Funding will support a framework for greater efficiencies, collaboration in research, and enhanced patient experience during clinical trials
The ALS Association has made a three-year, $652,543 commitment to support new collaborative initiatives that will encourage therapeutic pipeline development, improve ALS trial efficiency and quality, and enhance the patient experience with trial access, recruitment, and retention efforts. Activities will take place at the Sean M. Healey & AMG Center for ALS at Mass General in collaboration with the Barrow Neurological Institute and the Northeast ALS Consortium (NEALS).
“An important part of our commitment to ALS research is to invest in processes and procedures that can be institutionalized across the research community to create efficiencies, to facilitate global collaboration and expedite impact,” said Kuldip Dave, Ph.D., vice president of research at The ALS Association.
Support from The ALS Association will improve the efficiency and quality of trials by providing high-quality site training on clinical conduct of trials and outcome measures used to evaluate efficacy of treatment. This training is particularly relevant due to challenges to trial conduct brought on by the current Covid-19 situation. Together, we will coordinate efforts to accelerate therapy development by increased distribution of bio-samples to investigators and pharma for development of important biomarkers; partner with people and families with ALS and ALS clinical trialists to continue to improve patient center trial designs and increase access opportunities; and attract and train new investigators in clinical trial design and conduct.
The multiyear commitment continues longstanding support The ALS Association has provided to the collaborating organizations. In January, the Association committed $3 million over three years to support the first ever ALS platform trial, which will take place at the Healey Center in collaboration with the Barrow Neurological Institute and NEALS.
Drs. Merit Cudkowicz, Director of the Healey Center for ALS and Chief of Neurology at Mass General, Harvard Medical School and Jeremy Shefner, Chair of the Department of Neurology, and Senior Vice President of Barrow Neurological Institute at Dignity Health St. Joseph’s Hospital and Medical Center, shared how they are thankful for the support of The ALS Association.
“One of the most important initiatives NEALS has developed over the years is to train current and upcoming investigators, coordinators and evaluators both on the activities necessary to perform high quality trials, and to direct the trials of the future. The funding we receive from The ALS Association enables us to continue and expand these educational activities and to make sure that voices from patients and advocates are heard and attended to as our field expands,” said Dr. Shefner.
Dr. Cudkowicz added: “The funding will build on prior Association support for the NEALS Biorepository to provide ALS research investigators worldwide with quick and broad access to biofluid samples. Biomarkers can accelerate diagnosis and screening of treatments. We are grateful to the many patients and families who kindly contributed data and samples to the NEALS Biorepository.” For access to biofluid samples for ALS research, please visit https://www.neals.org/for-als-researchers/neals-sample-repository/.
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 our 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 partner 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, foundations and our team. Together we can design more efficient and more effective clinical trials and broaden access for people with ALS.
For more information, please email healeycenterforals@mgh.harvard.edu and visit the center’s website https://www.massgeneral.org/als/
About the Barrow Neurological Institute
The Gregory Fulton ALS and Neuromuscular Center and the BNI Contract Research Organization are focused on delivering expert patient care and conducting ALS biomarker studies and facilitating the conduct of ALS clinical trials. We conduct studies based on fluid biomarkers, neurophysiological tools including Electrical Impedance Myography, and complex language studies that evaluate both the motor and cognitive components of speech in ALS patient and which have the potential to serve as markers of subtle dysfunction both for early diagnosis and disease progression. Our CRO provides expert outcome measure training for many trials, and we provide disease specific trial monitoring to ensure high quality trial conduct. We partner with Healey Center leaders to provide a variety of educational offerings to ALS specialists, trainees, patients and caregivers.
The Fulton ALS Center is led by Drs. Jeremy Shefner, Chair and Senior Vice President of Barrow Neurological Institute, Robert Bowser, Chief of Neurobiology at Barrow, Shafeeq Ladha, Director of the Fulton Center, and Meghan Hall, Director of the BNI CRO.
About the NEALS Consortium
The NEALS ALS Consortium is an international, independent, non‐profit group of researchers at 135 member sites in North America, Australia, Lebanon, Italy, and Israel who collaboratively conduct clinical research in Amyotrophic Lateral Sclerosis (ALS) and other motor neuron diseases. Our mission is to translate scientific advances into new treatments for people with ALS and motor neuron diseases as rapidly as possible. For more information, please visit http://www.neals.org.