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OA as a Serious Disease

 Use this link to read: White Paper - OA as a Serious Disease

Pre-Competitive Consortium for Osteoarthritis
Osteoarthritis Research Society International

The pathway for developing structure modifying drugs for osteoarthritis (OA) has been complicated by the fact that OA is a heterogeneous disease process and by the inability to predict which patients will progressively lose function and develop more joint damage. This has led to an effort through the Osteoarthritis Initiative of the National Institute of Health (OAI-NIH) to define the natural history of a cohort of representative OA patients. Additionally, in 2010 the Osteoarthritis Research Society International (OARSI), in response to a Food and Drug Administration (FDA) Federal Register notice requesting additional information on issues related to clinical development programs for drugs and medical devices for the treatment and prevention of OA, provided feedback to the FDA on relevant questions related to OA assessment and clinical trial design. Subsequently, in 2011, OARSI in collaboration with the Foundation for the NIH (FNIH) initiated a 2.5-year study to further explore imaging and biomarkers as predictors of disease progression and clinical outcomes.

The mission of the Pre Competitive Consortium for Osteoarthritis (PCCOA) is to advance development of structure modifying therapies for the treatment of patients with OA. The proposed strategy is to enhance collaboration among stakeholders and promote the sharing of knowledge of barriers and opportunities for OA drug discovery and development. It is anticipated that a new synthesis of the expertise of academic researchers, clinical investigators, and representatives from pharmaceutical and biotechnology R&D segments can effectively inform the drug approval process about ways to remove the current barriers to new treatments for OA. The current US Food and Drug (FDA) approval process for structure modifying drugs for OA requires concomitant improvement in a qualified and validated imaging or biochemical marker and improvement in the signs and symptoms of the disease. This creates formidable challenges for the development of structure modifying drugs for OA. The aim of the PCCOA is to design a pathway to establish the importance of OA as a serious condition for which there are currently no satisfactory therapies according to the FDA definition:

The PCCOA will oversee the development of a white paper supporting the argument that OA is a serious condition. This will require an extensive review of the epidemiology of OA, impact on quality of life, associated symptoms and functional disability, and association with increased risk of comorbidity and mortality. An additional systematic review of clinically relevant outcomes in OA will be undertaken to establish the argument that biomarker (biochemical and/or imaging) intermediate endpoints can serve as surrogates of structural change endpoints and that the measured changes are meaningful as they relate to the clinical outcomes of pain and stiffness, need for assistive devices or need for joint replacement. Lastly, but most importantly, the PCCOA will collaborate with patients to gain their perspectives which will further inform the strategic messaging to be delivered to governmental agencies within the US and Europe.

For more information, contact Valorie Thompson ( vthompson@mac.com)

 

Thank you to the industry supporters of this initiative:

EMD Serono

Fidia Pharmaceuticals

Flexion

Nordic Biosciences

Spinifex

 

PCCOA Executive Committee
PCCOA Writing Group (Co-Chairs and Proposed Members)
Francis Berenbaum, MD, PhD
Head, Department of Rheumatology
Faculty of Medicine Pierre & Marie Curie Paris VI
Saint-Antoine Hospital
Paris, France
Lyn March, MB BS, MSc, PhD (Co-Chair)
Professor of Medicine and Public Health
Senior Staff Specialist in Rheumatology and Clinical Epidemiology
Institute of Bone and Joint Research
Sydney Medical School
University of Sydney
Sydney, NSW, Australia
Philip G. Conaghan, MB BS, PhD
Professor of Musculoskeletal Medicine
University of Leeds
Consultant Rheumatologist
Leeds Teaching Hospitals NHS Trust & Leeds Primary Care Trust
Deputy Director, Leeds NIHR
Biomedical Research Unit
Leeds, UK
Gillian Hawker, MD (Co-Chair)
Senior Scientist, Women’s College Research Institute
Chair, Department of Medicine
Sir John and Lady Eaton Professor, Department of Medicine
Professor, Institute of Health Policy, Management and Evaluation
University of Toronto
Toronto, Canada
Gillian Hawker, MD
Senior Scientist, Women’s College Research Institute
Chair, Department of Medicine
Sir John and Lady Eaton Professor, Department of Medicine
Professor, Institute of Health Policy, Management and Evaluation
University of Toronto
Toronto, Canada
Nigel Arden, MBBBS, FRCP, MSc, MD
Professor in Rheumatic Diseases and Consultant Rheumatologist
University of Southampton
Southampton University Hospitals NHS Trust
Reader in Musculoskeletal Sciences and Consultant Rheumatologist
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
Botnar Research Centre
University of Oxford
United Kingdom
Marc C. Hochberg, MD, MPH
Professor of Medicine, Epidemiology and Public Health
Head, Division of Rheumatology & Clinical Immunology
Vice Chair, Department of Medicine
University of Maryland School of Medicine
Baltimore, Maryland, USA

Marita Cross, BSc, MPH, PhD
Post-Doctoral Fellow
Institute of Bone and Joint Research
University of Sydney
Sydney, NSW, Australia

Virginia Byers Kraus, MD, PhD
President, OARSI
Professor of Medicine
Division of Rheumatology, Duke University School of Medicine
Duke Molecular Physiology Institute
Durham, North Carolina, USA

David Felson, MD
NIHR Manchester Musculoskeletal Biomedical Research Unit
University of Manchester
United Kingdom
Director, Clinical Epidemiology
Professor of Medicine and Public Health
Boston University School of Medicine
Boston, Massachusetts
USA
Lee S. Simon, MD
Former Division Director
FDA Analgesic, Anti-inflammatory, Ophthalmologic Drug Products Division (CDER)
Principal, SDG LLC
Cambridge, Massachusetts, USA
Francis Guillemin, MD, PhD
Professor of Epidemiology and Public Health
School of Public Health, Faculty of Medicine
University of Nancy
France
  Catherine Hill, MBBS, MSc, FRACP
Consultant Rheumatologist
The Queen Elizabeth Hospital, Adelaide
Woodville, South Australia
Australia
  Graeme Jones, MBBS, FRACP, FAFPHM, MMedSC, MD
Professor of Rheumatology and Epidemiology
Head, Musculoskeletal Unit, Menzies Research Institute
University of Tasmania
Head, Department of Rheumatology, Royal Hobart Hospital
Hobart, TAS, Australia
 

Tore Kvien, MD, PhD
Professor of Rheumatology, University of Oslo
Head, Department of Rheumatology
Diakonhjemmet Hospital
Oslo, Norway

  Michael Nevitt, PhD, MPH
Professor, University of California San Francisco School of Medicine
Department of Epidemiology and Biostatistics,
San Francisco
California, USA
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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