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Genome-Based Therapeutics Targeted Drug Discovery and Development: Workshop Summary (2012) / Chapter Skim
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4 Emerging Technologies in Drug Development
Pages 29-36

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From page 29...
... These include not only DNA sequencers but a wide variety of new tools for gathering, analyzing, and disseminating genetic and genomic information. Three speakers at the workshop discussed technologies now being used and under development for genomic-based drug discovery and development.
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From page 30...
... Whole-genome sequencing has two main areas of application: biological understanding and genomic medicine. Understanding the molecular and genetic bases of thousands of human diseases, developing better targeted drugs and other therapies, including those for disease prevention, and developing personal genome interpretation software will require the sequencing of millions of genomes, Drmanac said.
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From page 31...
... Genomic data will need to be integrated with complete transcriptome and epigenome analysis for the relevant tissues of each subject, but whole genome sequencing can provide a foundation to integrate over other kinds of data. In this way, drugs could be developed for distinct genomic states and individual DNA sequences, such as genetically engineered stem cells or drugs that attack only cancer cells with specific DNA signatures.
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From page 32...
... Prospective studies are limited by turnaround times for analysis, and retrospective studies can have difficulties securing the appropriate samples. Finally, complex biology requires a better knowledge of disease pathways and thorough interpretation, not just raw data.
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From page 33...
... The company has been doing several types of studies with pharmaceutical partners. It is running single-agent clinical trials, longitudinal studies, multiple simultaneous Phase I trials in which individual samples are tested for multiple biomarkers, and analyses of samples from failed Phase III trials that did not meet clinical endpoints but produced evidence of responders for whom a drug might be valuable.
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From page 34...
... Where a strong diagnostic hypothesis exists, a strong scientific rationale allows for patient selection through all stages of development. This situation can provide a relatively fast development path and a relatively straightforward path to approval.
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From page 35...
... Overcoming these issues will require extensive drug and technology pipelines, effective collaborations, cross-functional teams, and strategic information gathering to provide robust datasets for better-informed and efficient drug development. In addition, said Fridlyand, the development strategy needs to include feedback from development to research in order to improve disease molecular classification and biomarker hypothesis generation.
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Key Terms

  • clinical trials
  • foundation medicine
  • complete genomics
  • genomic information
  • scientific rationale

  • multiple biomarkers
  • genetic variants
  • tive studies
  • strong diagnostic
  • patient selection

  • turnaround times
  • biology requires
  • phase iii
  • diagnostic hypothesis
  • distinct genomic

  • drug discovery
  • genetic bases
  • involved genetic
  • alternative clinical
  • meet clinical

  • extensive drug
  • reshape drug
  • predefined genetic
  • genetic alterations
  • genomic states

  • genomic medicine
  • genetic information
  • genomic data
  • clinical endpoints
  • complete genomic


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