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Who Is Involved

The FDA leads the Sentinel System and Sentinel Initiative. In this capacity, the FDA:

  • Maintains decision-making authority and handles administering the Sentinel System contract
  • Establishes strategic priorities
  • Issues project requests
  • Reviews all work products

FDA Sentinel Leadership

Gerald Del Pan portrait photo
Gerald J. Dal Pan, MD, MHS
Director, CDER Office of Surveillance and Epidemiology
Robert Ball headshot photo
Robert Ball, MD, MPH
Deputy Director, CDER Office of Surveillance and Epidemiology
Professional headshot of Patricia "Trish" Bright
Patricia (“Trish”) Bright, PhD, MSPH
Associate Director for Sentinel, CDER Office of Surveillance and Epidemiology

Additional members of the FDA Sentinel Core Team:

  • Epidemiologist Team
    • Sarah Dutcher, PhD (Lead)
    • Jummai Apata, MBBS, DrPH
    • Jose J. Hernandez, RPh, MPH, MSc, PhD
    • Jamal T. Jones, PhD, MPH
    • Terrence (Terry) Lee, PhD., MPH
    • Fatma Shebl, MD, PhD, MS
    • Youjin Wang, PhD, RPh
  • Program Management Team
    • CAPT Jamila Mwidau, RN, MPH (Lead) 
    • LCDR Noah Argual, PharmD
    • Chanelle Jones, MHA, CPhT
    • Lucia Menegussi, BSN, MS, MSL

Lead Hubs

The IC has four Lead Hubs. These four hubs make up the Executive Leadership Team. Below are the four Lead Hubs in the Executive Leadership Team.

  1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School
  2. Duke University School of Medicine 
  3. Kaiser Permanente Washington Health Research Institute with the University of Washington School of Public Health
  4. Vanderbilt University Medical Center Department of Biomedical Informatics

Advisory Board

The Advisory Committee supports the Lead Hubs. The Advisory Committee provides strategic guidance to the IC. It comprises top thought leaders in healthcare innovation. This includes academia, government, and industry. 

Innovation Cores

The Innovation Cores identify novel technologies that could lead to new innovation projects. 

Innovation Partners and the National Network of Innovation Experts

Innovation Partners are industry leaders in technology innovation. 

The National Network of Innovation Experts also works with the Innovation Cores. It comprises individuals in academic and other research settings.  They have expertise in various domains of methods, innovation, and technology. 

Together, these two groups lead and support projects within the IC. They are innovators and pioneers in: 

  • Data science
  • Pharmacoepidemiology
  • Biostatistics
  • Biomedical informatics
  • Natural language processing
  • Machine learning and other areas of artificial intelligence
  • Signal detection
  • Advanced causal inference methods
  • Data linkage and integration
  • Pragmatic trials
  • Real-world evidence generation

Below is a list of Advisory Committee members, Innovation Partners, and National Network of Innovation Experts.

Click here to learn more about the Sentinel Innovation Center. 

The Harvard Pilgrim Health Care Institute leads the Sentinel Operations Center. They partner with a broad range of Data and Academic Partners to answer FDA’s questions. Together, these Collaborating Institutions provide healthcare data and scientific, technical, and organizational expertise.

Below is a complete list of Collaborating Institutions.

  1. Aetna, a CVS Health company*
  2. Brigham and Women's Hospital: Division of Pharmacoepidemiology & Pharmacoeconomics in the Department of Medicine
  3. Carelon Research/Elevance Health*
  4. Duke University School of Medicine: Department of Population Health Sciences (Medicare Fee-for-Service and Medicaid data)*
  5. Harvard T.H. Chan School of Public Health
  6. HCA Healthcare
  7. Health Care Systems Research Network
  8. HealthVerity
  9. Humana, Inc.*
  10. Kaiser Permanente Center for Effectiveness and Safety Research
  11. Merative 
  12. Optum*
  13. TriNetX
  14. University of Florida College of Pharmacy: Department of Pharmaceutical Outcomes & Policy
  15. University of North Carolina Gillings School of Global Public Health: Center for Pharmacoepidemiology
  16. University of Pennsylvania School of Medicine: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology
  17. Vanderbilt University Medical Center, Department of Health Policy (Tennesee Medicaid data)*

* Indicates Collaborating Institutions that are also Data Partners

Click here to learn more about the Sentinel Operations Center. 

Sentinel generates evidence by partnering with various organizations such as: 

  • Academic medical centers
  • Healthcare systems
  • Health insurance companies

The following Data Partners have data in the Sentinel Common Data Model:

  1. Aetna, a CVS Health company 
  2. Carelon Research/Elevance Health
  3. Duke University School of Medicine: Department of Population Health Sciences (Medicare Fee-for-Service and Medicaid data)
  4. HealthPartners Institute
  5. Humana, Inc.
  6. Kaiser Permanente Colorado Institute for Health Research
  7. Kaiser Permanente Hawai'i, Center for Integrated Health Care Research
  8. Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc.
  9. Kaiser Permanente Northwest Center for Health Research
  10. Kaiser Permanente Washington Health Research Institute
  11. Marshfield Clinic Research Institute
  12. Optum
  13. Vanderbilt University Medical Center, Department of Health Policy (Tennessee Medicaid data)

Contributions from Sentinel Data Partners are coordinated through the Sentinel Operations Center (SOC). In this model:

  1. FDA submits a study design to SOC
  2. SOC distributes analytic code to applicable Sentinel Data Partners to run on their source data
  3. Sentinel Data Partners return de-identified data to SOC
  4. SOC aggregates data from Sentinel Data Partners, and delivers final results to FDA

Learn more about how Sentinel gets its data.