April 2013

ACT-AD to Hold Expert Consensus Retreat on Combination Therapies

The most recent ACT-AD FDA/Allies meeting in November 2012 revealed an emerging interest in pursuing combination therapy development for Alzheimer’s disease. Collaboration will be essential for achieving combination development, and while challenges to collaboration among industry partners are formidable, they are not insurmountable. One recommendation from the November 2012 meeting was to convene an intensive, consensus-building process for achieving the shared vision of combination therapy to treat, and one day prevent, Alzheimer’s disease.

Based on that recommendation, ACT-AD has organized a follow-on retreat to generate a roadmap for how combination therapies can be used to achieve the shared vision. The meeting is co-sponsored by the Alzheimer’s Association and the Critical Path Institute. It will take place on May 28-30, 2013 at the Grand Hyatt in Washington, DC.

For the final report from the November 2012 meeting, click here.

ACT-AD Weighs In on FDA Guidance on Early AD Development

In March Russell Katz, M.D. and Nicholas Kozauer, M.D. of the FDA’s Division of Neurology Products published an article in the New England Journal of Medicine (NEJM), clarifying the agency’s proposed guidance to industry for designing and conducting clinical trials involving patients with early Alzheimer’s disease.

The draft guidance opens the door to the use of a single scale combining assessments of both cognition and function for those in trials at the earliest stages of Alzheimer’s disease. The guidance also suggests that approval of a therapy based on such outcomes alone could conceivably be achieved through the FDA’s accelerated approval pathway.

ACT-AD submitted comments on the draft guidance commending FDA for its interest in utilizing the accelerated approval pathway as a viable option for Alzheimer’s disease treatments. The comments had a number of suggestions, including that FDA clarify the level of evidence it needs for inclusion of patients into either early-stage trials. ACT-AD also suggested that the agency hold a public meeting before it begins incorporating any commenter feedback into its final guidance

For the full draft guidance, click here.

To read ACT-AD’s comments, click here.

Alzheimer’s Research Would Get $80 Million Increase Under Obama’s 2014 Budget

On April 10 the Obama Administration released the President’s Budget for Fiscal Year 2014 (FY 14). The President’s proposal prioritizes funding for the National Institute on Aging (NIA) recommending a total increase of $83 million. $80 million of this increase would be dedicated to Alzheimer’s disease research to support specific recommendations from the 2012 National Institute on Aging’s Alzheimer’s Disease Research Summit 2012: Path to Treatment and Prevention.

The FY 14 budget also includes a prominent mention of biomedical research at NIH that is aimed at improving our understanding of the nature of aging and extending the healthy, active years of life. Examples of such research were highlighted during a 90-minute briefing given by Dr. Richard Hodes, the Director of the NIA, before representatives of the Friends of the National Institute on Aging (FoNIA) on March 22, 2013.

To read the President’s FY14 Budget, click here.