The purpose of the meeting at the Bethesda Hyatt today is to showcase the accomplishments of the Osteoarthritis Initiative (OAI) and to discuss plans for an extension of the initiative. There will be a series of presentations to provide an overview of the OAI and related studies and to explore possibilities for the extension of follow up of the cohort for additional years.

Session I of the meeting will begin with an introduction to the OAI from Dr. Michael Nevitt, who leads this initiative as the principal investigator of the data coordinating center, describing what has been done during the initial 6 years of the contract. Following his presentation, Dr. Charles McCullough, will provide a perspective of what can be done with the data generated by the OAI, which are available for use on a public web site (https://oai.epi-ucsf.org/datarelease/).

To explain some of the needs that spawned the development of the OAI, Dr. Janet Woodcock will give the perspective of the FDA with regard to the need for discovery of disease biomarkers in clinical areas such as OA and role of the Critical Path Initiative in stimulating such research. Following Dr. Woodcock, Dr. Monica Luchi, who has participated in the OAI as a representative to the Steering Committee from Novartis for the past 6 years, will discuss the perspective of the pharmaceutical industry on biomarker initiatives.

Session II consists of two parts with presentations by three of the four OAI clinical center principal investigators followed by presentations by the principal investigators of the current three ancillary studies to the OAI. The overall focus of the clinical center presentations is the various perspectives on osteoarthritis-related pain that are being captured in the OAI. These presentations give a brief glimpse of what can be explored with the data that currently exist in the OAI database. The second part of the session consists of presentations from the principal investigators of the three current ancillary studies to the OAI. These ancillary studies were submitted to the NIH as investigator-initiated research project grants, underwent peer review, and are being supported by NIAMS. Each of these ancillary studies adds measures and analyses related to the hypotheses and specific aims of the project. Resultant data will become part of the OAI public data.

Session III focuses on the use of the OAI data by the broader OA research community. There are 4 presentations by investigators who have obtained funding to carry out analyses of OAI data and images through grants sponsored by pharmaceutical companies, private foundation, and/or NIH-funded mechanisms. These presentations are a sample of the broad range of investigations being carried out with the public data.

The fifth presentation of the session will be given by Dr. Stefan Lohmander, an international leader in osteoarthritis research, to provide a perspective on what the expectations were for the OAI and how these can best be fulfilled.

During Session IV, Drs. Nevitt and McCullough will present the plans for the extension of the follow up of the OAI cohort on behalf of the OAI investigators and Steering Committee and what might be achieved by these additional years and outcome data. These presentations will be followed by discussion periods to assess the overall interest in extending and enhancing this public private initiative. The audience is encouraged to participate in the discussion period at this time and following any of the presentations throughout the day.

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