translational medicine （橋渡し研究） : bridge over the valley of death （死の...
TRANSCRIPT
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 SciencesUniversity 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 PatientTR は患者で始まり患者で終わる
ClinicalMedicine
BasicResearch
Patient studies: Therapeutic Intervention
Patient studies: Disease Pathogenesis
What is Translational Research
The Translational Continuum:TR の連続性 From Discovery to Delivery （発見から配送ま
で）
LeadLead
Optimization
DrugTarget Lead
LeadOptimiz-
ation
TargetValidat-
ion
GMPClinicalTrials
ClinicalDelivery
The EnablersThe Enablers
DiscoveryResearch
High Throughputand Design
MedicinalChemistry
Models: Mice
Primates
Manufacturing Patients G l o b a lH e a l t h
Ph.D.MD
IndustryChemist
Translational Ph.D.Physician-Scientist
PhysicianScientist
ClinicalInvestigator
Clinicians
The Human CapitalThe Human Capital
Translational MedicineTranslational Medicine （橋（橋渡し医学）渡し医学）
Fundamental
MedicalDiscovery
PotentialNew Drug
Approved New
Theraupetic
TheTheValley ofValley of
DeathDeath
TranslateTranslateIntoInto
CommercializeCommercializeIntoInto
基盤的な医学の発見
死の谷を橋渡しして
可能性のある新薬剤を開発し
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）
Basic Disease- Investigative Clinical Trials Clinical
Research Oriented Medicine Epidemiology Practice of
Research Health Svcs Rsch Medicine
PhysicianScientists （ MD PhD)
TCR
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）
Infrastructure（下部組織）
Human Capital （人的資本） : Translational Medicine Program
Basic Disease- Investigative Clinical Trials Clinical
Research Oriented Medicine Epidemiology Practice of
Research Health Svcs Rsch Medicine
PhysicianScientists
TCR
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）
Basic Disease- Investigative Clinical Trials Clinical
Research Oriented Medicine Epidemiology Practice of
Research Health Svcs Rsch Medicine
TCR
Infrastructure（下部組織）
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
Basic Disease- Investigative Clinical Trials Clinical
Research Oriented Medicine Epidemiology Practice of
Research Health Svcs Rsch Medicine
TCR
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
INDUSTRY
BENCHKey performers:A*STAR BMRC RIs,
universities
BEDSIDEKey performers:
MOH (viz. hospitals, specialist centres)
>> Grow health services, public health research
>> Build critical mass of human capital, supernumerary to clinical service needs
>> Establish flagship programmes from bench-to-bedside (heart/ metabolic, neuro, cancer, eye, infectious disease)
Driven by A*, EDB,
Bio*One
Driven by EDB, Bio*One
>> Develop best enabling resources in Asia for translational research
>> Strengthen regulatory framework for translational and clinical research.
Driven by multi-agency BMS
Exco
Interaction strengthened by new entities arising from hospital-medical school partnerships
>> Develop strong investigational med capability
>> Be preferred site for early phase
clinical trials in Asia
Research ScholarshipsResearch Scholarships （研究奨（研究奨学金）学金）
Masters of Clinical Investigation
MD- PhD
MBA-MD
Research Fellowships
________________
Talent Development ProgrammesTalent Development Programmes（才能育成プログラム）（才能育成プログラム）
• Singapore Translational Research Investigator Awards (STaR)
• Clinician Scientist Awards (CSA)
• Transition Awards
Talent Development ProgrammesTalent Development Programmes （才能育成プログラム）（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 InstituteClinical Research Institute （臨床研究施（臨床研究施設）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) Translational and Clinical Research (TCR) Flagship ProgrammesFlagship Programmes
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
Five TCR Programmes awarded - S$25mil each
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）
2007 2008Mid 20062000
Nov 07Kent Ridge CampusJoint NUHS established
Mar 08STaRDaniel Tenen, David Virchup, Michael Chee, Wong Tien Yin
Feb 07CSI2 Snr Inv Award4 Inv Award
Jul 07TCR Flagship$25M for Gastric Cancer (led by NUS)
Aug 07Outram CampusGMS launched; inaugural batch of 26 students
Mar 08Training pipeline2 AST- PhDMCI launched
Jul 08TCR Flagship$25M each for Eye & Neurosciences
Oct 08TCR Flagship$25M to be awarded for CV/metabolism, and ID
Mar 08Strategic Research InfraProposed i) Research space (RBF, ARF, IMU):16,000sqm at KR, 23,000sqm at Outram; ii) IMUs: 24 beds in KR, 30 beds in Outram
Strengthening TCR
Jan 08Academic Clinical Research OrgnDuke to establish SCRI in 08
2006Multi-Agency BMS Exco reconstituted; co-chaired by MOH & A*STAR
BM
S P
has
e 1
(200
0-20
05)
Jul 06Launch of
BMS Phase 2$1.55B for
TCR 2007: Establishment of SICS, SIgN, ETC
Mar 08CSA4 Senior Inv &1 Inv
Feb 08 Established CBME
Clinical Imaging Research Clinical Imaging Research
Centre (CIRC)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.