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Session 3: Dose Optimization in Oncology: Finding the “Right” Dose for Patients
Session Chair(s)
Mallorie Fiero, PhD
Master Mathematical Statistician, CDER
FDA, United States
Satrajit Roychoudhury, PhD
Executive Director, Statistical Research and Innovation
Pfizer, Inc., United States
Drug development in oncology presents several challenges unique to this therapeutic area. Balancing the benefits and risks provides longer survival while maintaining or improving the quality of life. In the current oncology paradigm, the objective of phase 1 trials is to determine the highest tolerable dose, based on the assumption that higher doses will provide greater efficacy. Without formal dose-finding, the current paradigm does not adequately evaluate inter-patient variability in treatment response and toxicity. Moreover, it provides a limited picture of long-term toxicity. This session will focus on different strategies of dose determination for oncology drugs that seek to optimize dose selection as well as enable a complete understanding of the relationship between drug exposure and clinical outcomes.
Learning Objective : - Identify the limitations of current dose-finding paradigm in oncology
- Recognize FDA’s “Project Optimus” and ongoing development of dose optimization guidance
- Evaluate alternative strategies to improve dose-finding in oncology trials
- Identify key considerations for selecting appropriate dose optimization strategies in oncology
Speaker(s)
Dose Optimization in Oncology Trials
Joyce Cheng, PhD
FDA, United States
Lead Mathematical Statistician
Speaker
Paul Frewer, MS
Astra Zeneca, United Kingdom
Senior Director, Early Oncology Statistics, Oncology Biometrics
Speaker
Christoffer Boshoff
Prizer, Inc., United States
Chief Development Officer – Oncology
Speaker
Cara Rabik, MD, PhD
FDA, United States
Medical Officer
Speaker
Stacy S Shord, PharmD
FDA, United States
Deputy Division Director, Division of Cancer Pharmacology II, OCP, CDER
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