Indiana CTSI Retreat: Purdue University

The virtual Indiana CTSI retreat hosted by Purdue University will take place on Friday, February 26. The theme will be, “Developing innovative medical devices: From concept to clinic.” The event will be centered around navigating the regulatory pathway for medical devices by talking with leaders at the FDA, clinicians, researchers and other industry experts.

Registration information is available here.

Dr. Jeffrey E. Shuren, MD, JD, Director of the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), will be featured during an hour-long keynote discussion. Participants in the retreat will be invited to engage in this interactive conversation.

In his leadership of CDRH, Shuren is responsible for the review of FDA-regulated medical devices and diagnostics in the United States and for helping to facilitate medical device innovation, including overseeing devices and diagnostics related to COVID-19. He also provides vision, leadership, and strategic direction regarding the regulation of medical devices in the United States and engagement with international partners.

The keynote discussion will be one of several opportunities during the retreat to connect with other key leaders at the FDA, as well as clinicians, university researchers and industry experts.

The tentative agenda includes:

• 10:00 am – Welcome and introduction to Indiana CTSI
  • Aaron Lottes, PhD, George Wodicka, PhD, Purdue University
  • Sharon Moe, MD, Sarah Wiehe,  MD, MPH, Indiana CTSI
• 10:15 am – Keynote Q&A
  • Jeffrey E. Shuren, MD, JD, FDA
• 11:15 am – Break
• 11:25 am – Translational Pathway: From Academic Discovery to Regulatory Review
  • Neal Fearnot, PhD, President of MED Institute Incorporated and Cook Advanced Technologies
• 11:40 am – Translational Pathway: Early Feasibility Studies – A First Step Into Clinical Studies
  • Andrew Farb, MD, Chief Medical Officer for Cardiovascular Devices, FDA
• 11:55 am – Translational Pathway: Future of Medical Device Development Across Indiana and the Midwest Region – Importance of Academic Partnerships
  • Rob Lyles, President of Cook Regentec
• 12:10 pm – Panel Discussion
  • Speakers from Translational Pathways sessions
  • Douglas Kelly, MD, Center for Devices & Radiological Health Deputy Center Director for Science, FDA
• 12:30 pm – Lunch break
• 1:00 pm – Parallel Workshops featuring FDA leaders, industry experts, clinicians and Purdue University leadership
  • Pediatric Medical Devices
    • Craig Goergen, PhD, Leslie A. Geddes Associate Professor of Biomedical Engineering, Purdue University
    • Nicole Ibrahim, PhD, Director of the Division of Circulatory Support, Structural and Vascular Devices, FDA (extensive experience in pediatric medical devices)
    • Susan Alpert, MD, PhD, Consultant
    • David Reuter, MD, PhD, Director, Cardiac Innovations at Seattle Children’s
    • Vincent Devlin, MD, Chief Medical Officer of the Office of Orthopedic Devices, FDA
  • Diagnostics and Disease Detection
    • Jacqueline Linnes, PhD, Marta E. Gross Assistant Professor of Biomedical Engineering, Purdue University
    • Timothy Stenzel, MD, PhD, Director of the Office for In Vitro Diagnostics and Radiological Health, FDA (responsible for reviewing COVID and other diagnostic tests)
    • Kay Taylor, Vice President Regulatory Affairs, Life Science and IDS, Becton Dickinson
    • Alan Wright, MD, Chief Medical Officer, Roche Diagnostics
    • Laurence Coyne, PhD, Division Director for Restorative, Repair and Trauma Devices, FDA
  • Digital Health and Wearable Devices
    • Chi Hwan Lee, PhD, Leslie A. Geddes Assistant Professor of Biomedical Engineering, Purdue University
    • Bakul Patel, Director of the FDA’s Digital Health Center of Excellence; digital health includes mobile health, wearable devices, telehealth, and personalized medicine
    • Subbu Venkatraman, PhD, Chief Technology Officer, Eko
    • CAPT Raquel Peat, PhD, Director of the Office of Orthopedic Devices, FDA
    • Yvonne Chan, MD, PhD, Senior Director Medical Affairs for Digital Medicine, Otsuka
  • Invasive and Implantable Devices
    • Hyowon (Hugh) Lee, PhD, Associate Professor of Biomedical Engineering, Purdue University
    • Misti Malone, PhD, Assistant Director for Peripheral Interventional Devices, FDA (extensive experience in drug-device combination products)
    • Ram Iyer, PhD, Global Director of Regulatory Science, Cook Medical
    • Ken Cavanaugh, Deputy Director of the Office of Cardiovascular Devices, FDA
    • William Jung, Division Director for Joint Arthroplasty Devices, FDA
    • Ronald Jean, Division Director for Spinal Devices, FDA
    • Spencer King, MD, Emory University
• 2:30 pm – Workshop Report-outs and Wrap-up
• 3:00 pm – Adjourn