Madelyn “Mimi” Huang, Ph.D.

Dr. Madelyn “Mimi” Huang is a Toxicologist at Premier Consulting, a business unit of Premier Research. She provides expert advice to sponsors and innovators addressing various critical nonclinical aspects of therapeutic product development. Her areas of expertise include designing nonclinical programs to support clinical studies, writing and reviewing regulatory submissions for global regulatory authorities, and crafting regulatory strategies. She has experience in the development of small molecules and cell and gene therapies, as well as in developing drug products via the FDA’s 505(b)(2) pathway.

Dr. Huang obtained her Ph.D. in Toxicology at the University of North Carolina at Chapel Hill and is a Diplomate of the American Board of Toxicology (2022-present). She has published 18 articles in peer-reviewed journals on topics spanning a wide range of toxicology, from basic environmental chemical research to pharmaceutical regulatory strategy.