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TRANSCELERATE BIOPHARMA INC: Form 990, tax year 2020

View the entire original 990 at ProPublica ↗

Organization
TRANSCELERATE BIOPHARMA INC (EIN 46-0886344)
Tax period
2020-01-01 to 2020-12-31
Filed
2021-05-13
IRS object ID
202141339349301774
Schema version
2020v4.1
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)
Return2021-05-13T11:02:00-05:00ReturnTs
Tax Period End2020-12-31TaxPeriodEndDt

Preparer Firm PreparerFirmGrp

FieldValueIRS element (for citing)
Preparer Firm EIN131639826PreparerFirmEIN

Preparer Firm Name PreparerFirmName

FieldValueIRS element (for citing)
Business Name Line1EISNERAMPER LLPBusinessNameLine1Txt

Preparer US Address PreparerUSAddress

FieldValueIRS element (for citing)
Address Line1130 NORTH 18TH STREET SUITE 3000AddressLine1Txt
CityPHILADELPHIACityNm
State AbbreviationPAStateAbbreviationCd
ZIP191032757ZIPCd
FieldValueIRS element (for citing)
Return Type990ReturnTypeCd
Tax Period Begin2020-01-01TaxPeriodBeginDt

Filer Filer

FieldValueIRS element (for citing)
EIN460886344EIN

Business Name BusinessName

FieldValueIRS element (for citing)
Business Name Line1TRANSCELERATE BIOPHARMA INCBusinessNameLine1Txt
FieldValueIRS element (for citing)
Business Name ControlTRANBusinessNameControlTxt
Phone4845391230PhoneNum

US Address USAddress

FieldValueIRS element (for citing)
Address Line11001 CONSHOHOCKEN STATE RD NO 1-6AddressLine1Txt
CityWEST CONSHOHOCKENCityNm
State AbbreviationPAStateAbbreviationCd
ZIP19428ZIPCd

Business Officer BusinessOfficerGrp

FieldValueIRS element (for citing)
PersonDALVIR GILL PHDPersonNm
Person TitleCEOPersonTitleTxt
Phone4845391230PhoneNum
Signature2021-05-11SignatureDt
Discuss With Paid PreparerYes (1)DiscussWithPaidPreparerInd

Signing Officer SigningOfficerGrp

Person Full Name PersonFullName

FieldValueIRS element (for citing)
Person FirstDALVIRPersonFirstNm
Person LastGILL PHDPersonLastNm
FieldValueIRS element (for citing)
SSN999009999SSN

Preparer Person PreparerPersonGrp

FieldValueIRS element (for citing)
Preparer PersonHELEN M MARTINPreparerPersonNm
PTINP01330899PTIN
Phone2158818800PhoneNum

Additional Filer Information AdditionalFilerInformation

Trusted Customer TrustedCustomerGrp

FieldValueIRS element (for citing)
Trusted Customer2TrustedCustomerCd
Authentication Assurance LevelAAL1AuthenticationAssuranceLevelCd
Identity Assurance LevelIAL1IdentityAssuranceLevelCd
FieldValueIRS element (for citing)
Tax2020TaxYr
Build TS2022-09-23 18:48:47ZBuildTS

Form 990 IRS990

FieldValueIRS element (for citing)
Address ChangeYes (X)AddressChangeInd
Principal OfficerDALVIR GILL PHDPrincipalOfficerNm

US Address USAddress

FieldValueIRS element (for citing)
Address Line11001 CONSHOHOCKEN STATE RD NO 1-655AddressLine1Txt
CityWEST CONSHOHOCKENCityNm
State AbbreviationPAStateAbbreviationCd
ZIP19428ZIPCd
FieldValueIRS element (for citing)
Gross Receipts$31,974,894GrossReceiptsAmt
Group Return For Affiliates0GroupReturnForAffiliatesInd
Organization501cYes (X)Organization501cInd
Website AddressWWW.TRANSCELERATEBIOPHARMAINC.COMWebsiteAddressTxt
Type Of Organization CorpYes (X)TypeOfOrganizationCorpInd
Formation2012FormationYr
Legal Domicile StateDELegalDomicileStateCd
Activity Or MissionIMPROVE THE HEALTH OF PEOPLE IN THE WORLD BY ENHANCING THE R&D OF INNOVATIVE THERAPIES.TRANSCELERATE BIOPHARMA INC. IS A NON-PROFIT ORGANIZATION DEDICATED TO IMPROVING THE HEALTH OF PEOPLE AROUND THE WORLD BY ACCELERATING AND ENHANCING THE RESEARCH AND DEVELOPMENT (R&D) OF INNOVATIVE NEW THERAPIES. THE ORGANIZATION'S MISSION IS TO COLLABORATE ACROSS THE GLOBAL BIOPHARMACEUTICAL R&D COMMUNITY TO IDENTIFY, DESIGN AND FACILITATE IMPLEMENTATION OF SOLUTIONS DESIGNED TO DRIVE THE EFFICIENT, EFFECTIVE AND HIGH QUALITY DELIVERY OF NEW MEDICINES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS.ActivityOrMissionDesc
Voting Members Governing Body20VotingMembersGoverningBodyCnt
Voting Members Independent19VotingMembersIndependentCnt
Total Employee25TotalEmployeeCnt
Total Volunteers0TotalVolunteersCnt
Total Gross UBI$0TotalGrossUBIAmt
Net Unrelated Bus Txbl Incm$0NetUnrelatedBusTxblIncmAmt
PY Contributions Grants$0PYContributionsGrantsAmt
CY Contributions Grants$0CYContributionsGrantsAmt
PY Program Service Revenue$27,593,333PYProgramServiceRevenueAmt
CY Program Service Revenue$31,908,666CYProgramServiceRevenueAmt
PY Investment Income$386,012PYInvestmentIncomeAmt
CY Investment Income$66,228CYInvestmentIncomeAmt
PY Other Revenue$0PYOtherRevenueAmt
CY Other Revenue$0CYOtherRevenueAmt
PY Total Revenue$27,979,345PYTotalRevenueAmt
CY Total Revenue$31,974,894CYTotalRevenueAmt
PY Grants And Similar Paid$0PYGrantsAndSimilarPaidAmt
CY Grants And Similar Paid$0CYGrantsAndSimilarPaidAmt
PY Benefits Paid To Members$0PYBenefitsPaidToMembersAmt
CY Benefits Paid To Members$0CYBenefitsPaidToMembersAmt
PY Salaries Comp Emp Bnft Paid$6,651,073PYSalariesCompEmpBnftPaidAmt
CY Salaries Comp Emp Bnft Paid$7,623,942CYSalariesCompEmpBnftPaidAmt
PY Total Prof Fndrsng Expns$0PYTotalProfFndrsngExpnsAmt
CY Total Prof Fndrsng Expns$0CYTotalProfFndrsngExpnsAmt
CY Total Fundraising Expense$0CYTotalFundraisingExpenseAmt
PY Other Expenses$20,048,999PYOtherExpensesAmt
CY Other Expenses$20,484,023CYOtherExpensesAmt
PY Total Expenses$26,700,072PYTotalExpensesAmt
CY Total Expenses$28,107,965CYTotalExpensesAmt
PY Revenues Less Expenses$1,279,273PYRevenuesLessExpensesAmt
CY Revenues Less Expenses$3,866,929CYRevenuesLessExpensesAmt
Total Assets BOY$45,613,199TotalAssetsBOYAmt
Total Assets EOY$49,374,410TotalAssetsEOYAmt
Total Liabilities BOY$36,755,773TotalLiabilitiesBOYAmt
Total Liabilities EOY$36,650,129TotalLiabilitiesEOYAmt
Net Assets Or Fund Balances BOY$8,857,426NetAssetsOrFundBalancesBOYAmt
Net Assets Or Fund Balances EOY$12,724,281NetAssetsOrFundBalancesEOYAmt
Info In Schedule O Part IIIYes (X)InfoInScheduleOPartIIIInd
MissionTRANSCELERATE BIOPHARMA INC. IS DEDICATED TO IMPROVING THE HEALTH OF PEOPLE AROUND THE WORLD BY ACCELERATING AND ENHANCING THE RESEARCH AND DEVELOPMENT (R&D) OF INNOVATIVE NEW THERAPIES.THE ORGANIZATION'S MISSION IS TO COLLABORATE ACROSS THE GLOBAL BIOPHARMACEUTICAL R&D COMMUNITY TO IDENTIFY, DESIGN AND FACILITATE IMPLEMENTATION OF SOLUTIONS DESIGNED TO DRIVE THE EFFICIENT, EFFECTIVE AND HIGH QUALITY DELIVERY OF NEW MEDICINES. TRANSCELERATE EVOLVED FROM CONVERSATIONS AT VARIOUS FORUMS FOR EXECUTIVE R&D LEADERSHIP TO DISCUSS CURRENT ISSUES FACING THE INDUSTRY, AND EXAMINE SOLUTIONS FOR ADDRESSING COMMON CHALLENGES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS.MissionDesc
Significant New Program Srvc0SignificantNewProgramSrvcInd
Significant Change0SignificantChangeInd
Expense$20,914,117ExpenseAmt
Revenue$31,908,666RevenueAmt
DescOUTLINED BELOW ARE A FEW OF THE NUMEROURS YEAR-END ACHIEVEMENTS THROUGHOUT THE TRANSCELERATE PORTFOLIO.TRANSCELERATE BUILT AND LAUNCHED A COVID-19 MODULE IN DATACELERATE AVAILABLE TO MEMBER COMPANIES, AND QUALIFYING BIOPHARMACEUTICAL COMPANIES AND BIOMEDICAL RESEARCH AGENCIES TO SHARE PSEUDONYMIZED/ANONYMIZED PATIENT-LEVEL DATA, WITH APPROPRIATE LEGAL, TECHNICAL, AND PROCESS SAFEGUARDS TO PROTECT THE PRIVACY OF PATIENT DATA, FROM BOTH THE INVESTIGATIONAL PRODUCT AND CONTROL ARMS OF COVID-19-RELATED CLINICAL TRIALS MAY BE SHARED, ALONG WITH SUPPORTING STUDY-LEVEL DOCUMENTATION (E.G., STUDY PROTOCOL AND CRFS).COMMON TEMPLATES FOR NONCLINICAL STUDIES BEGAN THE DEVELOPMENT OF THE NONCLINICAL COMMON REPORT TEMPLATE (NCRT) WITH A VIRTUAL ROUNDTABLE OF KEY STAKEHOLDERS. THIS IS AN INITIATIVE OF BIOCELERATE LLC, A WHOLLY-OWNED SUBSIDIARY OF TRANSCELERATE WHICH IS TREATED AS A DISREGARDED ENTITY FOR TAX PURPOSES. DEVELOPED AND RELEASED VERSION 1.0 OF THE NCRT, A COMPANION TO THE NONCLINICAL COMMON PROTOCOL TEMPLATE, ALONG WITH THE SUPPORTING MATERIALS "APPROACHES TO IMPLEMENTATION IN YOUR ORGANIZATION AND "'WHY COMMON TEMPLATES?' INITIATIVE OVERVIEW." THE NCRT IS CURRENTLY AVAILABLE FOR VOLUNTARY ADOPTION. PRESENTED A POSTER AT THE SOCIETY OF TOXICOLOGY CONFERENCE IN MARCH ON NONCLINICAL PROTOCOL HARMONIZATION.BIOCELERATE'S SEND HARMONIZATION FOR CROSS-STUDY ANALYSIS PUBLISHED A MANUSCRIPT CO-AUTHORED WITH THE FDA UNDER A PUBLIC-PRIVATE PARTNERSHIP IN REGULATORY TOXICOLOGY AND PHARMACOLOGY. THE MANUSCRIPT, "SEND HARMONIZATION & CROSS-STUDY ANALYSIS: A PROPOSAL TO BETTER HARVEST THE VALUE FROM SEND DATA," HIGHLIGHTS THE POTENTIAL OF UTILIZING SEND DATASETS FOR CROSS-STUDY ANALYSIS AND THE CHALLENGES OF DOING SO CURRENTLY. ESTABLISHED A COLLABORATION WITH PHUSE TO FURTHER DEMONSTRATE THE VALUE OF LEVERAGING SEND DATASETS FOR CROSS-STUDY ANALYSIS. PRESENTED AT SOCIETY OF TOXICOLOGY CONFERENCE AND THE AMERICAN COLLEGE OF TOXICOLOGY ANNUAL MEETING, "USING SEND DATA SETS TO ENABLE LARGE-SCALE DATA ANALYTIC APPROACHES FOR PRECLINICAL TOXICOLOGY DATA." SUBMITTED PROPOSED HARMONIZATION RECOMMENDATIONS TO CDISC FOR CONSIDERATION IN THE NEXT VERSION OF THE SEND IG.TRANSCELERATE'S ECONSENT INITIATIVE UPDATED ITS GLOBAL LANDSCAPE ASSESSMENT MAP. IN TOTAL, 40 COUNTRIES HAVE ENABLED ECONSENT SUBMISSIONS, OF WHICH 31 COUNTRIES HAVE ACTIVELY FACILITATED THE PROCESS OF CONSENTING PATIENTS USING ECONSENT.THE CLINICAL RESEARCH AWARENESS INITIATIVE PUBLISHED A PAPER, "CLINICAL RESEARCH AWARENESS: A PROPOSED STUDY DESIGN TO ASSESS THE ROLE OF SHARED DECISION MAKING IN THE CONSIDERATION OF CLINICAL TRIAL PARTICIPATION." THE PATIENT TECHNOLOGY (PT) INITIATIVE RELEASED ITS REDESIGNED SOLUTIONS PAGE, COMPLETE WITH A TOOLKIT THAT HELPS USERS APPROACH IMPLEMENTATION OF PATIENT TECHNOLOGY EFFECTIVELY WITH LONG-TERM PLANNING AND SCALABILITY IN MIND. THE TEAM HAS ALSO RELEASED NEW TOOLS FOR THE PT JOURNEY, SUCH AS A PATIENT CONSIDERATIONS DOCUMENT, AND AN UPDATED REGULATORY LANDSCAPE TOOL.THE CLINICAL RESEARCH ACCESS AND INFORMATION EXCHANGE (CRAIE) INITIATIVE PUBLISHED "PATIENT PREFERENCES WHEN SEARCHING FOR CLINICAL TRIALS AND ADHERENCE OF STUDY RECORDS TO CLINICALTRIALS.GOV GUIDANCE IN KEY REGISTRY DATA FIELDS." THE INITIATIVE ALSO PUBLISHED AN INFOGRAPHIC, "WHAT PATIENTS WANT TO SEE IN CLINICAL TRIAL REGISTRIES." BASED ON A GLOBAL PATIENT SURVEY WITH 1,070 RESPONSES, IT DETAILS WHAT INFORMATION IS HELPFUL WHEN PATIENTS BEGIN THEIR SEARCH FOR CLINICAL TRIALS IN A REGISTRY AND WHAT INFORMATION PATIENTS FIND IMPORTANT. THE PATIENT EXPERIENCE INITIATIVE PUBLISHED TWO PAPERS, BOTH IN DIA'S THERAPEUTIC INNOVATION & REGULATORY SCIENCE (TIRS). THE FIRST, ENTITLED "AMPLIFYING THE VOICE OF THE PATIENT IN CLINICAL RESEARCH: DEVELOPMENT OF TOOLKITS FOR USE IN DESIGNING AND CONDUCTING PATIENT-CENTERED CLINICAL STUDIES," DISCUSSES HOW THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT (P-PET) AND THE STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE TOOLKIT (SPFQ) WERE DEVELOPED. THE OTHER, ENTITLED "EVALUATION OF THE CONTENT VALIDITY AND CROSS-CULTURAL VALIDITY OF THE STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE (SPFQ)," EVALUATES THE CONTENT AND CROSS-CULTURAL VALIDITY OF THE SPFQ IN INDICATIONS OTHER THAN ONCOLOGY AND NON-ENGLISH SPEAKING COUNTRIES. THE PATIENT EXPERIENCE INITIATIVE ALSO RELEASED THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT TRANSLATED INTO JAPANESE. IT ALSO LAUNCHED AN INFOGRAPHIC THAT DETAILS THE HOW AND WHY OF THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT (P-PET) AND STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE (SPFQ) TOOLKIT CREATION.THE MODERNIZING CLINICAL TRIAL CONDUCT INITIATIVE PUBLISHED A WHITEPAPER, "BEYOND COVID-19: MODERNIZING CLINICAL TRIAL CONDUCT." THE WHITEPAPER PROPOSES THE ONGOING UTILIZATION OF INNOVATIVE CLINICAL TRIAL CONTINUITY SOLUTIONS IMPLEMENTED DURING COVID-19 BY SPECIFICALLY CITING IMPLEMENTATION CHALLENGES, LESSONS LEARNED AND OPPORTUNITIES FOR THE CONTINUITY SOLUTIONS MOVING FORWARD. THE MODERNIZING CLINICAL TRIAL CONDUCT INITIATIVE ALSO DEVELOPED FIVE CONTINUITY SOLUTION CASE STUDIES AND PUBLISHED ITS WORKSHOP FINDINGS.TRANSCELERATE ESTABLISHED A REAL WORLD DATA (RWD) INITIATIVE. TRANSCELERATE'S GOAL WITH THIS NEW INITIATIVE IS TO COLLABORATE WITH GLOBAL REGULATORY AGENCIES TO DEVELOP A FRAMEWORK FOR RWD THAT DEFINES TOOLS, METHODOLOGIES, USE CASES AND APPROPRIATE LEVELS OF EVIDENCE TO SUPPORT REGULATORY DECISION MAKING.THE DIGITAL DATA FLOW (DDF) INITIATIVE SUCCESSFULLY LAUNCHED AND COMPLETED A VIRTUAL HACKATHON. THE CLINICAL CONTENT AND REUSE (CC&R) INITIATIVE RELEASED A NEW SOLUTION, THE "CLINICAL STUDY REPORT (CSR) CONSIDERATIONS FOR STUDIES DISRUPTED BY THE COVID-19 PANDEMIC." THIS DOCUMENT WAS CREATED BY CLINICAL SCIENTISTS, PHARMACOVIGILANCE EXPERTS, DATA SCIENTISTS, AND OTHER PROFESSIONALS TO IDENTIFY THE IMPORTANT TOPICS THAT CLINICAL RESEARCHERS AND RESEARCH SPONSORS MAY CONSIDER AS THEY ADAPT THEIR STUDIES AND CLINICAL STUDY REPORTS DUE TO DISRUPTIONS CAUSED BY COVID-19.CC&R PUBLISHED ITS EIGHTH ANNUAL COMMON PROTOCOL TEMPLATE SUITE RELEASE. IN PARTNERSHIP WITH THE CLINICAL RESEARCH ACCESS & INFORMATION EXCHANGE INITIATIVE, THE COMMON PROTOCOL TEMPLATE IS NOW INTEGRATED WITH THE CLINICAL TRIAL REGISTRATION TOOL TO ENABLE EVALUATION OF THE QUALITY AND PATIENT FRIENDLY TEXT OF THE BRIEF TITLE AND BRIEF SUMMARY DATA AND CAN NOW EXPORT 35+ DATA FIELDS FOR AUTOMATING QUALITY REGISTRY SUBMISSIONS TO CLINICALTRIALS.GOV.THE (HTD) SHARING (CONTROLS) INITIATIVE ANNOUNCED TWO NEW PUBLICATIONS. "ASSESSMENT OF PLACEBO RESPONSE IN OBJECTIVE AND SUBJECTIVE OUTCOME MEASURES IN RHEUMATOID ARTHRITIS CLINICAL TRIALS," FOUND THAT EVEN PATIENTS RANDOMIZED TO PLACEBO IN A RHEUMATOID ARTHRITIS TRIAL DEMONSTRATED IMPROVED OUTCOMES, A FINDING THAT MAY INFLUENCE FUTURE TRIAL DESIGN. THE OTHER, ENTITLED "HISTORICAL CONTROLS IN RANDOMIZED CLINICAL TRIALS: OPPORTUNITIES AND CHALLENGES," INCLUDES INSIGHTS INTO THE POTENTIAL FOR LARGE-SCALE HISTORICAL PLACEBO DATA TO BE USED BY DRUG DEVELOPERS AND PATIENTS TO GUIDE TRIAL DESIGN AND ANALYSIS. THE ESOURCE INITIATIVE HELPED SUPPORT THE DEVELOPMENT OF THE CLINICAL RESEARCH SPONSOR LABORATORY SEMANTICS IN FHIR IMPLEMENTATION GUIDE (IG). THE GUIDE, PUBLISHED BY HEALTH LEVEL SEVEN INTERNATIONAL (HL7) AND ADOPTED AS A STANDARD FOR TRIAL USE, PROVIDES DIRECTION FOR USING HL7'S FAST HEALTHCARE INTEROPERABILITY RESOURCES (FHIR).ESOURCE IS COLLABORATING WITH PROJECT VULCAN FHIR ACCELERATOR PROGRAM, A MULTI-STAKEHOLDER INITIATIVE THAT AIMS TO USE WIDELY ACCEPTED HEALTH CARE STANDARDS TO ENABLE DATA EXCHANGE TO STREAMLINE TRANSLATIONAL AND CLINICAL RESEARCH.THE RISK BASED MONITORING (RBM) INITIATIVE PUBLISHED A NEW REPORT, "MEASURING THE IMPACT OF RISK BASED MONITORING." THE DOCUMENT PROVIDES A DETAILED LOOK INTO THE PAST, PRESENT AND FUTURE EVOLUTION OF RBM METRICS, LESSONS LEARNED, AND BEST PRACTICES FOR DEFINING AND MEASURING RBM VALUE TO STAKEHOLDERS THROUGH METRICS AND FUTURE TRENDS. TRANSCELERATE EXPEDITED THE RELEASE OF ITS PROTOCOL DEVIATIONS (PD) TOOLKIT AND SOLUTIONS PAGE. THE TOOLKIT CONSISTS OF: A PROCESS GUIDE, WHICH OUTLINES A PROPOSED FRAMEWORK DESCRIBING FLEXIBLE PD MANAGEMENT APPROACHES, ELEMENTS FOR CONSIDERATION BASED UPON INTERPRETATION OF THE ICH E3 DEFINITION FOR IMPORTANT PD AND OTHER ASSOCIATED PD GUIDANCE; A PROCESS MAP OF THE PD MANAGEMENT PROCESS CONTAINING PROCESSES FOR BOTH IMPORTANT AND NON-IMPORTANT DEVIATIONS; A DECISION TREE TO GUIDE IN THE IDENTIFICATION AND CLASSIFICATION OF IMPORTANT AND NON-IMPORTANT PROTOCOL DEVIATIONS; AN ASSESSMENT TOOL TO ASSIST IN THE IDENTIFICATION AND DOCUMENTATION OF PROTOCOL-SPECIFIC "IMPORTANT" DEVIATIONS.THE QUALITY MANAGEMENT SYSTEM (QMS) INITIATIVE DEVELOPED AN INFOGRAPHIC BASED OFF OF FIVE CASE STUDIES, "EXPLORING THE VALUE IN IMPLEMENTING A CLINICAL QUALITY MANAGEMENT SYSTEM FRAMEWORK."Desc
Total Program Service Expenses$20,914,117TotalProgramServiceExpensesAmt
Described In Section501c30DescribedInSection501c3Ind
Schedule B Required0ScheduleBRequiredInd
Political Campaign Acty0PoliticalCampaignActyInd
Subject To Proxy TaxYes (1)SubjectToProxyTaxInd
Donor Advised Fund0DonorAdvisedFundInd
Conservation Easements0ConservationEasementsInd
Collections Of Art0CollectionsOfArtInd
Credit Counseling0CreditCounselingInd
Donor Rstr Or Quasi Endowments0DonorRstrOrQuasiEndowmentsInd
Report Land Building EquipmentYes (1)ReportLandBuildingEquipmentInd
Report Investments Other Sec0ReportInvestmentsOtherSecInd
Report Program Related Invst0ReportProgramRelatedInvstInd
Report Other Assets0ReportOtherAssetsInd
Report Other Liabilities0ReportOtherLiabilitiesInd
Include FIN48 Footnote0IncludeFIN48FootnoteInd
Independent Audit Fincl Stmt0IndependentAuditFinclStmtInd
Consolidated Audit Fincl Stmt0ConsolidatedAuditFinclStmtInd
School Operating0SchoolOperatingInd
Foreign Office0ForeignOfficeInd
Foreign Activities0ForeignActivitiesInd
More Than5000 K To Org0MoreThan5000KToOrgInd
More Than5000 K To Individuals0MoreThan5000KToIndividualsInd
Professional Fundraising0ProfessionalFundraisingInd
Fundraising Activities0FundraisingActivitiesInd
Gaming Activities0GamingActivitiesInd
Operate Hospital0OperateHospitalInd
Grants To Organizations0GrantsToOrganizationsInd
Grants To Individuals0GrantsToIndividualsInd
Schedule J RequiredYes (1)ScheduleJRequiredInd
Tax Exempt Bonds0TaxExemptBondsInd
Loan Outstanding0LoanOutstandingInd
Grant To Related Person0GrantToRelatedPersonInd
Business Rln With Org Mem0BusinessRlnWithOrgMemInd
Business Rln With Fam Mem0BusinessRlnWithFamMemInd
Business Rln With35 Ctrl Ent0BusinessRlnWith35CtrlEntInd
Deductible Non Cash Contri0DeductibleNonCashContriInd
Deductible Art Contribution0DeductibleArtContributionInd
Terminate Operations0TerminateOperationsInd
Partial Liquidation0PartialLiquidationInd
Disregarded EntityYes (1)DisregardedEntityInd
Related Entity0RelatedEntityInd
Related Organization Ctrl Ent0RelatedOrganizationCtrlEntInd
Activities Conducted Prtshp0ActivitiesConductedPrtshpInd
Schedule O RequiredYes (1)ScheduleORequiredInd
IRP Document23IRPDocumentCnt
IRP Document W2 G0IRPDocumentW2GCnt
Backup Wthld ComplianceYes (1)BackupWthldComplianceInd
Employee25EmployeeCnt
Employment Tax Returns FiledYes (1)EmploymentTaxReturnsFiledInd
Unrelated Bus Incm Over Limit0UnrelatedBusIncmOverLimitInd
Foreign Financial Account0ForeignFinancialAccountInd
Prohibited Tax Shelter Trans0ProhibitedTaxShelterTransInd
Taxable Party Notification0TaxablePartyNotificationInd
Nondeductible Contributions0NondeductibleContributionsInd
Indoor Tanning Services0IndoorTanningServicesInd
Subj To Tax Rmnrtn Ex Prcht PymtYes (1)SubjToTaxRmnrtnExPrchtPymtInd
Subject To Excs Tax Net Invst Inc0SubjectToExcsTaxNetInvstIncInd
Info In Schedule O Part VIYes (X)InfoInScheduleOPartVIInd
Governing Body Voting Members20GoverningBodyVotingMembersCnt
Independent Voting Member19IndependentVotingMemberCnt
Family Or Business Rln0FamilyOrBusinessRlnInd
Delegation Of Mgmt Duties0DelegationOfMgmtDutiesInd
Change To Org Documents0ChangeToOrgDocumentsInd
Material Diversion Or Misuse0MaterialDiversionOrMisuseInd
Members Or StockholdersYes (1)MembersOrStockholdersInd
Election Of Board MembersYes (1)ElectionOfBoardMembersInd
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 Policy0DocumentRetentionPolicyInd
Compensation Process CEOYes (1)CompensationProcessCEOInd
Compensation Process OtherYes (1)CompensationProcessOtherInd
Investment In Joint Venture0InvestmentInJointVentureInd
Upon RequestYes (X)UponRequestInd

Books In Care Of Detail BooksInCareOfDetail

Business Name BusinessName

FieldValueIRS element (for citing)
Business Name Line1ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATIONBusinessNameLine1Txt
FieldValueIRS element (for citing)
Phone4845391235PhoneNum

US Address USAddress

FieldValueIRS element (for citing)
Address Line11001 CONSHOHOCKEN STATE ROAD STEAddressLine1Txt
CityWEST CONSHOHOCKENCityNm
State AbbreviationPAStateAbbreviationCd
ZIP19428ZIPCd

Form990 Part VII Section A Form990PartVIISectionAGrp (33 entries)

TitleTitleTxtAverage Hours Per WeekAverageHoursPerWeekRtIndividual Trustee Or DirectorIndividualTrusteeOrDirectorIndReportable Comp From OrgReportableCompFromOrgAmtReportable Comp From Rltd OrgReportableCompFromRltdOrgAmtOther CompensationOtherCompensationAmtOfficerOfficerIndHighest Compensated EmployeeHighestCompensatedEmployeeInd
MICHELLE ROHRER
CHAIR OF BOARD OF DIRECTORS0.50Yes (X)$0$0$0
ROB MACKENZIE
VICE CHAIR OF BOARD OF DIRECTORS0.50Yes (X)$0$0$0
ROY BAYNES
BOARD MEMBER0.50Yes (X)$0$0$0
DIETMAR BERGER
BOARD MEMBER (EFF 6/29/20)0.50Yes (X)$0$0$0
CHRIS CORSICO
BOARD MEMBER0.50Yes (X)$0$0$0
NEIL GALLAGHER
BOARD MEMBER (EFF 1/13/20)0.50Yes (X)$0$0$0
MARTIN HOLST LANGE
BOARD MEMBER0.50Yes (X)$0$0$0
ELLIOTT LEVY
BOARD MEMBER0.50Yes (X)$0$0$0
IRIS LOEW-FRIEDRICH
BOARD MEMBER0.50Yes (X)$0$0$0
ROBERT METCALF
BOARD MEMBER0.50Yes (X)$0$0$0
DAVID NICHOLSON
BOARD MEMBER (THRU 5/11/20)0.50Yes (X)$0$0$0
JOHN OIDTMAN
BOARD MEMBER0.50Yes (X)$0$0$0
KATHRYN OWEN
BOARD MEMBER0.50Yes (X)$0$0$0
JOHN REED
BOARD MEMBER (THRU 6/28/20)0.50Yes (X)$0$0$0
STEFFEN ROELLINGER
BOARD MEMBER0.50Yes (X)$0$0$0
PETER RONCO
BOARD MEMBER (EFF 3/26/20)0.50Yes (X)$0$0$0
ROB SCOTT
BOARD MEMBER (THRU 1/12/20)0.50Yes (X)$0$0$0
MEHDI SHAHIDI
BOARD MEMBER0.50Yes (X)$0$0$0
BADHRI SRINIVASAN
BOARD MEMBER0.50Yes (X)$0$0$0
PAUL STOFFELS
BOARD MEMBER (THRU 3/25/20)0.50Yes (X)$0$0$0
ANN TAYLOR
BOARD MEMBER0.50Yes (X)$0$0$0
TAKUKO YAMADA-SAWADA
BOARD MEMBER0.50Yes (X)$0$0$0
BERNHARDT G ZEIHER
BOARD MEMBER0.50Yes (X)$0$0$0
DALVIR GILL
CHIEF EXECUTIVE OFFICER40.00Yes (X)$1,830,866$0$68,226Yes (X)
ROBERT BAKER
CORPORATE SECRETARY (EFF 6/29/20)0.50$0$0$0Yes (X)
ULO PALM
CORPORATE SECRETARY (THRU 6/28/20)0.50$0$0$0Yes (X)
ANDREW LEE
TREASURER0.50$0$0$0Yes (X)
JANICE CHANG
CHIEF OPERATING OFFICER40.00$679,746$0$42,393Yes (X)
JENNIFER A BURGESS
VP GLOBAL ENGAGEMENT AND COMM.40.00$389,933$0$43,539Yes (X)
CARA L RINALDI
EXEC DIRECTOR OF PORTFOLIO MGMT40.00$300,458$0$46,939Yes (X)
JENEEN DONADEO
SENIOR DIRECTOR OF PORTFOLIO MGMT40.00$293,119$0$33,493Yes (X)
ANTHONY GARGES
HEAD OF FINANCE AND ADMINISTRATION40.00$298,833$0$38,704Yes (X)
PATRICE WRIGHT
HEALTH AUTHORITY ENGAGEMENT DIRECTOR40.00$217,885$0$26,135Yes (X)
FieldValueIRS element (for citing)
Total Reportable Comp From Org$4,010,840TotalReportableCompFromOrgAmt
Tot Reportable Comp Rltd Org$0TotReportableCompRltdOrgAmt
Total Other Compensation$299,429TotalOtherCompensationAmt
Indiv Rcvd Greater Than100 K21IndivRcvdGreaterThan100KCnt
Former Ofcr Employees Listed0FormerOfcrEmployeesListedInd
Total Comp Greater Than150 KYes (1)TotalCompGreaterThan150KInd
Compensation From Other Srcs0CompensationFromOtherSrcsInd

Contractor Compensation ContractorCompensationGrp (5 entries)

Address Line1ContractorAddress/ForeignAddress/AddressLine1TxtCityContractorAddress/ForeignAddress/CityNmCountryContractorAddress/ForeignAddress/CountryCdServicesServicesDescCompensationCompensationAmtAddress Line1ContractorAddress/USAddress/AddressLine1TxtCityContractorAddress/USAddress/CityNmState AbbreviationContractorAddress/USAddress/StateAbbreviationCdZIPContractorAddress/USAddress/ZIPCd
PA CONSULTING GROUP INC
10 BRESSENDEN PLACELONDONUKCONSULTING SERVICES$3,433,964
ACCENTURE LLP
CONSULTING & IT SERVICES$3,334,935161 N CLARK STREETCHICAGOIL60601
KILPATRICK TOWNSEND
LEGAL SERVICES$2,502,746601 14TH STREET NW SUITE 900WASHINGTONDC20005
COGNIZANT
IT SERVICES$2,250,000211 QUALITY CIRCLECOLLEGE STATIONTX77845
FLUID EDGE
CONSULTING SERVICES$1,284,29910 MYSTIC LANEMALVERNPA19355
FieldValueIRS element (for citing)
Cntrct Rcvd Greater Than100 K21CntrctRcvdGreaterThan100KCnt

Program Service Revenue ProgramServiceRevenueGrp

FieldValueIRS element (for citing)
DescMEMBERSHIP DUESDesc
Business900099BusinessCd
Total Revenue Column$31,908,666TotalRevenueColumnAmt
Related Or Exempt Func Income$31,908,666RelatedOrExemptFuncIncomeAmt
FieldValueIRS element (for citing)
Total Program Service Revenue$31,908,666TotalProgramServiceRevenueAmt

Investment Income InvestmentIncomeGrp

FieldValueIRS element (for citing)
Total Revenue Column$66,228TotalRevenueColumnAmt
Exclusion$66,228ExclusionAmt

Total Revenue TotalRevenueGrp

FieldValueIRS element (for citing)
Total Revenue Column$31,974,894TotalRevenueColumnAmt
Related Or Exempt Func Income$31,908,666RelatedOrExemptFuncIncomeAmt
Unrelated Business Revenue$0UnrelatedBusinessRevenueAmt
Exclusion$66,228ExclusionAmt
FieldValueIRS element (for citing)
Info In Schedule O Part IXYes (X)InfoInScheduleOPartIXInd

Comp Current Ofcr Directors CompCurrentOfcrDirectorsGrp

FieldValueIRS element (for citing)
Total$2,621,231TotalAmt
Management And General$2,621,231ManagementAndGeneralAmt

Other Salaries And Wages OtherSalariesAndWagesGrp

FieldValueIRS element (for citing)
Total$4,144,359TotalAmt
Program Services$2,310,605ProgramServicesAmt
Management And General$1,833,754ManagementAndGeneralAmt

Pension Plan Contributions PensionPlanContributionsGrp

FieldValueIRS element (for citing)
Total$133,822TotalAmt
Program Services$78,309ProgramServicesAmt
Management And General$55,513ManagementAndGeneralAmt

Other Employee Benefits OtherEmployeeBenefitsGrp

FieldValueIRS element (for citing)
Total$441,889TotalAmt
Program Services$271,734ProgramServicesAmt
Management And General$170,155ManagementAndGeneralAmt

Payroll Taxes PayrollTaxesGrp

FieldValueIRS element (for citing)
Total$282,641TotalAmt
Program Services$137,354ProgramServicesAmt
Management And General$145,287ManagementAndGeneralAmt

Fees For Services Legal FeesForServicesLegalGrp

FieldValueIRS element (for citing)
Total$2,455,522TotalAmt
Program Services$1,981,094ProgramServicesAmt
Management And General$474,428ManagementAndGeneralAmt

Fees For Services Accounting FeesForServicesAccountingGrp

FieldValueIRS element (for citing)
Total$132,503TotalAmt
Management And General$132,503ManagementAndGeneralAmt

Fees For Services Other FeesForServicesOtherGrp

FieldValueIRS element (for citing)
Total$12,258,711TotalAmt
Program Services$11,641,530ProgramServicesAmt
Management And General$617,181ManagementAndGeneralAmt

Advertising AdvertisingGrp

FieldValueIRS element (for citing)
Total$60,643TotalAmt
Program Services$44,200ProgramServicesAmt
Management And General$16,443ManagementAndGeneralAmt

Office Expenses OfficeExpensesGrp

FieldValueIRS element (for citing)
Total$162,676TotalAmt
Program Services$644ProgramServicesAmt
Management And General$162,032ManagementAndGeneralAmt

Information Technology InformationTechnologyGrp

FieldValueIRS element (for citing)
Total$4,654,052TotalAmt
Program Services$4,330,473ProgramServicesAmt
Management And General$323,579ManagementAndGeneralAmt

Occupancy OccupancyGrp

FieldValueIRS element (for citing)
Total$160,793TotalAmt
Management And General$160,793ManagementAndGeneralAmt

Travel TravelGrp

FieldValueIRS element (for citing)
Total$86,409TotalAmt
Program Services$26,226ProgramServicesAmt
Management And General$60,183ManagementAndGeneralAmt

Conferences Meetings ConferencesMeetingsGrp

FieldValueIRS element (for citing)
Total$21,959TotalAmt
Program Services$2,948ProgramServicesAmt
Management And General$19,011ManagementAndGeneralAmt

Insurance InsuranceGrp

FieldValueIRS element (for citing)
Total$197,306TotalAmt
Management And General$197,306ManagementAndGeneralAmt

Other Expenses OtherExpensesGrp (4 entries)

DescDescTotalTotalAmtManagement And GeneralManagementAndGeneralAmtProgram ServicesProgramServicesAmt
EXCESS COMPENSATION TAX$174,482$174,482
RECRUITING$84,720$25,720$59,000
DUES$26,958$1,958$25,000
BOOKS, SUBSCRIPTIONS, R$6,155$1,155$5,000

All Other Expenses AllOtherExpensesGrp

FieldValueIRS element (for citing)
Total$1,134TotalAmt
Management And General$1,134ManagementAndGeneralAmt

Total Functional Expenses TotalFunctionalExpensesGrp

FieldValueIRS element (for citing)
Total$28,107,965TotalAmt
Program Services$20,914,117ProgramServicesAmt
Management And General$7,193,848ManagementAndGeneralAmt
Fundraising$0FundraisingAmt

Cash Non Interest Bearing CashNonInterestBearingGrp

FieldValueIRS element (for citing)
BOY$13,386,925BOYAmt
EOY$18,363,859EOYAmt

Savings And Temp Cash Invst SavingsAndTempCashInvstGrp

FieldValueIRS element (for citing)
BOY$2,764,069BOYAmt
EOY$1,588,161EOYAmt

Accounts Receivable AccountsReceivableGrp

FieldValueIRS element (for citing)
BOY$27,803,793BOYAmt
EOY$29,239,481EOYAmt

Prepaid Expenses Defrd Charges PrepaidExpensesDefrdChargesGrp

FieldValueIRS element (for citing)
BOY$146,491BOYAmt
EOY$171,062EOYAmt
FieldValueIRS element (for citing)
Land Bldg Equip Cost Or Other Bss$14,458LandBldgEquipCostOrOtherBssAmt
Land Bldg Equip Accum Deprec$14,458LandBldgEquipAccumDeprecAmt

Land Bldg Equip Basis Net LandBldgEquipBasisNetGrp

FieldValueIRS element (for citing)
BOY$0BOYAmt
EOY$0EOYAmt

Investments Pub Traded Sec InvestmentsPubTradedSecGrp

FieldValueIRS element (for citing)
BOY$1,500,074BOYAmt

Other Assets Total OtherAssetsTotalGrp

FieldValueIRS element (for citing)
BOY$11,847BOYAmt
EOY$11,847EOYAmt

Total Assets TotalAssetsGrp

FieldValueIRS element (for citing)
BOY$45,613,199BOYAmt
EOY$49,374,410EOYAmt

Accounts Payable Accr Expnss AccountsPayableAccrExpnssGrp

FieldValueIRS element (for citing)
BOY$4,847,107BOYAmt
EOY$5,560,963EOYAmt

Deferred Revenue DeferredRevenueGrp

FieldValueIRS element (for citing)
BOY$31,908,666BOYAmt
EOY$31,089,166EOYAmt

Total Liabilities TotalLiabilitiesGrp

FieldValueIRS element (for citing)
BOY$36,755,773BOYAmt
EOY$36,650,129EOYAmt
FieldValueIRS element (for citing)
Organization Follows FASB117Yes (X)OrganizationFollowsFASB117Ind

No Donor Restriction Net Assets NoDonorRestrictionNetAssetsGrp

FieldValueIRS element (for citing)
BOY$8,857,426BOYAmt
EOY$12,724,281EOYAmt

Total Net Assets Fund Balance TotalNetAssetsFundBalanceGrp

FieldValueIRS element (for citing)
BOY$8,857,426BOYAmt
EOY$12,724,281EOYAmt

Tot Liab Net Assets Fund Balance TotLiabNetAssetsFundBalanceGrp

FieldValueIRS element (for citing)
BOY$45,613,199BOYAmt
EOY$49,374,410EOYAmt
FieldValueIRS element (for citing)
Reconcilation Revenue Expnss$3,866,929ReconcilationRevenueExpnssAmt
Net Unrlzd Gains Losses Invst-$74NetUnrlzdGainsLossesInvstAmt
Other Changes In Net Assets$0OtherChangesInNetAssetsAmt
Method Of Accounting AccrualYes (X)MethodOfAccountingAccrualInd
Accountant Compile Or Review0AccountantCompileOrReviewInd
FS Audited0FSAuditedInd
Federal Grant Audit Required0FederalGrantAuditRequiredInd

Schedule C IRS990ScheduleC

FieldValueIRS element (for citing)
Substantially All Dues Nonded0SubstantiallyAllDuesNondedInd
Only In House LobbyingYes (1)OnlyInHouseLobbyingInd
Agree Carryover Prior Year0AgreeCarryoverPriorYearInd

Schedule D IRS990ScheduleD

Equipment EquipmentGrp

FieldValueIRS element (for citing)
Other Cost Or Other Basis$4,202OtherCostOrOtherBasisAmt
Depreciation$4,202DepreciationAmt
Book Value$0BookValueAmt

Other Land Buildings OtherLandBuildingsGrp

FieldValueIRS element (for citing)
Other Cost Or Other Basis$10,256OtherCostOrOtherBasisAmt
Depreciation$10,256DepreciationAmt
Book Value$0BookValueAmt
FieldValueIRS element (for citing)
Total Book Value Land Buildings$0TotalBookValueLandBuildingsAmt

Schedule J IRS990ScheduleJ

FieldValueIRS element (for citing)
Board Or Committee ApprovalYes (X)BoardOrCommitteeApprovalInd
Severance Payment0SeverancePaymentInd
Supplemental Nonqual Rtr Plan0SupplementalNonqualRtrPlanInd
Equity Based Comp Arrngm0EquityBasedCompArrngmInd

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
DALVIR GILL
CHIEF EXECUTIVE OFFICER$642,543$0$1,188,323$0$0$0$11,400$0$56,826$0$1,899,092$0$0$0
JANICE CHANG
CHIEF OPERATING OFFICER$460,903$0$218,843$0$0$0$11,400$0$30,993$0$722,139$0$0$0
JENNIFER A BURGESS
VP GLOBAL ENGAGEMENT AND COMM.$301,237$0$88,696$0$0$0$11,418$0$32,121$0$433,472$0$0$0
CARA L RINALDI
EXEC DIRECTOR OF PORTFOLIO MGMT$241,191$0$59,267$0$0$0$6,105$0$40,834$0$347,397$0$0$0
ANTHONY GARGES
HEAD OF FINANCE AND ADMINISTRATION$204,785$0$94,048$0$0$0$11,400$0$27,304$0$337,537$0$0$0
JENEEN DONADEO
SENIOR DIRECTOR OF PORTFOLIO MGMT$229,845$0$63,274$0$0$0$11,400$0$22,093$0$326,612$0$0$0
PATRICE WRIGHT
HEALTH AUTHORITY ENGAGEMENT DIRECTOR$204,552$0$13,333$0$0$0$8,733$0$17,402$0$244,020$0$0$0

Supplemental Information Detail SupplementalInformationDetail

FieldValueIRS element (for citing)
Form And Line ReferencePART I, LINE 3FormAndLineReferenceDesc
ExplanationTHE BOARD CHAIR, WITH INPUT FROM OTHER DIRECTORS OR A SUBCOMMITTEE OF THE BOARD, ANNUALLY REVIEWS AND APPROVES THE CEO'S COMPENSATION PACKAGE.ExplanationTxt

Schedule O IRS990ScheduleO

Supplemental Information Detail SupplementalInformationDetail (8 entries)

Form And Line ReferenceFormAndLineReferenceDescExplanationExplanationTxt
FORM 990, PART III, LINE 4ATHE INTERPRETATIONS OF PHARMACOVIGILANCE GUIDANCES & REGULATIONS (IGR-PV) AND THE INTERPRETATIONS OF CLINICAL GUIDANCES & REGULATIONS (IGR-CLINICAL) INITIATIVES LAUNCHED THEIR NEW SOLUTIONS PAGES. THE IGR CLINICAL'S QUALITY TOLERANCE LIMITS TEAM RELEASED SEVERAL SOLUTIONS: IN DIA TIRS, A PEER-REVIEWED PUBLICATION ENTITLED "QUALITY TOLERANCE LIMITS: FRAMEWORK FOR SUCCESSFUL IMPLEMENTATION IN CLINICAL DEVELOPMENT." A QTL INFOGRAPHIC, A SET OF FREQUENTLY ASKED QUESTIONS THAT ADDRESS SOME OF THE COMMON MISCONCEPTIONS ABOUT QTLS. A QTL PLAN TEMPLATE THAT WILL ALLOW A COMPANY TO DOCUMENT A QTL MONITORING APPROACH AT THE STUDY LEVEL. IGR CLINICAL'S GENERAL DATA PRIVACY REGULATION (GDPR) DATA REUSE TOPIC ALSO RELEASED ITS SUITE OF SOLUTIONS. THE CORNERSTONE OF THIS SET IS "A PRIVACY FRAMEWORK FOR CLINICAL DATA REUSE: SECONDARY DATA USE IN THE PHARMACEUTICAL INDUSTRY." AN OVERVIEW VIDEO AND ADDITIONAL TOOLS FROM THE FRAMEWORK, INCLUDING A GLOSSARY, STEP-BY-STEP BEST PRACTICE MODEL, DEFINITION OF PRIMARY AND SECONDARY USE OF CLINICAL DATA, AND A REUSE ASSESSMENT FORM. THE INTELLIGENT AUTOMATION OPPORTUNITIES IN PHARMACOVIGILANCE (IAO) INITIATIVE HAS LAUNCHED ITS SOLUTIONS PAGE. THE IMPETUS OF THIS LAUNCH IS THE INTERACTIVE ICSR AND AUTOMATION TECHNOLOGIES TOOL (IATT), WHICH IS AN INTERACTIVE PROCESS FLOW DEPICTING EACH STEP WITHIN THE INDIVIDUAL CASE SAFETY REPORT (ICSR) PROCESS. A REFRESH LATER IN 2020 SERVES AS A PLATFORM TO REPORT TECHNOLOGY IMPLEMENTATION DATA WITHIN THE SAME ICSR PROCESS MAP STRUCTURE AS THE ORIGINAL TOOL. ACCOMPANYING THIS REFRESH IS A VIDEO DEMONSTRATING HOW THIS TOOL CAN BE PROPERLY USED AND ADOPTED. ADDITIONALLY, IAO RELEASED ONE OF ITS FOUNDATIONAL MANUSCRIPTS IN PHARMACEUTICAL MEDICINE. THE PAPER, "AUTOMATION OPPORTUNITIES IN PHARMACOVIGILANCE: AN INDUSTRY SURVEY," OFFERS A SYSTEMATIC REVIEW FRAMEWORK FOR AUTOMATION OF THE ICSR PROCESS. IAO AUTHORED AN ADDITIONAL PAPER, "UTILIZING ADVANCED TECHNOLOGIES TO AUGMENT PHARMACOVIGILANCE SYSTEMS: CHALLENGES AND OPPORTUNITIES." THE IAO INITIATIVE ADDED THE 2020 TECHNOLOGY MATRIX TO ITS SOLUTIONS PAGE. ADDITIONALLY, THE TEAM HAS ADDED A CASE FOR ADOPTION RESOURCE THAT WILL HELP COMPANIES BETTER UNDERSTAND AND UTILIZE TRANSCELERATE'S IAO SOLUTIONS. THE INTERPRETATIONS OF GUIDANCE & REGULATIONS IN PHARMACOVIGILANCE (IGR-PV) INITIATIVE HAS COLLABORATED ON TWO NEW PAPERS: IN THE FIRST PAPER, "INDUSTRY EXPERIENCE AND PERSPECTIVE ON CLINICAL TRIAL SAFETY REPORTING TO THE FDA." THE SECOND PAPER, "THE EVOLVING REMIT OF THE REFERENCE SAFETY INFORMATION: OBSERVATIONS ON IMPLEMENTATION OF THE 2017 CLINICAL TRIALS FACILITATION GROUP (CTFG) QUESTION & ANSWER DOCUMENT" FOCUSES ON THE 2017 CTFG Q&A ON REFERENCE SAFETY INFORMATION. IGR PV'S PRESENTATION OF SAFETY RISKS THROUGHOUT THE PRODUCT LIFECYCLE (PORTL) TOPIC TEAM COMPLETED ITS 2020 SOLUTIONS. "A FRAMEWORK ON THE SAFETY RISKS THROUGHOUT THE PRODUCT LIFECYCLE" PROVIDES AN OUTLINE OF REGULATORY REQUIREMENTS AND CONSIDERATIONS FOR PRESENTING RISKS WITHIN KEY SAFETY-RELATED REGULATORY DOCUMENTS REQUIRED AT THE VARIOUS PRODUCT LIFECYCLE STAGES. A VIDEO GIVES AN OVERVIEW OF THE FRAMEWORK. TRANSCELERATE ESTABLISHED A NEW INITIATIVE ENTITLED PHARMACOVIGILANCE AGREEMENTS OPTIMIZATION (PVAO). THE ADVANCING SAFETY ANALYTICS (ASA) INITIATIVE LAUNCHED ITS ASSETS PAGE, FEATURING THE TEAM'S FIRST PUBLISHED PAPER, "INVESTIGATING OVERLAP IN SIGNALS FROM EVDAS, FAERS, AND VIGIBASE." IT ALSO PUBLISHED AN INFOGRAPHIC THAT ILLUSTRATES THE RESULTS OF ITS DRUG SAFETY MANUSCRIPT THAT INDICATES, FOR THE MAJORITY OF DRUGS, THAT THERE IS NO SIGNIFICANT DIFFERENCE BETWEEN THE NUMBER AND TYPES OF SAFETY SIGNALS THAT ARISE FROM THE THREE MAIN DATA SOURCES. THE ASA INITIATIVE PUBLISHED A PAPER, "SIGNAL MANAGEMENT: CURRENT LANDSCAPE AND CONSIDERATIONS FOR BEST PRACTICES." THIS PAPER REVIEWS THE CURRENT LANDSCAPE OF SIGNAL MANAGEMENT AND PROPOSES A SIMPLIFIED, END-TO-END FRAMEWORK WHILE HIGHLIGHTING SOME BEST PRACTICES. BAYER BECAME A MEMBER COMPANY IN EARLY 2020.
FORM 990, PART VI, SECTION A, LINE 6THE MEMBERS OF THE CORPORATION CONSIST OF SUCH FIRMS AND CORPORATIONS THAT ARE APPROVED FOR MEMBERSHIP FROM TIME TO TIME BY THE BOARD OF DIRECTORS OR ITS DESIGNEES IN ACCORDANCE WITH THE POLICIES AND PROCEDURES OF THE CORPORATION. THE CORPORATION HAS THE FOLLOWING CATEGORIES OF MEMBERS: A. TIER I MEMBERS - TO BE ELIGIBLE FOR TIER I MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT IN EXCESS OF $2.5 BILLION. ELIGIBILITY FOR TIER I MEMBERSHIP IS ESTABLISHED BASED UPON A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE THREE (3) YEAR PERIOD PRECEDING THE DATE THE COMPANY APPLIES TO JOIN THE CORPORATION. THE INITIAL TIER I MEMBERS ARE FURTHER DEFINED AS THE "CHARTER MEMBERS." B. TIER II MEMBERS - TO BE ELIGIBLE FOR TIER II MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $2.5 BILLION BUT MORE THAN $100 MILLION. ELIGIBILITY FOR TIER II MEMBERSHIP WILL BE ESTABLISHED BASED UPON A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE THREE (3) YEAR PERIOD PRECEDING THE DATE THE COMPANY APPLIES TO JOIN THE CORPORATION. C. ASSOCIATE MEMBERS - TO BE ELIGIBLE FOR ASSOCIATE MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $100 MILLION.
FORM 990, PART VI, SECTION A, LINE 7ATHE BOARD OF DIRECTORS SHALL BE COMPRISED OF UP TO TWENTY-TWO (22) DIRECTORS; PROVIDED THAT: (I) TEN (10) SEATS ARE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE CHARTER MEMBERS; (II) UP TO FOUR (4) ADDITIONAL SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER I MEMBERS WHO ARE NOT CHARTER MEMBERS; (III) UP TO SIX (6) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER II MEMBERS; (IV) ONE (1) SEAT SHALL BE FILLED BY A DIRECTOR WHO IS A REPRESENTATIVE OF THE ASSOCIATE MEMBERS; AND (V) ONE (1) SEAT SHALL BE FILLED BY THE CHIEF EXECUTIVE OFFICER OF THE CORPORATION. THE CORPORATION'S BYLAWS STATE THAT DIRECTORS SHALL BE ELECTED OR APPOINTED, AS APPLICABLE, ANNUALLY AT THE ANNUAL MEETING OF MEMBERS AND SHALL SERVE UNTIL THE FOLLOWING ANNUAL MEETING OF MEMBERS AND UNTIL THEIR SUCCESSORS ARE ELECTED OR APPOINTED, AS APPLICABLE, AND QUALIFIED. EACH CHARTER MEMBER SHALL HAVE THE RIGHT TO APPOINT A REPRESENTATIVE OF THE CHARTER MEMBER TO SERVE AS A CHARTER MEMBER DIRECTOR. TIER I AT-LARGE DIRECTORS SHALL BE ELECTED BY A PLURALITY VOTE OF THE TIER I MEMBERS, WHICH INCLUDE THE CHARTER MEMBERS. TIER II DIRECTORS SHALL BE ELECTED BY A PLURALITY VOTE OF THE TIER II MEMBERS. ANY ASSOCIATE MEMBER DIRECTOR SHALL BE ELECTED BY A PLURALITY VOTE OF THE ASSOCIATE MEMBERS. THE CEO DIRECTOR SHALL SERVE EX-OFFICIO, FOR SO LONG AS HE OR SHE SHALL HOLD THE OFFICE OF CHIEF EXECUTIVE OFFICER. TRANSCELERATE DOES NOT PRESENTLY HAVE ANY ASSOICATE MEMBERS THEREFORE, THE ASSOICATE MEMBER BOARD SEAT IS CURRENTLY VACANT. EACH TIER I MEMBER SHALL BE ENTITLED TO THREE (3) VOTES AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER 1 MEMBERS ARE ENTITLED TO VOTE. EACH TIER II MEMBER SHALL BE ENTITLED TO ONE (1) VOTE AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER II MEMBERS ARE ENTITLED TO VOTE. ASSOCIATE MEMBERS SHALL BE ENTITLED TO NOTICE OF AND TO ATTEND MEETINGS OF THE MEMBERS BUT SHALL NOT BE ENTITLED TO VOTE AT SUCH MEETINGS, PROVIDED HOWEVER, ASSOCIATE MEMBERS SHALL HAVE THE RIGHT TO CAST ONE (1) VOTE EACH WITH RESPECT TO THE ELECTION OF THE NOMINEE TO FILL THE ASSOCIATE MEMBER BOARD POSITION. NOTWITHSTANDING THE ABOVE, IN ORDER TO BE ELIGIBLE TO VOTE, A MEMBER MUST BE IN GOOD STANDING AND ITS DUES AND ASSESSMENTS PAID IN FULL.
FORM 990, PART VI, SECTION B, LINE 11BTHE FINANCE COMMITTEE AND MANAGEMENT REVIEW AND APPROVE THE FORM 990. THE FORM IS THEN DISTRIBUTED TO ALL MEMBERS OF THE BOARD FOR THEIR REVIEW BEFORE FILING WITH THE INTERNAL REVENUE SERVICE.
FORM 990, PART VI, SECTION B, LINE 12CEACH DIRECTOR AND OFFICER OF THE CORPORATION IS REQUIRED TO ANNUALLY ACKNOWLEDGE THE CONFLICT OF INTEREST POLICY, AFFIRMING THAT SUCH PERSON HAS RECEIVED, READ AND UNDERSTANDS, AND AGREED TO COMPLY WITH THE CONFLICT OF INTEREST POLICY.
FORM 990, PART VI, SECTION B, LINE 15THE BOARD CHAIR, WITH INPUT FROM OTHER DIRECTORS OR A SUBCOMMITTEE OF THE BOARD, ANNUALLY REVIEWS AND APPROVES THE CEO'S COMPENSATION PACKAGE. THE CEO APPROVES THE COMPENSATION FOR THE CHIEF OPERATING OFFICER, AND ALL OTHER EMPLOYEES.
FORM 990, PART VI, SECTION C, LINE 19THE ORGANIZATION'S GOVERNING DOCUMENTS, FINANCIAL STATEMENTS, AND CONFLICT OF INTEREST POLICY AND OTHER CORPORATE POLICIES ARE AVAILABLE UPON REQUEST.
FORM 990, PART IX, LINE 11GPROJECT MANAGEMENT FEES: PROGRAM SERVICE EXPENSES 8,892,797. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 8,892,797. EXTERNAL CONTRACTOR SUPPORT: PROGRAM SERVICE EXPENSES 2,406,397. MANAGEMENT AND GENERAL EXPENSES 1,862. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,408,259. COMMUNICATIONS FEES: PROGRAM SERVICE EXPENSES 342,336. MANAGEMENT AND GENERAL EXPENSES 615,319. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 957,655.

Schedule R IRS990ScheduleR

Id Disregarded Entities IdDisregardedEntitiesGrp

Disregarded Entity Name DisregardedEntityName

FieldValueIRS element (for citing)
Business Name Line1BIOCELERATE LLCBusinessNameLine1Txt

US Address USAddress

FieldValueIRS element (for citing)
Address Line11001 CONSHOHOCKEN STATE ROAD STE 1-AddressLine1Txt
CityWEST CONSHOHOCKENCityNm
State AbbreviationPAStateAbbreviationCd
ZIP19428ZIPCd
FieldValueIRS element (for citing)
EIN475492971EIN
Primary ActivitiesTO IMPROVE EFFICIENCIES IN PRECLINICAL RESEARCH.PrimaryActivitiesTxt
Legal Domicile StateDELegalDomicileStateCd
Total Income$1,416,666TotalIncomeAmt
End Of Year Assets$2,404,737EndOfYearAssetsAmt

Direct Controlling Entity Name DirectControllingEntityName

FieldValueIRS element (for citing)
Business Name Line1TRANSCELERATE BIOPHARMA INCBusinessNameLine1Txt