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Dr. Mansoor A. Khan's Lab

Personal Statement

After serving as a director of product quality research and SBRS scientist in FDA for 11 years, I have returned to academia to pursue and promote drug delivery and product development research. I am hoping that this transition will have practical implications for translational research to ensure that products are approvable by FDA and that patients enjoy the benefits of academic research.  My research in FDA and Texas A&M University supported science- based regulatory policy development in the Chemistry, Manufacturing and Controls (CMC), and the biopharmaceutics sections of new drugs, biotech products and abbreviated new drug applications to the Agency. We have applied the most current and validated analytical methods to evaluate new, generic and biotech drug products. We now have a variety of approaches to ascertain the most optimal delivery conditions under which a given therapeutic should be prepared and processed, as well as powerful methods to analyze the quality and performance of drug products. I have had the privilege to serve as the FDA representative to EMA (pediatric working group, and pediatric formulations committee), WHO (generic quality and pediatric guidelines committee), USP (expert panel on dosage forms), FIP (Program chair and Keynote Speaker), DOD/DARPA (continuous manufacturing advisory panel), Clinton HIV/AID panel (dosage forms expert), NIH (PI on the FDA:NIH IAG), and NASA (PI on the FDA:NASA Research Cooperative Agreement). Prior to joining the FDA in 2004, I was a Professor of Pharmaceutics and founding Director of the Graduate Program in the School of Pharmacy at Texas Tech University. I have published over 335 peer-reviewed manuscripts on formulation science and bioavailability-bioequivalence issues related to drug products. I have also been an editor of five texts including "Quality by Design for Biopharmaceutical Product Development", and 35 book chapters, 200 abstracts/poster presentations, and more than 250 invited presentations world-wide.

Contribution to Science

  • 3D printing of dosage forms
    I was “Application Team Lead” for the approval of first 3D printed drug product (NDA #207958, Spritam®). We have published papers on various aspects of 3D printed formulations and have presented on 3DPs in national and international conferences.

  • Pediatric dosage forms
    I have had the privilege to serve as the FDA representative to EMA (pediatric working group, and pediatric formulations committee) and WHO (generic quality and pediatric guidelines committee) for pediatric dosage form development. I am also member of ‘Pediatric Anti-retroviral Drug Optimization’, Committee at WHO. We have developed many platform drug delivery systems to mask bitter taste of drugs and impart dose flexible properties, which is critical for pediatric dosage forms.

  • Pharmacokinetic evaluation
    We have developed bioanalytical methods, and evaluated comparative bioavailability and pharmacokinetics parameters in human and animals (dogs and rabbits). I was leading efforts at FDA evaluating pharmacokinetic of topically acting drugs, and long acting formulations.

  • Formulation design and development
    Drug delivery and dosage form development requires an integration of several basic and applied science areas, and very often there is a gap that is not seen through until very late in the development paradigm. Therefore, most academic discoveries end up as a theoretical exercise if not appropriately consulted at the right time for IND and NDA studies. My research on formulations has been focused on identifying these gaps and developing the metrics for public discussion and eventual adoption of standards as a science-based public policy.

  • Formulations Evaluations and post-marketing corrections
    After antiviral and all other drug products are approved, their scale-up and post marketing action begins. A thorough understanding of the products by quality by design paradigm entails an understanding of product and process so that the products can be made consistently. The understanding requires an interplay of drug substance, excipients, processes to develop dosage forms, stability studies, container closure systems, environment, in vitro in vivo correlation, and analytical validations to understand the product variability. Sometimes, when the patients take these medications, serious adverse events and fatalities happen. My research has allowed us to determine the root cause analyses with scientific precision and corrections.

Published Work: uajIAX/bibliography/54053455/public/?sort=date&direction=ascending
Citations - 14,669; h-index - 58; I -10 index – 238 (accessed google scholar on Aug 19, 2021

Ongoing Research Projects

National Institutes of Health (R56)                                                                           
Title: Age-appropriate flexible pediatric drug delivery systems
Role: PI

August 2021 - July 2023

Food and Drug Administration                                                                                             
Title: Formulation of hydrocodone bitartrate opioid drug product expected to have similar rate and extent of release as HYSINGLA intact tablet but designed to be inferior product when chewed
Role: PI

June 2019 – Sept  2021

Food and Drug Administration                                                                                              
Title: Assessment of smoking and vaping risk of opioids and commercial products, and standardization of methods to assess these properties

Sept 2019 - Sept 2021

Texas A&M University, Presidential Clinical Research Partnership Grant                          
Title: Tolfenamic Acid-based Therapeutic Regimen for Treatment of Pancreatic Cancer
Role: PI

Sept 2021 - Aug 2023