The Biomarker (BM) Development team is responsible for the development of BM assays to enable project transition from discovery to preclinical development candidate (PDC), and then into clinical trials.
The team drives the BM strategy for EDDC’s precision medicines from program inception and translates it to First-in-Human studies and beyond. Prior to clinical development, the team establishes robust pharmacodynamic (PD) BM assays and, if required, performs development tests for suitable patient selection biomarker assays, to enhance the chances for clinical success and differentiation. Diagnostic assays for selection BMs are selected in alignment with clinical development objectives and validated and clinically implemented using a network of external partners operating in CAP/CLIA labs.
The team has their key expertise in assay design and feasibility studies, design verification and validation (in compliance with industrial standards), preclinical/clinical sample management and processing, data analyses as well as FDA-compliant data reporting. The following areas are performed routinely:
- BM assay development includes preclinical assay optimisation and proof-of-mechanism studies in vitro and in vivo (preclinical and clinical) using methods that are nucleic acid, protein and/or tissue-based (e.g., RT-qPCR, ELISA, IHC, Western blots, etc.)
- Design verification/analytical validation for the development of diagnostic assays (stability studies, analytical accuracy, sensitivity, specificity, etc.) following CLSI/CLIA/CAP/ISO13485 guidelines
- BM correlation studies (PK/PD, PD and efficacy correlations, etc.), providing supportive BM data to clinicians to inform and guide early phase trials
- BM implementation in clinical trials (laboratory manual writing, sample requisition forms, clinical data analysis, clinical sample management, clinical logistics, site training, and writing of BM part of clinical study report)
- Report writing for regulatory submissions in compliance with eCTD format
- IRB (Institutional Review Board) application and management
- Establishment of external strategic alliances with academic and industrial partners (e.g., POLARIS@GIS, DxD Hub, IMCB, MiRXES) to maximise portfolio/asset value