Japanese Safety Japanese Safety Pharmacology SocietyPharmacology Society

Meeting of PromotersSeptember 5th, 2009

Keiji Yamamoto, DVM, MBA, PhD

Attendees – a total of 16Attendees – a total of 16

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

Name, OrganizationName, Organization

Japanese Safety Pharmacology Society (JSPS)

Agreed to establish as an independent and non-profit organization

Main activity is to hold an annual meetingmay develop cooperative relationship with

other societies◦Safety Pharmacology Society◦Japan Society of Toxicology◦Japanese Society of Pharmacology

BoD members BoD members

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

Main activityMain activity

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

Meeting TopicsMeeting Topics

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

Topics (continued)Topics (continued)

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)

Relation with SPSRelation with SPS

K. Yamamoto will explain the situation in Japan in the coming SPS meeting.