WALTHAM, Mass., Oct. 2, 2018 /PRNewswire/ -- Accelerated Cure Project (ACP) for Multiple Sclerosis (MS) today announced it has entered into a ground-breaking collaboration with EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada, to capture and integrate the perspectives of people affected by MS into the design and implementation of clinical trials in MS. The patient-focused drug development collaboration will be supported through iConquerMS™ (www.iConquerMS.org), a research initiative of the Accelerated Cure Project, and will inform EMD Serono's MS clinical trial program. The collaboration includes the development and validation of patient-reported outcomes (PROs) in drug development.
The program aligns with Patient-Focused Drug Development (PFDD) guidance from the U.S. Food & Drug Administration (FDA), which defines PFDD as a systematic approach to ensure that patients' experiences, perspectives, needs and priorities are captured and meaningfully incorporated into drug development and evaluation. The collaboration will convene team members from EMD Serono and from the iConquerMS people-powered research network to collaborate on the design and endpoints of clinical trials, defining measures and meaningfulness of treatment benefit for people living with MS. Additionally, iConquerMS participants will provide input across all stages of the study through workshops, document reviews, focus groups and surveys. The iConquerMS patient portal will also be used to gather new data on the final MS patient-reported outcome measures from hundreds of people living with MS.
"Those of us living with multiple sclerosis have the most valuable understanding of what matters most when it comes to treatment of this condition," said Laura Kolaczkowski, Lead Patient Representative and Co-Principal Investigator of iConquerMS. "The collaboration between the iConquerMS initiative and EMD Serono is an important opportunity for our collective voices and insights to be heard and to drive real progress in research, drug development, and ultimately in the fight against MS."
"The rapid growth of patient-reported outcomes in clinical research is important progress not only for people living with MS, but for organizations seeking to develop and deliver new therapies to the market that make a real difference in the lives of patients," said Robert McBurney, Ph.D., President and CEO of the Accelerated Cure Project for MS and Co-Principal Investigator for iConquerMS. "We are delighted to partner with EMD Serono to break silos of information and advance the engagement of patients across the entirety of the clinical research process."
iConquerMS™ (www.iConquerMS.org) is a research initiative by and for individuals living with MS who contribute their ideas and their health data. iConquerMS™ was established in 2014 by the Accelerated Cure Project for MS, a non-profit organization with proven experience sharing resources with MS researchers worldwide, in partnership with Feinstein Kean Healthcare and Arizona State University. Funding for iConquerMS™ has been largely provided by the Patient-Centered Outcomes Research Institute (PCORI) (www.PCORI.org). Approximately 4,600 individuals living with MS are currently registered as iConquerMS™ research participants, constituting a large and growing cohort for data-driven research into topics of interest for people living with MS. iConquerMS™ is open to research collaborations with U.S. and international academic, government and industry organizations.
ACP (www.acceleratedcure.org) is a patient-founded non-profit organization dedicated to accelerating research efforts to improve diagnoses, optimize treatment outcomes, and develop cures for MS. The organization promotes scientific collaboration and accelerates research by rapidly and cost-effectively providing researchers with the resources they need to explore novel research ideas that can lead to better care for people living with MS.
About EMD Serono, Inc.
EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada – is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and multiple sclerosis. Today, the business has approximately 1,300 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com
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Feinstein Kean Healthcare
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Accelerated Cure Project for MS
SOURCE Accelerated Cure Project for Multiple Sclerosis