FDA’s Data Enterprise Modernization July 20, 2021 2:00 PM – 5:00 PM July 21, 2021 2:00 PM – 5:30 PM Participant List:

Thomas Acciani Felipe Aguel Center for Devices and Radiological Health Center for Devices and Radiological Health U.S. Food and Drug Administration U.S. Food and Drug Administration

Laleh Amiri-Kordestani Robert Ball Center for Drug Evaluation and Research Center for Drug Evaluation and Research U.S. Food and Drug Administration U.S. Food and Drug Administration

Tammy Beckham Jonathan Bidwell Center for Devices and Radiological Health Center for Devices and Radiological Health U.S. Food and Drug Administration U.S. Food and Drug Administration

Patrick Bowen Jeffrey Brown Center for Devices and Radiological Health Harvard Medical School U.S. Food and Drug Administration

Atul Butte Robert Califf University of California, San Francisco Verily Life Sciences

Daniel Canos Brian Canter Center for Devices and Radiological Health Duke-Robert J. Margolis, MD, Center for Health U.S. Food and Drug Administration Policy

David Carrell Grace Chai Kaiser Permanente Washington Health Center for Drug Evaluation and Research Research Institute U.S. Food and Drug Administration

Aloka Chakravarty Blair Childs Office of the Commissioner Premier Inc. U.S. Food and Drug Administration

Meredith Chuk Antoinette Coleman Office of the Commissioner Office of the Commissioner U.S. Food and Drug Administration U.S. Food and Drug Administration

John Concato Rena Conti Center for Drug Evaluation and Research Boston University U.S. Food and Drug Administration

Jacqueline Corrigan-Curay Cathy Critchlow Center for Drug Evaluation and Research Inc. U.S. Food and Drug Administration

William Crown Fran Cunningham Brandeis University U.S. Department of Veteran Affairs

Gerald Dal Pan Kathleen Davies Center for Drug Evaluation and Research Office of the Commissioner U.S. Food and Drug Administration U.S. Food and Drug Administration

Vid Desai Pam Douglas Office of Information Management and MITRE Corporation Technology U.S. Food and Drug Administration

Nancy Dreyer Joseph Franklin IQVIA Office of the Commissioner U.S. Food and Drug Administration

Jennifer Goldsack Daniel Gottlieb Digital Medicine Society Center for Drug Evaluation and Research U.S. Food and Drug Administration

Donna Gulbinski Anne Heatherington Civica Rx Takeda Pharmaceuticals

Rachele Hendricks-Sturrup Michie Hunt Duke-Robert J. Margolis, MD, Center for Health Center for Drug Evaluation and Research Policy U.S. Food and Drug Administration

Balaji Iyer Ram Iyer Microsoft Corporation Office of the Commissioner U.S. Food and Drug Administration

Eva Katcher Troy Kirchenbauer MITRE Corporation Vizient, Inc.

Swati Kulkarni Trevan Locke Office of the Commissioner Duke-Robert J. Margolis, MD, Center for Health U.S. Food and Drug Administration Policy

David Margraf Mark McClellan University of Minnesota Duke-Robert J. Margolis, MD, Center for Health Policy

Vera Mucaj Pamela Ogonowski Datavant Office of Regulatory Affairs U.S. Food and Drug Administration

Valerie Parker Bakul Patel Duke-Robert J. Margolis, MD, Center for Health Center for Devices and Radiological Health Policy U.S. Food and Drug Administration

Eric Perakslis Jeremy Rassen Aetion, Inc.

Eugene Reilly Linda Ricci Office of Regulatory Affairs Center for Devices and Radiological Health U.S. Food and Drug Administration U.S. Food and Drug Administration

Donna Rivera Thomas Roades Oncology Center of Excellence Duke-Robert J. Margolis, MD, Center for Health U.S. Food and Drug Administration Policy

Laura Roe Morgan Romine Office of the Commissioner Duke-Robert J. Margolis, MD, Center for Health U.S. Food and Drug Administration Policy

Matthew Rosenberg Patrick Ryan Center for Drug Evaluation and Research Observational Health Data Sciences and U.S. Food and Drug Administration Informatics

Anindita Saha Soumi Saha Center for Devices and Radiological Health Premier Inc. U.S. Food and Drug Administration

Matthew Sample Stephen Schondelmeyer AmerisourceBergen Corporation University of Minnesota

David Shaywitz Christina Silcox Astounding HealthTech Duke-Robert J. Margolis, MD, Center for Health Policy

Mary Ann Slack Kevin Starry Center for Drug Evaluation and Research Office of Regulatory Affairs U.S. Food and Drug Administration U.S. Food and Drug Administration

Douglas Throckmorton Gina Valo Center for Drug Evaluation and Research Office of the Commissioner U.S. Food and Drug Administration U.S. Food and Drug Administration

Nina Walia Susan Winckler Office of the Commissioner Reagan-Udall Foundation U.S. Food and Drug Administration

Cecilia Wolyniak Charile Yongpravat Office of Regulatory Affairs Center for Devices and Radiological Health U.S. Food and Drug Administration U.S. Food and Drug Administration

Nevine Zariffa Heather Zenk Office of the Commissioner AmerisourceBergen Corporation U.S. Food and Drug Administration