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Enhancing Adoption of Innovative Approaches in Clinical Trials
Session Chair(s)
Meghana Chalasani, MHA
Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER
FDA, United States
This forum will explore the U.S. FDA Center for Drug Evaluation and Research's portfolio of clinical trial innovation activities, including its newly established CDER Center for Clinical Trial Innovation (C3TI). C3TI serves as a central hub supporting innovative approaches to clinical trials aimed at improving the efficiency of drug development. Speakers from the FDA will elaborate on C3TI and its role in supporting innovative clinical trial designs. The FDA presenters will be joined by industry and patient speakers for a panel discussion on opportunities to enhance implementation and adoption of innovative approaches in clinical trials, aiming to ensure patient-centric trial design, improve the efficiency of clinical trials, increase the participation of diverse populations, and, in turn, accelerate the development of safe and effective new drugs.
Learning Objective : Discuss key challenges or barriers to implementation and adoption of innovative approaches in clinical trial design, conduct, and execution; Discuss strategies to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution.
Speaker(s)
Panelist
Kevin Bugin, PhD, MS, RAC
FDA, United States
Deputy Director of Operations, Office of New Drugs, CDER
Panelist
Ella Balasa
Balasa Consulting, United States
Patient Advocate and Engagement Consultant
Panelist
Michelle Rohrer, PhD
Genentech, A Member of the Roche Group, United States
Senior Vice President, Global Head of Product Development Regulatory and Policy
Panelist
Allison Cuff Shimooka, MBA
TransCelerate Biopharma Inc, United States
Chief Operating Officer
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