Reforms urgently needed to streamline road to Alzheimer's

These are conclusions of a report on Alzheimer's drug development that will be discussed today at the "Alzheimer's Disease Summit: The Path to 2025" held at the New York Academy of Sciences (the Academy). The Summit, co-convened by the Academy, the Global CEO Initiative on Alzheimer's Disease (CEOi) and the U.S. National Institute on Aging/National Institutes of Health (NIH), brings together global leaders from government, academia, non-governmental organizations, and industry to accelerate progress on Alzheimer's research and development over the next decade. This Summit follows on the first Alzheimer's Disease Research Summit convened by the NIH in 2012.

"The Path to 2025" Summit comes during a pivotal time for Alzheimer's disease, as the requisite conditions for drug development success -- from finance, business, science, and government -- are converging, creating worldwide momentum in the fight against Alzheimer's. Helping drive this momentum, the new report, "Economic Analysis of Opportunities to Accelerate Alzheimer's Research and Development," available at www.nyas.org/Pathto2025report and commissioned by the Academy from RTI International, is presented today as a working draft to elicit comments and evaluation by the Alzheimer's experts at the Summit. A final version of the report will be published in Annals of the New York Academy of Sciences in early 2014, and is intended to serve as a further stimulus for action among stakeholders in the Alzheimer's field.

As the report draft delineates, rapid action is sorely needed. "Alzheimer's disease is a global emergency. It robs people of dignity in their final years and takes a debilitating toll on national economies," says New York Academy of Sciences President and CEO Ellis Rubinstein. "Progress in developing new therapies has been unacceptably slow, and so we must rethink how Alzheimer's research is carried out so that we can accelerate our understanding of what causes this complex disease."

"Global leadership and collaboration across business and government are essential to drive coordinated action, promote rapid innovation, and spur the focus needed to achieve a means of prevention and effective diagnosis, treatment, and care for Alzheimer's and dementia," says George Vradenburg, Convener of the CEOi. "The inefficiencies in the current drug development system can be addressed and we can meet the goal of stopping Alzheimer's by 2025."

Alzheimer's disease and other dementias currently affect more than 35 million people worldwide, with 2010 global expenditures alone reaching more than US $600 billion. The burden of Alzheimer's disease is projected to rise steeply as the number of people living with it roughly doubles by 2035, and triples by 2060, because of aging populations worldwide. Despite numerous large-scale drug trials, a treatment to slow or stop the progression of Alzheimer's has thus far proven elusive, and current therapies treat symptoms in limited populations for short periods of time. Recognizing the global implications of this crisis, the G8 is preparing for its first-ever meeting on dementia in London in December 2013.

Cost of Alzheimer's Drug Development Currently Three Times Industry Average

One of the significant findings in the report is that the major bottlenecks in identifying an effective Alzheimer's disease treatment are the high cost and risk of drug development and research, particularly large clinical trials of thousands of patients over multiple years that test a single drug. The report estimates that the total cost of bringing an effective Alzheimer's treatment to market currently approaches $6 billion -- nearly three times the industry average for drug development. (Total cost includes expenditures on an effective drug and on the failed drugs preceding it.)

The report considers the likely economic impacts of adopting a series of recommendations made by government agencies, expert panels, and other bodies to streamline how Alzheimer's drugs are developed and tested. Among the reforms recommended are:

• Developing reliable disease markers to predict the progression of Alzheimer's disease in different patients and better match people with treatments likely to work for them;

• Making clinical trials more efficient and less costly by establishing global trial-ready cohorts of eligible clinical trial participants as well as using adaptive trial designs that will enable the testing of multiple drugs, in combination, tailored for different at-risk populations;

• Establishing data-sharing arrangements for companies to share precompetitive research results so that other scientists can learn more rapidly how to slow or stop Alzheimer's; and

• Promoting public-private partnerships that pool resources from governments, academia, industry, and patient advocates to co-invest in Alzheimer's drug development and testing.

The report estimates that implementing these and other reforms to Alzheimer's drug development would reduce the total cost of developing an effective Alzheimer's treatment by nearly $4 billion and reduce significantly the overall timeline to develop and introduce a successful Alzheimer's treatment, bringing both more in line with the industry average. The recommended reforms would also lead to increased private investment in Alzheimer's drug development.

Speeding the availability of an Alzheimer's drug that can slow or stop the disease by 2025 could have tremendous benefit for patients and health systems. By creating conditions favorable to Alzheimer's drug development through targeted recommendations, 7 million case-years of dementia could be averted and upwards of $100 billion in healthcare expenditures could be saved over a 15-year period in the United States alone, according to the Academy-commissioned report.