Critical Path Institute (C-Path) is a non-profit organization created to improve the

drug development Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for r ...

process; its consortia include more than 1,600 scientists from government regulatory and research agencies,

academia An academy ( Attic Greek: Ἀκαδήμεια; Koine Greek Ἀκαδημία) is an institution of secondary or tertiary higher learning (and generally also research or honorary membership). The name traces back to Plato's school of philosophy ...

, patient organizations, and bio-pharmaceutical companies.

Background

The U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA) launched the Critical Path Initiative in 2004 to transform the way FDA-regulated medical products are developed, evaluated, and manufactured. C-Path was created as an independent organization to respond to the needs outlined in the FDA's initiative and with support and funding from the FDA
Science Foundation Arizona
and the

Tucson, Arizona , "(at the) base of the black

ill ILL may refer to: * ''I Love Lucy'', a landmark American television sitcom * Illorsuit Heliport (location identifier: ILL), a heliport in Illorsuit, Greenland * Institut Laue–Langevin, an internationally financed scientific facility * Interlibrar ...

, nicknames = "The Old Pueblo", "Optics Valley", "America's biggest small town" , image_map = , mapsize = 260px , map_caption = Interactive ...

community. It operates as a neutral third party to enable scientists from the regulated industry and international regulatory agencies to work together with scientists from academia and patient groups to improve the drug development process.

Approach

In the interest of national and global

public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...

, C-Path develops large databases of aggregated clinical trial data that can be used to study disease progression. These data are also used to develop and qualify

biomarkers In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, ...

and clinical outcome assessment instruments that are shared with the greater community for use in drug development. C-Path also develops quantitative models to facilitate the design of efficient clinical trials.

C-Path Programs

C-Path programs are focused on reducing the time, cost, and risk of drug development and regulatory review. Where appropriate, C-Path forms consortia that are public/private partnerships that aim to improve the drug development process.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. * The Predictive Safety Testing Consortium (PSTC) works to find improved safety

biomarker In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, p ...

s to detect drug induced

toxicity Toxicity is the degree to which a chemical substance or a particular mixture of substances can damage an organism. Toxicity can refer to the effect on a whole organism, such as an animal, bacterium, or plant, as well as the effect on a subs ...

. * The Patient-Reported Outcome (PRO) Consortium develops, evaluates, and qualifies PRO instruments (e.g., questionnaires) for use in

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

s designed to assess the safety and effectiveness of medical products. * The Critical Path to TB Drug Regimens (CPTR) aims to accelerate the development of new, safe, and highly effective

tuberculosis treatment Tuberculosis management describes the techniques and procedures utilized for treating tuberculosis (TB). The medical standard for active TB is a short course treatment involving a combination of isoniazid, rifampicin (also known as Rifampin), p ...

regimens with shortened durations of therapy. *The

Polycystic Kidney Disease Polycystic kidney disease (PKD or PCKD, also known as polycystic kidney syndrome) is a genetic disorder in which the renal tubules become structurally abnormal, resulting in the development and growth of multiple cysts within the kidney. These ...

(PKD) Consortium evaluates the evidence supporting total kidney volume (TKV) as a biomarker for assessing the progression of autosomal dominant PKD. *The Critical Path for Alzheimer's Disease (CPAD) aims to increase the efficiency of the development process of new treatments for Alzheimer disease (AD) and related

neurodegenerative disorders A neurodegenerative disease is caused by the progressive loss of structure or function of neurons, in the process known as neurodegeneration. Such neuronal damage may ultimately involve cell death. Neurodegenerative diseases include amyotrophic ...

with impaired cognition and function. *The Critical Path for

Parkinson's Parkinson's disease (PD), or simply Parkinson's, is a long-term degenerative disorder of the central nervous system that mainly affects the motor system. The symptoms usually emerge slowly, and as the disease worsens, non-motor symptoms become ...

(CPP) works to improve the clinical trial process. *The Data Collaboration Center (DCC) develops data solutions for scientific research. *The Duchenne Regulatory Science Consortium (D-RSC) supports collaborative research through shared data access and

tools. *The Electronic Patient-Reported Outcome Consortium (e-PRO) supports the collection of patient-focused outcomes data in clinical trials. *The

Huntington's Disease Huntington's disease (HD), also known as Huntington's chorea, is a neurodegenerative disease that is mostly inherited. The earliest symptoms are often subtle problems with mood or mental abilities. A general lack of coordination and an uns ...

Regulatory Science Consortium (HD-RSC) aims to accelerate the regulatory approval of Huntington's disease therapies. *The International

Neonatal An infant or baby is the very young offspring of human beings. ''Infant'' (from the Latin word ''infans'', meaning 'unable to speak' or 'speechless') is a formal or specialised synonym for the common term ''baby''. The terms may also be used t ...

Consortium (INC) seeks to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates. *The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) works to qualify a new measure of

disability Disability is the experience of any condition that makes it more difficult for a person to do certain activities or have equitable access within a given society. Disabilities may be cognitive, developmental, intellectual, mental, physical, s ...

as a primary or secondary endpoint for future trials of MS therapies. *The

Type 1 Diabetes Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that originates when cells that make insulin (beta cells) are destroyed by the immune system. Insulin is a hormone required for the cells to use blood sugar f ...

Consortium (T1D) works to qualify islet autoimmunity antibodies as prognostic biomarkers. *The goal of the Transplant Therapeutics Consortium (TTC) is to accelerate the

medical product Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care prac ...

development process for transplantation. *The TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS) curates and standardizes Phase III

tuberculosis Tuberculosis (TB) is an infectious disease usually caused by ''Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in w ...

(TB) clinical trial data. *The successfully completed

Pediatric Pediatrics ( also spelled ''paediatrics'' or ''pædiatrics'') is the branch of medicine that involves the medical care of infants, children, adolescents, and young adults. In the United Kingdom, paediatrics covers many of their youth until th ...

Trials Consortium worked toward the efficient evaluation of innovative drugs, biologics, and devices for children.

Location

C-Path is headquartered in

Tucson, Arizona , "(at the) base of the black

, nicknames = "The Old Pueblo", "Optics Valley", "America's biggest small town" , image_map = , mapsize = 260px , map_caption = Interactive ...

. Raymond L. Woosley, M.D., Ph.D. founded C-Path in 2005 and is President Emeritus. Kristen Swingle is currently C-Path's Interim President and Chief Operating Officer. The Board of Directors includes Robert M. Califf, Wainwright Fishburn, Timothy R Franson, Kay Holcombe, Jeffrey E Jacob, former Pfizer CFO Alan Levin and biochemist

Paula J. Olsiewski Paula J. Olsiewski is an American biochemist who is a Contributing Scholar at the Johns Hopkins Center for Health Security. She was a Program Director at the Alfred P. Sloan Foundation, where she created and directed the Foundation's programs in ...

References

External links

Critical Path Institute

U.S. Food and Drug Administration

National Institutes of Health

European Medicines Agency
{{authority control Pharmaceutical research institutes Pharmaceutical industry Drug discovery