2014-11-10T10:18:20-06:00 2013-12-31 131639826 EISNERAMPER LLP 101 WEST AVENUE PO BOX 458 JENKINTOWN PA 190460458 990 2013-01-01 460886344 TRANSCELERATE BIOPHARMA INC TRAN 6102707620 709 SWEDELAND ROAD NO UW2103 KING OF PRUSSIA PA 19406 DALVIR GILL PHD CEO 6102707620 2014-11-10 1 STEVEN GLUECK P00856557 2158818800 2013 2015-11-30 17:44:51Z DALVIR GILL PHD 709 SWEDELAND ROAD NO UW2103 KING OF PRUSSIA PA 19406 13643765 0 X WWW.TRANSCELERATEBIOPHARMAINC.COM X 2012 PA TRANSCELERATE BIOPHARMA INC. IS A NON-PROFIT ORGANIZATION FOCUSED ON ADVANCING INNOVATION IN RESEARCH AND DEVELOPMENT (R&D) AND IDENTIFYING AND SOLVING COMMON R&D CHALLENGES WITH THE GOAL OF DELIVERING MORE HIGH QUALITY MEDICINES TO PATIENTS. 17 16 2 0 0 0 0 0 5671000 13630000 1849 13765 0 0 5672849 13643765 0 0 0 0 0 1109529 0 0 16752 5494217 5713774 5494217 6823303 178632 6820462 5857436 9075300 5678804 1902607 178632 7172693 X TRANSCELERATE BIOPHARMA INC. IS A NON-PROFIT ORGANIZATION FOCUSED ON ADVANCING INNOVATION IN RESEARCH AND DEVELOPMENT (R&D) AND IDENTIFYING AND SOLVING COMMON R&D CHALLENGES WITH THE GOAL OF DELIVERING MORE HIGH QUALITY MEDICINES TO PATIENTS. 1 0 3943936 13630000 RISK BASED MONITORING - DEVELOP MODEL AND APPROACH FOR RISK BASED MONITORING OF CLINICAL TRIALS IN ORDER TO ENHANCE PATIENCE SAFETY AND ENSURE THE QUALITFY OF CLINCIAL TRIAL DATA.SHARED INVESTIGATOR PLATFORM - DEVELOP A SINGLE INTUITIVE INTERFACE FOR CLINICAL INVESTIGATORS USABLE ACROSS THE INDUSTRY. THE PLATFORM WILL REDUCE THE BURDEN ON CLINICAL TRIAL INVESTIGATORS AND SITES BY ENABLING A SINGLE SIGN-ON AND ACCESS TO MULTIPLE SPONSORS' SYSTEM THROUGH A SINGLE INTERFACE.SITE QUALIFICATION AND TRAINING- DEVELOPED A FRAMEWORK FOR MUTUAL RECOGNITION OF GCP TRAINING AND SITE QUALIFICATION CREDENTIALS IN ORDER TO REALIZE EFFICIENCIES AND ACCELERATE STUDY START-UP TIMELINES.CLINCIAL DATA STANDARDS - IN PARTNERSHIP WITH CDISC, FDA, AND THE CRTICAL PATH INSTITUE, DEVELOP INDUSTRY-WIDE DATA STANDARDS IN PRIORITY THERAPEUTIC AREAS TO SUPPORT THE EXCHANGE AND SUBMISSION OF CLINICAL RESEARCH AND META-DATA, IMPROVING PATIENT SAFETY AND OUTCOMES.COMPARATOR DRUGS - ESTABLISH RELIABLE, RAPID SOURCING OF QUALITY PRODUCTS FOR USE IN CLINICAL TRIALS THROUGH A COMPARATOR SUPPLY MODEL ENABLING ACCELERATED TRIAL TIMELINES AND ENHANCED PATIENT SAFETY.NEW INITIATIVES IN 2014:COMMON CLINICAL TRIAL PROTOCOL TEMPLATES - WORKING WITH OTHER INDUSTRY STAKEHOLDERS AND REGULATORS, TRANSCELERATE SEEKS TO DEVELOP A MODEL FORMAT FOR CLINICAL TRIAL PROTOCOLS AND PROTOCOL ENDPOINTS, IN ALIGNMENT WITH THE ONGOING TRANSCELERATE CLINICAL DATA STANDARDS PROJECT. THIS WILL SIMPLIFY STUDY PROTOCOLS, FACILITATE DATA INTERPRETATION AND ENABLE DOWN-STREAM AUTOMATION OF MANY CLINICAL PROCESSES, INCREASING PRODUCTIVITY AND REDUCING COSTS FOR INDUSTRY STAKEHOLDERS. SPECIAL POPULATIONS CLINICAL TRIAL NETWORKS (PEDIATRIC AND MINORITY) - TRANSCELERATE, WORKING CLOSELY WITH THE INVESTIGATOR COMMUNITY, WILL EXPLORE WAYS TO INCREASE THE NUMBER OF CLINICAL TRIALS AND NUMBER OF PATIENTS PARTICIPATING IN CLINCIAL TRIALS FOR DRUGS DEVELOPED TO TREAT CHILDREN, ADOLESCENTS AND MINORITY POPULATIONS WHICH WILL RESULT IN ACCELERATED DEVELOPMENT OF NEW DRUGS OR INDICATIONS AS WELL AS REDUCED CLINICAL TRIAL COSTS.INVESTIGATOR REGISTRY - TRANSCELERATE'S INVESTIGATOR REGISTRY WILL CREATE A SHARED REPOSITORY OF INVESTIGATOR CONTACT DETAILS ANDSITE-RELATED DATA. THIS INITIATIVE IS AIMED AT ACCELERATING THE IDENTIFICATION AND RECRUITMENT OF QUALIFIED INVESTIGATORS, WHICH WILL AVOID DUPLICATION OF STANDARD SITE AND LEAD TO THE CREATION OF A COMMON SOURCE FOR INVESTIGATOR DOCUMENTATION, AND THEREBY REDUCING COSTS AND TRIAL LENGTH.QUALITY MANAGEMENT SYSTEMS TRANSCELERATE IS EXPLORING WAYS TO IMPROVE QUALITY INDUSTRY-WIDE THROUGH PARTNERSHIPS WITH REGULATORY AGENCIES AND INDUSTRY STAKEHOLDERS TO ASSURE DATA INTEGRITY, MINIMIZE DELAYS IN CLINCIAL TRIALS, AND BRING DRUGS TO THE MARKET MORE QUICKLY.CLINICAL DATA TRANSPARENCY TRANSCELERATE IS DEVELOPING A POSITION ON THE BEST AND MOST EFFICIENT METHODS FOR REDACTING PRIVACY INFORMATION FOUND IN CLINICAL STUDY REPORTS. THE BENEFITS ARE TO MEET THE NEEDS OF INDUSTRY STAKEHOLDERS WHILE PRESERVING THE PRIVACY OF PATIENT, INVESTIGATORS, AND CLINICAL TRIAL STAFF. 3943936 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 9 0 1 2 1 0 0 0 0 0 0 X 17 16 0 0 1 0 1 1 1 1 1 0 0 1 1 0 0 0 0 1 0 0 X ANTHONY GARGES FINANCE LEAD 6102707620 709 SWEDELAND ROAD KING OF PRUSSIA PA 19406 ANNALISA JENKINS CHAIR OF BOARD OF DIRECTORS 0.50 X 0 0 0 STEVEN C GILMAN BOARD MEMBER 0.50 X 0 0 0 JOHN M LEONARD BOARD MEMBER 0.50 X 0 0 0 PABLO CAGNONI BOARD MEMBER 0.50 X 0 0 0 BRIAN DANIELS BOARD MEMBER 0.50 X 0 0 0 BRIGGS MORRISON BOARD MEMBER 0.50 X 0 0 0 CORSEE SANDERS BOARD MEMBER 0.50 X 0 0 0 ELIAS ZERHOUNI 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 JOHN HUBBARD BOARD MEMBER 0.50 X 0 0 0 KLAUS DUGI BOARD MEMBER 0.50 X 0 0 0 MARCO TAGLIETTI BOARD MEMBER 0.50 X 0 0 0 PATRICK VALLANCE BOARD MEMBER 0.50 X 0 0 0 PAUL STOFFELS BOARD MEMBER 0.50 X 0 0 0 PETER CARBERRY BOARD MEMBER 0.50 X 0 0 0 DALVIR GILL CHIEF EXECUTIVE OFFICER 40.00 X X 600000 0 38069 LYNN MARKS CORPORATE SECRETARY 0.50 X 0 0 0 MARTIN FITCHET TREASURER 1.00 X 0 0 0 600000 0 38069 1 0 1 0 ACCENTURE LLP 2005 MARKET ST ONE COMMERCE SQ 15TH PHILADELPHIA PA 19103 CONSULTING 3418939 SOA SOFTWARE INC 12100 WILSHIRE BLVD STE 1800 LOS ANGELES CA 90025 COMPUTER, SOFTWARE 450000 PENTICO SOLUTIONS INC 385 BODINE RD BERWYN PA 19312 CONSULTING 368329 KILPATRICK TOWNSEND & STOCKTON LLP 1114 AVENUE OF THE AMERICAS 21 NEW YORK NY 10036 LEGAL 334603 4 MEMBERSHIP DUES 900099 13630000 13630000 13630000 13765 13765 13643765 13630000 0 13765 X 983069 983069 81360 81360 18007 18007 27093 27093 569795 359462 210333 104590 104590 4660849 3512093 1148756 46631 5133 41498 40674 17549 23125 30000 30000 100255 5949 94306 56817 56817 52472 43750 8722 34939 34939 MISCELLANEOUS 16752 16752 6823303 3943936 2862615 16752 394218 2924035 4590834 4505325 847800 1020028 24584 40326 638058 52472 0 585586 5857436 9075300 2472728 706431 3206076 1196176 0 5678804 1902607 X 178632 7172693 178632 7172693 5857436 9075300 6820462 173599 0 X X 0 1 X 1 0 0 1 0 638058 52472 585586 585586 X 23831850 10201850 10201850 13630000 13765 13765 13643765 16851554 10028251 10028251 6823303 0 6823303 PART XI, LINE 4B - OTHER ADJUSTMENTS: INVESTMENT INCOME 13,765. 1 X 0 0 0 DALVIR GILL CHIEF EXECUTIVE OFFICER 500000 0 100000 0 0 0 0 0 38069 0 638069 0 0 0 PART I, LINE 3 THE BOARD APPROVES THE COMPENSATION AND BONUS OF THE CEO. FORM 990, PART III, LINE 2 UPDATE: TRANSCELERATE BIOPHARMA INC LAUNCHED FIVE FURTHER INITIATIVES WHICH INCLUDE THE CREATION OF A COMMON CLINICAL TRIAL PROTOCOL TEMPLATES, A PROJECT TO IMPROVE THE PARTICIPATION OF PEDIATRIC AND DIVERSE PATIENT POPULATIONS, THE DEVELOPMENT OF A GLOBAL INVESTIGATOR REGISTRY, A PROJECT FOCUSED ON QUALITY INDUSTRY WIDE, AND THE DEVELOPMENT OF THE MOST EFFICIENT METHOD OF REDACTING PRIVACY INFORMATION IN CLINICAL STUDY REPORTS. FORM 990, PART VI, SECTION A, LINE 4 SECTION 2.01(A)(I) OF THE BYLAWS ORIGINALLY PROVIDED THAT: THE INITIAL TIER 1 MEMBERS, DEFINED AS THOSE MEMBERS WHOSE MEMBERSHIP HAS BEEN ACCEPTED BY THE BOARD OF DIRECTORS AND WHICH HAVE PAID THE INITIAL MEMBERSHIP DUES WITHIN SIXTY (60) DAYS OF INCORPORATION OF THE CORPORATION, SHALL BE THE CHARTER MEMBERS OF THE CORPORATION. THE BOARD OF DIRECTORS VOTED TO AMEND THE BYLAWS TO PROVIDE THE INITIAL TIER 1 MEMBERS, DEFINED AS THOSE MEMBERS WHOSE MEMBERSHIP HAS BEEN ACCEPTED BY THE BOARD OF DIRECTORS AND WHICH HAVE PAID THE INITIAL MEMBERSHIP DUES BY NO LATER THAN DECEMBER 31, 2012, SHALL BE THE CHARTER MEMBERS OF THE CORPORATION. 2. SECTION 2.01(A)(II) OF THE BYLAWS ORIGINALLY PROVIDED THAT: 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 $500 MILLION. THE BOARDED OF DIRECTORS VOTED TO AMEND THE BYLAWS TO PROVIDE: 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. 3. SECTION 2.01(A)(III) OF THE BYLAWS ORIGINALLY PROVIDED THAT: 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 $500 MILLION OR BE AN EXTERNAL PARTNER OF PHARMACEUTICAL COMPANIES IN CLINICAL TRIALS. THE BOARDED OF DIRECTORS VOTED TO AMEND THE BYLAWS TO PROVIDE: 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. 4. SECTION 3.02 OF THE BYLAWS ORIGINALLY PROVIDED THAT: THE INITIAL BOARD OF DIRECTORS SHALL BE COMPRISED OF UP TO SEVENTEEN (17) MEMBERS; PROVIDED THAT: (I) A MINIMUM OF TEN (10) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER I MEMBERS WHO ARE CHARTER MEMBERS (AS DESIGNATED AS SUCH BY THE BOARD OF DIRECTORS OF THE CORPORATION IN ITS SOLE DISCRETION) (CHARTER MEMBER DIRECTORS) AND, IF SUCH NUMBER IS INCREASED IN THE FUTURE, THE REMAINDER OF SUCH SEATS RESERVED MAY BE FILLED BY TIER I MEMBERS THAT ARE NOT CHARTER MEMBERS (TIER I DIRECTORS); (II) AT LEAST FIVE (5) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER II MEMBERS (TIER II DIRECTORS) . . . . THE BOARDED OF DIRECTORS VOTED TO AMEND THE BYLAWS TO PROVIDE: THE BOARD OF DIRECTORS SHALL BE COMPRISED OF UP TO TWENTY (20) MEMBERS; PROVIDED THAT: (I) A MINIMUM OF TWELVE (12) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER I MEMBERS WHO ARE CHARTER MEMBERS (AS DESIGNATED AS SUCH BY THE BOARD OF DIRECTORS OF THE CORPORATION IN ITS SOLE DISCRETION) (CHARTER MEMBER DIRECTORS) AND, IF SUCH NUMBER IS INCREASED IN THE FUTURE, THE REMAINDER OF SUCH SEATS RESERVED MAY BE FILLED BY TIER I MEMBERS THAT ARE NOT CHARTER MEMBERS (TIER I DIRECTORS); (II) AT LEAST SIX (6) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER II MEMBERS (TIER II DIRECTORS) . . . . 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 CATAGORIES 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 1 MEMBER 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 CORPORATIONS BY-LAWS 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. FORM 990, PART VI, SECTION A, LINE 7B 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 15A THE TRANSCELERATE BOARD OF DIRECTORS PREPARES AND APPROVES THE COMPENSATION PACKAGE FOR THE CEO. 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 CONSULTANTS: PROGRAM SERVICE EXPENSES 3,502,901. MANAGEMENT AND GENERAL EXPENSES 1,148,756. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 4,651,657. OUTSIDE CONTRACT: PROGRAM SERVICE EXPENSES 9,192. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 9,192. FORM 990,PART XII, QUESTION 2C THE FINANCE COMMITTEE OF THE BOARD ASSUMES OVERSIGHT RESPONSIBILITY FOR THE AUDIT PROCESS. THIS PROCESS REMAINS UNCHANGED FROM THE PRIOR YEAR. FORM 990,PART VI, SECTION B, LINE 13 THE ORGANIZATION DOES NOT HAVE A WRITTEN WHISTLEBLOWER POLICY. A WHISTLEBLOWER POLICY IS BEING DEVELOPED AND WILL BE ADOPTED. FORM 990,PART VI, SECTION B, LINE 14 THE ORGANIZATION DOES NOT HAVE A WRITTEN DOCUMENT RETENTION AND DESTRUCTION POLICY. A DOCUMENT RETENTION AND DESTRUCTION POLICY IS BEING DEVELOPED AND WILL BE ADOPTED.