Critical Path Institute

Critical Path Institute

Critical Path Institute (C-Path) is an independent, non-profit organization 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 consortia that currently include over 1,000 scientists from government regulatory and research agencies, academia, patient advocacy organizations, and thirty major pharmaceutical companies.[1][2][3][4]



New drug development can cost nearly $1 billion and take, on average, 15 years to get from laboratory testing to regulatory approval;[5][6] only five- to 15-percent of new medicines that enter human testing reach the market.[5][7] In 2010, only 21 new drugs were approved for marketing.[8]

To address the declining productivity of the pharmaceutical industry, the U.S. Food and Drug Administration (FDA) launched the Critical Path Initiative (CPI) in 2004, its national strategy for forming collaborations to transform the way FDA-regulated medical products are developed, evaluated, and manufactured.[9] C-Path was created, with full support from the FDA and initial funding from the state of Arizona, to fill an essential role as a neutral third party that enables scientists from the regulated industry and international regulatory agencies to work together in establishing a faster, safer, and more efficient path through the drug development process.[4][10]

Since its launch in 2005, five C-Path consortia—made up of participants from industry, academia, regulatory agencies, and patient advocacy groups—have focused on identifying the best methods for testing drug safety and efficacy, and sharing their data and knowledge about major diseases (clinical trial data, quantitative disease progression models, and biomarkers).[11] In order to maintain its status as a neutral, trusted third-party, C-Path receives no funding from companies that develop products regulated by the FDA, and as such, relies on in-kind contributions, philanthropic support, foundation and federal grants, a volunteer board of directors, and community engagement to accomplish its mission.


C-Path works with over 1,000 scientists from over 30 major pharmaceutical companies around the world under a common legal agreement; this agreement allows the sharing of data to generate new scientific knowledge and tools that will enable the design of more efficient clinical trials leading to rapid approval of therapies. They also work with scientists from academia, the National Institutes of Health, the Centers for Disease Control, the World Health Organization, the Bill & Melinda Gates Foundation, and others. C-Path focuses on work that has been identified as high priority by the FDA and is in the interest of national and global public health.[4][12][13][14]

Qualification Process

C-Path and FDA scientists have worked together to identify the guiding principles for how biomarkers can be scientifically reviewed in order to bring greater efficiency to the drug development process.[15] Instead of describing biomarkers with general terms such as “validated” or “surrogate endpoints” as is generally done, C-Path prefers the designation qualified for a specific use or fit for use. By specifying the intended “use,” much greater clarity is provided on the context and intent for using a biomarker. Once a scientific consensus on how a biomarker can be used to support specific decisions to be made by the industry and/or the FDA, it can be designated as qualified for that use. Based on the work with C-Path consortia, the FDA recently released a Draft Guidance for Qualification of Drug Development Tools. This is the process being used by C-Path consortia and others to obtain regulatory decisions on the acceptability of new testing methods in drug development.

C-Path Consortia

C-Path consortia are public/private partnerships[16] that are revolutionizing the drug development process.[17][18][19][20] Readers Digest selected C-Path as one of 18 Ideas to Reform Health Care, citing its ability to “bring together the FDA and drug, biotech, and diagnostic companies (many of them fierce competitors) to talk more openly so patients can get safer drugs more quickly and inexpensively.”[21]

  • The Predictive Safety Testing Consortium (PSTC) was the first of C-Path’s consortia, and brings together pharmaceutical companies to share and qualify one another's safety testing methods. The process included advisors from the FDA and its European counterpart, the European Medicines Agency (EMA). The industry members of the consortium share experience with pre-clinical and clinical safety biomarkers in six workgroups: carcinogenicity, kidney, liver, muscle, vascular injury, and cardiac hypertrophy. All biomarker research programs have a strong clinical and translational focus to select new safety tools that are applicable across the drug development spectrum.[22][23]
  • The Patient-Reported Outcome (PRO) Consortium was formed by C-Path in cooperation with the FDA and the medical products industry. Its purpose is to develop, evaluate, and qualify PRO instruments (e.g., questionnaires) for use in clinical trials designed to assess the safety and effectiveness of medical products. PRO instruments offer a means for capturing how a patient feels or functions with respect to her/his health or condition. Instruments are currently being developed to support label claims for efficacy in asthma, depression, irritable bowel syndrome, diabetes, mild cognitive impairment, and cancer (breast and lung).[20]
  • The Coalition Against Major Diseases (CAMD) includes patient advocacy groups, biopharmaceutical companies, foundations, and advisors from the FDA, EMA, the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute on Aging (NIA). Members share pre-competitive data and knowledge that will more efficiently and safely speed development of treatments and preventions for Alzheimer’s, Parkinson’s, Huntington’s, and other debilitating neuro-degenerative diseases. CAMD’s overall objective is to help scientists identify clinical and laboratory characteristics (biomarkers) of patients destined to develop Alzheimer’s but before they are symptomatic and therefore more likely to benefit from new therapies. CAMD gathers and submits the evidence for the FDA and EMA to officially designate such tools as qualified for use in drug development.[9]
CAMD developed and launched the largest standardized database of combined clinical trials to be openly shared by pharmaceutical companies and made available to qualified researchers around the world. This database—involving anonymous data from approximately 4,000 Alzheimer's patients—provides a platform from which to design more efficient clinical trials to test new treatments. This will allow the industry to more rapidly identify potential therapies that prevent the disease or halt its progression.[9]
  • The Critical Path to TB Drug Regimens (CPTR) is a collaboration of pharmaceutical companies, government, regulatory, and multilateral agencies, donors, academia, advocates, and NGOs that aims to accelerate the development of new, safe, and highly effective tuberculosis treatment regimens with shortened durations of therapy.[24] Joining the Bill & Melinda Gates Foundation and the Global Alliance for TB Drug Development (TB Alliance) as CPTR founding organizations, C-Path provides overall program management for this initiative and leads one component, the CPTR Regulatory Science Consortium.
  • The Polycystic Kidney Disease (PKD) Consortium was created and is managed by C-Path with funding from the PKD Foundation, and includes three academic medical centers (University of Colorado, Emory University, and Mayo Clinic). Its mission is to evaluate the evidence supporting total kidney volume (TKV) as a biomarker for assessing the progression of autosomal dominant PKD. If the data support the conclusion that TKV is an early and reliable predictor of subsequent renal failure, C-path will submit a request to the FDA that TKV be qualified as a measure of disease progression that can be used in drug development to test the efficacy of new drugs.[25]


C-Path is headquartered in Tucson, Arizona, with offices in Phoenix, Arizona, and Rockville, Maryland. Raymond L. Woosley, M.D., Ph.D. is the founding President & CEO.


  1. ^ Woosley, R. L. "The FDA’s Critical Path Initiative." PharmacoVigilance Review 1.3 (August 2007): 16-18
  2. ^ U.S. Food and Drug Administration. The Critical Path Initiative: Transforming the Way FDA-Regulated Products are Developed, Evaluated, Manufactured, and Used April 2009
  3. ^ FDA: Paving the Pathway for Innovation
  4. ^ a b c Woodcock, J; Woosley, R (2008). "The FDA critical path initiative and its influence on new drug development". Annual review of medicine 59: 1–12. doi:10.1146/ PMID 18186700. 
  5. ^ a b Dimasi, JA; Feldman, L; Seckler, A; Wilson, A (2010). "Trends in risks associated with new drug development: success rates for investigational drugs". Clinical pharmacology and therapeutics 87 (3): 272–7. doi:10.1038/clpt.2009.295. PMID 20130567. 
  6. ^ "Drug Development Timeline".
  7. ^ Coons, S. J. "The FDA's Critical Path Initiative: a Brief Introduction." Clinical Therapeutics 31.11(2009): 2572-2573
  8. ^
  9. ^ a b c Romero, K; De Mars, M; Frank, D; Anthony, M; Neville, J; Kirby, L; Smith, K; Woosley, RL (2009). "The Coalition Against Major Diseases: developing tools for an integrated drug development process for Alzheimer's and Parkinson's diseases". Clinical pharmacology and therapeutics 86 (4): 365–7. doi:10.1038/clpt.2009.165. PMID 19763117. 
  10. ^ Coons, Stephen Joel (2009). "The FDA's critical path initiative: A brief introduction". Clinical Therapeutics 31 (11): 2572–3. doi:10.1016/j.clinthera.2009.11.035. PMID 20110002. 
  11. ^ C-Path. "The Critical Path Institute.". Retrieved 2011-03-27. 
  12. ^ Woosley, R. L. and J. Cossman. "Drug Development and the FDA’s Critical Path Initiative." Clinical Pharmacology & Therapeutics 81.1 (2007): 129-33
  13. ^ Mattes, WB (2008). "Public consortium efforts in toxicogenomics". Methods in molecular biology (Clifton, N.J.) 460: 221–38. doi:10.1007/978-1-60327-048-9_11. PMID 18449490. 
  14. ^ Goodsaid, FM; Frueh, FW; Mattes, W (2008). "Strategic paths for biomarker qualification". Toxicology 245 (3): 219–23. doi:10.1016/j.tox.2007.12.023. PMID 18280028. 
  15. ^ Mattes, WB; Walker, EG (2009). "Translational Toxicology and the Work of the Predictive Safety Testing Consortium". Clinical Pharmacology & Therapeutics 85 (3): 327–30. doi:10.1038/clpt.2008.270. PMID 19158666. 
  16. ^ "Critical Path Initiative.". Retrieved 2011-03-27. 
  17. ^ Woosley, R L; Myers, R T; Goodsaid, F (2010). "The Critical Path Institute’s Approach to Precompetitive Sharing and Advancing Regulatory Science". Clinical Pharmacology & Therapeutics 87 (5): 530–3. doi:10.1038/clpt.2010.27. 
  18. ^ "FDA Announces Partnership with Critical Path Institute to Conduct Essential Research to Spur Medical Innovation"
  19. ^ Kola, Ismail; Landis, John (2004). "Opinion: Can the pharmaceutical industry reduce attrition rates?". Nature Reviews Drug Discovery 3 (8): 711–6. doi:10.1038/nrd1470. 
  20. ^ a b U.S. Department of Health and Human Services Food and Drug Administration. "Innovation or Stagnation: Challenges and Opportunity on the Critical Path to New Medical Products." March 2004.
  21. ^ "18 Ideas to Reform Health Care Now." Reader's Digest, November 2008.
  22. ^ Goodsaid, F. M., F. W. Frueh, and W. B. Mattes. "The Predictive Safety Testing Consortium: A Synthesis of the Goals, Challenges and Accomplishments of the Critical Path." Drug Discovery Today: Technologies 4.2(2007): 47-50
  23. ^ Mattes, WB; Walker, EG (2009). "Translational toxicology and the work of the predictive safety testing consortium". Clinical pharmacology and therapeutics 85 (3): 327–30. doi:10.1038/clpt.2008.270. PMID 19158666. 
  24. ^ "The Critical Path to TB Regimens Initiative.". Retrieved 2011-03-27. 
  25. ^ "Mayo Clinic Translational Polycystic Kidney Disease (PKD) Center;" "Building a Drug Development Machine."

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