Director of Regulatory Science
Critical Path Institute
Huong Huynh is a regulatory professional with over 20 years of experience working in academia, non-profit organizations, and regulatory agency. Huong is responsible for knowledge management and integration of regulatory intelligence, building relationships and partnerships for business development, and bridging communication with regulatory authorities. Huong has proven abilities to navigate difficult landscapes, lead executive meetings with FDA and EMA, lead multi-disciplinary teams in cross-functional and matrixed organizations, and engage with external key opinion leaders and scientific experts. Huong works with multiple stakeholders from regulatory agencies, non-profit organizations, patient advocate groups, and biopharmaceutical industries to develop regulatory strategies to advance novel drug development tools including biomarkers, clinical endpoints, patient-reported outcome measures, clinical trial simulation tools and other quantitative solutions to address unmet medical needs through scientific collaborations in the pre-competitive space. As a former review pharmacologist at FDA, Huong was responsible for assessing 505(b)(2) and 505(j) original and generic, abbreviated new drug applications and for the interpretation and development of regulatory guidance and policies. From this experience, Huong is uniquely qualified to establish and lead new initiatives and partnerships across diverse disease areas, including rare diseases, neurodegenerative disorders, metabolic diseases, and pediatric conditions. In addition, Huong is passionate about training and education of the next generation of workforce, as an instructor of the University of Arizona College of Law's Graduate Certificate in Regulatory Science program.
Wednesday, October 8, 2025
2:15 PM - 3:15 PM EST