Scientific Program
Thursday, September 10, 2009
10:00 am-12:00 pm Pre-Congress Workshop:
1. OARSI-FDA-Initiative
In 2007, in response to an FDA federal register notice, OARSI submitted a proposal and was granted approval to lead a centralized effort of conducting and managing the coordination of a critical appraisal of certain fundamentals of the science related to the design of clinical development programs for human drugs, biological products, and medical devices for the treatment and prevention of OA. The information requested by the FDA will help to inform the FDA as they embark upon the updating of the current 1999 Draft Guidance for Industry, Clinical Development Programs for Drugs, Devices and Biological Products Intended for the Treatment of OA. This session will provide an update on the work accomplished by OARSI in 2008, the first year of this 2-year Initiative.
Speakers
Steven Abramson, MD (Co-Chair)
Marc C. Hochberg, MD, MPH (Co-Chair)
Victor Goldberg, MD
David Hunter, MD, PhD
Joanne Jordan, MD, MPH (pending)
Virginia Byers Kraus, MD, PhD
Nancy E. Lane, MD
10:00 am-12:00 pm Pre-Congress Workshop
2. Osteoarthritis Initiative: Advanced Topics On Use And Analysis Of The OAI
Public Data
Osteoarthritis is the most common form of arthritis and the major cause of activity limitation and physical disability in older people. At present, therapies available to treat osteoarthritis are limited. The Osteoarthritis Initiative (OAI) study is an innovative public-private partnership between the NIH and the pharmaceutical industry. The overarching goal of the OAI is to create a public data resource for use in developing and validating imaging, biochemical and genetic biomarkers for disease onset and progression. The OAI is a longitudinal cohort study of nearly 5,000 men and women with knee OA, or at high risk of developing it, and is now in its fifth year of follow-up. During the first 4 years of follow-up, radiographic images, clinical data and biological specimens were collected at each annual visit. Images and clinical data from the baseline, 12- and 24-month follow-up visits have been made available to investigators around the world through OAI Online, a publicly accessible website (www.OAI.ucsf.edu). Data from the 36-month visit will be available later this year. To date, there are over 1,230 registered users of OAI Online in 57 countries. Almost 3,400 clinical datasets have been downloaded from this public website and almost 160 image sets have been distributed to national and international users. This workshop at the 2009 OARSI meeting will be of interest to both new and current users of this unique and rich public data resource and will facilitate analyses by investigators with existing experience with the OAI public data.
Speakers:
Research questions that can be addressed
using OAI data: possibilities and limitations
Michael C. Nevitt, PhD
OAI Online: access to clinical data, images and
biospecimens, and data browsing tools
Susan M. Rubin, MPH
OAI images and image-derived biomarkers
John Lynch, PhD
Longitudinal and hierarchical analytic
strategies for OAI Data
Charles McCulloch, PhD
2009 World Congress Program |
|
| 2:00 pm-2:10 pm | Welcome from President and Congress Co-Chairs |
| 2:10 pm-3:30 pm | Plenary Session 1 – Biomarkers Role of Biomarkers in Diagnosis and Monitoring of OA |
| 2:10 pm-2:30 pm | Clinical Perspective on the Role of Biomarkers and the Diagnosis and Monitoring of OA Virginia Byers Kraus, MD, PhD |
| 2:30 pm-2:50 pm | Basic Science Perspective on the Role of Biomarkers in the Diagnosis and Monitoring of OA Dick Heinegard, MD, PhD |
| 2:50 pm-3:00 pm | Q & A |
| 3:00 pm-3:30 pm | Two Abstract Presentations |
| 3:30 pm-4:00 pm | Break |
| 4:00 pm-5:15 pm | Plenary Session 2 - Intrinsic vs.Extrinsic Cartilage Repair |
| 4:00 pm-4:30 pm | Intrinsic Point of View Ernst Hunziker, MD |
| 4:30 pm-5:00 pm | Extrinsic Point of View Connie Chu, MD |
| 5:00 pm-5:15 pm | 15-minute Discussion |
| 5:15 pm-5:45 pm | Break |
| 5:45 pm-6:30 pm | Opening Ceremony / Lifetime Achievement, Basic and Clinical Award Presentations |
| 6:30 pm-7:00 pm | Keynote Lecture - Aging, Inflammation, and OA Martin Lotz, MD |
| 7:00 pm-8:30 pm | Opening Reception With Exhibitors |