Therapeutic Development In The Absence Of Predictive Animal Models Of Nervous System Disorders

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Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders

Author: National Academies of Sciences, Engineering, and Medicine
language: en
Publisher: National Academies Press
Release Date: 2017-06-24
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.
Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders

Author: National Academies of Sciences, Engineering, and Medicine
language: en
Publisher: National Academies Press
Release Date: 2017-05-24
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.
Notes in the Category of C

Notes in the Category C: Reflections on Laboratory Animal Care and Use addresses how to improve laboratory animal care and use, also characterizing the current state of the industry and speculating on its long-term future. It offers analysis from a professional who has spent a lot of time in the trenches, also highlighting new approaches to produce further advances in the field. As the proper care and use of lab animals is critically important to scientists and those who depend on data generated from those animals, this comprehensive book is an ideal resource on the topic. Physicians, patients and their families, consumers, federal and non-profit research funding entities, health advocacy organizations, the FDA, EPA, regulatory approval agencies, and companies that invest billions in R&D to create new diagnostics, drugs, vaccines and medical devices will find this an informative addition for their work. - Offers an open dialogue about problems and issues in laboratory animal science - Discusses various approaches to making laboratory animal science programs more cost-effective - Presents new frameworks for lab animal medicine that may advance better veterinary care and improve informative animal models