October 2011

ACT-AD to Hold Annual FDA/AD Allies Meeting on Phase II Trials

ACT-AD will offer another opportunity for patient groups, researchers and industry to interact with the FDA on methods for improving the efficiency of clinical trials for Alzheimer’s disease therapies. The increasing length and size of clinical trials for Alzheimer’s products is impeding patient access to new treatments. This meeting will explore the challenges of Alzheimer’s drug development and potential avenues to improve this process in the future. Individuals involved in current and recent Alzheimer’s trials will reflect upon their experiences designing a Phase II study. These presentations will be followed by a panel discussion.

The workshop is a public event that will be held on December 9, 2011 from 8:00 a.m. to 1:00 p.m. at the Hilton Rockville Executive Meeting Center in Rockville, MD. There is no fee to attend and all ACT-AD members are encouraged to participate.

For more information, please contact Cynthia Bens at [email protected].

ACT-AD Chair Makes Remarks on Prescription Drug User Fee Program

On October 24th, ACT-AD Chair Daniel Perry presented remarks at a public meeting on the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA IV, currently set to expire in September of 2012, authorizes the Food and Drug Administration (FDA) to collect user fees from companies wishing to submit their products for agency review. The intention is that the fees would be used to provide an additional revenue stream for FDA to hire more staff, improve systems, and establish a better managed drug review process to speed up the delivery of needed therapies to the public.

In his remarks, Mr. Perry emphasized the need for FDA to have the ability to play a more significant role in encouraging the development of new therapies for diseases like Alzheimer’s by increasing their capacity to qualify biomarkers and other endpoints for use in development, and to continue assessing the benefits and risks of new therapies post-approval so as not to delay treatments for patients who may benefit from them.

The PDUFA reauthorization process has historically been conducted through negotiations between the Agency and regulated industries, however the current round of negotiations allowed for patient groups to engage in monthly consultations with FDA representatives to enable all stakeholders to have an early voice in shaping the PDUFA V agreement.

To read the full text of Mr. Perry’s remarks, click here.

New Alzheimer’s Disease Health Center Launches on VisualMD.com

A new Alzheimer’s Disease Health Center launched on October 24, 2011. This virtual resource is the newest addition to VisualMD.com, a multimedia website designed to educate the public on issues concerning health and wellness. The Alzheimer’s Disease Health Center educates visitors on the devastating clinical and social effects of Alzheimer’s disease. It covers the biology of Alzheimer’s disease and its impact on brain function, the difference between Alzheimer’s disease and normal cognitive aging, and provides information on risk factors and possible prevention strategies. The goal is to demystify the fatal disease by providing as much information as is known in a visually stimulating format. Janssen Alzheimer’s Immunotherapy (AI) and Pfizer Inc. supported the creation of the VisualMD.com Alzheimer’s program.

To experience the Alzheimer’s Disease Health Center, visit The VisualMD.

Effort to Discover the Keys to Alzheimer’s Disease Continues

ACT-AD and its members know all too well the physical, social and economic toll Alzheimer’s disease presents for patients and their families. We are also aware that the burdens will continue to grow as the aging of the population leads to increased numbers of patients and loved ones who are affected by Alzheimer’s disease – unless we do something about it now.

Dr. Michael Weiner, M.D., principal investigator of one of the largest clinical trials on Alzheimer’s disease (AD) in history, is working with colleagues from around the country to find answers to who gets AD, how it progresses, and how best to stop it. Dr. Weiner is not only leading the Alzheimer’s Disease Neuroimaging Initiative (ADNI) – the largest and most comprehensive AD research study of its kind sponsored by the National Institute on Aging—he is also a caregiver to his mother, who has Alzheimer’s. According to Dr. Weiner, one of the most significant hurdles facing the AD scientific community is not the complex disease itself, but the lack of volunteers for clinical trials and the resulting slow rate of discovery.

To date, ADNI research has made significant contributions to the study of AD, and scientists believe we are at the cusp of further discoveries. To continue at the pace needed to be successful against this “silent epidemic,” ADNI is looking for volunteers to participate in its critical research. To be a part of the fight against Alzheimer’s disease and to support those providing care for the millions of men and women suffering with Alzheimer’s, click here or call 1-800-438-4380.