Shuguang Huang, PhD (Stat4ward)
Topic: Statistics in Biomarker Development
Biomarker has always played a critical role in biomedical research. In recent years, due to the advancement of technologies, biomarkers become more important in drug and diagnostics product development. In drug developments, biomarkers become widely used as companion diagnostics (CDx), drug resistance/response monitoring via molecular residual disease (MRD), surrogate endpoints, etc. In diagnostics, detections of rare signals become possible due to many new sensitive technologies.
In this presentation, I will give an overview of how statistics play an important role in different types of biomarker developments.
Dr. Shuguang Huang has 20 years of experience working in pharmaceutical and diagnostic companies. He had assumed technical and management positions at Eli Lilly, Wyeth, and Pfizer. His most position was Associate VP, department head of Biostatistics at Helomics, a cancer diagnostic company. In 2014, he co-founded and assumed the Chief Scientific Officer position for the statistics consulting company Stat4ward.
His expertise includes (i) In-depth real-life expertise in assay development and validation. (ii) data mining and exploratory analysis using high-throughput assay technologies. (iii) Broad experience with various assay technologies and their applications in drug development and biomarker assay development. (iv) Statistical process control. (v) IVD/LTD regulatory submission – PMA, 510(k), CLIA.
Dr. Huang is a committee member of the AAPS Flow Cytometry Action Programming Committee and a committee member for a few CLSI guideline development teams. He has conducted a few workshops across the US teaching Assay validation based on CLSI guidelines. He has 30 peer-reviewed publications.