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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. 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. 4) THE CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM (CDISC) STANDARD FOR PARKINSON'S DISEASE HAS BEEN DEVELOPED AND PUBLISHED AND IS AVAILABLE FOR USE. 5) 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. 6) 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. 7) AN EFFORT HAS BEGUN TO DEVELOP 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 HAVE SUBMITTED BRIEFING DOSSIERS TO THE FDA THAT INCLUDE THEIR QUALITATIVE RESEARCH AND A DRAFT INSTRUMENT: COGNITION, IRRITABLE BOWEL SYNDROME, ASTHMA, AND DEPRESSION. TWO WORKING GROUPS, NON-SMALL CELL LUNG CANCER AND FUNCTIONAL DYSPEPSIA, HAVE SUBMITTED BRIEFING DOSSIERS TO THE FDA THAT INCLUDE THE RESULTS OF THEIR CONCEPT ELICITATION, THE PROTOCOL, AND THEIR STUDY DOCUMENTS, AS PART OF THE CONSULTATION AND ADVICE STAGE. RHEUMATOID ARTHRITIS IS COMPLETING THEIR GAP ANALYSIS AND LITERATURE REVIEW.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 NEPHROTOXICITY WORKING GROUP HAS SUBMITTED TWO IMPORTANT BRIEFING PACKAGES TO THE FDA AND EMA: ONE ON KIDNEY CLINICAL SAFETY BIOMARKERS WITH THE LEARNING-PHASE DATA FROM THE HEALTHY VOLUNTEER STUDY AND THE OTHER ON KIDNEY RODENT SAFETY BIOMARKERS FOR A FINAL EVALUATION. STUDIES TO MONITOR THE BIOMARKERS' PERFORMANCE IN PATIENTS WHO ARE ALREADY BEING MONITORED DUE TO NECESSARY TREATMENT WITH POTENTIALLY TOXIC THERAPIES ARE IN PROGRESS 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 NEARLY READY TO SUBMIT THEIR RESULTS IN A FINAL BRIEFING PACKAGE. WORK IS ALSO UNDERWAY TO ASSESS THE VALUE OF PRECLINICAL BIOMARKERS TO DETECT DRUG INDUCED INJURY IN THE 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. WORK IS UNDERWAY TO DEVELOP A HOLLOW FIBER MODEL FOR USE TO SELECT DRUG REGIMENS, AND INFORM DOSING DECISIONS. A NEW EFFORT WAS LAUNCHED THIS YEAR TO HELP DEVELOP A RAPID DRUG SENSITIVITY TEST TO AID IN INFORMING APPROPRIATE TREATMENT DECISIONS FOR PATIENTS THAT HAVE DRUG RESISTANT FORMS OF TB. 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. BOTH AGENCIES ASKED FOR SOME ADDITIONAL DATA AND REQUESTED THAT THE FINAL PACKAGE BE SUBMITTED. 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        <NamePerson>PETER B CORR MD PHD</NamePerson>
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          <AddressUS>
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      <FeesForServicesAccounting>
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        <ManagementAndGeneral>4644</ManagementAndGeneral>
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      <OtherExpenses>
        <Description>DUES AND SUBSCRIPTIONS</Description>
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      <OtherExpenses>
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        <BOY>27141</BOY>
        <EOY>15471</EOY>
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        <EOY>8716861</EOY>
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        <EOY>5205240</EOY>
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        <BOY>157298</BOY>
        <EOY>54495</EOY>
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        <EOY>3511621</EOY>
      </TotalNetAssetsFundBalances>
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        <EOY>8716861</EOY>
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        <FinancialStatementSeparate>X</FinancialStatementSeparate>
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      <FederalGrantAuditPerformed>1</FederalGrantAuditPerformed>
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        <CurrentTaxYearMinus3Years>5617050</CurrentTaxYearMinus3Years>
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        <CurrentTaxYearMinus1Year>7998908</CurrentTaxYearMinus1Year>
        <CurrentTaxYear>5915630</CurrentTaxYear>
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        <CurrentTaxYearMinus4Years>5016728</CurrentTaxYearMinus4Years>
        <CurrentTaxYearMinus3Years>5617050</CurrentTaxYearMinus3Years>
        <CurrentTaxYearMinus2Years>7857830</CurrentTaxYearMinus2Years>
        <CurrentTaxYearMinus1Year>7998908</CurrentTaxYearMinus1Year>
        <CurrentTaxYear>5915630</CurrentTaxYear>
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        <CurrentTaxYearMinus1Year>22660</CurrentTaxYearMinus1Year>
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        <CurrentTaxYearMinus1Year>20745</CurrentTaxYearMinus1Year>
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        <NamePerson>ESLIE DENNIS MD</NamePerson>
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        <NamePerson>STEPHEN COONS PHD</NamePerson>
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        <NamePerson>DIANE STEPHENSON PHD</NamePerson>
        <Title>ED, CAMD CONSORTIUM</Title>
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        <NamePerson>DEBRA HANNA PHD</NamePerson>
        <Title>ED, CPTR CONSORTIUM</Title>
        <BaseCompensationFilingOrg>148918</BaseCompensationFilingOrg>
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      <Form990ScheduleJPartIII>
        <ReturnReference>PART I, LINE 1B</ReturnReference>
        <Explanation>HEALTH CLUB DUES WERE PROVIDED TO THE PRESIDENT/CEO. THERE WAS NOT A SPECIFIC WRITTEN POLICY FOR THIS, BUT WAS IN ACCORDANCE WITH INSTRUCTIONS FROM THE BOARD OF DIRECTORS.</Explanation>
      </Form990ScheduleJPartIII>
      <Form990ScheduleJPartIII>
        <ReturnReference>PART I, LINE 4A</ReturnReference>
        <Explanation>CAROLYN COMPTON RECEIVED A PAYMENT OF $225,000 UNDER THE TERMS OF HER SEVERANCE AGREEMENT.</Explanation>
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    <IRS990ScheduleO documentId="RetDoc1044400001">
      <GeneralExplanation>
        <ReturnReference>FORM 990, PART VI, SECTION A, LINE 8B</ReturnReference>
        <Explanation>THERE ARE NO COMMITTEES WITH AUTHORITY TO ACT ON BEHALF OF THE GOVERNING BODY.</Explanation>
      </GeneralExplanation>
      <GeneralExplanation>
        <ReturnReference>FORM 990, PART VI, SECTION B, LINE 11</ReturnReference>
        <Explanation>FORM 990 IS PREPARED BY AN EXTERNAL CPA FIRM USING INFORMATION PROVIDED BY THE ORGANIZATION. THE FORM IS REVIEWED BY THE ORGANIZATION'S ACCOUNTING ASSOCIATE, COO, PRESIDENT/CEO, AND ANOTHER OUTSIDE CPA PRIOR TO BEING FINALIZED.</Explanation>
      </GeneralExplanation>
      <GeneralExplanation>
        <ReturnReference>FORM 990, PART VI, SECTION B, LINE 12C</ReturnReference>
        <Explanation>OFFICERS AND DIRECTORS MUST FILL OUT CONFLICT OF INTEREST DISCLOSURES ANNUALLY. EMPLOYEES COMPLETE THE CONFLICT OF INTEREST FORM UPON HIRING AND UPDATE THE DOCUMENT AS NEEDED. EMPLOYEES ARE REMINDED ANNUALLY TO REVIEW THEIR STATUS. THESE DISCLOSURES ARE REVIEWED BY THE PRESIDENT/CEO AND THE COO.</Explanation>
      </GeneralExplanation>
      <GeneralExplanation>
        <ReturnReference>FORM 990, PART VI, SECTION B, LINE 15</ReturnReference>
        <Explanation>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.</Explanation>
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      <GeneralExplanation>
        <ReturnReference>FORM 990, PART VI, SECTION C, LINE 19</ReturnReference>
        <Explanation>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.</Explanation>
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      <GeneralExplanation>
        <Identifier>OTHER FEES</Identifier>
        <ReturnReference>FORM 990, PART IX, LINE 11G</ReturnReference>
        <Explanation>RESEARCH SUPPORT SERVICES: PROGRAM SERVICE EXPENSES 1,980,305. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,980,305. CONSULTING: PROGRAM SERVICE EXPENSES 339,727. MANAGEMENT AND GENERAL EXPENSES 19,798. FUNDRAISING EXPENSES 450. TOTAL EXPENSES 359,975. OTHER PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 188,338. MANAGEMENT AND GENERAL EXPENSES 83,554. FUNDRAISING EXPENSES 1,899. TOTAL EXPENSES 273,791.</Explanation>
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        <NameOfDisregardedEntity>
          <BusinessNameLine1>THE CRITICAL PATH FOUNDATION</BusinessNameLine1>
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        <AddressUS>
          <AddressLine1>1730 EAST RIVER ROAD SUITE 200</AddressLine1>
          <City>TUCSON</City>
          <State>AZ</State>
          <ZIPCode>85718</ZIPCode>
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        <PrimaryActivities>RAISING AND CONTRIBUTING FUNDS TO CRITICAL PATH INSTITUTE</PrimaryActivities>
        <LegalDomicileState>AZ</LegalDomicileState>
        <ExemptCodeSection>501(C)(3)</ExemptCodeSection>
        <PublicCharityStatus>11</PublicCharityStatus>
        <DirectControllingEntityName>
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          <AddressLine1>1730 EAST RIVER ROAD SUITE 200</AddressLine1>
          <City>TUCSON</City>
          <State>AZ</State>
          <ZIPCode>85718</ZIPCode>
        </AddressUS>
        <PrimaryActivities>FACILITATE WORK WITH EUROPEAN MEDICINES AGENCY</PrimaryActivities>
        <LegalDomicileForeignCountry>UK</LegalDomicileForeignCountry>
        <DirectControllingEntityName>
          <BusinessNameLine1>CRITICAL PATH INSTITUTE</BusinessNameLine1>
        </DirectControllingEntityName>
        <ControlledOrg>1</ControlledOrg>
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      <GiftGrantOrCapContrToOtherOrg>0</GiftGrantOrCapContrToOtherOrg>
      <GiftGrantOrCapContrFrOtherOrg>0</GiftGrantOrCapContrFrOtherOrg>
      <LoansOrGuaranteesToOtherOrg>0</LoansOrGuaranteesToOtherOrg>
      <LoansOrGuaranteesFromOtherOrg>0</LoansOrGuaranteesFromOtherOrg>
      <DividendsRelatedOrganization>0</DividendsRelatedOrganization>
      <SaleOfAssetsToOtherOrg>0</SaleOfAssetsToOtherOrg>
      <PurchaseOfAssetsFromOtherOrg>0</PurchaseOfAssetsFromOtherOrg>
      <ExchangeOfAssets>0</ExchangeOfAssets>
      <RentalOfFacilitiesToOtherOrgs>0</RentalOfFacilitiesToOtherOrgs>
      <RentalOfFacilitiesFrOtherOrgs>0</RentalOfFacilitiesFrOtherOrgs>
      <PerformOfServicesForOtherOrgs>0</PerformOfServicesForOtherOrgs>
      <PerformOfServicesByOtherOrgs>0</PerformOfServicesByOtherOrgs>
      <SharingOfFacilities>1</SharingOfFacilities>
      <SharingOfPaidEmployees>1</SharingOfPaidEmployees>
      <ReimbursementPaidToOtherOrg>0</ReimbursementPaidToOtherOrg>
      <ReimbursementPaidByOtherOrg>0</ReimbursementPaidByOtherOrg>
      <OtherTransferToOtherOrg>0</OtherTransferToOtherOrg>
      <OtherTransferFromOtherOrg>0</OtherTransferFromOtherOrg>
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  </ReturnData>
</Return>