Initiative Overview

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, allowing for better compounds to progress to clinical development
  • Reduce animal use by optimizing toxicity study design through the replacement, refinement, and reduction of animals in preclinical testing
  • Increase confidence in early decision making through greater understanding of on-target/off-target toxicity and the incidence of rare and incidental findings to bring better compounds to patients faster
  • 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 nonclinical data types

NEW! To read and download our “Toxicology Data Sharing: Leveraging Data Sharing To Enable Better Decision Making In Research And Development” paper, click here.

BioCelerate has devised several Use Cases describing how use of DataCelerate® could potentially generate the benefits noted above. DataCelerate is currently only available to TransCelerate and BioCelerate Member Companies. To inquire about joining these organizations, please contact membership@transceleratebiopharmainc.com or refer to our Membership Application.

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

Initiative Assets