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