Proof of Concept Data
The Client. A small start-up wishing to demonstrate a drug's unique selling points in a first-in-human study.
The Challenge. The drug was a novel agent with unique pharmacokinetic and pharmacodynamic properties. This start-up client wished to demonstrate these properties using customised monocyte assays in series of single ascending dose and multiple ascending dose studies.
The phase I clinical research organisation sought out Java Clinical's expertise to develop and implement these assays alongside standard phase I safety and pharmacokinetic assays.
The Approach. Based on the client's initial specification, Java Clinical rapidly produced a feasibility study outlining how we could address the client's needs.
Working closely with the phase I CRO at a joint bid defence meeting, Java Clinical Research's presentation detailing our proposed development and implementation of the customised assays was crucial to securing the contract.
Working to tight timelines, we developed methods based on state-of-the-art laboratory procedures to isolate a highly pure population of monocytes from whole blood in a clinical trial setting. This allowed measurement of drug effects, to demonstrate a unique property of the drug.
We adapted a complicated flow cytometry assay used in preclinical work to demonstrate specific pharmacodynamic effects in monocyte samples from this phase I study.
We researched, adapted and validated biochemical assays of monocyte function along with a third party vendor to provide additional pharmacodynamic data.
Logistical procedures were developed to ensure that all samples were processed for the various assays in parallel, while meeting study sampling timepoints and assay time constraints.
The Outcome. Java Clinical scientists worked effectively alongside staff from the phase I CRO to implement three customised assays alongside standard clinical trial procedures.
Results of the assays were rapidly reported to inform dosing decisions for successive cohorts.
Java Clinical's assays demonstrated clinical proof of concept in a first-in-human study.
During this study the start-up company sold the compound to a top-ten pharma company for future development.
