Dr. Ajaz Hussain

Ajaz Hussain is a seasoned expert in medicinal product development, manufacturing, and regulatory processes, with a career spanning academia, industry, and regulatory agencies. As 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.

Ph.D. in Biopharmaceutics & Pharmacokinetics

University of Cincinnati (1981–1986)

B.Pharm.

University of Mumbai (1978–1981)

Higher Secondary Education and Certification

K J Somaiya College of Science & Commerce (1977–1978)

Primary, Secondary, and Higher Secondary Education

Kendriya Vidyalaya, IIT Powai, Mumbai (1966–1977)

Practitioner of Life in Science and Creativity

Independent Individual Advisor, Freelance (Jan 2020 - Present)

Member Of The Board Of Advisors

DIANT Pharma Inc, Freelance (Mar 2021 - Present)

Member Board of Advisors

ValGenesis, Inc, Contract (Nov 2005 - Present)

Member Of The Board Of Directors

ValGenesis, Inc (Sep 2017 - Feb 2021)

Advisor

Emmersive Infotech, Freelance (Aug 2020 - Dec 2023)

Advisor

GreatFour Systems Inc, Freelance (Jun 2017 - Dec 2023)

Member of the AGP Advisory Board Applied SmartFactory

Applied Materials, Contract (Jan 2017 - Dec 2023)

Member of the Advisory Board

CONTINUUS Pharmaceuticals, Inc, Freelance (Mar 2015 - Mar 2022)

President

National Institute for Pharmaceutical Technology and Education (Mar 2016 - Dec 2020)

Executive Director

National Institute for Pharmaceutical Technology and Education (Oct 2014 - Mar 2016)

Independent Business Owner

Ajaz S. Hussain | Insight, Advice & Solutions LLC (Jul 2013 - Jul 2018)

CSO & President Biotechnology

Wockhardt (Jul 2012 - Jun 2013)

Chief Scientific Officer

Philip Morris International (Jan 2012 - Jul 2012)

Vice President Next Generation Product Assessment

Philip Morris International (Jan 2009 - Jul 2012)

VP & Global Head Biopharmaceutical Development

Sandoz (Oct 2005 - Dec 2008)

Deputy Director

Office of Pharmaceutical Science, CDER, FDA (Jan 1995 - Oct 2005)

Associate Professor of Pharmaceutics

University of Cincinnati - College of Pharmacy (May 1989 - Dec 1994)

Assistant Professor of Pharmacy

Ohio Northern University - College of Pharmacy (Jun 1986 - May 1989)