NESTcc Charter

NESTcc’s organizational structure consists of a multi-stakeholder Governing Committee, which is a Committee established by the MDIC Board of Directors, and an Executive Director supported by program staff.

Working Groups composed of experts representing diverse perspectives may be established by the Governing Committee on an ad hoc basis.

Governing Committee

The NESTcc Governing Committee is comprised of key stakeholders from across the medical device ecosystem committed to the success of NESTcc and charged with inaugurating a Coordinating Center that is inclusive, patient-focused, and anchored in accountability and transparency.

The Governing Committee approved the launch of the Data Quality Subcommittee and the Methods Subcommittee, which are charged with developing data quality standards and identifying appropriate statistical methods for the use of Real-World Data (RWD).

The Governing Committee also approved the establishment of a multi-stakeholder Active Surveillance Task Force, which is tasked with establishing a Roadmap for leveraging NESTcc’s work to advance active surveillance and subsequently launch NESTcc’s first active surveillance projects.

Naomi Aronson, Ph.D.

Naomi Aronson, Ph.D.

Executive Director, Clinical Evaluation, Innovation, and Policy, Blue Cross Blue Shield Association (BCBSA)
Kathleen Blake, M.D., MPH

Kathleen Blake, M.D., MPH

NESTcc Governing Committee Treasurer, Vice President of Healthcare Quality at the American Medical Association (AMA)
Marc Boutin, J.D.

Marc Boutin, J.D.

CEO National Health Council
Michael Gibson, MS, MA, M.D., FRCP, FAHA, FSCAI, FACC

Michael Gibson, MS, MA, M.D., FRCP, FAHA, FSCAI, FACC

Professor of Medicine, Harvard Medical School, and CEO of the non-profit Baim Institute of Clinical Research

Pamela Goldberg, MBA

Pamela Goldberg, MBA

President and CEO of the Medical Device Innovation Consortium (MDIC)
Bill Hanlon, Ph.D.

Bill Hanlon, Ph.D.

Chief Development Officer and Head of Global Regulatory Affairs at LabCorp/Covance, and American Clinical Laboratory Association (ACLA) nominee
Adrian Hernandez, M.D., MHS

Adrian Hernandez, M.D., MHS

NESTcc Governing Committee Chair, Professor of Medicine at Duke School of Medicine, Vice Dean and Executive Director of the Duke Clinical Research Institute (DCRI)
Tamara Syrek Jensen, J.D.

Tamara Syrek Jensen, J.D.

Director, Coverage and Analysis Group, Center for Clinical Standards and Quality
Jennifer Kerr, MS, CCRA, RAC

Jennifer Kerr, MS, CCRA, RAC

President, Cook Research Incorporated, Medical Device Manufacturers Association (MDMA) nominee

Harlan Krumholz, M.D., SM

Harlan Krumholz, M.D., SM

Professor of Medicine and Epidemiology & Public Health at Yale University, and Director of the Yale New Haven Hospital Center for Outcomes Research and Evaluation (CORE)
Jennifer Luray, MPA

Jennifer Luray, MPA

Senior Advisor, Research!America

David Maggs, M.D.

David Maggs, M.D.

Vice President, Medical Affairs, Becton Dickinson Technologies and Innovation
Danelle Miller, BS, MA, J.D.

Danelle Miller, BS, MA, J.D.

Vice President of Global Regulatory Policy and Intelligence, Roche Diagnostics, AdvaMed nominee
Vance Moore

Vance Moore

President of Business Integration at Mercy
Diane Pickles, BA

Diane Pickles, BA

Program Director, One Brave Idea, American Heart Association
Art Sedrakyan, M.D., Ph.D.

Art Sedrakyan, M.D., Ph.D.

Professor of Population Health Sciences, Weill Cornell Medicine, and Director, Institute for Health Technologies and Interventions at Medical Device Epidemiology Network’s Coordinating, Science & Infrastructure Center
Jeffrey Shuren, M.D., J.D.

Jeffrey Shuren, M.D., J.D.

Director of FDA’s Center for Devices and Radiological Health (CDRH)
Diane Wurzburger, J.D.

Diane Wurzburger, J.D.

NESTcc Governing Committee Vice Chair, Regulatory Affairs Executive at GE Healthcare, and Medical Imaging & Technology Alliance (MITA) nominee