Developing Multimodal Therapies for Brain Disorders Proceedings of a Workshop (2017) / Chapter Skim
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Appendix B: Workshop Agenda
Appendix B: Workshop Agenda
Pages 67-78
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From page 67... ...
Further discussion is needed about methodologies for determining efficacy and safety in multimodal therapies compared with monotherapies and for comparing across multiple types of multimodal therapy. Multimodal therapy approaches also raise a number of important regulatory issues, both regarding combinations of regulated products (e.g., drug plus de 67
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From page 68... ...
This workshop, hosted by the Forum on Neuroscience and Nervous System Disorders, will bring together key stakeholders to examine scientific, clinical, regulatory, and reimbursement issues related to multimodal approaches and identify potential opportunities to enhance clinical outcomes for individuals with psychiatric and neurological disorders. Rather than delving deeply into specific interventions, the workshop will aim to examine general principles, barriers, and potential solutions and opportunities that may apply across multimodal therapy development for brain disorders.
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From page 69... ...
Joynt Professor in Neurology Senior Associate Dean for Clinical Research Director of the Clinical & Translational Science Institute University of Rochester Medical Center SARAH H LISANBY, Workshop Co-Chair Director, Division of Translational Research National Institute of Mental Health National Institutes of Health SESSION I: STATE-OF-THE-SCIENCE IN MULTIMODAL THERAPIES FOR BRAIN DISORDERS Session Objectives: • Explore examples of recent advances in the development of multimodal therapeutic approaches for brain disorders and approaches to using these therapies.
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From page 70... ...
Part C: Simultaneous Use of Two Modalities in a Single Procedure Combining Devices with Cognitive Enhancement BRUCE LUBER Staff Scientist Experimental Therapeutics & Pathophysiology Branch National Institute of Mental Health Individually Targeted Combination of Transcranial Magnetic Stimulation and a Psychosocial Intervention TIMOTHY STRAUMAN Professor of Psychology and Neuroscience Duke University 2:50 p.m. Discussion Among Speakers and Workshop Participants 3:30 p.m.
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From page 71... ...
LISANBY, Session Moderator Director, Division of Translational Research National Institute of Mental Health 3:55 p.m. Part A: Regulatory Considerations Combination Products at the Food and Drug Administration PATRICIA LOVE Deputy Director, Office of Combination Products Food and Drug Administration Evaluating Multimodal Products at the Center for Drug Evaluation and Research BILLY DUNN Director, Division of Neurology Products Office of Drug Evaluation I Center for Drug Evaluation and Research Food and Drug Administration Evaluating Multimodal Products at the Center for Devices and Radiological Health CARLOS PEÑA Director, Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration
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From page 72... ...
Department of Veterans Affairs 4:55 p.m. Discussion Among Speakers and Workshop Participants 5:30 p.m.
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From page 73... ...
Questions and Answers with Workshop Participants 9:30 a.m. BREAK SESSION III: ESTABLISHING EFFICACY AND SAFETY IN MULTIMODAL THERAPIES FOR BRAIN DISORDERS Session Objectives: Discuss methodologies for establishing efficacy and safety for multimodal therapies compared to monotherapies, including clinical and statistical considerations.
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From page 74... ...
Joynt Professor in Neurology Senior Associate Dean for Clinical Research Director of the Clinical & Translational Science Institute University of Rochester Medical Center 9:55 a.m. Platform Trials for Multimodal Therapies ROGER LEWIS Senior Medical Scientist, Berry Consultants Professor and Chair, Department of Emergency Medicine, Harbor-UCLA Medical Center Quantification of Dose with Devices MAROM BIKSON Professor of Biomedical Engineering The City College of the City University of New York Quantification of Dose in Psychosocial Interventions WOLFGANG LUTZ (via WebEx)
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From page 75... ...
Discussion Among Speakers, Discussants, and Workshop Participants 11:45 a.m. LUNCH SESSION IV: INDUSTRY PERSPECTIVES Session Objectives: • Discuss industry perspectives on particular technical, scientific, and commercial challenges to bringing these systems to market, and examine lessons learned from successful examples of collaborations on multimodal approaches.
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From page 76... ...
2:15 p.m. Session Overview and Objectives KARL KIEBURTZ, Workshop Co-Chair and Session Moderator SARAH H
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From page 77... ...
Role of Disease-Specific Research Funding in Multimodal Therapy Development JAMES HENDRIX Director, Global Science Initiatives, Medical and Scientific Relations Alzheimer's Association BRIAN FISKE Senior Vice President, Research Programs The Michael J Fox Foundation for Parkinson's Research 3:00 p.m.
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From page 78... ...
Closing Remarks KARL KIEBURTZ, Workshop Co-Chair SARAH H LISANBY, Workshop Co-Chair 4:30 p.m.
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