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C-Path and CDISC launch CFAST

Friday, September 14, 2012

The Clinical Data Interchange Standards Consortium (CDISC), a global non-profit charitable organization, and Critical Path Institute (C-Path), a Tucson, Ariz.-based non-profit organization committed to improving human health and well-being, have launched their joint Coalition For Accelerating Standards and Therapies (CFAST), a follow-up to the partnership agreement signed earlier this year.

CFAST is an initiative to accelerate clinical research and medical product development by facilitating the creation and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health. To date, CDISC has either released draft or provisional standards packages covering five different disease areas: Parkinson’s, Alzheimer’s, tuberculosis, virology and pain. Upcoming releases will include therapeutic area standards packages for polycystic kidney disease, cardiovascular disease and schizophrenia.

“CFAST will serve as a strong partner assisting the FDA in meeting their PDUFA V performance goals of ‘improving efficiency of human drug review through required data submissions standardization.’ We are optimistic that this partnership will truly make a difference in the review process,” said Dr. Carolyn Compton, president and CEO of C-Path.

Interchange attendees can participate in discussions with a number of people who are actively working to improve public health. Keynote speakers include Dr. Janet Woodcock of the FDA and Ann Martin of Europe’s Innovative Medicines Initiative (IMI). Patient advocacy groups with participating representation include One Mind for Research, DataSphere (a biopharma data sharing initiative), the Vradenburg Foundation and the Michael J. Fox Foundation. Other participating organizations are the Japan Translational Research Informatics Institute, the U.S. National Cancer Institute, the Texas eHealth Alliance, Duke University and the University of Rochester.

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