In 2019 USP created an Expert Panel (New Advancements in Product Performance Testing) to do a gap analysis on the need for and possible creation of tests/standards for measuring the performance of drug products. The results of Working Groups within the Expert Panel have been presented in a series of articles in Pharmacopeal Forum and Dissolution Technology. The purpose of this webinar is to present to stake holders and interested members of the pharmacy community, the findings of the Working Group dealing with inhalation and nasal products and allow for questions and suggestion from participants for improvement/modifications for the Working Group’s findings.

Learning Objectives:
• Understand the role of stimuli article as opposed to Official or Informational Chapters in the United States Pharmacopeia (USP).
• Describe the process used by the USP Expert Panel to identify existing tests, gaps and challenges involved in drug performance testing.

• Evaluate the findings of the Working Group addressing inhalation and nasal products as presented in the stimuli article.
• Question and provide input to the findings of the Inhalation and Nasal Working Group.

Masahiro Sakagami, Ph.D.

Masahiro Sakagami, Ph.D. is Professor of Pharmaceutics at the Virginia Commonwealth University (VCU) School of Pharmacy in Richmond, Virginia, USA. He received B.S. and M.S. degrees in Chemical Engineering at Waseda University in Japan (1989 and 1991, respectively) and a Ph.D. degree in Pharmaceutical Sciences at VCU (2000). In 1991-1996, he was a scientist in inhaled and nasal drug delivery research and product development division at a pharmaceutical industry, Teijin, in Japan. Dr. Sakagami has a wealth of experience and high expertise in academic and industrial research in the areas of biopharmaceutics and pharmacology of respiratory drug delivery, along with regulatory testing of inhaled drug products. He has published over 50 original research studies, expert reviews, and book chapters and has given over 40 invited presentations at conferences, industry, and academia, all in these areas of his expertise. His recent research is focused on inhaled drug discovery and development in emphysema, COPD, and pulmonary fibrosis, as well as dissolution testing for inhaled drug products. Dr. Sakagami served on the USP (United States Pharmacopeia) Advisory Panel for the Performance Tests of Inhalation Dosage Forms (2006-2010). He is also a member of a USP Expert Panel for New Advancements in Product Performance Testing (2019-present) and of the USP Dosage Form Expert Committee (2020-present). He also served as an advisory expert or consultant for pharmaceutical companies. At VCU, Dr. Sakagami is actively engaged in advising graduate students in research, serving as the Pharmaceutics Graduate Program Director, and teaching in the School of Pharmacy Pharm.D. and graduate curriculums.