FURP.ORG / PUBLIC DATA EXPLORER

CRITICAL PATH INSTITUTE: Form 990, tax year 2017

View the entire original 990 at ProPublica ↗

Organization
CRITICAL PATH INSTITUTE (EIN 20-1991334)
Tax period
2017-07-01 to 2018-06-30
Filed
2019-02-27
IRS object ID
201900589349301615
Schema version
2017v2.3
Source
Download XML · Original 990 at ProPublica

Every field in the e-filed return. Faint text is the IRS element name, for citing.

Return header ReturnHeader

FieldValueIRS element (for citing)
Return2019-02-27T20:09:24-06:00ReturnTs
Tax Period End2018-06-30TaxPeriodEndDt

Preparer Firm PreparerFirmGrp

FieldValueIRS element (for citing)
Preparer Firm EIN860683059PreparerFirmEIN

Preparer Firm Name PreparerFirmName

FieldValueIRS element (for citing)
Business Name Line1BEACHFLEISCHMAN PCBusinessNameLine1Txt

Preparer US Address PreparerUSAddress

FieldValueIRS element (for citing)
Address Line11985 E RIVER ROAD SUITE 201AddressLine1Txt
CityTUCSONCityNm
State AbbreviationAZStateAbbreviationCd
ZIP85718ZIPCd
FieldValueIRS element (for citing)
Return Type990ReturnTypeCd
Tax Period Begin2017-07-01TaxPeriodBeginDt

Filer Filer

FieldValueIRS element (for citing)
EIN201991334EIN

Business Name BusinessName

FieldValueIRS element (for citing)
Business Name Line1CRITICAL PATH INSTITUTEBusinessNameLine1Txt
FieldValueIRS element (for citing)
Business Name ControlCRITBusinessNameControlTxt
Phone5205473440PhoneNum

US Address USAddress

FieldValueIRS element (for citing)
Address Line11730 EAST RIVER ROAD NO 200AddressLine1Txt
CityTUCSONCityNm
State AbbreviationAZStateAbbreviationCd
ZIP857185898ZIPCd

Business Officer BusinessOfficerGrp

FieldValueIRS element (for citing)
PersonSTEVEN BROADBENT MBAPersonNm
Person TitleCOOPersonTitleTxt
Phone5205473440PhoneNum
Signature2019-02-14SignatureDt
Discuss With Paid PreparerYes (1)DiscussWithPaidPreparerInd

Preparer Person PreparerPersonGrp

FieldValueIRS element (for citing)
Preparer PersonKAREN K MCCLOSKEY CPAPreparerPersonNm
PTINP00099644PTIN
Phone5203214600PhoneNum
Preparation2019-02-14PreparationDt

Filing Security Information FilingSecurityInformation

IP Address IPAddress

FieldValueIRS element (for citing)
I Pv4 Address64.128.200.66IPv4AddressTxt
FieldValueIRS element (for citing)
IP2019-02-14IPDt
IP Tm15:48:27IPTm
IP TimezoneUSIPTimezoneCd
Filing License TypePFilingLicenseTypeCd
At Submission Creation Device Id100786DC4CA6AC734CEB2D953EA696EF9CD62243AtSubmissionCreationDeviceId
At Submission Filing Device Id8D176FDB9A9846D98182556421F389029B96F31FAtSubmissionFilingDeviceId
FieldValueIRS element (for citing)
Tax2017TaxYr
Build TS2019-02-21 02:37:17ZBuildTS

Form 990 IRS990

FieldValueIRS element (for citing)
Principal OfficerMARTHA BRUMFIELD PHDPrincipalOfficerNm

US Address USAddress

FieldValueIRS element (for citing)
Address Line11730 EAST RIVER ROAD NO 200AddressLine1Txt
CityTUCSONCityNm
State AbbreviationAZStateAbbreviationCd
ZIP857185898ZIPCd
FieldValueIRS element (for citing)
Gross Receipts$15,267,826GrossReceiptsAmt
Group Return For Affiliates0GroupReturnForAffiliatesInd
Organization501c3Yes (X)Organization501c3Ind
Website AddressWWW.C-PATH.ORGWebsiteAddressTxt
Type Of Organization CorpYes (X)TypeOfOrganizationCorpInd
Formation2004FormationYr
Legal Domicile StateAZLegalDomicileStateCd
Activity Or MissionCREATE AND MANAGE INTERNATIONAL COLLABORATIONS AND DEVELOP NOVEL TOOLS, ENABLING THE FASTER DEVELOPMENT OF SAFER MEDICAL PRODUCTS.ActivityOrMissionDesc
Voting Members Governing Body15VotingMembersGoverningBodyCnt
Voting Members Independent14VotingMembersIndependentCnt
Total Employee80TotalEmployeeCnt
Total Volunteers13TotalVolunteersCnt
Total Gross UBI$0TotalGrossUBIAmt
Net Unrelated Bus Txbl Incm$0NetUnrelatedBusTxblIncmAmt
PY Contributions Grants$10,085,049PYContributionsGrantsAmt
CY Contributions Grants$10,019,550CYContributionsGrantsAmt
PY Program Service Revenue$5,531,847PYProgramServiceRevenueAmt
CY Program Service Revenue$5,164,609CYProgramServiceRevenueAmt
PY Investment Income$50,971PYInvestmentIncomeAmt
CY Investment Income$83,667CYInvestmentIncomeAmt
PY Other Revenue$2,500PYOtherRevenueAmt
CY Other Revenue$0CYOtherRevenueAmt
PY Total Revenue$15,670,367PYTotalRevenueAmt
CY Total Revenue$15,267,826CYTotalRevenueAmt
PY Grants And Similar Paid$1,853,946PYGrantsAndSimilarPaidAmt
CY Grants And Similar Paid$1,359,100CYGrantsAndSimilarPaidAmt
PY Benefits Paid To Members$0PYBenefitsPaidToMembersAmt
CY Benefits Paid To Members$0CYBenefitsPaidToMembersAmt
PY Salaries Comp Emp Bnft Paid$7,188,245PYSalariesCompEmpBnftPaidAmt
CY Salaries Comp Emp Bnft Paid$8,046,940CYSalariesCompEmpBnftPaidAmt
PY Total Prof Fndrsng Expns$0PYTotalProfFndrsngExpnsAmt
CY Total Prof Fndrsng Expns$0CYTotalProfFndrsngExpnsAmt
CY Total Fundraising Expense$0CYTotalFundraisingExpenseAmt
PY Other Expenses$6,113,896PYOtherExpensesAmt
CY Other Expenses$5,105,672CYOtherExpensesAmt
PY Total Expenses$15,156,087PYTotalExpensesAmt
CY Total Expenses$14,511,712CYTotalExpensesAmt
PY Revenues Less Expenses$514,280PYRevenuesLessExpensesAmt
CY Revenues Less Expenses$756,114CYRevenuesLessExpensesAmt
Total Assets BOY$16,508,211TotalAssetsBOYAmt
Total Assets EOY$14,421,996TotalAssetsEOYAmt
Total Liabilities BOY$10,541,940TotalLiabilitiesBOYAmt
Total Liabilities EOY$7,699,611TotalLiabilitiesEOYAmt
Net Assets Or Fund Balances BOY$5,966,271NetAssetsOrFundBalancesBOYAmt
Net Assets Or Fund Balances EOY$6,722,385NetAssetsOrFundBalancesEOYAmt
Info In Schedule O Part IIIYes (X)InfoInScheduleOPartIIIInd
MissionTHE 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.MissionDesc
Significant New Program Srvc0SignificantNewProgramSrvcInd
Significant Change0SignificantChangeInd
Expense$10,965,542ExpenseAmt
Grant$1,359,100GrantAmt
Revenue$5,164,609RevenueAmt
DescSEE SCHEDULE ODesc
Total Program Service Expenses$10,965,542TotalProgramServiceExpensesAmt
Described In Section501c3Yes (1)DescribedInSection501c3Ind
Schedule B RequiredYes (1)ScheduleBRequiredInd
Political Campaign Acty0PoliticalCampaignActyInd
Lobbying ActivitiesYes (1)LobbyingActivitiesInd
Subject To Proxy Tax0SubjectToProxyTaxInd
Donor Advised Fund0DonorAdvisedFundInd
Conservation Easements0ConservationEasementsInd
Collections Of Art0CollectionsOfArtInd
Credit Counseling0CreditCounselingInd
Temp Or Permanent Endowments0TempOrPermanentEndowmentsInd
Report Land Building EquipmentYes (1)ReportLandBuildingEquipmentInd
Report Investments Other Sec0ReportInvestmentsOtherSecInd
Report Program Related Invst0ReportProgramRelatedInvstInd
Report Other Assets0ReportOtherAssetsInd
Report Other Liabilities0ReportOtherLiabilitiesInd
Include FIN48 FootnoteYes (1)IncludeFIN48FootnoteInd
Independent Audit Fincl StmtYes (1)IndependentAuditFinclStmtInd
Consolidated Audit Fincl Stmt0ConsolidatedAuditFinclStmtInd
School Operating0SchoolOperatingInd
Foreign Office0ForeignOfficeInd
Foreign ActivitiesYes (1)ForeignActivitiesInd
More Than5000 K To OrgYes (1)MoreThan5000KToOrgInd
More Than5000 K To Individuals0MoreThan5000KToIndividualsInd
Professional Fundraising0ProfessionalFundraisingInd
Fundraising Activities0FundraisingActivitiesInd
Gaming Activities0GamingActivitiesInd
Operate Hospital0OperateHospitalInd
Grants To OrganizationsYes (1)GrantsToOrganizationsInd
Grants To Individuals0GrantsToIndividualsInd
Schedule J RequiredYes (1)ScheduleJRequiredInd
Tax Exempt Bonds0TaxExemptBondsInd
Engaged In Excess Benefit Trans0EngagedInExcessBenefitTransInd
PY Excess Benefit Trans0PYExcessBenefitTransInd
Loan Outstanding0LoanOutstandingInd
Grant To Related Person0GrantToRelatedPersonInd
Business Rln With Org Mem0BusinessRlnWithOrgMemInd
Business Rln With Fam Mem0BusinessRlnWithFamMemInd
Business Rln With Officer Ent0BusinessRlnWithOfficerEntInd
Deductible Non Cash Contri0DeductibleNonCashContriInd
Deductible Art Contribution0DeductibleArtContributionInd
Terminate Operations0TerminateOperationsInd
Partial Liquidation0PartialLiquidationInd
Disregarded Entity0DisregardedEntityInd
Related EntityYes (1)RelatedEntityInd
Related Organization Ctrl EntYes (1)RelatedOrganizationCtrlEntInd
Transaction With Control Ent0TransactionWithControlEntInd
Trnsfr Exmpt Non Chrtbl Rltd Org0TrnsfrExmptNonChrtblRltdOrgInd
Activities Conducted Prtshp0ActivitiesConductedPrtshpInd
Schedule O RequiredYes (1)ScheduleORequiredInd
IRP Document14IRPDocumentCnt
IRP Document W2 G0IRPDocumentW2GCnt
Backup Wthld ComplianceYes (1)BackupWthldComplianceInd
Employee80EmployeeCnt
Employment Tax Returns FiledYes (1)EmploymentTaxReturnsFiledInd
Unrelated Bus Incm Over Limit0UnrelatedBusIncmOverLimitInd
Foreign Financial Account0ForeignFinancialAccountInd
Prohibited Tax Shelter Trans0ProhibitedTaxShelterTransInd
Taxable Party Notification0TaxablePartyNotificationInd
Nondeductible Contributions0NondeductibleContributionsInd
Quid Pro Quo Contributions0QuidProQuoContributionsInd
Form8282 Property Disposed Of0Form8282PropertyDisposedOfInd
Rcv Fnds To Pay Prsnl Bnft Cntrct0RcvFndsToPayPrsnlBnftCntrctInd
Pay Premiums Prsnl Bnft Cntrct0PayPremiumsPrsnlBnftCntrctInd
Indoor Tanning Services0IndoorTanningServicesInd
Info In Schedule O Part VIYes (X)InfoInScheduleOPartVIInd
Governing Body Voting Members15GoverningBodyVotingMembersCnt
Independent Voting Member14IndependentVotingMemberCnt
Family Or Business RlnYes (1)FamilyOrBusinessRlnInd
Delegation Of Mgmt Duties0DelegationOfMgmtDutiesInd
Change To Org Documents0ChangeToOrgDocumentsInd
Material Diversion Or Misuse0MaterialDiversionOrMisuseInd
Members Or Stockholders0MembersOrStockholdersInd
Election Of Board Members0ElectionOfBoardMembersInd
Decisions Subject To Approva0DecisionsSubjectToApprovaInd
Minutes Of Governing BodyYes (1)MinutesOfGoverningBodyInd
Minutes Of CommitteesYes (1)MinutesOfCommitteesInd
Officer Mailing Address0OfficerMailingAddressInd
Local Chapters0LocalChaptersInd
Form990 Provided To Gvrn BodyYes (1)Form990ProvidedToGvrnBodyInd
Conflict Of Interest PolicyYes (1)ConflictOfInterestPolicyInd
Annual Disclosure Covered PrsnYes (1)AnnualDisclosureCoveredPrsnInd
Regular Monitoring EnfrcYes (1)RegularMonitoringEnfrcInd
Whistleblower PolicyYes (1)WhistleblowerPolicyInd
Document Retention PolicyYes (1)DocumentRetentionPolicyInd
Compensation Process CEOYes (1)CompensationProcessCEOInd
Compensation Process OtherYes (1)CompensationProcessOtherInd
Investment In Joint Venture0InvestmentInJointVentureInd
States Where Copy Of Return Is FldAZStatesWhereCopyOfReturnIsFldCd
Upon RequestYes (X)UponRequestInd

Books In Care Of Detail BooksInCareOfDetail

Business Name BusinessName

FieldValueIRS element (for citing)
Business Name Line1ANNA M MIDKIFF CPABusinessNameLine1Txt
FieldValueIRS element (for citing)
Phone5206478382PhoneNum

US Address USAddress

FieldValueIRS element (for citing)
Address Line11730 EAST RIVER ROAD NO 200AddressLine1Txt
CityTUCSONCityNm
State AbbreviationAZStateAbbreviationCd
ZIP857185898ZIPCd

Form990 Part VII Section A Form990PartVIISectionAGrp (22 entries)

TitleTitleTxtAverage Hours Per WeekAverageHoursPerWeekRtIndividual Trustee Or DirectorIndividualTrusteeOrDirectorIndReportable Comp From OrgReportableCompFromOrgAmtReportable Comp From Rltd OrgReportableCompFromRltdOrgAmtOther CompensationOtherCompensationAmtOfficerOfficerIndHighest Compensated EmployeeHighestCompensatedEmployeeInd
D CRAIG BRATER MD
BOARD MEMBER1.00Yes (X)$0$0$0
THE HONORABLE JAMES C GREENWOOD
BOARD MEMBER1.00Yes (X)$0$0$0
KAY HOLCOMBE
BOARD MEMBER1.00Yes (X)$0$0$0
MICHAEL KASSER MBA PHD
BOARD MEMBER1.00Yes (X)$0$0$0
SHAUN A KIRKPATRICK MA
BOARD MEMBER1.00Yes (X)$0$0$0
RICHARD T MYERS JR
BOARD MEMBER1.00Yes (X)$0$0$0
CINDY PARSEGHIAN MBA
BOARD MEMBER1.00Yes (X)$0$0$0
ALASTAIR JJ WOOD MB CHB
BOARD MEMBER1.00Yes (X)$0$0$0
PETER BARTON HUTT LLB LLM
BOARD MEMBER1.00Yes (X)$0$0$0
ALAN G LEVIN MS CPA
BOARD MEMBER1.00Yes (X)$0$0$0
PAULA OLSIEWSKI PHD
BOARD MEMBER1.00Yes (X)$0$0$0
JEFFREY E JACOB SM
DEPUTY CHAIRPERSON1.00Yes (X)$0$0$0
M WAINWRIGHT FISHBURN JR
VICE CHAIRPERSON1.00Yes (X)$0$0$0Yes (X)
TIMOTHY R FRANSON MD
CHAIRPERSON OF THE BOARD1.00Yes (X)$0$0$0Yes (X)
MARTHA BRUMFIELD PHD
CEO/PRESIDENT40.00Yes (X)$296,591$0$29,794Yes (X)
STEVEN BROADBENT MBA
COO/TREASURER40.00$194,127$0$26,519Yes (X)
LEWIS BARBIERI
SECRETARY40.00$114,661$0$18,817Yes (X)
LYNN D HUDSON PHD
EXECUTIVE DIRECTOR40.00$200,763$0$18,056Yes (X)
JOHN-MICHAEL SAUER PHD
EXECUTIVE DIRECTOR40.00$191,505$0$29,988Yes (X)
STEPHEN J COONS PHD
EXECUTIVE DIRECTOR40.00$185,620$0$21,631Yes (X)
STEVE ARNERIC PHD
EXECUTIVE DIRECTOR40.00$171,353$0$24,267Yes (X)
DEBRA HANNA PHD
EXECUTIVE DIRECTOR40.00$176,101$0$24,700Yes (X)
FieldValueIRS element (for citing)
Total Reportable Comp From Org$1,530,721TotalReportableCompFromOrgAmt
Tot Reportable Comp Rltd Org$0TotReportableCompRltdOrgAmt
Total Other Compensation$193,772TotalOtherCompensationAmt
Indiv Rcvd Greater Than100 K24IndivRcvdGreaterThan100KCnt
Former Ofcr Employees Listed0FormerOfcrEmployeesListedInd
Total Comp Greater Than150 KYes (1)TotalCompGreaterThan150KInd
Compensation From Other Srcs0CompensationFromOtherSrcsInd

Contractor Compensation ContractorCompensationGrp (5 entries)

Address Line1ContractorAddress/USAddress/AddressLine1TxtCityContractorAddress/USAddress/CityNmState AbbreviationContractorAddress/USAddress/StateAbbreviationCdZIPContractorAddress/USAddress/ZIPCdServicesServicesDescCompensationCompensationAmtAddress Line1ContractorAddress/ForeignAddress/AddressLine1TxtCityContractorAddress/ForeignAddress/CityNmCountryContractorAddress/ForeignAddress/CountryCdForeign PostalContractorAddress/ForeignAddress/ForeignPostalCd
RESEARCH TRIANGLE INSTITUTE
200 PARK OFFICES DRIVERESEARCH TRIANGLE PARKNC27709RESEARCH$365,350
EPHIBIAN
3180 N SWAN ROADTUCSONAZ85712IT SERVICES$159,419
LOTOS NILE
PO BOX 90245NASHVILLETN37209PUBLIC RELATIONS$144,000
CLINICAL OUTCOME SOLUTIONS
CLINICAL RESEARCH$142,370UNIT 68 BASEPOINT SHEARWAY ROADFOLKESTONEUKCT19 4RH
COVANCE LABORATORIES INC
PO BOX 2464BURLINGTONNC27216RESEARCH$123,900
FieldValueIRS element (for citing)
Cntrct Rcvd Greater Than100 K14CntrctRcvdGreaterThan100KCnt
Government Grants$3,480,022GovernmentGrantsAmt
All Other Contributions$6,539,528AllOtherContributionsAmt
Total Contributions$10,019,550TotalContributionsAmt

Program Service Revenue ProgramServiceRevenueGrp (2 entries)

DescDescBusinessBusinessCdTotal Revenue ColumnTotalRevenueColumnAmtRelated Or Exempt Func IncomeRelatedOrExemptFuncIncomeAmt
RESEARCH SUPPORT FEES541700$5,147,122$5,147,122
OTHER REVENUE900099$17,487$17,487
FieldValueIRS element (for citing)
Total Program Service Revenue$5,164,609TotalProgramServiceRevenueAmt

Investment Income InvestmentIncomeGrp

FieldValueIRS element (for citing)
Total Revenue Column$83,667TotalRevenueColumnAmt
Exclusion$83,667ExclusionAmt

Total Revenue TotalRevenueGrp

FieldValueIRS element (for citing)
Total Revenue Column$15,267,826TotalRevenueColumnAmt
Related Or Exempt Func Income$5,164,609RelatedOrExemptFuncIncomeAmt
Unrelated Business Revenue$0UnrelatedBusinessRevenueAmt
Exclusion$83,667ExclusionAmt
FieldValueIRS element (for citing)
Info In Schedule O Part IXYes (X)InfoInScheduleOPartIXInd

Grants To Domestic Orgs GrantsToDomesticOrgsGrp

FieldValueIRS element (for citing)
Total$1,231,975TotalAmt
Program Services$1,231,975ProgramServicesAmt

Foreign Grants ForeignGrantsGrp

FieldValueIRS element (for citing)
Total$127,125TotalAmt
Program Services$127,125ProgramServicesAmt

Comp Current Ofcr Directors CompCurrentOfcrDirectorsGrp

FieldValueIRS element (for citing)
Total$697,022TotalAmt
Program Services$150,841ProgramServicesAmt
Management And General$546,181ManagementAndGeneralAmt

Other Salaries And Wages OtherSalariesAndWagesGrp

FieldValueIRS element (for citing)
Total$5,981,035TotalAmt
Program Services$4,213,271ProgramServicesAmt
Management And General$1,767,764ManagementAndGeneralAmt

Pension Plan Contributions PensionPlanContributionsGrp

FieldValueIRS element (for citing)
Total$422,435TotalAmt
Program Services$281,320ProgramServicesAmt
Management And General$141,115ManagementAndGeneralAmt

Other Employee Benefits OtherEmployeeBenefitsGrp

FieldValueIRS element (for citing)
Total$493,117TotalAmt
Program Services$330,165ProgramServicesAmt
Management And General$162,952ManagementAndGeneralAmt

Payroll Taxes PayrollTaxesGrp

FieldValueIRS element (for citing)
Total$453,331TotalAmt
Program Services$304,185ProgramServicesAmt
Management And General$149,146ManagementAndGeneralAmt

Fees For Services Legal FeesForServicesLegalGrp

FieldValueIRS element (for citing)
Total$17,962TotalAmt
Program Services$13,533ProgramServicesAmt
Management And General$4,429ManagementAndGeneralAmt

Fees For Services Accounting FeesForServicesAccountingGrp

FieldValueIRS element (for citing)
Total$123,073TotalAmt
Program Services$90,511ProgramServicesAmt
Management And General$32,562ManagementAndGeneralAmt

Fees For Services Lobbying FeesForServicesLobbyingGrp

FieldValueIRS element (for citing)
Total$60,284TotalAmt
Program Services$57,964ProgramServicesAmt
Management And General$2,320ManagementAndGeneralAmt

Fees For Services Other FeesForServicesOtherGrp

FieldValueIRS element (for citing)
Total$2,436,169TotalAmt
Program Services$2,359,796ProgramServicesAmt
Management And General$76,373ManagementAndGeneralAmt

Advertising AdvertisingGrp

FieldValueIRS element (for citing)
Total$205,483TotalAmt
Program Services$138,274ProgramServicesAmt
Management And General$67,209ManagementAndGeneralAmt

Office Expenses OfficeExpensesGrp

FieldValueIRS element (for citing)
Total$355,357TotalAmt
Program Services$314,960ProgramServicesAmt
Management And General$40,397ManagementAndGeneralAmt

Information Technology InformationTechnologyGrp

FieldValueIRS element (for citing)
Total$366,686TotalAmt
Program Services$303,966ProgramServicesAmt
Management And General$62,720ManagementAndGeneralAmt

Occupancy OccupancyGrp

FieldValueIRS element (for citing)
Total$523,915TotalAmt
Program Services$96,591ProgramServicesAmt
Management And General$427,324ManagementAndGeneralAmt

Travel TravelGrp

FieldValueIRS element (for citing)
Total$460,119TotalAmt
Program Services$438,449ProgramServicesAmt
Management And General$21,670ManagementAndGeneralAmt

Conferences Meetings ConferencesMeetingsGrp

FieldValueIRS element (for citing)
Total$388,900TotalAmt
Program Services$379,065ProgramServicesAmt
Management And General$9,835ManagementAndGeneralAmt

Depreciation Depletion DepreciationDepletionGrp

FieldValueIRS element (for citing)
Total$32,303TotalAmt
Program Services$21,675ProgramServicesAmt
Management And General$10,628ManagementAndGeneralAmt

Insurance InsuranceGrp

FieldValueIRS element (for citing)
Total$55,137TotalAmt
Program Services$36,997ProgramServicesAmt
Management And General$18,140ManagementAndGeneralAmt

Other Expenses OtherExpensesGrp (3 entries)

DescDescTotalTotalAmtProgram ServicesProgramServicesAmtManagement And GeneralManagementAndGeneralAmt
DUES AND SUBSCRIPTIONS$38,894$35,154$3,740
BAD DEBT$35,000$35,000
MISCELLANEOUS$6,390$4,725$1,665

Total Functional Expenses TotalFunctionalExpensesGrp

FieldValueIRS element (for citing)
Total$14,511,712TotalAmt
Program Services$10,965,542ProgramServicesAmt
Management And General$3,546,170ManagementAndGeneralAmt
Fundraising$0FundraisingAmt

Cash Non Interest Bearing CashNonInterestBearingGrp

FieldValueIRS element (for citing)
BOY$1,969,152BOYAmt
EOY$3,026,764EOYAmt

Savings And Temp Cash Invst SavingsAndTempCashInvstGrp

FieldValueIRS element (for citing)
BOY$5,994,076BOYAmt
EOY$4,831,456EOYAmt

Pledges And Grants Receivable PledgesAndGrantsReceivableGrp

FieldValueIRS element (for citing)
BOY$1,212,619BOYAmt
EOY$166,823EOYAmt

Accounts Receivable AccountsReceivableGrp

FieldValueIRS element (for citing)
BOY$400,363BOYAmt
EOY$596,248EOYAmt

Prepaid Expenses Defrd Charges PrepaidExpensesDefrdChargesGrp

FieldValueIRS element (for citing)
BOY$159,773BOYAmt
EOY$92,347EOYAmt
FieldValueIRS element (for citing)
Land Bldg Equip Cost Or Other Bss$662,965LandBldgEquipCostOrOtherBssAmt
Land Bldg Equip Accum Deprec$579,794LandBldgEquipAccumDeprecAmt

Land Bldg Equip Basis Net LandBldgEquipBasisNetGrp

FieldValueIRS element (for citing)
BOY$73,630BOYAmt
EOY$83,171EOYAmt

Investments Pub Traded Sec InvestmentsPubTradedSecGrp

FieldValueIRS element (for citing)
BOY$6,674,273BOYAmt
EOY$5,615,214EOYAmt

Other Assets Total OtherAssetsTotalGrp

FieldValueIRS element (for citing)
BOY$24,325BOYAmt
EOY$9,973EOYAmt

Total Assets TotalAssetsGrp

FieldValueIRS element (for citing)
BOY$16,508,211BOYAmt
EOY$14,421,996EOYAmt

Accounts Payable Accr Expnss AccountsPayableAccrExpnssGrp

FieldValueIRS element (for citing)
BOY$753,078BOYAmt
EOY$600,978EOYAmt

Deferred Revenue DeferredRevenueGrp

FieldValueIRS element (for citing)
BOY$9,788,862BOYAmt
EOY$7,098,633EOYAmt

Total Liabilities TotalLiabilitiesGrp

FieldValueIRS element (for citing)
BOY$10,541,940BOYAmt
EOY$7,699,611EOYAmt
FieldValueIRS element (for citing)
Organization Follows SFAS117Yes (X)OrganizationFollowsSFAS117Ind

Unrestricted Net Assets UnrestrictedNetAssetsGrp

FieldValueIRS element (for citing)
BOY$5,966,271BOYAmt
EOY$6,722,385EOYAmt

Total Net Assets Fund Balance TotalNetAssetsFundBalanceGrp

FieldValueIRS element (for citing)
BOY$5,966,271BOYAmt
EOY$6,722,385EOYAmt

Tot Liab Net Assets Fund Balance TotLiabNetAssetsFundBalanceGrp

FieldValueIRS element (for citing)
BOY$16,508,211BOYAmt
EOY$14,421,996EOYAmt
FieldValueIRS element (for citing)
Reconcilation Revenue Expnss$756,114ReconcilationRevenueExpnssAmt
Other Changes In Net Assets$0OtherChangesInNetAssetsAmt
Method Of Accounting AccrualYes (X)MethodOfAccountingAccrualInd
Accountant Compile Or Review0AccountantCompileOrReviewInd
FS AuditedYes (1)FSAuditedInd

FS Audited Basis FSAuditedBasisGrp

FieldValueIRS element (for citing)
Separate Basis Fincl StmtYes (X)SeparateBasisFinclStmtInd
FieldValueIRS element (for citing)
Audit CommitteeYes (1)AuditCommitteeInd
Federal Grant Audit RequiredYes (1)FederalGrantAuditRequiredInd
Federal Grant Audit PerformedYes (1)FederalGrantAuditPerformedInd

Schedule A IRS990ScheduleA

FieldValueIRS element (for citing)
Public Organization170Yes (X)PublicOrganization170Ind

Gifts Grants Contri Rcvd170 GiftsGrantsContriRcvd170Grp

FieldValueIRS element (for citing)
Current Tax Year Minus4 Years$5,370,782CurrentTaxYearMinus4YearsAmt
Current Tax Year Minus3 Years$10,269,811CurrentTaxYearMinus3YearsAmt
Current Tax Year Minus2 Years$10,197,464CurrentTaxYearMinus2YearsAmt
Current Tax Year Minus1 Year$10,085,049CurrentTaxYearMinus1YearAmt
Current Tax Year$10,019,550CurrentTaxYearAmt
Total$45,942,656TotalAmt

Total Calendar Year170 TotalCalendarYear170Grp

FieldValueIRS element (for citing)
Current Tax Year Minus4 Years$5,370,782CurrentTaxYearMinus4YearsAmt
Current Tax Year Minus3 Years$10,269,811CurrentTaxYearMinus3YearsAmt
Current Tax Year Minus2 Years$10,197,464CurrentTaxYearMinus2YearsAmt
Current Tax Year Minus1 Year$10,085,049CurrentTaxYearMinus1YearAmt
Current Tax Year$10,019,550CurrentTaxYearAmt
Total$45,942,656TotalAmt
FieldValueIRS element (for citing)
Substantial Contributors Tot$21,404,373SubstantialContributorsTotAmt
Public Support Total170$24,538,283PublicSupportTotal170Amt

Gross Investment Income170 GrossInvestmentIncome170Grp

FieldValueIRS element (for citing)
Current Tax Year Minus4 Years$70,230CurrentTaxYearMinus4YearsAmt
Current Tax Year Minus3 Years$82,059CurrentTaxYearMinus3YearsAmt
Current Tax Year Minus2 Years$80,580CurrentTaxYearMinus2YearsAmt
Current Tax Year Minus1 Year$48,471CurrentTaxYearMinus1YearAmt
Current Tax Year$83,667CurrentTaxYearAmt
Total$365,007TotalAmt
FieldValueIRS element (for citing)
Total Support$46,307,663TotalSupportAmt
Gross Receipts Rltd Activities$22,488,531GrossReceiptsRltdActivitiesAmt
Public Support CY1700.52990PublicSupportCY170Pct
Public Support PY1700.59930PublicSupportPY170Pct
Thirty Thr Pct Suprt Tests CY170Yes (X)ThirtyThrPctSuprtTestsCY170Ind

Schedule B IRS990ScheduleB

Schedule C IRS990ScheduleC

Total Direct Lobbying TotalDirectLobbyingGrp

FieldValueIRS element (for citing)
Filing Organizations Total$60,816FilingOrganizationsTotalAmt

Total Lobbying Expend TotalLobbyingExpendGrp

FieldValueIRS element (for citing)
Filing Organizations Total$60,816FilingOrganizationsTotalAmt

Other Exempt Purpose Expend OtherExemptPurposeExpendGrp

FieldValueIRS element (for citing)
Filing Organizations Total$14,450,896FilingOrganizationsTotalAmt

Total Exempt Purpose Expend TotalExemptPurposeExpendGrp

FieldValueIRS element (for citing)
Filing Organizations Total$14,511,712FilingOrganizationsTotalAmt

Lobbying Nontaxable Amount LobbyingNontaxableAmountGrp

FieldValueIRS element (for citing)
Filing Organizations Total$875,586FilingOrganizationsTotalAmt

Grassroots Nontaxable GrassrootsNontaxableGrp

FieldValueIRS element (for citing)
Filing Organizations Total$218,897FilingOrganizationsTotalAmt

Tot Lbbyng Grassroot Mns Non Tx TotLbbyngGrassrootMnsNonTxGrp

FieldValueIRS element (for citing)
Filing Organizations Total$0FilingOrganizationsTotalAmt

Tot Lbby Expend Mns Lbbyng Non Tx TotLbbyExpendMnsLbbyngNonTxGrp

FieldValueIRS element (for citing)
Filing Organizations Total$0FilingOrganizationsTotalAmt

Avg Lobbying Nontaxable Amount AvgLobbyingNontaxableAmountGrp

FieldValueIRS element (for citing)
Current Year Minus3$809,246CurrentYearMinus3Amt
Current Year Minus2$883,297CurrentYearMinus2Amt
Current Year Minus1$909,814CurrentYearMinus1Amt
Current Year$875,586CurrentYearAmt
Total$3,477,943TotalAmt
FieldValueIRS element (for citing)
Lobbying Ceiling$5,216,915LobbyingCeilingAmt

Avg Total Lobbying Expend AvgTotalLobbyingExpendGrp

FieldValueIRS element (for citing)
Current Year Minus3$67,262CurrentYearMinus3Amt
Current Year Minus2$11,731CurrentYearMinus2Amt
Current Year Minus1$61,348CurrentYearMinus1Amt
Current Year$60,816CurrentYearAmt
Total$201,157TotalAmt

Avg Grassroots Nontaxable AvgGrassrootsNontaxableGrp

FieldValueIRS element (for citing)
Current Year Minus3$202,312CurrentYearMinus3Amt
Current Year Minus2$220,824CurrentYearMinus2Amt
Current Year Minus1$227,454CurrentYearMinus1Amt
Current Year$218,897CurrentYearAmt
Total$869,487TotalAmt
FieldValueIRS element (for citing)
Grassroots Ceiling$1,304,231GrassrootsCeilingAmt

Supplemental Information Detail SupplementalInformationDetail

FieldValueIRS element (for citing)
Form And Line ReferencePART II-A, LINE 1BFormAndLineReferenceDesc
ExplanationC-PATH SPENT A MINOR AMOUNT OF FUNDS ON LOBBYING IN FYE 06/30/2018. GENERALLY, C-PATH DOES NOT LOBBY FOR OR AGAINST ANY SPECIFIC LEGISLATION. C-PATH EXPENDS SOME TIME AND RESOURCES TO EDUCATE MEMBERS OF CONGRESS IN THE AREA OF DRUG DEVELOPMENT.ExplanationTxt

Schedule D IRS990ScheduleD

Leasehold Improvements LeaseholdImprovementsGrp

FieldValueIRS element (for citing)
Other Cost Or Other Basis$42,014OtherCostOrOtherBasisAmt
Depreciation$39,338DepreciationAmt
Book Value$2,676BookValueAmt

Equipment EquipmentGrp

FieldValueIRS element (for citing)
Other Cost Or Other Basis$179,139OtherCostOrOtherBasisAmt
Depreciation$179,139DepreciationAmt
Book Value$0BookValueAmt

Other Land Buildings OtherLandBuildingsGrp

FieldValueIRS element (for citing)
Other Cost Or Other Basis$441,812OtherCostOrOtherBasisAmt
Depreciation$361,317DepreciationAmt
Book Value$80,495BookValueAmt
FieldValueIRS element (for citing)
Total Book Value Land Buildings$83,171TotalBookValueLandBuildingsAmt
Footnote TextYes (X)FootnoteTextInd
Total Rev Etc Audited Fincl Stmt$15,267,826TotalRevEtcAuditedFinclStmtAmt
Revenue Not Reported$0RevenueNotReportedAmt
Revenue Subtotal$15,267,826RevenueSubtotalAmt
Revenue Not Reported Fincl Stmt$0RevenueNotReportedFinclStmtAmt
Total Revenue Per Form990$15,267,826TotalRevenuePerForm990Amt
Tot Expns Etc Audited Fincl Stmt$14,511,712TotExpnsEtcAuditedFinclStmtAmt
Expenses Not Reported$0ExpensesNotReportedAmt
Expenses Subtotal$14,511,712ExpensesSubtotalAmt
Expenses Not Rpt Fincl Stmt$0ExpensesNotRptFinclStmtAmt
Total Expenses Per Form990$14,511,712TotalExpensesPerForm990Amt

Supplemental Information Detail SupplementalInformationDetail

FieldValueIRS element (for citing)
Form And Line ReferencePART X, LINE 2:FormAndLineReferenceDesc
ExplanationFINANCIAL STATEMENT FIN 48 (ASC 740) FOOTNOTE: C-PATH IS EXEMPT FROM INCOME TAXES UNDER BOTH FEDERAL (INTERNAL REVENUE CODE SECTION 501(C)(3)) AND ARIZONA INCOME TAX LAWS, AND IS CLASSIFIED AS OTHER THAN A PRIVATE FOUNDATION UNDER INTERNAL REVENUE CODE SECTION 509(A)(2). INCOME FROM CERTAIN ACTIVITIES NOT DIRECTLY RELATED TO C-PATH'S TAX-EXEMPT PURPOSE, HOWEVER, MAY BE SUBJECT TO TAXATION AS UNRELATED BUSINESS TAXABLE INCOME (UBTI). GAAP REQUIRES MANAGEMENT TO PERFORM AN EVALUATION OF ALL TAX POSITIONS TAKEN OR EXPECTED TO BE TAKEN IN THE COURSE OF PREPARING C-PATH'S TAX RETURNS TO DETERMINE WHETHER THE TAX POSITIONS MEET A "MORE LIKELY THAN NOT" STANDARD OF BEING SUSTAINED UNDER EXAMINATION BY THE APPLICABLE TAXING AUTHORITIES. THIS EVALUATION IS REQUIRED TO BE PERFORMED FOR ALL OPEN TAX YEARS, AS DEFINED BY THE VARIOUS STATUTES OF LIMITATIONS, FOR FEDERAL AND STATE PURPOSES. C-PATH IS REQUIRED TO FILE INFORMATIONAL RETURNS FOR FEDERAL AND STATE PURPOSES AND, IF IT HAS UBTI, FEDERAL AND STATE INCOME TAX RETURNS. MANAGEMENT HAS PERFORMED ITS EVALUATION OF TAX POSITIONS TAKEN ON ALL OPEN TAX YEARS AND HAS DETERMINED THAT THERE WERE NO POSITIONS TAKEN THAT DO NOT MEET THE "MORE LIKELY THAN NOT" STANDARD. SHOULD C-PATH EVER BE SUBJECT TO PENALTIES AND INTEREST ASSESSED BY VARIOUS TAXING AUTHORITIES, THEY WOULD BE CLASSIFIED AS MANAGEMENT AND GENERAL EXPENSES.ExplanationTxt

Schedule F IRS990ScheduleF

FieldValueIRS element (for citing)
Grant Records MaintainedYes (1)GrantRecordsMaintainedInd

Account Activities Outside US AccountActivitiesOutsideUSGrp

FieldValueIRS element (for citing)
RegionEUROPE (INCLUDING ICELAND & GREENLAND) - ALBANIA, ANDORRA, AUSTRIA, BELGIUMRegionTxt
Offices0OfficesCnt
Employee0EmployeeCnt
Type Of Activities ConductedGRANTS TO RECIPIENTS LOCATED IN REGIONTypeOfActivitiesConductedTxt
Specific Services ProvidedCLINICAL RESEARCHSpecificServicesProvidedTxt
Region Total Expenditures$127,125RegionTotalExpendituresAmt
FieldValueIRS element (for citing)
Subtotal Offices0SubtotalOfficesCnt
Subtotal Employees0SubtotalEmployeesCnt
Continuation Total Office0ContinuationTotalOfficeCnt
Continuation Total Employee0ContinuationTotalEmployeeCnt
Total Office0TotalOfficeCnt
Total Employee0TotalEmployeeCnt
Subtotal Spent$127,125SubtotalSpentAmt
Continuation Spent$0ContinuationSpentAmt
Total Spent$127,125TotalSpentAmt

Grants To Org Outside US GrantsToOrgOutsideUSGrp

FieldValueIRS element (for citing)
RegionEUROPE (INCLUDING ICELAND & GREENLAND) - ALBANIA, ANDORRA, AUSTRIA, BELGIUMRegionTxt
Purpose Of GrantCLINICAL RESEARCHPurposeOfGrantTxt
Cash Grant$127,125CashGrantAmt
Manner Of Cash DisbursementWIRE TRANSFERMannerOfCashDisbursementTxt
FieldValueIRS element (for citing)
Total Other Org1TotalOtherOrgCnt
Transfer To Foreign Corp0TransferToForeignCorpInd
Interest In Foreign Trust0InterestInForeignTrustInd
Foreign Corp OwnershipYes (1)ForeignCorpOwnershipInd
Passive Foreign Investmest Co0PassiveForeignInvestmestCoInd
Foreign Partnership0ForeignPartnershipInd
Boycott Countries0BoycottCountriesInd

Supplemental Information Detail SupplementalInformationDetail

FieldValueIRS element (for citing)
Form And Line ReferencePART I, LINE 2:FormAndLineReferenceDesc
ExplanationCRITICAL PATH INSTITUTE ENTERS INTO SUBAWARD AGREEMENTS WITH SUBRECIPIENTS AND REVIEWS PROGRESS DELIVERABLES AND COSTS.ExplanationTxt

Schedule I IRS990ScheduleI

FieldValueIRS element (for citing)
Grant Records MaintainedYes (1)GrantRecordsMaintainedInd

Recipient Table RecipientTable (6 entries)

Address Line1USAddress/AddressLine1TxtAddress Line2USAddress/AddressLine2TxtCityUSAddress/CityNmState AbbreviationUSAddress/StateAbbreviationCdZIPUSAddress/ZIPCdRecipient EINRecipientEINIRC SectionIRCSectionDescCash GrantCashGrantAmtPurpose Of GrantPurposeOfGrantTxt
BAYLOR RESEARCH INSTITUTE
1950 N STEMMONS FREEWAY SUITE 5010LOCKBOX 846275DALLASTX75207751921898501(C)(3)$400,459DEVELOP A HOLLOW FIBER MODEL FOR TUBERCULOSIS RESEARCH
REGENTS OF THE UNIVERSITY OF CALIFORNIA
1855 FOLSOM STREET BOX 0897SAN FRANCISCOCA94143946036493STATE OF CALIFORNIA$173,425DEVELOP A DISEASE PROGRESSION MODEL FOR TUBERCULOSIS
UNIVERSITY OF FLORIDA
PO BOX 113001GAINSVILLEFL32611596002052STATE OF FLORIDA$55,100DEVELOP A POPULATION PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) MODEL FOR TUBERCULOSIS
CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM
PO BOX 2068ROUND ROCKTX78680043503931501(C)(3)$263,981DEVELOP CLINICAL DATA STANDARDS
THE TRANSLATIONAL GENOMICS RESEARCH INSTITUTE
445 N FIFTH STREET SUITE 600PHOENIXAZ85004753065445501(C)(3)$293,585DEVELOP THE RESEQTB INTEGRATED PIPELINE
FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH INC
9650 ROCKVILLE PIKE SUITE 3411BETHESDAMD20814521986675501(C)(3)$45,425CLINICAL EVALUATION AND QUALIFICATION OF KIDNEY SAFETY BIOMARKERS STUDY
FieldValueIRS element (for citing)
Total501c3 Org6Total501c3OrgCnt

Supplemental Information Detail SupplementalInformationDetail

FieldValueIRS element (for citing)
Form And Line ReferencePART I, LINE 2:FormAndLineReferenceDesc
ExplanationCRITICAL PATH INSTITUTE ENTERS INTO SUBAWARD AGREEMENTS WITH SUBRECIPIENTS AND REVIEWS PROGRESS DELIVERABLES AND COSTS.ExplanationTxt

Schedule J IRS990ScheduleJ

FieldValueIRS element (for citing)
Compensation CommitteeYes (X)CompensationCommitteeInd
Form990 Of Other OrganizationsYes (X)Form990OfOtherOrganizationsInd
Written Employment ContractYes (X)WrittenEmploymentContractInd
Compensation SurveyYes (X)CompensationSurveyInd
Board Or Committee ApprovalYes (X)BoardOrCommitteeApprovalInd
Severance Payment0SeverancePaymentInd
Supplemental Nonqual Rtr Plan0SupplementalNonqualRtrPlanInd
Equity Based Comp Arrngm0EquityBasedCompArrngmInd
Comp Based On Revenue Of Flng Org0CompBasedOnRevenueOfFlngOrgInd
Comp Bsd On Rev Related Orgs0CompBsdOnRevRelatedOrgsInd
Comp Bsd Net Earns Flng Org0CompBsdNetEarnsFlngOrgInd
Comp Bsd Net Earns Rltd Orgs0CompBsdNetEarnsRltdOrgsInd
Any Non Fixed Payments0AnyNonFixedPaymentsInd
Initial Contract Exception0InitialContractExceptionInd

Rltd Org Officer Trst Key Empl RltdOrgOfficerTrstKeyEmplGrp (7 entries)

TitleTitleTxtBase Compensation Filing OrgBaseCompensationFilingOrgAmtCompensation Based On Rltd OrgsCompensationBasedOnRltdOrgsAmtBonus Filing OrganizationBonusFilingOrganizationAmountBonus Related OrganizationsBonusRelatedOrganizationsAmtOther Compensation Filing OrgOtherCompensationFilingOrgAmtOther Compensation Rltd OrgsOtherCompensationRltdOrgsAmtDeferred Compensation Flng OrgDeferredCompensationFlngOrgAmtDeferred Comp Rltd OrgsDeferredCompRltdOrgsAmtNontaxable Benefits Filing OrgNontaxableBenefitsFilingOrgAmtNontaxable Benefits Rltd OrgsNontaxableBenefitsRltdOrgsAmtTotal Compensation Filing OrgTotalCompensationFilingOrgAmtTotal Compensation Rltd OrgsTotalCompensationRltdOrgsAmtComp Report Prior990 Filing OrgCompReportPrior990FilingOrgAmtComp Report Prior990 Rltd OrgsCompReportPrior990RltdOrgsAmt
MARTHA BRUMFIELD PHD
CEO/PRESIDENT$296,591$0$0$0$0$0$22,600$0$7,194$0$326,385$0$0$0
STEVEN BROADBENT MBA
COO/TREASURER$194,127$0$0$0$0$0$15,509$0$11,010$0$220,646$0$0$0
LYNN D HUDSON PHD
EXECUTIVE DIRECTOR$200,763$0$0$0$0$0$15,716$0$2,340$0$218,819$0$0$0
JOHN-MICHAEL SAUER PHD
EXECUTIVE DIRECTOR$191,505$0$0$0$0$0$15,681$0$14,307$0$221,493$0$0$0
STEPHEN J COONS PHD
EXECUTIVE DIRECTOR$185,620$0$0$0$0$0$14,729$0$6,902$0$207,251$0$0$0
STEVE ARNERIC PHD
EXECUTIVE DIRECTOR$171,353$0$0$0$0$0$13,371$0$10,896$0$195,620$0$0$0
DEBRA HANNA PHD
EXECUTIVE DIRECTOR$176,101$0$0$0$0$0$14,520$0$10,180$0$200,801$0$0$0

Schedule O IRS990ScheduleO

Supplemental Information Detail SupplementalInformationDetail (8 entries)

Form And Line ReferenceFormAndLineReferenceDescExplanationExplanationTxt
FORM 990, PART III, LINE 4A, PROGRAM SERVICE ACCOMPLISHMENTSTHE CRITICAL PATH INSTITUTE (C-PATH) IS AN INDEPENDENT, NON-PROFIT ORGANIZATION UNIQUELY DEDICATED TO ADVANCING MULTIPLE ASPECTS OF THE FDA'S CRITICAL PATH INITIATIVE BY CREATING COLLABORATIONS AMONG REGULATORS (SCIENTISTS FROM THE FDA AND EMA), THE REGULATED MEDICAL PRODUCT INDUSTRY, ACADEMIA, PATIENT GROUPS, AND OTHER ORGANIZATIONS THAT ADVANCE MEDICAL INNOVATION THROUGH THE DEVELOPMENT OF TOOLS AND METHODS BASED UPON SOUND, CONSENSUS-BASED SCIENCE. THE ACCOMPLISHMENTS FOR THIS FISCAL YEAR REPORT INCLUDE: THE COALITION AGAINST MAJOR DISEASES WAS REBRANDED AS THE CRITICAL PATH FOR ALZHEIMER'S DISEASE. IT DEVELOPS TOOLS AND NOVEL METHODOLOGIES TO ACCELERATE PROGRESS IN THE DEVELOPMENT OF PREVENTION AND TREATMENT STRATEGIES FOR ALZHEIMER'S DISEASE. THIS YEAR'S ACCOMPLISHMENTS INCLUDE: (1) RECEIVING A LETTER OF SUPPORT FROM THE EMA ENCOURAGING INDUSTRY SPONSORS TO SHARE WITH CPAD THE PATIENT-LEVEL DATA FROM COMPLETED PHASE II AND III CLINICAL TRIALS, INCLUDING ACTIVE AND CONTROL ARMS, ALLOWING CPAD TO COMPLETE DEVELOPMENT AND VALIDATION OF A PROPOSED QUANTITATIVE MODEL FOR IMPLEMENTATION BY SPONSORS ACTIVELY DESIGNING CLINICAL TRIALS IN AMNESTIC MILD COGNITIVE IMPAIRMENT (AMCI). (2) GENERATED GRAPHICAL USER INTERFACE-BASED UPDATES TO THE AD MILD-TO-MODERATE CLINICAL TRIAL SIMULATION TOOL AND MILD COGNITIVE IMPAIRMENT (MCI) CLINICAL TRIAL SIMULATION TOOL - THE HIPPOCAMPAL NEUROIMAGING-INFORMED AMNESTIC MCI CLINICAL TRIAL SIMULATOR. (3) INCREASED USE OF THE DATABASE AND MODELS. THE CRITICAL PATH FOR PARKINSON'S CONSORTIUM'S GOALS ARE TO DEVELOP QUANTITATIVE MODEL-BASED TOOLS TO ACCELERATE THE TREATMENT OF PARKINSON'S DISEASE, ESPECIALLY FOR THOSE INDIVIDUALS EXPERIENCING THE FIRST CLINICAL SIGNS OF MOTOR SYMPTOM ONSET. THEIR ACCOMPLISHMENTS THIS YEAR INCLUDE:(1) SUBMISSION TO EMA AND FDA OF THE FIRST MODELING TOOL FOR PARKINSON'S- "MODEL-BASED CLINICAL TRIAL ENRICHMENT TOOL FOR PARKINSON DISEASE CLINICAL TRIALS". (2) RECEIVED FDA'S FORMAL RESPONSE TO CPP'S LETTER OF INTENT OUTLINING RECOMMENDATIONS FOR WHAT SHOULD BE SUBMITTED IN THE MODELING BRIEFING DOCUMENT. (3) EMA QUALIFICATION ADVICE LETTER RECEIVED FOR THE MODEL-BASED CLINICAL TRIAL ENRICHMENT TOOL FOR PARKINSON'S DISEASE CLINICAL TRIALS. THE MISSION OF THE CRITICAL PATH TO TB DRUG REGIMENS INITIATIVE IS TO ACCELERATE THE DEVELOPMENT OF NOVEL TB DRUG REGIMENS THAT ARE SAFER, SHORTER, AND MORE EFFICACIOUS THAN THE CURRENT STANDARD OF CARE. THEIR MISSION EXPANDED TO ACCELERATE THE DEVELOPMENT OF A CLINICALLY USEFUL IN VITRO RAPID DRUG SUSCEPTIBILITY ASSAY TO SUPPORT TB REGIMEN DEVELOPMENT AND DEPLOYMENT. THEIR ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) ELEVEN NEW TB CLINICAL DATASETS WERE ACQUIRED, CURATED, AND INTEGRATED INTO THE TB PLATFORM FOR AGGREGATION OF CLINICAL TB STUDIES (TB-PACTS) PLATFORM AND MADE ACCESSIBLE TO QUALIFIED RESEARCHERS. TO DATE, OVER 55 APPLICATIONS HAVE BEEN SUBMITTED AND 42 HAVE BEEN APPROVED TO SUPPORT TB RESEARCH. (2) COMPLETED THE STAGE 2 ANALYSIS OF TB RE-ANALYSIS OF FLUOROQUINOLONE EXECUTED CLINICAL TRIALS (TB-REFLECT), WHICH FOCUSED ON ISONIAZID RESISTANT SUB-COHORT AND EXAMINATION OF SAFETY FINDINGS FOR STANDARD OF CARE REGIMENS WHICH CONTAIN A FLUOROQUINOLONE. (3) COMPLETED OR SIGNIFICANTLY ADVANCED THE FOLLOWING MODELING AND SIMULATION PROJECTS: POPULATION PK/PD, LIQUID CULTURE, QUANTITATIVE SYSTEMS PHARMACOLOGY, AND CARDIAC RISK ASSESSMENT ALGORITHM. ADDITIONALLY, HFS-TB EXPERIMENTS CHARACTERIZING THE PK/PD ATTRIBUTES OF THREE DRUGS AND REGIMENS FOR TB HAVE BEEN COMPLETED, WITH FOUR EXPERIMENTS ONGOING. OTHER MODEL-BASED ANALYSES ARE ONGOING TO IDENTIFY PREFERRED METHODS FOR THE TRANSLATION OF DATA FROM IN VITRO AND IN VIVO (ANIMAL) MODELS TO PREDICT CLINICAL OUTCOMES FOR ANTI-TB DRUGS AND REGIMENS. (4) EXPANDED ANALYSES TO SUPPORT PBPK QUALIFICATION EFFORTS BASED ON FEEDBACK FROM EMA'S SCIENTIFIC ADVICE WORKING PARTY (SAWP). FURTHER ANALYSES DESIGNED TO VERIFY PBPK GRANULOMA MODEL PERFORMANCE ARE IN PROGRESS. THE DATA COLLABORATION CENTER IS A CENTER WITHIN C-PATH TO ENABLE MULTIPLE ORGANIZATIONS TO WORK TOGETHER IN A NEUTRAL SETTING AND SHARE CLINICAL DATA IN ORDER TO OPTIMIZE ITS VALUE IN CREATING NEW INSIGHTS AND TOOLS THAT ACCELERATE DRUG DEVELOPMENT IN AREAS WITH UNMET MEDICAL NEEDS. THE DCC SUPPORTS DATA SHARING PROJECTS ALIGNED WITH SPECIFIC C-PATH CONSORTIA AS WELL AS DATA SHARING INITIATIVES THAT ARE INDEPENDENT OF C-PATH CONSORTIA. ITS ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) LAUNCHED THE DUCHENNE'S REGULATORY SCIENCE CONSORTIUM (D-RSC) DATABASE WHICH WILL BE USED IN THE DEVELOPMENT OF A DMD DISEASE PROGRESSION MODEL AND CLINICAL TRIAL SIMULATION PLATFORM. (2) LAUNCHED THE CATALYSIS FOUNDATION ONLINE DATA REPOSITORY TO PROVIDE A PLATFORM TO MAKE DATASETS FROM A TREATMENT RESPONSE BIOMARKER STUDY OF TB POSITIVE, HIV NEGATIVE PATIENTS AVAILABLE TO QUALIFIED TB RESEARCHERS. (3) LAUNCHED THE FRIEDREICH'S ATAXIA INTEGRATED CLINICAL DATABASE FOR USE BY QUALIFIED RESEARCHERS. (4) RELEASED TB-PACTS VERSION 2.0 CONTAINING DATA FROM 14 NEW TB STUDIES FOR A TOTAL OF 17. THE DUCHENNE REGULATORY SCIENCE CONSORTIUM'S GOAL IS TO SUPPORT COLLABORATIVE RESEARCH AND REGULATORY QUALIFICATION OF NEW DRUG DEVELOPMENT TOOLS FOR DUCHENNE MUSCULAR DYSTROPHY, TO ENABLE THE EARLIEST POSSIBLE PATIENT ACCESS TO NEW TREATMENTS. THEIR ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) ACQUIRED TWELVE DATASETS, AND DATA SHARING AGREEMENTS FOR ADDITIONAL DATASETS ARE UNDERWAY. PRESENTLY, ~1,100 INDIVIDUAL PATIENT RECORDS ARE INCLUDED IN THE D-RSC DATABASE, EXCLUDING DATA FROM A PATIENT REPORTED REGISTRY THAT WILL NOT BE USED FOR ANALYSIS. APPROXIMATELY 4000-5000 DATA-POINTS ARE IN THE DATABASE FOR EACH MEASURE OF INTEREST. PARTS OF THE DATABASE ARE OPEN FOR USE BY CONSORTIUM MEMBERS AND HAVE BEEN USED BY AT LEAST FOUR COMPANY MEMBERS AND BY PPMD IN SUPPORT OF INITIAL ANALYSIS AROUND THE DEVELOPMENT OF THE DUCHENNE PLATFORM TRIAL. (2) PUBLISHED THE CDISC THERAPEUTIC AREA USER GUIDE. (3) DEVELOPMENT OF THE LETTER OF INTENT AND MODELING PLAN ARE UNDERWAY. THE GOAL OF THE ELECTRONIC PATIENT-REPORTED OUTCOME CONSORTIUM IS TO ADVANCE THE SCIENCE OF CLINICAL TRIAL ENDPOINT ASSESSMENT BY COLLABORATIVELY SUPPORTING AND CONDUCTING RESEARCH, DESIGNING AND DELIVERING EDUCATIONAL OPPORTUNITIES, AND DEVELOPING AND DISSEMINATING BEST PRACTICE RECOMMENDATIONS FOR ELECTRONIC COLLECTION OF CLINICAL OUTCOME DATA. THEIR ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) CONTRIBUTED TO EMA'S GOOD CLINICAL PRACTICE INSPECTORS WORKING GROUP (GCP IWG) BY OFFERING THE EPRO CONSORTIUM'S STAKEHOLDER PERSPECTIVE DURING PAST MEETING OF THE GCP IWG ON TOPICS SUCH AS: RESPONSIBILITIES OF EPRO PROVIDERS REGARDING SOURCE DATA, USE OF ELECTRONIC INFORMED CONSENT, AND RESPONSIBILITIES OF EPRO PROVIDERS WHEN COLLECTING ELECTRONIC SIGNATURES. C-PATH LAUNCHED A NEW CONSORTIUM IN PARTNERSHIP WITH CHDI FOUNDATION TO WORK ON DRUG DEVELOPMENT TOOLS FOR HUNTINGTON'S DISEASE. THE ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) RECRUITED 14 INDUSTRY PARTNERS AND 16 SCIENTIFIC ADVISORS. (2) DEVELOPED AND PUBLISHED THE CDISC HD-SPECIFIC THERAPEUTIC AREA USER GUIDE. (3) CREATED A COMPREHENSIVE INVENTORY OF HD CLINICAL DATA SETS AND MODELING AND SIMULATION TOOLS. (4) ACQUIRED THE FIRST TWO DATA SETS, ENROLL-HD, AN ONGOING NATURAL HISTORY STUDY THAT INCLUDES 8000 SUBJECTS, AND TRACK-HD, A COMPLETED OBSERVATIONAL STUDY THAT INVESTIGATED POTENTIAL OUTCOME MEASURES IN OVER 300 SUBJECTS. ACTIVE CONVERSATIONS ARE ONGOING WITH FOUR ADDITIONAL DATA CONTRIBUTORS. (5) LAUNCHED WORKING GROUP ACTIVITIES WITH FOCUS ON CONTEXT-OF-USE, CRITERIA FOR REGULATORY READINESS OF BIOMARKERS, AND AN IMMEDIATE ACTION PLAN TO SEEK REGULATORY FEEDBACK ON CLINICAL OUTCOME ASSESSMENTS CURRENTLY IN DEVELOPMENT.
FORM 990, PART III, LINE 4AAT THE REQUEST OF THE FDA, C-PATH FORMED AN INTERNATIONAL NEONATAL CONSORTIUM (INC). THE PURPOSE OF THE CONSORTIUM IS TO ACCELERATE THE DEVELOPMENT OF SAFE AND EFFECTIVE THERAPIES FOR NEONATES. INC ENGAGES THE GLOBAL NEONATAL COMMUNITY - FAMILIES, NEONATAL NURSES, ACADEMIC SCIENTISTS, REGULATORS, PHARMACEUTICAL INVESTIGATORS, ADVOCACY ORGANIZATIONS, AND FUNDERS - TO FOCUS ON THE NEEDS OF THE NEONATE. THIS PAST YEAR INC'S CLINICAL PHARMACOLOGY WORKGROUP DEVELOPED A WHITE PAPER TO ASSIST REGULATORS IN PREPARING GUIDANCE ON THE CLINICAL PHARMACOLOGY CONSIDERATIONS FOR NEONATES, INCLUDING RECOMMENDATIONS FOR SAFER FORMULATIONS ENCOMPASSING EASE OF ADMINISTRATION. INC'S BRONCHOPULMONARY DYSPLASIA (BPD) WORKGROUP DESCRIBED POTENTIAL ENDPOINTS FOR TRIALS TO EVALUATE TREATMENTS FOR CHRONIC PULMONARY INSUFFICIENCY OF PREMATURITY (CPIP). INC'S SEIZURE WORKGROUP DEVELOPED RECOMMENDATIONS FOR USE IN A MASTER PROTOCOL TO EVALUATE MEDICATIONS TO TREAT NEONATAL SEIZURES. INC'S DATA WORKGROUP REVIEWED THE VALUE AND NEEDS FOR SHARING NEONATAL DATA AND PROPOSED A GLOBAL APPROACH TO COLLECTING, STANDARDIZING, AND SHARING DATA. INC'S CLINICAL PHARMACOLOGY ADVERSE EVENT SUBGROUP COMPLETED DEVELOPMENT OF THE NEONATAL ADVERSE EVENT SEVERITY GRADING SCALE (NAESS) AND HAVE INCORPORATED THE NEW AE TERMINOLOGY INTO THE NATIONAL CANCER INSTITUTE - ENTERPRISE VOCABULARY SERVICES (NCI-EVS) ONLINE THESAURUS. INC SUBMITTED COMMENTS ON THE NOTICE OF PROPOSED RULEMAKING (NPRM) "FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS" TO U.S. HEALTH AND HUMAN SERVICES' OFFICE FOR HUMAN RESEARCH PROTECTIONS AND ALSO SUPPLIED INPUT ON DRUGS AND THERAPEUTIC AREAS THAT REQUIRE FURTHER STUDY IN NEONATES, IN RESPONSE TO NATIONAL INSTITUTE OF CHILD HEALTH AND DEVELOPMENT'S REQUEST FOR INFORMATION ON THE BEST PHARMACEUTICALS FOR CHILDREN ACT PRIORITIES IN PEDIATRIC THERAPEUTICS 2017. THE MULTIPLE SCLEROSIS OUTCOME ASSESSMENTS CONSORTIUM HAS A GOAL TO OBTAIN REGULATORY QUALIFICATION OF AN IMPROVED CLINICAL OUTCOME ASSESSMENT INSTRUMENT AS A PRIMARY OR SECONDARY ENDPOINT IN CLINICAL TRIALS OF MULTIPLE SCLEROSIS (MS) THERAPIES. THEIR ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) EXECUTED THE STATISTICAL ANALYSIS PLAN (FOR A SINGLE MEASURE) DEVELOPED FOR FDA AND SUBMITTED THE FINAL QUALIFICATION PACKAGE. (2) EXECUTED THE STATISTICAL ANALYSIS PLAN (INCLUDING FOUR MEASURES) DEVELOPED FOR EMA AND THE "VOICE OF THE PATIENT" METHODOLOGY AND SUBMITTED THE FINAL QUALIFICATION PACKAGE TO THE EMA. THE POLYCYSTIC KIDNEY DISEASE OUTCOMES CONSORTIUM HAS DEVELOPED AND OBTAINED REGULATORY QUALIFICATION FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND THE EUROPEAN MEDICINES AGENCY (EMA) OF TOTAL KIDNEY VOLUME (TKV) AS A PROGNOSTIC BIOMARKER FOR USE IN CLINICAL TRIALS FOR NEW THERAPIES FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD). THE CONSORTIUM CONTINUES TO EXPLORE ALTERNATE CLINICAL ENDPOINTS, INCLUDING A COMPOSITE ENDPOINT, INNOVATIVE CLINICAL TRIAL DESIGNS, AND REGULATORY PATHWAYS TO HELP EXPEDITE NEW THERAPIES IN PKD. THE FDA HAS COMMUNICATED THAT TKV IS A "REASONABLY LIKELY SURROGATE," WHICH MAKES IT ELIGIBLE FOR AN ACCELERATED APPROVAL PROCESS AT THE FDA. SIX NEW COMPANIES ARE NOW WORKING TO DEVELOP THERAPIES FOR THIS DISEASE. THE FDA APPROVED OTSUKA'S DRUG (JYNARQUETM). THIS IS THE FIRST-EVER FDA-APPROVED TREATMENT FOR PKD. ALTHOUGH IT WAS NOT A DIRECT OUTPUT OF PKDOC, THE CONSORTIUM'S WORK POSITIVELY CONTRIBUTED TO ADVANCES IN THE FIELD CONSISTENT WITH THIS SUCCESS STORY. THE PATIENT-REPORTED OUTCOME CONSORTIUM HAS A GOAL TO ESTABLISH AND MAINTAIN A COLLABORATIVE FRAMEWORK WITH APPROPRIATE STAKEHOLDERS FOR THE QUALIFICATION OF PATIENT-REPORTED OUTCOME (PRO) INSTRUMENTS AND OTHER CLINICAL OUTCOME ASSESSMENT (COA) TOOLS THAT WILL BE MADE AVAILABLE FOR USE IN CLINICAL TRIALS WHERE COA-BASED ENDPOINTS ARE USED TO SUPPORT PRODUCT LABELING CLAIMS. TWO PRO MEASURES WERE QUALIFIED BY FDA FOR EXPLORATORY USE, THE SYMPTOMS OF MAJOR DEPRESSIVE DISORDER SCALE (SMDDS) AND THE NON-SMALL CELL LUNG CANCER SYMPTOM ASSESSMENT QUESTIONNAIRE (NSCLC-SAQ). OTHER PRO MEASURES WHICH HAVE BEEN SUBMITTED TO FDA FOR QUALIFICATION FOR EXPLORATORY USE INCLUDE: (1) THE ASTHMA DAILY SYMPTOM DIARY (ADSD) AND (2) THE FUNCTIONAL DYSPEPSIA SYMPTOM DIARY (FDSD). THE PRO CONSORTIUM HAS ISSUED A TOTAL OF 10 LICENSES FOR USE OF PRO CONSORTIUM MEASURES INCLUDING THE SMDDS, THE NSCLCSAQ, AND THE MYELOFIBROSIS SYMPTOM ASSESSMENT FORM V4.0 (MFSAF V4.0). THE FOLLOWING COAS ARE IN VARIOUS STAGES OF THE DEVELOPMENT AND/OR QUALIFICATION PROCESS: UCSD PERFORMANCE-BASED SKILLS ASSESSMENT FOR MILD COGNITIVE IMPAIRMENT (UPSA-MCI), DIARY FOR IRRITABLE BOWEL SYNDROME SYMPTOMS-C (DIBSS-C) FOR CONSTIPATION PREDOMINANT IBS, DIARY FOR IRRITABLE BOWEL SYNDROME SYMPTOMS-D (DIBSS-D) FOR DIARRHEA PREDOMINANT IBS, DIARY FOR IRRITABLE BOWEL SYNDROME SYMPTOMS-M (DIBSS-M) FOR MIXED IBS, AN OPTIMIZED PROMIS PHYSICAL FUNCTION SHORT FORM FOR MS PATIENTS, PEDIATRIC ASTHMA DIARY - OBSERVER (PAD-O), PEDIATRIC ASTHMA DIARY - CHILD (PAD-C), RHEUMATOID ARTHRITIS WG - PROMIS SHORT FORM V1.0 - FATIGUE 10A. THE PREDICTIVE SAFETY TESTING CONSORTIUM HAS A GOAL TO BRING TOGETHER PHARMACEUTICAL COMPANIES TO SHARE AND VALIDATE INNOVATIVE SAFETY TESTING METHODS UNDER ADVISEMENT OF THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), EUROPEAN MEDICINES AGENCY (EMA), AND JAPAN'S PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA). CURRENTLY PSTC IS FOCUSED ON DEVELOPING AND OBTAINING REGULATORY QUALIFICATION OF IMPROVED CLINICAL SAFETY BIOMARKERS FOR USE IN DRUG DEVELOPMENT. THIS YEAR THE CONSORTIUM'S ACCOMPLISHMENTS INCLUDE: (1) IN COOPERATION WITH THE FDA, LAUNCHED THE PILOT BIOMARKER DATA REPOSITORY (BMDR) PROJECT DESIGNED TO COLLECT AND ANALYZE KIDNEY SAFETY BIOMARKER DATA. (2) RECEIVED A LETTER OF SUPPORT FROM EMA FOR THE USE OF GLUTAMATE DEHYDROGENASE (GLDH), A SPECIFIC BIOMARKER OF DRUG-INDUCED HEPATIC INJURY IN HUMANS. (3) ACHIEVED FDA QUALIFICATION OF A PANEL OF CLINICAL DRUG-INDUCED KIDNEY INJURY BIOMARKERS FOR USE IN PHASE 1 CLINICAL TRIALS. THE TYPE I DIABETES CONSORTIUM (T1D) IS FOCUSING ON QUALIFYING ISLET AUTOIMMUNITY ANTIBODIES AS SUSCEPTIBILITY/RISK BIOMARKERS TO BE USED IN THE DEVELOPMENT OF THERAPIES FOR THE TREATMENT, AND ULTIMATELY, THE PREVENTION, OF TYPE 1 DIABETES. THIS YEAR T1D SECURED THE FOLLOWING DATA SETS AND IS CURRENTLY WORKING TO BUILD AN INTEGRATED DATABASE TO SUPPORT QUALIFICATION: THE COLORADO DIABETES AUTOIMMUNITY STUDY IN THE YOUNG (DAISY), THE ENVIRONMENTAL DETERMINANTS OF DIABETES IN THE YOUNG (TEDDY), TRIALNET NATURAL HISTORY STUDY (TN01-NH), THE GERMAN BABYDIAB AND BABYDIET STUDIES, AND THE DIABETES PREVENTION TRIAL (DPT-1). THE CONSORTIUM SUBMITTED A LETTER OF INTENT TO FDA AND RECEIVED A POSITIVE RESPONSE TO THE LETTER OF INTENT FROM THE FDA AND WAS ASKED TO PROCEED TO THE NEXT STEP IN THE QUALIFICATION PROCESS: THE DEVELOPMENT OF THE QUALIFICATION PLAN. THE CONSORTIUM IS NOW WORKING ON THE DRAFTING OF THE QUALIFICATION PLAN FOCUSING, IN PART, ON THE BUILDING OF AN ASSAY PUBLICATION LIBRARY AND REVIEWING THE ASSAY METHODOLOGY USED FOR ALL DATA TO COMPLETE THE ANALYTICAL CONSIDERATIONS SECTION OF THE DOCUMENT. THE CONSORTIUM HAS INITIATED CONSTRUCTION OF A MODELING ANALYSIS PLAN TO ENABLE THE GENERATION OF THE T1D DISEASE PROGRESSION MODEL REQUIRED TO SUPPORT THE REGULATORY ENDORSEMENT OF THE ISLET AUTOANTIBODIES. THE TRANSPLANTATION THERAPEUTICS CONSORTIUM IS WORKING TO IDENTIFY MECHANISMS AND DRUG DEVELOPMENT TOOLS TO ACCELERATE DRUG DISCOVERY FOR TRANSPLANT PATIENTS, THROUGH THE COLLABORATIVE INVOLVEMENT OF KEY STAKEHOLDERS IN THE FIELD. THE CONSORTIUM IS INITIALLY FOCUSING ON KIDNEY TRANSPLANT BUT MAY EXPAND TO OTHER SOLID ORGAN TRANSPLANTS IN THE FUTURE. THIS YEAR THE TTC INITIATED TWO WORKGROUPS, THE ENDPOINTS AND BIOMARKERS WORKGROUP, AND THE DRUG SAFETY PROFILE CHARACTERIZATION AND LABELING WORKGROUP. THE INITIAL FOCUS OF THE CONSORTIUM IS TO SEEK FDA ENDORSEMENT FOR A QUANTITATIVE DRUG DEVELOPMENT TOOL CAPABLE OF OPTIMIZING CLINICAL TRIAL DESIGNS IN KIDNEY TRANSPLANTATION, BY INFORMING SPONSOR DECISION MAKING REGARDING CLINICAL TRIAL DESIGN, SIZE, AND DURATION, OPTIMIZE DOSING STRATEGIES, PREDICT SAFETY SIGNALS, SUPPORT EVIDENCE OF EFFECTIVENESS, AND ENDPOINT SELECTION. THROUGH FDA'S BROAD AGENCY ANNOUNCEMENT PROCEDURE, TTC RECEIVED FUNDING TO SUPPORT THE INITIAL FOCUS AREA OF DEVELOPING A MODEL.
FORM 990, PART VI, SECTION A, LINE 2MIKE KASSER AND JEFF JACOB HAVE A BUSINESS RELATIONSHIP. PETER HUTT AND JEFF JACOB HAVE A BUSINESS RELATIONSHIP. WAIN FISHBURN AND JEFF JACOB HAVE A BUSINESS RELATIONSHIP. JEFF JACOB AND SHAUN KIRKPATRICK HAVE A BUSINESS RELATIONSHIP.
FORM 990, PART VI, SECTION B, LINE 11BFORM 990 IS PREPARED BY AN EXTERNAL CPA FIRM USING INFORMATION PROVIDED BY THE ORGANIZATION. THE FORM IS REVIEWED BY THE ORGANIZATION'S COMPTROLLER, COO, PRESIDENT/CEO, THE BOARD AUDIT, FINANCE, AND RISK COMMITTEE, AND THE BOARD OF DIRECTORS PRIOR TO BEING FINALIZED.
FORM 990, PART VI, SECTION B, LINE 12CALL MEMBERS OF THE BOARD OF DIRECTORS AND ALL OFFICERS OF THE ORGANIZATION ARE REQUIRED TO FILL OUT A CONFLICT OF INTEREST FORM ANNUALLY. THE RESULTS ARE COMPILED AND REVIEWED BY THE BOARD'S AUDIT, FINANCE, AND RISK COMMITTEE. ANY ACTUAL OR PERCEIVED CONFLICTS THAT HAVE THE POTENTIAL TO BIAS ANY DISCUSSIONS OR DECISIONS BY THE BOARD ARE DISCUSSED BY THE BOARD. ANY DIRECTOR WITH A REAL OR POTENTIAL CONFLICT WILL RECUSE THEMSELVES FROM ANY DISCUSSION OR DECISION WHERE THE CONFLICT HAS A BEARING.
FORM 990, PART VI, SECTION B, LINE 15A BOARD OF DIRECTORS COMPENSATION COMMITTEE MEETS AND REVIEWS EXECUTIVE COMPENSATION ANNUALLY. EVERY FEW YEARS THE COMMITTEE SEEKS AN INDEPENDENT COMPENSATION CONSULTING ORGANIZATION. AFTER THE CONSULTING ORGANIZATION HAS BEEN RETAINED, THE COMPENSATION COMMITTEE RECEIVES THE CONSULTANT'S EXECUTIVE COMPENSATION REVIEWS AND RECOMMENDATIONS. THIS INFORMATION IS THEN USED AS A BASIS FOR THE COMPENSATION COMMITTEE'S RECOMMENDATION TO THE BOARD OF DIRECTORS. THE LAST INDEPENDENT COMPENSATION SURVEY WAS CONDUCTED FOR THE CEO IN AUGUST 2011. THE CEO'S SALARY HAS REMAINED CONSTANT SINCE THE TIME OF HER HIRE. AN OVERALL SALARY PROGRAM FOR EMPLOYEES, WHICH IS DEVELOPED BASED ON SALARY SURVEY INFORMATION, MUST BE APPROVED BY THE BOARD OF DIRECTORS COMPENSATION COMMITTEE BEFORE IMPLEMENTATION. ALL EMPLOYEE SALARY INCREASES MUST BE APPROVED BY THE PRESIDENT/CEO.
FORM 990, PART VI, SECTION C, LINE 19ARTICLES OF INCORPORATION CAN BE FOUND ON THE ARIZONA CORPORATION COMMISSION WEBSITE. THE CONFLICT OF INTEREST POLICY AND THE FINANCIAL STATEMENTS (VIA THE ANNUAL REPORT) ARE POSTED ON THE INSTITUTE'S WEBSITE.
FORM 990, PART IX, LINE 11GRESEARCH SUPPORT SERVICES: PROGRAM SERVICE EXPENSES 1,404,700. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,404,700. CONSULTING: PROGRAM SERVICE EXPENSES 836,851. MANAGEMENT AND GENERAL EXPENSES 68,397. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 905,248. OTHER PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 118,245. MANAGEMENT AND GENERAL EXPENSES 7,976. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 126,221.

Schedule R IRS990ScheduleR

Id Related Tax Exempt Org IdRelatedTaxExemptOrgGrp (3 entries)

Address Line1USAddress/AddressLine1TxtCityUSAddress/CityNmState AbbreviationUSAddress/StateAbbreviationCdZIPUSAddress/ZIPCdEINEINPrimary ActivitiesPrimaryActivitiesTxtLegal Domicile StateLegalDomicileStateCdExempt Code SectionExemptCodeSectionTxtPublic Charity StatusPublicCharityStatusTxtBusiness Name Line1DirectControllingEntityName/BusinessNameLine1TxtControlled OrganizationControlledOrganizationIndAddress Line1ForeignAddress/AddressLine1TxtCityForeignAddress/CityNmCountryForeignAddress/CountryCdForeign PostalForeignAddress/ForeignPostalCdLegal Domicile Foreign CountryLegalDomicileForeignCountryCd
CRITICAL PATH FOUNDATION
1730 EAST RIVER ROAD SUITE 200TUCSONAZ85718204780896RAISING AND CONTRIBUTING FUNDS TO CRITICAL PATH INSTITUTEAZ501(C)(3)LINE 11CRITICAL PATH INSTITUTEYes (1)
CRITICAL PATH GLOBAL LTD
FACILITATE WORK WITH EUROPEAN MEDICINES AGENCYCRITICAL PATH INSTITUTEYes (1)20-22 BEDFORD ROWLONDONUKWC1R 4JSUK
CRITICAL PATH INSTITUTE LTD
FACILITATE WORK WITH EUROPEAN MEDICINES AGENCYCRITICAL PATH INSTITUTEYes (1)33 SIR JOHN ROGERSONS QUAYDUBLINEI2EI
FieldValueIRS element (for citing)
Receipt Of Int Annts Rnts Rylts0ReceiptOfIntAnntsRntsRyltsInd
Gift Grnt Or Cap Contri To Oth Org0GiftGrntOrCapContriToOthOrgInd
Gift Grnt Cap Contri From Oth Org0GiftGrntCapContriFromOthOrgInd
Loans Or Guarantees To Other Org0LoansOrGuaranteesToOtherOrgInd
Loans Or Guarantees From Oth Org0LoansOrGuaranteesFromOthOrgInd
Div Related Organization0DivRelatedOrganizationInd
Asset Sale To Other Org0AssetSaleToOtherOrgInd
Asset Purchase From Other Org0AssetPurchaseFromOtherOrgInd
Asset Exchange0AssetExchangeInd
Rental Of Facilities To Oth Org0RentalOfFacilitiesToOthOrgInd
Rental Of Fclts From Oth Org0RentalOfFcltsFromOthOrgInd
Perform Of Services For Oth Org0PerformOfServicesForOthOrgInd
Perform Of Services By Other Org0PerformOfServicesByOtherOrgInd
Sharing Of FacilitiesYes (1)SharingOfFacilitiesInd
Paid Employees SharingYes (1)PaidEmployeesSharingInd
Reimbursement Paid To Other Org0ReimbursementPaidToOtherOrgInd
Reimbursement Paid By Other Org0ReimbursementPaidByOtherOrgInd
Transfer To Other Org0TransferToOtherOrgInd
Transfer From Other Org0TransferFromOtherOrgInd