Biomarkers and Diagnostics Consulting, LLC empowers client utilization of biomarkers and diagnostics in drug development and patient management. Over 25+ years, we have helped the industry achieve the ideal trifecta: quality, efficiency, and cost-effectiveness.
We assist....
- Pharmaceutical and Biotechnology Companies (Oncology, immunology, cardiovascular, metabolic)
- Clinical Laboratories
- Investors and Tech Appraisers
We consult on....
- Biomarkers: planning, discovery, qualification & implementation
- Prcciion Medicine
- GCP, GLP, QC/QA & Compliance
- Data analysis & bioinformatics
- Assessment of business opportunities
We achieved....
- 120+ successful consultations and 35+ full-scale projects for our clients
- 2 FDA-approved drugs
- 5 FDA approvals of high complexity IVD devices
- 120+ PI-PIV clinical trials
- 35+ drug development programs in immuno/oncology, cardiovascular, immunology, diabetes, and atherosclerosis
- 7 oncology CDx programs; from strategy to PMA
- 10+ due diligence initiatives for M&A, investment and licensing opportunities