2020-10-27T14:36:41-05:00 2019-12-31 BDO USA LLP 100 PARK AVENUE NEW YORK NY 100175001 990 2019-01-01 134128413 GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT INC % ANGELA VANDERPLOEG GLOB 2122277540 40 WALL STREET 24TH FLOOR NEW YORK NY 10005 ANGELA VANDERPLOEG CFO 2122277540 2020-10-27 true Paul Hammerschmidt P01384178 2128858000 71.249.96.48 26308920203015000010 2020-10-27 P 5B647EDC1EA3D2D73D6BFB779DE102FCC5954E55 39C0125CC38244DCDF9016B1ED97A2DB16F09D4F 2019 2021-01-29 14:40:06Z TB ALLIANCE ANGELA VANDERPLOEG 40 WALL STREET 24TH FLOOR NEW YORK NY 10005 174873899 false X WWW.TBALLIANCE.ORG X 2000 DE TO ACCELERATE THE DISCOVERY & DEVELOPMENT OF NEW DRUGS TO FACILITATE THE CONTROL OF TUBERCULOSIS THROUGHOUT THE WORLD AND THE ACCESSIBILITY OF THESE DRUGS TO THE GLOBAL COMMUNITY. 8 7 51 9 0 0 62252482 68288037 0 0 1019722 106399584 11286 186278 63283490 174873899 278027 522335 0 0 13493212 14649391 0 0 1312399 46544406 54363353 60315645 69535079 2967845 105338820 75171538 189418881 15761770 24731091 59409768 164687790 X TB ALLIANCE IS A NOT-FOR-PROFIT ORGANIZATION DEDICATED TO THE DISCOVERY, DEVELOPMENT AND DELIVERY OF BETTER, FASTER-ACTING AND AFFORDABLE TUBERCULOSIS DRUGS THAT ARE AVAILABLE TO THOSE WHO NEED THEM. false false 59508295 252950 0 RESEARCH AND DEVELOPMENT - TB Alliance is a not-for-profit product development partnership (PDP), uniquely positioned to leverage a global network of public and private partners to most efficiently advance TB drug development. A PDP builds partnerships between the public, private, academic, and philanthropic sectors to drive the development of new products for underserved markets. As a PDP, TB Alliance sets research and product development strategy and holds direct management oversight of its projects, which are carried out in partnership with external research facilities and contractors. We combine the research and development expertise of our staff with the skills and resources of our partners to harness the most promising science wherever it may exist around the world. This model minimizes costs, including overhead and investments in infrastructure, while optimizing scientific capability to speed new TB drug development. Our business model and diverse partnerships allow TB Alliance to leverage additional partner services for every dollar invested in the TB Alliance. NIX-TB - The phase 3 Nix-TB trial is an open-label, single arm trial that is evaluating the BPaL regimen. Nix-TB participants with extensively drug-resistant tuberculosis (XDR-TB) and treatment-intolerant or non responsive multidrug-resistant (MDR) TB were treated with bedaquiline, pretomanid and linezolid over six months, extended to nine months in two cases, with the intent to cure. Nix-TB enrolled 109 participants in three sites in South Africa. Results published in the New England Journal of Medicine showed a 90% treatment success rate. In 2019, the US FDA approved pretomanid as part of this regimen. In the year following US approval, BPaL has been approved in the European Union and India as well as recommended by the World Health Organization for use in operational research settings. OPTIMIZED FIRST-LINE DRUGS IN CHILDREN >5KG - TB Alliance is working to develop appropriate child-friendly formulations of the current standard TB treatment. The first wave of these new products has already reached market, with more than 90 countries ordering over 1 million treatment courses since launch in 2016. SIMPLICITB - SimpliciTB is evaluating the efficacy, safety and tolerability of a novel and potentially shorter drug regimen (BPaMZ) for patients with drug-sensitive (DS) and drug-resistant (MDR) pulmonary tuberculosis (specifically multidrug-resistant TB and mono-resistance to isoniazid and rifampicin). The BPaMZ regimen is comprised of four different antimicrobials: Bedaquiline (B), Pretomanid (Pa), Moxifloxacin (M) and Pyrazinamide (Z). The new drug regimen will be administered for four months to patients with DS-TB, and for six months to patients with MDR-TB or mono-resistance to rifampicin or isoniazid. Results in the DS-TB arm will be compared to a control group of the standard six-month drug regimen for DS-TB (HRZE). ZENIX - The phase 3 ZeNix clinical trial is evaluating the BPaL regimen to treat extensively drug resistant tuberculosis (XDR-TB) and those with pre-XDR-TB and multi-drug resident TB (MDR-TB) whose prior treatment has failed or who have not tolerated their treatment. It seeks to optimize linezolid dosing as part of the BPaL regimen, evaluating both the linezolid dose and the linezolid duration. 3821906 269386 0 PUBLIC AFFAIRS AND POLICY - TB ALLIANCE HAS CRITICAL ALLIANCES WITH PUBLIC AND PRIVATE ORGANIZATIONS TO RAISE AWARENESS ABOUT TUBERCULOSIS ("TB") AND ADVOCATE FOR PUBLIC AND PRIVATE INVOLVEMENT IN RESEARCH FOR THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY TO THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR ON THE DEVELOPMENT OF THESE MEDICINES. TB Alliance continues to pursue an explicit committment to our "AAA Mandate" - that all new products will be adopted, available, and affordable to those with TB. 469270 0 0 BUSINESS DEVELOPMENT - TB ALLIANCE NEGOTIATES, IMPLEMENTS AND MANAGES AGREEMENTS WITH PUBLIC AND PRIVATE ORGANIZATIONS WORLDWIDE AND DOES SO BY ADHERING TO SOUND BUSINESS PRACTICES WHILE ENSURING THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY TO THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR TO HELP DEVELOP NEW MEDICINES FOR TB INDICATIONS. 63799471 true true false false false false false false false false true false false false true true true false false true true true false false false false false true false true false false false false false false false false false false false false false false false false false true 115 0 true 51 true false true BE false false false false false false false false false false X 8 7 false false false false false false false true true false false true true true true true true true true false NY X ANGELA VANDERPLOEG 2122277540 40 WALL STREET 24TH FLOOR NEW YORK NY 10005 X DR MELVIN SPIGELMAN PRESIDENT/CEO 45.0 0.0 X X 859558 0 81162 DR NADER FOTOUHI CHIEF SCIENTIFIC OFFICER 45.0 0.0 X 501422 0 80454 DR DANIEL EVERITT SR. MEDICAL OFFICER & VP 45.0 0.0 X 415406 0 60664 COLLEEN PERO SECRETARY/CAO 45.0 0.0 X 416403 0 45844 ROBERT LORETTE SR. VP, BUSINESS DEVELOPMENT 45.0 0.0 X 394347 0 59120 DR PAUL BRUINENBERG SR. MEDICAL OFFICER 45.0 0.0 X 365125 0 57730 Sandeep Juneja Senior VP, Market Access 45.0 0.0 X 339463 0 69738 WILLO BROCK SENIOR VP, EXTERNAL AFFAIRS 45.0 0.0 X 345925 0 54949 DR KATHLEEN SCHOSTACK VP, PROGRAM & ALLIANCE MGMT. 45.0 0.0 X 342225 0 58177 ANGELA VANDERPLOEG TREASURER/CFO 45.0 0.0 X 324562 0 68729 DR CARL MENDEL SENIOR VP, R&D (THRU 6/2019) 45.0 0.0 X 314789 0 36162 Dr Eugene Sun SENIOR VP, R&D (EFF 6/2019 45.0 0.0 X 232966 0 30118 DR BRUCE CARTER CHAIRMAN 3.0 0.0 X X 0 0 0 DR MARIO RAVIGLIONE VICE-CHAIR 3.0 0.0 X X 0 0 0 DR DEBREWORK ZEWDIE VICE-CHAIR (thru 12/2019) 3.0 0.0 X X 0 0 0 Jan Landberg from 12 DIRECTOR 3.0 0.0 X 0 0 0 DAVID NORTON DIRECTOR (thru 12/2019) 3.0 0.0 X 0 0 0 ARIEL PABLOS-MENDEZ DIRECTOR 3.0 0.0 X 0 0 0 NANCY MILLER RICH DIRECTOR 3.0 0.0 X 0 0 0 SHALINI SHARP DIRECTOR 3.0 0.0 X 0 0 0 Mitchell Warren from DIRECTOR 3.0 0.0 X 0 0 0 4852191 0 702847 37 false true false PPD GLOBAL LIMITED GRANTA PARK CAMBRIDGE 0 UK CB21 6GQ GLOBAL CRO 8759071 WUXI APTEC HONGKONG LIMITED 288 FUTE ZHONGLU SHANGHAI 0 CH 200131 INTEGRATED R&D SVCS. 3186403 BARC NV INDUSTRIEPARK ZWIJNAARDE 3 BE B-9052 Global Laboratory 2681043 RTI International PO Box 900002 RALEIGH NC 27675 Integrated R&D SVCS 1696406 Charles River Laboratories Inc PO Box 27812 NEW YORK NY 10087 Integrated R&D SVCS 1623760 80 41745689 26542348 68288037 0 1399584 1399584 0 0 0 0 0 105000000 105000000 105000000 105000000 0 0 0 0 0 0 0 0 0 MISCELLANEOUS INCOME 900099 186278 186278 186278 174873899 0 0 106585862 X 11454 11454 0 510881 510881 0 3378011 2326606 779598 271807 0 8795648 6994715 1261726 539207 644487 514324 90637 39526 349589 303363 28745 17481 1481656 1140859 243126 97671 0 637644 504658 132986 92464 92464 0 0 0 11673932 11196786 461115 16031 0 357280 81392 272188 3700 1117525 615675 452007 49843 0 1314035 974689 238731 100615 1037418 813154 95948 128316 0 349636 201793 100275 47568 0 0 7209 5309 1336 564 217012 79051 137961 R&D PROJECT EXPENSES 36509210 36509210 0 0 PUBLIC AND MEDIA OUTREACH 928480 928480 0 0 DUES AND SUBSCRIPTIONS 121508 87072 34366 70 69535079 63799471 4423209 1312399 1567 0 72418626 182678043 21625 1716923 189791 882162 0 0 0 0 0 0 0 0 2451450 3455762 4403918 3778069 28337 625849 0 0 0 0 0 0 0 0 60142 60142 75171538 189418881 8822090 12118780 0 0 6938408 12606418 0 0 0 0 0 0 0 0 0 0 1272 5893 15761770 24731091 X 59409768 164687790 0 0 59409768 164687790 75171538 189418881 X 105338820 -60798 X false true X true true true X 61185278 52895919 57593669 62252482 68288037 302215385 0 0 61185278 52895919 57593669 62252482 68288037 302215385 151293021 150922364 77246 137450 357901 1019722 1399584 2991903 0 0 0 54928 11286 186278 252492 305459780 0.49408 0.46508 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 3317524 2693396 624128 618618 616897 1721 467776 467776 625849 0 DEFERRED RENT 5893 5893 X 174873899 174873899 174873899 69535079 69535079 69535079 PART X, LINE 2: Under Financial Accounting Standards Board (FASB) Accounting Standards codification ("ASC") 740, "Income Taxes", an organization must recognize the tax benefit associated with tax positions taken for tax return purposes when it is more likely than not the position will be sustained upon examination by a taxing authority. Global Alliance for TB Drug Development, Inc. does not believe it has taken any material uncertain tax positions and, accordingly, it has not recorded any liability for unrecognized tax benefits. The organization has filed for and received income tax exemptions in the jurisdictions where it is required to do so. Additionally, The organization has filed IRS Form 990 information returns, as required, and all other applicable returns in jurisdictions where so required. For the year ended December 31, 2019, there was no interest or penalties recorded or included in the statement of activities. The organization is subject to routine audits by a taxing authority. true East Asia and the Pacific Program Services ADMIN EXPENSES 5000 East Asia and the Pacific Program Services CONSULTING SERVICES 784339 East Asia and the Pacific Grantmaking 283509 East Asia and the Pacific Program Services R&D Research 4800026 Europe (Including Iceland and Greenland) 1 Program Services ADMIN EXPENSES 154183 Europe (Including Iceland and Greenland) 6 Program Services CONSULTING SERVICES 1654894 Europe (Including Iceland and Greenland) Program Services R&D Research 16879445 Middle East and North Africa Program Services ADMIN EXPENSES 413 North America Program Services R&D Research 37075 Russia and the Newly Independent States Program Services ADMIN EXPENSES 593 Russia and the Newly Independent States 2 Program Services CONSULTING SERVICES 7471 Russia and the Newly Independent States Grantmaking 20546 South America Program Services ADMIN EXPENSES 16 South America 2 Program Services CONSULTING SERVICES 115096 South America Grantmaking 32183 South Asia Program Services ADMIN EXPENSES 74246 South Asia Program Services CONSULTING SERVICES 28519 South Asia Program Services R&D Research 1656303 Sub-Saharan Africa Program Services ADMIN EXPENSES 323737 Sub-Saharan Africa 10 Program Services CONSULTING EXPENSES 410602 Sub-Saharan Africa Grantmaking 174643 Sub-Saharan Africa Program Services R&D Research 452267 Sub-Saharan Africa 1 5 Program Services SALARY EXPENSES 643234 1 10 1 15 2 25 24877554 3660786 28538340 Russia and the Newly Independent States comm. engage. 16820 WIRE Sub-Saharan Africa comm. engage. 10394 WIRE Sub-Saharan Africa COMM. ENGAGE 14250 WIRE Sub-Saharan Africa COMM. ENGAGE 27956 WIRE East Asia and the Pacific Indonesia 252950 WIRE South America COMM. ENGAGE 31433 WIRE Sub-Saharan Africa COMM. ENGAGE 21909 WIRE Sub-Saharan Africa COMM. ENGAGE 16750 WIRE Sub-Saharan Africa COMM. ENGAGE 13988 WIRE East Asia and the Pacific COMM. ENGAGE 28310 WIRE Sub-Saharan Africa COMM. ENGAGE 7002 WIRE Sub-Saharan Africa COMM. ENGAGE 49044 WIRE 10 2 false false false false false false PART I, LINE 2: The grantee is required to provide the organization with an itemized accounting of expenditures for the Project and a report on the progress of the Project on a schedule specified in the agreement. This requirement is outlined in the signed agreement between both parties. true Fund for the City of New York 121 Avenue of the Americas NEW YORK NY 10013 132612524 501(C)(3) 10000 TB AWARENESS 1 PART I, LINE 2: The grantee is required to provide the organization with an itemized accounting of expenditures for the Project and a report on the progress of the Project on a schedule specified in the agreement. This requirement is outlined in the signed agreement between both parties. X X X X X false false false false false false false true false DR MELVIN SPIGELMAN PRESIDENT/CEO 557282 0 302276 0 0 0 47160 0 34002 0 940720 0 0 0 ANGELA VANDERPLOEG TREASURER/CFO 277576 0 46986 0 0 0 21472 0 47257 0 393291 0 0 0 COLLEEN PERO SECRETARY/CAO 311548 0 104855 0 0 0 25831 0 20013 0 462247 0 0 0 DR CARL MENDEL SENIOR VP, R&D (THRU 6/2019) 181711 0 133078 0 0 0 20471 0 15691 0 350951 0 0 0 Dr Eugene Sun SENIOR VP, R&D (EFF 6/2019 232966 0 0 0 0 0 15031 0 15087 0 263084 0 0 0 DR NADER FOTOUHI CHIEF SCIENTIFIC OFFICER 371159 0 130263 0 0 0 32828 0 47626 0 581876 0 0 0 DR DANIEL EVERITT SR. MEDICAL OFFICER & VP 324456 0 90950 0 0 0 25942 0 34722 0 476070 0 0 0 ROBERT LORETTE SR. VP, BUSINESS DEVELOPMENT 294392 0 99955 0 0 0 25524 0 33596 0 453467 0 0 0 WILLO BROCK SENIOR VP, EXTERNAL AFFAIRS 257291 0 88634 0 0 0 21003 0 33946 0 400874 0 0 0 DR PAUL BRUINENBERG SR. MEDICAL OFFICER 302864 0 62261 0 0 0 23739 0 33991 0 422855 0 0 0 DR KATHLEEN SCHOSTACK VP, PROGRAM & ALLIANCE MGMT. 268426 0 73799 0 0 0 21000 0 37177 0 400402 0 0 0 Sandeep Juneja Senior VP, Market Access 276703 0 62760 0 0 0 22246 0 47492 0 409201 0 0 0 PART I, LINE 7: Merit bonuses are paid to staff members based on annual performance. See Schedule O response to Form 990, Part VI, Section B, Lines 15a and 15b for additional detail. FORM 990, PART VI, SECTION B, LINE 11B: Form 990 was prepared by a nationally recognized accounting firm in conjunction with the organizations financial department. Draft Form 990 was reviewed by the organizations finance department and Senior Management, and then provided to all members of the Board of Directors in draft via electronic mail, with an opportunity for them to comment or make inquiry before it was filed with the Internal Revenue Service. FORM 990, PART VI, SECTION B, LINE 12C: The organization's conflict policy is distributed to officers and directors annually along with a questionnaire that is completed by all officers and directors in which they are asked to disclose information regarding actual or potential conflicts. These questionnaires are collected and reviewed annually to ensure compliance with the conflict policy. The policy itself also requires any director or officer to promptly disclose any conflict of interest. Interested directors and officers are required to recuse themselves from any decision on matters in which they have an interest, and such recusal is noted in the minutes. FORM 990, PART VI, SECTION B, LINES 15A AND 15B: The Compensation Committee, which consists of three independent Board members, annually reviews the CEO and officers compensation in conjunction with an evaluation of organizational performance. The committee recommends adjustments in compensation to the full board for review and approval, within the context of an agreed upon competitive position. The competitiveness of compensation is periodically benchmarked using independent salary survey data from the not-for-profit and for-profit industry. The compensation committee documentation includes the performance assessment, comparable data and the source of this data, and the recommended adjustments. The minutes of the full Board include documentation of the approved decisions. The minutes of the board and committee are prepared before the later of the next meeting or 60 days after the final decision of the board and the committee. FORM 990, PART VI, SECTION C, LINE 19: THE ORGANIZATION MAKES ITS GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY, AND FINANCIAL STATEMENTS AVAILABLE TO THE PUBLIC UPON REQUEST. FORM 990, PART IX, LINE 11G: PROFESSIONAL SERVICES AND AGREEMENTS INCLUDE INDIVIDUAL CONSULTANTS WHO ARE CONTRIBUTING THEIR SPECIFIC EXPERTISE RELATED TO OUR CLINICAL TRIALS AND OTHER EARLY STAGE AND PRECLINICAL DISCOVERY WORK. EXPERTISE IN SUCH AREAS AS PHARMACOVIGILANCE, NON-GLP BIOANALYSIS, ANALYTICAL EVALUATION OF DRUG STABILITY AND PROGRAM MANAGEMENT ARE SOME OF THE SERVICES REQUIRED IN ORDER TO COMPLETE OUR SCIENTIFIC RESEARCH AND DEVELOPMENT. THESE CONSULTANTS ARE MANAGED BY OUR STAFF, WHO COORDINATE THE WORK NECESSARY TO BE COMPLETED AMONG ALL OUTSIDE PARTIES. FORM 990, PART XI, LINE 9: FOREIGN TRANSLATION LOSS....$(60,798). FORM 990 PART IX LINE 11G DESCRIPTION:PROFESSIONAL SVCS & AGREEMENTS TOTAL FEES:11673932