Ajaz Hussain’s professional goal is to contribute towards improving the predictability of medicinal product development, manufacturing, and associated regulatory processes. As the Deputy Director Office of Pharmaceutical Science, he led some of the US FDA’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.
Dr. Hussain’s corporate experience includes leadership in the development and/or regulatory submissions of first-in-class biosimilars, follow-on proteins, 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 develop strategies and systems that successfully advanced development programs for plant-based vaccines and products aimed at tobacco harm reduction. Ajaz also ensured the credibility of the scientific evidence used to seek regulatory discussions and submissions.
Dr. Hussain’s experience at Wockhardt has helped him understand the opportunities and talent companies in India possess, the challenges they face, and how they can develop effective solutions to maintain and enhance competitiveness and credibility. He also has extensive teaching experience, having served as a tenured Associate Professor of Pharmaceutics at the University of Cincinnati, where he established a research program in Computer-Aided Formulation Design. Based on his extensive experience in academia, the US FDA, and industry, he founded Insight Advice & Solutions LLC, his consulting practice.
Ajaz received his Ph.D. 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 a recipient of several awards from the US FDA, including the FDA’s Scientific Achievement Award. Ajaz also received the Distinguished Alumni Award from the University of Cincinnati.