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Virtual

Mar 29, 2023 10:00 AM - Mar 31, 2023 4:15 PM

(US Eastern Standard Time)

DIA/FDA Biostatistics Industry and Regulator Forum

Join us virtually from the comfort of your home/office March 29-31 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 7: Innovation for Dose Optimization - Updates from Project Optimus

Session Chair(s)

Mallorie  Fiero, PhD

Mallorie Fiero, PhD

Master Mathematical Statistician, CDER

FDA, United States

Lisa Renee Bailey Iacona, PhD, MPH

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

Current Regulatory Considerations on Dosage Optimization in the Development of Oncology Products

Mengdie Yuan, PhD

Food and Drug Administration, United States

Mathematical Statistician

Ying  Yuan, PhD

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

Maozhen  Gong, PhD

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

Julie M Bullock, PharmD

Speaker

Julie M Bullock, PharmD

Certara, United States

Senior Vice President

Nam Atiqur Rahman, PhD

Speaker

Nam Atiqur Rahman, PhD

FDA, United States

Division Director

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