The National Multiple Sclerosis Society and Critical Path Institute Create the Multiple Sclerosis Outcome Assessments Consortium
New York, Cleveland, and Tucson – December 6, 2012 –
The National Multiple Sclerosis Society and Critical Path Institute (C-Path) announced today that they have joined forces to launch the Multiple Sclerosis Outcome Assessments Consortium (MSOAC). This coalition of industry, academia, patient representatives, regulatory agencies, and the National MS Society will develop new standards for assessing outcomes in clinical trials of MS therapies. The MSOAC will collect, standardize, and analyze data from MS studies with the goal of qualifying a new clinician-reported outcome measure of disability as a primary endpoint for future MS trials.
“Robust clinical outcome measures are greatly needed to evaluate new treatments for MS,” stated Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The consortium approach pioneered by FDA and C-Path will facilitate a combination of available data and expertise to generate the best possible drug development tool.” C-Path’s President and CEO, Carolyn Compton, added that “C-Path consortia are ‘action tanks’ that tackle what no one organization can take on solo.”
Forming consortia to accelerate drug treatment development is a new strategy employed by disease foundations in achieving their mission. “The Society recognized the gap in the MS treatment pipeline, and seized the opportunity to bring together the stakeholders needed to move the field forward in this way,” indicated Cynthia Zagieboylo, president and CEO at the National MS Society. “It is vital that we have tools to rapidly assess the effectiveness of potential treatments for MS,” added Dr. Timothy Coetzee, Chief Research Officer, at the National MS Society.
The new clinical outcome measure will spur the development of therapies for all forms of
MS. “Presently there are no treatments for the progressive forms of MS, and it’s difficult to detect changes as the disease gradually takes its toll,” emphasized Dr. Richard Rudick, Director of the Mellen MS Center at the Cleveland Clinic Foundation and a co-leader of the new consortium. “A sensitive clinical outcome measure of disability would address this unmet need.”
“This is a powerful consortium with all the necessary expertise to tackle what has proven to be a seriously challenging area and one which is fundamental to the timely evaluation of potential new treatments – particularly for the progressive forms of MS,” commented Dr. Alan Thompson, Chairman Medical and Scientific Advisory Board of MS International Federation.
The new consortium will be co-directed by Dr. Lynn Hudson (Chief Science Officer, C-Path), Dr. Nicholas LaRocca (Vice President, Health Care Delivery and Policy Research, National MS Society), and Dr. Richard Rudick (Vice Chairman, R&D, Neurological Institute and Director, Mellen Center, Cleveland Clinic Foundation).
MS is a chronic, unpredictable neurological disease that affects the central nervous system. It involves an immune system attack against the brain and spinal cord. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. These problems may be permanent or may come and go. According to the National MS Society, at least 400,000 Americans have MS, and every hour someone is newly diagnosed. MS affects about 2.1 million people worldwide.
ABOUT THE NATIONAL MULTIPLE SCLEROSIS SOCIETY:
The National MS Society addresses the challenges of each person affected by MS. To fulfill this mission, the Society funds cutting-edge research, drives change through advocacy, facilitates professional education, collaborates with MS organizations around the world, and provides programs and services designed to help people with MS and their families move forward with their lives. In 2011 alone, through its national office and 50-state network of chapters, the Society devoted $164 million to programs and services that assisted more than one million people. To move us closer to a world free of MS, the Society also invested $40 million to support more than 325 new and ongoing research projects around the world. The Society is dedicated to achieving a world free of MS. Join the movement at www.nationalMSsociety.org.
ABOUT CRITICAL PATH INSTITUTE (C-PATH):
Established in 2005 as a non-profit organization, C-Path was formed with public and private philanthropic support from the University of Arizona, the US Food and Drug Administration (FDA), and the Tucson community. Additional funding has been provided by Science Foundation Arizona (SFAz). C-Path is committed to improving human health and well-being by developing new technologies and methods to accelerate the development and review of medical products. An international leader in forming collaborations around this mission, C-Path has established global, public- private partnerships that include more than 1,000 scientists from government regulatory agencies, academia, patient advocacy organizations, and 41 major pharmaceutical companies. C-Path has headquarters in Tucson, AZ.
For more information, visit
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Arney Rosenblat Dianne Janis
National MS Society Critical Path Institute
212 476-0436 520 382-1399