Indiana CTSI Retreat: Purdue University

February 26, 2021 @ 10:00 am – 3:00 pm America/Indiana/Indianapolis Timezone

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. Some of those people include:

  • FDA leaders:
    • Timothy Stenzel, MD, PhD, Director of the Office for In Vitro Diagnostics and Radiological Health, responsible for reviewing COVID and other diagnostic tests
    • Bakul Patel, Director of the FDA’s Digital Health Center of Excellence; digital health includes mobile health, wearable devices, telehealth, and personalized medicine
    • Nicole Ibrahim, Director of the Division of Circulatory Support, Structural and Vascular Devices, with extensive experience in pediatric medical devices
    • Misti Malone, PhD, Assistant Director for Peripheral Interventional Devices, with extensive experience in drug-device combination products
  • Industry experts:
    • Kay Taylor, Vice President Regulatory Affairs, Life Science and IDS, Becton Dickinson
    • Subbu Venkatraman, PhD, Chief Technology Officer, Eko
    • Ram Iyer, Global Director of Regulatory Science, Cook Medical
    • Amra Racic, Sr. Regulatory Affairs Program Manager, Medtronic
  • Clinicians:
    • David Reuter, PhD, Director, Cardiac Innovations at Seattle Children’s
    • Nabil Dib, MD, Founder and President, International Society for Cardiovascular Translational Research (ISCTR)
    • Two others, who will be announced later
  • Leadership from the Purdue University Biomedical Engineering program
    • George Wodicka, PhD, Dane A. Miller Head of Biomedical Engineering; Professor of Biomedical Engineering and Electrical and Computer Engineering
    • Aaron Lottes, PhD, Associate Professor of Engineering Practice
    • Craig Goergen, PhD, Leslie A. Geddes Associate Professor of Biomedical Engineering
    • Jacqueline Linnes, PhD, Marta E. Gross Assistant Professor of Biomedical Engineering
    • Chi Hwan Lee, PhD, Leslie A. Geddes Assistant Professor of Biomedical Engineering
    • Hyowon (Hugh) Lee, PhD, Associate Professor of Biomedical Engineering

Participants in the retreat will also have the opportunity to hear presentations and a panel discussion with the following FDA experts and industry leaders:

  • Andrew Farb, MD, Chief Medical Officer for Cardiovascular Devices, FDA
  • Douglas Kelly, MD, Center for Devices & Radiological Health Deputy Center Director for Science, FDA
  • Neal Fearnot, PhD, President of MED Institute Incorporated and Cook Advanced Technologies
  • Rob Lyles, President of Cook Regentec
|2021-01-15T15:29:38-05:00January 8th, 2021|0 Comments

About the Author:

Anna Carrera
Anna Carrera is the research communications manager for Indiana University's Precision Health Initiative, IU School of Medicine Research Affairs and the Indiana Clinical and Translational Sciences Institute. She joined the team in June 2019 after working as a TV news reporter for ten years. She loves sharing stories about the great research being done across the state to improve the health of Hoosiers.

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