2016-05-13T12:15:11-05:00 2015-12-31 131639826 EISNERAMPER LLP 130 NORTH 18TH STREET SUITE 3000 PHILADELPHIA PA 191032757 990 2015-01-01 460886344 TRANSCELERATE BIOPHARMA INC TRAN 6102706394 100 FOUR FALLS CORP CENTER NO 655 WEST CONSHOHOCKEN PA 19428 DALVIR GILL PHD CEO 6102706394 2016-05-11 1 HELEN M MARTIN P01330899 2158818800 2015 2016-09-27 15:27:22Z X DALVIR GILL PHD 100 FOUR FALLS CORP CENTER NO 655 WEST CONSHOHOCKEN PA 19428 25465264 0 X WWW.TRANSCELERATEBIOPHARMAINC.COM X 2012 DE IMPROVE 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. TRANSCELERATE EVOLVED FROM CONVERSATIONS AT VARIOUS FORUMS FOR EXECUTIVE R&D LEADERSHIP TO DISCUSS CURRENT ISSUES FACING THE INDUSTRY, AND EXAMINE SOLUTIONS FOR ADDRESSING AGREED-UPON COMMON CHALLENGES. MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS. 20 19 10 0 0 0 0 0 15276176 25400000 17212 65264 0 0 15293388 25465264 0 0 0 0 2052132 3386042 0 0 0 9728191 12883454 11780323 16269496 3513065 9195768 34898547 43370074 24786391 24062150 10112156 19307924 X TRANSCELERATE 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 AND TO COLLABORATE ACROSS THE 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 AGREED-UPON COMMON CHALLENGES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS. 0 0 10216507 25400000 TRANSCELERATE EXPERIENCED SEVERAL SIGNIFICANT ACCOMPLISHMENTS IN 2015. SPECIFICALLY:CLINICAL DATA STANDARDS IN COLLABORATION WITH CFAST, GREW THE NUMBER OF PUBLISHED DATA STANDARDS TO 19 WITH 7 OF THOSE BEING PUBLISHED IN 2015.CLINICAL DATA TRANSPARENCY PUBLISHED A PAPER ON DATA ANONYMIZATION AND ADDRESS ONGOING REGULATORY CHANGES.THE COMMON PROTOCOL TEMPLATE INITIATIVE COMPLETED FIRST TEMPLATE RELEASE (CPT V1.0) TO MEMBER COMPANIES, INCLUDING A BASIC AS WELL AS A TECHNOLOGY ENABLED VERSION, AND RELEASED THE BASIC TEMPLATE AND SUPPORTING MATERIAL TO THE PUBLIC ON THE TRANSCELERATE WEBSITE.THE COMPARATOR NETWORK WITH 9 MEMBER COMPANIES IN THE NETWORK, LAUNCHED AN IT SYSTEM TO FACILITATE TRANSACTIONS AND EXTENDED NETWORK SCOPE TO INCLUDE ACTIVE PLACEBO EXCHANGE, WHICH HAS SURPASSED 100 TRANSACTIONS SINCE NETWORK INCEPTION.THE INVESTIGATOR REGISTRY WENT LIVE WITH ITS FIRST RELEASE, WHICH ENABLES THE INTEGRATION OF PERSON, FACILITY, AND PROTOCOL DATA FROM VARIOUS SOURCES AND PROVIDES ONE RECORD FOR A TRAINING PROVIDER.PLACEBO / STANDARD OF CARE FINALIZED A WHITE PAPER WHICH WAS PUBLISHED TO THE TRANSCELERATE WEBSITE, SELECTED A VENDOR TO PERFORM DATA CONVERSION SERVICES, AND RECEIVED INITIAL TRIAL DATA FOR THE DATABASE.RISK BASED MONITORING CONTINUED TO PROMOTE RBM METHODOLOGY BY PUBLISHING PAPERS ON CENTRAL MONITORING, DATA INTEGRITY AND GCP MISCONDUCT, A TECHNOLOGY WHITE PAPER AND AN RBM UPDATE.THE QUALITY MANAGEMENT SYSTEM INITIATIVE PUBLISHED THE QMS CONCEPT PAPER VISION & OUTLINE AND CONCEPT PAPER IN DIA TIRS, AND SUBMITTED THE CLINICAL QMS CONCEPTUAL FRAMEWORK TO ICH FOR CONSIDERATION AS A GUIDANCE.THE SHARED INVESTIGATOR PLATFORM (SIP) PREPARED FOR R1.0 GO-LIVE, WHICH INCLUDED THE INTEGRATION OF THE INVESTIGATOR REGISTRY.THE SITE QUALIFICATION & TRAINING INITIATIVE PUBLISHED FIRST 7 (OF 11) TOPICS OF INFORMATIONAL PROGRAM FOR SITE STAFF LESS EXP. IN CONDUCTING CLINICAL RESEARCH AND SURPASSED 115,000 GCP TRAINING CERTIFICATES ISSUED TO-DATE, ELIMINATING THE NEED FOR INVESTIGATORS TO TAKE REDUNDANT GCP TRAINING. ELABELS, ECONSENT AND PATIENT AWARENESS & ACCESS WERE ESTABLISHED AS NEW ACTIVE INITIATIVES.ADDITIONALLY, IN 2015, TRANSCELERATE ANNOUNCED THE LAUNCH OF BIOCELERATE, A NEW SUBSIDIARY OF TRANSCELERATE THAT AIMS TO IMPROVE EFFICIENCIES IN PRECLINICAL RESEARCH. BIOCELERATE WILL EXPLORE AREAS IN PRECLINICAL RESEARCH THAT HAVE UNMET NEEDS AND COULD BENEFIT FROM A COLLABORATION APPROACH. TOXICOLOGY DATA SHARING IS THE FIRST INITIATIVE FOR BIOCELERATE, FOCUSING ON TARGET-RELATED TOXICITY IN PRECLINICAL STUDIES. THE INITIATIVE WILL ENABLE ACCESS TO A BROADER CROSS-COMPANY SET OF TOXICOLOGY DATA. THE KNOWLEDGE GATHERED THROUGH THE INITIATIVE WILL HELP WITH EFFECTIVE TRANSLATION OF NONCLINICAL FINDINGS AND ATTEMPT TO CLOSE CRITICAL GAPS THAT EXIST IN UNDERSTANDING THE RELATIONSHIP BETWEEN PATIENT RESPONSE AND PRECLINICAL TOXICOLOGY FINDINGS. INITIATIVES WILL BE APPROVED BY A GOVERNING COUNCIL MADE UP OF PARTICIPATING BIOCELERATE MEMBER COMPANIES. 10216507 0 0 0 1 0 0 0 0 0 1 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 22 0 1 10 1 0 0 0 0 0 0 X 20 19 0 0 0 0 1 1 0 1 1 0 0 1 1 0 0 1 0 1 1 0 X ANTHONY GARGES FINANCE LEAD 6102706394 709 SWEDELAND ROAD KING OF PRUSSIA PA 19406 IRIS LOEW-FRIEDRICH CHAIR OF BOARD OF DIRECTORS 0.50 X 0 0 0 CORSEE SANDERS VICE CHAIR OF BOARD OF DIRECTORS 0.50 X 0 0 0 LYNN MARKS CORPORATE SECRETARY 0.50 X X 0 0 0 ANDREW LEE TREASURER 0.50 X X 0 0 0 ALISE REICIN BOARD MEMBER 0.50 X 0 0 0 ALFRED SANDROCK BOARD MEMBER 0.50 X 0 0 0 BERNHARDT ZEIHER BOARD MEMBER 0.50 X 0 0 0 CHRISTOPHER CORSICO BOARD MEMBER 0.50 X 0 0 0 DAVID NICHOLSON BOARD MEMBER 0.50 X 0 0 0 ELIAS ZARHOUNI BOARD MEMBER 0.50 X 0 0 0 ELLIOT LEVY BOARD MEMBER 0.50 X 0 0 0 GARRY NEIL BOARD MEMBER 0.50 X 0 0 0 JAN LUNDBERG BOARD MEMBER 0.50 X 0 0 0 MICHAEL SEVERINO BOARD MEMBER 0.50 X 0 0 0 PATRICK VALLANCE BOARD MEMBER 0.50 X 0 0 0 PATRIZIA CAVAZZONI BOARD MEMBER 0.50 X 0 0 0 PAUL STOFFELS BOARD MEMBER 0.50 X 0 0 0 PAUL BIONDI BOARD MEMBER 0.50 X 0 0 0 PETER KRISTENSEN BOARD MEMBER 0.50 X 0 0 0 ROY BAYNES BOARD MEMBER 0.50 X 0 0 0 SEAN BOHEN BOARD MEMBER 0.50 X 0 0 0 TAKUKO YAMADA-SAWADA BOARD MEMBER 0.50 X 0 0 0 DALVIR GILL CHIEF EXECUTIVE OFFICER 40.00 X X 896133 0 58145 JANICE CHANG SENIOR VICE PRESIDENT OF GLOBAL OPERATIONS 40.00 X 398656 0 31464 JENNIFER A BURGESS DIRECTOR OF COMMUNICATIONS 40.00 X 208432 0 29781 ROBERT A HAWKEY DIRECTOR OF QUALITY 40.00 X 148864 0 14244 CARA L RINALDI DIRECTOR OF PORTFOLIO MANAGEMENT 40.00 X 141155 0 19550 ANTHONY GARGES FINANCE LEAD 40.00 X 129375 0 20168 SARAH L PLUSH DIRECTOR OF OPERATION 40.00 X 124053 0 18631 2046668 0 191983 7 0 1 0 ACCENTURE LLP 161 N CLARK STREET CHICAGO IL 60601 CONSULTING 5763352 KILPATRICK TOWNSEND 601 14TH STREET NW SUITE 900 WASHINGTON DC 20005 LEGAL SERVICES 2408630 THE NORTH HIGHLAND COMPANY PO BOX 101353 ATLANTA GA 30392 CONSULTING 400803 BLISS INTERGRATED COMMUNICATIONS LLC 500 FIFTH AVENUE SUITE 300 NEW YORK NY 10110 CONSULTING 391161 KINAPSE LIMITED 27-37 ST GEORGES ROAD LONDON UK SW194 4EU CONSULTING 378177 14 MEMBERSHIP DUES 900099 25400000 25400000 25400000 65264 65264 25465264 25400000 0 65264 X 1384398 1384398 1750675 341523 1409152 29615 5954 23661 125813 4000 121813 95541 19542 75999 2293138 1513444 779694 117653 117653 8211101 7426038 785063 34336 34300 36 162238 5507 156731 501015 396813 104202 15000 15000 744485 455068 289417 133468 14318 119150 3453 3453 100863 100863 BAD DEBT 500000 500000 RECRUITING 60077 60077 BOOKS, SUBSCRIPTIONS, R 5702 5702 DUES 850 850 75 75 16269496 10216507 6052989 0 4236350 2841650 11098434 20201922 19500000 20186667 55229 122906 14458 9376 8534 5082 0 11847 34898547 43370074 2086391 3442150 22700000 20620000 24786391 24062150 X 10112156 19307924 10112156 19307924 34898547 43370074 9195768 0 X 0 0 0 0 1 0 4202 3735 467 10256 5641 4615 5082 X 0 0 0 DALVIR GILL CHIEF EXECUTIVE OFFICER 537333 0 358800 0 0 0 10600 0 47545 0 954278 0 0 0 JANICE CHANG SENIOR VICE PRESIDENT OF GLOBAL OPER 316156 0 82500 0 0 0 10600 0 20864 0 430120 0 0 0 JENNIFER A BURGESS DIRECTOR OF COMMUNICATIONS 204432 0 4000 0 0 0 8337 0 21444 0 238213 0 0 0 ROBERT A HAWKEY DIRECTOR OF QUALITY 148864 0 0 0 0 0 5955 0 8289 0 163108 0 0 0 CARA L RINALDI DIRECTOR OF PORTFOLIO MANAGEMENT 141155 0 0 0 0 0 0 0 19550 0 160705 0 0 0 PART I, LINE 3 THE EXECUTIVE COMMITTEE APPROVES THE COMPENSATION AND BONUS OF THE CEO. 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 $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 OR BE AN EXTERNAL PARTNER OF PHARMACEUTICAL COMPANIES IN CLINICAL TRIALS. FORM 990, PART VI, SECTION A, LINE 7A THE BOARD OF DIRECTORS SHALL BE COMPRISED OF UP TO TWENTY (20) MEMBERS; PROVIDED THAT: (I) TEN (10) SEATS ARE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE CHARTER MEMBERS; (II) UP TO TWO (2) 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 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 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. 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 11 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 15 THE TRANSCELERATE EXECUTIVE COMMITTEE PREPARES AND APPROVES THE COMPENSATION PACKAGE FOR THE CEO. THE CEO APPROVES THE COMPENSATION FOR THE SENIOR VICE PRESIDENT OF GLOBAL OPERATIONS, ALONG WITH ALL OTHER KEY EMPLOYEES. FORM 990, PART VI, SECTION C, LINE 19 THE ORGANIZATION'S GOVERNING DOCUMENTS, FINANCIAL STATEMENTS, AND CONFLICT OF INTEREST POLICY ARE AVAILABLE UPON REQUEST. FORM 990, PART IX, LINE 11G OUTSIDE CONTRACT - TECHNOLOGY CONSULTING SERVICES: PROGRAM SERVICE EXPENSES 2,315,875. MANAGEMENT AND GENERAL EXPENSES 19,830. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,335,705. CONSULTANTS -TECHNOLOGY CONSULTING SERVICES: PROGRAM SERVICE EXPENSES 3,623,602. MANAGEMENT AND GENERAL EXPENSES 354,883. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 3,978,485. CROSS WS FEES: PROGRAM SERVICE EXPENSES 1,473,061. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,473,061. MARKETING CONSULTANT - OUTSIDE CONSULTANT: PROGRAM SERVICE EXPENSES 13,500. MANAGEMENT AND GENERAL EXPENSES 410,350. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 423,850. FORM 990, PART VI, SECTION B, LINE 14 THE ORGANIZATION PLANS TO DEVELOP AND ADOPT A WRITTEN DOCUMENT RETENTION AND DESTRUCTION POLICY IN THE FUTURE. BIOCELERATE LLC 709 SWEDELAND ROAD KING OF PRUSSIA PA 19406 475492971 TO IMPROVE EFFICIENCIES IN PRECLINICAL RESEARCH. DE 0 2333280 TRANSCELERATE BIOPHARMA INC