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Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
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C
Workshop Agenda

SEX DIFFERENCES AND IMPLICATIONS FOR TRANSLATIONAL NEUROSCIENCE RESEARCH: A WORKSHOP

Background: Basic research that involves delineating meaningful drug effects and behavioral and physiological responses that differ between the sexes can be costly and time consuming because the research requires additional experiment groups and protocols. However, epidemiological and clinical studies indicate substantial sex differences in response to drugs. The sex differences cut across other parameters such as socioeconomic factors, race, age, etc. In the current era of translational research and personalized medicine, taking sex differences into account is important so that these drug effects can be more accurately understood. This is particularly important in the neurosciences because of the complex nature of many disorders of the nervous system, including mental, neurological, and substance use disorders. Consequently, the Institute of Medicine’s Forum on Neuroscience and Nervous System Disorders is hosting a workshop to explore the key principles and strategies used by basic translational researchers and industry in studying sex differences in the neurosciences for the therapy development pathway.


Meeting Objectives: The objectives of this workshop are to

  • briefly outline the public health importance of studying sex difference in the nervous system, in health and sickness, including the potential application to healthcare delivery;

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
  • identify the scientific principles that should be considered when designing preclinical experiments that will examine sex differences, including strategies to bridge between preclinical and clinical studies;

    • discuss when and how sex differences should and should not be considered;

  • explore the key principles and strategies used by academic clinicians to effectively use basic research for preclinical and clinical application and study (i.e., Phases 0–IV), including approaches used by researchers to decide how and when to consider the potential importance of sex differences;

  • explore how and when industry considers and addresses studying sex differences, given regulatory guidelines;

  • examine the advantages, constraints, and implication of performing “valid analysis” versus requiring statistical outcomes between the sexes;

  • identify the next steps that will be critical to establishing a set of principles that could be used by a variety of stakeholders in considering when and how to incorporate studying sex differences into translational research efforts.

March 8, 2010


Franciscan Ballroom

Sir Francis Drake Hotel

450 Powell Street, San Francisco, CA

8:30 a.m.

Welcome, Introductions, and Workshop Objectives

 

Rae Silver, Cochair

Professor, Natural and Physical Sciences

Columbia University

 

Stevin Zorn, Cochair

Executive Vice President

Neuroscience Research

Lundbeck

SESSION I:
SEX DIFFERENCES IN RESEARCH: NEED, DESIGN, STUDY

Session Objectives:

  • Briefly outline the public health importance of studying sex difference in the nervous system, in health and sickness, including the potential application to healthcare delivery.

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
  • Identify the scientific principles that should be considered when designing preclinical experiments that will examine sex differences, including strategies to bridge between preclinical and clinical studies.

    • Discuss when and how sex differences should and should not be considered.

  • Explore the key principles and strategies used by academic clinicians and industry to effectively use basic research for preclinical and clinical application and study (i.e., Phases 0–IV), including approaches used by researchers to decide how and when to consider the potential importance of sex differences.

Opening Remarks

8:40 a.m.

What Are Some of the Challenges for Sex Differences Research and How Can They Be Overcome?

 

Vivian Pinn

Director

Office of Research on Women’s Health

National Institutes of Health

9:00 a.m.

What Are the Scientific Principles for Studying Sex

 

Differences in Health and Disease?

Arthur Arnold

Professor and Chair

Department of Physiological Science

University of California–Los Angeles

9:20 a.m.

When and How Should Sex Differences in Drug Response Be Studied?

 

Jeff Mogil

Chair, Pain Studies

Department of Psychology

McGill University

9:40 a.m.

What Factors Will Affect the Successful Translation of Sex Differences from Preclinical to Clinical Studies?

 

Jon Levine

Professor

Department of Neurobiology and Physiology

Northwestern University

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×

10:00 a.m

When and How Should Sex Differences in Disease Susceptibility Be Studied?

 

Kathryn Sandberg

Professor, Medicine and Physiology

Director, Center for Study of Sex Differences

Georgetown University Medical Center

10:20 a.m.

BREAK

10:35 a.m.

Panel Presentations: Depression

 

Katherine Wisner

Professor, Psychiatry, Obstetrics, and Gynecology

University of Pittsburgh School of Medicine

Director, Women’s Behavioral HealthCARE

University of Pittsburgh Medical Center

 

Jill Goldstein

Professor, Psychiatry and Medicine

Departments of Psychiatry and Medicine at Harvard Medical School

Director of Research, Connors Center for Women’s Health and Gender Biology

Brigham and Women’s Hospital

 

Etienne Sibille

Associate Professor

Department of Psychiatry

Center for Neuroscience

Translational Neuroscience Program

University of Pittsburgh

 

Carla Canuso

Senior Director, External Innovation

Neuroscience Therapeutic Area

Johnson & Johnson Pharmaceutical Research and Development, LLC

11:25 a.m.

Discussion with Panelists and Attendees

 

Richard Nakamura, Moderator

Director, Division of Intramural Research Programs

National Institute of Mental Health

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×

11:55 a.m.

LUNCH

12:50 p.m.

Panel Presentations: Pain and Pain Perception

 

Karen Berkley

Professor, Psychology and Neuroscience

Department of Psychology

Florida State University

 

Emeran Mayer

Professor

Departments of Medicine, Physiology, Psychiatry, and Biobehavioral Sciences

Director, UCLA Center for Neurovisceral Sciences and Women’s Health

University of California–Los Angeles

 

Linda LeResche

Professor

Department of Oral Medicine

School of Dentistry

University of Washington

1:20 p.m.

Discussion with Panelists and Attendees

 

Chi-Ming Lee, Moderator

Executive Director, Translational Science

AstraZeneca Pharmaceuticals

1:50 p.m.

Panel Presentations: Sleep Medicine

 

Roseanne Armitage

Professor, Department of Psychiatry

Adjunct Professor, Department of Psychology

Director, Sleep and Chronophysiology Laboratory

University of Michigan

 

Jeanne Duffy

Assistant Professor of Medicine

Division of Sleep Medicine

Harvard Medical School

Director, Chronobiology Core

Division of Sleep Medicine

Department of Medicine

Brigham and Women’s Hospital

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×

 

Rachel Manber

Professor, Psychiatry and Behavioral Science

Director, Stanford Sleep Medicine Clinic

Stanford University

 

Martica Hall

Associate Professor

Psychiatry, Psychology, and Clinical and Translational Sciences

University of Pittsburgh School of Medicine

2:30 p.m.

Discussion with Panelists and Attendees

 

Rae Silver, Moderator

Professor, Natural and Physical Sciences

Columbia University

3:00 p.m.

BREAK

3:15 p.m.

Panel Presentations: Multiple Sclerosis and Neuroinflammation

 

Robert Fox

Staff Neurologist and Medical Director

Mellen Center for Multiple Sclerosis at Cleveland Clinic

 

Halina Offner

Professor, Neurology and Anesthesiology and Perioperative Medicine

Oregon Health and Science University

 

Rhonda Voskuhl

Professor, Neurology

Director, Multiple Sclerosis Research and Treatment Program

University of California–Los Angeles

3:45 p.m.

Discussion with Panelists and Attendees

 

Paul Hoffman, Moderator

Associate Chief of Staff for Research and Program Development

North Florida/South Georgia Veterans Health System

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×

SESSION II:
REVIEW

Session Objectives: Based on today’s presentations and discussions, a panel will synthesize and discuss key points and ideas that examined

  • the principles that should be considered when designing preclinical experiments that will examine sex differences, including strategies to bridge between preclinical and clinical studies;

    • when and how sex differences should and should not be considered;

  • the key principles and strategies used by academic clinicians and industry to effectively use basic research for preclinical and clinical application and study (i.e., Phase 0–IV), including approaches used by researchers to decide how and when to consider the potential importance of sex differences.

4:15 p.m.

Panel Review and Discussion

 

Richard Nakamura

Director, Division of Intramural Research Programs

National Institute of Mental Health

 

Chi-Ming Lee

Executive Director, Translational Science

AstraZeneca Pharmaceuticals

 

Rae Silver

Professor, Natural and Physical Sciences

Columbia University

 

Paul Hoffman

Associate Chief of Staff for Research and Program Development

North Florida/South Georgia Veterans Health System

4:45 p.m.

Closing Discussion with Attendees

5:15 p.m.

ADJOURN

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×

March 9, 2010

9:00 a.m.

Welcome and Review of Day One

 

Rae Silver, Cochair

Professor, Natural and Physical Sciences

Columbia University

 

Stevin Zorn, Cochair

Executive Vice President

Neuroscience Research

Lundbeck

9:20 a.m.

Keynote Talk

 

Morgan Sheng

Vice President, Neuroscience

Genentech

9:50 a.m.

Panel Discussion: Reporting Sex Differences in Research in Publications

 

Sean Murphy (Journal of Neurochemistry)

Professor, Department of Neurological Surgery

University of Washington School of Medicine

 

Marie-Francoise Chesselet (Experimental Neurology)

Professor, Neurology

Chair, Department of Neurobiology Reed Neurological Research Center

University of California–Los Angeles

SESSION III:
FDA REGULATIONS AND PERSPECTIVES FROM INDUSTRY

Session Objectives:

  • Discuss regulatory practices regarding the inclusion of males and females in clinical trials.

  • Explore how and when industry considers and addresses studying sex differences, given regulatory guidelines.

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
  • Identify industry’s constraints on assessing sex differences in all phases of clinical trials.

  • Examine the advantages, constraints, and implications of performing “valid analysis” versus requiring statistical outcomes between the sexes.

 

Stevin Zorn, Session Chair

Executive Vice President

Neuroscience Research

Lundbeck

10:10 a.m.

Panel Presentations

 

Ameeta Parekh

Director, Research and Development

Office of Women’s Health

Food and Drug Administration

 

Carlos Zarate

Clinical Professor, Psychiatry and Behavioral Sciences

George Washington University

Chief, Experimental Therapeutics

Mood and Anxiety Disorders Program

National Institute of Mental Health

 

Douglas Feltner

Vice President, Global Translational

Medicine and Neuroscience

Pfizer

10:50 a.m.

Discussion with Panelists and Attendees

 

Stevin Zorn, Session Chair

Executive Vice President

Neuroscience Research

Lundbeck

SESSION IV:
NEXT STEPS

Session Objectives: Identify the next steps that will be critical to establishing a set of principles that could be used by a variety of stakeholders in

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×

considering when and how to incorporate the study of sex differences into research.

11:20 a.m.

Moderated Discussion with Attendees

 

Rae Silver, Cochair

Professor, Natural and Physical Sciences

Columbia University

 

Stevin Zorn, Cochair

Executive Vice President

Neuroscience Research

Lundbeck

Wrap-Up Discussion Questions:

  1. What are the key opportunities where understanding sex differences will have the greatest healthcare impact?

  2. What are some of the critical factors (e.g., biological, epidemiological, health economics, sociological, ethical) and how would they guide the consideration of studying sex differences to improve health care?

  3. When and how should sex differences in disease susceptibility be studied?

  4. When and how should sex differences in drug response be studied?

  5. What are some of the barriers that impede sex differences research and how can they be overcome?

  6. How can academic clinicians and basic researchers help improve translational neuroscience efforts in the area of sex differences research?

  7. What factors will affect the successful translation of sex differences from preclinical to clinical studies?

12:00 p.m.

ADJOURN

Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
Page 89
Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
Page 90
Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
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Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
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Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
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Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
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Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
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Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
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Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
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Suggested Citation:"Appendix C: Workshop Agenda." Institute of Medicine. 2011. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13004.
×
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Biological differences between the sexes influence not only individual health but also public health, biomedical research, and health care. The Institute of Medicine held a workshop March 8-9, 2010, to discuss sex differences and their implications for translational neuroscience research, which bridges the gap between scientific discovery and application.

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