration trials in oncology. This session will focus on dose optimization challenges and innovation in the areas of trial design, endpoints, and analysis. This session will also provide an update on FDA Oncology Center of Excellence’s Project Optimus and explore the role of statisticians in multi-disciplinary teams when considering a dose-optimization study.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss updates in FDA’s Project Optimus and ongoing development of dose optimization guidance
- Evaluate potential innovative study designs related to dose optimization
- Recognize approaches to develop a composite endpoint to select an optimal dose
Speaker(s)
Mengdie Yuan, PHD
Mathematical Statistician, Food and Drug Administration, United States
Current Regulatory Considerations on Dosage Optimization in the Development of Oncology Products
Ying Yuan, PHD
Bettyann Asche Murray Distinguished Professor, University of Texas MD Anderson Cancer Center, United States
Design Strategies and Statistical Considerations for Dose Optimization
Maozhen Gong, PHD
Statistical Science Associate Director, AstraZeneca, United States
Selection of the Optimal Dose Using Efficacy and Safety Utility - An Extension of BOIN12 Trial Design for Utility-Based Dose Finding
Julie M Bullock, PHARMD
Senior Vice President, Certara, United States
Speaker
Nam Atiqur Rahman, PHD
Division Director, FDA, United States
Speaker
Have an account?