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CDISC and TransCelerate BioPharma Announce Landmark Asthma Data Standard Released for Public Review


9/19/2013 9:12:54 AM

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AUSTIN, Texas, Sept. 18, 2013 /PRNewswire/ -- The Clinical Data Interchange Standards Consortium (CDISC) and TransCelerate BioPharma Inc. ("TransCelerate"), are pleased to announce that version 1.0 of the Asthma Therapeutic Area (TA) Data Standard is now available for public review on the CDISC website.

The Asthma TA standard is the first standard to have been developed with TransCelerate's active participation in the Coalition for Accelerating Standards and Therapies (CFAST) initiative. CFAST, a joint initiative of CDISC and the Critical Path Institute (C-Path), was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health. CFAST collaborators include the U.S. Food and Drug Administration (FDA), TransCelerate, the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), with participation and input from many other organizations.

The TA data standards augment an existing suite of CDISC global standards for clinical research, which streamline the entire clinical research process, saving time and money while improving data quality and enabling development of scientific insights for the benefit of patients. CDISC TA standards developed to date, including those for Alzheimer's and Parkinson's diseases, have led to a faster, scalable standards development process that is now being implemented for Asthma. It is anticipated that the process followed for this standard will serve as a model for the development of many more therapeutic area data standards through the CFAST Initiative. The Asthma TA data standard specifically includes variables being collected in clinical research studies in support of therapies for asthma in adults. To access and comment on the Asthma TA draft standard now available for public review, please visit the CDISC website at http://www.cdisc.org/therapeutic.

"The CDISC Asthma Therapeutic Area Standard is a significant achievement for CDISC, and marks a major milestone in our collaborative efforts with TransCelerate, which has contributed significant resources to the CFAST Initiative," stated Rhonda Facile, CDISC Senior Director of Standards & Development, who is leading the Asthma project. "We would also like to thank the CDISC Technical Teams (BRIDG, CDASH, SDS, Terminology and ADaM), as well as the NCI, NIH Heart Lung and Blood Institute (NHLBI), FDA, and those on the CFAST TA Standards Steering Committee for their efforts in developing this landmark standard."

"TransCelerate is happy to participate in the development of therapeutic area data standards via the CFAST initiative," said Dalvir Gill, PhD, Chief Executive Officer of TransCelerate. "The efficient, consensus-based development of such standards is aligned with our goal of collaborating to improve data flow, quality and interoperability in and across clinical trials ultimately bringing new therapeutics to patients."

ABOUT CDISC

CDISC is a 501(c)(3) global non-profit charitable organization, with over 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

ABOUT TransCelerate BioPharma Inc.

TransCelerate BioPharma Inc. was formed in 2012 and is a non-profit organization focused on advancing innovation in research and development (R&D), identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients. TransCelerate evolved from discussions at various forums for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges. Founding members include AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi, and all have representation on the Board of Directors. Additional members include Astellas Pharma Inc., Biogen Idec, Braeburn Pharmaceuticals, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.) and Onyx Pharmaceuticals.

Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com/.

CDISC Contact:

TransCelerate Contact :

Andrea Vadakin

Shannon Caudill

+1.316.558.0160

+1.740.281.3715

avadakin@cdisc.org

shannon.caudill@porternovelli.com

SOURCE The Clinical Data Interchange Standards Consortium; TransCelerate BioPharma Inc.



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