Huong Huynh

Full Name for Training Certificates: Huong Huynh

Job Title: Director of Regulatory Science

Company/Organization: Critical Path Institute

Division: Office of Chief Science Officer

Other Areas of Interest: Artificial intelligence and machine learning., pharmacovigilance, real-world evidence, real-world data, patient-reported outcome, digital health technologies

Bio: I have a deep interest in giving back and training the next cadre of scientists, from undergraduate and graduate students to postdoctoral scientists and early career professionals. I am a pharmacologist by training with over 20 years combined experience in academic research, training and education, and regulatory review. After 9 years in academic research and administration, I joined the US FDA where I served as a review pharmacologist and contributed to the assessment and approval of submissions under the Generic Drugs User Fee Agreement. After 10 years at the FDA, I transitioned to my current role as Director of Regulatory Science at the Critical Path Institute, where I collaborate with public-private partnerships to address unmet medical needs by de-risking the drug development process and building regulatory confidence in novel drug development tools. My previous volunteer services include leading the FDA Women of CDER, and volunteering on the San Diego Regulatory Affairs Network (SDRAN) Education Committee, FDA Alumni Association Board, FDA/IPEC-Americas Working Group, American Association of Medical Colleges GREAT Group’s Postdoctorate Leaders Section, and National Postdoctoral Association Board.

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