Marc Cantillon, MD, presents the critical role of public/private partnerships in creating innovative tools to advance the development of new Alzheimer’s disease therapies
TUCSON, Ariz.--(BUSINESS WIRE)-- Marc Cantillon, MD, Executive Director of the Coalition Against Major Diseases (CAMD) at Critical Path Institute (C-Path), presented testimony last Thursday, December 9, 2010, to the Subcommittee on Health for the Committee on Energy and Commerce of the U.S. House of Representatives in Washington, DC at a hearing on "Alzheimer's Disease: The Ongoing Challenges." Other witnesses included CAMD members and participants, Dr. Marcelle Morrison-Bogorad, Director, Division of Neuroscience, National Institute of Aging, National Institutes of Health; Harry Johns, President and CEO, Alzheimer’s Association; and Eric J. Hall, President and CEO, Alzheimer’s Foundation of America.
Despite alarming statistics on the impact of Alzheimer’s disease and continuing reports of failures of new drugs in development, Dr. Cantillon presented an encouraging message to the Subcommittee by describing CAMD’s mission and important progress to date. He expressed thanks to the Subcommittee for their critical role in making it possible for the U.S. Food and Drug Administration (FDA) to create Critical Path public/private partnerships as outlined in the FDA Amendments Act of 2007. CAMD was one of the first of these partnerships awarded by the FDA, and is already creating and identifying novel tools that will speed the development of new medicines for Alzheimer’s.
CAMD is a unique, global, public/private collaboration of over 200 scientists from 12 biopharmaceutical companies, academic institutions, three government regulatory agencies, six patient advocacy organizations, and other key stakeholders. CAMD is helping identify and adopt innovative testing methods that lead to increased efficiency, safety, and speed in developing new therapies for major diseases, including an initial focus on Alzheimer’s disease. In his testimony, Dr. Cantillon expressed why this type of collaboration, led and facilitated by a neutral organization such as C-Path, is essential to bring about needed improvements in the way drugs are tested. C-Path focuses on “applied regulatory science,” i.e., the science that can improve the quality, accuracy, and efficiency of decision-making by scientists in the FDA and regulated industry.
According to Raymond Woosley, MD, PhD, President and CEO of C-Path, “The greatest challenges facing biomedical researchers in the 21st century are neurodegenerative diseases. CAMD is working to replicate the collaborative and innovative environment that enabled rapid, yet enduring, progress against HIV/AIDS in the 1980s.”
In June 2010, CAMD launched a first-ever database of combined clinical trials to be openly shared by pharmaceutical companies. Containing information from approximately 4,000 Alzheimer's patients from eleven industry-sponsored clinical trials, it is now available to qualified researchers around the world and provides a standardized platform from which they can design more efficient clinical trials of new treatments. This will allow the industry to more rapidly identify potential therapies that have a positive effect on disease progression.
Speaking at the public launch of the CAMD Alzheimer’s disease database, Joshua Sharfstein, MD, Principal Deputy Commissioner of the U.S. Food and Drug Administration, remarked, “The FDA has supported and actively participated in this innovative and unprecedented public/private partnership from its inception. The agency is strongly committed to CAMD and other regulatory science collaborations that can speed safe and effective treatments to the public.”
Mark McClellan, MD, PhD, who launched FDA’s Critical Path Initiative during his tenure as FDA Commissioner, also notes the need for better tools in drug development. “The CAMD database is a promising step in this process for attacking neurodegenerative diseases,” said Dr. McClellan, now Director of the Engelberg Center for Health Care Reform and Leonard D. Schaeffer Chair in Health Policy Studies at the Brookings Institution, which co-convened CAMD with C-Path.
“Neurodegenerative diseases have, for the most part, remained beyond the reach of medical researchers, and continue to result in skyrocketing costs for treatment, chronic suffering, and the loss of lives,” said Dr. Cantillon. “CAMD projects are designed to develop tools that identify patients before they develop symptoms of their diseases, i.e., while brain tissue and function can still be saved. This will allow researchers to test therapies that have the capacity to prevent or slow these diseases so patients can maintain independence and the highest possible quality of life.”
About Critical Path Institute (C-Path): An independent, non-profit organization established in 2005, C-Path is committed to transformational improvement of the drug development process. An international leader in forming collaborations around this mission, C-Path has established first-of-its-kind global partnerships that currently include over 750 scientists from government regulatory agencies, academia, patient advocacy organizations, and thirty major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona, with offices in Phoenix, Arizona, and Rockville, Maryland. For more information, visit www.c-path.org.
About CAMD: CAMD is a consortium jointly created by C-Path and the Engelberg Center for Health Care Reform at the Brookings Institution. It is a public/private partnership funded by the U.S. Food and Drug Administration and Science Foundation Arizona in which over 200 scientists from 20 member organizations share pre-competitive data and knowledge that will speed development of new therapies for prevention and possible cure of Alzheimer’s, Parkinson’s, Huntington’s, and other debilitating neurodegenerative diseases. CAMD’s overall objective is to help scientists develop new tests (biomarkers) that identify patients before they develop symptoms of these diseases and therefore, more likely to benefit from new therapies. For more information on CAMD and the database, visit http://www.c-path.org/CAMD.cfm.
CAMD Members: Abbott, Alliance for Aging Research, Alzheimer's Association, Alzheimer's Foundation of America, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, CHDI Foundation Inc, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Forest Research Institute, Genentech Inc., GlaxoSmithKline, Johnson & Johnson, Michael J. Fox Foundation, National Health Council, Novartis Pharmaceuticals Corporation, Parkinson's Action Network, Parkinson's Disease Foundation, Pfizer, Inc., and sanofi-aventis US Inc.
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