MDEpiNet Think Tank I: Active Surveillance

Capitalizing on the National/International Infrastructure to Develop Methods for 21 Century Active Surveillance

Agenda

https://collaboration.fda.gov/p7t3jsjptli/

https://collaboration.fda.gov/p73krg6ro4z/

https://collaboration.fda.gov/p72v8nuho3d/

https://collaboration.fda.gov/p59zzmfglv9/

8:00-8:15Opening Remarks Program Leaders: Sharon-Lise Normand, Harvard Frederic Resnic, Lahey Danica Marinac-Dabic, FDA8:15-9:30Plenary Session: Harnessing Real World Evidence for Active Surveillance: Moderators: Kathleen Hewitt, ACC and Ben Moscovitch, Pew Electronic Patient Data Linkage to EHR– Harlan Krumholz, Yale (30 min) Legal Environment– Robert Portman, Powers, Pyles, Sutter & Verville (30 min) Audience Questions (15 min)09:30-10:50Session 1: Envisioning Active Surveillance This session will describe what is meant by active surveillance today for devices and what it should include in the future. Moderator: Joseph Ross, Yale 1) Regulatory Perspective: Thomas Gross, FDA (15 min) 2) Small company perspective: Jeff Dunkel, Titan Spine (15 min) 3) Large company perspective: Richard Kuntz, Medtronic (15 min) 4) Public Health Perspective: Dale Nordenberg, Novasano Health & Science (15 min)11:05-12:20Session 2: Case Studies in Medical Device Surveillance: Today This session will focus on understanding specific examples of medical device surveillance. Each example to be a focused presentation including goal, approach, findings, and lessons learned. Moderator: Michael Matheny, Vanderbilt Example 1: Device surveillance using national registries – Frederic Resnic, Lahey (15 min) Example 2: Device surveillance using integrated health care delivery system – Guy Cafri, Kaiser (15 min) Example 3: Canadian Pilot – Mark Roche, ONC (15 min) Audience Discussion: Led by Moderator (30 min)13:20-14:55Session 3: Device Surveillance Methodology Efforts Today: Where are the Gaps? This session will identify the gaps by discussing strengths and weaknesses in the Session 2 Case studies (including scalability, sustainability, methodological consensus, alert/signal communication (to regulators, manufacturers, providers, patients) and operational control. Moderators: Sharon-Lise Normand, Harvard and Jesse Berlin, J&J Panel Members: Roseann White – Duke, Vahan Simonyan – FDA, Myoung Kim – J&J, Daniel Caños – CMS15:10–16:10Session 4: Prioritizing Methodology Developments This session will begin development of recommendations regarding the intersecting priorities of specific surveillance models. Moderators: Danica Marinac-Dabic, FDA and Harlan Krumholz, Yale Panel Members: Theodore Lystig – Medtronic, Libbe Englander – Pharm3r, Liz Paxton – Kaiser, Michael Matheny – Vanderbilt, Patient representative (TBA)16:10-16:45Closing Remarks: Sharon-Lise Normand, Harvard, Frederic Resnic, Lahey and Danica Marinac-Dabic, FDA 1) Review key next steps, 2) Identify authorship teams for white papers, 3) Announce next meeting and timeline.