Chairman of the organizing committee: Tetsuo Miwa, Ph.D.
(Takeda Pharmaceutical Company Limited)

The 20th Workshop of the Japanese Society for the Study of Xenobiotics will be held on April 13th(Thursday) and 14th (Friday), 2006. The topic this year is ‘Pharmacokinetic technologies to break through the bottleneck of drug discovery and development’.

The difficulties surrounding the drug discovery and development are increasing each year, and this clearly shows in the decreased numbers of newly approved drugs. It is not just within the pharmaceutical companies of Japan that this problem exists, as all the major companies overseas, the so-called mega-pharma, are all having the same difficulties to greater or lesser degrees. Although many technologies of drug development have been discovered within the past 15 years, starting with the genomic technology, they have not resulted in the new pipelines or increased numbers of approved drugs that were envisioned by some. We have called this phenomenon, ‘the bottle neck of drug discovery and development’, and one of the reasons for it is thought to be the large gap between the pharmacological action at the molecular level and at the actual clinical level, which is exacerbated by the lack of ideas and tools to fill the gap. We believe that pharmacokinetic evaluation can be used as a strong tool to bridge the gaps in the drug development process, and that is the reason we have named our topic for this year, ‘‘Pharmacokinetic technologies to break through the bottle neck of drug discovery and development’.

In this workshop we will focus on current pharmacokinetic technologies, show how they can be applied to the drug development process, and discuss in detail those technologies that can be put into practice by the researchers of pharmacokinetics. We have setup sessions in four fields, which have all been rapidly progressing in the past few years and are expected to develop further. We have invited a selection of Japanese and international frontline professors and industrial scientists to talk about the current situation and issues in these areas. We look forward to your active participation, and the opportunity for lively discussion.

1) Discovery ADME/Tox Screening
In addition to pharmacokinetic studies being made on compounds under development, they are becoming more actively employed in discovery research, to aid in the design and selection of development candidates. Thus, in discovery research, high throughput screening technology can be used to gather a variety of ADME/Tox data, which can then be combined with information technology (IT) and in silico predictions to comprehensively explore both actual and virtual ADME/Tox properties.
In this session, we would like to introduce, and discuss the current topics and issues related to pharmacokinetic studies at the discovery stage, as well as discuss the outlook for the future and possible directions in which the research should go.

2) From Preclinical ADME to Clinical Pharmacokinetics (Integration of Experimental Data and a Mathematical Model)
Improving the probability of success and enhancing the speed of drug discovery can be expected with the application of PK and/or PD modeling and simulations. These approaches can be used, not only in clinical development, but also in discovery research, such as for target validation, biomarker discovery, and extrapolation of clinical PK/PD from preclinical data. In this type of study, it is important to know how to effectively correlate the data collected from experiment with those from the model. This session will introduce the latest studies in this context and the outlook for the future, ranging from discovery to the clinical field.

3) PK/PD Studies Using In Vivo Imaging Technologies
In vivo imaging, such as PET and MRI, is being used actively in diagnosis as a way to monitor vital functions, non-invasively and in real time. Currently, by using in vivo imaging as a biomarker for PK/PD analysis, many clinical studies are progressing for compound and target proof of concept (POC), as well as dosage selection. Furthermore, by using in vivo imaging, it has become possible to monitor the time-course for transport/accumulation of drugs in local parts of the body, and it has now become possible to obtain pharmacokinetic information that was unknown in the past. Here, we will introduce how to use these effective imaging technologies in PK/PD studies, especially for drug discovery and development.

4) Facilitating Clinical Trials
In this session, we will learn about research activities that directly link discovery research and clinical research. The Human Micro Dosing (H-MD) test was an exploratory clinical trial proposed by a European society, EUFEP, as part of the program of New Safe Medicines Faster (NSMF). We will introduce the H-MD testing in Europe, with a focus on the consortium research.
You will hear that the IYAKUHIN KAIHATSU SHIEN KIKOU (Association for Promoting Drug Discovery: APDD), supported by the Japanese Society of the Study of Xenobiotics (JSSX), is also starting discussions on how the H-MD testing will be carried out here in Japan. Meanwhile, the knowledge derived from basic research on drug-metabolizing enzymes is required for clinical applications of individual medicines. The current knowledge in this area will be introduced and through these discussions we hope to find a direction in which to promote exploratory clinical trials in Japan.

In addition to the 4 sessions above, we have planned two Keynote lectures and a Special lecture. Pharmacokinetic studies will continue to link various fields and play an important role in the development of drugs. We have asked frontline professors in each of the fields of drug discovery, imaging diagnosis, and individual medicines to present Keynote and Special lectures. We hope to hear from these specialists what is expected of pharmacokinetic studies, from their point of view.

Finally, we would like to mention that this workshop will become more valuable for all speakers and participants if everyone contributes with active discussion. We look forward to having many attendees, and ask, on behalf of the members of the organizing committee, for your active participation.

For your registration, please contact the following:
Hidetoshi Horibe, Ph.D.
Research Manager, Pharmaceutical Research Division
Takeda Pharmaceutical Company Limited
e-mail: Horibe_Hidetoshi@takeda.co.jp

“Final Program”