"This platform trial will significantly speed efficacy trials for ALS research, and is a major advancement for ALS research," said Calaneet Balas, President and CEO of The ALS Association. "In addition to supporting the HEALEY ALS Platform Trial, we will be working to ensure the rest of the research pipeline is moving fast enough to keep up. We are delighted to be partnering with Dr. Merit Cudkowicz and her team on this project."
The platform trial model, already proven successful in the cancer field, will greatly accelerate therapy development by allowing investigators to test more drugs, increase patient access to trials, and reduce the cost by quickly and efficiently evaluating the effectiveness of multiple therapies. New treatments are added to the platform trial as they become available, thereby decreasing the gap in time from identification of an exciting therapy to testing. Shared infrastructure, common data and sample collection processes, and central governance within the Platform trial will lead to operational efficiencies and time and cost savings.
Dr. Merit Cudkowicz, Director of the Healey Center for ALS and Chief of Neurology at Mass General shared that she is thankful for the support of The ALS Association.
"Working closely together, we will bring new therapies forward faster for people with ALS," said Cudkowicz.
"The Platform Trial builds on previous ALS Association supported research on many new ALS targets and trial innovations. The HEALEY ALS Platform Trial initiative can only succeed with the support and involvement of the entire ALS community. We look forward to ongoing partnerships with people and families with ALS, all ALS foundations, our colleagues in the NEALS Consortium, industry partners and regulatory agencies," Cudkowicz added.
Funding from The ALS Association will directly support various parts of the platform trial. Specifically, the following activities will directly benefit from funding from The ALS Association: the Clinical and Data Coordination Center activities at Mass General, the Biomarker Development Endpoint Engine, and the Monitoring and Outcome Measures Core at Barrow Neurological Institute. The ALS Association will become an integral part of the Foundations and Benefactors Committee responsible for advising on study progress, data sharing, budget matters, fundraising, patient recruitment/retention and variety of other scientific and operational topics. In addition, the trial will be supported by enrollment of patients at ALS Association Certified Centers of Excellence, Recognized Treatment Centers, and other affiliated centers.
This award to the Healey Center builds on a long relationship The ALS Association has had with Massachusetts General Hospital, Dr. Cudkowicz and other researchers. The Association has committed over $9 million since 2010 to ALS researchers at Massachusetts General Hospital.
About The ALS Association
The ALS Association is the largest private funder of ALS research in the world. The Association funds global research collaborations, provides assistance for people with ALS and their families through its nationwide network of chapters and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association builds hope and enhances quality of life while urgently searching for new treatments and a cure. For more information about The ALS Association, visit our website at www.alsa.org.
About the Sean M. Healey & AMG Center for ALS at Mass General
At the Sean M. Healey & AMG Center for ALS at Mass General, we are on a quest to discover life-saving therapies for all people who are affected by ALS. Launched in November, 2018, we are a diverse group of researchers and clinicians determined to accelerate the pace of ALS therapy development.
Under the leadership of Merit Cudkowicz, MD, Chief of Neurology, and a Science Advisory Council of international experts, we are partnering with other experts around the globe to reimagine how to develop the right novel therapies for the right people at the right time. We believe strongly in the partnership between people with ALS, caregivers and our team. Together we can design more efficient and more effective clinical trials and broaden access for people with ALS.