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1 Introduction and Overview
Pages 1-8

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From page 1...
... . In addition, there is an increased probability of clinical trial failures at later stages in the drug development pipeline, even though resource investments are high for these drugs (Bunnage, 2011)
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... Richard Hodes, director of the National Institute on Aging and a co-chair of the workshop planning committee, summarized the following key points highlighted during the workshop:  Animal models can provide critical insight on specific disease mechanisms or targets of interest.  Many participants noted that animal models typically do not ful ly mimic or recapitulate nervous system disorders.
From page 3...
... . Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials,3 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.
From page 4...
... Many participants noted that discussions regarding how to accelerate to first-inhuman trials would be premature before considering improvements at earlier stages in the drug development process. These themes, listed on the next page, are expanded on in the succeeding chapters.
From page 5...
... o Phenotyping: Several participants noted that the current model of drug development does not facilitate translation of discovery research directly into clinical trials for new thera peutics. One speaker highlighted that the field has lost track of clinical phenotyping and endotyping even though failures
From page 6...
... For example, iPSCs may be better than animal models for target identification. Humanized animal models may help improve understanding of nervous system disorders and identify mechanisms of disease by engrafting human tissue stem cells in to mice, a few participants noted.
From page 7...
...  Humans as the starting point: Several participants noted that an initial focus on human phenotypes rather than animal models might better inform the drug discovery process. Some partici pants suggested going directly into the patient population to validate targets.
From page 8...
... Several participants noted the value of pre-IND meetings to discuss specific questions prior to submission of applications.  Precompetitive space: Participants discussed opportunities for the scientific community (academia, industry, and government)


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