In silico deep phenotyping-based research and patient stratification
The CK-CARE registry collects a unique range of data from patients with atopic dermatitis (currently more than 1,500 patients included; age range: birth to 99 years) including, among others, following aspects: current severity (SCORAD and EASI), age of onset, detailed disease course and history, family background, associated diseases (including infections) and comorbidities (asthma, rhinitis, other allergies) of patients and relatives, sociodemographic information, life style, past and current treatment regimens, intolerances, quality of life, routine lab data such as total and detailed sensitization profile of specific IgE (ISAC Chip), …. High quality photography is performed for each patient. The patients are seen once per year for up to 5 years, thus providing follow up data, of particular interest in the pediatric population. Overall, based on the detailed questionnaire and results from the clinical examination, more than 1,500 data points are generated per patient and per visit.
The registry also includes an increasing number of (i) patients who are in remission of their AD, (ii) patients with psoriasis, (iii) control patients who have other atopic disorders but no AD as well as (iv) normal non-atopic individuals.
The registry offers a unique opportunity for in depth in silico analysis to better understand the complex phenotype of atopic dermatitis and its comorbidities as a valuable help for strategic decisions in drug development programs.
Contracted research projects for drug and biomarker discovery.
Using the samples of the CK-CARE biorepository and the technology platform, we offer a unique opportunity to test your therapeutic approach and strategy, new molecules or diagnostic test procedures on high quality and clinically well characterized biomaterial from patients and control individuals (including normal and other inflammatory skin conditions for sensitivity and specificity purposes). The biomaterial from the CK-CARE biobank is also an ideal material for comparative studies with a well-defined population and for control purposes.
Storage of samples from preclinical and clinical trials (phases I-IV).
Our extended experience in operating large biorepositories offers the best conditions for the labeling, short/long term storage and management of biospecimen collected during preclinical and clinical procedures/trials.
Histology and immunohistochemical staining procedures belong to the well-established investigational tools in dermatology. For drug discovery and for biomarker programs in the context of clinical trials, we offer a large panel of staining procedures using specific antibodies directed against structural and cellular features in the skin to explore the in situ impact of new compounds on the inflammatory infiltrate and/or the epithelial and dermal compartments. A dedicated team of experienced histopathologists will provide the qualitative and quantitative analysis of the results. In case of need of reference biopsies and for sensitivity/specificity purposes, the CK-CARE biorepository can provide adequate material from well characterized patients and control individuals. We will also be able to scan the slides for further image analysis and A.I. approaches on the stained samples.
Analysis of soluble mediators in liquid samples
Measurement of soluble mediators in liquid biospecimen such as serum, sputum, interstitial fluids or culture supernatants is a major pillar in biomarker programs flanking clinical drug development. Our platform offers a panel of different technologies including Luminex and the newest generation multiplex analysis using the state-of-the-art Olink technology (the mandatory internal bridging controls for these technologies are provided by samples from the CK-CARE biorepository). Any body fluids, including obtained those from skin biopsies, can be measured by our highly sensitive Olink-technology.
Multicolor flow cytometric analysis of blood or skin samples provide a useful tool to analysis the behavior of the cells before, during and after the therapy with new compounds. Our platform is equipped with several modern multicolor flow cytometers such as FACS Aria and Galios (both 10 colors), as well as BD LSRFortessa (18 colors).
We provide a state-of-the-art RNA isolation and processing for expression profiling from biosamples of any kind. Sequence and array-based technologies are used for a comprehensive coverage for RNA transcriptomic analysis of the samples from your program.
Biomarker discovery and development services
We provide a competent project management for all above-mentioned services and help in the design of trials aim to identify new biomarkers as potential companion diagnostics. Candidate biomarkers can be combined into panels of significant discriminatory power and thereby be used for diagnostic, prognostic or predictive purposes. Beyond discovery programs, our services can provide valuable help for validation steps (replication studies) as well as for regulatory qualification/fitness for use.