2021-08-05T13:10:17-05:00 2020-12-31 582676261 Rogers & Company PLLC 8300 Boone Boulevard Suite 600 Vienna VA 22182 990 2020-01-01 263727917 Reagan-Udall Foundation for the Food and Drug Administration Inc REAG 2028492075 1900 L Street NW No 835 Washington DC 20036 Susan C Winckler RPh Esq Chief Executive Officer 2028492075 2021-08-05 1 Susan Winckler RPh Esq 999009999 Jie Chen CPA P01049760 7038930300 2021-07-30 2 AAL1 IAL1 2020 2022-09-23 18:48:47Z Susan C Winckler RPh E 1900 L Street NW No 835 Washington DC 20036 4920128 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. 14 14 11 0 0 0 1800144 2391995 920539 2485707 35048 22326 22794 -41901 2778525 4858127 0 0 0 0 1164355 1576299 0 0 276592 1356892 2866191 2521247 4442490 257278 415637 4065358 5042218 976206 1537973 3089152 3504245 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 2920865 2485707 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. 643974 COVID-19 Evidence Accelerator - The COVID-19 Evidence Accelerator, created in collaboration with Friends of Cancer Research, is a forum for stakeholders across the health care spectrum to share real-world data to foster a better understanding of the virus, and the impact of FDA-regulated diagnostic and therapeutic products used in the pandemic response. 209094 Vaccine Confidence Project (COVID-19) - Focused specifically on communication about FDA's role in vaccine review and authorization/approval, the Vaccine Confidence Project aims to provide the vaccine-hesitant with the information they need to decide whether or not to receive a COVID-19 vaccine. Project components included listening sessions with traditionally under-represented populations, message development, and message testing. 82617 Expanded Access Navigator Program - EA - The cornerstone of our expanded access outreach, education, and support, the Navigator is a comprehensive web-based tool that guides users through the process of accessing investigational medications after appropriate approved therapies have been exhausted. The Navigator houses the eRequest app, provides stakeholder guides, a company directory, and extensive resources. 91316 Nutrition Public-Private Partnership - Developing public-private partnership to advance education and strategies that can ultimately reduce nutrition-related chronic disease, including the launch of a Nutrition Communications Network. 173933 3947866 1 1 0 0 0 0 0 0 0 0 1 0 0 0 1 1 1 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 14 0 1 11 1 0 0 0 0 0 1 1 0 0 0 0 0 0 X 14 14 0 0 0 0 0 0 0 1 1 0 0 1 1 1 1 1 1 1 0 0 X Dave Woodbury 2028492067 1900 L Street Suite 835 Washington DC 20036 Ellen Sigal PhD Chair 4.00 X X 0 0 0 Richard Schilsky MD Vice Chair 4.00 X X 0 0 0 Jonathan Leff MBA Finance Chair 4.00 X X 0 0 0 Kay Holcombe MS Secretary 4.00 X X 0 0 0 Ed Allera JD Director 4.00 X 0 0 0 Georges Benjamin MD Director 4.00 X 0 0 0 Allan Coukell BScPharm Director 4.00 X 0 0 0 Helen Darling MA Director 4.00 X 0 0 0 Sally Greenberg JD Director 4.00 X 0 0 0 Garry Neil MD Director 4.00 X 0 0 0 Andrew von Eschenbach MD Director 4.00 X 0 0 0 Lynne Zydowsky PhD Director 4.00 X 0 0 0 Molly Fogarty Director 4.00 X 0 0 0 Adrian Hernandez MD Director 4.00 X 0 0 0 Susan C Winckler RPh Esq Chief Executive Officer 40.00 X 229257 0 23554 Amar Bhat PhD Chief Operating Officer 40.00 X 179316 0 60022 Carla Rodriguez-Watson PhD IMEDS Scientific Director 40.00 X 177971 0 30057 Lea Ann McNee MA Director of Communications and Engagement 40.00 X 148925 0 27218 David Woodbury MBA Director of Operations 40.00 X 154450 0 27067 Jacques Daphnis IMEDS Program Manager 40.00 X 105560 0 14974 995479 0 182892 6 0 1 0 Alston & Bird LLP 1201 W Peachtree St NE4900 Atlanta GA 30309 Legal services 120000 1 387150 1712867 291978 2391995 IMEDS Contract 541900 2485707 2485707 2485707 22326 22326 20100 387150 62001 -41901 -41901 4858127 2485707 0 -19575 X 492149 390613 30756 70780 912259 724049 57010 131200 35670 28311 2229 5130 43557 34571 2722 6264 92664 73546 5791 13327 110717 106561 3419 737 63363 63363 2299719 2273854 9712 16153 8423 6205 1423 795 21371 15743 3613 2015 112081 99051 8855 4175 98887 70495 12351 16041 1621 546 1075 24285 24005 280 55809 41115 9425 5269 8805 6487 1487 831 Miscellaneous 47425 42259 3534 1632 Dues and Subscriptions 7183 5292 1213 678 Professional Developmen 3251 2580 203 468 IRB expense 3251 3129 100 22 4442490 3947866 218032 276592 308782 879236 3381420 3026785 194410 987838 13740 156 32117 48524 284349 198702 120857 85647 14032 14032 4065358 5042218 460810 1395927 474070 114329 41326 27717 976206 1537973 X 2679562 3285207 409590 219038 3089152 3504245 4065358 5042218 415637 -544 0 X X 0 1 X 1 0 X 3669596 2881213 1847894 1800144 2391995 12590842 3669596 2881213 1847894 1800144 2391995 12590842 3007136 9583706 11 13 9575 35048 22326 66973 2999 2999 12660814 3979371 0.75700 0.63970 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 84473 53132 31341 199876 145570 54306 85647 Deferred rent/tenant improvement allowance 27717 27717 X 4919584 -544 62001 61457 4858127 0 4858127 4504491 62001 62001 4442490 0 4442490 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. Part XI, Line 2d - Other Adjustments: Direct benefits to donors 62,001. Part XII, Line 2d - Other Adjustments: Direct benefits to donors 62,001. 2020 Gala 407250 387150 20100 62001 407250 387150 20100 62001 62001 -41901 X 0 0 0 0 0 0 0 0 0 Susan C Winckler RPh Esq Chief Executive Officer 229257 0 0 0 0 0 12375 0 11179 0 252811 0 0 0 Amar Bhat PhD Chief Operating Officer 158316 0 21000 0 0 0 12630 0 47392 0 239338 0 0 0 Carla Rodriguez-Watson PhD IMEDS Scientific Director 176971 0 1000 0 0 0 11076 0 18981 0 208028 0 0 0 David Woodbury MBA Director of Operations 153450 0 1000 0 0 0 9330 0 17737 0 181517 0 0 0 Lea Ann McNee MA Director of Communications and Engag 147925 0 1000 0 0 0 4665 0 22553 0 176143 0 0 0 Form 990, Part III, line 2 The organization conducted two new programs in response to the COVID-19 pandemic: 1) COVID-19 Evidence Accelerator, and 2) Vaccine Confidence Project. The organization also conducted Nutrition Public-Private Partnership program to advance education and strategies that can ultimately reduce nutrition-related chronic disease. Form 990, Part III, line 3 The Big Data for Patients Project was ceased in this tax year. Form 990, Part VI, Section B, line 11b After the Form 990 is prepared by the independent accountants it is reviewed by the Chief Executive Officer 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 Temporary staff expense: Program service expenses 0. Management and general expenses 2,218. Fundraising expenses 0. Total expenses 2,218. Data partners: Program service expenses 1,858,776. Management and general expenses 0. Fundraising expenses 0. Total expenses 1,858,776. Other professional fees: Program service expenses 381,135. Management and general expenses 7,494. Fundraising expenses 16,153. Total expenses 404,782. Program consultants: Program service expenses 33,943. Management and general expenses 0. Fundraising expenses 0. Total expenses 33,943. 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.