Today, senior representatives from the U.S. Food and Drug Administration (FDA) and the National Institute on Aging (NIA) at the National Institutes of Health (NIH) joined with advocates, federal colleagues, researchers, and industry to explore collaborations for advancing the most up-to-date knowledge in Alzheimer's disease research into clinical trials at the ACT-AD Coalition's Ninth Annual FDA/Alzheimer's Disease Allies Meeting in North Bethesda, Md.
The theme of this year's meeting was "Starting with the End in Mind: Aligning the Science to Close Gaps in Alzheimer's Disease Therapeutic Development."
"Our 2015 ACT-AD meeting focused on the state of research, including existing gaps, into the underlying causes of Alzheimer's disease and the pathways for successful treatment. This year, we picked up where that meeting left off," says ACT-AD Executive Director Cynthia Bens. "At our meeting today, attendees held a frank discussion on whether NIH research is on track to help definitively close knowledge gaps identified by the FDA that will promote more successful therapeutic development. The consensus is that we have made significant strides, but we need to continue to refine strategies that increase research collaborations between government agencies, researchers, advocates, and industry. We look forward to continuing to build on the progress we made today."
The main areas of focus at the meeting included: the most recent research on Alzheimer's disease pathology and genetics; efforts to identify reliable biomarkers in treatment trials and advance novel biomarkers; and symptomatic approaches to improve treatment of major behavioral and psychiatric aspects of the disease.
The meeting featured a trio of expert presentations:
- NIH Initiatives to Inform Alzheimer's Disease Therapeutic Development, Richard Hodes, M.D., National Institute on Aging
- Genetic and Biomarker Advances from Clinical Trials in Early Alzheimer's Disease, Carole Ho, M.D., Denali, and Vissia Viglietta, M.D., Ph.D., Biogen
- Findings from Current Trials Treating Behavioral and Psychiatric Symptoms of Alzheimer's Disease, Paul Rosenberg, M.D., Johns Hopkins University
Also, a distinguished panel of experts explored the scientific and regulatory considerations for developing meaningful disease-modifying and symptomatic Alzheimer's disease treatments.
ACT-AD and its partners will provide a more detailed summary of the results of today's meeting at a future date.
ACT-AD is a coalition of more than 50 national organizations representing patients, providers, caregivers, consumers, older Americans, researchers, and employers seeking to accelerate development of potential cures and treatments for Alzheimer's disease. The coalition is directed by an Advisory Council made up of representatives from the Alliance for Aging Research (AAR), Alzheimer's Foundation of America (AFA), American Society on Aging (ASA), National Alliance for Caregiving (NAC), National Association of Area Agencies on Aging (n4a), National Consumers League (NCL), Research!America, and the Society for Women's Health Research. The coalition is sponsored in part by Alkermes, Anavex, Avanir, Axovant, Biogen Idec, Eli Lilly, Genentech, Janssen, Lundbeck, Merck, and Novartis.