2024-08-19T14:05:32-05:00 2023-12-31 521392008 GELMAN ROSENBERG & FREEDMAN 4550 MONTGOMERY AVE SUITE 800N BETHESDA MD 208142930 990 2023-01-01 812076517 INSTITUTE FOR ADVANCED CLINICAL TRIALS FOR CHILDREN INST 3016057571 199 E MONTGOMERY AVENUE 100 ROCKVILLE MD 20850 LAURA LOPEZ CFAO 3016057571 2024-08-19 1 0 ELIZABETH W HELLER P00397829 3019519090 2023 2024-08-08 14:25:15Z VIVIANNA GUZMAN F 199 E MONTGOMERY AVENUE 100 ROCKVILLE MD 20850 1463891 0 X WWW.IACTC.ORG X 2016 DE SEE PART III, LINE 1. 8 8 18 8 0 0 2354048 1126270 935146 258947 -15128 78674 0 0 3274066 1463891 132174 134894 0 0 3498361 2084411 0 13329 373631 1477335 1064161 5107870 3296795 -1833804 -1832904 5456460 3501048 258426 135918 5198034 3365130 X TO FUNCTION AS A NONPROFIT EDUCATIONAL, SCIENTIFIC AND RESEARCH ORGANIZATION TO EXPEDITE AND IMPROVE PEDIATRIC DRUG DEVELOPMENT FOR THE BENEFIT OF CHILDREN AND ENABLE AND ADVANCE PEDIATRIC CLINICAL RESEARCH PRESCRIBED BY REGULATION THROUGH: (CONTINUED ON SCHED.O) 0 0 2040676 134894 258947 DURING THIS TIME PERIOD, THE ORGANIZATION PROVIDED EXPERT GUIDANCE AND INPUT ON MULTIPLE PEDIATRIC CLINICAL DEVELOPMENT PLANS AND PEDIATRIC CLINICAL TRIALS WITH THE GOAL OF IMPROVING THE PROCESSES AND ACCELERATING THE DEVELOPMENT OF INNOVATIVE PRODUCTS FOR USE IN CHILDREN. ADDITIONALLY, THE ORGANIZATION ALSO CONNECTED REGULATORY QUALITY TRIAL READY SITES IN OUR PEDIATRIC CLINICAL TRIAL SITE NETWORK WITH CLINICAL TRIALS FOR A VARIETY OF BIOPHARMACEUTICAL COMPANIES ACROSS MULTIPLE THERAPEUTIC AREAS.THE ORGANIZATION UTILIZED ITS NETWORK OF EXPERTS TO CONVENE WORKING GROUPS TO ADDRESS PROBLEMS IN PEDIATRIC CLINICAL DEVELOPMENT COMMON ACROSS A VARIETY OF STAKEHOLDERS, THAT OTHERWISE WOULD NOT BE ADDRESSED IN A PRECOMPETITIVE MANNER.THE ORGANIZATION BROUGHT TOGETHER PEDIATRIC RESEARCH EXPERTS FROM ALL SECTORS ACADEMIA, CHILDREN'S HOSPITALS, INDUSTRY AND REGULATORY AGENCIES TO CONDUCT PEDIATRIC RESEARCH EDUCATIONAL WEBINARS TO CREATE A CONTINUOUS LEARNING ENVIRONMENT TO EXPAND BEST PRACTICES IN CLINICAL TRIALS CONDUCT AND IMPROVE QUALITY, SPEND AND VALUE. THROUGH THESE EDUCATIONAL INITIATIVES, THE ORGANIZATION HOPES TO FOSTER A COLLABORATIVE ENVIRONMENT WHERE RESEARCHERS CAN SHARE THEIR KNOWLEDGE AND EXPERIENCES TO IMPROVE THE QUALITY AND EFFICIENCY OF PEDIATRIC CLINICAL TRIALS. ULTIMATELY, THE GOAL IS TO ACCELERATE THE DEVELOPMENT OF NEW THERAPIES FOR CHILDREN AND IMPROVE OVERALL HEALTH OUTCOMES FOR PEDIATRIC POPULATIONS. 2040676 1 1 0 1 0 0 0 0 0 0 1 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 23 0 1 18 1 0 0 0 0 0 0 0 0 0 0 0 0 X 8 8 0 0 0 0 1 1 0 1 1 0 0 1 1 1 1 1 1 1 1 0 AL AR CA FL GA HI IL KS KY MD MA MI MN MS NH NJ NM NY NC OR PA RI SC TN UT VA WV WI X LAURA LOPEZ 3016057571 199 E MONTGOMERY AVENUE 100 ROCKVILLE MD 20850 ELIZABETH GAROFALO CHAIRWOMAN 3.00 X X 0 0 0 MARTHA BRUMFIELD SECRETARY/TREASURER 3.00 X X 0 0 0 BARRY BROOKS DIRECTOR 3.00 X 0 0 0 JAMES POMFRET DIRECTOR 3.00 X 0 0 0 MAX COPPES DIRECTOR 3.00 X 0 0 0 JEFF BARRETT DIRECTOR 3.00 X 0 0 0 DANIEL JORGENSEN DIRECTOR 3.00 X 0 0 0 TAMAROH LEWIS DIRECTOR 3.00 X 0 0 0 CYNTHIA JACKSON DILIBERTI COO, UNTIL 8/2023 40.00 X 124552 0 18065 VIVIANNA GUZMAN EXECUTIVE DIRECTOR, FROM 7/2023 40.00 X 240784 0 6095 GARY NOEL CMO, UNTIL 7/2023 40.00 X 122119 0 2198 ALEX LEBEAUT CEO, UNTIL 1/2023 40.00 X 67169 0 579 ALBERT JOHN ALLEN CMO, FROM 8/2023 10.00 X 48758 0 0 HOLLY HUNTINGTON HEAD, CLINICAL RESEARCH NTWK 40.00 X 222700 0 23714 LAURA LOPEZ CFAO 40.00 X 187448 0 26058 CALLIE HEATON DIR. CLINICAL PROJECT MGMT 40.00 X 166766 0 8218 ANGELA PRICE DIR. CLINICAL SITE NETWORK - QI 40.00 X 145393 0 17842 GABRIELA TULLOCH SR. MGR. CLINICAL SITE NETWORK 40.00 X 134197 0 21206 FAYNE MOORE SR. MGR. CLINICAL SITE NTWK 40.00 X 125337 0 21462 ANUSHREE PARIKH CLINICAL PROJECT MANAGER 40.00 X 102200 0 13443 1687423 0 158880 10 0 1 0 STEVEN H BIONDOLILLO PO BOX 812120 WELLESLEY MA 02482 SIGNATURE MARKETING & FUNDRAISING 105000 1 650000 179961 296309 1126270 CLINICAL PROGRAM GUIDA 900099 258947 258947 258947 78674 78674 1463891 258947 0 78674 X 134894 134894 1090238 771362 289750 29126 760318 557066 173103 30149 31097 22443 6927 1727 72176 51757 16291 4128 130582 93743 32486 4353 27598 15662 7625 4311 92699 52608 25611 14480 35999 15069 8719 12211 13329 13329 574200 245934 142302 185964 22187 6865 13585 1737 173358 31850 112238 29270 36760 12832 20268 3660 75172 19129 20172 35871 1485 378 398 709 560 560 24143 9084 12453 2606 3296795 2040676 882488 373631 1507358 567036 2459656 2223516 1272132 558560 64483 35368 86644 82969 10646 7845 3361 2801 62826 30798 5456460 3501048 81326 107685 117175 59925 28233 258426 135918 X 3948034 2815130 1250000 550000 5198034 3365130 5456460 3501048 -1832904 0 X 0 1 X 1 0 X 4916202 5953742 4045844 2354048 1126270 18396106 4916202 5953742 4045844 2354048 1126270 18396106 8836335 9559771 79565 49330 13051 19941 78674 240561 18636667 4047068 0.51300 0.52300 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 0 36329 36329 3247137 3283466 314173 78543 0 0 314173 314173 471260 36329 36329 78543 78543 117815 5045 5045 0 5601 2800 2801 2801 LEASE LIABILITY 28233 28233 1463891 0 1463891 0 1463891 3296795 0 3296795 0 3296795 1 UNIVERSITY OF CALIFORNIA IRVINE 120 THEORY SUITE 200 IRVINE CA 926971050 952226406 GOV'T 7500 0 ADMINISTRATIVE STARTUP FEE THE UNIVERSITY OF NEW MEXICO MSC09 5225 1 UNIVERSITY OF NEW MEXICO ALBUQUERQUE NM 871310001 856000642 GOV'T 10000 0 TRANSFER DATA CONTRIBUTION AGREEMENT ANN & ROBERT H LURIE CHILDREN'S HOSPITAL OF CHICAGO 225 EAST CHICAGO AVENUE BOX 271 CHICAGO IL 606112605 362170833 501(C)(3) 47740 0 TRANSFER DATA CONTRIBUTION AGREEMENT CHILDREN'S MERCY KANSAS CITY 2401 GILLHAM ROAD KANSAS CITY MO 64108 440605373 501(C)(3) 55197 0 TRANSFER DATA CONTRIBUTION AGREEMENT DRISCOLL CHILDREN'S HOSPITAL 3533 S ALAMEDA CORPUS CHRISTI TX 78411 742577746 501(C)(3) 10000 0 TRANSFER DATA CONTRIBUTION AGREEMENT 5 0 PART I, LINE 2: I-ACT FOR CHILDREN MAINTAINS A PRE-QUALIFIED REGULATORY READY PEDIATRIC SITE NETWORK CONSISTING OF SITES IN THE UNITED STATES, AUSTRALIA, CENTRAL AND SOUTH AMERICA. I-ACT FOR CHILDREN'S INFRASTRUCTURE SUPPORTS A VARIETY OF PROGRAMS FOR CLINICAL TRIAL SITES. THESE PROGRAMS INCLUDE QUARTERLY INFORMATIONAL CALLS TO KEEP SITES UPDATED AND INFORMED ON THE LATEST DEVELOPMENTS IN PEDIATRIC RESEARCH, SITE STAFF EDUCATIONAL FORUMS (4 OCCURRED IN 2023), SITE STAFF EDUCATIONAL GRANT PROGRAMS, AND A YEARLY SITE STAFF AWARD. WE PROVIDE ASSISTANCE TO OUR SITES WITH NAVIGATING THE SHARED INVESTIGATOR PLATFORM (SIP), WHICH IS REQUIRED BY SOME SPONSORS FOR A SITE TO BE SELECTED AS AN INVESTIGATIONAL SITE. OUR SITE NETWORK STAFF ALSO PERFORM REGULAR ENGAGEMENT CALLS AND ON-SITE VISITS ENSURING ONGOING QUALITY, STAFFING, PROCESSES AND TO MITIGATE ANY ISSUES WHICH MAY BE DISCOVERED. ADDITIONALLY, I-ACT FOR CHILDREN MAINTAINS A SECURE NETWORK PORTAL TO ENHANCE COLLABORATION AND COMMUNICATION AMONG ITS MEMBERS. AS PART OF A FEDERAL GRANT SUBAWARD WITH CRITICAL PATH INSTITUTE, I-ACT FOR CHILDREN'S SITE NETWORK WAS UTILIZED TO CONTRACT SITES (4 PAID IN 2023) FOR TRANSFER OF REAL-WORLD DATA TO CRITICAL PATH INSTITUTE WHICH GRANT FUNDS WERE PAID UPON DATA APPROVAL. X X X 0 0 0 0 0 0 0 1 0 VIVIANNA GUZMAN EXECUTIVE DIRECTOR, FROM 7/2023 240784 0 0 0 0 0 0 0 6095 0 246879 0 0 0 HOLLY HUNTINGTON HEAD, CLINICAL RESEARCH NTWK 219700 0 3000 0 0 0 9125 0 14589 0 246414 0 0 0 LAURA LOPEZ CFAO 187448 0 0 0 0 0 7906 0 18152 0 213506 0 0 0 CALLIE HEATON DIR. CLINICAL PROJECT MGMT 166766 0 0 0 0 0 6659 0 1559 0 174984 0 0 0 ANGELA PRICE DIR. CLINICAL SITE NETWORK - QI 145393 0 0 0 0 0 4900 0 12942 0 163235 0 0 0 GABRIELA TULLOCH SR. MGR. CLINICAL SITE NETWORK 134197 0 0 0 0 0 4767 0 16439 0 155403 0 0 0 PART I, LINE 7 HOLLY HUNTINGTON, LISTED IN FORM 990, PART VII, SECTION A, LINE 1A RECEIVED $3000 PERFORMANCE BONUS PAYMENT IN 2023. FORM 990, PART III, LINE 1 CONTINUATION: 1) THE DEVELOPMENT AND MAINTENANCE OF A PEDIATRIC RESEARCH SITE NETWORK, 2) OFFERING COMPREHENSIVE GUIDANCE TO STREAMLINE PEDIATRIC STUDY DESIGN AND FEASIBILITY ASSESSMENTS, 3) PROVIDING EDUCATIONAL RESOURCES THAT ILLUMINATE PIVOTAL CHANGES AND BEST PRACTICES WITHIN THE REALM OF PEDIATRIC CLINICAL TRIALS, 4) IMPLEMENTING A QUALITY, SPEED AND VALUE (QSV) IMPROVEMENT PROGRAM THAT ENHANCES PROCESSES ACROSS ALL NETWORK SITES ENGAGED IN PEDIATRIC RESEARCH, 5) ENGAGING IN ANY LAWFUL ACT OR ACTIVITY FOR WHICH CORPORATIONS MAY BE ORGANIZED UNDER THE DELAWARE GENERAL CORPORATION LAW. AS AMENDED FROM TIME TO TIME. ALSO, TO ENGAGE IN ANY LAWFUL ACT OR ACTIVITY PERMITTED FOR ORGANIZATIONS EXEMPT FROM FEDERAL INCOME TAX UNDER SECTION 501(C)(3) OF THE INTERNAL REVENUE CODE. FORM 990, PART VI, SECTION A, LINE 6 THE ORGANIZATION HAS THREE CLASSES OF MEMBERS (1) FOUNDING MEMBERS, CONSISTING OF CRITICAL PATH INSTITUTE, ELIZABETH GAROFALO, M.D., AND MARTHA BRUMFIELD, PH.D.; (2) SUSTAINING MEMBERS, CONSISTING OF ORGANIZATIONS THAT PROVIDE SUBSTANTIAL UNRESTRICTED FUNDS AS DUES TO THE CORPORATION OVER AN INITIAL MEMBERSHIP TERM OF FIVE YEARS, WITH ANNUAL CONTINUATION OPTION; AND (3) GENERAL MEMBERS, CONSISTING OF THOSE SUPPORTING THE PURPOSE AND ACTIVITIES OF THE CORPORATION OVER A ONE-YEAR TERM OF MEMBERSHIP. FORM 990, PART VI, SECTION A, LINE 7A FOUNDING AND SUSTAINING MEMBERS HAVE THE RIGHT TO VOTE ON THE BOARD OF DIRECTOR NOMINEES. FORM 990, PART VI, SECTION B, LINE 11B FORM 990 IS PREPARED BY AN EXTERNAL CPA FIRM USING INFORMATION PROVIDED BY THE ORGANIZATION. THE FORM IS REVIEWED BY THE AUDIT AND COMPENSATION COMMITTEE AND THE BOARD OF DIRECTORS PRIOR TO BEING FINALIZED. FORM 990, PART VI, SECTION B, LINE 12C TO ENSURE THE ORGANIZATION OPERATES IN A MANNER CONSISTENT WITH CHARITABLE PURPOSES AND DOES NOT ENGAGE IN ACTIVITIES THAT COULD JEOPARDIZE TAX-EXEMPT STATUS, PERIODIC REVIEWS SHALL BE CONDUCTED. THE PERIODIC REVIEWS SHALL, AT A MINIMUM, INCLUDE THE FOLLOWING SUBJECTS: (1) WHETHER COMPENSATION ARRANGEMENTS AND BENEFITS ARE REASONABLE, BASED ON COMPETENT SURVEY INFORMATION, AND THE RESULT OF ARM'S LENGTH BARGAINING, AND (2) WHETHER PARTNERSHIPS, JOINT VENTURES AND ARRANGEMENTS WITH MANAGEMENT ORGANIZATIONS CONFIRM TO THE CORPORATION'S WRITTEN POLICIES, ARE PROPERLY RECORDED, REFLECT REASONABLE INVESTMENT OR PAYMENTS FOR GOODS AND SERVICES, FURTHER CHARITABLE PURPOSE AND DO NOT RESULT IN INUREMENT, IMPERMISSIBLE PRIVATE BENEFIT OR IN AN EXCESS BENEFIT TRANSACTION. WHEN CONDUCTING THE PERIODIC REVIEWS, THE ORGANIZATION MAY, BUT NEED NOT, USE OUTSIDE ADVISORS. IF OUTSIDE ADVISORS ARE USED, THEIR USE SHALL NOT RELIEVE THE GOVERNING BOARD OF ITS RESPONSIBILITY FOR ENSURING PERIODIC REVIEWS ARE CONDUCTED. FORM 990, PART VI, SECTION B, LINE 15 THE TOP MANAGEMENT OFFICIAL, EXECUTIVE DIRECTOR, HAS COMPENSATION REVIEWED BY AN INDEPENDENT PERSON (HR CONSULTANT AND AUDIT AND COMPENSATION COMMITTEE CHAIR, OR BOARD OF DIRECTORS APPOINTEE), COMPARABILITY DATA FROM BENCHMARKING AND DELIBERATION AND DECISION IS REFLECTED IN THE BOARD MEETING MINUTES. THE APPROVED PAY RATE UPON HIRE IS VALIDATED BY A SIGNED OFFER LETTER BY THE BOARD CHAIRPERSON FOR THE EXECUTIVE DIRECTOR. FOR THE CMO AND CFO POSITIONS, THE EXECUTIVE DIRECTOR, OR THE BOARD OF DIRECTORS CHAIRPERSON, WILL EVALUATE THE BENCHMARKING AND SIGN THE OFFER LETTER FOR THE APPROVED PAY RATE. FORM 990, PART VI, SECTION C, LINE 19 THE ARTICLES OF INCORPORATION, CONFLICT OF INTEREST POLICY AND FINANCIAL STATEMENTS ARE AVAILABLE UPON REQUEST. FORM 990, PART IX, LINE 11G COMMUNICATION & PUBLIC RELATIONS: PROGRAM SERVICE EXPENSES 7,202. MANAGEMENT AND GENERAL EXPENSES 4,167. FUNDRAISING EXPENSES 5,446. TOTAL EXPENSES 16,815. PAYROLL & BENEFIT SERVICES: PROGRAM SERVICE EXPENSES 4,499. MANAGEMENT AND GENERAL EXPENSES 2,603. FUNDRAISING EXPENSES 3,402. TOTAL EXPENSES 10,504. RECRUITMENT: PROGRAM SERVICE EXPENSES 47. MANAGEMENT AND GENERAL EXPENSES 28. FUNDRAISING EXPENSES 35. TOTAL EXPENSES 110. CONTRACTOR - PHYSICIAN: PROGRAM SERVICE EXPENSES 26,822. MANAGEMENT AND GENERAL EXPENSES 15,520. FUNDRAISING EXPENSES 20,282. TOTAL EXPENSES 62,624. OTHER PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 207,364. MANAGEMENT AND GENERAL EXPENSES 119,984. FUNDRAISING EXPENSES 156,799. TOTAL EXPENSES 484,147.