Moheb M. Nasr, PhD
Moheb M. Nasr, PhD is a Pharmtech editorial advisory board (EAB) member.
Moheb M. Nasr, PhD
Director,
Office of New Drug Quality
Assessment, CDER/FDA
Moheb Nasr is the director of the Office of New Drug Quality Assessment (ONDQA), in the Center for Drug Evaluation and Research (CDER), at the US Food and Drug Administration. ONDQA is responsible for quality assessments (pre- and postmarketing) of new drugs regulated by CDER. Nasr obtained his PhD degree in Chemistry at the University of Minnesota in Minneapolis.
Nasr holds a BS degree in Pharmacy and a Master’s degree in Pharmaceutical Analysis, both from Cairo University, Egypt. Nasr joined FDA in 1990, and assumed his current position in June 2003. He is leading the restructuring of the pharmaceutical quality assessment program at FDA. Nasr is a member of FDA’s Council on Pharmaceutical Quality, and is an elected fellow of the American Association of Pharmaceutical Scientists (AAPS).
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
