Dr. Robert Califf, FDA Commissioner, to Open 2016 CDISC International Interchange

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The Clinical Data Interchange Standards Consortium (CDISC) announced today that Dr. Robert Califf, FDA Commissioner, will give the opening keynote at the 2016 CDISC International Interchange at 8:00AM ET on 28 September in Bethesda, MD. Dr. Califf will expand upon the theme of the 02 August 2016 CDISC Strategy Session: “The Future of Medical Research and the Role of Standards: Forming Connections Towards Complementary Systems.”

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CDISC is honored to have Dr. Califf open the 2016 International Interchange to present highlights of the August Strategy Session.

The Clinical Data Interchange Standards Consortium (CDISC) announced today that Dr. Robert Califf, FDA Commissioner, will give the opening keynote at the 2016 CDISC International Interchange at 8:00AM ET on 28 September in Bethesda, MD. Dr. Califf will expand upon the theme of the 02 August 2016 CDISC Strategy Session: “The Future of Medical Research and the Role of Standards: Forming Connections Towards Complementary Systems.”

“CDISC is honored to have Dr. Califf open the 2016 International Interchange to present highlights of the August Strategy Session,” said Dr. Rebecca Kush, CDISC President and CEO. “Outcomes from this Session were driven by sixty leaders from the U.S., Europe and Japan, who provided insightful perspectives on the means by which collaboration, global CDISC standards and related enablers can catalyze more efficient and innovative medical research.” 

Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute.

Dr. Califf will be joined by two other prominent professionals presenting keynote addresses, Dr. Warren Kibbe, Deputy Director, National Cancer Institute (NCI) and Director of the Center for Biomedical Informatics and IT (CBIIT); and Dr. Sean Khozin, Senior Medical Officer, Office of Hematology and Oncology Products, FDA. Dr. Kibbe will present “The Value of Standards in Precision Medicine and Oncology.” Dr. Khozin will present “From Big Data to Smart Data.”

CDISC International Interchange attendees will have the opportunity to learn best practices and gain information on the latest developments regarding the use of data standards in clinical research. The conference will also feature sessions focused on data sharing, the use of CDISC standards for nutrition research by Danone, the use of CDISC standards in studies sponsored by NIH/NIAID Division of AIDS at academic research centers, and the development of CDISC standards for a variety of therapeutic areas, which collectively affect over one billion people worldwide. A special session this year, chaired by Drs. Ron Fitzmartin (FDA) and Yuki Ando (PMDA), will cover requirements for CDISC standards when submitting data to regulatory authorities to obtain approval for new treatments. Additional representatives from the U.S. FDA and PMDA who will participate in the Interchange include Dr. Lisa LaVange, Dr. Stephen Wilson, Dr. Lilliam Rosario, Dr. Eileen Navarro, Dr. Vaishali Popat, Dr. Laura Lee Johnson, Virginia Hussong, Mitra Rocca, Benjamin Vali, Helena Sviglin, Lisa Lin, Boris Brodsky, Ta-Jen Chen and Hiroshi Sakaguchi. Regulatory requirements for CDISC standards begin 01 October 2016 for submissions to the Japan PMDA, and 17 December 2016 for the U.S. FDA.

The conference takes place 28-29 September 2016 in Bethesda, Maryland at the Bethesda North Marriott Hotel and Conference Center. CDISC authorized education and special workshops for clinicians, researchers and informaticians will be held on 26, 27 and 30 September. The 2016 conference theme is “Fostering Cutting-Edge Innovation to Advance Research.”

CDISC is grateful to all those who contribute to making CDISC Interchanges possible. CDISC extends special gratitude to Accenture for its fourth year Global Diamond sponsorship and to Omnicomm for their Global Ruby sponsorship of CDISC Interchanges. To learn more about this conference and ways to become involved with CDISC, please visit the International Interchange page on the CDISC website.

About CDISC
CDISC is a 501(c)(3) global non-profit charitable organization that streamlines research and enables connections to healthcare through the development of clinical research data standards. CDISC has developed a suite of standards to support clinical research from protocol through analysis and reporting. CDISC standards make it possible for data to speak the same language, empowering simple data collection and private sharing that makes the most of the valuable information offered by patients participating in research studies around the globe. Using CDISC standards from the start of studies enables Smarter Research to Unlock Cures (http://www.unlockcures.org), saving 70-90% time in the start-up of clinical research studies and ~60% overall in terms of time and resources to conduct research. CDISC is the patient’s advocate, creating therapeutic area data standards for over 25 different disease areas that advance medical product development and various types of clinical research.

CDISC is funded through the generous support of over 400 member organizations, as well as through grants, Authorized Education courses and CDISC events. To find out more about how to support CDISC, please visit http://www.cdisc.org.

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Andrea Vadakin, Director of Communications and Public Relations
CDISC
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