AI/ML reviewer
U.S. Food and Drug Administration
Dr. Ruihao Huang is a key member of the Innovation and Partnership Program within the office of clinical pharmacology (OCP) at the U.S. Food and Drug Administration, where he serves as a reviewer specializing in artificial intelligence and machine learning. In this capacity, he assesses the risk, explainability, and robustness of AI/ML components used in clinical trials and drug development. Dr. Huang obtained his Ph.D. in applied mathematics from Michigan Technological University in 2019 and subsequently joined the FDA in 2021. He has contributed to several AI/ML related IND and EUA reviews. In a recent review, he developed a novel AI/ML algorithm to identify appropriate population for the treatment, which supported the authorization decision. Dr. Huang also co-leads various ML research initiatives focused on precision medicine, interpretable ML methodology, enrichment strategy, and casual inference for heterogeneous treatment effect.