LEADER 04109nam 2200601 450 001 9910789232503321 005 20230803202224.0 010 $a0-309-29249-2 010 $a0-309-29247-6 035 $a(CKB)3710000000103374 035 $a(EBL)3379237 035 $a(SSID)ssj0001191230 035 $a(PQKBManifestationID)11708378 035 $a(PQKBTitleCode)TC0001191230 035 $a(PQKBWorkID)11219918 035 $a(PQKB)11381147 035 $a(MiAaPQ)EBC3379237 035 $a(WaSeSS)bw9780309292467 035 $a(Au-PeEL)EBL3379237 035 $a(CaPaEBR)ebr10863892 035 $a(OCoLC)923289754 035 $a(EXLCZ)993710000000103374 100 $a20140506h20142014 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aImproving and accelerating therapeutic development for nervous system disorders $eworkshop summary /$fSheena M. Posey Norris [and three others], rapporteurs ; Forum on Neuroscience and Nervous System Disorders : Board on Health Sciences Policy 210 1$aWashington, District of Columbia :$cNational Academies Press,$d2014. 210 4$dİ2014 215 $a1 online resource (119 p.) 300 $aDescription based upon print version of record. 311 $a0-309-29246-8 320 $aIncludes bibliographical references. 327 $a""Front Matter""; ""Reviewers""; ""Contents""; ""1 Introduction and Overview""; ""2 Drug Development Challenges""; ""3 Target Identification""; ""4 Target Validation""; ""5 Opportunities to Improve and Accelerate the Drug Development Pipeline""; ""6 Perspectives on Next Steps""; ""Appendix A: References""; ""Appendix B: Workshop Agenda""; ""Appendix C: Registered Attendees"" 330 $a"Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials."--$cPublisher's website. 606 $aDrug development$vCongresses 606 $aDrug approval$vCongresses 606 $aClinical trials$vCongresses 615 0$aDrug development 615 0$aDrug approval 615 0$aClinical trials 676 $a615.1 702 $aNorris$b Sheena M. Posey 712 02$aInstitute of Medicine (U.S.) 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910789232503321 996 $aImproving and accelerating therapeutic development for nervous system disorders$93742586 997 $aUNINA