June 22, 2:00 - 5:00 p.m.

Scope: The intent of this satellite meeting is to explore the feasibility of developing biomedical research resources such as databases for the standardized assessment of application-specific informatics software tools. The first two presentations will provide a high-level overview of the need for standardized IT and informatics software tools to support future clinical research and clinical decision-making in the private sector. The next presentation will describe a success story for a public/private partnership that supports the development of informatics software research resources for image processing methods as applied to Osteoarthritis, the public private partnership organized by the Foundation of NIH (FNIH). The next two presentations are intended to provide a report on progress on an emerging FNIH public/private partnership to support databases for the standardized assessment of informatics software tools for cancer imaging, where lung cancer screening, diagnosis, and therapy response database resources are being proposed as a demonstration project. The informatics tools and methods necessary to support this cancer model can potentially be extended as a trans-NIH research resource for informatics software tools assessment. The final presentations include case reports from two imaging companies that describe their interest in the development of informatics database resources. The panel members will then explore how these research resources could be developed as a trans-NIH effort, initially for imaging databases, but to include other databases such as molecular profiling or other biosensor data.

Agenda

Extramural Co-Chairs: Laurence Clarke, Ph.D., NCI lclarke@mail.nih.gov Karen Skinner, Ph.D., NIDA kskinner@mail.nih.gov   External Co-Chairs: Michael Vannier, M.D., University of Chicago Michael Knopp, M.D., Ohio State University
1:50 - 2:15 p.m.	Shaping Government and Industry: Vision for Health Care Information Technology National Alliance for Technology Information Bill Head Vice President for Policy and Government Affairs www.nahit.org
2:15 - 2:30 p.m.	Standards for Commercial Data Management Systems (CDISC) Wayne Kubick, Ph.D. www.cdisc.org
2:30 - 2:45 p.m.	Public/Private Partnerships: A Success Story Osteoarthritis Initiative Gayle Lester, Ph.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases www.fnih.org
2:45 - 3:00 p.m.	Overview of the FNIH and the Imaging Database Initiative Wendy Sanhai, Ph.D. www.fnih.org
3:00 - 3:15 p.m.	Scientific Goals: FNIH-NCI Imaging Database Initiative Potential Expansion as a Trans-NIH Initiative Laurence Clarke, Ph.D. National Cancer Institute www3.cancer.gov/bip/steercom.htm
3:15 - 3:30 p.m.	Device and Drug Case Report Imaging Database Initiative Ricardo Avila GE Global Research, USA
3:30 - 3:45 p.m.	Device Industry Case Report: Imaging Database Initiative Informatics Resources Requirements for Clinical Trials Gudrun Zahlmann Siemens: Erlangen, Germany
3:45 - 4:00 p.m.	Coffee Break
4:00 - 4:30 p.m.	Panel Discussion Co-Chairs All the above presenters NIH Road Map Representatives Dushanka Kleinman National Institute of Dental and Craniofacial Research Carl Roth National Heart, Lung, and Blood Institute FDA Representative David Brown Center for Devices and Radiological Health TBA
4:30 - 5:00 p.m.	Open Discussion
5:00 p.m.	End of Satellite Meeting