2017-05-08T08:42:41-05:00 2016-12-31 131639826 EISNERAMPER LLP 130 NORTH 18TH STREET SUITE 3000 PHILADELPHIA PA 191032757 990 2016-01-01 460886344 TRANSCELERATE BIOPHARMA INC TRAN 4845391230 100 FOUR FALLS CORP CENTER NO 655 WEST CONSHOHOCKEN PA 19428 DALVIR GILL PHD CEO 4845391230 2017-04-24 1 HELEN M MARTIN P01330899 2158818800 64.238.150.4 2017-04-24 16:01:40 ED P DBDF583CE31E3164A18CA5FE06236636278EF75B F81DCA92B917B4887B7FAF71296E4FB236FABEB0 2016 2021-01-29 14:40:06Z X DALVIR GILL PHD 100 FOUR FALLS CORP CENTER NO 655 WEST CONSHOHOCKEN PA 19428 20679184 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.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS. 19 18 12 0 0 0 0 0 25400000 20620000 65264 59184 0 0 25465264 20679184 0 5000 0 0 3386042 3631766 0 0 0 12883454 20096938 16269496 23733704 9195768 -3054520 43370074 44721813 24062150 28468410 19307924 16253403 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 COMMON CHALLENGES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS. 0 0 17930739 20620000 IN 2016, TRANSCELERATE DELIVERED THE FOLLOWING ACCOMPLISHMENTS:LAUNCHED A NEW RELEASE OF THE INVESTIGATOR REGISTRY AND ALSO LAUNCHED THE SHARED INVESTIGATOR PLATFORM THAT WILL GREATLY ENHANCE COMMUNICATION BETWEEN CLINICAL TRIAL SPONSORS AND CLINICAL TRIAL INVESTIGATORS TRIAL INVESTIGATORS. 10 MEMBER COMPANIES HAVE JOINED AND ARE ACTIVELY SHARING DATA IN THE INVESTIGATOR REGISRY. 3 MEMBER COMPANIES HAVE ADOPTED THE SHARED INVETIGATOR PLATFORM AND ARE USING IT WITH NEW STUDIES.RELEASED A BASIC AND TECHNOLOGY ENABLED VERSION OF A COMMON PROTOCOL TEMPLATE, DOWNLOADED MORE THAN 1400 TIMES ACROSS 500+ ORGANIZATIONS IN 10 MONTHS SINCE RELEASE.CONTINUED TO PARTNER WITH THE STANDARD-SETTING ORGANIZATION CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC. TO DELIVER INDUSTRY-WIDE THERAPEUTIC AREA STANDARDS IN THE AREAS OF COPD, TUBERCULOSIS, BREAST CANCER, KIDNEY TRANSPLANT, RHEUMATOID ARTHRITIS, MAJOR DEPRESSIVE DISORDER, PAIN, DIABETIC KIDNEY DISEASE, EBOLA AND MALARIA.CREATED AND LAUNCHED A PLATFORM TO SHARE PLACEBO DATA FROM CLINICAL STUDIES ACROSS PARTICIPATING CLINICAL TRIAL SPONSOR COMPANIES. PUBLISHED 3 SIGNIFICANT PAPERS (CLINICAL QUALITY MANAGEMENT SYSTEM CONCEPT PAPER, ISSUE MANAGEMENT, AND KNOWLEDGE MANAGEMENT) ARTICULATING PRINCIPLES FOR A PROACTIVE QUALITY APPROACH TO ALL STAGES OF CLINICAL RESEARCH.PUBLISHED A MODEL APPROACH FOR DATA DE-IDENTIFICATION AND ANONYMIZATION OF INDIVIDUAL PATIENT DATA IN CLINICAL STUDIES.THE ELABELS INITIATIVE HAD THREE SIGNIFICANT DELIVERIES: (1) A PROOF OF CONCEPT FOR ELECTRONIC LABELS FOR CLINICAL TRIAL SUPPLIES; (2) A ROBUST IMPLEMENTATION TOOLKIT TO GUIDE ORGANIZATIONS ON THE TRANSITION TO ELABELS, WHICH WAS RELEASED TO TRANSCELERATE MEMBER COMPANIES; AND (3) A RIGOROUS EXTERNAL ENGAGEMENT APPROACH WHICH INCLUDED NUMEROUS SESSIONS WITH PATIENTS, SITES AND GLOBAL HEALTH AUTHORITIES TO SECURE FEEDBACK.THE E-CONSENT INITIATIVE LAUNCHED A DRAFT VERSION OF E-CONSENT IMPLEMENTATION GUIDANCE FOR PUBLIC COMMENT. TRANSCELERATE ALSO LAUNCHED NEW INITIATIVES FOCUSED ON CLINICAL TRIAL AWARENESS, ACCESS, PATIENT EXPERIENCE AND PATIENT TECHNOLOGY.BIOCELERATE'S TOXICOLOGY DATA SHARING INITIATIVE FINALIZED DETAILED BUSINESS REQUIREMENTS & USE CASES FOR SHARING TOXICOLOGY & BACKGROUND CONTROL DATA ACROSS PARTICIPATING MEMBER COMPANIES. 17930739 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 21 0 1 12 1 0 0 0 0 0 0 X 19 18 0 0 0 0 1 1 0 1 1 0 0 1 1 0 0 1 0 1 1 0 X ANTHONY GARGES ASSOCIATE DIRECTOR OF FINANCE 4845391235 100 FOUR FALLS CORP CENTER SUITE WEST CONSHOHOCKEN PA 19428 IRIS LOEW-FRIEDRICH CHAIR OF BOARD OF DIRECTOR 0.50 X 0 0 0 ELLIOTT LEVY VICE CHAIR OF BOARD OF DIR 0.50 X 0 0 0 ALISE REICIN 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 ZERHOUNI BOARD MEMBER 0.50 X 0 0 0 JAN LUNDBERG BOARD MEMBER 0.50 X 0 0 0 MICHELLE ROHRER 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 PETER KRISTENSEN BOARD MEMBER 0.50 X 0 0 0 PETER RONCO BOARD MEMBER 0.50 X 0 0 0 ROB SCOTT 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 1528004 0 51807 LYNN MARKS CORPORATE SECRETARY 0.50 X 0 0 0 ANDREW LEE TREASURER 0.50 X 0 0 0 JANICE CHANG SENIOR VICE PRESIDENT OF GLOBAL OPERATIONS 40.00 X 446425 0 32736 JENNIFER A BURGESS SENIOR DIRECTOR OF COMMUNICATIONS 40.00 X 261847 0 37107 SARAH L PLUSH DIRECTOR OF OPERATIONS 40.00 X 151757 0 19767 CARA L RINALDI SENIOR DIRECTOR OF PORTFOLIO MANAGEMENT 40.00 X 192733 0 38651 ANTHONY GARGES ASSOCIATE DIRECTOR OF FINANCE 40.00 X 157299 0 22853 2738065 0 202921 6 0 1 0 ACCENTURE LLP 161 N CLARK STREET CHICAGO IL 60601 CONSULTING & IT SERVICES 7598455 KILPATRICK TOWNSEND 601 14TH STREET NW SUITE 900 WASHINGTON DC 20005 LEGAL SERVICES 2205503 KINAPSE LIMITED 27-37 ST GEORGES ROAD LONDON UK SW194 4EU CONSULTING 1562315 COGNIZANT 211 QUALITY CIRCLE COLLEGE STATION TX 77845 IT SERVICES 1404605 YOH SERVICES LLC PO BOX 654068 DALLAS TX 75265 CONSULTING 1380861 16 MEMBERSHIP DUES 900099 20620000 20620000 20620000 59184 59184 20679184 20620000 0 59184 X 5000 5000 2058973 2058973 1237013 338816 898197 40087 12364 27723 185987 185987 109706 18767 90939 2177884 1645742 532142 138935 138935 15650529 14946840 703689 93277 54685 38592 161818 161818 675756 535088 140668 101710 101710 197293 101719 95574 420735 270761 149974 2518 2518 109304 109304 FACILITIES COSTS 227068 227068 BAD DEBT 86667 86667 RECRUITING 45226 45226 DUES 5321 500 4821 2897 457 2440 23733704 17930739 5802965 0 2841650 2026630 20201922 21694408 20186667 20833333 122906 153031 14458 11894 5082 2564 11847 11847 43370074 44721813 3442150 5135077 20620000 23333333 24062150 28468410 X 19307924 16253403 19307924 16253403 43370074 44721813 -3054520 0 X 0 0 0 0 1 0 4202 4202 0 10256 7692 2564 2564 X 0 0 0 DALVIR GILL CHIEF EXECUTIVE OFFICER 555295 0 972709 0 0 0 10600 0 41207 0 1579811 0 0 0 JANICE CHANG SENIOR VICE PRESIDENT OF GLOBAL OPER 336958 0 95753 0 13714 0 10600 0 22136 0 479161 0 0 0 JENNIFER A BURGESS SENIOR DIRECTOR OF COMMUNICATIONS 214847 0 47000 0 0 0 10525 0 26582 0 298954 0 0 0 SARAH L PLUSH DIRECTOR OF OPERATIONS 128007 0 23750 0 0 0 2162 0 17605 0 171524 0 0 0 CARA L RINALDI SENIOR DIRECTOR OF PORTFOLIO MANAGEM 157933 0 34800 0 0 0 7760 0 30891 0 231384 0 0 0 ANTHONY GARGES ASSOCIATE DIRECTOR OF FINANCE 128319 0 28980 0 0 0 6318 0 16535 0 180152 0 0 0 PART I, LINE 3 THE TRANSCELERATE EXECUTIVE COMMITTEE PREPARES AND APPROVES THE COMPENSATION PACKAGE 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. 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 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 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 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 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 EXTERNAL CONTRACTOR SUPPORT: PROGRAM SERVICE EXPENSES 6,989,404. MANAGEMENT AND GENERAL EXPENSES 234,142. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 7,223,546. PROJECT MANAGEMENT FEES: PROGRAM SERVICE EXPENSES 7,852,288. MANAGEMENT AND GENERAL EXPENSES 94,033. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 7,946,321. COMMUNICATIONS AND MARKETING FEES: PROGRAM SERVICE EXPENSES 105,148. MANAGEMENT AND GENERAL EXPENSES 375,514. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 480,662. 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 100 FOUR FALLS CORP CENTER SUITE 65 WEST CONSHOHOCKEN PA 19428 475492971 TO IMPROVE EFFICIENCIES IN PRECLINICAL RESEARCH. DE 2333333 2874395 TRANSCELERATE BIOPHARMA INC