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 build strategies and systems to successfully move forward development programs on plant-based vaccines and products for tobacco harm reduction. Ajaz also ensured credibility of the scientific evidence used to seek regulatory discussions and submissions.

Dr. Hussain’s 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.

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 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.