Who We Are?
Encore Biotech, LLC – Your Strategic Partner
Dr. Hu founded Encore Biotech, LLC to provide tailored consulting services to biotech and pharmaceutical companies, ensuring efficient product development, regulatory success, and market access. Through strategic insights, risk mitigation, and innovative solutions, Encore Biotech, LLC helps clients accelerate innovation and bring life-changing medical technologies to patients worldwide.
Dr. Hu
With over 25 years of experience spanning the FDA, diagnostics, and pharmaceutical industries, Dr. Hu brings unparalleled expertise in regulatory strategy, biomarker development, in vitro diagnostics (IVDs), and precision medicine. Dr. Hu has been at the forefront of medical innovation, leading teams through the complexities of R&D, manufacturing, clinical trials, and regulatory approvals.
FDA Expert
Over a decade at the FDA, overseeing the regulation of IVDs, LDTs, companion diagnostics, digital pathology, AI/ML-enabled devices, and liquid biopsy technologies. Led teams reviewing premarket and postmarket submissions, and played a pivotal role in policy development for a broad range of molecular diagnostics such as early cancer detection, tumor profiling, MRD and companion diagnostics.
Industry Expertise
Extensive leadership in biomarker discovery, diagnostics development, clinical testing, and regulatory affairs across top biotech and pharmaceutical companies, including Genetron Health, GlaxoSmithKline, Metabolon, and Becton Dickinson.
Industry Expertise
Extensive leadership in biomarker discovery, diagnostics development, clinical testing, and regulatory affairs across top biotech and pharmaceutical companies, including Genetron Health, GlaxoSmithKline, Metabolon, and Becton Dickinson.
Regulatory & Compliance Mastery
Deep understanding of FDA, NMPA, CAP/CLIA, ISO, and global regulatory pathways for innovative diagnostics and medical devices, streamlining regulatory approvals and market access.
Precision Medicine & Oncology Focus
Specialized in companion diagnostics, molecular cancer diagnostics, and early cancer screening, guiding companies to co-develop diagnostics and therapies for personalized medicine.
Precision Medicine & Oncology Focus
Specialized in companion diagnostics, molecular cancer diagnostics, and early cancer screening, guiding companies to co-develop diagnostics and therapies for personalized medicine.
Global Influence & Thought Leadership
Invited speaker at 50+ national and international conferences, advisor for a number of regulatory and scientific organizations and recipient of numerous FDA awards for contributions to medical diagnostics and regulatory excellence.
Industry Expertise
Extensive leadership in biomarker discovery, diagnostics development, clinical testing, and regulatory affairs across top biotech and pharmaceutical companies, including Genetron Health, GlaxoSmithKline, Metabolon, and Becton Dickinson.
Regulatory & Compliance Mastery
Deep understanding of FDA, NMPA, CAP/CLIA, ISO, and global regulatory pathways for innovative diagnostics and medical devices, streamlining regulatory approvals and market access.
Precision Medicine & Oncology Focus
Specialized in companion diagnostics, molecular cancer diagnostics, and early cancer screening, guiding companies to co-develop diagnostics and therapies for personalized medicine.
Global Influence & Thought Leadership
Invited speaker at 50+ national and international conferences, advisor for a number of regulatory and scientific organizations and recipient of numerous FDA awards for contributions to medical diagnostics and regulatory excellence.