Agenda: Sex Difference Implications Translational Neuroscience Research
AGENDA (5 March 2010)
Sex Differences and Implications for
Translational Neuroscience Research - A Workshop
March 8 and 9, 2010
Franciscan Ballroom
Sir Francis Drake Hotel
450 Powell Street
San Francisco, CA 94102
8:30 a.m. Welcome, Introductions, and Workshop Objectives
Rae Silver, co-Chair
Professor of Natural and Physical Sciences
Columbia University
Stevin Zorn, co-Chair
Executive Vice President
Neuroscience Research
Lundbeck
Session I: Sex differences in Research: need, design, study
Session Objective:
-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 pre-clinical experiments that will examine sex differences, including strategies to bridge between pre-clinical 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 utilize basic research for pre-clinical and clinical application and study (i.e., phase 0-4), including approaches used by researchers to decide how and when to take into consideration the potential importance of sex differences.
Opening Remarks
8:40 a.m. What are some of the challenges to sex differences research and how can they be overcome?
Vivian Pinn
Associate Director for Research on Women's Health
Office of the Director
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 in 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 of 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 of psychiatry, obstetrics, gynecology
University of Pittsburgh School of Medicine
Director, Women's Behavioral HealthCARE
University Pittsburgh Medical Center
Jill Goldstein
Professor of Psychiatry and Medicine
Departments of Psychiatry and Medicine at Harvard Medical School
Director of Research
Connors Center for Women’s Health & Gender Biology
Brigham and Women’s Hospital
Etienne Sibille
Associate Professor
Center for Neuroscience
Department of Psychiatry
University of Pittsburgh
Carla Canuso
Senior Director, External Innovation
Neuroscience Therapeutic Area
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
11:25 a.m. Discussion with panelists and attendees
Richard Nakamura, Moderator
Director of the Division of Intramural Research Programs
NIMH
11:55 a.m. LUNCH
12:50 p.m. Panel Presentations: Pain and pain perception
Karen Berkley
Professor of Psychology and Neuroscience
Department of Psychology
Florida State University
Emeran Mayer
Professor
Departments of Medicine, Physiology, Psychiatry & Biobehavioral Sciences
Director, UCLA Center for Neurovisceral Sciences & 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 & Women's Hospital
Rachel Manber
Professor, Psychiatry & 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 of Natural and Physical Sciences
Columbia University
3:00 p.m. BREAK
3:15 p.m. Panel Presentations: Multiple Sclerosis and Neuro-inflammation
Robert Fox
Staff Neurologist and Medical Director
Mellen Center for Multiple Sclerosis at Cleveland Clinic
Halina Offner
Professor of Neurology and Anesthesiology and Perioperative Medicine
Oregon Health & Science University
Rhonda Voskuhl
Professor of 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
-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 pre-clinical experiments that will examine sex differences, including strategies to bridge between pre-clinical 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 utilize basic research for pre-clinical and clinical application and study (i.e., phase 0-4), including approaches used by researchers to decide how and when to take into consideration the potential importance of sex differences.
4:15 p.m. Panel Review and Discussion
Richard Nakamura
Director of the Division of Intramural Research Programs
NIMH
Chi-Ming Lee
Executive Director, Translational Science
AstraZeneca Pharmaceuticals
Rae Silver
Professor of Natural and Physical Sciences
Columbia University
Paul Hoffman
Associate Chief of Staff for Research and Program Development
North Florida/South Georgia Veterans Health System
4:55 p.m. Closing Discussion with Attendees
5:15 p.m. ADJOURN
Draft AGENDA
Sex Differences and Implications for
Translational Neuroscience Research - A Workshop
DAY 2
March 9
Franciscan Ballroom
Sir Francis Drake Hotel
450 Powell Street
San Francisco, CA 94102
9:00 a.m. Welcome and Review of Day One
Rae Silver, co-Chair
Professor of Natural and Physical Sciences
Columbia University
Stevin Zorn, co-Chair
Executive Vice President
Neuroscience Research
Lundbeck
9:20 a.m. Keynote Talk
Morgan Sheng
Vice President of 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 of Neurology
Chair, Department of Neurobiology Reed Neurological Research Center
University of California, Los Angeles
Session III: FDA Regulations and Perspectives from Industry
Session Objective:
Discuss the regulatory practices regarding including males and females in clinical trials
Explore how and when industry considers and addresses studying sex differences, given regulatory guidelines
Identify industry's constraints regarding assessing sex differences in all phases of clinical trials
Examine the advantages, constraints, and implication 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
NIMH
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 Objective: 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 research.
11:20 a.m. Moderated Discussion with Attendees
Rae Silver, co-Chair
Professor of Natural and Physical Sciences
Columbia University
Stevin Zorn, co-Chair
Executive Vice President
Neuroscience Research
Lundbeck
Wrap-Up Discussion Questions:
-What are the key opportunities where understanding sex difference 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 which 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?
Noon Adjourn
Back to Meeting