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Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
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B

Workshop Agenda

Improving Translation of Animal Models for Nervous
System Disorders:
A Workshop

March 28-29, 2012

Institute of Medicine
Keck Building, Room 100
Washington, DC

Background: Nervous system disorders and diseases are highly prevalent and substantially contribute to the national disease burden. Animal models have significantly increased our understanding of nervous system disorders. Yet, in spite of these advances, there still remains a large gap in treatment options that are high in efficacy but low in side effects for many diseases. And for some diseases there are no treatment options. More than 80 percent of research projects fail to reach clinical trials. Of those nervous system drugs that do make it to clinical trials, only 8 percent end up being approved. These statistics translate to drug approval rates that are 50 percent lower than drugs for other therapeutic areas. Given the tremendous disease burden associated with nervous system diseases and disorders, the goal of this workshop is to bring together key stakeholders to discuss potential opportunities for maximizing the translation of effective therapies from animal models to clinical practice.

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×

Meeting Objectives:

• Discuss key issues that contribute to poor translation of animal models in nervous system disorders.

o Examine case studies that highlight successes and failures in the development and application of animal models.

• Consider strategies to increase the scientific rigor of preclinical efficacy testing.

o Explore the benefits and challenges to developing standardized animal and behavioral models.

o Identify methods to facilitate development of corresponding animal and clinical endpoints.

• Identify methods that would maximize bidirectional translation between basic and clinical research.

• Determine the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.

DAY ONE

1:30 p.m. Opening Remarks

RICHARD HODES, Co-Chair

STEVEN PAUL, Co-Chair

SESSION I: EVALUATION OF CURRENT ANIMAL MODELS

Session Objective: Identify critical limitations impacting translation of therapies from animal models to clinical practice. Explore current expectations of animal models to predict therapeutic efficacy. Determine the impact of generalization of animal model capabilities. Examine the role of animal model–derived data in making decisions about moving therapeutics into clinical trials.

1:40 p.m. Overview and Session Objectives

STEVIN ZORN, Session Chair

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
1:45 p.m. Examination of Current Expectations for Animal Models

STEVEN PAUL

Director

Helen and Robert Appel Alzheimer’s Disease Research Institute

Weill Cornell Medical College

2:00 p.m. Choice and Validation of Animal Models for CNS Drug Discovery

MARK TRICKLEBANK

Director and Senior Research Fellow

Eli Lilly and Co.

2:15 p.m. Impact of Publication Bias

KATRINA KELNER

Editor

Science Translational Medicine

2:30 p.m. Q&A with Speakers

SESSION II: CASE STUDIES

Breakout Objective: Conduct in-depth analysis of six case studies in which animal models have ranged in translational success. Specifically, breakout groups will focus on three key questions: (1) Would this research area benefit from a new or improved standardized animal or behavioral models (e.g., testing conditions, reference standards)? (2) Do animal and human endpoints match for this case study? (3) What is needed to bridge the gap between animal models and clinical science?

3:00 p.m. Overview and Session Objectives

RICHARD HODES and STEVEN PAUL

Session Chairs

3:10 p.m. BREAK OUT INTO GROUPS
 
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
3:25 p.m. Breakout 1: Animal Models for Neurodegeneration

ROBERT FERRANTE, Moderator

Professor

Departments of Neurological Surgery, Neurology, and Neurobiology

University of Pittsburgh

TIM COETZEE, Discussant

Chief Research Officer

National Multiple Sclerosis Society

Breakout 2: Animal Models for Alzheimer’s Disease

BRADLEY HYMAN, Moderator

John B. Penny Jr. Professor of Neurology

Harvard Medical School

RICHARD HODES, Discussant

Director

National Institute on Aging

SHARON ROSENZWEIG-LIPSON, Discussant

IVS Pharma Consulting

Breakout 3: Animal Models for Stroke

CONSTANTINO IADECOLA, Moderator

George C. Cotzias Distinguished Professor of Neurology and Neuroscience

Weill Cornell Medical College

WALTER KOROSHETZ, Discussant

Deputy Director

National Institute for Neurological Disorders and Stroke

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×

STEVEN PAUL, Discussant

Director

Helen and Robert Appel Alzheimer’s Disease Research Institute

Weill Cornell Medical College

Breakout 4: Animal Models for Schizophrenia:
Cognition Enhancement and Antipsychotic Efficacy

HOLLY MOORE, Moderator

Associate Professor

Clinical Neurobiology in Psychiatry

Columbia University

MARK GEYER, Discussant

Professor

Department of Psychiatry

University of California, San Diego

STEVIN ZORN, Discussant

Executive Vice President

Neuroscience Research

Lundbeck USA

Breakout 5: Animal Models for Addiction

ATHINA MARKOU, Moderator

Professor

Department of Psychiatry

University of California, San Diego

ALAN LESHNER, Discussant

Chief Executive Officer

American Association for the Advancement of Science

GERARD MAREK, Discussant

Project Director

Neuroscience Development

Abbott Laboratories

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×

Breakout 6: Animal Models for Pain

A. VANIA APKARIAN, Moderator

Professor

Neuroscience Institute

Northwestern University

DAVID SHURTLEFF, Discussant

Acting Deputy Director

National Institute on Drug Abuse

 
4:15 p.m. Breakout Groups Report Out and Panel Discussion with Participants (15 minutes per group)

• What common themes were identified in:

o standardization needs

o endpoints

o basic science/clinical research gap

 
6:00 p.m. ADJOURN

DAY TWO

Note: Continental breakfast will be available at 8:00 a.m.

SESSION III: THE VALUE OF STANDARDIZATION

Session Objective: Explore key components of animal model science that would benefit from standardization, such as behavioral paradigms. Examine the benefits and challenges to developing standardizations for animal and behavioral models. Discuss potential methods for dissemination of standards.

8:30 a.m. Overview and Session Objectives

WALTER KOROSHETZ, Session Chair

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
8:40 a.m. Standardization in Preclinical Models of Anxiety: Necessary But Not Sufficient

ANDREW HOMES

Chief

Laboratory of Behavioral and Genomic

Neuroscience

National Institute on Alcohol Abuse and Alcoholism

8:55 a.m. Developing New Methods for Cognitive Translation from Rodent to Human

TIM BUSSEY

Professor

Department of Experimental Psychology

University of Cambridge

9:10 a.m. AD Models and the Risk/Benefit Ratio of Standardization

LENNART MUCKE

Director, Gladstone Institute of Neurological Disease

Professor, Department of Neurology

University of California, San Francisco

9:25 a.m. Discussion with Speakers and Participants
 
10:00 a.m. BREAK

SESSION IV: CORRESPONDING ANIMAL AND CLINICAL ENDPOINTS

Session Objective: Discuss methods to facilitate development of equivalent or surrogate animal research and clinical trial endpoints. Explore the value of surrogate endpoints for nervous system disorders. Identify components that require recapitulation in both animal studies and clinical trials.

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
10:15 a.m. Overview and Session Objectives

SHARON ROSENZWEIG-LIPSON, Session Chair

10:30 a.m. Prepulse Inhibition: Corresponding Endpoints, But to What End?

NEAL SWERDLOW

Professor

Department of Psychiatry

University of California, San Diego

10:45 a.m. Choice of Endpoints—EAE to Approved Drug—One Huge Success; One Massive Failure

LARRY STEINMAN

Professor

Department of Neurology and Neurological Sciences

Stanford University

11:00 a.m. Improving Bidirectional Translation for Nervous System Disorders

MICHELA GALLAGHER

Krieger-Eisenhower Professor of Psychology and Neuroscience

Department of Psychological and Brain Sciences

Johns Hopkins University

11:15 a.m. Discussion with Speakers and Participants
 
11:45 a.m. LUNCH (will be provided for all participants)

SESSION V: THE BASIC AND CLINICAL SCIENCE GAP

Session Objective: Explore methods for increasing bidirectional application of research findings between basic and clinical researchers. Examine regulatory requirements that may either facilitate or impede translation of animal models. Identify methods to increase confidence in

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×

the movement from animal models to clinical trials, including replication of studies.

1:00 p.m. Overview and Session Objectives

MARK GEYER, Session Chair

1:10 p.m. Developing Better Animal Models of Etiology and Pathophysiology

RICHARD RANSOHOFF

Director

Neuroinflammation Research Center

Cleveland Clinic

1:30 p.m. Panel Discussion on the Session Topic (15 minutes/speaker)

DEANNA BARCH

Professor of Psychology, Psychiatry and Radiology

Washington University

GERRY DAWSON

Chief Science Officer

P1vital

HUGO GEERTS

Scientific Liaison Officer

In Silico Biosciences

THOMAS STECKLER

Senior Scientific Director

Neuroscience Drug Discovery

Johnson & Johnson

2:30 p.m. Discussion with Speakers and Participants
 
3:00 p.m. BREAK
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×

SESSION VI: FUTURE DIRECTIONS AND NEXT STEPS

Session Objective: Define important, yet practical, expectations for animal models in nervous system disorders. Identify opportunities and key stakeholders necessary for the success of improving translation of animal models. Identify key components of the infrastructure support that will be required for implementation.

3:15 p.m. Overview and Session Objectives

RICHARD HODES and STEVEN PAUL

Session Chairs

3:25 p.m. Session Synopsis and Next Steps

STEVIN ZORN, Session I Chair

RICHARD HODES, Session II Co-Chair

STEVEN PAUL, Session II Co-Chair

WALTER KOROSHETZ, Session III Chair

SHARON ROSENZWEIG-LIPSON, Session IV Chair

MARK GEYER, Session V Chair

4:25 p.m. Discussion with Speakers and Participants
 
5:00 p.m. ADJOURN
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 83
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 84
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 85
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 86
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 87
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 88
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 89
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 90
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 91
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2013. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13530.
×
Page 92
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Nervous system diseases and disorders are highly prevalent and substantially contribute to the overall disease burden. Despite significant information provided by the use of animal models in the understanding of the biology of nervous system disorders and the development of therapeutics; limitations have also been identified. Treatment options that are high in efficacy and low in side effects are still lacking for many diseases and, in some cases are nonexistent. A particular problem in drug development is the high rate of attrition in Phase II and III clinical trials. Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans?

On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice. The primary focus of the workshop was to examine mechanisms for increasing the efficiency of translational neuroscience research through discussions about how and when to use animal models most effectively and then best approaches for the interpretation of the data collected. Specifically, the workshop objectives were to: discuss key issues that contribute to poor translation of animal models in nervous system disorders, examine case studies that highlight successes and failures in the development and application of animal models, consider strategies to increase the scientific rigor of preclinical efficacy testing, explore the benefits and challenges to developing standardized animal and behavioral models. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary also identifies methods to facilitate development of corresponding animal and clinical endpoints, indentifies methods that would maximize bidirectional translation between basic and clinical research and determines the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.

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