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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)
Current Regulatory Considerations on Dosage Optimization in the Development of Oncology Products
Mengdie Yuan, PhD
Food and Drug Administration, United States
Mathematical Statistician
Design Strategies and Statistical Considerations for Dose Optimization
Ying Yuan, PhD
University of Texas MD Anderson Cancer Center, United States
Bettyann Asche Murray Distinguished Professor
Selection of the Optimal Dose Using Efficacy and Safety Utility - An Extension of BOIN12 Trial Design for Utility-Based Dose Finding
Maozhen Gong, PhD
AstraZeneca, United States
Statistical Science Associate Director
Speaker
Julie M Bullock, PharmD
Certara, United States
Senior Vice President
Speaker
Nam Atiqur Rahman, PhD
FDA, United States
Division Director
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