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Appendix C: Workshop Agenda
Pages 89-98

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From page 89...
... 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.
From page 90...
... 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.
From page 91...
... • 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.
From page 92...
... 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.
From page 93...
... 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
From page 94...
... 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.
From page 95...
... 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.
From page 96...
... 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.
From page 97...
... 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.
From page 98...
... 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.


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