Dr. Warren Kibbe of NCI and Dr. Sean Khozin of FDA to Keynote 2016 CDISC International Interchange: “Fostering Cutting-edge Innovation to Advance Research”

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The Clinical Data Interchange Standards Consortium (CDISC) announced today that 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, will be keynote speakers at the upcoming CDISC International Interchange.

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Dr. Kibbe’s commitment to Precision Medicine and the Cancer Moonshot and Dr. Khozin’s presentation ‘From Big Data to Smart Data’ will no doubt serve as motivating messages and reinforce the role of CDISC in enabling smarter research to unlock cures.

The Clinical Data Interchange Standards Consortium (CDISC) announced today that 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, will be keynote speakers at the upcoming CDISC International Interchange. 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 conference theme for 2016 is “Fostering Cutting-Edge Innovation to Advance Research.”

“CDISC is pleased to have two such inspiring speakers present keynote addresses at our flagship conference,” said Dr. Rebecca Kush, CDISC President and CEO. “Dr. Kibbe’s commitment to Precision Medicine and the Cancer Moonshot and Dr. Khozin’s presentation ‘From Big Data to Smart Data’ will no doubt serve as motivating messages and reinforce the role of CDISC in enabling smarter research to unlock cures.”

The annual International Interchange 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 5 million patients. 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. Representatives from the U.S. FDA who will participate in the Interchange include Boris Brodsky, Ta-Jen Chen, Dr. Ron Fitzmartin, Virginia Hussong, Dr. Laura Lee Johnson, Dr. Lisa LaVange, Dr. Eileen Navarro, Dr. Vaishali Popat, Mitra Rocca, Dr. Lilliam Rosario, Benjamin Vali, and Dr. Stephen Wilson. Dr. Yuki Ando and Hiroshi Sakaguchi will participate from the Japan PMDA. Regulatory requirements begin 01 October 2016 for submissions to the Japan PMDA, and 17 December 2016 for the U.S. FDA.

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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