PEDRA

The Fraunhofer ITEM has long-standing experience in the assessment of drug safety and efficacy. With our special expertise in the fields of preclinical and clinical drug testing we are dedicated to supporting our clients in the development of novel targeted- and immuno-oncological therapies. By utilizing clinical samples, we generate molecular and functional preclinical data for your projects, whereas our in-house GDPR-compliant data management and bioinformatics allow custom-fit data analysis and supports you during the course of project. Our comprehensive portfolio enables us to provide fully flexible, scalable, and tailor-made R&D solutions as well as regulatory support by our experts with a track-record in communicating with the respective authorities to facilitate the market readiness of your applications products.

We have developed a Platform for Ex-Vivo Drug Response Assays (PEDRA) that mirrors the clinical patient situation in vitro by using disease-specific models generated from clinical samples, recruited individually for each project. PEDRA comprises several ex-vivo assays of variable cellular complexity. In combination with state-of-the-art readouts drug safety and efficacy can be assessed for a broad range of anticancer treatments. Because PEDRA preserves the original cellular composition of the organ of interest, it is ideal for testing novel IO therapies incl. CPI and ADC.

• Project-specific patient recruitment
• Enrichment of pure cell populations and isolation of single cells from tissues and liquid biopsies
• Preclinical model generation of varying complexity (single and mixed cell type up to complex heterologous or autologous tissue models using precision-cut tissue slices)
• Drug response assessment for different types of cancer and cancer therapy (small molecules, RNA therapeutics, PPI modulators, CPI, ADC, CAR-T/-NK cells)
• Multiomics analysis ((epi-)genome, exome, transcriptome, miRNA, targeted proteome) of tissue and liquid biopsies down to a single cell
• Functional drug response analysis by using a broad range of state-of-the-art technologies and validated test systems (incl. HTPS infrastructure, confocal imaging, multicolor flow cytometry, cytokine release assays)
• Customized bioinformatic data analysis, evaluation, and consultancy
• GDPR-compliant contracting and handling of patient material and clinical data
• Clinical trial design initiation and regulatory support by seasoned experts with a track-record in communicating with authorities

• Fast: 1-3 weeks from patient recruitment to analyzed data sets
• Flexible: fully modular and custom-tailored workflows
• Scalable: 1-100 compounds testable in parallel on primary patient-derived models of different complexity
• Adaptable: applicable for different cancer types and applications like efficacy, toxicity, and IO studies
• Translational: preclinical data generated based on individually recruited disease-specific clinical samples improving clinical translation
• Comprehensive: from project planning to preclinical/clinical testing including regulatory support all from one source
• Direct access: clinical samples routinely available by close embedding into clinical infrastructure (longitudinal sampling and clinical follow-ups possible)