Save the Date for ACT-AD’s Tenth Annual FDA/AD Allies Meeting, November 16
Mark your calendars! ACT-AD’s Tenth Annual FDA/AD Allies Meeting is set for Thursday, November 16, 2017, at the Bethesda North Marriott Hotel and Conference Center (5701 Marinelli Road, North Bethesda, Maryland 20852). The meeting will begin at 9:30 a.m. and end by 4:00 p.m. To register for the event, go here.
ACT-AD’s Bens to Speak at Information Technology & Innovation Foundation Event on PDUFA
ACT-AD Executive Director Cynthia Bens will serve as a panelist for “Speeding Cures for Patients: How Congress Can Update the Prescription Drug User Fee Act to Spur Biopharmaceutical Innovation” on Tuesday, June 6, 2017, in Washington, DC. The event will focus on recent research from the Information Technology & Innovation Foundation (ITIF), highlighting why speedy reauthorization of PDUFA is critical. For more details and to register for the event, go here.
ACT-AD’s Bens Speaks on Patient Engagement at the FDA
ACT-AD Executive Director Cynthia Bens participated in a “Learn from the Pros” panel on May 12 during a public workshop sponsored by the FDA’s Office of Professional Affairs and Stakeholder Engagement titled “Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research.” The meeting was designed to educate advocacy groups on how they can work with the FDA to advance patient engagement in regulatory activities. To find out more, please go here.
Congress Advances FDA User Fee Reauthorization
This month, Congress took steps to reauthorize the FDA’s medical products user fee programs. The current programs, set to expire in September, provide resources and personnel to ensure that the FDA efficiently reviews drugs, biologics and medical devices. The Senate Committee on Health, Education, Labor, and Pensions and the House Energy and Commerce Subcommittee on Health overwhelmingly approved their respective bills, S.934 and H.R. 2430, to renew these critical programs for the next five years. The full House Energy and Commerce Committee is expected to consider H.R. 2430 in June.
Cynthia Bens and Ryne Carney of the Alliance for Aging Research have represented the ACT-AD Coalition’s interests in discussion on the user fee agreements with the FDA, industry, advocacy groups and members of Congress since July of 2015. ACT-AD will continue to support Congress’ efforts to send a final bill to the President before the August Congressional recess.
FDA Commissioner Stresses Importance of Science-Based Decision-Making
Newly confirmed FDA Commissioner Scott Gottlieb addressed FDA staff on May 15 to lay out his immediate priorities for the agency. In his remarks, Dr. Gottlieb highlighted the promise of new scientific opportunities in giving hope for a cure to many more diseases. Gottlieb also emphasized the need to implement the 21st Century Cures Act to ensure FDA is taking steps to foster innovation and regulating areas of promising new technology in ways that do not raise the cost of development or reduce innovation. He further praised the FDA’s staff for their dedication to public health and FDA’s “special mission” to serve a larger societal purpose. ACT-AD looks forward to working with Commissioner Gottlieb to provide opportunities for people living with Alzheimer’s disease to improve their health and, in his own words, “live with dignity.” A transcript of his speech is available here.
NIA Releases Infographic to Highlight the Severity of Memory Loss
The National Institute on Aging recently published an infographic that emphasizes the difference between age-related forgetfulness and more serious cognitive problems. The infographic is available to view and download here.
Exercise May Help in Fight Against Alzheimer’s Disease
Researchers at the University of Maryland conducted a study on the impact of physical activity on brain physiology, which they hope will provide more insight on how to restore protective neuronal connections. The team found increased connectivity to the brain’s posterior cingulate cortex (PCC)/precuneus region among older adults with mild cognitive impairment after a 12-week exercise intervention. The PCC/precuneus region is important in understanding Alzheimer’s and cognitive impairment, as a loss of connectivity to this area of the brain is associated with memory loss and protein buildup. Learn more about the study here.
Researchers Say Positive Social Support May Be Linked to Reduced Dementia Risk
A research team at the University of East Anglia found “having a reliable, approachable, and understanding relationship with spouses or partners, children, and other immediate family” is associated with a reduced risk of developing dementia. However, negative support from family led to an increased risk. “This work is a step toward better understanding the impact of social relationships on dementia risk, but further research is needed to better establish any potential causal mechanisms that may drive these associations,” said University of East Anglia senior lecturer Dr. Mizanur Khondoker. To learn more about these findings, go here.
Gene Mutation May Accelerate Memory Loss in Alzheimer’s Disease
In a recent study published in Neurology, experts say a gene mutation called the BDNF Val66Met allele plays a role in speeding up memory loss and thinking skills in those who are at risk for developing Alzheimer’s disease. “Because this gene can be detected before the symptoms of Alzheimer’s start, and because this presymptomatic phase is thought to be a critical period for treatments that could delay or prevent the disease, it could be a great target for early treatments,” said study author Dr. Ozioma Okonkwo. To read the full study, go here.
Save the Date for NIA’s Inclusion Across the Lifespan Workshop, June 1-2, 2017
The National Institute on Aging (NIA) will convene an expert workshop on appropriate inclusion of pediatric and older populations in research studies involving human subjects. The workshop will address barriers and opportunities for these populations to get involved in clinical studies. For more details about the workshop, go here.
ADDF’s Conference on Alzheimer’s Drug Discovery, September 11-12, 2017
The Alzheimer’s Drug Discovery Foundation will hold its 18th Annual International Conference on Alzheimer’s Drug Discovery in Jersey City, New Jersey. The two-day event will gather top researchers, who are developing innovative treatments for Alzheimer’s disease and related dementias. Scholarships are available for graduate and postdoctoral fellows to attend the conference at no cost. More information about the scholarship can be found here. General details about the conference are available here.