Mansoor Khan, R.Ph., Ph.D., is a Senior Biomedical Research Scientist (SBRS) and serves as the Director of Product Quality Research in the Center for Drug Evaluation and Research (CDER) in FDA. Prior to joining FDA in 2004, Dr. Khan was a Professor of Pharmaceutics and Director of Graduate Program in the School of Pharmacy at Texas Tech University. He has earned his Ph.D. degree in Industrial Pharmacy from the St. John’s University School of Pharmacy in 1992. He has published over 210 peer-reviewed manuscripts, four texts, 15 book chapters, and has been invited to give more than 150 presentations world-wide. Dr. Khan’s research focuses primarily in the area drug formulations design and development of “challenging molecules.”
It encompasses pediatric dosage forms, nanoparticles, modified release dosage forms, biosimilar characterization, particulate engineering, and scientific underpinnings of Quality by Design utilizing novel Process Analytical Technologies. As the Director of Product Quality Research, Dr. Khan serves as the CDER’s principal advisor on all matters related to planning and conducting research to study the impact on product quality, changes in bulk drug substances, formulation component and composition, and manufacturing equipment and processes. As a recognized expert, Dr. Khan participates fully in policy formulation; planning and evaluating programs, including oversight of pharmaceutical science activities to insure that basic and original research are considered in major CDER decisions. He maintains contact with “state of the science” in order to integrate the most advanced research theory or practice in the field of pharmaceutical science into the Center’s new, generic, and biotech drug programs. Dr. Khan is an AAPS Fellow, and serves on the editorial board of several leading journals.
University of Maryland’s Augsburger Receives Top Pharmaceutical Sciences Award
10/14/2012 Larry Augsburger, PhD, professor emeritus at the University of Maryland School of Pharmacy, has received the 2012 Distinguished Service Award of the American Association of Pharmaceutical Scientists (AAPS), one of the highest honors bestowed by the group of 12,000 members in more than 70 countries.
Larry Augsburger, PhD, professor emeritus at the University of Maryland School of Pharmacy
Augsburger is internationally recognized for his research and mentoring in pharmaceutics, drug process engineering, and in dietary supplements. He has been a leader in original research that has enabled modernizing some key U.S. Food and Drug Administration (FDA) policies.
One of his achievements was directing University of Maryland-FDA collaborative research programs that supported the development of the critically important FDA guidances on scale-up and post-approval changes (SUPAC) for drugs in the market. Augsburger and his team showed that certain formulation and process changes in drug preparations such as tablets and capsules result in significant differences in how a drug is absorbed and becomes available to the human body in order to exert its therapeutic effect, while others do not.
This research has led to science-based FDA policies that provided relief from certain regulatory testing and other requirements in the areas of drug product development, pharmaceutical processing, generic drugs, and bioavailability/bioequivalence outcomes.
Also, industry sources credit SUPAC with reducing expenditures by hundreds of thousands of dollars for a single drug postapproval change submission. “Dr. Augsburger’s outstanding research achievements, with their significant global impact, combined with his dedicated service to AAPS, have significantly and meaningfully advanced both the pharmaceutical sciences and the American Association of Pharmaceutical Sciences,” says Glenn Van Buskerk, PhD, managing member of the Nonclinical Drug Development Consulting Services, LLC of Basking Ridge, N.J.
At the University of Maryland, Augsburger has served as the School of Pharmacy’s Shangraw Professor of Industrial Pharmacy and Pharmaceutics, chair of the Department of Pharmaceutics, and director of pharmaceutics graduate programs. He established the Drug Development Facility in the School, which later became UPM Pharmaceuticals, Inc., a University-affiliated for-profit firm for developing drugs and manufacturing clinical supplies founded in 1997.
Before joining the University of Maryland faculty in 1969, he was a senior research scientist for Johnson & Johnson Services, Inc. of New Brunswick, N.J.
“Dr. Augsburger has been a trailblazer in ensuring that the science of industrial pharmaceutics is integral to the drug development process,” says Natalie D. Eddington, PhD, FAAPS, FCP, dean and professor at the School of Pharmacy. “He is a pioneer in fostering science-based decisions as the underpinning of regulatory guidance. His leadership in developing the scientific framework for FDA guidances (SUPAC-IR, SUPAC-MR and IVIVC) has helped to forward the tenants of the FDA’s Critical Path Initiative. “The entire School of Pharmacy is very proud of Dr. Augsburger’s accomplishments and the work that he has done to ensure excellence in industrial pharmaceutics,” she says.
He served as an executive officer of AAPS from 1999 to 2002 and as the group’s president in 1999. As president, Augsburger put a plan in place to help assure there would be adequate pharmacy education and a steady supply of qualified pharmaceutical scientists for the future.
“Larry’s emphasis on the education of future pharmaceutical scientists cuts to the very core of the disciplines of the AAPS,” says Dale Wurster, PhD, professor of pharmaceutics and graduate college associate dean at the University of Iowa.
At AAPS, Augsburger also focused on a national issue at that time concerning the quality of dietary supplements, also known as nutraceuticals, and the development of suitable standards and tests to by which to demonstrate quality. There were many disturbing reports: some products were found to have well below the labeled amount of supplement, others had unsafe contaminants, and some nutraceuticals simply did not disintegrate.
He recalls, “There was concern that since they were not regulated like drugs, and were being judged more like foods, adequate consideration was not being given to the establishment of suitable quality and performance standards for these products and the development of qualified methods for their development and manufacture. My feeling was that there was no one better than pharmaceutical scientists to address these issues.”
Now retired from the School’s faculty, Augsburger continues to write and consult and observe the drug development industry.
He says, “Today, there is a nexus of things going on in the field, including a positive change in the FDA’s regulatory stance in the past five to 10 years that encourages the pharmaceutical industry to take a more modern look at drug product development and manufacture with an eye toward building-in quality (“quality by design”). ”
He continues, “In order to respond to this enlightened regulatory approach, the pharmaceutical industry has to adopt new methods and develop a more fundamental understanding of their formulations and processes.”
Augsburger’s research has been supported by more than $13 million in grants and contracts. He has published 116 original manuscripts, five books, 24 book chapters and monographs, acquired four patents (plus several provisional patents filed), and given 191 invited presentations to national and international audiences.
Among his awards are the International Pharmaceutical Federation Industrial Pharmacy medal, the FDA Commissioner’s Special Citation, the AAPS Research Achievement Award, the AAPS Outstanding Educator Award, and the AAPS Dale E. Wurster Research Award in Pharmaceutics. In 2001, he was selected the University of Maryland Researcher of the Year, the highest research award of the Baltimore campus.
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