Transcript ホームズ教授講演会 資料②

Translational Medicine（橋渡し研究）:
Bridge Over the Valley of Death（死の谷
に掛ける橋）
Edward W. Holmes, MD
Vice Chancellor Emeritus, Health Sciences
University of California San Diego
President, Sanford Consortium for Regenerative
Medicine
Goals of Translational Medicine（TRの
ゴール）
• Advance our insight and understanding of
human disease（ヒト疾患の洞察と理解の進歩
させる）
• Use these advances to improve the health of
individuals and populations（個人および人口
全体の健康の改善にこれらの進歩を使う）
• Enhance economic well being of society（社会
経済の健全性を増進する）
Translational Medicine Has a Broad Remit
（TRは広いレミットを有する）
TransMed Starts and Ends with the Patient
TRは患者で始まり患者で終わる
Clinical
Medicine
Patient studies: Disease Pathogenesis
Patient studies: Therapeutic Intervention
Basic
Research
What is Translational Research
• Translation does not end with the ribosome,
and it does not begin with a clinical trial
• （TRはリボソームで終わるのではなく臨床研
究で終わるのでもない）
• Broad enterprise that spans disease
pathogenesis to discovery of therapeutic
targets to demonstration of clinical
effectiveness （TRは病気の病態から治療標的の発見と臨床効
果の実証にまでわたる広範な企画である）
The Translational Continuum:TRの連続性
From Discovery to Delivery（発見から配送まで）
Drug
Target
Lead
Lead
Optimization
Target
Validation
GMP
Clinical
Trials
Clinical
Delivery
The Enablers
Discovery
Research
High
Throughput
and Design
Medicinal
Chemistry
Models:
Mice
Primates
Lead
Manufacturing
Patients
Lead
Optimization
Global
Health
The Human Capital
Ph.D.
MD
Chemist
Translational Ph.D.
Physician-Scientist
Physician
Scientist
Industry
Clinical
Investigator
Clinicians
Translational Medicine（橋渡し医学）
死の谷を橋渡しして
Translate
Into
Fundamental
Medical
Discovery
基盤的な医学の発見
The
Valley of
Death
Commercialize
Into
Potential
New
Drug
可能性のある
新薬剤を開発し
Approved
New
Theraupetic
承認された新規治療へと
商業化してゆく
Causes of the Valley of Death
• Too few well trained Physician Scientists（よく
鍛えられたMD,PhDが非常に少ない）
• Lack of adequate infrastructure（適切な下部組
織が欠如）
• Funding to support the people and
infrastructure（人と下部組織を支持する資金）
Human and Physical Capital(人的物理的資本）:
Translational Medicine Program（TRプログラム）
TCR
Basic
Research
DiseaseOriented
Research
Investigative
Medicine
Clinical Trials
Epidemiology
Health Svcs Rsch
Clinical
Practice of
Medicine
Physician
Scientists（MD PhD)
Infrastructure
（下部組織）
Project Teams（研究チーム）
Regulatory Experts
（レギュラトリーサイエンス
の専門家）
Human Capital（人的資本）:
Translational Medicine Program
TCR
Basic
Research
DiseaseOriented
Research
Investigative
Medicine
Physician
Scientists
Clinical Trials
Epidemiology
Health Svcs Rsch
Clinical
Practice of
Medicine
Bridge over the Valley of Death（死の谷に掛ける橋）:
(1) Physician Scientists（MD, Ph.D)
• Training（訓練）- dual training; clinical and
scientific（臨床と科学の二重の訓練）
• Protected time（時間の保護）- 80% research
（研究）; 20% clinical（臨床）
• Environment- Leadership respects and
supports dual mission（統率力で２重の指名を
尊重し支持する）
• Endangered species（絶滅危惧種）international shortage（国際的に欠乏）
Facilities(施設）:
Translational Medicine Program（TMプログラム）
TCR
Basic
Research
DiseaseOriented
Research
Investigative
Medicine
Clinical Trials
Epidemiology
Health Svcs Rsch
Infrastructure
（下部組織）
Clinical
Practice of
Medicine
Bridge over the Valley of Death（死の谷に掛ける橋） :
(2) Infrastructure（下部組織）
• Clinical Research Facilities for Patient Studies
（患者研究のために臨床研究施設）
• Access to development technologies（進歩する
技術へアクセスする）: High Through Put
Screening, Medicinal Chemistry, Mab
production, device prototype production
• Access to GMP facilities, Toxicology
assessment（GMPに準拠した施設）、毒物学的評価
へのアクセス）
Team Members（チームメンバー）:
Translational Medicine Program
TCR
Basic
Research
DiseaseOriented
Research
Investigative
Medicine
Clinical Trials
Epidemiology
Health Svcs Rsch
Clinical
Practice of
Medicine
Team Specialists（チームの専門家集団）
Project Teams(プロジェクトチーム）
Regulatory Experts（レギュラトリーサイエンスの専門家）
Bridge over the Valley of Death（死の谷に掛ける橋） :
(3) Team Members
• Nurses and Study Coordinators（看護師と研究
のコーディネーター）
• Project Team（研究チーム）
• Regulatory Expertise（レギュラトリーサイエン
スの専門家）
• Advisory Panel with industry and business
expertise in addition to scientific expertise（企
業やビジネスの専門家と関連を持った相談役
の審査団）
Bridge over the Valley of Death（死の谷に掛ける橋） :
(4) Business Development Office（ビジネスを発展させるオフィス）
• Intellectual Property and Technology Transfer
（知的財産と技術移転）
• Legal support for contract services（契約のた
めの法的な支持）, etc
• Industrial Partnership Office（産業連携オフィス）
Key Recommendations
>> Develop best enabling resources in Asia for translational research
>> Strengthen regulatory framework for translational and clinical research.
Driven by A*,
EDB,
Bio*One
INDUSTRY
Driven by
EDB, Bio*One
Driven by multiagency BMS
Exco
BENCH
Key performers:
A*STAR BMRC RIs,
universities
Interaction strengthened by new
entities arising from hospitalmedical school partnerships
>> Develop strong
investigational
med capability
>> Be preferred site
for early phase
clinical trials in Asia
BEDSIDE
Key performers:
MOH (viz. hospitals,
specialist centres)
>> Grow health
services, public
health research
>> Establish flagship programmes from bench-to-bedside
(heart/ metabolic, neuro, cancer, eye, infectious disease)
>> Build critical mass of human capital, supernumerary to clinical service needs
Research Scholarships（研究奨学
金）
Masters of Clinical Investigation
MD- PhD
MBA-MD
Research Fellowships
________________
Talent Development Programmes（才
能育成プログラム）
• Singapore Translational
Research Investigator
Awards (STaR)
• Clinician Scientist Awards
(CSA)
• Transition Awards
Talent Development Programmes
（才能育成プログラム）
• 100% of academic salary
provided（100%のアカデミ
アとしての給料を供給）
• Guarantee of 70-80% of
time protected for
research（70～80%の研究
時間を保証する）
• Variable laboratory
support（種々の実験室での
支持）
Clinical Research Institute（臨床研究施設）
One-stop centre providing infrastructure support,
to conduct clinical trials （One-stop centreが臨床試
験を実施する下部組織の支持を供給する）
Translational and Clinical Research (TCR)
Flagship Programmes
Five TCR Programmes awarded - S$25mil each
Disease Areas
Awardees
Host Institution
Gastric Cancer
- Genomics and
biomarkers trials
A/Prof Yeoh Khay
Guan
National University
of Singapore
Neuroscience
- Schizophrenia and
related psychoses
A/Prof Chong Siow
Ann
Institute of Mental
Health
Eye Diseases
- Glaucoma and
corneal disorders
Prof Donald Tan
Singapore Eye
Research Institute
Infectious Disease
- Dengue treatment
and prevention
A/Prof Leo Yee Sin
Tan Tock Seng
Hospital
Metabolic Diseases
- Developmental
pathways
A/Prof Chong Yap
Seng
National University
of Singapore
Other TCR Initiatives（他のTCR主導権）
• Experimental Therapeutics Centre (ETC)
– Established to fill the gap between identification of
therapeutic targets and synthesis of lead compounds or
biologics for clinical trials（治療標的の決定とリード化合物
の合成や臨床試験のための生物学との間のギャップを埋
める）
• Singapore Institute for Clinical Sciences
(SICS)
– Research institute to bridge basic scientists at Bioplois
with clinical investigators in AMCs（バイオポリスの基礎
研究者とAMCcの臨床研究者との懸け橋となる研究施設）
• Restructured IRBs
– Domain specific IRBs that cover all public hospitals（す
べての公立病院を包括する領域に特化したIRB)
Other TCR Initiatives
• Singapore Consortium for Cohort Studies
(SCCS)
– Common infrastructure for coordination of cohort studies
and collection of phenotypic data(コホート研究のコーディ
ネートと特性データの収集のための共通下部組織）
• Singapore Tissue Network (STN)
– National resource for collection, storage, and retrieval of
human tissue samples to support translational and clinical
research（TRやCRを支持するためのヒト組織サンプルの収集
保管検索のための国立資源
• Clinical Research Imaging Center (CIRC)
– Advanced imaging technologies dedicated to human
research studies（ヒト研究の特化した最新のイメージング技
術）
Singapore’s Niche in Translational and
Clinical Research（TRとCRでのシンガ
ポールの相応しい位置）
• Asian Phenotype（アジア人の特性）
• Focus on Diseases of Interest to
Singapore or Special Ability to Study in
Singapore（シンガポールにとって興味のある
病気またはシンガポールでの特徴的な研究能
力）
• Investigational Medicine and POC
Studies（研究医学やPOC研究）
BMS Phase 1 (2000-2005)
Strengthening TCR
2006
Multi-Agency BMS
Exco reconstituted;
co-chaired by MOH &
A*STAR
Jul 06
Launch of
BMS Phase 2
$1.55B for
TCR
Nov 07
Kent Ridge Campus
Joint NUHS established
Aug 07
Outram Campus
GMS launched;
inaugural batch of
26 students
Jul 07
TCR Flagship
$25M for Gastric
Cancer (led by NUS)
Feb 07
CSI
2 Snr Inv Award
4 Inv Award
2007: Establishment of
SICS, SIgN, ETC
2000
Mid 2006
2007
Oct 08
TCR Flagship
$25M to be awarded for
CV/metabolism, and ID
Mar 08
CSA
4 Senior Inv
&1 Inv
Mar 08
STaR
Daniel Tenen, David
Virchup, Michael Chee,
Wong Tien Yin
Mar 08
Training
pipeline
2 AST- PhD
MCI launched
Mar 08
Strategic Research Infra
Proposed i) Research space (RBF, ARF,
IMU):16,000sqm at KR, 23,000sqm at
Outram; ii) IMUs: 24 beds in KR, 30 beds
in Outram
Jul 08
TCR Flagship
$25M each for Eye & Neurosciences
Jan 08
Academic Clinical Research Orgn
Duke to establish SCRI in 08
Feb 08 Established CBME
2008
Clinical Imaging Research
Centre (CIRC)
• In Apr 08, Ministry of Trade & Industry approved S$31.8mil from
S&T2010 to fund CIRC activities for 5 years.
• Construction of CIRC Phase 1 facility at the NUS Centre for Life
Sciences began in early March 2008 and completed on 18
September 2008.
• The Siemens 3 Tesla clinical whole body MRI installed in Phase 1
facility in July 2008.
• Construction for CIRC Phase 2 facility at the new NUS Centre for
Translational Medicine has begun and will be completed in March
2011.
• Ongoing exploration of partnerships with MOH, Duke-NUS GMS etc
to develop CIRC's clinical programmes and advancing imaging
techniques such as PET-MR.