- Creation of translational strategies to enable smooth transition of candidate molecules into the clinic.
- Designing and performing in vitro studies on human primary cells and disease tissue samples as well as ex vivo analyses for biomarker selection.
- Access to samples from healthy volunteers and patients through contracts with local hospitals.
- Human biological samples are managed in line with the highest standards and policies for acquisition, transfer and disposal of human biological material.
Track record in designing and performing challenge studies during Phase I, which provide early readouts and proof of mechanism in humans.
A recent example of the development and application of a GPCR Biomarker assay is described in a case study below.
- As part of an integrated GPCR antagonist drug discovery program, an assay measuring neutrophil activation by changes in expression of activation epitope on CD11b surface marker by flow cytometry was developed. The assay was established in peripheral human whole blood. Antagonist effects were monitored as inhibition of agonist-induced CD11b activation epitope expression. Based on activity in the assay the minimal anticipated biological effective level was determined for Phase I. In addition, the developed assay was used in Phase I to demonstrate inhibition of agonist-induced CD11b activation epitope expression at the predicted human dose. The Phase I data was subsequently used to determine the dose range for Phase II proof of concept studies.
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