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Day 2 (October 25th, 2022) - Retinal Implant Workshop Agenda

Time (Eastern)

Topic

Name of Session Chair / Speakers


8:30 am - 8:35 am

Day 2: Welcome & Recap

  • Tieuvi Nguyen, PhD Food and Drug Administration

8:35 am - 9:45 am


SESSION 4: Evaluation of Bioelectronic Implants: Safety

8:35 am - 9:05 am

Bioelectronic Implants: Overview of Clinical Safety Endpoints and Evidence

  • James Weiland, PhD University of Michigan

9:05 am - 9:45 am

Moderated Q&A: Safety of Bioelectronic Implants

Moderator:

  • Michael Repka, MD, MBA Johns Hopkins University

Panelists:

  • Gislin Dagnelie, PhD, Johns Hopkins University

  • Mark Humayun, MD, PhD, University of Southern California Institute for Biomedical Therapeutics

  • Raymond Iezzi, MD, Mayo Clinic

  • Robert MacLaren, MB ChB DPhil FRCOphth FRCS FACS FMedSci, University of Oxford

  • Joseph Martel, MD, University of Pittsburgh

  • José-Alain Sahel, MD, University of Pittsburgh

  • Philip Troyk, PhD, Illinois Institute of Technology

  • James Weiland, PhD, University of Michigan

9:45 am - 9:55 am


Break 9:55 am - 11:35 am


SESSION 5: Clinical Outcome Assessments and Patient Preference 9:55 am - 10:20 am

FDA Regulatory framework for Clinical Outcomes Assessments and Patient Preference

  • Fraser Bocell, PhD Food and Drug Administration

  • David Gebben, PhD Food and Drug Administration

10:20 am - 10:40 am

Clinical Outcomes Assessment for Bioelectronic Implants: NEI Perspective

  • Emily Chew, MD National Eye Institute

10:40 am - 11:10 am

Clinical Outcomes Assessment and Performance-Based Testing for Bioelectronic Implants: University of Pittsburgh

  • Emily Grattan, PhD, OTR/L University of Pittsburgh

  • Rakie Cham, PhD University of Pittsburgh

  • Jose Sahel, MD University of Pittsburgh

11:10 am - 11:15 am

Patient Experiences


11:15 am - 11:35 am

Moderated Q&A: Clinical Outcomes Assessment for Bioelectronic Implants

Moderator:

  • Michelle Tarver, MD, PhD Food and Drug Administration

Panelists:

  • Fraser Bocell, PhD Food and Drug Administration

  • Emily Chew, MD National Eye Institute

  • Todd Durham, PhD Foundation Fighting Blindness

  • Emily Grattan, PhD, OTR/L University of Pittsburgh

  • David Gebben, PhD Food and Drug Administration

  • John McInerney, MS Blind and Vision Rehabilitation Services of Pittsburgh

11:35 am - 12:20 pm


Break 12:20 pm - 1:30 pm


SESSION 6: Effectiveness 12:20 pm - 12:50 pm

Bioelectronic Implants: Overview of Clinical Effectiveness Endpoints and Evidence

  • Gislin Dagnelie, PhD Johns Hopkins University

12:50 pm - 1:30 pm Moderated Q&A: Effectiveness of Bioelectronic Implants

Moderator:

  • Elvin Ng Food and Drug Administration

Panelists:

  • Jessy Dorn, PhD Ceribell, Inc.

  • Shelley Fried, PhD Harvard Medical School

  • Yannick LeMer, MD Hôpital Fondation Adolphe de Rothschild

  • Sandra Montezuma, MD University of Minnesota

  • Mahi Muqit, MBChB BSc (Hons) FRCOphth PhD Moorfields Eye Hospital

  • Joseph F. Rizzo III, MD Harvard Medical School

  • Philip Troyk, PhD Illinois Institute of Technology

  • Daniel Yoshor, MD University of Pennsylvania

1:30 pm - 2:30 pm


SESSION 7: Post-market Considerations


1:30 pm - 1:50 pm

FDA: Post-Approval Studies, Postmarket Surveillance and Real World Evidence

  • Nilsa Loyo-Berrios, PhD Food and Drug Administration

1:50 pm - 2:00 pm

Patient Experiences


2:00 pm - 2:30 pm

Moderated Q&A: Post-Market Considerations

Moderator:

  • Michael Repka, MD, MBA Johns Hopkins University

Panelists:

  • Patient Representatives

  • Megan Collins, MD Johns Hopkins University

  • Lloyd Diamond, CEO Pixium Vision

  • Nilsa Loyo-Berrios, PhD Food and Drug Administration

  • Flora Lum, MD American Academy of Ophthalmology

  • Elicia M Pillion, Au.D Walter Reed National Military Medical Center

  • Arup Roy, PhD Zikron, Inc.

  • Eberhart Zrenner, MD University of Tuebingen

2:30 pm - 3:40 pm

SESSION 8: Government Agency Opportunities for Device Innovation


2:30 pm - 3:10 pm Government Agency Programs for Bioelectronic Implants

  • Sohi Rastegar, PhD National Science Foundation

  • Paek Lee, PhD National Eye Institute

  • Lina Kubli, PhD Department of Veterans Affairs

  • Tian Wang, PhD Congressionally Directed Medical Research Programs

  • Joeanna Arthur, PhD Defense Advanced Research Projects Agency

  • Elvin Ng Food and Drug Administration

3:10 pm - 3:40 pm

Moderated Q&A: Government Agency Opportunities for Device Innovation

Co-moderators:

  • Mark Humayun, MD, PhD University of Southern California Institute for Biomedical Therapeutics

  • Jose Sahel, MD University of Pittsburgh

Panelists:

  • Malvina Eydelman, MD Food and Drug Administration

  • Tony Gover, PhD National Eye Institute

  • Lina Kubli, PhD, Department of Veterans Affairs

  • Sohi Rastegar, PhD National Science Foundation

  • Tian Wang, PhD Congressionally Directed Medical Research Programs

  • Joeanna Arthur, PhD Defense Advanced Research Projects Agency

3:40 pm - 3:45 pm

Day 2: Workshop Concluding Remarks and Next Steps

  • Jose Sahel, MD University of Pittsburgh

  • Malvina Eydelman, MD Food and Drug Administration

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