2017-11-15T16:43:39-06:00 2016-12-31 582676261 Rogers & Company PLLC 8300 Boone Boulevard Suite 600 Vienna VA 22182 990 2016-01-01 263727917 Reagan-Udall Foundation for the Food and Drug Administration Inc REAG 2028492075 1900 L Street NW No 835 Washington DC 20036 June S Wasser Executive Director 2028492075 2017-11-15 1 Nicole M Prince CPA P01315245 7038930300 2017-11-15 72.214.41.82 2017-11-15 17:43:33 ES P 6C9B1A35775087DBDB8A6D25ECA509C7F6C27838 6C9B1A35775087DBDB8A6D25ECA509C7F6C27838 2016 2017-02-10 21:41:12Z X June Wasser 1900 L Street NW No 835 Washington DC 20036 3669607 0 X www.reaganudall.org X 2009 MD The Foundation's primary purpose is to support the scientific mission of the U.S. Food and Drug Administration by advancing regulatory science and research to modernize medical, veterinary, food, food ingredient and cosmetic product development, accelerate innovation and enhance product safety pursuant to Section 770 of the Federal Food, Drug and Cosmetic Act. The Foundation provides a unique opportunity to bring all parties to the table to work together to create new science. 13 13 10 0 0 0 3849070 3669596 0 0 11 11 0 0 3849081 3669607 0 342999 0 0 807223 636844 0 0 19740 3708974 1625623 4516197 2605466 -667116 1064141 1384427 1807309 731494 90235 652933 1717074 X The Foundation's primary purpose is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety pursuant to Section 770 of the Federal Food, Drug, and Cosmetic Act. 1 1 1858629 342999 Innovation in Medical Evidence Development and Surveillance (IMEDS) - The Reagan-Udall Foundation has formed a public-private partnership to provide access for private-sector entities, such as regulated industry, academic institutions, and non-profit organizations, to a system based on the Food and Drug Administration's (FDA) Sentinel Initiative. 250076 Big Data for Patients Project - A project funded by the Patient-Centered Outcomes Research Institute (PCORI) that helps train and educate patient advocates on issues related to the use of big data in biomedical research. 141151 Critical Path to Tuberculosis Drug Regimens Project - The Reagan-Udall Foundation is a partner in the global initiative to accelerate the development of new tuberculosis (TB) multi-drug regimens.The Foundation is proactively bringing together a broad range of international stakeholders with diverse perspectives to identify, prioritize, and work toward resolving regulatory science issues and challenges of drug development and treatments for people with TB. 105961 Expanded Access Navigator Program - EA - also known as compassionate use, named-patient use, or single-patient access - provides some patients who have serious or life-threatening diseases or conditions with access to investigational treatments not approved by the U.S. Food and Drug Administration. The Reagan-Udall Foundation's Expanded Access Navigator provides physicians, patients, and caregivers with guidance on EA and related topics. 40923 Other program services that help to further accomplish the organization's tax exempt purpose. 146884 2396740 1 1 0 0 0 0 0 0 0 0 1 0 0 0 0 1 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 10 0 1 10 1 0 0 0 0 0 0 0 0 0 0 X 13 13 0 0 0 0 0 0 0 1 1 0 0 1 1 1 1 1 1 1 0 0 X June Wasser 2028492075 1900 L Street Suite 835 Washington DC 20036 Ellen V Sigal PHD Chairman 4.00 X X 0 0 0 Richard L Schilsky MD Vice Chairman 4.00 X X 0 0 0 Kay Holcombe Secretary 4.00 X X 0 0 0 Sally J Greenberg JD Director 4.00 X X 0 0 0 Georges C Benjamin MD Director 4.00 X 0 0 0 Pamela G Bailey Director 4.00 X 0 0 0 Allan Coukell Director 4.00 X 0 0 0 Helen Darling Director 4.00 X 0 0 0 Garry Neil MD Director 4.00 X 0 0 0 Robert Meyer MD Director 4.00 X 0 0 0 Diana Zuckerman PHD Director 4.00 X 0 0 0 Tadataka Yamada MD Director 4.00 X 0 0 0 Sherine E Gabriel MD MSC Director 4.00 X 0 0 0 Mark McCellan MD PHD Director 4.00 X 0 0 0 Jonathan Leff MBA Director 4.00 X 0 0 0 June Wasser Executive Director 40.00 X 171531 0 9024 Nancy Beck Director 40.00 X 125040 0 17889 296571 0 26913 2 0 1 0 Ephir Inc 145 Tremont Street 4th Floor Boston MA 02111 Database Management 247000 Amazon Web Services Inc 12900 Worldgate Drive Herndon VA 20170 Database Hosting 199254 Troy McCall 104 Gorge Court Cary NC 27518 Consulting 108332 Truven Health Analytics Inc 7700 Old Georgetown Road 6th floor Bethesda MD 20814 Research Data 105055 4 1000000 2669596 3669596 11 11 3669607 0 0 11 X 342999 342999 180555 140545 35727 4283 354021 275571 70052 8398 22980 17888 4547 545 35801 27867 7085 849 43487 33850 8605 1032 75151 69949 4881 321 92647 86235 6017 395 1141237 1117448 22304 1485 53743 47819 5354 570 648 570 73 5 167878 146416 20191 1271 56147 53578 2243 326 25076 23928 1002 146 2952 2596 335 21 4592 4088 455 49 Moving and other 4552 4513 2 37 Registrations 1000 880 113 7 2605466 2396740 188986 19740 1172430 1513095 25224 25235 13929 173113 5823 150120 7224 100338 45251 5124 55087 17600 27732 1384427 1807309 549628 69939 20296 181866 0 731494 90235 X 11692 603142 641241 1113932 652933 1717074 1384427 1807309 1064141 0 X X 0 1 X 1 0 X 911268 4126161 4226045 3848959 3669596 16782029 911268 4126161 4226045 3848959 3669596 16782029 7719746 9062283 160 45 8 11 11 235 16782264 0.54000 0.50070 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 15136 11465 3671 85202 33786 51416 55087 X 3669607 0 3669607 0 3669607 2605466 0 2605466 0 2605466 Part X, Line 2: Management has evaluated the Foundation's tax positions and concluded that the Foundation's financial statements do not include any uncertain tax positions. 1 University of Illinois 1901 S First Street Suite A Champaign IL 61820 376000511 501(c)(3) 60000 n/a n/a IMEDS Methods Research University of North Carolina 910 Raleigh Road Chapel Hill NC 27514 566001393 501(c)(3) 100000 n/a n/a IMEDS Methods Research Brigham & Women's Hospital 75 Francis St Boston MA 02115 042312909 501(c)(3) 182999 n/a n/a IMEDS Methods Research 3 0 Part I, Line 2: Reagan Udall Foundation for the Food and Drug Administration, Inc. reviews grant reports and monitors grant progress toward milestones. X 0 0 0 0 0 0 0 0 0 June Wasser Executive Director 93750 0 0 0 77781 0 0 0 9024 0 180555 0 0 0 Form 990, Part III, line 2 The Expanded Access Navigator program was started during the year. Form 990, Part III, line 3 The IMEDS Methods Developments program ceased during the year. Form 990, Part VI, Section B, line 11b After the Form 990 is prepared by the independent accountants it is reviewed by the Executive Director and the Treasurer before being filed with the IRS. Form 990, Part VI, Section B, line 12c The conflict of interest policy covers all members of the Board, its Committees, business associates, and Foundation staff and their immediate families. It is monitored by annual written information statements which are reviewed and maintained by the Board and General Counsel. The entire Board reviews each transaction to come before the Board for potential or actual conflicts (past, present, or future) are identified, the person determined to have a conflict is recused from deliberation and voting. The identified conflicts of interest and appropriate recusals are documented in the minutes of each Board or Committee meeting. Form 990, Part VI, Section B, line 15a The CEO's performance and compensation is annually reviewed and approved by the Executive Committee with input from the Board. This entire process is documented. Salaries of all staff are reviewed annually by the CEO using compensation survey data for comparable size and type organizations. Form 990, Part VI, Section C, line 19 The Foundation makes its governing documents, conflict of interest policy, and financial statements available to the public upon request. Form 990, Part IX, line 11g Data licensing and analysis: Program service expenses 410,800. Management and general expenses 0. Fundraising expenses 0. Total expenses 410,800. Data partners: Program service expenses 51,321. Management and general expenses 0. Fundraising expenses 0. Total expenses 51,321. IMEDS LAB: Program service expenses 247,000. Management and general expenses 0. Fundraising expenses 0. Total expenses 247,000. Other professional fees: Program service expenses 92,853. Management and general expenses 6,479. Fundraising expenses 426. Total expenses 99,758. Program consultants: Program service expenses 116,371. Management and general expenses 15,477. Fundraising expenses 1,017. Total expenses 132,865. Payroll service fees: Program service expenses 1,368. Management and general expenses 348. Fundraising expenses 42. Total expenses 1,758. Curriculum Development : Program service expenses 92,295. Management and general expenses 0. Fundraising expenses 0. Total expenses 92,295. Scientific advisor: Program service expenses 55,440. Management and general expenses 0. Fundraising expenses 0. Total expenses 55,440. Advisory and research services: Program service expenses 50,000. Management and general expenses 0. Fundraising expenses 0. Total expenses 50,000. Form 990, Part XII, Line 2c: The Foundation's Finance Committee is responsible for oversight of the audit, including selection of the independent accountant. The process has not changed from prior years.