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Toxicology & Background Control Data Sharing Initiative

Rationale

Vision

This Initiative will enable participating companies to make data-driven decisions on compound progression based on an increased understanding of on-target and off-target toxicity.

The scope of the Initiative is to design, develop, and maintain a centralized data lake capable of storing, visualizing, analyzing, and linking toxicology and background control data, both in structured and unstructured data formats.

Unmet Needs

  • Due to a deficit of published toxicology study results, there is limited industry understanding of target-related toxicity
  • Inability to answer toxicity questions due to lack of a centralized, searchable repository housing data in a standardized format
  • Databases within each member company are limited; as such, regulators tend to have a better view of the data landscape than companies

Benefits

  • Reduce drug development costs by identifying fatally flawed compounds earlier and optimizing toxicity study design through the replacement, refinement, and reduction of animal use
  • Increase confidence in early decision making through greater understanding of on-target and off-target toxicity
  • Improve ability to respond to regulators by leveraging a larger set of data to determine the significance of rare and incidental findings
  • Increase IT Systems efficiency by leveraging an industry standard software model for the data repository to capture economies of scale, cost savings, and enhanced functionality

Available Assets

The Toxicology & Background Control Data Sharing initiative is collaborating with a technology partner to develop a data sharing platform with the following capabilities:

  • A hosted, stand-alone platform that will provide data sharing capabilities for participating Member Companies
  • Import of structured data (e.g. CDISC SEND format) and unstructured data (e.g. PDF format)
  • Automated de-identification and harmonization tools for structured data
  • Enhanced search, visualization, and analytical tools
  • A flexible core infrastructure enabling the long-term vision of sharing and linking other preclinical data types

BioCelerate has devised several Use Cases describing how use of DataCelerate could potentially generate the benefits noted above.

For further information on our Use Cases see our Initiative Assets below.

Initiative Assets