Delivering extensive pharmacodynamic assays in Phase I

Proteomics in clinical trials

The Client

A large pharmaceutical corporation developing a novel agent.

The Challenge

With no preclinical model of drug response, there were considerable unknowns about the mechanism, cellular effects and subject responses expected with this compound. Java worked with the customer to develop a suite of tailored pharmacodynamic assays further characterise the compound in Phase I. Critically, this approach allowed drug effects to be well characterised in the early stages of clinical research – when overall costs are much lower.

The Approach

The methodology that Java developed for this study featured innovative clinical research procedures and rarely used techniques which were customised to target the areas of interest. We also relied on established assays tailored to the drug being studied.

The procedures performed (14 in total) included imaging, cell culture, transcriptomics, proteomics, biochemical and functional assays. Java:

  • Developed methodologies for each of these techniques
  • Implemented some in preclinical testing
  • Trained Phase I staff in sample collection and processing

Many samples were shipped to Java for analysis, some by our in-house scientific team while others were subcontracted to our network of technology core facilities in local universities. This enabled Java to provide high technology assays such as proteomics and next-generation sequencing (including data analysis and bioinformatics) in a controlled environment under the aegis of an experienced Clinical Research Organisation.

The Outcome

  • Obtained extensive data on drug mechanism and effects, identified novel drug actions.
  • Results suggested new drug indications based on previously unknown effects.
  • Comprehensive reporting, analysis and discussion with the client on the significance of the results