November 2015


Senate Committee Considers FDA Commissioner Nomination 

The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing this month on President Obama’s nominee for commissioner of the U.S. Food and Drug Administration, Robert Califf, M.D. Dr. Califf, a cardiologist and clinical trial expert from Duke University, was nominated in October to lead the agency. Califf brings with him decades of knowledge in clinical research and experience working with patients, industry, and government to successfully bring new medical products to market. Members of the HELP committee were largely supportive of Dr. Califf’s nomination, but raised questions about the FDA’s reliance on non-binding guidance to communicate with industry as well as the impact costly clinical trials have on patient access to new therapies.  The Senate is expected to vote on Dr. Califf’s nomination in December. The hearing webcast and Dr. Califf’s testimony can be found here.

FDA Hosts Workshop on Neurodiagnostics

The FDA’s Center for Devices and Radiological Health (CDRH) held a two-day workshop on neurodiagnostics and non-invasive brain stimulation medical devices on November 19-20. The focus of the first day of the workshop was cognitive assessment devices intended to provide health care professionals with an evaluation of cognitive function through non-invasive measurements. The workshop included presentations by CDRH on its process for classifying these types of devices based on risk, as well as mechanisms that enable device sponsors to engage with FDA early in the device development process to better navigate this emerging space. Several presentations acknowledged the promise of technology to aid in monitoring brain health and assisting physicians in detecting cognitive impairment. The importance of technology in providing patients and caregivers with more information on cognitive health was underscored by Stacy Haller, president and CEO of the BrightFocus Foundation, an ACT-AD member, who spoke on a multi-stakeholder panel during day one of the workshop. A webcast and select presentations can be viewed here. 

FDA Continues Monthly Stakeholder Consultation on PDUFA and MDUFA 

FDA hosted the next in a series of monthly meetings with patient and research advocacy groups to discuss the status of negotiations on the reauthorization of the prescription drug and medical device user fee programs. The MDUFA meeting held on October 26 provided an opportunity for CDRH representatives to highlight activities they have undertaken to improve representation of demographic subgroups in clinical trials.  The meeting also allowed FDA to have stakeholders identify their top priorities for the reauthorization of the medical device user fee program. These priorities include securing resources for CDRH to enhance patient preference activities, improving efficiency in pre- and post-marketing data collection, establishing a system for incorporation of patient registries and unique device identifiers, and enabling cross-center coordination on combination products and companion diagnostics. The PDUFA meeting on November 16 focused on the evolution of FDA’s Sentinel System for post-market surveillance and projects the agency is involved in to leverage data sources to confirm regulatory decisions. ACT-AD was represented by the Alliance for Aging Research during both discussions.

Conference on Alzheimer’s Disease-Related Dementias, March 29-30, 2016

Mark your calendars for March 29-30, 2016, for the Alzheimer’s Disease-Related Dementias 2016 Summit at the National Institutes of Health campus in Bethesda, Md. ACT-AD is pleased to be one of the sponsors of the conference. For more information, please go here. The conference is also seeking “recommendations for research on frontotemporal degeneration, health disparities, Lewy body dementia (including Parkinson’s disease dementia), multiple etiology dementias, and vascular contributions to dementia.” The suggestions they receive “will be considered during the development of a set of updated recommendations and presented for public comment at the ADRD Summit 2016.” Get more information here.

New Paper on ‘Current Dementia R&D Landscape’

This Office of Health Economics has released a new research paper that offers a summary of current research and development into dementia, including an analysis of successes and failures of treatments. You can download the report here.  Access to the report is free but registration is required.

NIH Starts Initiative on Alzheimer’s Disease and Down Syndrome

The National Institutes of Health has announced an initiative that seeks to discover Alzheimer’s disease biomarkers in those with Down syndrome. It will also track the progression of AD in those with the condition. Currently, experts have little information about the links between Alzheimer’s disease and Down syndrome, so this landmark initiative aims to benefit researchers. Read more here.

November 1-7 Was National Memory Screening Week

On November 1-7, we recognized National Memory Screening Week, which highlighted the importance of memory screenings in helping practitioners proactively diagnose memory loss. The Alzheimer’s Foundation of America offers a National Memory Screening Program that provides “free, confidential memory screenings to individuals concerned about memory loss with the objective of early detection and intervention.”  Learn more here. 

New Infographic on the Impact of Alzheimer’s Disease Research

The Biotechnology Industry Organization has released an infographic that is a great resource to demonstrate the impact of Alzheimer’s disease and the promise of AD research. It is a useful tool to educate others about the serious nature of this devastating disease. See it here. 

Experts Say Immune System in Brain Could Help Remove Amyloid Plaques

A new study discusses the potential of the brain’s immune system to help fight Alzheimer’s disease through elimination of amyloid plaques. According to lead study author M. Kerry O’Banion, M.D., Ph.D., “This research confirms earlier observations that, when activated to fight inflammation, the brain’s immune system plays a role in the removal of amyloid beta. We have also demonstrated that the immune system can be manipulated in a manner that accelerates this process, potentially pointing to a new therapeutic approach to Alzheimer’s disease.” Read more in the Journal of Neuroinflammation.