November 2013

ACT-AD Has a Presence at CTAD 2013

From November 13-November 16, ACT-AD was represented at the 6th annual Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Diego, CA. This marks the third year that coalition representatives participated in the meeting of more than 600 of the world’s leading academic and industry Alzheimer’s scientists.

The conference opened with the presentation of a lifetime achievement to Dr. Rusty Katz, for his contributions to Alzheimer’s drug development as former head of FDA’s Division of Neurology Products. The award presentation was followed by a panel on current methodological and regulatory considerations for clinical trials in early Alzheimer’s disease. That panel included a presentation by Dr. Nicholas Kozauer, FDA’s current Medical Team Lead for Alzheimer ’s disease. During his talk Dr. Kozauer highlighted the Agency’s draft guidance on considerations for Alzheimer’s disease therapeutic development. ACT-AD also hosted an event at CTAD where more than 60 key opinion leaders met to discuss issues related to demonstrating clinical meaningfulness in the earliest stages the disease and further developing the scientific rationale for pursuing combination therapy for Alzheimer’s disease.

For more on the CTAD program, visit www.ctad-alzheimer.com.

FDA User Fees Get Congressional Support

Currently, the Federal Government is operating under a Continuing Resolution that extends current spending levels and across-the-board sequester cuts until January 15, 2014 when another shutdown could be possible. It seems likely at this point that an impasse leading to a shutdown could be overcome through private negotiations between Chairs Rep. Paul Ryan (R – WI) and Sen. Patty Murray (D – WA), which some speculate may involve the closing of tax loopholes as a way to raise revenue and return FY 14 discretionary spending to their FY 12 level.

Of all the agencies affected by the funding cuts, the Food and Drug Administration has the unique misfortune of having its non-appropriated dollars subjected to the 5.1% sequester. Despite being recognized with budget increases by both the House and Senate appropriations committees for its expanded duties and services, the Office of Management and Budget (OMB) recently decided that user fees FDA collects from industries the Agency regulates to review products are going to be treated as appropriations.

On November 15, a Congressional sign-on letter was circulated by House Agriculture Appropriations Committee member Representative Yoder (R-KS), and sent to the Office of Management and Budget (OMB). The letter asks OMB to reconsider its decision to have the sequester apply to user fees. The letter states that the sequestration of private dollars unrelated to the government deficit “…compromises the good faith of industries that chose to enter into such an agreement,” and “also has the potential to cripple an essential public health agency that relies on outside resources for well over 60 percent of its drug review budget.” Bipartisan support for a user fee exemption is growing with letters like these, and bills like H.R. 2725 (the FDA Safety Over Sequestration Act of 2013) and S. 1413 (FDA User Fee Protection Act), which are supported by ACT-AD.

To read Rep. Yoder’s OMB letter, click here.

To view past support letters for H.R. 2725 and S. 1413, click here, and here.

Alzheimer’s Foundation of America Hosts 11th Annual National Memory Screening Day

In honor of National Alzheimer’s Awareness Month, the Alzheimer’s Foundation of America, an ACT-AD member, sponsored its 11th annual National Memory Screening Day on November 19. During National Memory Screening Day, five to ten minute face-to-face screenings were administered by qualified healthcare professionals (i.e., physicians, psychologists, nurses, nurse practitioners, social workers, pharmacists). Screening sites included Alzheimer’s agencies, assisted living residences, long-term care facilities, doctors’ offices, hospitals, senior centers, YMCA locations, pharmacies and other local venues.

In 2012, an estimated 85,000 people participated at more than 2,300 community sites nationwide. This year, the co-chairs of the bi-partisan House Alzheimer’s Caucus, Representatives Maxine Waters (D-CA) and Chris Smith (R – NJ), issued a resolution recognizing AFA’s screening initiative and encouraging participation. Thanks in part to their support, this year a record high 7,100 local sites offered free, confidential memory screenings and educational materials to the public.

For more information visit www.nationalmemoryscreening.org.

Alzheimer’s Foundation of America and the National Alliance for Caregiving to Hold Conference on NAPA Implementation

On December 3, two ACT-AD members, the Alzheimer’s Foundation of America and the National Association for Caregiving, will be hosting a conference titled, From Plan to Practice: Implementing NAPA in Your State. The event will bring together federal and state policymakers who have developed comprehensive plans to provide support and services to people with Alzheimer’s disease and their family caregivers to discuss innovative caregiving models, and successful state-level implementation.

The conference will be held at the Pew Conference Center, at 901 E Street NW Washington, DC. Attendance is free, and participation via webinar is available through registration. The conference is open to all, though seating is limited.

To view the conference agenda, click here.

For additional information on how to register, click here.

Alzheimer’s Registry to Aid in Clinical Trial Recruitment

Every 68 seconds, someone is diagnosed with Alzheimer’s disease. Without true scientific breakthroughs, the number of people age 65 and older with Alzheimer’s disease may nearly triple, from 5.2 million to a projected 13.8 million and healthcare costs are projected to soar to $1.2 trillion by 2050.

Recruiting participants for clinical trials is one of the biggest barriers to research and development for new Alzheimer’s treatments. There is a common misconception that clinical trials only focus on people who are ill and have no other options; however many of the Alzheimer’s prevention studies on the horizon need thousands of cognitively healthy individuals to participate.

Researchers must consider 10-20 times the number of people needed to actually fill a clinical trial. This means significant delays can hamper research for a disease which is the only top 10 cause of death without a treatment or cure. The Alzheimer’s Prevention Registry helps match healthy enrollees with investigators in their community, which could cut the time to complete studies in half and help researchers get results faster.

Visit www.endALZnow.org to learn more.