The 28th Workshop of the Japanese Society for the Study of Xenobiotics

Eiichi Fuse

Chair: Eiichi Fuse
(Clinical Science Department, Development Division, Kyowa Hakko Kirin Co., Ltd.)

On May 8 (Thu) and 9 (Fri), 2014, we will hold the 28th Workshop of the Japanese Society for the Study of Xenobiotics (JSSX) at Gakujutsu Sogo Center (Hitotsubashi Hall). The topic in this Workshop will be, in conjunction with the 8th Short Course, “Recent Trends and Future Development in R&D and Regulations on Biopharmaceuticals”, consisting of the following 3 subtopics:

Subtopic 1: R&D on Nucleic Acid Drugs
Subtopic 2: R&D on Antibody Drugs
Subtopic 3: New Insight on Biopharmaceuticals

As you know, a recent expansion of sales of biopharmaceuticals deserves special mention. Biopharmaceuticals with sales of more than 1 billion dollars that are called “blockbuster drugs” included only 6 products in 2002, but in 2010, 26 products were included in this category. Of these drugs, 5 products are ranked in the top 10 sales pharmaceuticals. In this context, many pharmaceutical companies have been engaged in research and development of biopharmaceuticals. In addition, pharmacokinetics researchers are required to be familiar with R&D and information on regulations for high-molecular drugs to utilize analytical techniques as well as an ability and experiences to analyze pharmacokinetics that have been already developed.

In annual meetings of the JSSX in the past few years, many topics related to biopharmaceuticals have been selected to discuss. In particular, topics related to biopharmaceuticals, entitled “Current Status and Future Vision of Protein Preparation; Studies of Safety and Pharmacokinetics, Drug Examination and Approval” and “Current Status and Vision of R&D on Nucleic Acid Drugs” were introduced and discussed, respectively, in forums held in 2010 and 2012.

In this Workshop, we asked for lectures on trends of R&D and regulations on biopharmaceuticals including new drugs and biosimilars, primarily on antibody drugs and nucleic acid drugs, not limited to pharmacokinetics researches, from not only pharmaceutical companies but also regulatory agencies and academia. Consequently, we have an opportunity to provide 9 topics from 7 pharmaceutical companies in Japan, not overseas market leaders in this Workshop. For a trend of regulatory issues, Dr. Teruyo Arato, Professor of Hokkaido University will speak on nucleic acid drugs, and Dr. Kenji Sawanobori from PMDA will deliver a lecture on overall biopharmaceuticals including biosimilars. Dr. Yoshiro Saito of the National Institute of Health Sciences will speak on pharmacokinetics and drug-drug interactions in biopharmaceuticals including the differences from those in low-molecular drugs. Furthermore, Mr. Mitsuru Miyata of Nikkei Business Publications, Inc will present on a trend in R&D of biopharmaceuticals with a title of “Next Challenge in Practical Application of Biopharmaceuticals” from a standpoint independent of the pharmaceutical industry. Please let me take this opportunity to first thank all the related people for their kind support to this Workshop. We hope to make this Workshop a place where researchers from industry, academia and government meet together to share information on the current status of biopharmaceuticals in order to discuss new roles of pharmacokinetic researchers in the future. We look forward to having many people join us from various fields including but not limited to pharmacokinetics.