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Appendix B: Workshop Agenda
Pages 85-100

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From page 85...
... Several issues raise ethical questions, including the potential for off-label, over-the-counter, or do-it-yourself uses or for enhancement. Given the growing interest in non-invasive neuromodulation devices for the central nervous system, the goal of this workshop is to explore opportunities, challenges, and ethical questions 85
From page 86...
... • Explore current and potential use reimbursement practices for therapeutic use of non-invasive neuromodulation devices. o Explore the evidence base and acceptable therapeutic outcome measures used in reimbursement decisions.
From page 87...
... MARK HALLETT Chief, Human Motor Control Section National Institute of Neurological Disorders and Stroke 9:05 a.m. Non-Invasive Neuromodulation Technology • Provide an overview of non-invasive neuromodulation devices, including electromagnetic devices and other developing devices, such as those involving ultrasound and light.
From page 88...
... VICTOR KRAUTHAMER Division of Biomedical Physics Office of Science and Engineering Labs Food and Drug Administration LEONARDO ANGELONE Division of Biomedical Physics Office of Science and Engineering Labs Food and Drug Administration SESSION I: THERAPEUTIC AND NON-THERAPEUTIC USES Session Objectives: Discuss potential benefits and risks of non-invasive neuromodulation devices based on known short- and long-term central nervous system mechanisms of action. Explore the scientific landscape of device development for both therapeutic and non-therapeutic uses.
From page 89...
... Panel Remarks ROY HAMILTON Assistant Professor of Neurology University of Pennsylvania SARAH "HOLLY" LISANBY Professor and Chair Department of Psychiatry & Behavioral Sciences Duke University ALEXANDER ROTENBERG Associate Professor of Neurology Harvard Medical School Senior Associate in Neurology Boston Children's Hospital W JEFFREY ELIAS Associate Professor of Neurological Surgery and Neurology Director of Stereotactic and Functional Neurosurgery University of Virginia School of Medicine 10:35 a.m.
From page 90...
... 11:25 a.m. Session Overview and Objectives JEFFREY NYE, Moderator Vice President Neuroscience Innovation and Scientific Partnership Strategy Janssen Research and Development, LLC Johnson & Johnson Innovation 11:30 a.m.
From page 91...
... Overview Talk ROBERT CHEN Professor of Neurology University of Toronto 1:40 p.m. Panel Remarks DYLAN EDWARDS Director, Laboratory for Non-Invasive Brain Stimulation and Human Motor Control Burke Medical Research Institute Associate Professor, Department of Neurology Weill Cornell Medical College ROI COHEN KADOSH Wellcome RCD Fellow and University Research Lecturer University of Oxford DANIEL WETMORE Director, Intellectual Property and Usability Thync MICHAEL FOX Assistant Professor of Neurology Harvard University 2:20 p.m.
From page 92...
... 3:00 p.m. Session Overview and Objectives JEFFREY NYE, Session Moderator Vice President Neuroscience Innovation and Scientific Partnership Strategy Janssen Research and Development, LLC Johnson & Johnson Innovation Regulatory Pathways for Non-Invasive Devices • How does the regulatory landscape contrast for non-invasive devices versus other medical devices?
From page 93...
... 3:05 p.m. TIMOTHY MARJENIN Chief, Neurostimulation Devices Branch Food and Drug Administration 3:25 p.m.
From page 94...
... 8:35 a.m. Session Overview and Objectives HANK GREELY, Session Moderator Director, Stanford Program in Neuroscience and Society Stanford University 8:40 a.m.
From page 95...
... Discussion Among Speakers and Workshop Participants 10:30 a.m. Break SESSION IV: REIMBURSEMENT Session Objectives: Explore current and potential use reimbursement practices for therapeutic uses of non-invasive neuromodulation devices.
From page 96...
... RHONDA ROBINSON-BEALE Senior Vice President and Medical Officer Blue Cross of Idaho OSCAR MORALES Founding Director, Transcranial Magnetic Stimulation Service McLean Hospital 11:20 a.m. Improving the Evidence Base for Reimbursement • What is the current evidence base used for reimbursement?
From page 97...
... MARY HAILEY Vice President of Health Policy and Government Relations Neuronetics ERIC LIEBLER Vice President, Scientific, Medical, and Governmental Affairs electroCore JOHN REPPAS Director of Public Policy Neurotechnology Industry Organization 12:20 p.m. Discussion Among Speakers and Workshop Participants 12:45 p.m.
From page 98...
... 1:35 p.m. Panel Discussion: Session Moderators ALVARO PASCUAL-LEONE, Workshop Co-Chair Professor of Neurology Associate Dean for Clinical and Translational Research Harvard Medical School JEFFREY NYE, Workshop Co-Chair Vice President Neuroscience Innovation and Scientific Partnership Strategy Janssen Research and Development, LLC Johnson & Johnson Innovation FRANCES JENSEN Professor and Chair of Neurology Perelman School of Medicine University of Pennsylvania HANK GREELY, Workshop Co-Chair Director, Stanford Program in Neuroscience and Society Stanford University RHONDA ROBINSON-BEALE Senior Vice President and Medical Officer Blue Cross of Idaho
From page 99...
... APPENDIX B 99 2:25 p.m. Discussion Among Speakers and Workshop Participants 2:45 p.m.


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