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Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates
Session Chair(s)
Yao-Yao Zhu, MD, PhD
Regulatory Affairs Director
AstraZeneca, United States
This forum provides a general view and challenges of the study design in cell and gene therapy trials. A panel of experts interpret FDA guidance, share their own experience for study design, and discuss the trends in this area.
Learning Objective : Describe regulatory principles of the trial design for cell and gene therapy products; Identify specific design elements such as selection of study population; Discuss the selection of control, safety monitoring; Discuss challenges and new trends.
Speaker(s)
Panelist
Katherine A. High, MD
Rockefeller University, United States
Co-Founder and Former President, Sparks Therapeutics; Visiting Professor
Panelist
Vaishali Popat, MD, MPH
FDA, United States
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER
Clinical Considerations for Oncology Cell and Gene Therapy Trials
Ke Liu, MD, PhD
Marengo Therapeutics, United States
Chief Development Officer
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