The heterogeneous presentation of clinical cases and the complex requirements by health authorities and care management contribute to making the development of innovative treatment options more challenging and complex. QPS recognizes these challenges and works together with clients to explore the possibilities of implementing and executing new research techniques in our Phase 1 units.
QPS Netherlands recently completed a challenging clinical trial in 20 healthy subjects, exploring the effects of an innovative IMP on inflammatory gene expression in skin biopsies, following exposure to UVB radiation. This skin model can be used to demonstrate disease-associated changes in expression of genes involved in immune and chemokine regulation, growth and repair, and in upregulation or down regulation of genes, which can be proposed as novel biomarkers of certain disorders.
QPS’ Principal Investigator collected two skin biopsies from each enrolled subject. The first skin biopsy was collected from a skin area that has received UVB radiation and developed erythema, the second biopsy was collected from the same anatomical area but from skin that has not received the UVB radiation.
Our expertise in these complex research models can be applied to many indications, and/or biomarker studies, in early phase drug development in both healthy subjects and patients.
Khalid Abd-Elaziz, MD, clinical pharmacologist, Principal Investigator, Associate Medical Director and Safety Officer /em>