Somewhere between 2.4 and 5.1 million Americans are afflicted with Alzheimer’s disease. Experts expect that count to double in the next 20 years. And the most powerful pharmaceutical companies in the world have discovered almost nothing to stop or even slow effects of the disease.
That’s where the Tucson-based Critical Path Institute (C-Path) comes in.
On June 11, C-Path’s Coalition Against Major Diseases (CAMD), a consortium of patient groups, drug makers, and representatives of several government regulatory and research bodies, announced that it was opening access to a comprehensive online data repository of records from some 4,000 participants in clinical trials for drugs to treat Alzheimer’s disease.
All 11 of the Alzheimer’s clinical trials–conducted by Abbott Laboratories Inc., AstraZeneca PLC, GlaxoSmithKline PLC, Johnson & Johnson Inc., and sanofi-aventis U.S. Inc.–had been declared failures; the therapeutic candidates didn’t work as researchers hoped they would. But the firms knew that the information collected about participants during studies could be enormously valuable for future research, especially if data from multiple trials could be examined together. So the companies approached C-Path and asked for help.
“Companies said they’re running into a stone wall with Alzheimer’s and Parkinson’s,” said Raymond Woosley, C-Path’s president and CEO, in the Wall Street Journal. “We really believe drugs are failing because we honestly don’t understand the disease.”
Via the CAMD, some of the barriers to unlocking the mechanism of Alzheimer’s are being removed. Because the coalition’s member companies agreed on a common protocol for member data collection, recording, and submission, the database records of all 4,000 trial participants can be examined in aggregate. Comparing data from one trial to another is possible because the information submitted by the companies comes from control-group participants in their trials–those Alzheimer’s patients not receiving experimental treatments.
“This unprecedented data sharing is game-changing for companies that are developing new therapies for neuro-degenerative diseases,” Dr. Woosley said. “Scientists around the world will be able to analyze this new combined data from pharmaceutical companies, add their own data, and consequently better understand the course of these diseases.”
Under the terms that C-Path brokered for the CAMD’s data repository, not only researchers at the participating companies, but any researcher with a legitimate inquiry, will be granted free access to the collected information.
“Innovation no longer happens solely in one company’s lab,” said Frank Casty, AstraZeneca’s vice president of technical evaluations, in the Journal. “It is happening through constant interaction between scientists in the biopharma industry, patient advocates, academia, and government.”
The hope of C-Path and the CAMD’s participants is that researchers will achieve more efficient progress in future studies not only from the raw information in the database, but also the common clinical standards. Some of the most perplexing and disappointing failures of drug candidates have likely resulted from flaws in trial design.
“This is the kind of thing that’s not going to produce a new treatment next week,” said Joshua Sharfstein, deputy commissioner for the U.S. Food and Drug Administration, in an Associated Press news report. Still, he added, “it’s the kind of collaboration that does represent a major shift in thinking about how to accelerate drug development.
“I think the FDA recognizes that one thing that can accelerate drug development is sharing information that is relevant to a disease,” Sharfstein said in the Journal.
The new data repository is C-Path’s latest initiative to make development of new therapeutics safer, faster, and cheaper. The organization made headlines in March for its work with the FDA, the Bill & Melinda Gates Foundation, and the Global Alliance for TB Drug Development to develop means for drug candidates for tuberculosis to be tested together.
The Predictive Safety Testing Consortium, the first consortium that C-Path developed, earned renown in 2008 for achieving approval from U.S. and European government regulators of seven new preclinical biomarker tests that researchers can use when assessing therapeutics’ safety. Just a week ago, the Japanese Pharmaceuticals and Medical Devices Agency also approved that set of biomarkers.
Dr. Woosley said in the Arizona Daily Star that C-Path expects the CAMD data repository to grow substantially and expand beyond records of Alzheimer’s patients. The immediate additions to the repository are expected to be other neurological diseases, such as Parkinson’s and Huntington’s, as well as tuberculosis.
“We want it to grow like crazy,” Dr. Woosley said. “We need to do this with every disease out there–lung cancer, kidney disease. This should be standard in the future–every disease in the computer.”
For more information:
“New attack mounted to combat dementia,” Arizona Daily Star, 06/12/2010
“Drug Makers Will Share Data From Failed Alzheimer’s Trials,” Wall Street Journal, 06/11/2010
“Drug companies share data to speed brain research,” Associated Press, 06/11/2010
Critical Path Institute news release, 06/11/2010