Biomarkers and Diagnostics Consulting

Biomarkers and Diagnostics Consulting (BDC) empowers client utilization of biomarkers and diagnostics in drug development and patient management. We have helped pharma/biotech, diagnostic companies, and clinical labs achieve the ideal trifecta: quality, efficiency, and cost-effectiveness. Below are some ways we can help you achieve optimal results.... Pharma/Biotech: Guide biomarkers and precision medicine (PM)/companion diagnostic (CDx) strategy Assess strengths, weaknesses, opportunities, and threats (SWOT) for CDx and advise on product target profile Guide decision making to pursue universal IVD manufacturer or lab-developed-test as CDx provider Qualify, negotiate, and manage third party laboratory and IVD partners Plan and manage CDx bridging studies Advise on clinical trial design from translational medicine aspects for POC, POM, efficacy, and safety assessment Plan, manage, and interpret results from studies for therapeutic target and biomarker discovery Ensure assay/technology validity for its purpose Audit and ensure third party QC/QA and regulatory compliance Enable mitigation of biological, pre-analytical, analytical, and post-analytical variables; establish lab manual for sample acquisition, processing, storage, and handling Adjudicate, analyze, and present clinical biomarker data for exploratory purposes or go/no-go decisions Review and advise on preclinical data robustness and its commutability to clinic Conduct due diligence and product assessment for in-licensing and M&A Advise on organizational structure of biomarker, translational medicine, and precision medicine functions, as well as build/ buy/ally growth strategies Clinical Laboratories: Guide startups from plan to operation, including obtaining required federal and state certifications and accreditation Direct CLIA labs with different specialties nationwide (board-certified in Clinical Chemistry, Molecular Diagnostics, and Toxicology; licensed lab director in multiple states) Enable established organizations to introduce new lines of service ...Read More