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Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders Proceedings of a Workshop (2017) / Chapter Skim
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1 Introduction and Overview
Pages 1-4

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From page 1...
... . This retreat by industry has been fueled by the high failure rate of compounds in advanced clinical trials for nervous system disorders, according to Steven Hyman, director of the Stanley Center for Psychiatric Research at the Broad Institute of Massachusetts Institute of Technology and Harvard University.
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From page 2...
... Consequently, they may fail to predict efficacy and may even screen out potentially effective compounds. In 2013, a second workshop was convened: Accelerating Therapeutic Development for Nervous System Disorders Toward First-in-Human Trials,3 where participants explored the potential usefulness of supplementing animal models of basic mechanisms with new technologies and approaches, including human induced pluripotent stem (iPS)
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From page 3...
... The workshop will bring together key stakeholders to discuss scientific, regulatory, and business challenges and to identify potential opportunities in this do main to accelerate therapeutic development to address unmet medical needs. Invited presentations and discussions will be designed to: • Explore the utility of novel approaches from genetic, stem cell, and molecular imaging research for target identification and validation (e.g., establishing predictive validity in proof-of-concept studies)
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From page 4...
... Chapter 3 presents two case studies that showcase novel approaches being used in the field to develop treatments for Parkinson's disease and schizophrenia. Innovative modeling approaches are the focus of Chapter 4, including cellular approaches that exploit emerging iPS cell technologies and discoveries that enable growing cells in three dimensions, genetically engineered primate models, and computational quantitative systems pharmacology modeling of brain circuits.
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Key Terms

  • predictive animal
  • drug development
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  • clinical trials
  • failure rate

  • disease mechanisms
  • therapeutic development
  • bringing compounds
  • existing animal
  • tive animal

  • menting animal
  • humanized animal
  • potential usefulness
  • including human
  • challenges addressed

  • growing cells
  • workshop brought
  • issue underlying
  • individual workshop
  • proceedings summarize

  • neuroscience forum
  • regulatory implications
  • david michelson
  • experimental biology
  • clinical studies

  • vanced clinical
  • neuroscience drug
  • human disease
  • induced pluripotent
  • mal model


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