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Critical Path Institute

EIN 20-1991334 · Tucson, AZ

Public records show a registered, tax-exempt organization in good standing.

LegitimacyPassesRegistration and standingFinancial healthGood75 out of 100GovernanceStrong100 out of 100Impact evidenceDescribes programsHow well its results are evidenced

What it says it does

THE CRITICAL PATH INSTITUTE IS A CATALYST IN THE DEVELOPMENT OF NEW APPROACHES THAT ADVANCE MEDICAL INNOVATION AND REGULATORY SCIENCE. THIS IS ACHIEVED BY LEADING TEAMS THAT SHARE DATA, KNOWLEDGE AND EXPERTISE RESULTING IN SOUND, CONSENSUS BASED SCIENCE.

Income
$46.8 million
Spending
$40.2 million
Spent on programs
78%
Reserves
4.9 months of spending
Largest source of income
government grants, 44%
Employees
176
Volunteers
16
Highest pay
$519,080, ceo

Source: Form 990 for the year ending June 30, 2025, filed with the Internal Revenue Service. Rating method 2026.2. How we rate

Financial health

Good: 75 out of 100. Higher than 51% of charities in its peer group (medical research, $10m to $100m).

  • Reserves

    20 of 35

    Spendable reserves would cover 4.9 months of spending.

  • Debt

    10 of 20

    It owes 32% of what it owns.

  • Living within its means

    15 of 15

    Income exceeded spending by 14% of income.

  • Income trend

    15 of 15

    Income rose 10% on the year before.

  • Spending floor

    15 of 15

    78% of spending went to programs and raising each dollar of donations cost 0 cents.

Source: Form 990 for the year ending June 30, 2025, filed with the Internal Revenue Service. Rating method 2026.2. How we rate

Governance

Strong: 100 out of 100. Higher than 44% of charities in its peer group (medical research, $10m to $100m).

  • Independent board

    25 of 25

    16 of 16 voting board members are independent.

  • Conflict of interest policy

    15 of 15

    Has a written conflict of interest policy.

  • Whistleblower policy

    8 of 8

    Has a written whistleblower policy.

  • Record keeping policy

    7 of 7

    Has a written policy on keeping and destroying records.

  • Board minutes

    5 of 5

    Keeps minutes of board meetings.

  • Board sees the tax return

    10 of 10

    Gave the board a copy of this return before filing it.

  • Pay set independently

    5 of 5

    Sets its chief executive's pay through independent review and comparison.

  • Independent check of accounts

    15 of 15

    Its accounts were audited by an independent accountant.

  • No reported misuse

    10 of 10

    Reports no diversion of assets, excess benefits or loans to insiders.

Source: Form 990 for the year ending June 30, 2025, filed with the Internal Revenue Service. Rating method 2026.2. How we rate

Impact evidence

Describes programs. Its tax return describes what it does but we have found no measurable results in it.

Programs described in its return (4)
  1. $6.7 million spent. CP-RND WAS FOUNDED IN SEPTEMBER 2022 PURSUANT TO THE ACT FOR ALS IN ORDER TO DEVELOP COLLABORATIONS THAT ADVANCE TREATMENTS TO IMPROVE THE LIVES OF THOSE AFFECTED BY RARE NEURODEGENERATIVE DISEASES, INCLUDING ALS. IN THE FIRST TWO YEARS OF THE PROJECT, CP-RND HAS ACHIEVED IMPORTANT MILESTONES REGARDING THE FOCUS ON PATIENT-FOCUSED DRUG DEVELOPMENT, DATA COLLECTION AND AGGREGATION, AND DRUG DEVELOPMENT TOOL SOLUTIONS TO ADDRESS THE GAPS IN DRUG DEVELOPMENT FOR RARE NEURODEGENERATIVE DISEASES. CP-RND ALSO ESTABLISHED A PWLE WORKING GROUP IN COORDINATION WITH ACCELERATING MEDICINE PARTNERSHIP (AMP IN FNIH) TO GIVE AND RECEIVE FEEDBACK ON ALS-RELATED PROJECTS. CP-RND HAS INITIATED WORKING GROUPS FOCUSED ON CLINICAL OUTCOME ASSESSMENTS (COAS), DIGITAL HEALTH TECHNOLOGY TOOLS AND DATA IN ORDER COLLABORATE WITH KEY OPINION LEADERS TO MORE CLEARLY IDENTIFY AND ADDRESS GAPS IN DRUG DEVELOPMENT. UPON RECOMMENDATION BY THE FDA, CP-RND COMPLETED A THOROUGH EVALUATION OF THE COMMON COAS USED IN ALS CLINICAL TRIALS AGAINST THE FDA'S ROADMAP FOR DEVELOPING PATIENT-FOCUSED OUTCOME MEASURES AND MADE RECOMMENDATIONS ON METHODS TO IMPROVE OR DEVELOP COAS FOR KEY CONCEPTS IMPORTANT TO PWLE WITH ALS. CP-RND HAS RESEARCHED OVER 70 LARGE DATABASES, WITH A PRIORITY LISTING CREATED AND SHARED WITH NIH, FNIH AND FDA. CP-RND, IN PARTNERSHIP WITH RDCA-DAP, IS WORKING TO CREATE AN ALS DATA KNOWLEDGE PORTAL CONTAINING PRIORITIZED DATASETS THAT CAN BE STANDARDIZED AND USED BY STAKEHOLDERS TO ADVANCE RESEARCH IN ALS INCLUDING THE DEVELOPMENT OF DRUG DEVELOPMENT TOOLS. OF THE PRIORITY LISTING CREATED, THREE DATA SETS HAVE BEEN RECEIVED AND ARE IN VARIOUS STAGES OF CURATION AND AGGREGATION. PROGRESS FOR DATA DICTIONARY COLLECTION AND DATA SHARE AGREEMENTS REMAIN ONGOING WITH THE REMAINING DATA SETS IDENTIFIED.
  2. $6.1 million spent. RARE DISEASE CURES ACCELERATOR-DATA AND ANALYTICS PLATFORM (RDCA-DAP) - SEE SCHEDULE O RDCA-DAP IS AN FDA-FUNDED INITIATIVE THAT PROVIDES A CENTRALIZED AND STANDARDIZED INFRASTRUCTURE TO SUPPORT AND ACCELERATE RARE DISEASE CHARACTERIZATION WITH THE GOAL OF ACCELERATING THERAPY DEVELOPMENT. THE RDCA-DAP EFFORT STARTED IN 2019 AND LAUNCHED THE PUBLIC INTERFACE OF THE PLATFORM IN SEPTEMBER 2021. TO DATE, THE PLATFORM HOSTS OVER 80 RARE DISEASE DATA SETS REPRESENTING OVER 41 DISEASE STATES. THERE ARE NOW 642 PLATFORM USERS AND 43 ACTIVE WORKSPACES, WHERE USERS ACTIVELY LEVERAGE THE RDCA-DAP DATABASE TO INFORM RARE DISEASE RESEARCH AND DRUG DEVELOPMENT ACTIVITIES. ACTIVE AGREEMENTS CURRENTLY INCLUDE 42 DATA CONTRIBUTION AGREEMENTS, 8 NORD DATA CONTRIBUTION COVERSHEETS, 3 CORDS REGISTRY DATA CONTRIBUTION COVERSHEETS, AND 34 TASK FORCE AGREEMENTS. RDCA-DAP LEVERAGED FRIEDREICH'S ATAXIA DATABASE TO DEVELOP A CLINICAL TRIAL SIMULATION TOOL TO INFORM TRIAL DESIGN IN FA. THE TOOL ENTERED REGULATORY SUBMISSION TO THE OFFICE OF CLINICAL PHARMACOLOGY IN SEPTEMBER 2024. THREE TASK FORCES STRUCTURED AS SMALL SCALE PUBLIC PRIVATE PARTNERSHIPS WERE LAUNCHED IN 2023 AND 2024 TO LEVERAGE THE DATABASE AND ADVANCE DRUG DEVELOPMENT SOLUTIONS. THE PROGRESSIVE SUPRANUCLEAR PALSY AND LIMB-GIRDLE MUSCULAR DYSTROPHY TASK FORCES ARE ADVANCING DISEASE PROGRESSION MODELING TO INFORM TRIAL DESIGN, AND THE RARE MITOCHONDRIAL DISEASES TASK FORCE IS FOCUSED ON DATA AGGREGATION TO DEVELOP RECOMMENDATIONS AIMED AT ENHANCING REAL WORLD DATA COLLECTION AND BEST PRACTICES. 2023 MARKED THE RELEASE OF CRITICAL PATH ONTOLOGY (CPONT) APPLICATION, WHICH FACILITATES MAPPING AND LINKING BETWEEN DIFFERENT STANDARDIZED DATA VOCABULARIES. IN ADDITION, A PUBLICATION WAS PUBLISHED IN THE JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS (BARRETT JS ET AL., 2023). LASTLY, THE PROGRAM MADE A SIGNIFICANT IMPACT ON PROFESSIONAL DEVELOPMENT IN 2024, WITH EIGHT WEBINARS HELD AS PART OF ITS PROFESSIONAL DEVELOPMENT SERIES, REACHING 772 REGISTRANTS AND 37,344 ATTENDEES.
  3. $2.9 million spent. CRITICAL PATH INSTITUTE'S TRANSLATIONAL THERAPEUTICS ACCELERATOR (TRXA) - SEE SCHEDULE O CRITICAL PATH INSTITUTE'S TRANSLATIONAL THERAPEUTICS ACCELERATOR (TRXA), LAUNCHED IN 2022, IS DESIGNED TO ASSIST ACADEMIC INVESTIGATORS IN OVERCOMING THE DRUG DEVELOPMENT "VALLEY OF DEATH" BY PROVIDING STRATEGIC FUNDING AND MENTORSHIP. THROUGH ITS BRIDGING RESEARCH AND INNOVATION IN DRUG DEVELOPMENT GRANTS (BRIDGE) PROGRAM, INVESTIGATORS ARE SUPPORTED BY TRXA IN DEFINING AND IMPLEMENTING EFFECTIVE PATHWAYS FOR ADVANCING PROMISING THERAPEUTIC CANDIDATES FROM THE LABORATORY TOWARD CLINICAL EVALUATION. IN 2024, TRXA SUPPORTED FOUR (4) DRUG DEVELOPMENT PROJECTS WITH A TOTAL OF $1,612,597 IN GRANT FUNDING. IN ADDITION TO FUNDING, GRANTEES RECEIVED THE FOLLOWING: - STRATEGIC AND TACTICAL EXPERTISE IN DRUG DISCOVERY AND DEVELOPMENT, INCLUDING CONSIDERATIONS IN REGULATORY SCIENCE AND PRECLINICAL STRATEGY. - RESOURCES AND HANDS-ON GUIDANCE TO BUILD COMPREHENSIVE DATA PACKAGES THAT STRENGTHEN THE VALUE AND ATTRACTIVENESS OF THERAPEUTIC CANDIDATES FOR PARTNERSHIP WITH BIOTECHNOLOGY OR PHARMACEUTICAL COMPANIES. - SUPPORT IN ENGAGEMENT OF CONTRACT RESEARCH ORGANIZATIONS (CROS) TO CONDUCT KEY DISCOVERY-PHASE EXPERIMENTS AND VALIDATE ACADEMIC FINDINGS, ENSURING DATA ROBUSTNESS AND REPRODUCIBILITY. IN ADDITION, THROUGH ITS 2024 REQUEST FOR PROPOSALS, TRXA IDENTIFIED SEVEN (7) NEW PROJECTS FOR BRIDGE AWARDS, TOTALING $2.4 MILLION, TO BE FUNDED IN THE 2025 CALENDAR YEAR.
  4. $15.7 million spent. CRITICAL PATH INSTITUTE ALSO EXECUTES OTHER PROJECTS AND CONSORTIA IN AREAS INCLUDING THERAPEUTICS FOR THE ATAXIAS, POLYCYSTIC KIDNEY DISORDER, ALZHEIMER'S DISEASE, PARKINSON'S, TB, SICKLE CELL DISEASE, TYPE 1 DIABETES, DUCHENNE MUSCULAR DYSTROPHY, ALPHA-1 ANTITRYPSIN DEFICIENCY, LYSOSOMAL DISEASES, MODEL INFORMED DRUG DEVELOPMENT, PATIENT-REPORTED OUTCOME, ELECTRONIC CLINICAL OUTCOME ASSESSMENT, RARE DISEASE CLINICAL OUTCOME ASSESSMENT, TRANSPLANT THERAPEUTICS, PREDICTIVE SAFETY TESTING, PEDIATRICS, AND OTHERS.

Source: Form 990 for the year ending June 30, 2025, filed with the Internal Revenue Service. Rating method 2026.2. How we rate

Legitimacy checks

  1. Is it registered with the IRS? Passed.

    Listed in the IRS master file of tax-exempt organizations as a 501(c)(3) charitable organization.

    Source: Exempt Organizations Business Master File, Internal Revenue Service, file dated September 7, 2026.

  2. Has the IRS revoked its tax-exempt status? Passed.

    Not on the IRS automatic revocation list.

    Source: Automatic revocation of exemption list, Internal Revenue Service, file dated September 30, 2026.

  3. Are donations tax-deductible? Passed.

    On the IRS list of organizations eligible to receive tax-deductible contributions.

    Source: Publication 78 data: organizations eligible for tax-deductible contributions, Internal Revenue Service, file dated September 10, 2026.

  4. Is it keeping up with its IRS filings? Passed.

    Most recent return on file covers the year ending June 2025.

    Source: Exempt Organizations Business Master File, Internal Revenue Service, file dated September 7, 2026.

  5. How long has it been tax-exempt? Passed.

    Recognized by the IRS since May 2005.

    Source: Exempt Organizations Business Master File, Internal Revenue Service, file dated September 7, 2026.

  6. Is it in good standing with state regulators? Passed.

    Not on California's list of charities barred from soliciting. Other states are not yet checked.

    Source: May Not Operate or Solicit for Charitable Purposes list, California Attorney General, Registry of Charities and Fundraisers, file dated October 7, 2026.

Ratings and checks are our reading of public records, using the published method. They are not a statement about anyone's honesty. If you work for this organization, you can send corrections or results, confirm you want gifts through Veridonate, or ask to be removed from giving.