Abstract Details

Title The Multiple Sclerosis Outcomes Assessment Consortium: Accelerating Development of Treatments for Multiple Sclerosis

Topic MS and Related Diseases

Presentation(s) S31 - (-)

Poster/Presentation
Number 001

Objective

Background Successful development of disease-modifying drugs for relapsing forms of MS is a landmark achievement in neurotherapeutics. However, treatments that slow disability progression by inhibiting neural degeneration or promoting regeneration are lacking. This represents a significant unmet medical need. Effective trial designs based on MRI lesions and relapses will not be optimal studies focused on disability progression. New, validated outcome measures focused on disability will be required. The US FDA has established a pathway to qualify new clinician reported outcomes measures.

Design/Methods The MSOAC is a coalition of industry, academia, patient representatives, regulatory and other government agencies, and the NMSS. To achieve the goal, the MSOAC will create tools that will expedite and benefit the field of MS therapeutics. These include a pooled clinical trial database and a CDISC therapeutic data standard for MS. In close collaboration with the FDA and European Medicines Agency (EMA), MSOAC members will contribute data and insights to arrive at a scientific consensus on an improved outcome measure. The coalition will be well-positioned for additional collaborative projects aimed at accelerating development of more effective treatments for MS.

Results Participating companies, academic investigators, advocacy organizations, and regulatory agencies will be listed, details of the project plan, and current status will be presented.

Conclusions The MSOAC represents a new paradigm in multidisciplinary, collaborative research in which all sectors of the drug development enterprise collaborate in an effort to accelerate progress in developing treatment for Progressive MS.

Authors/Disclosures
Nicholas LaRocca, PhD (National Multiple Sclerosis Society) PRESENTER	No disclosure on file
Lynn Hudson	No disclosure on file
Richard A. Rudick, MD, FAAN (Optimal Brain Health Consultants)	Dr. Rudick has received personal compensation for serving as an employee of Biogen. Dr. Rudick has received stock or an ownership interest from Biogen. Dr. Rudick has received publishing royalties from a publication relating to health care.
David J. Burn, MD (Regional Neuroscience Centre)	No disclosure on file

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