Our Team

Arlington Biomedical

Partner

Dr. Lei is a seasoned expert in drug development and molecular diagnostics, with over 25 years of experience in regulatory affairs, biomarker strategy, and clinical trial support. Dr. Lei brings unique expertise in biomarker development and validation, drug–diagnostic co-development, companion diagnostics, and IVD/LDT product development.

A proven leader, Dr. Lei has successfully established CLIA/CAP-certified laboratories in both large institutions and startup environments and has served as a CAP inspection team leader for multiple domestic and international inspections. Board-certified by the American Board of Medical Genetics and Genomics (ABMGG), Dr. Lei is highly experienced in molecular genetics, oncology, infectious diseases, and biomarker-driven diagnostics.

Throughout a distinguished career, Dr. Lei has led and supported numerous clinical trials through biomarker strategy development and assay validation, managed CRO services, and built strategic partnerships for companion diagnostics. As a clinical laboratory director, Dr. Lei has held leadership roles across hospitals, industry, and independent reference laboratories, driving innovation and excellence in molecular diagnostics and personalized medicine.