Ajaz S. Hussain

Ajaz Hussain’s professional goal is to contribute towards improve predictability of medicinal product development, manufacturing and associated regulatory processes. As the Deputy Director Office of Pharmaceutical Science he led some of the U.S. Food and Drug Administration’s major initiatives to develop regulatory policies that already have, and will continue to have, a significant impact on product development and approval in many geographies. His corporate experience includes leadership of the development and/or regulatory submissions of first-in-class Biosimilar, Follow-on Protein and Complex Generic products at Sandoz. At Philip Morris International, he took on the challenge of higher levels of uncertainty (regulatory and business) and product complexity to build strategies and systems to successfully move forward development programs on plant-based vaccines, products for tobacco harm reduction, and ensure credibility of scientific evidence to seek regulatory discussions and submissions. His experience at Wockhardt has helped him to understand the opportunities and talent companies in India have, the challenges they face, and how they can bring forward effective solutions to maintain and enhance competitiveness and credibility. He also has an extensive teaching experience, he served as a tenured Associate Professor of Pharmaceutics at the University of Cincinnati, where he established a research program on Computer Aided Formulation Design. Based on his broad experience in academia, US FDA, and industry he founded his consulting practice Insight Advice & Solutions LLC.

Dr. Hussain received PhD in Biopharmaceutics and Pharmacokinetics from the University of Cincinnati (1986). He has published over 100 scientific articles and is a frequent invited speaker at scientific conferences. He is a Fellow of the American Association of Pharmaceutical Scientists, the Swiss Society for Pharmaceutical Sciences and recipient of several awards at FDA including the FDA’s Scientific Achievement Award and a the Distinguished Alumni Award from the University of Cincinnati.