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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
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B

Workshop Agenda

Multimodal Therapies for Brain Disorders: A Workshop

June 14-15, 2016

Keck Center
500 Fifth Street, NW | Room 100
Washington, DC 20001

Background: Multimodal therapy approaches (i.e., combinations of interventions aimed at different aspects of a disease) are emerging as potential ways to enhance clinical outcomes for patients with psychiatric and neurological disorders. This could include, for example, concomitant prescription of a drug along with a device, biologic, or behavioral/psychosocial intervention (including, e.g., cognitive remediation, lifestyle adjustment, dietary intervention, or animate therapy). Another example would be the simultaneous use of a neuromodulation device during performance of a specific neurocognitive task. While such a multimodal approach is consistent with the common clinical practice of combining interventions, there are important questions regarding how these interventions interact (in terms of additive, subtractive, or synergistic therapeutic as well as adverse effects), how they should be used, in what subsets of patients, and in what amounts or for what period of time. 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-

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×

vice) and approaches in which only one product is regulated (e.g., drug/device plus psychosocial intervention). Related questions arise for reimbursement, for example, would payers only pay for care if it includes both drugs and psychotherapy if that is what the data show is effective?

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.

Meeting Objectives:

  • Explore recent advances in the development of multimodal therapeutic approaches for psychiatric and neurological disorders and approaches to using these therapies (e.g., earlier versus later in disease progression), and discuss future research needs to further advance understanding of these approaches.
  • Highlight disease areas in which a multimodal approach could be particularly useful (e.g., areas in which the pathophysiology is well understood, or areas in which mono-modal approaches have been insufficiently effective).
  • Discuss methodologies for establishing efficacy and safety for multimodal therapies compared to monotherapies, including clinical trials and statistical considerations.
  • Consider regulatory issues for multimodal therapies, including for approaches in which only one component is regulated (e.g., drug plus psychosocial intervention), and discuss potential opportunities for addressing challenges.
  • Consider reimbursement issues for multimodal therapies for nervous system disorders, and discuss potential opportunities for addressing challenges.
  • Incorporate lessons learned from other therapeutic areas in which multimodal approaches are more frequently used (e.g., cardiology, diabetes, cancer).
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×

DAY ONE: June 14, 2016

1:30 p.m. Opening Remarks and Discussion of Definitions

KARL KIEBURTZ, Workshop Co-Chair

Robert J. 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.
  • Discuss future research needs to further advance understanding of these approaches.
  • Highlight disease areas in which a multimodal approach could be particularly useful.
1:50 p.m. Overview and Session Objectives

TIMOTHY STRAUMAN, Session Co-Moderator

Professor of Psychology and Neuroscience

Duke University

KEITH HILDEBRAND, Session Co-Moderator

Senior Principal Scientist, Technical Fellow Neuromodulation

Medtronic, Inc.

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
2:00 p.m.

Part A: Two Pharmacological Interventions Approved as a Co-Delivery

Drug/Drug and Drug/Biologic Combinations for Alzheimer’s Disease

JAMES HENDRIX

Director, Global Science Initiatives, Medical and Scientific Relations

Alzheimer’s Association

2:10 p.m.

Part B: Concomitant Prescription of Two Interventions with Different Modalities

Drug−Device Combinations for Epilepsy

MARTHA MORRELL

Chief Medical Officer, NeuroPace

Clinical Professor of Neurology and, by courtesy, Neurosurgery

Stanford University

Combining Drugs and Psychosocial Interventions in Adolescents with Bipolar Disorder

KIKI CHANG (via WebEx)

Professor of Psychiatry and Behavioral Sciences

Stanford University Medical Center

2:30 p.m.

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. BREAK
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×

SESSION II: REGULATORY AND REIMBURSEMENT CONSIDERATIONS

Session Objectives:

  • Consider regulatory and reimbursement issues for multimodal therapies, including for approaches in which two components are regulated (e.g., drug plus device) and approaches in which only one component is regulated (e.g., drug plus psychosocial intervention).
  • Explore evidentiary standards needed for regulation and reimbursement, and consider how different approval pathways and evidentiary standards across FDA centers impact multimodal approaches.
  • Discuss potential opportunities for addressing challenges.
3:45 p.m. Session Overview and Objectives

SARAH H. 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

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×

Evaluating Multimodal Products at the Center for Biologics Evaluation and Research

WILSON BRYAN

Director, Division of Clinical Evaluation & Pharmacology/Toxicology

Office of Cellular, Tissue, and Gene Therapies

Center for Biologics Evaluation and Research

Food and Drug Administration

4:35 p.m. Part B: Payer Considerations

Private Payer Considerations

RHONDA ROBINSON-BEALE

Senior Vice President and Chief Medical Officer

Blue Cross of Idaho

Perspectives from a Government Payer

STEVEN PIZER

Associate Professor of Health Economics

Department of Pharmacy and Health Systems Sciences

Northeastern University

and Chief Economist, Health Care Financing & Economics

U.S. Department of Veterans Affairs

4:55 p.m. Discussion Among Speakers and Workshop Participants
5:30 p.m. Adjourn Day One
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×

DAY TWO: June 15, 2016

8:30 a.m. Day Two Opening Remarks

KARL KIEBURTZ, Workshop Co-Chair

SARAH H. LISANBY, Workshop Co-Chair

KEYNOTE TALK: FUTURE DIRECTIONS IN CLINICAL TRIALS AND REGULATORY APPROACHES FOR MULTIMODAL THERAPIES

8:40 a.m.

ROBERT CALIFF

Commissioner of Food and Drugs

Food and Drug Administration

9:00 a.m. 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. Potential topics may include

  • Addressing challenges of intervention fidelity (e.g., site-to-site and time-to-time consistency) with behavioral interventions (psychotherapy, exercise);
  • Interpretation when the two modalities have different time courses (e.g., drug goes for longer than behavioral intervention);
  • Interpretation when one modality encounters more intolerability;
  • Different approaches to assessing dose, especially in psychosocial interventions; or
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
  • Innovative approaches to trial design that are specifically relevant to multimodal approaches and may help address the levels of evidence required for regulation and reimbursement.
9:45 a.m. Session Overview and Objectives

KARL KIEBURTZ, Session Moderator

Robert J. 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)

Professor and Head of Clinical Psychology and Psychotherapy

University of Trier, Germany

10:45 a.m. Discussants:

BILLY DUNN

Director, Division of Neurology Products

Office of Drug Evaluation I

Center for Drug Evaluation and Research

Food and Drug Administration

RHONDA ROBINSON-BEALE

Senior Vice President and Chief Medical Officer

Blue Cross of Idaho

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×

STEVEN PIZER

Associate Professor of Health Economics

Department of Pharmacy and Health Systems Sciences

Northeastern University

and Chief Economist, Health Care Financing & Economics

U.S. Department of Veterans Affairs

11:15 a.m. 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.
  • Explore potential mechanisms for addressing challenges and enabling multimodal therapy development programs.
12:30 p.m. Session Overview and Objectives

STEVIN ZORN, Session Moderator

Executive Scientist in Residence

Lundbeck

12:40 p.m.

Challenges and Opportunities for Integration of Therapeutic Devices into Psychiatr

JEFFREY NYE

Vice President, Neuroscience Innovation and Scientific Partnership Strategy

Janssen Research and Development, LLC

Johnson & Johnson Innovation

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×

Intrathecal Infusion Therapy for Chronic Pain: Challenges, Lessons, and Opportunities

KEITH HILDEBRAND

Senior Principal Scientist, Technical Fellow

Neuromodulation

Medtronic, Inc.

Pfizer–MedGenesis Therapeutix Collaboration on Glial Cell Line-Derived Neurotrophic Factor (GDNF) Protein and Convection Enhanced Delivery (CED) Technology for Parkinson’s Disease

ERICH MOHR

Chair & Chief Executive Officer

MedGenesis Therapeutix Inc.

CHRISTOPHER SHAFFER

Associate Research Fellow

Pfizer Inc.

1:20 p.m. Discussion Among Speakers and Workshop Participants
2:00 p.m. BREAK

SESSION V: MOVING FORWARD

Session Objectives:

  • Discuss the roles of NIH, other research agencies, and disease-specific organizations in supporting the development of multimodal therapies.
  • Synthesize and discuss key highlights from the workshop presentations and discussions and, most importantly, identify next steps and promising areas for future action and research.
2:15 p.m. Session Overview and Objectives

KARL KIEBURTZ, Workshop Co-Chair and Session Moderator

SARAH H. LISANBY, Workshop Co-Chair and Session Moderator

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
2:20 p.m.

Role of Research Agencies in De-Risking Multimodal Therapy Development

AMIR TAMIZ

Program Director, NIH Blueprint NeuroTherapeutics Network

National Institutes of Health

STUART HOFFMAN

Senior Scientific Advisor for Brain Injury

Office of Research and Development

Department of Veterans Affairs

2:40 p.m.

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. Discussion with Workshop Participants
3:15 p.m.

Panel Discussion: Identifying Gaps, Opportunities, and Next Steps Highlighted in Workshop Presentations and Discussions

KARL KIEBURTZ, Workshop Co-Chair and Session III Moderator

SARAH H. LISANBY, Workshop Co-Chair and Session II Moderator

KEITH HILDEBRAND, Session I Co-Moderator

TIMOTHY STRAUMAN, Session I Co-Moderator

STEVIN ZORN, Session IV Moderator

EMMELINE EDWARDS

Director, Division of Extramural Research

National Center for Complementary and Integrative Health

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
4:00 p.m. Discussion with Workshop Participants
4:20 p.m. Closing Remarks

KARL KIEBURTZ, Workshop Co-Chair

SARAH H. LISANBY, Workshop Co-Chair

4:30 p.m. Adjourn Workshop
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 67
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 68
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 69
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 70
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 71
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 72
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 73
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 74
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 75
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 76
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 77
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2017. Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23657.
×
Page 78
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Multimodal therapy approaches that combine interventions aimed at different aspects of disease are emerging as potential—and perhaps essential—ways to enhance clinical outcomes for patients with psychiatric and neurological disorders. In order to examine the general principles underlying multimodal therapies and to explore challenges, potential barriers, and opportunities for their development, the National Academies of Sciences, Engineering, and Medicine convened a workshop in June 2016. Participants explored scientific, clinical, regulatory, and reimbursement issues related to multimodal approaches and potential opportunities to enhance clinical outcomes for individuals with nervous system disorders. This publication summarizes the presentations and discussions from the workshop.

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