TOWN HALL WITH THE FDA (Non-CME)

Moderator(s)

• 

  Joshua Beckman, MD

  Chief, Division of Vascular Medicine
  UT Southwestern Medical Center
  Vascular Medicine
  Dallas, Texas, United States

  Disclosure(s): Janacare: Stockholder - Privately-held company
  Medtronic: Consultant
  Merck: Consultant
  Novartis: Consultant
  Novo Nordisk: Consultant
  Regeneron: Consultant
  tourmaline: Consultant
• MM

  Misti Malone, PhD

  FDA
  Silver Spring, Maryland, United States

  Disclosure(s): No financial relationships to disclose

Panel(s)

• 

  Ehrin Armstrong, MD

  Interventional Cardiology and Vascular Intervention
  Swedish Medical Center
  Interventional Cardiology
  Denver, Colorado, United States

  Disclosure(s): No financial relationships to disclose
• DB

  Donna Buckley, MD

  FDA
  Silver Spring, Maryland, United States

  Disclosure(s): No financial relationships to disclose
• 

  Brian DeRubertis, MD

  Chief, Division of Vascular Surgery
  NewYork-Presbyterian / Weill Cornell Medical Center
  Vascular Surgery
  New York, New York, United States

  Disclosure(s): Abbott Vascular: Advisory Board; Consultant; Grants/Research Support Recipient; Speaker/Honoraria (includes speakers bureau, symposia, and expert witness)
  BD (formerly Bard): Advisory Board; Consultant
  Boston Scientific: Advisory Board; Consultant; Grants/Research Support Recipient
  Cagent: Grants/Research Support Recipient; Speaker/Honoraria (includes speakers bureau, symposia, and expert witness)
  Concept Medical: Advisory Board; Consultant; Grants/Research Support Recipient; Speaker/Honoraria (includes speakers bureau, symposia, and expert witness)
  Medtronic: Advisory Board; Consultant; Speaker/Honoraria (includes speakers bureau, symposia, and expert witness)
• FD

  Finn Donaldson, PhD

  FDA
  Silver Spring, Maryland, United States

  Disclosure information pending.
• 

  Michael Jaff, DO

  Professor of Medicine (retired)
  Harvard Medical School
  Vascular Medicine
  Maple Grove, Minnesota, United States

  Disclosure(s): Access Vascular: Stockholder - Privately-held company
  Boston Scientific: Employee; Stockholder - Publicly-traded company (excludes mutual/index funds)
  Efemoral: Stockholder - Privately-held company
  Embolitech: Stockholder - Privately-held company
  Gilde Healthcare: Consultant
  Healthcare InRoads: Owner/Co-Owner, or Founder/Co-Founder
  Heartbeam: Stockholder - Publicly-traded company (excludes mutual/index funds)
  Janacare: Stockholder - Privately-held company
  Nectero: Stockholder - Privately-held company
  Primacea: Owner/Co-Owner, or Founder/Co-Founder
  R3 Vascular: Stockholder - Privately-held company
• 

  Suresh Vedantham, MD

  Professor and Assistant Dean
  Washington University in St. Louis
  Interventional Radiology
  St. Louis, Missouri, United States

  Disclosure(s): Medi USA: Grants/Research Support Recipient

Presentations:

• 8:00am - 8:07am PT

  Non-Clinical Test Strategies Prior to Initiation of IDE Studies
  

  Speaker: Finn Donaldson, PhD
• 8:07am - 8:14am PT

  During Trial Design, Balancing Surrogate Markers With Patient-Reported Outcomes as Trial Endpoints
  

  Speaker: Donna Buckley, MD
• 8:14am - 8:21am PT

  Panel Discussion
• 8:21am - 8:28am PT

  Assessing Endpoints During a Trial: How Do You Work With the FDA to Make Sure We're Aligned?
  

  Speaker: Misti Malone, PhD
• 8:28am - 8:35am PT

  The PI Experience: Working With the FDA to Design Trial Endpoints Before and During the Trial
  

  Speaker: Ehrin Armstrong, MD – Swedish Medical Center
• 8:35am - 8:42am PT

  Panel Discussion
• 8:42am - 8:49am PT

  The Increasing Role of Real-World Trials in Vascular Research
  

  Speaker: Michael Jaff, DO – Harvard Medical School
• 8:49am - 8:56am PT

  Common Pitfalls for Using RWE to Support Marketing Submissions
  

  Speaker: Misti Malone, PhD
• 8:56am - 9:00am PT

  Panel Discussion