OA Drug Development Workshop Presentations & Papers
Presenters discussed many aspects of osteoarthritis and development of drugs to treat it, including its epidemiology, challenges to assessing disease progression, potential biomarkers, difficulties of evaluating long-term benefits to the patient and challenges to achieving FDA approval. View and download the supporting presentations below.
Overview of Burden of Disease
Tuhina Neogi, MD, PhD
Chief of Rheumatology
Professor of Medicine and Epidemiology
Boston University Schools of Medicine and of Public Health
2020 OA Clinical Studies Conference Chair, Arthritis Foundation
Landscape of OA Drug Development – Regulatory Perspective
Robert B. Shibuya, MD
Medical Officer
Division of Anesthesiology, Addiction Medicine, and Pain Medicine
Office of Neuroscience/Office of New Drugs/CDER
US Food and Drug Administration
Landscape of OA Biologic Development – Regulatory Perspective
Elizabeth Hart, MD
Branch Chief, General Medicine 1
Office of Tissues and Advanced Therapies Center for Biologics Evaluation and Research
US Food and Drug Administration
Regulatory Considerations on Biomarkers and Assessment of Long-term Benefit in OA
Nikolay P. Nikolov, MD
Director, Division of Rheumatology and Transplant Medicine
Office of Immunology and Inflammation
Office of New Drugs
US Food and Drug Administration
Biochemical Markers in OA
Virginia Kraus, MD, PhD
Professor of Medicine, Pathology, and Orthopaedic Surgery
Duke University
Arthritis Foundation OA Clinical Trials Network Member
Imaging Biomarkers in OA – MRI vs. X-Ray
Frank Roemer, MD
Professor of Radiology, Friedrich-Alexander University of Erlangen-Nürnberg,
Adjunct Professor of Radiology, Boston University School of Medicine
Imaging Biomarkers in OA – Quantitative MRI
Sharmila Majumdar, PhD
Professor of Radiology
University of California, San Francisco
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Role of Biomarkers in Drug Development
Jeffrey Siegel, MD
Office Director
Office of Drug Evaluation Sciences
Office of New Drugs / Center for Drug Evaluation and Research
US Food and Drug Administration
Statistical Considerations on the Use of Surrogate Endpoints
Thomas R. Fleming, PhD
Professor of Biostatistics
University of Washington, Seattle
Challenges with Assessment of Disease Progression – Clinical and Structural
Timothy McAlindon, MD, MPH
Professor of Medicine
Tufts University Medical Center
Lessons Learned – Sprifermin Case Study
Marc C. Hochberg, MD, MPH
Professor of Medicine and Epidemiology and Public Health
Vice Chair, Department of Medicine
University of Maryland
Lessons Learned from Clinical Programs to Assess Disease Progression: Canakinumab Case Study
Philip Conaghan, MBBS, PhD
Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds
Deputy Director, NIHR Leeds Biomedical Research Centre
Considerations of Assessment of Long-term Pain and Function
Daniel Clauw, MD
Professor of Anesthesiology, Medicine (Rheumatology) and Psychiatry
Director, Chronic Pain and Fatigue Research Center
University of Michigan
Proposed Concept Clinical Endpoints of Long-term Benefit
Yura Kim, PhD
Mathematical Statistician
Office of Biostatistics
US Food and Drug Administration
FDA Workshop Summary
Technical Highlights
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