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Appendix B: Workshop Agenda
Pages 87-100

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From page 87...
... Two themes that emerged from the workshop were that many have lost confidence in the ability of animal models to predict efficacy and that current animal models may, in fact, be screening out potentially effective compounds. Another theme was the need to combine animal models with emerging translational tools and technologies in therapeutic development.
From page 88...
... Review of workshop on Improving Translation of Animal Models for Nervous System Disorders RICHARD HODES Director National Institute on Aging
From page 89...
... The therapeutic development pathway: From the lab to the clinic WILLIAM POTTER Senior Advisor Office of the Director National Institute of Mental Health 9:15 a.m. Meeting the medical need: The benefits and risks of aggressively moving compounds forward JASON KARLAWISH Professor of Medicine, Medical Ethics, and Health Policy Perelman School of Medicine University of Pennsylvania 9:30 a.m.
From page 90...
... 11:00 a.m. Overview and session objectives RAJESH RANGANATHAN, Session Chair Director Office of Translational Research National Institute of Neurological Disorders and Stroke Speakers will focus on the following questions:  How could this area of research speed therapeutic development?
From page 91...
... Stem Cell Program UCSD School of Medicine 11:25 a.m. Humanized animal models IRVING WEISSMAN Director, Institute of Stem Cell Biology and Regenerative Medicine Professor of Pathology and Developmental Biology Stanford University 11:45 a.m.
From page 92...
... 1) Neurodevelopmental disorders: Autism and schizophrenia KEVIN EGGAN Associate Professor Harvard Stem Cell Institute Harvard University 2)
From page 93...
... BREAK SESSION III: EVALUATING THERAPEUTIC DEVELOPMENT PATHWAYS Session Objectives: Explore mechanisms by which evidence is evaluated in decisions to commit to therapeutic development approaches. Discuss ways in which new and emerging tools and technologies could increase confidence in decision making.
From page 94...
... Government perspective STORY LANDIS Director National Institute of Neurological Disorders and Stroke 3) Academic perspective REISA SPERLING Director, Center for Alzheimer's Research and Treatment Professor of Neurology Harvard Medical School 4:35 p.m.
From page 95...
... 8:35 a.m. Overview and session objectives WILLIAM POTTER, Session Chair Senior Advisor Office of the Director National Institute of Mental Health 8:40 a.m.
From page 96...
... ROBERT CONLEY Distinguished Lilly Scholar Regulatory Leader, Biomedicines Eli Lilly and Company ERIC BASTINGS Deputy Director Division of Neurology Products, Center for Drug Evaluation and Research U.S. Food and Drug Administration NI KHIN Medical Team Leader Division of Psychiatry Products, Center for Drug Evaluation and Research U.S.
From page 97...
...  How important is it to fully understand mechanisms and molecular pathways of action prior to initiation of the IND enabling package? KIRAN REDDY Principal Third Rock Ventures STEVE ELMS Managing Partner Aisling Capital KAZUMI SHIOSAKI Managing Director MPM Capital
From page 98...
... Target ID/validation DANIEL WEINBERGER Director and CEO Lieber Institute for Brain Development 3) Screening/optimization ADRIAN IVINSON Director, Harvard NeuroDiscovery Center Harvard University 4)
From page 99...
... Imagining new therapeutic development pathways (with Q&A) CHRISTOPHER AUSTIN Director National Center for Advancing Translational Sciences National Institutes of Health 2:10 p.m.
From page 100...
... 3:30 p.m. Final comments JOHN DUNLOP, Co-Chair FRED GAGE, Co-Chair 3:45 p.m.


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