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Neuron. 2014 Nov 5;84(3):546-53. doi: 10.1016/j.neuron.2014.10.007. Epub 2014 Nov 5.

Improving and accelerating drug development for nervous system disorders.

Author information

1
Forum on Neuroscience and Nervous System Disorders, Institute of Medicine, Washington, DC 20001, USA.
2
Forum on Neuroscience and Nervous System Disorders, Institute of Medicine, Washington, DC 20001, USA. Electronic address: baltevogt@nas.edu.
3
Innovative Medicines and Early Development Unit, AstraZeneca Neuroscience, Cambridge, MA 02139, USA.
4
Salk Institute for Biological Studies, La Jolla, CA 92037, USA.
5
Stanley Center for Psychiatric Research, Broad Institute of MIT and Harvard University, Cambridge, MA 02142, USA.

Abstract

Advances in the neurosciences have placed the field in the position where it is poised to significantly reduce the burden of nervous system disorders. However, drug discovery, development, and translation for nervous system disorders still pose many unique challenges. The key scientific challenges can be summarized as follows: mechanisms of disease, target identification and validation, predictive models, biomarkers for patient stratification and as endpoints for clinical trials, clear regulatory pathways, reliability and reproducibility of published data, and data sharing and collaboration. To accelerate nervous system drug development, the Institute of Medicine's Forum on Neuroscience and Nervous System Disorders has hosted a series of public workshops that brought together representatives of industry, government (including both research funding and regulatory agencies), academia, and patient groups to discuss these challenges and offer potential strategies to improve the translational neuroscience.

PMID:
25442933
PMCID:
PMC4254615
DOI:
10.1016/j.neuron.2014.10.007
[Indexed for MEDLINE]
Free PMC Article

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