Invitation to the 20th Workshop of the Japanese Society
for the Study of Xenobiotics
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 ePharmacokinetic
technologies to break through the bottleneck of drug
discovery and developmentf.
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,
ethe bottle neck of drug discovery and developmentf,
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, eePharmacokinetic technologies to break through
the bottle neck of drug discovery and developmentf.
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
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
For your registration, please contact the following:
Hidetoshi Horibe, Ph.D.
Research Manager, Pharmaceutical Research Division
Takeda Pharmaceutical Company Limited