Launchof a new Diploma, MSc & PhD programme
in Research & Developmentof Products to meet Public Health Needs
Kenji Hirayama
Institute of Tropical Medicine
Nagasaki University
Win Gutterrage, Janis Lazdins, Juntra Karbwang(WHO/TDR, Switzerland), Jin Hong Hu (Second
Military Medical Univ, China), Kesara Na-Bangchang(Thammasat Univ, Thailand), Chitr Sitthi-amorn(Chulalongkorn Univ, Thailand), Kiichiro Tsutani(Univ of Tokyo, Japan), Ivan Valez (Univ of Antioquia,Colombia),

Why necessary?
Drug/vaccine/diagnostics Research &Development for the developing countries
Should be promoted more underinternational settings (10/90 gap, NeglectedDisease)
More human resources are needed
Diploma, MSc & PhD programme
in Research & Developmentof Products to meet Public Health Needs

Who can teach whom?
There is no single university who can cover
all the areas of Product development.
World-wide search for the best teachers
Synthetic
Chemistry

Toxicology

Genomics
Proteiomics

AnimalModel

Immunology

Pharmaco
Kenetics

VaccineClinicaltrialsDiagnostic
tools

GCP

Data
Management

Traditional
Medicine Intellectual Registration Pharmaco
Property
vigilance

International Collaborative Efforts!

Postgraduate Education
Cooperated by the network ofInternational Universities
Nagasaki University, The Univ. of Tokyo (Japan)
Thammasat Univ., Chulalongkorn Univ.
Mahidol Univ. (Thailand)
Second Military Medical University (China)
Univ. of Antioquia (Colombia)
Supported by
WHO/TDR andPharmaceutical Society of Japan

SevenUniversities

Final Picture of the Programme
Diploma Course

Step 1on R&D of Products
to Meet Public Health
Needs

Initiation Course toShow all the process
Of Productdevelopment

Specialty selection andinitial training to get

Step 2Master degree

PhD course
More intensive research training
and Thesis work
Step 3Given the PhD fromregistered University

Registry ofVariety ofSpecialtiesDiploma, MSc & PhD programme in Research & Developmentof Products to meet Public Health Needs
SecondCooperating
Thammasat Nagasaki,
MilitaryUniversities
Tokyo
Chulalongkorn
MedicalAntioquia

MahidolStudents’Registration

Related area’sLaboratories
Will beRegistered toAccept thestudents

Administration Office ofThe Programme
At Nagasaki University
5 weeks
Diploma course

PharmaBasic
1-4 years
SciencResearch worke

Clinicalscience

EthicsMSc, PhD on PD Given by the original universityDiploma Course
on Research & Development of Products
to Meet Public Health Needs
Sponsored by Nagasaki University
in cooperation with Thammasat University, Chulalongkorn University,China Second Military Medical University, Antioquia University
and The Graduate School of Pharmaceutical Sciences of The Universityof Tokyoin collaboration with WHO/TDRand The Pharmaceutical Society of Japan (PSJ)

Nagasaki University, Japan
October 2 - November 8, 2006

Module 1 ：Orientation○Key medical and public health issues, and the need for new products○Discovery research and product development Stakeholders

Module 2： Drug Development○Drug Discovery○Chemical Manufacturing and Control○Preclinical and Toxicology

Module 3: Vaccine Development○Vaccine Discovery○Vaccine Development

Module 4: Diagnostic Development
Module 5:Good Clinical Practice (GCP)○GMP, GLP, GCP, ICH○Ethical Review and Guideline○Field Trip to Factory

Module 6:Clinical Data Management
Module 7:Post Registration Activities○Pharmacovigilance, PPP, Intelligent Property

Course Orientation

President, Prof. Dr. Hiroshi Saitoh, Nagasaki University, Japan
Professor Dr. Kenji Hirayama, Director of the course, Nagasaki
University, Japan
Dr. Janis Lazdins, WHO/TDR, Geneva
Prof. Dr. Eiji Uchida, Showa University, Tokyo, Japan

Vaccine Development

Dr. Howard Engers, AHARI, Ethiopia
Prof. Dr. Kenji Hirayama, Nagasaki University, Japan
Prof. Dr.Weiqing Pan, Second Military Medical University, China
Dr. Masahiko Ehara, Nagasaki University, Japan
Prof. Dr. Kouichi Morita, Nagasaki University, Japan
Dr. Takeshi Arakawa, Ryukyu University, Japan
Dr. Kiyoshi Horiuchi, GlaxoSmithKline KK, Tokyo, Japan
Dr. Shigeyuki Kano, International Medical Center of Japan, Toky
Dr. Pele Chong, Taiwan
Dr. Shigeharu Ueda, The Research Foundation for Microbial
Diseases of Osaka University (BIKEN), Japan
Dr. Nobuhiro Noro, GlaxoSmithKline KK, Tokyo, Japan
Dr. Yasushi Yoshino, Dr. Masaru Iwasaki, GlaxoSmithKline KK,Tokyo, Japan

More than 60
Professors andDrug Development
Mr. Nobuhiro Noro, GSK, JapanLecturers ofDr. Hisashi Ohta, Tsukuba Institute Merck Banyu Pharmaceutical, Japan
Dr. Prof. Tadashi Yoshimoto, Nagasaki University,Nagasaki,JapanExpertise
Prof. Shigeru Katamine, Nagasaki University, Nagasaki, Japan
Assoc. Prof. Dr. Prasit Palithapolkarnpim, BIOTEC, Thailand
have come fromDr. Mitsuyoshi Kinoshita, Otsuka pharmaceutical, Osaka, Japan
Prof. Dr. Kiyoshi Kita, The University of Tokyo, Japan all over the
Dr. Masato Sasaki, Roche Diagnostics KK, Tokyo, Japan
Dr. Kenichi Osawa, Merck Banyu Pharma, Japanworld
Prof. Dr. Susumi Hatakeyama, Nagasaki University, Japan

GCP Data Management

Prof. Dr. Masaaki Kai, Nagasaki University, Japan
Dr.Vichai Chokevivat, FERCAP, Thailand
Prof. Dr. Hiroaki Nagaoka, Nagasaki International University,JapanProf.Dr. Cristina Torres, FERCAP, Thailand
Assoc. Prof. Supornchai Matangkasobat, Mahidol University, Thailand
Prof. Dr. Kenji Hirayama, Nagasaki University, Japan
Dr. Shunsuke Ono, University of Tokyo, Japan
Dr. Allan Johansen, Roche Products Pty limited, Australia
Dr. Hiroyuki Itoh, Astellas Pharma Inc, Japan
Prof.Dr. Masakatsu Shibasaki, The University of Tokyo,
Dr. Tsutomu Kurosawa, Osaka University, JapanJapan
Assoc. Prof. Dr. Wongwiwat Tassaneeyakul, Kon Kaen University, Thailand
Dr. Tetsuro Satoh, Kaketsuken, Kumamoto, Japan
Dr. Soisanwan Satarug, University of Queensland, Australia
Dr. Charcrin Na-Bangchang, TU-CDMC, Thailand
Dr. Kazuki Osawa, Nagasaki University, Japan
Dr. Rui Wang, SMMC-CDMC, China
Dr. Tadaaki Taniguchi, Japanese Association of Pharmaceutical
Dr. Arunachalam Rajagopal, CMC-CDMC, India
Medicine (JAPHMED), Merck Banyu Pharma, Japan
Dr. Jose Fernando Florez Arango, CMC-CDMC, Colombia
Dr. Kenji Nonaka, Japanese Association of Pharmaceutical Medicine
Dr. Sangkae Chamnanvanakij, TU-CDMC, Thailand(JAPHMED), Merck Banyu Pharma, Japan
Dr.Kimihiro Kasamo, Japanese Association of PharmaceuticalMedicine(JAPHMED), Merck Banyu Pharma, Japan
Dr. Shyh-Yuh Liou, Japan Section GlaxoSmithKline, Japan
Prof. Dr. L. Jeyaseelan, Christian Medical University, Vellor, India Prof. Dr. Chitr Sitthi-amorn, Chulalongkorn University, Thailand
Prof. Dr. Kazuko Kimura, Kanazawa University, Japan
Prof.Dr. Koji Kawakami, Kyoto University, Kyoto, Japan
Dr. Kihito Takahashi, JAPHMED, Merck Banyu Pharma
Prof. Dr. Juntra Karbwang, WHO/TDR, Switzerland
Prof. Dr.Yupin, FDA, Thailand
Prof. Dr. Kiichiro Tsutani, University of Tokyo
Professor Dr. Kiichiro Tsutani, University of Tokyo, Japan
Dr.
Janis
Lazdins,TDR/WHO,Geneva
Prof. Dr. Yupin, FDA, Thailand
Dr. Ichiro Arai, Manager, R&D Strategy Dept. Tsumura & Co.
Prof.
Dr.
Chitr
Sitthi-amorn,
Chulalongkorn
University, Thailand
Professor Dr. Luping Qin, China
Prof. Dr. Hiroko Yamane, Graduate Institute for Policy Studies, Japan
Prof. Dr. Juntra Karbwang, WHO/TDR, Geneva
Prof.Dr. Kenji Hirayama, Course Director, ITM, Nagasaki University

Post-registration Activities

Opening Ceremony October 2, 2006

President Saito

Janis
WHO/TDR

UchidaShowa Univ

Module 1Introduction
Noro
GSK Japan

Module 2.
Drug Discovery
Kita Prof
Univ Tokyo
Kinoshita
OtsukaKatamine Prof
Ohta Merck
Prasit
Biotech
BKK

Noro GSKElaine Chen Taiwan

Intellectual Property
Osawa, Merck Banyu

Tepanata, Chanida
Orapin from Thailand

Yoshimoto, Kai
Hatakeyama Profs
Nagasaki Univ
Song, Zhang, Wang
Military Medical Univ
China

Nagaoka
CMC

Supornchai
Mahidol
Katalina, Jerver fromColombia

ItohAstellasRegulatory
And
Animal model
OnoUniv Tkyo

Kurosawa
Osaka Univ

PreclinicalSoisanwan
Queensland Univ
Australia

Toxicology

Wongwiwat
Kon Koen Univ
ThailandAnimal Facility
Nagasaki Univ
OsawaOsawa

Clinical Development
Merck Banyu Japan
Taniguchi
KasamoShyh-Yuh LiouJapan Section GSK

Pharmacogenetics

NonakaMerck

Nonaka Merck Banyu

Clinical Development
Many examples

Jeyseelan
Study design
India
Many Statistics

Miltefosine
Very much
Impressive!
JuntraWHO/TDR

FDA and PMDA
Kawakami
Kyoto UnivS

TraditionalMedicine

Arai
TsumuraQin
China
Tsutani Prof Univ.Tokyo

Half way!!

Jiraporn Thailand

HowardKenji

Module 3. Vaccine

Vaccine Lab Visit
ITM, Nagasaki Univ.

PanMalaria, Cholera, West Nile
Vaccines Ehara, Morita, ITM Nagasaki

Ueda
Biken

Arakawa
RyukyuHoriuchi GSK

Kano
IMCJYoshino GSKSpecial Lecture
Tamiflu

Shibasaki Prof
Univ Tokyo
Horiuchi, Iwasaki
GSK

NoroGSK

SasakiRoche

Module 4
Diagnostic Tool
Development

Jose
Antioquia

SankaeMOH
Lui Wang
SecondMilitary
MedicalUniv

Module 5
Data Management
Charcrin
Thammasat
Raja Gabal
Christian Med Univ

KenjiFERCAP
Vichai, MOH Thailand

Cristina
FERCAPUP

Module 6
GCP
Allan Johansen
RocheVaccine Factory
Kaketuken
KumamotoSatohVaccine Factory
Kaketuken
Kumamoto
GLP, GMP

Vaccine Factory
Kaketuken
KumamotoGLP, GMP

Module 7
Post-registration
Activities

KimuraKanazawa
Univ.

Tsutani U.Tokyo
Pharmacoeconomics
Takahashi,
Merck Banyu

Public private partnership

Prof Chitr
Public HealthNeeds

Prof Yamane
Policy Study
UnivIntellectualProperty

Yanis
Opening and Closing

Yupin Thai FDA

Diploma Ceremony
November 8, 2006
ITM Nagasaki Univ.
Japan

Diploma Ceremony
November 8, 2006
ITM Nagasaki Univ.
Japan

Director General Hayashi of Ministry of Education
President Saito, Katamine Vice President, Aoki,Tomonaga, Kohno, Matsumura, Deans, Institute ofTropical Medicine, Graduate sch Medical Sciences,
Faculty of Medicine, Faculty of Pharmacy, Prof
Chitr of Chulalongkorn, Juntra, Janis of TDR,
Tsutani of Univ Tokyo, Yupin from Thai FDA
Takagi, Mizota, Hirayama Profs of ITM

海外講師

所属

国内講師

WHO

Janis Lazdins

長崎大学 学長

齋藤 寛

琉球大学 助教授

新川 武

WHO

Juntra Karbwang

長崎大学 コースデイレクター

平山 謙二

GSK

堀内清

タイ･バイオテック助教授

Prasit Palitapongarnpim

昭和大学 教授

内田 英二（株）GSK取締役開発本部副本部長

岩崎 甫

タイ･マヒドール大学教授

Supornchai Matangkasobat

東京 GSK

野呂 信弘

国立国際医療センター研究所適正技術開発・移転研究部

狩野繁之

タイ･コンケン大学助教授

Wongwiwat Tassaneeyakul

日本製薬医学医師連合会 会長

高橋 希人

大阪大学 名誉教授 BIKEN

上田重晴ｵｰｽﾄﾗﾘｱ・クィーンズランド大学

Soisanwan Satarug

長崎大学

片峰 茂

GSK

吉野秦

タイ･タマサート大学教授

Kesara Na Bangchang

長崎大学

芳本 忠

ロシュダイアグノスチック MD顧客サポート事業部

佐々木政人

クリスチャン医学大学教授

L. Jeeyaseelan

東京大学大学院教授

北 潔

東京大学大学院薬学系研究科長

柴崎正勝

中国・第二軍医学校 教授

Luping Qin

萬有製薬

大澤健一

金沢大学 大学院教授

木村和子

WHO

Howard Engers

長崎大学

畑山範

政策研究大学院大学 教授

山根裕子

中国第二軍医学校教授

Weiqing Pan

長崎国際大学教授

長岡寛明

Fercap 教授

Cristina Torres

長崎大学

甲斐雅亮

タイ政府 保健省審議官

Vichai Choikvivat

東京大学大学院

小野俊介

ｵｰｽﾄﾗﾘｱ・ロシュプロダクツ

Allan Johansen

アステラス製薬

伊東洋行

タイ･タマサート大学

Charcrin Na Bangchang

大阪大学医学部

黒澤努

中国第二軍医学校 医学部

Rui WANG

萬有製薬

谷口忠明

Armauer Hansen ResearchInstitute

Lawrence Yamuah

萬有製薬

野中健史

タイ・タマサート大学 教授

Sangkae Chamnanawakit

萬有製薬

笠茂公弘

ｺﾛﾝﾋﾞｱ・ｱﾝﾁｵｷｱ大学

Jose Fernando Arango

GSK筑波装薬研究所

劉 世玉

インド・ｸﾘｽﾁｬﾝ医学大学 教授

Arunachalam Rajagopal

医薬品医療機器総合機構審議役

森 和彦

タイ･チュラロンコン大学学部長

Chitr Sitthi amorn

東京大学 大学院

津谷喜一郎

タイ厚生省

Pakdee Pothisiri

ツムラ（株）

新井一郎

チュラロンコン大学 教授

Nijsiri RUANGRUNGSI

長崎大学

江原雅彦

中国第二軍医学校 教授

Jia HE

長崎大学

森田公一

Public 20%
Private 25%
Academia 55%

Kesara

Chitr

Kenji

Ivan

Juntra and Janis

Julia and Hu

Stakeholders of PD Diploma Course

Tsutani