safety issues are usually found during clinical trials or when drugs are on the market. Tests for finding safety problems earlier are few and not reliable. The CPI highlights that there are great efforts to be made and that a new safety toolkit would include the ability to predict failures due to safety before human testing in clinical trials and to demonstrate safety before a drug is on the market. The safety toolkit would lead to better safety standards by helping to predict safety performance efficiently and quickly and will decrease uncertainty.
FDA announced its partnership with the Critical Path Institute (C-Path) in December 2005 to help it to reach the goals of the CPI (FDA, 2006d). C-Path is an independent, publicly funded, nonprofit organization founded by FDA, the University of Arizona, and SRI International. It was created to fulfill the mission of the CPI, which is to “create innovative collaborations in education and research that enable the safe acceleration of the process for developing new medical products” (The Critical Path Institute, 2006). FDA leaders stated that some of the projects developed by C-Path will help to achieve many of the objectives outlined in the opportunities list discussed above.
In March 2006, shortly after the release of the Opportunities Report, FDA announced that it will be taking on an advisory role in the new Predictive Safety Testing Consortium of C-Path and five pharmaceutical companies. The partnership will “share internally developed laboratory methods to predict the safety of new treatments before they are tested in humans” (FDA, 2006b). The collaboration is in line with the public-private partnerships stressed as a major need to improve drug development in the CPI. CDER’s J. Woodcock commented that this is a “concrete example of the power of the collaborative nature of the Critical Path Initiative.”
AAMC (Association of American Medical Colleges), FDA, Center for Drug Development Science at the University of California, San Francisco. 2005. Drug Development Science Obstacles and Opportunities for Collaboration Among Academia, Industry and Government. [Online]. Available: https://services.aamc.org/Publications/showfile.cfm?file=version45.pdf [accessed October 10, 2005].
AAMC. 2006. Collaboration Key to Overcoming Obstacles to Drug Development. [Online]. Available: http://www.aamc.org/newsroom/pressrel/2005/050815.htm [accessed June 14, 2006].
CDER (Center for Drug Evaluation and Research). 2005. Drug Safety Oversight Board (DSB), MAPP 4151-3. [Online]. Available: http://www.fda.gov/cder/mapp/4151-3.pdf [accessed June 20, 2005].
CDER. 2006. Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies. Rockville, MD: CDER.
The Critical Path Institute. 2006. Welcome to C-Path. [Online]. Available: http://www.c-path.org/ [accessed June 14, 2006].
DeClaire J. 2005. Which Drugs Should Health Plans Cover? [Online]. Available: