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Institute of Medicine (US) Forum on Neuroscience and Nervous System Disorders. Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary. Washington (DC): National Academies Press (US); 2011.

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Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary.

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CWorkshop 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;
  • 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 Presiden
 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.
  • 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
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
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
 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

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

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.
  • 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 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
Copyright © 2011, National Academy of Sciences.
Bookshelf ID: NBK53384
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