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Coalition for Accelerating Standards and Therapies (CFAST): The Ultimate Drug Development Drivers
Session Chair(s)
Rebecca Daniels Kush, PhD
President, Catalysis; Chief Scientific Officer
Elligo Health Research, United States
The Coalition for Accelerating Standards and Therapies (CFAST) was formed by the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) "to accelerate clinical research and medical product development by creating and maintaining data standard, tools and methods for conducting research in therapeutic areas that are important to public health." CFAST was officially launched in October 2012. This session will focus on CFAST activities, specifically the development of data standards and the implementation of these standards to accelerate the development and review of new therapies and to enhance the information that can be obtained from streamlining the sharing, aggregation and analysis of clinical research data. CFAST is working with FDA, TransCelerate, the Innovative Medicines Initiative (IMI), ACRES, other partners and countless volunteers in this endeavor.
Learning Objective : Discuss the importance of data standards and their implementation to improve global clinical research processes and knowledge gained from research data; Identify how CFAST will support the FDA in its efforts to improve the quality and speed in reviews of regulatory submissions for new therapies.
Speaker(s)
Panelist
David C. Jordan, PhD, MSc
Retired, United States
Panelist
Brian Harvey, MD
Global Liver Institute, United States
Executive Vice President and Board Member
Panelist
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
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