2025-05-14T07:33:35-05:00 2024-12-31 871353108 EISNER ADVISORY GROUP LLC 130 NORTH 18TH STREET SUITE 3000 PHILADELPHIA PA 191032757 990 2024-01-01 460886344 TRANSCELERATE BIOPHARMA INC TRAN 4845391230 300 CONSHOHOCKEN STATE ROAD 420 WEST CONSHOHOCKEN PA 19428 JANICE CHANG CEO 4845391230 2025-05-08 1 0 HELEN M MARTIN P01330899 2158818800 2024 2025-03-06 01:10:19Z JANICE CHANG 300 CONSHOHOCKEN STATE ROAD 420 WEST CONSHOHOCKEN PA 19428 38595799 0 X WWW.TRANSCELERATEBIOPHARMAINC.COM X 2012 DE IMPROVE THE HEALTH OF PEOPLE IN THE WORLD BY ENHANCING THE R&D OF INNOVATIVE THERAPIES. 22 21 33 27 0 0 0 0 33395000 37402000 773812 1193799 0 0 34168812 38595799 0 0 0 0 9951190 9759153 0 0 0 22569959 21980786 32521149 31739939 1647663 6855860 48107662 55325009 36490338 36830722 11617324 18494287 X 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. 0 0 22012036 37402000 IN 2024, TRANSCELERATE CONTINUED TO FOCUS ON ADVANCING CLINICAL RESEARCH BY HARNESSING COLLABORATION TO ADDRESS SYSTEMIC CHALLENGES AND ACCELERATING INNOVATION. THE ORGANIZATION MADE IMPORTANT STRIDES AIMED AT BRIDGING THE GAP BETWEEN CLINICAL RESEARCH AND PATIENT CARE, MAKING VITAL TRIAL INFORMATION MORE EASILY ACCESSIBLE AND HELPING THE INDUSTRY DELIVER LIFE-SAVING MEDICINES BETTER AND FASTER.TRANSCELERATE'S PORTFOLIO OF WORK ALIGNED TO THREE CORE AREAS: 1) TRANSFORMING CONNECTIVITY, TO REDEFINE HOW RESEARCH AND CARE INTERACT; 2) INFORMATION SHARING AND REUSE, TO LEVERAGE EXISTING DATA FOR ENABLING FASTER DISCOVERIES; AND 3) INNOVATIVE TRIAL DESIGN, TO PUT PATIENTS AT THE HEART OF CLINICAL TRIALS.MEMBERSHIP GREW TO MORE THAN 20 LEADING BIOPHARMA COMPANIES, FURTHER STRENGTHENING COLLABORATIVE EFFORTS. THE ORGANIZATION LED 15 ACTIVE INITIATIVES AND COMPLETED THE YEAR WITH MORE THAN 35 TOOLS AND SOLUTIONS IN PROGRESS. SINCE ITS FOUNDING IN 2012, TRANSCELERATE HAS DEVELOPED MORE THAN 570 TOOLKITS, EMPLOYING AN APPROACH THAT COMBINES RAPID IMPROVEMENTS FOR IMMEDIATE IMPLEMENTATION WITH LONG-TERM SOLUTIONS TO TRANSFORM THE R&D ECOSYSTEM.SOME HIGHLIGHTS OF TRANSCELERATE'S PORTFOLIO OF WORK IN 2024: DIGITAL DATA FLOW INITIATIVE: MODERNIZE CLINICAL TRIALS BY ENABLING DIGITIZATION OF PROTOCOLS, AUTOMATION OF DATA FLOW AND STREAMLINING THE R&D PROCESS, REDUCING CYCLE TIMES AND IMPROVING DATA QUALITY. HISTORICAL TRIAL DATA SHARING INITIATIVE: ENABLE COMPANIES TO IMPROVE STUDY DESIGN, REDUCE PLACEBO USE AND ACCELERATE DRUG DEVELOPMENT BY RESPONSIBLY AND SECURELY SHARING AND REUSING DATA. MODERNIZING INDIVIDUAL CASE SAFETY REPORT (ICSR) MANAGEMENT INITIATIVE: SEEKS TOS TRANSFORM THE ICSR SYSTEM, WHICH WOULD REDUCE DUPLICATION, ENABLE REAL-TIME SAFETY DATA ACCESS AND ENHANCE PATIENT SAFETY THROUGH MORE EFFICIENT PROCESSING. EMBEDDED PRAGMATIC TRIALS INITIATIVE: AIMS TO FACILITATE THE ABILITY TO CONDUCT PRAGMATIC CLINICAL TRIALS BY DEVELOPING RESOURCES, PROVING FEASIBILITY AND ADDRESSING OPERATIONAL DIFFERENCES TO BETTER INTEGRATE RESEARCH INTO ROUTINE CARE. MODERNIZING CLINICAL TRIAL CONDUCT INITIATIVE: ADVANCE TRIALS BY HELPING COMPANIES ADOPT PATIENT-FRIENDLY TECHNOLOGIES LIKE TELEMEDICINE, OFFERING MORE FLEXIBILITY WHILE ENSURING PATIENT SAFETY AND DATA INTEGRITY.TRANSCELERATE COLLABORATED WITH VARIOUS ORGANIZATIONS INCLUDING THE ASSOCIATION OF CLINICAL RESEARCH ORGANIZATIONS (ACRO), THE EU PATIENT-CENTRIC CLINICAL TRIAL PLATFORMS (EU-PEARL), AND THE CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM (CDISC).THE ACRO COLLABORATION RESULTED IN CO-CREATION OF TOOLS TO SUPPORT THE IMPLEMENTATION OF THE INTERNATIONAL COUNCIL FOR HARMONIZATION'S NEW GOOD CLINICAL PRACTICE GUIDELINES AROUND THE WORLD. THROUGH THE EU-PEARL PARTNERSHIP, PROGRESS WAS MADE TO SIMPLIFY THE APPROACH TO PATIENT-FRIENDLY PLATFORM TRIALS. THE COLLABORATION WITH CDISC HELPED TO ACCELERATE THE DEVELOPMENT OF CLINICAL DATA EXCHANGE STANDARDS FOR PROTOCOL DIGITIZATION. TRANSCELERATE ENGAGED IN PRODUCTIVE DIALOGUE AND ACTION WITH GLOBAL HEALTH AUTHORITIES TO ACCELERATE THE PACE OF CHANGE THROUGH IMPLEMENTATION OF A HOLISTIC APPROACH TO ENGAGEMENT, ACTIVE PARTICIPATION WITH HEALTH AUTHORITIES AT CONFERENCES AND PUBLIC EVENTS, AND ADVANCEMENT OF KNOWLEDGE AND EDUCATION THROUGH SHARING OF INSIGHTS, LEARNINGS AND DATA. TRANSCELERATE ALSO SHARED INSIGHTS ACROSS THE R&D ECOSYSTEM: HOSTING 10 PUBLIC WEBINARS REACHING 4000+ PROFESSIONALS, PUBLISHING WHITE PAPERS TACKLING EVERYTHING FROM DECENTRALIZED TRIALS TO REAL-WORLD DATA, AND BEING FEATURED IN TOP INDUSTRY PUBLICATIONS. THE ORGANIZATION ALSO SHARED ITS VOICE AT OVER 40 LEADERSHIP-LEVEL EVENTS ACROSS 27 CITIES AND 12 COUNTRIES. THE ORGANIZATION'S WORK IN 2024 WAS AND WILL CONTINUE TO BE GEARED AROUND BUILDING A MORE EFFICIENT, PATIENT-CENTERED FUTURE FOR CLINICAL RESEARCH. 22012036 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 26 0 1 33 1 0 0 0 0 0 0 1 0 X 22 21 0 0 1 0 1 1 0 1 1 0 0 1 1 1 1 1 0 1 1 0 X ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATION 4845391230 300 CONSHOHOCKEN STATE ROAD STE 420 WEST CONSHOHOCKEN PA 19428 JANICE CHANG CEO 40.00 X X 1062291 0 42514 KATHRYN OWEN CHAIR OF BOARD OF DIRECTORS 0.50 X 0 0 0 BADHRI SRINIVASAN VICE CHAIR OF BOARD OF DIRECTOR 0.50 X 0 0 0 ELIAV BARR BOARD MEMBER 0.50 X 0 0 0 DIETMAR BERGER BOARD MEMBER 0.50 X 0 0 0 CHRIS CORSICO BOARD MEMBER 0.50 X 0 0 0 ROB GOODWIN BOARD MEMBER 0.50 X 0 0 0 LYKKE HINSCH GYLVIN BOARD MEMBER (EFF 6/2024) 0.50 X 0 0 0 NARIMON HONARPOUR BOARD MEMBER 0.50 X 0 0 0 CHRISTOPH KOENEN BOARD MEMBER 0.50 X 0 0 0 MARIA KOUTSOPOULOU BOARD MEMBER 0.50 X 0 0 0 BARI KOWAL BOARD MEMBER 0.50 X 0 0 0 FABIO LIEVANO BOARD MEMBER (EFF 11/2024) 0.50 X 0 0 0 IRIS LOEW-FRIEDRICH BOARD MEMBER 0.50 X 0 0 0 CRISTIAN MASSACESI BOARD MEMBER 0.50 X 0 0 0 ROBERT METCALF BOARD MEMBER 0.50 X 0 0 0 MICHELLE ROHRER BOARD MEMBER 0.50 X 0 0 0 MERDAD PARSEY BOARD MEMBER 0.50 X 0 0 0 MOKASH SHARMA BOARD MEMBER 0.50 X 0 0 0 TOM SENDEROVITZ BOARD MEMBER (EFF 4/2024) 0.50 X 0 0 0 TADAAKI TANIGUCHI BOARD MEMBER 0.50 X 0 0 0 TAKUKO YAMADA-SAWADA BOARD MEMBER 0.50 X 0 0 0 ULI BROEDL BOARD MEMBER (THRU 6/2024) 0.50 X 0 0 0 MARTIN HOLST LANGE BOARD MEMBER (THRU 4/2024) 0.50 X 0 0 0 RAGAD ATTAR BOARD MEMBER (EFF-5/24/ THRU-8/24) 0.50 X 0 0 0 ROOPAL THAKKAR BOARD MEMBER (THRU 4/2024) 0.50 X 0 0 0 ALLISON CUFF SHIMOOKA COO 40.00 X 582003 0 54161 ANDREW LEE TREASURER 0.50 X 0 0 0 STEPHEN LIN SECRETARY (THRU 11/2024) 0.50 X 0 0 0 JENNIFER A BURGESS VP, GLOBAL COMMUNICATIONS & ENGAGEMENT 40.00 X 461236 0 44362 ANTHONY GARGES HEAD OF FINANCE & ADMINISTRATION 40.00 X 397818 0 47267 CARA L RINALDI VP, PORTFOLIO MANAGEMENT 40.00 X 417189 0 53497 JENEEN DONADEO EXEC. PORTFOLIO DIRECTOR 40.00 X 395823 0 33953 ROBERT DICICCO VP, PORTFOLIO MANAGEMENT 40.00 X 389486 0 66267 3705846 0 342021 24 0 1 0 PA CONSULTING GROUP INC 10 BRESSENDEN PLACE LONDON UK CONSULTING SERVICES 7607821 ACCENTURE LLP 161 N CLARK STREET CHICAGO IL 60601 CONSULTING & IT SERVICES 3059291 KILPATRICK TOWNSEND 601 14TH STREET NW SUITE 900 WASHINGTON DC 20005 LEGAL SERVICES 3024932 CDISC 401 W 15TH STREET SUITE 520 AUSTIN TX 78701 CONSULTING SERVICES 1174012 ARTEMIS FACTOR LLC 314 CARLYLE ROAD WEST CHESTER PA 19382 CONSULTING SERVICES 942230 16 MEMBERSHIP DUES 541900 37402000 37402000 37402000 1193799 1193799 38595799 37402000 0 1193799 X 1740969 1740969 6642296 4007775 2634521 213770 105657 108113 735580 442491 293089 426538 216100 210438 3092416 1733598 1358818 24450 24450 14469089 13251635 1217454 56419 13720 42699 36218 65 36153 2739885 2133216 606669 352881 352881 494988 107779 387209 253413 253413 253731 253731 RECRUITING 175406 175406 ADMINISTRATIVE FEES 14177 14177 EXCESS COMPENSATION TAX 13562 13562 BOOKS, SUBSCRIPTIONS, R 2200 2200 1951 1951 31739939 22012036 9727903 0 3936830 2528531 11814650 21990173 32162984 30577703 166215 201619 26983 26983 48107662 55325009 3088338 3827722 33402000 33003000 36490338 36830722 X 11617324 18494287 11617324 18494287 48107662 55325009 6855860 21103 0 X 0 0 0 0 1 0 X X 0 0 0 JANICE CHANG CEO 785811 0 276480 0 0 0 13800 0 28714 0 1104805 0 0 0 ALLISON CUFF SHIMOOKA COO 441896 0 140107 0 0 0 13800 0 40361 0 636164 0 0 0 JENNIFER A BURGESS VP, GLOBAL COMMUNICATIONS & ENGAGEME 341937 0 119299 0 0 0 13800 0 30562 0 505598 0 0 0 CARA L RINALDI VP, PORTFOLIO MANAGEMENT 309790 0 107399 0 0 0 0 0 53497 0 470686 0 0 0 ROBERT DICICCO VP, PORTFOLIO MANAGEMENT 300262 0 89224 0 0 0 7594 0 58673 0 455753 0 0 0 ANTHONY GARGES HEAD OF FINANCE & ADMINISTRATION 269134 0 128684 0 0 0 13800 0 33467 0 445085 0 0 0 JENEEN DONADEO EXEC. PORTFOLIO DIRECTOR 304859 0 90964 0 0 0 13800 0 20153 0 429776 0 0 0 PART I, LINE 3 THE BOARD CHAIR, WITH INPUT FROM OTHER DIRECTORS OR A SUBCOMMITTEE OF THE BOARD, ANNUALLY REVIEWS AND APPROVES THE CEO'S COMPENSATION PACKAGE. FORM 990, PART I, LINE 6, TOTAL NUMBER OF VOLUNTEERS: THE TOTAL NUMBER OF VOLUNTEERS OF 27, ENCOMPASSES ALL ACTIVE BOARD MEMBER THROUGHOUT THE CALENDAR YEAR. FORM 990, PART VI, SECTION A, LINE 4 DURING 2024, THE BOARD OF DIRECTORS OF THE CORPORATION APPROVED AMENDING THE BYLAWS OF THE CORPORATION TO: (A) INCREASE FROM FIVE (5) TO SEVEN (7) THE NUMBER OF BOARD SEATS TO BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER I MEMBERS WHO ARE NOT CHARTER MEMBERS, AND ACCORDINGLY TO INCREASE THE TOTAL NUMBER OF DIRECTORS FROM 22 TO 24 TO REFLECT SUCH INCREASE; AND (B) ADJUST THE MEMBERSHIP TIER ELIGIBILITY THRESHOLDS AS DESCRIBED IN LINE 6 BELOW. FORM 990, PART VI, SECTION A, LINE 6 THE 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 AN AMOUNT EQUAL TO $3.3 BILLION AS OF JANUARY 1, 2024, WHICH AMOUNT SHALL THEREAFTER BE ADJUSTED FOR INFLATION IN ACCORDANCE WITH THE U.S. CPI INDEX (THE "TIER I THRESHOLD"). THE ADJUSTED TIER I THRESHOLD SHALL BE ANNOUNCED TO THE MEMBERS PERIODICALLY BY THE FINANCE COMMITTEE OR THE BOARD OF DIRECTORS. ELIGIBILITY FOR TIER I MEMBERSHIP IS ESTABLISHED BASED UPON THE AVERAGE OF A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE PRECEDING THREE (3) YEAR PERIOD. 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 THE TIER I THRESHOLD BUT MORE THAN AN AMOUNT EQUAL TO $134 MILLION AS OF JANUARY 1, 2024, WHICH AMOUNT SHALL THEREAFTER BE ADJUSTED FOR INFLATION IN ACCORDANCE WITH THE U.S. CPI INDEX (THE "TIER II THRESHOLD"). THE ADJUSTED TIER II THRESHOLD SHALL BE ANNOUNCED TO THE MEMBERS PERIODICALLY BY THE FINANCE COMMITTEE OR THE BOARD OF DIRECTORS.. ELIGIBILITY FOR TIER II MEMBERSHIP WILL BE ESTABLISHED BASED UPON THE AVERAGE OF A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE PRECEDING THREE (3) YEAR PERIOD. 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 THE TIER II THRESHOLD. FORM 990, PART VI, SECTION A, LINE 7A THE BOARD OF DIRECTORS SHALL BE COMPRISED OF UP TO TWENTY-FOUR (24) DIRECTORS; PROVIDED THAT: (I) TEN (10) SEATS ARE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE CHARTER MEMBERS; (II) UP TO SEVEN (7) 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; AND (IV) 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. THE CEO DIRECTOR SHALL SERVE EX-OFFICIO, FOR SO LONG AS HE OR SHE SHALL HOLD THE OFFICE OF CHIEF EXECUTIVE OFFICER. EACH TIER I MEMBER SHALL BE ENTITLED TO THREE (3) VOTES AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER I 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. 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 11B THE 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 12C EACH 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 15 THE ORGANIZATION'S EXECUTIVE COMPENSATION COMMITTEE, CONSISTING OF INDEPENDENT DIRECTORS, ANNUALLY REVIEWS AND APPROVES THE CEO'S COMPENSATION PACKAGE. THE CEO APPROVES THE COMPENSATION FOR THE CHIEF OPERATING OFFICER, AND ALL OTHER KEY EMPLOYEES. FORM 990, PART VI, SECTION C, LINE 19 THE ORGANIZATION'S GOVERNING DOCUMENTS, FINANCIAL STATEMENTS, CONFLICT OF INTEREST POLICY AND OTHER CORPORATE POLICIES ARE AVAILABLE UPON REQUEST. FORM 990, PART IX, LINE 11G PROJECT MANAGEMENT FEES: PROGRAM SERVICE EXPENSES 11,209,160. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 11,209,160. EXTERNAL CONTRACTOR SUPPORT: PROGRAM SERVICE EXPENSES 1,959,060. MANAGEMENT AND GENERAL EXPENSES 210,229. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,169,289. COMMUNICATIONS FEES: PROGRAM SERVICE EXPENSES 83,415. MANAGEMENT AND GENERAL EXPENSES 1,007,225. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,090,640. BIOCELERATE LLC 300 CONSHOHOCKEN STATE ROAD STE 420 WEST CONSHOHOCKEN PA 19428 475492971 TO IMPROVE EFFICIENCIES IN PRECLINICAL RESEARCH. DE 1351218 1565545 TRANSCELERATE BIOPHARMA INC