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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;



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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 ef- fects and behavioral and physiological responses that differ between the sexes can be costly and time consuming because the research requires ad- ditional 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 impor- tant 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 Neurosci- ence 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 differ- ence in the nervous system, in health and sickness, including the potential application to healthcare delivery; 

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0 SEX DIFFERENCES AND IMPLICATIONS • identify the scientific principles that should be considered when de- signing preclinical experiments that will examine sex differences, in- cluding 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 clini- cians to effectively use basic research for preclinical and clinical ap- plication 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 con- sidering 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 differ- ence in the nervous system, in health and sickness, including the potential application to healthcare delivery.

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 APPENDIX C • Identify the scientific principles that should be considered when de- signing preclinical experiments that will examine sex differences, in- cluding 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 clini- cians and industry to effectively use basic research for preclinical and clinical application and study (i.e., Phases 0–IV), including ap- proaches 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

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 SEX DIFFERENCES AND IMPLICATIONS 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

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 APPENDIX C 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

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 SEX DIFFERENCES AND IMPLICATIONS 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

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 APPENDIX C 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

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 SEX DIFFERENCES AND IMPLICATIONS 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.

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 APPENDIX C • Identify industry’s constraints on assessing sex differences in all phases of clinical trials. • Examine the advantages, constraints, and implications of perform- ing “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 establish- ing a set of principles that could be used by a variety of stakeholders in

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 SEX DIFFERENCES AND IMPLICATIONS 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: a. What are the key opportunities where understanding sex differ- ences will have the greatest healthcare impact? b. What are some of the critical factors (e.g., biological, epidemiologi- cal, health economics, sociological, ethical) and how would they guide the consideration of studying sex differences to improve health care? c. When and how should sex differences in disease susceptibility be studied? d. When and how should sex differences in drug response be studied? e. What are some of the barriers that impede sex differences research and how can they be overcome? f. How can academic clinicians and basic researchers help improve translational neuroscience efforts in the area of sex differences research? g. What factors will affect the successful translation of sex differences from preclinical to clinical studies? 12:00 p.m. ADJOURN