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).
Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries
May 30th 2025In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.
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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
