Pharmaceutical Discovery Toxicology

Toxicity remains a leading cause of attrition in the pharmaceutical industry.

Therefore, in order to improve productivity, the identification of potential toxic mechanisms, hazard assessment and quantification of risk is shifting from the development stage to the research stage of R&D. Such research-stage toxicology is generally termed discovery toxicology.

Discovery toxicology differs greatly from regulatory toxicology. In the latter, a single compound is empirically characterised over a lengthy period in a series of defined regulatory studies. In the former, the pharmacological target is constant whilst chemical structures evolve over a short timeframe as a result of the design-make-test cycle.  Since the aims of drug discovery are different to those of drug development, it follows that the approaches used in discovery toxicology are different from those in development (regulatory) toxicology.

CXR Biosciences and its staff have an extensive track record in discovery toxicology, having supported the programmes of leading pharmaceutical and biotechnology companies for many years. We understand the scientific and industry context in which the studies are performed, and our flexible scheduling means we can deliver quality data in the short timeframes demanded by a pharmaceutical research organisation.

Aims of Discovery Toxicology

Aim 1:
Reduce candidate drug attrition due to preclinical toxicity by providing toxicological data and information that facilitates:

  • Target selection
  • Chemical series selection
  • Chemical design
  • Candidate selection

Aim 2:
Provide toxicology information at candidate drug selection /nomination that permits:

  • Prospective design of (and additional endpoints to be included in) regulatory studies
  • Prospective risk assessment of identified toxicities
  • Prospective definition of investigative toxicology studies to be performed during development
  • Prospective engagement of regulatory authorities

Discovery Toxicology – the CXR Biosciences approach

CXR uses a hypothesis-driven approach to:

  • Review potential (e.g. on-target or secondary-target) or observed toxicity issues
  • Develop a bespoke, project-specific experimental programme
  • Perform the required experiments
  • Understand translational risk assessment, and drive chemical design and/or candidate selection

We have a team with many years industry experience of project-based discovery toxicology, and the extensive in-house technical capabilities needed to run in vitro and in vivo mechanistic studies.

Working with CXR can provide access to expertise that may not be “in-house”, or access to resource to manage peaks and troughs in your discovery toxicology workload. We provide services ranging from complete outsourcing of discovery toxicology programmes, to running individual discovery toxicology studies designed by the customer. In addition we can establish and run issue-specific mechanistic in vitro assays.

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Download the Pharmaceutical Discovery Toxicology brochure.

For further information about our discovery toxicology services, or to discuss a specific issue, please contact us.