Critical Path Institute (C-Path) is a nonprofit 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 regu ...

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 tertiary education. The name traces back to Plato's school of philosophy, founded approximately 386 BC at Akademia, a sanctuary of Athena, the go ...

, 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 List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(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 Tucson (; ; ) is a city in Pima County, Arizona, United States, and its county seat. It is the second-most populous city in Arizona, behind Phoenix, Arizona, Phoenix, with a population of 542,630 in the 2020 United States census. The Tucson ...

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 de ...

, 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, p ...

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 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, ...

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, bacteria, bacterium, or plant, as well as the effect o ...

. * 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 Management of tuberculosis refers to techniques and procedures utilized for treating tuberculosis (TB), or simply a treatment plan for TB. The medical standard for active TB is a short course treatment involving a combination of isoniazid, rifa ...

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 Alzheimer's disease (AD) is a neurodegenerative disease and the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems wit ...

(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 neurons, in the process known as neurodegeneration. Neuronal damage may also ultimately result in their death. Neurodegenerative diseases include amyotrophic lateral sclerosis, mul ...

with impaired cognition and function. *The Critical Path for

Parkinson's Parkinson's disease (PD), or simply Parkinson's, is a neurodegenerative disease primarily of the central nervous system, affecting both motor and non-motor systems. Symptoms typically develop gradually and non-motor issues become more prevalen ...

(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 an incurable neurodegenerative disease that is mostly Genetic disorder#Autosomal dominant, inherited. It typically presents as a triad of progressive psychiatric, cognitive, and ...

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

Neonatal In common terminology, a baby is the very young offspring of adult human beings, while infant (from the Latin word ''infans'', meaning 'baby' or 'child') is a formal or specialised synonym. The terms may also be used to refer to Juvenile (orga ...

Consortium (INC) seeks to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates. *The

Multiple Sclerosis Multiple sclerosis (MS) is an autoimmune disease resulting in damage to myelinthe insulating covers of nerve cellsin the brain and spinal cord. As a demyelinating disease, MS disrupts the nervous system's ability to Action potential, transmit ...

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 disability, cognitive, Developmental disability, d ...

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 occurs when the body's immune system destroys pancreatic cells (beta cells). In healthy persons, beta cells produce insulin. Insulin is a hormone require ...

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

tuberculosis Tuberculosis (TB), also known colloquially as the "white death", or historically as consumption, is a contagious disease usually caused by ''Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can al ...

(TB) clinical trial data. *The successfully completed

Pediatric Pediatrics (American English) also spelled paediatrics (British English), is the branch of medicine that involves the medical care of infants, children, adolescents, and young adults. In the United Kingdom, pediatrics covers many of their youth ...

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

Location

C-Path is headquartered in

. Raymond L. Woosley, M.D., Ph.D. founded C-Path in 2005 and is President Emeritus. Klaus Romero is currently CEO and Kristen Swingle is currently President and Chief Operating Officer. The Board of Directors includes Wainwright Fishburn, Timothy R. Franson, Bonnie Allin, Karen Bernstein, Louis Breton, Kay Holcombe, Jeffrey E. Jacob, Shaun A. Kirkpatrick, James W. Newman, former Pfizer CFO Alan Levin, Thomas Salmonson and biochemist Paula J. Olsiewski.

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