January 2012

National Alzheimer’s Project Act Draft Framework Released

On January 9, the U.S. Department of Health and Human Services released the Draft Framework for a National Plan to Address Alzheimer’s Disease. The National Alzheimer’s Project ACT (NAPA), signed into law last January, called for the creation of a national plan to combat the exponential growth in Alzheimer’s Disease and Related Dementias (ADRD) with input from a public-private Advisory Council on Alzheimer’s Research, Care, and Services. The Advisory Council is tasked with making recommendations to HHS for priority actions to expand, coordinate, and condense programs in order to improve the health outcomes of people with Alzheimer’s disease and dementia.

The Draft Framework for a National Plan was presented by the Advisory Council during their most recent meeting on January 17th and 18th, and highlighted actionable goals. Their primary goal is to to prevent and effectively treat Alzheimer’s disease by 2025. The meeting was open to the public and allowed time for input on the draft framework. Sue Peschin, COO of the Alliance for Aging Research, was present and commented on the importance of research, drug development, and appropriate funding for the the National Institute on Aging and the Food and Drug Administration in achieving this goal.

HHS will be collecting additional input on the draft framework through February 8, 2012. Comments can be sent to [email protected]. All comments will be shared with the Advisory Council on Alzheimer’s Research, Care, and Services and will inform the Draft National Plan which may be released during the week of February 20, 2012.

For more information on NAPA and the Advisory Council click here.

To view Sue Peschin’s full comments, click here.

Congress to Hear Recommendations for User Fee Reauthorization

On January 13, the U.S. Food and Drug Administration (FDA) formally announced that it had reached agreement on the fifth reauthorization of the Prescription Drug User Fee Program. HHS Secretary Sebelius transmitted the FDA’s recommendations to Congress prior to their January 15 deadline for consideration by Congress. FDA’s recommendations were developed in consultation both with drug industry representatives and with patient and consumer advocates. ACT-AD was represented in monthly meetings with the FDA on improvements to the user fee program.

The current program will expire on September 30, 2012, unless reauthorized by Congress. Under the FDA’s recommendations, fees paid by industry would support timely reviews of critical prescription drugs, advance the development of drugs for rare diseases, provide for enhanced communication with small or emerging companies, increase the use of standardized electronic data to improve quality and efficiency. Most importantly, it will foster the use of new clinical endpoints that improve drug development times and help address unmet medical needs.

The House Energy & Commerce Health Subcommittee will hold the first in a series of hearings on the FDA’s user programs on February 1 to examine the impact of prescription drug user fees on jobs, innovation, and patients.

Information on the hearing, can be found here.

Enhancements and recommendations for the user fee program, can be viewed here.

Alzheimer’s Challenge 2012 Introduced at Care Innovations Summit

On January 26, Janssen Alzheimer’s Immunotherapy, and Pfizer Inc., together with the Geoffrey Beene Gives Back® Alzheimer’s Initiative introduced the Alzheimer’s Challenge 2012. The Challenge calls for inventive concepts to help improve the diagnostic identification and tracking of Alzheimer’s disease. Specifically, it seeks the development of simple, cost-effective, consistent tools that could be easily used to assess memory, mood, thinking and activity level over time to help improve diagnosis and monitoring of people with Alzheimer’s disease.

With awards totaling $300,000 and access to experts in the Alzheimer’s community and other related fields, the Alzheimer’s Challenge 2012 provides an entrepreneurial springboard to harness new thinking and approaches to improve Alzheimer’s care. TheChallenge is open to anyone who thinks they have a creative solution and encourages them to submit an entry and be recognized.

A description of the Challenge, official rules, including prizes, judging criteria and timelines – are available on the Alzheimer’s Challenge 2012 website.

ACT-AD Member Hosts 6th Drug Discovery for Neurodegeneration Conference

The Alzheimer’s Drug Discovery Foundation’s 6th annual Drug Discovery for Neurodegeneration conference is taking place on Feb 12-14 in New York City. The primary goal of the conference is to train interdisciplinary scientists at the forefront of research in the principles of drug discovery for neurodegenerative disease. The conference will serve as a platform for scientists and industry leaders to exchange knowledge and resources and hopefully build public-private partnerships accelerating drug discovery. A journal of the outcomes of the conference will be published following the event.

For more information on the conference, click here.