Cross-sector stakeholders to create a roadmap for the successful redesign of Alzheimer’s disease clinical trials.
NEW YORK, June 10, 2013—The New York Academy of Sciences' Alzheimer's Disease and Dementia Initiative (ADDI) today gathered leaders from industry, government, and academia for the first of a two-day workshop titled, "Prevention of Alzheimer's Disease — What Will It Take?"
The goal of the workshop is to develop a shared roadmap that will lead to additional drug development, which is currently hindered by extensive clinical trial processes. Very few drugs are currently approved to treat Alzheimer's disease and none effectively targets the underlying cause of the disease. Currently, more than 5 million people in the U.S. suffer from Alzheimer's disease, and that number is expected to grow to 14 million by 2050 if left unchecked.
During the first day of the conference, working groups focused on unique challenges related to disease prevention, with special attention to applying methods of adaptive clinical design that provide greater flexibility to redesign clinical trials at interim states so as to capitalize on positive early results. The aim of such an effort, which has been successfully applied to other diseases such as cancer, is to make drug development more efficient and cost-effective.
"Industry, government, researchers and patients share a common goal: speeding the discovery of new therapies for Alzheimer's disease," says Dr. Jeffrey Nye of Janssen R&D and Johnson & Johnson Innovation. "The ADDI brings these stakeholders together to identify and eliminate roadblocks along the path. Working together we can shorten clinical trials and increase the number of new medicines tested," adds Dr. Nye, co-chair of the ADDI Leadership Council .
Working groups focused on achieving the following outcomes: agreement on drug target selection; definition of action items for ensuring safe and effective clinical design; and development of steps for implementing adaptive design methodology for Alzheimer's disease clinical trials.
Day two of the workshop will focus on creating a robust roadmap with clearly defined next steps for applying adaptive design methods to Alzheimer's clinical trials.
"The FDA is eager to work with companies to design clinical trials for new treatments for Alzheimer's disease that can determine effectiveness as efficiently as possible," says Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research. "These study designs could include adaptive elements, including procedures to eliminate treatment arms that lack effectiveness so that only those treatments likely to be effective are carried forward into definitive trials. We continue to encourage sponsors to submit protocols for our review that incorporate novel designs in this critical area of drug development."
"The Academy's Alzheimer's Disease and Dementia Initiative is the platform that will drive real outcomes in the advancement of Alzheimer's disease prevention," says Ellis Rubinstein, President and CEO of the Academy. "The ADDI enables stakeholders to put their weight behind not only a common goal, but a shared action plan to jumpstart effective drug development."
For more information on the ADDI and its Leadership Council members and partner organizations, visit http://www.nyas.org/WhatWeDo/Alzheimers.aspx.
For interview requests related to the two-day workshop or ADDI, please contact Diana Friedman (dfriedman@nyas.org; 212-298-8645).
About the New York Academy of Sciences
The New York Academy of Sciences is an independent, not-for-profit organization that since 1817 has been committed to advancing science, technology, and society worldwide. With 25,000 members in 140 countries, the Academy is creating a global community of science for the benefit of humanity. The Academy's core mission is to advance scientific knowledge, positively impact the major global challenges of society with science-based solutions, and increase the number of scientifically informed individuals in society at large. Please visit us online at www.nyas.org .
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