Dr Moheb Nasr is the Principal of his own consulting company, Nasr Pharma Regulatory Consulting (NPRC), which was established in February 2018. NPRC provides strategic regulatory consulting with focus on organizational aspects, manufacturing and pharmaceutical development innovation and CMC regulatory transformation. Dr Nasr continues to play a leading role in global regulatory harmonization and introduction of modern pharmaceutical manufacturing platforms, including Continuous Manufacturing. Dr Nasr represents PhRMA at ICH serving as ICH Q12 EWG Topic Lead.
Dr Nasr retired from GSK in August 2017. At GSK, Dr Nasr was responsible for the development and the execution of GSK CMC regulatory strategy and served as a member of GSK leadership and governance boards accountable for product development, manufacturing and supply, quality and regulatory oversight. In recognition of his scientific contributions and visionary leadership, Dr Nasr is an elected GSK Senior Research Fellow.
Prior to joining GSK, Dr Nasr spent over 22 years at US FDA. At FDA, Dr Nasr served as a bench chemist, regulatory scientist, director of FDA’s analytical laboratories, and FDA/CDER CMC regulatory office head. Dr Nasr established and led FDA’s Office of New Drug Quality Assessment (ONDQA).
Dr Nasr represented FDA and PhRMA at ICH and was instrumental in the development of the Quality by Design (QbD) concept and several regulatory ICH guidelines.
Dr Nasr obtained his Pharmacy degree at the University of Cairo, Egypt, and his Ph.D. degree in Chemistry at the University of Minnesota in Minneapolis, Minnesota, USA. Dr Nasr is an elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and the recipient of AAPS Regulatory Science Achievement Award, and University of Wisconsin Pharmaceutical Analysis Excellence Award. In addition, Dr Nasr is a recipient of numerous US Government awards.