PLATINUM2024

CRITICAL PATH INSTITUTE

Advancing Drug Development. Improving Lives. Together.

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

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CRITICAL PATH INSTITUTE

EIN: 20-1991334


Mission

Critical Path Institute (C-Path) is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDAs Critical Path Initiative. C-Path's mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path's global headquarters is in Tucson, Arizona and C-Paths Europe subsidiary is headquartered in Amsterdam, Netherlands.

Ruling year info

2005

Chief Executive Officer

Klaus Romero MD, MS

President and Chief Operating Officer

Kristen Swingle MS

Main address

1840 E River Rd Ste 100

Tucson, AZ 85718 USA

Show more contact info

EIN

20-1991334

Subject area info

Health

Science

Population served info

People with disabilities

People with diseases and illnesses

Researchers

NTEE code info

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

IRS subsection

501(c)(3) Public Charity

IRS filing requirement

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

Tax forms

Communication

Affiliations

See related organizations info

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?

Our Core Competencies

Data Management and Standards: Developing and implementing cutting-edge data
management practices and universal standards.

Biomarkers: Identifying and validating biomarkers to enhance drug
development efficiency.

Modeling & Analytics: Utilizing state-of-the-art modeling techniques and analytical
tools for more precise predictions and evaluations

Regulatory Science: Advancing the field of regulatory science to streamline
the review and approval processes.

Patient-Reported Outcomes: Crafting and refining tools for accurate and meaningful
measurement of clinical outcomes.

Population(s) Served

Our Neuroscience programs collaborate with industry, nonprofit organizations, academic partners, and regulatory agencies to enhance regulatory tools, accelerate drug development, optimize clinical trials, and advance therapeutic developments aimed at improving the lives of those affected by Alzheimer's , Parkinson's, Huntington's, Duchenne Muscular Dystrophy, rare neurodegenerative diseases including ALS and inherited ataxias.

Learn more about our programs here: https://c-path.org/area-of-focus/neuroscience/

Population(s) Served

The rare and orphan diseases program encompasses initiatives focused on solutions for Alpha-1 Antitrypsin Deficiency, lysosomal diseases, rare neurodegenerative diseases including ALS, Polycystic Kidney Disease, and leads a Rare Disease Cures Accelerator and Analytics Platform (RDCA-DAP), all working collaboratively with industry partners, academic researchers, regulators, and patient groups to accelerate drug development, enhance quality of life, and advance treatments for various rare diseases.

Learn more: https://c-path.org/area-of-focus/rare-and-orphan-diseases/

Population(s) Served

The pediatric program focuses on forging regulatory pathways, advancing treatments, and qualifying biomarkers to enhance the safety and effectiveness of therapies for pediatric populations.

https://c-path.org/area-of-focus/pediatrics/

Population(s) Served

The translational and safety sciences program, represented by initiatives like the Biomarker Data Repository (BmDR) for advancing qualification of novel biomarkers, CURE Drug Repurposing Collaboratory for capturing real-world clinical outcome data, Predictive Safety Testing Consortium for the independent assessment and validation of drug safety tests, and Translational Therapeutics Accelerator for supporting the translation of academic discoveries into therapeutics, aims to improve drug development by enhancing safety assessment through the qualification of organ-specific biomarkers, facilitating drug repurposing, validating safety testing methods, and accelerating the translation of new therapeutics from laboratory research to patient care.

https://c-path.org/area-of-focus/translational-safety-sciences/

Population(s) Served

The Clinical Outcome Assessment program, comprising initiatives like the eCOA Consortium for electronic data capture technologies, the Patient-Reported Outcome (PRO) Consortium for qualifying assessment tools measuring patient experiences, and the Rare Disease Clinical Outcome Assessment Consortium for identifying robust methodologies in rare disease trials, provides scientific guidance and fosters collaboration to ensure the accurate measurement of patient-focused outcomes in clinical trials, thereby enhancing drug development efforts with a focus on patient perspectives and rare disease treatments.

Population(s) Served
People with diseases and illnesses
People with diseases and illnesses
People with diseases and illnesses
People with diseases and illnesses
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

Context Notes

400+ Strategic Partnerships, including: • Alzheimer’s Association • FDA & EMA • Pfizer • Roche • The Michael J. Fox Foundation • University of Arizona

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

Total dollar amount of grants awarded

This metric is no longer tracked.
Totals By Year
Type of Metric

Output - describing our activities and reach

Direction of Success

Increasing

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

Endorsements for actionable solutions in drug development: 19 from EMA, 18 from FDA, and 1 from PMDA

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 Alzheimers database
More than 100 approved applicants will access the Alzheimers Clinical Trial Simulation Tool

Revenue vs. expenses:  breakdown

SOURCE: IRS Form 990 info
NET GAIN/LOSS:    in 
Note: When component data are not available, the graph displays the total Revenue and/or Expense values.

Liquidity in 2023 info

SOURCE: IRS Form 990

1.88

Average of 1.72 over 10 years

Months of cash in 2023 info

SOURCE: IRS Form 990

7.5

Average of 8.6 over 10 years

Fringe rate in 2023 info

SOURCE: IRS Form 990

20%

Average of 20% over 10 years

Funding sources info

Source: IRS Form 990

Assets & liabilities info

Source: IRS Form 990

Financial data

SOURCE: IRS Form 990

CRITICAL PATH INSTITUTE

Revenue & expenses

Fiscal Year: Jul 01 - Jun 30

SOURCE: IRS Form 990 info

Fiscal year ending: cloud_download Download Data

CRITICAL PATH INSTITUTE

Balance sheet

Fiscal Year: Jul 01 - Jun 30

SOURCE: IRS Form 990 info

The balance sheet gives a snapshot of the financial health of an organization at a particular point in time. An organization's total assets should generally exceed its total liabilities, or it cannot survive long, but the types of assets and liabilities must also be considered. For instance, an organization's current assets (cash, receivables, securities, etc.) should be sufficient to cover its current liabilities (payables, deferred revenue, current year loan, and note payments). Otherwise, the organization may face solvency problems. On the other hand, an organization whose cash and equivalents greatly exceed its current liabilities might not be putting its money to best use.

Fiscal year ending: cloud_download Download Data

CRITICAL PATH INSTITUTE

Financial trends analysis Glossary & formula definitions

Fiscal Year: Jul 01 - Jun 30

SOURCE: IRS Form 990 info

This snapshot of CRITICAL PATH INSTITUTE’s financial trends applies Nonprofit Finance Fund® analysis to data hosted by GuideStar. While it highlights the data that matter most, remember that context is key – numbers only tell part of any story.

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Business model indicators

Profitability info 2019 2020 2021 2022 2023
Unrestricted surplus (deficit) before depreciation $1,450,954 $910,945 $1,457,266 $1,610,649 $3,272,182
As % of expenses 9.5% 5.2% 6.3% 5.4% 10.2%
Unrestricted surplus (deficit) after depreciation $1,424,704 $880,023 $1,421,592 $1,575,836 $3,241,330
As % of expenses 9.3% 5.0% 6.2% 5.3% 10.1%
Revenue composition info
Total revenue (unrestricted & restricted) $16,797,670 $18,464,314 $24,427,097 $31,176,116 $35,267,282
Total revenue, % change over prior year 10.0% 9.9% 32.3% 27.6% 13.1%
Program services revenue 35.0% 28.7% 27.1% 26.0% 32.0%
Membership dues 0.0% 0.0% 0.0% 0.0% 0.0%
Investment income 1.3% 0.8% 0.0% 0.0% 1.1%
Government grants 22.4% 38.9% 54.5% 54.2% 53.7%
All other grants and contributions 41.2% 31.4% 18.4% 19.7% 13.1%
Other revenue 0.0% 0.2% 0.0% 0.0% 0.0%
Expense composition info
Total expenses before depreciation $15,346,716 $17,521,678 $22,969,831 $29,565,467 $31,977,526
Total expenses, % change over prior year 6.0% 14.2% 31.1% 28.7% 8.2%
Personnel 55.1% 62.2% 63.7% 58.8% 60.9%
Professional fees 13.7% 6.7% 9.5% 13.1% 9.0%
Occupancy 3.6% 3.3% 2.6% 2.0% 1.6%
Interest 0.0% 0.0% 0.0% 0.0% 0.0%
Pass-through 13.7% 15.4% 14.3% 14.3% 14.5%
All other expenses 13.8% 12.5% 9.8% 11.7% 14.0%
Full cost components (estimated) info 2019 2020 2021 2022 2023
Total expenses (after depreciation) $15,372,966 $17,552,600 $23,005,505 $29,600,280 $32,008,378
One month of savings $1,278,893 $1,460,140 $1,914,153 $2,463,789 $2,664,794
Debt principal payment $0 $0 $0 $0 $0
Fixed asset additions $0 $37,998 $42,240 $0 $0
Total full costs (estimated) $16,651,859 $19,050,738 $24,961,898 $32,064,069 $34,673,172

Capital structure indicators

Liquidity info 2019 2020 2021 2022 2023
Months of cash 7.7 7.2 8.4 6.7 7.5
Months of cash and investments 12.8 9.4 8.5 6.7 7.5
Months of estimated liquid unrestricted net assets 6.3 6.1 5.4 4.9 5.7
Balance sheet composition info 2019 2020 2021 2022 2023
Cash $9,911,102 $10,585,923 $16,037,888 $16,550,462 $19,946,924
Investments $6,402,760 $3,143,650 $249,017 $0 $0
Receivables $904,294 $2,575,419 $1,937,274 $3,141,154 $4,269,642
Gross land, buildings, equipment (LBE) $663,569 $462,785 $478,006 $409,253 $209,808
Accumulated depreciation (as a % of LBE) 88.4% 81.9% 81.1% 82.3% 80.1%
Liabilities (as a % of assets) 53.5% 45.8% 43.5% 39.8% 42.9%
Unrestricted net assets $8,147,089 $9,027,112 $10,448,704 $12,024,540 $15,265,870
Temporarily restricted net assets $0 N/A N/A N/A N/A
Permanently restricted net assets $0 N/A N/A N/A N/A
Total restricted net assets $0 $0 $0 $0 $0
Total net assets $8,147,089 $9,027,112 $10,448,704 $12,024,540 $15,265,870

Key data checks

Key data checks info 2019 2020 2021 2022 2023
Material data errors No No No No No

Operations

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

Documents
Letter of Determination is not available for this organization
Form 1023/1024 is not available for this organization

Chief Executive Officer

Klaus Romero MD, MS

Dr. Klaus Romero is a prominent clinician scientist and scholar, who serves as both the Chief Executive Officer and Chief Science Officer at Critical Path Institute. As a recognized thought-leader, Dr. Romero established C-Path's Quantitative Medicine Program and has been an instrumental leader in the growth of the organization's portfolio of transformative consortia and public-private-partnerships across more than 16 therapeutic development areas. As both a scientist and an executive, Dr. Romero led the generation of actionable drug development tools in Alzheimer's disease, which introduced a transformation in the drug development process for this indication. In tuberculosis, Romero's leadership was instrumental in generating a drug development infrastructure that allowed the approval of the first new individual drug and the first new regimen for this disease, in more than 50 years.

President and Chief Operating Officer

Kristen Swingle

Kristen Swingle is responsible for the daily operations of the organization as well as developing and implementing C-Path’s strategy and goals. She manages the organization’s finances, human resources, facilities, information technology and personnel. Before joining C-Path, Mrs. Swingle served as Vice President of Operations for CBR, a part of California Cryobank Life Sciences, where she oversaw stem cell manufacturing and quality operations and served as the site head for the Tucson facility which houses a stem cell laboratory, cryobank and call center operations. She brings nearly two decades’ worth of experience in the medical and molecular sciences industry to bear in her role as Chief Operating Officer and President. Additionally, she has served as AZ Bio Board of Directors Chairwoman for nearly five years and is a member of Women Business Leaders of the U.S. Health Care Industry Foundation. She has a BS in Biology from Northern Arizona University and an MS from Texas A&M.

Number of employees

Source: IRS Form 990

CRITICAL PATH INSTITUTE

Officers, directors, trustees, and key employees

SOURCE: IRS Form 990

Compensation
Other
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CRITICAL PATH INSTITUTE

Highest paid employees

SOURCE: IRS Form 990

Compensation
Other
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Compensation data
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CRITICAL PATH INSTITUTE

Board of directors
as of 04/29/2024
SOURCE: Self-reported by organization
Board of directors data
Download the most recent year of board of directors data for this organization
Board co-chair

Mr. M. Wainwright Fishburn

Cooley LLP

Term: 2023 - 2024


Board co-chair

Jeffrey Jacobson

Cancer Prevention Pharmaceuticals

Term: 2023 - 2024

Wainwright Fishburn

Shaun Kirkpatrick

Kay Holcombe

Alan Levin

Jeffrey Jacob

Tomas Salmonson

James W. Newman

Karen Bernstein

BioCentury

Mara Aspinall

Blue Stone Venture Partners

Robert Hemmings

Consilium Salmonson & Hemmings

Peter Hutt

Timothy Franson

Faegre Baker Daniels Consulting

Louis Breton

Bonnie Allin

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? Yes
  • 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? Not applicable

Organizational demographics

SOURCE: Self-reported; last updated 4/29/2024

Who works and leads organizations that serve our diverse communities? Candid partnered with CHANGE Philanthropy on this demographic section.

Leadership

The organization's leader identifies as:

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

The organization's co-leader identifies as:

Race & ethnicity
White/Caucasian/European
Gender identity
Female

Race & ethnicity

Gender identity

Transgender Identity

Sexual orientation

No data

Disability

No data

Contractors

Fiscal year ending
There are no fundraisers recorded for this organization.