|
||||||||||||||||
|
||||||||||||||||
The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. C
|
||||||||||||||||
 |
 |
Page 89 |
 |
|
 |
|
| ||||||||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 89
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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;
OCR for page 90
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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.
OCR for page 91
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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
OCR for page 92
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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
OCR for page 93
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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
OCR for page 94
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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
OCR for page 95
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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
OCR for page 96
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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.
OCR for page 97
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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
OCR for page 98
Sex Differences and Implications for Translational Neuroscience Research: Workshop Summary
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:
What are the key opportunities where understanding sex differences will have the greatest healthcare impact?
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?
When and how should sex differences in disease susceptibility be studied?
When and how should sex differences in drug response be studied?
What are some of the barriers that impede sex differences research and how can they be overcome?
How can academic clinicians and basic researchers help improve translational neuroscience efforts in the area of sex differences research?
What factors will affect the successful translation of sex differences from preclinical to clinical studies?
12:00 p.m.
ADJOURN