Active Surveillance Task Force

The NESTcc Governing Committee approved the establishment of a small, multi-stakeholder Active Surveillance Task Force charged with leveraging NESTcc’s work to advance active surveillance and subsequently launch NESTcc’s first active surveillance projects.

Task Force membership includes key stakeholder representation from patients, clinicians, health systems, the US Food and Drug Administration (FDA), payers, and the medical device industry. The Task Force will also include members with expertise in patient privacy as related to “big data.” This diverse composition provides perspectives essential to building NESTcc’s capacity to support a successful active surveillance program.

Additional information on the background of this Task Force, including the US Food and Drug Administration’s November 2018 update to the Medical Device Safety Action Plan outlining how NESTcc will be leveraged to more quickly detect emerging safety signals through active surveillance, can be found here.

Current Members

  • Kathleen Blake, MD, MPH, American Medical Association
  • Daniel Caños, PhD, MPH, U.S. Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH)
  • Heather Colvin, MPP, Johnson & Johnson
  • Kevin Haynes, PharmD, MSCE, Janssen
  • Harlan Krumholz, MD, SM, Yale School of Medicine
  • Brad Malin, PhD, Vanderbilt University
  • Bray Patrick-Lake, MFS, Evidation
  • Frederic Resnic, MD, MSc, Lahey Health

Past Members

  • Jose Pablo Morales, MD, FDA/CDRH
  • Danica Marinac-Dabic, MD, PhD, MMSc, FISPE, FDA/CDRH
  • Aron Yustein, MDFDA/CDRH

IT Cloud Working Group

The IT Cloud Working Group is charged with designing and building the Active Surveillance Cloud Infrastructure platform that will be used to facilitate the collection and analysis of real-world data for medical device safety signal detection and assessment.

Current Members

  • Daniel Caños, PhD, MPH, FDA/CDRH
  • Alexandra Cha, PhD, PMP, NESTcc/Booz Allen Hamilton
  • Joseph Drozda, MD, Mercy Health
  • Curtis Dudley, Mercy Health
  • Alexander Hanson, NESTcc/Booz Allen Hamilton
  • Steve Jones, MS, Pandera Systems
  • Jacqueline Puigbo, PhD, MS, FDA/CDRH
  • Frederic Resnic, MD, MSc, Lahey Health
  • LeRoy Ruggerio, Johnson & Johnson
  • Henry Ssemaganda, MD, MPH, Lahey Health
  • Daniel Zagales, Pandera Systems

Past Members

  • T.S. Sundar, MBA, McKesson
  • Joshua Sutton, MBA, Pandera Systems

Active Surveillance Methodology Working Group

The Active Surveillance Task Force approved the establishment of a small, multi-stakeholder Active Surveillance Methodology Working Group charged with providing oversight and methodologic expertise on NESTcc’s conducted literature review and drafted report determining the strengths and weaknesses of currently used safety signal detection methodology.

  • Bill Altonaga, MD, OD, BD
  • Francis Campion, MD, MITRE Corporation
  • Paul Coplan, ScD, MBA, MPH, Johnson & Johnson
  • Heidi Dohse, Tour de Heart
  • Rachele Hendricks-Sturrup, DHSc, MSc, MA, Duke-Margolis Center
  • Jacob Hicks, MS, BIOTRONIK, Inc.
  • April Lavender, RAC, Cook Medical
  • Theodore Lystig, PhD, Bridgebio
  • Hilal Maradit Kremers, MD, MSc, Mayo Clinic
  • Michael Matheny, MD, MS, MPH, Vanderbilt University Medical Center
  • Stephen Mikita, JD, SMA Foundation
  • Jacqueline Puigbo, PhD, MS, FDA/CDRH
  • Nicholas Wold, MS, Boston Scientific