03988nam 2200493 450 991082424450332120230809224629.00-309-45514-6(CKB)3710000001399073(MiAaPQ)EBC4871448(EXLCZ)99371000000139907320170703h20172017 uy 0engurcnu||||||||rdacontentrdamediardacarrierTherapeutic development in the absence of predictive animal models of nervous system disorders proceedings of a workshop /Lisa Bain [and three others], rapporteurs ; Forum on Neuroscience and Nervous System Disorders, Board on Health Sciences Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, MedicineWashington, District of Columbia :National Academies Press,2017.©20171 online resource (95 pages) illustrations0-309-45513-8 Includes bibliographical references.Introduction and overview -- Drug development for nervous system disorders: overview of challenges and potential opportunities -- Case studies: therapeutic development for Parkinson's disease and schizophrenia in the absence of predictive animal models of disease -- New modeling approaches for nervous system disorders -- Private-sector thresholds for investment in neuroscience clinical trials -- Ethical considerations -- Regulatory perspectives -- Appendix A: References -- Appendix B: Workshop agenda -- Appendix C: Registered attendees."Compared with other disease areas, central nervous system (CNS) disorders have had the highest failure rate for new compounds in advanced clinical trials. Most CNS drugs fail because of efficacy, and the core issue underlying these problems is a poor understanding of disease biology. Concern about the poor productivity in neuroscience drug development has gained intensity over the past decade, amplified by a retraction in investment from the pharmaceutical industry. This retreat by industry has been fueled by the high failure rate of compounds in advanced clinical trials for nervous system disorders. In response to the de-emphasis of CNS disorders in therapeutic development relative to other disease areas such as cancer, metabolism, and autoimmunity, the National Academies of Sciences, Engineering, and Medicine initiated a series of workshops in 2012 to address the challenges that have slowed drug development for nervous system disorders. Motivated by the notion that advances in genetics and other new technologies are beginning to bring forth new molecular targets and identify new biomarkers, the Academies hosted the third workshop in this series in September 2016. Participants discussed opportunities to accelerate early stages of drug development for nervous system disorders in the absence of animal models that reflect disease and predict efficacy. This publication summarizes the presentations and discussions from the workshop"--Publisher's description.Nervous systemDiseasesCongressesNervous systemDiseases615Bain Lisa J.1603466Stroud ClareKeren Noam I.Norris Sheena M. PoseyForum on Neuroscience and Nervous System Disorders.Board on Health Sciences Policy.Health and Medicine Division.National Academies of Sciences, Engineering, Medicine.Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders : a Workshop(2016 :Washington, D.C.)MiAaPQMiAaPQMiAaPQBOOK9910824244503321Therapeutic development in the absence of predictive animal models of nervous system disorders3933140UNINA