Mansoor A. Khan, PhD
Mansoor A. Khan, PhD
Mansoor A. Khan, PhD
Director,
FDA/CDER/DPQR
Mansoor A. Khan is the director of product quality research in the Center for Drug Evaluation and Research at the US Food and Drug Administration. Prior to joining FDA, Khan was a professor of pharmaceutics and director of graduate program in the School of Pharmacy at Texas Tech University Health Sciences Center. He is a registered pharmacist, and earned his PhD in Industrial Pharmacy from the St. John's University School of Pharmacy at New York in 1992. He has published more than 135 peer-reviewed manuscripts, four texts including Pharmaceutical and Clinical Calculations, five book chapters, and given more than 125 presentations in various meetings. Khan advised 10 PhD students in pharmaceutics.
Khan's research focus is primarily in the area of quality by design and process analytical technologies, controlled drug delivery of challenging molecules, oral delivery of macromolecules, and nanoparticles. He is the chair-elect of Pharmaceutics and Drug Delivery section of the American Association of Pharmaceutical Scientists (AAPS), and has been recognized as an AAPS fellow. He serves on the editorial board of Pharmaceutical Technology, the Journal of Clinical Research and Regulatory Affairs, and the journal Critical Reviews in Therapeutic Drug Carrier Systems.
Market Demands and Emerging Technologies Shape Outsourcing Models
June 5th 2025Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.
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.
The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
