Ajaz S. Hussain
Regulatory Science Advisor & Former Deputy Director, Office of Pharmaceutical Science
U.S. FDA

Ajaz Hussain is a seasoned expert in medicinal product development, manufacturing, and
regulatory processes, with a career spanning academia, industry, and regulatory agencies. As
former Deputy Director of the Office of Pharmaceutical Science at the US FDA, he led impactful
regulatory policy initiatives. In the corporate sphere, he has driven advancements in biosimilars,
complex generics, and plant-based vaccines at Sandoz and Philip Morris International. His
tenure at Wockhardt deepened his understanding of India’s pharmaceutical potential and
challenges. A former Associate Professor at the University of Cincinnati, he established a
research program in Computer-Aided Formulation Design and founded his consulting firm,
Insight Advice & Solutions LLC. Ajaz, a Ph.D. holder in Biopharmaceutics and Pharmacokinetics,
is a Fellow of prestigious pharmaceutical societies and has received numerous accolades,
including the FDA’s Scientific Achievement Award and the University of Cincinnati’s
Distinguished Alumni Award