Full biomarker services during clinical development
During IND preparation
▪ Define biomarker tests to be performed during the clinical trial based on preclinical data and available literature.
▪ Align with clinical team for: a) implementation of biomarker testing in clinical trial protocol including schedule of assessments (SoA), and b) drafting of the informed consent form (ICF).
▪ Identify a central laboratory and design collection kits, operational specific document (OSD) and lab manual for biomarker collection.
▪ Identify technology platforms and CROs (for tests not performed in-house) that support biomarker assays and fall within a pre-specified budget (negotiated/competitive CRO price through CDMF Bioconsulting).
▪ Guide development of techniques with in-house researchers or CROs to specify material and methods of testing and review assay development results until validation of the tests.
During clinical trial
▪ Analyze and interpret biomarker assays: at the patient level:
- by responder and non-responder criteria for ORR
- by disease control (PR, CR, SD patients) an non-disease control (PD patients) criteria for ORR
- by progression free survival
- by overall survival (and any other outcome important for particular studies)
▪ Define predictive biomarkers for response to treatment using AI/machine learning strategies and multimodal analysis.
▪ Inform on the pharmacodynamic activity / validate mechanism of action of the drug in patients.
▪ Identify biomarkers linked to safety/ adverse events.
Mid-Trial, Interim Analysis, and End Trial
▪ Implement biomarker testing and prioritize assays to align with clinical outcome and budget.
▪ Quality Assessments: contribute subject matter expertise for quality events and protocol deviations related to biomarker studies in the clinical protocols.
▪ Engage with specialized clinical sites including staff PI and pathologists regarding the biomarker activities.
▪ Contribute to clinical protocol amendments as well as OSD and lab manual amendments/updates as needed.
▪ Coordinate with clinical operations team for operational aspects of biomarker activities including answering questions, providing guidance, and sample transfer from sites to central lab.
▪ Coordinate with clinical operations team and data management team for sample reconciliation (missing samples from sites and/or central lab).
Post Trial
▪ Contribute to sections of the CSR that require biomarker results.
▪ Define biomarker-based grouping and threshold to implement subgroup stratification or biomarker-based enrollment in future clinical trials.
▪ Biomarker-based enrollment of patients in future clinical trials: help with companion diagnostic design and development including identification of CROs that will develop the diagnostic kit, specification of the material and methods for testing, and review of assay development results until validation of the kit.
▪ For future all-comers clinical trials with stratification option: coordinate with the biostatistical team the implementation of subgroup analysis in the protocol with the aim to show efficacy of the drug in specific patients and potentially make the clinical trial successful in the circumstance where the trial would not demonstrate benefit to all comers.