U.S. Food and Drug Administration Continues Funding Critical Path Institute

New multi-year grant furthers non-profit organization's work to accelerate the drug development process

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Sep 17, 2014, 10:33 ET

TUCSON, Ariz., Sept. 17, 2014 /PRNewswire-USNewswire/ -- The Critical Path Institute (C-Path) announced today that the U.S. Food and Drug Administration (FDA) has awarded the organization $2.1 million in first year funding of a five-year grant with the potential of $10.5 million over the five years. This is the second five-year grant that C-Path has received from the FDA under the Critical Path Initiative program. This continued funding will support C-Path's collaborative approach and ongoing, groundbreaking work to improve and accelerate the development and regulatory review of drugs.

In creating the Critical Path Initiative program, the FDA recognized that no one organization possessed the resources or expertise to fill the gaps between discovery at the bench and medical products at the bedside, and identified the need for public-private partnerships as the cornerstone solution to address these gaps. Since its founding in 2005, C-Path has addressed some of the most challenging issues in drug development by facilitating unprecedented collaborations among scientists from academia, the pharmaceutical industry, and government agencies. In its role as a trusted, non-partisan consensus builder, C-Path has achieved key milestones and advancements that have laid the groundwork for the development of safer, more effective medications.

"We are honored by the FDA's continued support," said Martha Brumfield, Ph.D., president and chief executive officer of C-Path. "This important funding ensures that our presence as a neutral entity reaching across inherent boundaries in the scientific community will continue to have a positive impact on the lives of people around the world."

C-Path's accomplishments since receiving its first FDA grant in 2009 include pioneering work in developing biomarkers to more accurately predict organ-specific toxicity; sharing expertise and clinical trial data, including establishing databases with standardized, aggregated, and integrated data for a number of diseases; delivering a clinical trial simulation tool for mild to moderate Alzheimer's disease; advancing tools such as biomarkers and clinical outcome assessment measures in disease areas such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, non-small cell lung cancer, rheumatoid arthritis, and others; and developing and publishing therapeutic area data standards – key information that supports the development of new treatments. In collaboration with the Clinical Data Interchange Standards Consortium (CDISC), C-Path has developed data standards for Alzheimer's and Parkinson's diseases, tuberculosis, and multiple sclerosis, as well as many others.

"For many patients, new clinical trial methods and the resulting approved treatments cannot come fast enough," says former Congressman James C. Greenwood, C-Path board member and current president and chief executive officer of the Biotechnology Industry Organization, an advocacy group representing more than 1,200 biotech companies, academic institutions, and related organizations. "The Critical Path Institute's work to accelerate those processes through innovative partnerships is helping to advance drug development, with the ultimate goal of better patient outcomes and longer, healthier lives."

About the Critical Path Institute
The Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the U.S. Food and Drug Administration (FDA). C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established seven global, public-private partnerships that currently include over 1,000 scientists from government and regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona. For more information, visit www.c-path.org

SOURCE Critical Path Institute