CRITICAL PATH INSTITUTE

Accelerating the Path to a Healthier World

aka C-Path   |   Tucson, AZ   |  www.c-path.org

Mission

The Critical Path Institute is a catalyst in the development of new approaches to advance medical innovation and regulatory science. We achieve this by leading teams that share data, knowledge and expertise resulting in sound, consensus based science. The Critical Path Institute (C-Path) is an independent, non-profit organization that brings together pharmaceutical, academic, government, patient and non-profit organizations to work on important drug and medical product development problems.

Ruling year info

2005

Interim President and Chief Operating Officer

520-444-2707 Kristen Swingle MS

Chief Scientific Officer

Klaus Romero MD, MS, FCP

Main address

1730 E River Rd Ste 200

Tucson, AZ 85718 USA

Show more contact info

EIN

20-1991334

NTEE code info

Other Medical Research N.E.C. (H99)

IRS filing requirement

This organization is required to file an IRS Form 990 or 990-EZ.

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Communication

Programs and results

What we aim to solve

SOURCE: Self-reported by organization

The development of new therapies for patients living with disease is a long, difficult, expensive, high risk endeavor. This makes it difficult to deliver new therapies to patients in a rapid, cost effective manner.

Our programs

SOURCE: Self-reported by organization

What are the organization's current programs, how do they measure success, and who do the programs serve?

Predictive Safety Testing Consortium

PSTC was formed and officially announced on March 16, 2006 by Health and Human Services Secretary Michael Leavitt, FDA Commissioner Dr. Andrew von Eschenbach and FDA Deputy Commissioner Dr. Janet Woodcock, who identified the consortium as “unprecedented” and a “shining example” of the type of work the FDA would like to see conducted.

PSTC brings together pharmaceutical companies to share and validate innovative safety testing methods under advisement of the FDA (Food and Drug Administration), its European counterpart, the EMA (European Medicines Agency), and PMDA (Japanese Pharmaceutical and Medical Devices Agency). PSTC was formed and officially announced on March 16, 2006 by Health and Human Services Secretary Michael Leavitt, FDA Commissioner Dr. Andrew von Eschenbach and FDA Deputy Commissioner Dr. Janet Woodcock, who identified the consortium as “unprecedented” and a “shining example” of the type of work the FDA would like to see conducted.

The FDA, EMA and PMDA participate as advisors, along with more than 250 participating scientists across industry and academia. The mission of PSTC is to identify new and improved safety testing methods and submit them for formal regulatory qualification by the FDA, EMA and PMDA.

The tests used to determine drug safety have not changed in decades. Although companies have developed newer safety testing methods, these are not generally accepted by the FDA or EMA as proof of safety. This is due, in part, because the methods used for testing are often different from company to company. That discrepancy leaves regulatory scientists uncertain about which methods should be preferred. Another key factor is that the tests have not, in the past, been independently validated. PSTC now fills that important role and serves as a neutral third party to assess drug safety tests.

PSTC’s nineteen corporate members have the same goal: to find improved safety testing methods. The members share their internally developed methods and test these methods developed by one another across the Consortium. Ten EMA and twenty-eight FDA scientists serve as advisors along with more than 250 participating scientists. C-Path leads the collaborative process and collects and summarizes the data.

Population(s) Served
People with diseases and illnesses

CPAD works on drug development tools to advance new therapy development for Alzheimer's and Parkinson's diseases.

These tools include data standards, clinical data databases, disease progression models, prognostic biomarkers, and clinical outcome assessment instruments.

Population(s) Served
People with diseases and illnesses

The Patient-Reported Outcome (PRO) Consortium is based upon a collaborative framework of appropriate stakeholders that develops qualified and publicly available PRO instruments for use in clinical trials in order to support labeling claims. The PRO Consortium was formed in December of 2008 and formally launched in March of 2009. The PRO Consortium’s membership is comprised of pharmaceutical companies along with representatives from the FDA, EMA and NIH who provide advice to the Coordinating Committee.

PRO instruments involve measurement of one or more aspects of a patient’s health status based on information gathered directly from the patient, without interpretation by physicians or others. Patients provide information concerning the impact of an intervention or therapy from their perspective. PRO instruments offer a means for capturing how a patient feels or functions with respect to her/his health, condition, or disease.

There are many disease areas for which adequate PRO instruments are not available. PRO instrument development is expensive, resource-intensive, and time consuming due to the extensive research and testing process. Under the direction of Stephen Joel Coons, PhD, the PRO Consortium provides a critical mass of experts with different skill sets, experiences, and perspectives. The PRO Consortium consists of scientists from C-Path, pharmaceutical, biotechnology, device, and diagnostic companies, FDA and National Institutes of Health (NIH).

Population(s) Served
People with diseases and illnesses

Critical Path Institute has established the Electronic Patient-Reported Outcome (ePRO) Consortium, in cooperation with firms that provide electronic data collection technologies/services to the medical products industry for capturing patient-reported outcome (PRO) endpoints in clinical trials.

The mission of the ePRO Consortium is to advance the quality, practicality, and acceptability of electronic data capture (EDC) methods used in clinical trials for PRO endpoint assessment. To accomplish this mission, they provide a non-competitive, neutral environment to test the measurement equivalence of PRO measures migrated to or among alternative administration methods. The ePRO Consortium will work with the PRO Consortium to migrate the PRO instruments developed within the PRO Consortium to all relevant EDC platforms. Further, specification documents will be developed for the adaptation/migration of existing PRO instruments to the relevant EDC platforms. The Consortium also will provide guidance on methodological considerations for PRO instrument migration and adaptation.

The ePRO Consortium provides a pre-competitive space where a critical mass of experts can collaborate to generate measurement equivalence data, develop specification documents and data standards, and produce methodological guidance on measurement issues related to ePRO applications. The ePRO Consortium will work closely with C-Path’s PRO Consortium, a group of pharmaceutical companies working to develop novel PRO measures, to make the new measures available in multiple data collection formats. The overarching aim is to enhance public health by optimizing the value of PRO data in medical product evaluation and clinical decision making.

Population(s) Served
People with diseases and illnesses

The Polycystic Kidney Disease (PKD) Outcomes Consortium is a successful collaboration between Critical Path Institute (C-Path), the PKD Foundation, Clinical Data Interchange Standards Consortium (CDISC), and four leading academic medical centers (Tufts University, University of Colorado – Denver, Emory University, and Mayo Clinic). Its mission is to promote research that will lead to the discovery of treatments for PKD and improve the lives of all it affects. The Consortium is led by C-Path and funded through a grant from the PKD Foundation and philanthropic donations. Additionally, a representative from the U.S. Food and Drug Administration (FDA) serves as an active advisor to the Consortium.

Autosomal Dominant PKD (ADPKD) is a debilitating genetic disease affecting more than 600,000 Americans and 12 million people worldwide and for which there is currently no known cure or effective treatment. Traditional endpoints of renal function only show changes very late in the course of the disease, making it difficult to assess the effectiveness of new medications. There is critical need for a biomarker that will assess disease progression at an earlier stage when patients may be more likely to respond to new therapies.

The primary goals of the PKD Consortium are to develop CDISC research data standards for PKD and to use clinical data from ADPKD patients collected over many years through patient registries and clinical trials to support the FDA-qualification of an imaging biomarker, Total Kidney Volume (TKV), as a biomarker in drug development trials.

Scientists will use the data collected to develop a disease progression model that will evaluate the relationship between TKV and the known complications of ADPKD, including rate of loss of kidney function, hypertension, gross hematuria, kidney stones, urinary tract infections, development of end-stage renal disease, and mortality. These analyses will be used to support the regulatory qualification of TKV as an accepted measure for assessing the progression of ADPKD in clinical trials in which new therapies are tested.

Population(s) Served
People with diseases and illnesses

The CPTR Initiative is a public‐private partnership initiated in March 2010 by Critical Path Institute, the Bill & Melinda Gates Foundation (BMGF) and the TB Alliance. With participation from the pharmaceutical industry, academia and national and global government agencies, a major portion of this effort is called the CPTR Regulatory Science Consortium, led by C‐Path, which includes:

Developing and integrating data standards, Qualifying biomarkers through the FDA/EMA, Developing quantitative disease progression (natural history) models,
Creating disease response metrics and assays, and Developing new pharmacokinetic/dynamic measures of drug interactions.

The purpose of the CPTR consortium is to deliver a safer, more efficacious and faster‐acting TB regimen by developing and promoting innovative regulatory science essential for supporting new combination drug development.

Since the launch of CPTR in 2010, the consortium has made significant progress. It has actively engaged the FDA, which has released updated regulatory guide-lines for developing new drug regimens. The FDA continues to work to create a more favorable environment for regimen development. In 2011, CDER head Dr. Janet Woodcock wrote an opinion piece in the New England Journal of Medicine expressing her support for “co-development” of therapies for life-threatening diseases such as TB. Additionally, in November 2010, the TB Alliance launched the first-ever clinical trial of a novel combination drug regimen for TB. The trial tested three promising TB drug candidates together, before two of them have been approved and registered individually for use against TB. The study met its milestones, validating the approach to regimen development set forth by CPTR and highlighting the promise of a novel regimen.

Population(s) Served
People with diseases and illnesses

Launched in December, 2012, MSOAC is C-Path’s newest consortium – another dynamic partnership formed to promote consensus science. Created jointly with the National Multiple Sclerosis Society, MSOAC will collect, standardize, and analyze data about MS with the goal of qualifying a new measure of disability as a primary or secondary endpoint for future trials of MS therapies.

The National Multiple Sclerosis Society recognized the gap in the MS treatment pipeline and decided to employ a method that has steadily gained support within the research community — consortia science. MSOAC brings stakeholders from industry, academia, patient representatives, and regulatory agencies together to spur development of drug development tools to assess the effectiveness of potential treatments for all forms of MS.

Population(s) Served
People with diseases and illnesses

Where we work

Our results

SOURCE: Self-reported by organization

How does this organization measure their results? It's a hard question but an important one.

Number of groups brought together in a coalition/alliance/partnership

This metric is no longer tracked.
Totals By Year
Population(s) Served

People with diseases and illnesses

Type of Metric

Output - describing our activities and reach

Direction of Success

Increasing

Number of active consortia or pre-consortia.

This metric is no longer tracked.
Totals By Year
Population(s) Served

People with diseases and illnesses

Type of Metric

Output - describing our activities and reach

Direction of Success

Holding steady

Our Sustainable Development Goals

SOURCE: Self-reported by organization

Learn more about Sustainable Development Goals.

Goals & Strategy

SOURCE: Self-reported by organization

Learn about the organization's key goals, strategies, capabilities, and progress.

Charting impact

Four powerful questions that require reflection about what really matters - results.

• Qualified biomarkers or Clinical Outcome Assessment Instruments
• Develop and maintain databases of high quality aggregated patient level clinical trial data
• Regulatory endorsement of a drug development tool (like a disease progression model)
• Provided input to a regulatory process or guidance
• Partner with CDISC to develop data standards
• Host/sponsor impactful scientific or technical workshop
• Published proceedings from workshop/conference
• Tracking utility of qualified tools as assessed by FDA and EMA
• Articles published in a trade journal

As C-Path’s leadership looks to the future, we are excited to take on new programs that focus on unmet needs in specific disease areas or disciplines such as model-based drug development, biomarker qualification, or clinical outcome assessment instrument development, where our expertise can make significant impact.

Decisions regarding new projects to be undertaken will be compatible with the vision, mission, and values of C-Path, and will be grounded in our core competencies. Additionally, all C-Path programs must involve an array of stakeholders. Maintaining neutrality is of paramount importance in our work.

C-Path has established its credibility in catalyzing change and driving results through our consortia model as evidenced by the growing number of requests from external organizations for assistance in achieving their objectives. This is further evidenced by the additional funding that C-Path received in 2013. We are prepared to expand our work to encompass new areas of cutting-edge regulatory science.

We are committed to bringing even more global expertise to bear on our work and to seeking new strategic alliances that will benefit ongoing programs or that open new doors to enter areas of unmet need where C-Path has not yet engaged and which are compatible with our mission and values.

C-Path's Core Competencies include:
Developing CDISC therapeutic area standards for clinical trial data storage and transmission
Developing aggregated databases of clinical trial data for research and use in developing drug development tools, including security and HIPPA regulations
Qualifying prognostic, pharmacodynamic, and safety biomarkers with the FDA and EMA for use in clinical trials
Developing and receiving regulatory endorsement for clinical trial simulation tools
Developing and qualifying clinical outcome assessment instruments for use in clinical trials
Development of other in vitro tools and models for use in drug development

7 Kidney preclinical biomarkers qualified with FDA, EMA, and PMDA.
1 Hippocampal imaging biomarker for selecting Alzheimer's disease patients qualified with EMA
1 Alzheimer's disease progression model and simulation platform endorsed by FDA and EMA
Provided input to several regulatory process guidance
C-Path has participated in the development of 24 CDISC standards
Hosted, sponsored and participated in dozens of scientific and technical workshops in 2020
Many articles published from workshop/conference
More than 468 approved applicants using the Alzheimer’s database
More than 100 approved applicants will access the Alzheimer’s Clinical Trial Simulation Tool

Financials

CRITICAL PATH INSTITUTE
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Operations

The people, governance practices, and partners that make the organization tick.

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Connect with nonprofit leaders

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  • Analyze a variety of pre-calculated financial metrics
  • Access beautifully interactive analysis and comparison tools
  • Compare nonprofit financials to similar organizations

Want to see how you can enhance your nonprofit research and unlock more insights? Learn More about GuideStar Pro.

CRITICAL PATH INSTITUTE

Board of directors
as of 4/16/2021
SOURCE: Self-reported by organization
Board co-chair

Mr. Tim Franson

Faegre Baker Daniels Consulting


Board co-chair

M. Wainwright Fishburn

Cooley LLP

Craig Brater

Wainwright Fishburn

Shaun Kirkpatrick

Richard Myers

Cindy Parseghian

Alastair Wood

Kay Holcombe

Peter Hutt

Alan Levin

Paula Olsiewski

Jeffrey Jacob

Tomas Salmonson

James Newman

Board leadership practices

SOURCE: Self-reported by organization

GuideStar worked with BoardSource, the national leader in nonprofit board leadership and governance, to create this section.

  • Board orientation and education
    Does the board conduct a formal orientation for new board members and require all board members to sign a written agreement regarding their roles, responsibilities, and expectations? No
  • CEO oversight
    Has the board conducted a formal, written assessment of the chief executive within the past year ? Yes
  • Ethics and transparency
    Have the board and senior staff reviewed the conflict-of-interest policy and completed and signed disclosure statements in the past year? Yes
  • Board composition
    Does the board ensure an inclusive board member recruitment process that results in diversity of thought and leadership? Yes
  • Board performance
    Has the board conducted a formal, written self-assessment of its performance within the past three years? No

Organizational demographics

SOURCE: Self-reported; last updated 04/16/2021

Who works and leads organizations that serve our diverse communities? GuideStar partnered on this section with CHANGE Philanthropy and Equity in the Center.

Leadership

The organization's leader identifies as:

Race & ethnicity
White/Caucasian/European
Gender identity
Female

The organization's co-leader identifies as:

Race & ethnicity
Hispanic/Latino/Latina/Latinx
Gender identity
Male

Race & ethnicity

Gender identity

 

Sexual orientation

No data

Disability

No data