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      <Desc>THE CRITICAL PATH INSTITUTE (C-PATH) IS AN INDEPENDENT, NON-PROFIT ORGANIZATION UNIQUELY DEDICATED TO IMPLEMENTING THE FDA'S CRITICAL PATH INITIATIVE BY CREATING COLLABORATIONS AMONG REGULATORS (SCIENTISTS FROM THE FDA AND EMA) THE REGULATED (MEDICAL PRODUCT INDUSTRY), ACADEMIA, PATIENTS ORGANIZATIONS, AND OTHER ORGANIZATIONS THAT RESULT IN ACCELERATED DEVELOPMENT OF SAFE, NEW MEDICAL PRODUCTS, AND SERVES AS A RESOURCE TO CONGRESS. THE ACCOMPLISHMENTS FOR THIS FISCAL YEAR REPORT INCLUDE:THE COALITION AGAINST MAJOR DISEASES (CAMD) DEVELOPS TOOLS AND PROCESSES TO ACCELERATE PROGRESS IN THE PREVENTION, TREATMENT AND CURE OF MAJOR NEURODEGENERATIVE DISEASES, INITIALLY FOCUSING ON ALZHEIMER'S AND PARKINSON'S DISEASES. ACCOMPLISHMENTS INCLUDE: 1) A PUBLIC DATABASE OF ALZHEIMER'S DISEASE CLINICAL TRIALS CONTINUES TO GROW IN SIZE AND USE. DATA FROM TWENTY FOUR CLINICAL TRIALS OF MEMBER COMPANIES COMPRISING 6,500 PATIENTS HAVE BEEN REMAPPED INTO THE NEW DATA STANDARD. THE DATABASE IS BEING USED BY NEARLY 250 SCIENTISTS FROM AROUND THE WORLD. 2) A DISEASE PROGRESSION MODEL CREATED FROM USE OF THE DATA FROM THE DATABASE, AND DATA FROM THE ALZHEIMER'S DISEASE NEUROIMAGING INITIATIVE STUDIES. THE MODEL, ALONG WITH A SIMULATION INFRASTRUCTURE, HAS BEEN FORMALLY ENDORSED BY THE FDA AND EMA FOR USE IN DESIGNING CLINICAL TRIALS FOR ALZHEIMER'S DISEASE. 3) A SERIES OF CEREBRAL SPINAL FLUID (CSF) AND HIPPOCAMPAL IMAGING BIOMARKERS WHICH HAVE BEEN STUDIED FOR USE IN IDENTIFYING EARLY SYMPTOMATIC PATIENTS WITH A HIGH LIKELIHOOD OF PROGRESSION TO DEMENTIA IN A SHORT PERIOD OF TIME. SUCH PATIENTS WOULD BE INCLUDED IN CLINICAL TRIALS OF THERAPIES FOR ALZHEIMER'S DISEASE. 4) LOW HIPPOCAMPAL VOLUME HAS BEEN QUALIFIED BY THE EUROPEAN MEDICINES AGENCY (EMA), AND A RESEARCH PLAN FOR BOTH SETS OF BIOMARKERS HAS BEEN SUBMITTED TO THE FDA. CAMD MEMBERS HAVE MET WITH AND RECEIVED FEEDBACK FROM THE FDA, HAVE RESPONDED TO THEIR QUESTIONS AND ARE NOW EXECUTING THE RESEARCH PLAN. 5) THE CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM (CDISC) STANDARD FOR PARKINSON'S DISEASE HAS BEEN DEVELOPED AND PUBLISHED AND IS AVAILABLE FOR USE. 6) AN UPDATED VERSION OF THE ALZHEIMER'S DISEASE CDISC STANDARD WAS DEVELOPED TO INCLUDE DATA ELEMENTS FOR PRE-DEMENTIA, ADDITIONAL COGNITIVE SCALES, AND ADDITIONAL BIOMARKERS. 7) A BRIEFING PACKAGE FOR SPECT IMAGING OF DOPAMINE TRANSPORT ACTIVITY FOR USE AS A CLINICAL TRIAL ENRICHMENT CRITERION FOR PARKINSON'S DISEASE HAS BEEN SUBMITTED TO THE FDA FOR ADVICE. 8) A BRIEFING PACKAGE HAS BEEN SUBMITTED IN THE PROCESS OF DEVELOPING AND QUALIFYING AN IMPROVED CLINICAL OUTCOME ASSESSMENT INSTRUMENT FOR EARLY STAGES OF ALZHEIMER'S DISEASE.THE PATIENT-REPORTED OUTCOME CONSORTIUM (PRO) WAS CREATED TO IDENTIFY AND PRIORITIZE THE MEDICAL PRODUCT DEVELOPMENT AREAS WHERE PRO INSTRUMENTS ARE NEEDED, AS WELL AS TO SUBMIT QUALIFICATION DOSSIERS TO REGULATORY AGENCIES FOR QUALIFICATION OF PRO INSTRUMENTS FOR USE IN REGULATORY AND DRUG DEVELOPMENT DECISION MAKING. THE FOLLOWING WORKING GROUPS ARE IN THE PROCESS OF DEFINING PLANS AND ADJUSTING BUDGETS FOR ITS QUANTITATIVE PILOT STUDY: ASTHMA WORKING GROUP, DEPRESSION WORKING GROUP, AND IRRITABLE BOWEL SYNDROME WORKING GROUP. TWO WORKING GROUPS, FUNCTIONAL DYSPEPSIA AND NON-SMALL CELL LUNG CANCER ARE CONTINUING THE WORK TO COMPLETE THE QUALITATIVE RESEARCH PHASE OF EACH PROJECT. THE COGNITION WORKING GROUP IS ABOUT TO BEGIN ITS WORK ON THE NEXT PHASE TO FURTHER DEVELOP, REFINE, AND EVALUATE THE DRAFT TO SUPPORT THE REGULATORY QUALIFICATION PROCESS. THE RHEUMATOID ARTHRITIS WORKING GROUP AWAITS THE RESULTS OF THE LITERATURE REVIEW CONDUCTED BY OMERACT IN ORDER TO INFORM ITS NEXT STEP OF THE PROJECT.THE PREDICTIVE SAFETY TESTING CONSORTIUM (PSTC) COMPILES, GENERATES, AND SUBMITS FOR REGULATORY REVIEW DATA ON NEW SAFETY BIOMARKERS TO BE USED IN DRUG DEVELOPMENT, THUS ADVANCING THE DRUG SAFETY ASSESSMENT PROCESS. THE FDA AND EMA HAVE ISSUED "LETTERS OF SUPPORT" ON THE KIDNEY SAFETY BIOMARKERS TO ENCOURAGE THEIR USE AND DATA COLLECTION FOR ULTIMATE CLINICAL QUALIFICATION. STUDIES ARE ONGOING TO MONITOR THE BIOMARKERS' PERFORMANCE IN PATIENTS WHO ARE ALREADY BEING MONITORED DUE TO NECESSARY TREATMENT WITH POTENTIALLY TOXIC THERAPIES AND ARE BEING RUN IN CONJUNCTION WITH THE FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH. THE SKELETAL MUSCLE WORKING GROUP HAS COMPLETED THEIR RESEARCH AND EVALUATION AND IS PREPARING TO PRESENT THEIR INFORMATION TO THE FDA TO GARNER A LETTER OF SUPPORT. WORK IS ALSO UNDERWAY TO ASSESS THE VALUE OF PRECLINICAL BIOMARKERS TO DETECT DRUG INDUCED INJURY IN THE LIVER, VASCULAR AND TESTICULAR SYSTEMS, AND DRUG INDUCED CARDIAC HYPERTROPHY.THE CRITICAL PATH TO TB REGIMENS (CPTR) IS A COLLABORATION WITH THE BILL AND MELINDA GATES FOUNDATION AND THE GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT. THE GOAL OF THIS COLLABORATION IS TO SIGNIFICANTLY SPEED DEVELOPMENT OF INNOVATIVE TREATMENT REGIMENS FOR TUBERCULOSIS. THE BIOMARKER AND CLINICAL ENDPOINT WORKING GROUP MET WITH THE FDA, AND WITH FDA'S SUPPORT AND ENCOURAGEMENT, ARE WORKING TO INCLUDE THE USE OF QUANTITATIVE LIQUID CULTURE RESULTS FOR DETERMINING TREATMENT SUCCESS OR FAILURE IN THE TB THERAPY DEVELOPMENT GUIDANCE. THE EMA SAWP HAS ISSUED A POSITIVE OPINION ABOUT A HOLLOW FIBER MODEL FOR USE TO SELECT DRUG REGIMENS, AND INFORM DOSING DECISIONS. WORK IS ONGOING TO HELP DEVELOP A RAPID DRUG SENSITIVITY TEST TO AID IN INFORMING APPROPRIATE TREATMENT DECISIONS FOR PATIENTS THAT HAVE DRUG RESISTANT FORMS OF TB. SEVERAL NEW TB MODELING EFFORTS WERE LAUNCHED THIS YEAR FROM A PHYSIOLOGICALLY-BASED PHARMACODYNAMIC MODEL TO A POPULATION-BASED DISEASE PROGRESSION MODEL TO AID IN THE UNDERSTANDING THE DISEASE AND FACILITATE THE DESIGN OF NEW CLINICAL TRIALS.A PARTNERSHIP WITH THE POLYCYSTIC KIDNEY DISEASE (PKD) FOUNDATION TO QUALIFY TOTAL KIDNEY VOLUME AS A PROGNOSTIC BIOMARKER FOR PKD HAS MADE SIGNIFICANT PROGRESS. THE CDISC DATA STANDARD IS COMPLETE WHICH HAS ENABLED A DATABASE TO BE CREATED FROM REGISTRY DATA FROM THREE ACADEMIC INSTITUTIONS AND TWO NIH STUDIES. IT CONTAINS LONGITUDINAL DATA ON OVER 3300 PKD PATIENTS. THE DATA HAS BEEN ANALYZED AND A BRIEFING PACKAGE WAS SUBMITTED TO BOTH THE FDA AND EMA. FINAL QUALIFICATION PACKAGES HAVE BEEN SUBMITTED TO THE FDA AND EMA AND THE CONSORTIUM IS WAITING FOR FINAL APPROVAL. THE MULTIPLE SCLEROSIS OUTCOME ASSESSMENT CONSORTIUM COLLABORATION HAS DEVELOPED AND PUBLISHED A NEW CDISC DATA STANDARD FOR MS AND HAVE CREATED AN MS DATABASE. 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        <FormAndLineReferenceDesc>FORM 990, PART VI, SECTION B, LINE 15</FormAndLineReferenceDesc>
        <ExplanationTxt>A 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. AN OVERALL SALARY PROGRAM FOR EMPLOYEES MUST BE APPROVED BY THE BOARD OF DIRECTORS BEFORE IMPLEMENTATION. ALL EMPLOYEE SALARY INCREASES MUST BE APPROVED BY THE PRESIDENT/CEO. THE LAST INDEPENDENT COMPENSATION SURVEY WAS CONDUCTED FOR THE CEO IN AUGUST 2011.</ExplanationTxt>
      </SupplementalInformationDetail>
      <SupplementalInformationDetail>
        <FormAndLineReferenceDesc>FORM 990, PART VI, SECTION C, LINE 19</FormAndLineReferenceDesc>
        <ExplanationTxt>ARTICLES 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.</ExplanationTxt>
      </SupplementalInformationDetail>
      <SupplementalInformationDetail>
        <FormAndLineReferenceDesc>FORM 990, PART IX, LINE 11G</FormAndLineReferenceDesc>
        <ExplanationTxt>RESEARCH SUPPORT SERVICES: PROGRAM SERVICE EXPENSES 1,359,518. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,359,518. CONSULTING: PROGRAM SERVICE EXPENSES 573,668. MANAGEMENT AND GENERAL EXPENSES 39,563. FUNDRAISING EXPENSES 36,504. TOTAL EXPENSES 649,735. OTHER PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 54,007. MANAGEMENT AND GENERAL EXPENSES 5,848. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 59,855.</ExplanationTxt>
      </SupplementalInformationDetail>
    </IRS990ScheduleO>
    <IRS990ScheduleR documentId="RetDoc1043400001">
      <IdRelatedTaxExemptOrgGrp>
        <DisregardedEntityName>
          <BusinessNameLine1>THE CRITICAL PATH FOUNDATION</BusinessNameLine1>
        </DisregardedEntityName>
        <USAddress>
          <AddressLine1>1730 EAST RIVER ROAD SUITE 200</AddressLine1>
          <City>TUCSON</City>
          <State>AZ</State>
          <ZIPCode>85718</ZIPCode>
        </USAddress>
        <EIN>204780896</EIN>
        <PrimaryActivitiesTxt>RAISING AND CONTRIBUTING FUNDS TO CRITICAL PATH INSTITUTE</PrimaryActivitiesTxt>
        <LegalDomicileStateCd>AZ</LegalDomicileStateCd>
        <ExemptCodeSectionTxt>501(C)(3)</ExemptCodeSectionTxt>
        <PublicCharityStatusTxt>11</PublicCharityStatusTxt>
        <DirectControllingEntityName>
          <BusinessNameLine1>CRITICAL PATH INSTITUTE</BusinessNameLine1>
        </DirectControllingEntityName>
        <ControlledOrganizationInd>1</ControlledOrganizationInd>
      </IdRelatedTaxExemptOrgGrp>
      <IdRelatedTaxExemptOrgGrp>
        <DisregardedEntityName>
          <BusinessNameLine1>CRITICAL PATH GLOBAL LTD</BusinessNameLine1>
        </DisregardedEntityName>
        <ForeignAddress>
          <AddressLine1>20-22 BEDFORD ROW</AddressLine1>
          <City>LONDON</City>
          <Country>UK</Country>
          <PostalCode>WC1R 4JS</PostalCode>
        </ForeignAddress>
        <PrimaryActivitiesTxt>FACILITATE WORK WITH EUROPEAN MEDICINES AGENCY</PrimaryActivitiesTxt>
        <LegalDomicileForeignCountryCd>UK</LegalDomicileForeignCountryCd>
        <DirectControllingEntityName>
          <BusinessNameLine1>CRITICAL PATH INSTITUTE</BusinessNameLine1>
        </DirectControllingEntityName>
        <ControlledOrganizationInd>1</ControlledOrganizationInd>
      </IdRelatedTaxExemptOrgGrp>
      <ReceiptOfIntAnntsRntsRyltsInd>0</ReceiptOfIntAnntsRntsRyltsInd>
      <GiftGrntOrCapContriToOthOrgInd>0</GiftGrntOrCapContriToOthOrgInd>
      <GiftGrntCapContriFromOthOrgInd>0</GiftGrntCapContriFromOthOrgInd>
      <LoansOrGuaranteesToOtherOrgInd>0</LoansOrGuaranteesToOtherOrgInd>
      <LoansOrGuaranteesFromOthOrgInd>0</LoansOrGuaranteesFromOthOrgInd>
      <DivRelatedOrganizationInd>0</DivRelatedOrganizationInd>
      <AssetSaleToOtherOrgInd>0</AssetSaleToOtherOrgInd>
      <AssetPurchaseFromOtherOrgInd>0</AssetPurchaseFromOtherOrgInd>
      <AssetExchangeInd>0</AssetExchangeInd>
      <RentalOfFacilitiesToOthOrgInd>0</RentalOfFacilitiesToOthOrgInd>
      <RentalOfFcltsFromOthOrgInd>0</RentalOfFcltsFromOthOrgInd>
      <PerformOfServicesForOthOrgInd>0</PerformOfServicesForOthOrgInd>
      <PerformOfServicesByOtherOrgInd>0</PerformOfServicesByOtherOrgInd>
      <SharingOfFacilitiesInd>1</SharingOfFacilitiesInd>
      <PaidEmployeesSharingInd>1</PaidEmployeesSharingInd>
      <ReimbursementPaidToOtherOrgInd>0</ReimbursementPaidToOtherOrgInd>
      <ReimbursementPaidByOtherOrgInd>0</ReimbursementPaidByOtherOrgInd>
      <TransferToOtherOrgInd>0</TransferToOtherOrgInd>
      <TransferFromOtherOrgInd>0</TransferFromOtherOrgInd>
    </IRS990ScheduleR>
  </ReturnData>
</Return>