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Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology
Session Chair(s)
Sherry Leonard, RAC
Senior Director, Regulatory Affairs
Stoke Therapeutics, Inc., United States
Use of the multiple expansion cohort design in oncology trials offers advantages and challenges. This session presents views on the success and hurdles of this design by regulators and industry. Implications for global development are also raised.
Learning Objective : Discuss the important differences between phase 1 FIH studies and the FIH multiple expansion cohort design; Identify key safety challenges and risk mitigation steps; Discuss ethical consideration with oncology studies involving expansion cohorts; Identify examples of implementation challenges and opportunities of this design; Describe lessons learned from industry and regulators.
Speaker(s)
The Use of Expansion Cohorts in First-in-Human Clinical Trials to Expedite Oncology Drug Development
Pamela Balcazar, MS
FDA, United States
Sr. Health Scientist, Oncology Center of Excellence, OC
Implementation Challenges and Opportunities with FIH Multiple Expansion Cohorts
Sherry Leonard, RAC
Stoke Therapeutics, Inc., United States
Senior Director, Regulatory Affairs
Ethical Considerations in Oncology Studies Involving Expansion Cohorts
Lindsay McNair, MD, MPH, MS
Equipoise Consulting, United States
Principal Consultant
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