1The Hamner Institutes at Research Triangle Park

A Global Vision for Advancing Public Health in the 21st Century促进 21世纪人类健康的全球策略

William F. Greenlee, PhDPresident and Chief Executive OfficerThe Hamner Institutes for Health Sciences

2The Hamner Institutes at Research Triangle Park

Discovery Research

Capture & Translation

Public Health Policy

New/Safer Medicines & Diagnostics

Business & Economic Development

End Game Driven Translational Research and Business Development

转化型研究和商务开发的终极模式

3The Hamner Institutes at Research Triangle Park

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Transforming the Risk Assessment Paradigm危险性评价模式的转换

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4The Hamner Institutes at Research Triangle Park

A New Vision for Chemical Safety Assessment

化学物安全评价的一个新视角

US National Academy of Sciences NRC Report (October 2007)

5The Hamner Institutes for Health Sciences

Target Identification

Hit Identification

Lead Identification

Lead Optimization

Pre-Clin. Development

Phase 1 Single &

repeat dose escalation

HVTs

Phase 2 Dose

Ranging inpatients

Phase 3

patients

Pre-Reg.

Phase 3b/4

The Current Drug Development Paradigm当前药物研发的模式

Actually it is a dilemma实际上是一场噩梦

Ten Years and One Billion Dollars!!

Funding for biomedical research has tripled (>$120 billion annually!) when adjusted for inflation in the past 15 years

Nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict behavior in people from laboratory animal models

Safety is the #1 reason drugs fail or have limited use

6The Hamner Institutes at Research Triangle Park

• Award Winning Scientific Staff• 3000 Publications (including Science and Nature)

• 400 Postdoctoral Trainees• 100 Predoctoral Trainees• International Programs in Chemical Safety Assessment

• Leadership Role for ToxCast 21 (in Partnership with US EPA)

A Global Leader in Environmental Health and Safety Sciences Research and Training

全球环境健康与安全科学研究和培训的权威机构

The Hamner Institutes Campus is located on a 56 acre site in the center of Research Triangle Park and nearby to Duke University, the University of North Carolina at Chapel Hill, and North Carolina State University.

35 Years of Research in Small Molecule Safety

7The Hamner Institutes at Research Triangle Park

The Hamner Model哈姆纳模式Protect Public

Health

Systems Biology – Business Development Platform

ChemicalIndustry

PharmaceuticalIndustry

Academe

Chemical Safety

Sciences

Drug Safety Sciences

New and SaferMedicines

Government

NIEHS – EPA – NIH – FDA

8The Hamner Institutes at Research Triangle Park

Building a NC Translational Life Sciences and Business Development Network建立一个北卡的生命科学和商务开发网络

9The Hamner Institutes at Research Triangle Park

Health Outcomes Based Systems Biology Platform

Hamner BiosciencesAccelerator

Business DevelopmentIndustry/Global

Partnerships

Capital DevelopmentInstitutes/CentersFaculty/Training

UNC-Chapel HillDrug Safety Sciences

Gene Therapy/Vector CoreNanomedicine

Cancer Therapeutics

Duke UniversityEnvironmental Oncology

Oligonucleotide TherapeuticsBiomarkers/Immune Monitoring

NC State UniversitySystems Engineering

Computational SciencesVeterinary Medicine

Wake Forest UniversityRegenerative Medicine

Tissue EngineeringDrug Safety Sciences

The Hamner InstitutesChemical/Drug Safety

Translational Biomedical ResearchGLP/GMP Support Facilities

Training ProgramsBusiness Development

Uniting North Carolina’s Universities A Translational Research Partnership联合北卡各大学进行转化性研究合作

10The Hamner Institutes at Research Triangle Park

The Institute for Drug Safety Sciences药物安全科学研究所

Dr. Janet Woodcock, US FDA, is Director of CDER and is responsible for all drug approvals in the USA.

• Safety is the #1 Reason that Drugs Fail or Have Limited Use

• Director Paul Watkins, MD is a Recognized World Leader in Drug Safety

• Integration of Human Clinical Data, with State-of-the-art, Animal Models, Human in vitro Systems and Computational Modeling

• Seamless Integration of Drug Safety with Efficacy to Accelerate Drug Development

11The Hamner Institutes at Research Triangle Park

•Clinical Studies and Post-Marketing Surveillance•Advanced Animal Models—”Humanized” Mice•Advanced Multi-Dimensional Human Organ Systems•High Throughput Readout and Capture

Systems Integration to Accelerate Drug Development and Inform Public Policy

系统整合以加速药物研发并制定相应的公共卫生政策

12The Hamner Institutes at Research Triangle Park

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Quantitative Systems Computational Models of Pathways and Networks Predict Human Physiology

量化的系统计算机生物模型用以预测人体生理变化

The “Virtual” Human

13The Hamner Institutes at Research Triangle Park

FASTER—SAFER—CHEAPER—ACCESSIBLE!!

Public Health Impact对公共健康的影响

Informed Public Health Policy on Chemical and Drug Safety—Protect Health/Prevent Disease

Accelerate the Development of New Medicines and Diagnostics

14The Hamner Institutes for Health Sciences

The 21st Century Drug Discovery & Development Paradigm21世纪药物研发的新模式

Pharma Companies – Decreasing Early R&D

Target Identification

Hit Identification

Lead Identification

Lead Optimization

Pre-Clin. Development

Phase 1 Single &

repeat dose escalation

HVTs

Phase 2 Dose

Ranging inpatients

Phase 3

patients

Pre-Reg.

Phase 3b/4

Target Identification

Hit Identification

Lead Identification

Lead Optimization

Pre-Clin. Development

Phase 1 Single &

repeat dose escalation

HVTs

Phase 2 Dose

Ranging inpatients

Phase 3

patients

Pre-Reg.

Phase 3b/4

Academic & other Non-Profit Organizations – Minimal Early Development Capability

Hit Identification

Lead Identification

Lead Optimization

Pre-Clin. Development Bridging the Gap

Target Identification

Hit Identification

Lead Identification

Lead Optimization

Pre-Clin. Development

Phase 1 Single &

repeat dose escalation

HVTs

Phase 2 Dose

Ranging inpatients

Phase 3

patients

Pre-Reg.

Phase 3b/4

15The Hamner Institutes at Research Triangle Park

Creating the Dual Gateway BetweenChina and North Carolina

在中国和北卡之间建立双向通道

16The Hamner Institutes at Research Triangle Park

Shanghai CDC-Hamner International Institute for Health and Safety Sciences

上海疾病预防控制中心 -哈姆纳国际健康及安全可学研究所

Official Signing CeremonyOctober 26, 2009

GoalStrengthen partnership in drug & environmental chemical safety

New in vivo and in vitro safety assessment technologies

Predictive computational models Environmental assessments Biomonitoring Training and education programs

TB drug-induce liver injury study in 1,000 patients launched in partnership with SCDC, The Hamner, and the University of North Carolina at Chapel Hill

17The Hamner Institutes at Research Triangle Park

Partnership with the Oslo Cancer Cluster与奥斯陆癌症中心

• MOU strengthens European Arm of the Global Biosciences Gateway

• Accelerate development of new cancer therapeutics by biotech companies and comprehensive cancer centers

• Support translational research, business development ， education and training

• Facilitate entry to USA, European and China markets

18The Hamner Institutes at Research Triangle Park

Global Bioscience Network全球生物科技网络

The Hamner +

NC Partners

The Hamner +

NC Partners

AcademiaAcademia

Gov’tagencies

Gov’tagencies

Non-profitsNon-profits IndustryIndustrySCDC + China

Partners

SCDC + China

Partners

AcademiaAcademia

Gov’tagencies

Gov’tagencies

Non-profitsNon-profits IndustryIndustry

Oslo Cancer

Cluster + Partners

Oslo Cancer

Cluster + Partners

AcademiaAcademia

Gov’tagencies

Gov’tagencies

Non-profitsNon-profits IndustryIndustry

19The Hamner Institutes at Research Triangle Park

Thank you for your attention ！非常感谢！