Transcript Japanese Safety Pharmacology Society

Japanese Safety
Pharmacology Society
Meeting of Promoters
September 5th, 2009
Keiji Yamamoto, DVM, MBA, PhD











K. Yamamoto (Takeda Pharmaceutical)
M. Tabo (Chugai)
T. Kitayama (Kyowahakko-Kirin)
H. Tashibu (Dainippon-Sumitomo)
C, Kasai (Astellas)
S. Toyoshima (Ootsuka)
M. Wasaki (Mitsubishi-Tanabe)
T. Hombo (Ina Research)
K. Chiba (Daiichi-Sankyo)
S. Hayashi (Nippon Shinyaku)
6 Observers
Attendees – a total of 16
Japanese Safety Pharmacology
Society (JSPS)
 Agreed to establish as an independent
and non-profit organization
 Main activity is to hold an annual meeting
 may develop cooperative relationship with
other societies

◦ Safety Pharmacology Society
◦ Japan Society of Toxicology
◦ Japanese Society of Pharmacology
Name, Organization



Pharmaceutical companies (~10)
CROs (~3)
Academia (~3)
◦ Dr. Hashimoto (Yokohama Yakka Univ)
◦ Dr. Tsubone (Tokyo Univ)
◦ Dr. Sugiyama (Yamanashi Univ)

Regulatory agency (at least 1)
◦ Dr. Ohno (NIHS)
◦ Dr. Nakazawa (NIHS)
◦ ?? (PMDA)

Rules will be revised in 2 years
BoD members


Annual meeting in Japan.
The 1st meeting will be in February 2010
◦ 50-100 attendees expected




2.5 SPs/industry x 30 companies
1 Toxs/industry x 30 companies
10 persons from Academia
5 persons from Regulatory (invited)
Organizer
Company
1st Meeting (Feb 2010)
Keiji Yamamoto
Takeda
2nd Meeting (Feb 2011)
Masahiko Wasaki
Tanabe-Mitsubishi
3rd Meeting (Feb 2012)
Chieko Kasai
Astellas
4th Meeting (Feb 2013)
Katsuyoshi Chiba
Daiichi-Sankyo
Main activity
Scientific session (Oral only?)
 Symposium

◦ Merge toxicity study with safety pharmacology
studies: Why, When, Who and How?
 Need mutual education between Tox- & SP gists
◦ New tools for safety pharmacology:
 iPS, Non-invasive SP methods
◦ Disease model for risk in specific patient
population
Meeting Topics

Regulatory session
◦ ICH guidelines (S6, S9, E14 and S7B, M3 and
vaccine)
◦ An official guide book for ICH guidelines will be
published in June 2010 (Activity has started
since June 2009 NIHS/PMDA/JPMA)
Topics (continued)

K. Yamamoto will explain the situation in
Japan in the coming SPS meeting.
Relation with SPS