Newsletter Volume 38, Number 1, 2023
Introduction
Spring will soon arrive. Congratulations to those who are graduating! Let’s move forward with dreams and hopes toward a new stage. Many years have passed since I graduated. Perhaps it is because of my age, but recently pharmacokinetic research seems to be changing and evolving faster and more diverse: ADCs, cells, LNPs, EVs, PROTAC, TikTok, AAV and nanomicelles. ．．．．． My head is starting to ache, but I promise to keep my curiosity and make next year a year of new challenges so that I will not be left behind by the Heisei & 2021 generation.
The World Baseball Classic will soon begin. While the Moriyasu Japan team was praised for its top 16 finish in last year’s World Cup, defeating the superior Spain and Germany, the baseball team is strongly expected to win the tournament. I will be cheering on the players of Samurai Japan as they play with all their might under unimaginable pressure, just for the sake of winning. (M.T.)
Introduction of Feature Articles
Topics
With the development of new discoveries and methods, the evaluation items and methods for pharmaceuticals and other products are constantly evolving from R&D to post-marketing evaluation. Correspondingly, regulatory information from regulatory authorities in Japan, the U.S., and Europe, as well as ICH and other regulatory bodies, is constantly updated. Here, we will introduce the latest technologies and findings used in drug development, regulatory information on drug review, and related information topics. We hope that this article will be of use to our members in their work.
Introduction to Pharmacokinetic Studies in Research and Development of Cell Therapy Products
Cell therapy is an innovative treatment that modifies or repairs the functions of cells, tissues, or organs by administering or transplanting living cells to patients. In the research and development of cell therapy products, cellular kinetics (CK) evaluation, which evaluates the concentration of cells in the blood over time, and biodistribution (BD) evaluation, which evaluates the migration of the product into tissues, are conducted. Since the properties of cell therapy products are very different from those of small molecule compounds, antibody drugs, nucleic acid drugs, etc., it is necessary to go beyond conventional wisdom in study design and data interpretation when assessing pharmacokinetics. In this article, we will introduce analytical methods for CK and BD evaluation of cell therapy products, pitfalls that experimenters often fall into when evaluating CK/BD, basic characteristics of CK and BD of cell therapy products, and usefulness of modeling and simulation for CK/BD analysis in several articles.