Newsletter Volume 37, Number 5, 2022

Introduction

　I have been away from the trips I used to take before the Corona Disaster, but recently I went hiking in the mountains for the first time in a long while. Unfortunately, the weather was not so good that day, and there were many times when I could not see the scenery around me due to fog, but when the fog lifted for a moment and I could see beautiful scenery such as blue skies and mountain ranges, I felt refreshed and relaxed. The occasional view through the fog was also very beautiful, but I would like to visit again when the weather is better so that I can enjoy the beautiful scenery to the fullest. It has been a long time since the new type of coronavirus infection spread throughout the world, and various things have been gradually eased, such as shortening the waiting period for infected people and removing the upper limit on the number of people who can enter the country. I do not know when the fog will clear, but I can only hope that it will soon.

　The 37th Annual Meeting is now approaching. This is the first time in three years since the 34th Annual Meeting that the meeting will be held on-site. I am looking forward to meeting you all in person and having various discussions and conversations with you. (T.I.)

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 being 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.