The Global CEO Initiative (CEOi) on Alzheimer's Disease and the New York Academy of Sciences (the Academy) today (February 20th) convened representatives from industry, academia, government and nonprofits to launch the development of a Global Alzheimer's Platform (GAP), designed to reduce the time and costs of Alzheimer's clinical trials, develop an infrastructure that promotes innovation, and assure international collaboration.
"Alzheimer's is a global epidemic that must be addressed with urgency and passion. The time, cost and risk of these trials are an impediment to speedy development of innovative therapies, and thus a critical, although challenging area for innovation," said George Vradenburg, convener of the CEOi. "We look forward to working with the Foundation for NIH to take advantage of their experience in managing large-scale collaborations, such as the Accelerating Medicines Partnership (AMP), as well as the FDA to develop the infrastructure required to advance innovation in drug development. Through our collaborative efforts here in the U.S. and with emerging consortia in Europe, we believe we can design a truly global clinical trial system of speed and power."
Currently, there is no global pool of patients eligible for clinical trials that researchers can access from anywhere in the world in order to identify appropriate trial cohorts. This creates barriers that slow the pace of drug development, a problem that is further compounded by the fact that each new Alzheimer's trial starts from the beginning in order to train the study staff and create multi-centered infrastructure.
Beyond the time it takes to test an Alzheimer's drug, there are also cost concerns. A recent report conducted by RTI International at the request of the Academy found that the cost of bringing an effective Alzheimer's treatment to market currently approaches $6 billion - nearly three times the industry average for drug development.
GAP will look to address these roadblocks through four core focuses, which include:
- Developing a global pool of eligible clinical trial candidates;
- Speeding trial activation by establishing new international standards for trial site certification;
- Creating a framework that will support innovative trial designs; and
- Establishing a sustainable funding model that delivers value across the public and private sectors.
"We can no longer afford to have Alzheimer's clinical trials siloed in a few locations around the world without a means to capture the knowledge that comes from these critical human contributions," said Ellis Rubinstein, President and CEO of the New York Academy of Sciences. "Through the development of GAP, government and industry can create more effective and streamlined Alzheimer's clinical trials, and tap new sources of revenue through innovative public-private partnerships."
The development of GAP is part of a new sense of urgency brought on by the November 2013 Summit on the Path to 2025 convened by the CEOi and the Academy, and followed by the December G8 Dementia Summit held in London, where member nations committed to stopping Alzheimer's. Currently, more than 44 million people worldwide suffer from the disease at a global cost of $605 billion annually. Without a means of prevention or cure, Alzheimer's and dementia is projected to triple in size and threaten the solvency of national health care systems the world over.