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

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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 

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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

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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 

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Biochemical Markers in OA

Virginia Kraus, MD, PhD 
Professor of Medicine, Pathology, and Orthopaedic Surgery 
Duke University 
Arthritis Foundation OA Clinical Trials Network Member 

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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 

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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
 

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Statistical Considerations on the Use of Surrogate Endpoints

Thomas R. Fleming, PhD 
Professor of Biostatistics 
University of Washington, Seattle 


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Challenges with Assessment of Disease Progression – Clinical and Structural

Timothy McAlindon, MD, MPH 
Professor of Medicine 
Tufts University Medical Center 



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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 

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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 

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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 

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Proposed Concept Clinical Endpoints of Long-term Benefit

Yura Kim, PhD 
Mathematical Statistician 
Office of Biostatistics 
US Food and Drug Administration 

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FDA Workshop Summary

Learn why this workshop is important for OA patients, what it was intended to accomplish and read some highlights of the discussion. 
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Technical Highlights

Read more in-depth about the workshop, including clinical research challenges, OA biomarkers, and assessment of disease progression. 
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