LEADER 03988nam 2200493 450 001 9910824244503321 005 20230809224629.0 010 $a0-309-45514-6 035 $a(CKB)3710000001399073 035 $a(MiAaPQ)EBC4871448 035 $a(EXLCZ)993710000001399073 100 $a20170703h20172017 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 00$aTherapeutic development in the absence of predictive animal models of nervous system disorders $eproceedings of a workshop /$fLisa 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, Medicine 210 1$aWashington, District of Columbia :$cNational Academies Press,$d2017. 210 4$dİ2017 215 $a1 online resource (95 pages) $cillustrations 311 $a0-309-45513-8 320 $aIncludes bibliographical references. 327 $aIntroduction 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. 330 1 $a"Compared with other disease areas, central nervous system (CNS) disorders have had the highest failure rate for new compounds in advanced clinical trials. Most CNS drugs fail because of efficacy, and the core issue underlying these problems is a poor understanding of disease biology. Concern about the poor productivity in neuroscience drug development has gained intensity over the past decade, amplified by a retraction in investment from the pharmaceutical industry. This retreat by industry has been fueled by the high failure rate of compounds in advanced clinical trials for nervous system disorders. In response to the de-emphasis of CNS disorders in therapeutic development relative to other disease areas such as cancer, metabolism, and autoimmunity, the National Academies of Sciences, Engineering, and Medicine initiated a series of workshops in 2012 to address the challenges that have slowed drug development for nervous system disorders. Motivated by the notion that advances in genetics and other new technologies are beginning to bring forth new molecular targets and identify new biomarkers, the Academies hosted the third workshop in this series in September 2016. Participants discussed opportunities to accelerate early stages of drug development for nervous system disorders in the absence of animal models that reflect disease and predict efficacy. This publication summarizes the presentations and discussions from the workshop"--$cPublisher's description. 606 $aNervous system$xDiseases$vCongresses 615 0$aNervous system$xDiseases 676 $a615 700 $aBain$b Lisa J.$01603466 702 $aStroud$b Clare 702 $aKeren$b Noam I. 702 $aNorris$b Sheena M. Posey 712 02$aForum on Neuroscience and Nervous System Disorders. 712 02$aBoard on Health Sciences Policy. 712 02$aHealth and Medicine Division. 712 02$aNational Academies of Sciences, Engineering, Medicine. 712 12$aTherapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders : a Workshop$f(2016 :$eWashington, D.C.) 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910824244503321 996 $aTherapeutic development in the absence of predictive animal models of nervous system disorders$93933140 997 $aUNINA