Co-organized by

全球医生组织(GlobalMD)

中国医学科学院

Chinese Academy of Medical Sciences

美国国立卫生研究院

The National Institutes of Health (NIH)

Clinical Center, the United States

中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛 2010年6月16-18日,北京,中国

主题主题主题主题: 建立中建立中建立中建立中、、、、美临床和转化医学研究合作与交流的桥梁美临床和转化医学研究合作与交流的桥梁美临床和转化医学研究合作与交流的桥梁美临床和转化医学研究合作与交流的桥梁

Focus On

Building a Bridge for Connection and Communication of

Clinical and Translational Research

Sino-American Symposium on

Clinical and Translational Research

June 16-18th, 2010 in Beijing, China

Sino-American Symposium on Clinical and Translational Research In China Co-organized by

Chinese Academy of Medical Sciences (CAMS)

GlobalMD organization (GlobalMD)

The United States National Institutes of Health (NIH) Clinical Center

Focus: Building a Bridge for Connection and Communication of Clinical Research

The Sino-American Symposium on Clinical and Translational Research (SAS-CTR) has been organized to bring together clinicians, researchers and health care officials, from hospitals, academia and governmental agencies. It is intended for those involved with human subjects clinical research, multi-national clinical trials and translational “bench to bedside” implementation

of research to improve health care delivery and the application of ethical regulations for quality research and health care.

Some of the most important themes relevant to the bilateral collaborations to the U.S. and China which may be discussed in this Symposium are:

• Perspectives and New Directions in Global Health Research,

• Infectious Diseases/Emerging infectious,

• Bioethics of Drug Trials and Human Subjects Research Protections,

• Gene Therapy and Genomics—Genetic and Cell-Based Technologies to Treat Disease,

• Cardiovascular Diseases– Early Diagnosis and Prevention of Heart Diseases

• Drug Trials and Drug Development Strategies,

• How the Study of Rare Diseases Leads to a Better Understanding of More Common Medical Problems,

• Clinical and Translational Research in Oncology,

• Stem Cell Therapeutic Studies and Guides for Clinical Trials

Purpose:

To foster China—U.S. collaboration in clinical and translational research, education / training, innovation, scientific discovery,

and global health care improvement.

Target Audience:

Physicians, clinical and biomedical researchers; health care practitioners, and medical association delegates.

Outcomes:

In addition to sharing new information regarding the updated clinical and translational research development in identified

specialty areas, after attending this Symposium, the participants should be able to:

• Have a better understanding of current status of clinical and translational research from a global, institutional and

professional perspective,

• Demonstrate knowledge of resources available to support quality clinical research in his/her professional areas of interest

• Identify feasible elements for clinical research collaboration and communication between the U.S. and China,

• Discuss research methodology and approaches appropriate for different diseases entities,

• Identify relevant international rules and bioethical concerns in clinical research and drug trials.

Sino-America Clinical and Translational Research Committee

________________________________ _______________________________

Co-Chair: Dr. Liu, Depei, MD, PhD. Co-Chair: Dr. John I. Gallin, MD

President of Chinese Academy of Med. Sciences Director of the NIH Clinical Center

Program Coordinators

Dr. Zhan, Qiming, MD, PhD., Vice President of Chinese Academy of Medical Sciences (CAMS)

Dr. Tim Shi, MD, PhD., Executive Director of GlobalMD Organization (GlobalMD)

Dr. Frederick P. Ognibene, M.D. Deputy Director, Educational Affairs and Strategic Partnerships, NIH Clinical Center

Contact information: Sino-American Symposium on Clinical and Translational Research in China GlobalMD China office: No. 65 Fuxin road, 10th Floor, Suite 1020-22, Haidian District, Beijing, Postcode: 100036, China

Office at the Chinese Academy of Med. Sci.: No. 9 Dong dian san tiao, Eastern District, Beijing, Postcode: 100730, China

The GlobalMD Head Office: 5632 Baltimore National Pike, Suite 202, Catonsville, Maryland 21028, U.S.A.

E-mail: admin@GlobalMD.org tim@GlobalMD.org Web site: www.ChinaCTS.org

June 16th: Setting the vision: Global, Sino-American and Institutional

8:00 – 9:00 Opening Ceremony

by Co-Chairmen, Dr. Liu, depei, President of CAMS and Dr. John I. Gallin, Director of NIH Clinical Center

Welcome Speech by Dr. Chen Zhu, the Minister of Health, China

9:00 – 10:00 Keynote Speeches: Trends in Globalization of Clinical and Translational Research – Current Status on Drug Development in China By Dr. Sang, Guowei, Vice President of the Chinese National Congress, the member of CAE.

Perspectives and New Directions in the NIH Global Health Research By Dr. Francis Collins, MD, PhD, Director of the National Institutes of Health (NIH), the U.S..

10:00 – 11:00 Translational Research Opportunities: From Basic, Curiosity-Driven Research to the Discovery of Practical Applications – Telomerase Research for Cancer and Aging by 2009 Nobel Medicine Laureate Carol Greider, The Johns Hopkins Univ. (invited)

11:15 – 12:00 Emerging Infections—the NIH NIAID Strategy and Global Clinical Research Case Study. By Dr. Anthony Fauci, Director of the NIAID, NIH, the member of American Society of Sciences.

From SARS to H1N1 Flu Global Pandemic — Respiratory Infectious Diseases and Prevention Strategy in China By Dr. Zhong, nanshan, Chairman of Chinese Society of Medicine, member of CAE

12:00 – 13:00 Lunch Break & Panel Discussion: Focus on Practical Strategy of Collaboration and Diseases Needed to be Working Together

13:00 – 16:00 Symposia: Concurrent Clinical Research Specialty

• Clinical and Translational Research on Cancer Therapeutic solutions (Moderator Dr. Zeng, yixin, Professor and the members of CAE, Cancer Research Institute, the CAMS )

• Drug Development and Clinical Trial (first time in human subjects) Safety Issue Monitoring (Moderator Dr. Wei, ruquan, Professor and the member of CAE, Sichuan Univ. West China Hospital)

• Clinical Research for Infectious and Transmitted Diseases (Moderator Dr. Chen, zhinan, Professor and the member of CAE, The 4th Military Medical University)

• Stem Cell Translational Research: Highlight the Scientific, Clinical, Regulatory, Ethical and Social Issues. (Moderator Dr. Fu, xiaobing, Professor and the member of CAE, The PLA General Hospital)

• Translational Research for Cardio-Vascular Diseases; Drug Pharmacogenetics and Imaging Trials (Moderator Dr. Hu, Dayi, Director for Cardio-vascular diseases Research Institute, People’s Hospital)

• Clinical Research for Endocrine-Metabolism and Auto-Immune Diseases—Diabetics Research (Moderator Dr. Guan, youfei, Deputy Dean of Basic Medical Research Institute, Peking Univ. Med. Center)

• Respiratory System and Environmental Related Health Care Issues (Moderator Dr. Zhong, nan shan, Professor and the member of CAE, Chairman of Chinese Medical Society)

16:00 – 17:00 Round Table Meeting: Infectious Disease/Emerging Infections and Vaccine development

17:00 – 18:00 Poster Session:

18:30 – 20:00 Welcome Bouquet: Special Lecture: Break-Through of Stem Cells Clinical Translational Research and Applications Dr. Curt Civin, Director for the Univ. of Maryland for Stem Cell Biology and Regenerative Medicine (Invited)

June 17th: Converting the vision into reality: Plans, Opportunities and Tools

8:30– 9:30 Advantages of Sino-American Collaboration, Communication and Opportunities: the Contribution from China By Dr Liu, Depei, Professor and President of Chinese Academy of Medical Sciences, the member of CAE

How to study the Rare Diseases Leads to a Better Understanding of More Common Medical Problems—

The NIH Clinical Research Enterprise

by Dr. John I. Gallin, M.D., Director of the NIH Clinical Center.

9:30- 10:15 Opportunity for building up the Clinical Research-Oriented Hospitals and Institutions to face the challenges of

medical and translational research development, globally– case study in China

By Dr. Dai, Kerong, M.D., Professor and the member of CAE

Epidemiology of Enteric Disease—Vaccine Trial By Dr. Roger Glass, Director of the NIH Fogarty International Center

10:15 – 11:15 Drug development and Evaluation under the regulations of China SFDA and the U.S. FDA, respectively.

By Dr Shao, mingli, Deputy Minister of Health and Director for the Chinese SFDA,

By Dr. Margaret Hamburg, MD,PhD. Director of the U.S. FDA Office.

11:15 – 12:00 Accreditation of Clinical Research for Research Institutions for Human Subjects Protection;

Bioethical Issue Related to Multi-National Clinical Trials.

Dr. Marjorie Speers, President of AAHRPP, the U.S.

12:00 – 13:00 Lunch Break/Panel Discussion: Clinical Drug Trials and regulatory policies in the U.S. and China

Preliminary Agenda Sino-American Symposium on Clinical and Translational Research in China

June 18th: Making it Happen: Management and Knowledge for Quality Clinical Research

8:30 - 9:30 Opportunities for Hospitals and Research Institutes: the NIH Common Fund supporting the Clinical and

Translational Research In global clinical research development.

By Dr. Barbara Alving, Director of the NIH’s National Center for Research Resources.

Managing the Reality of Principles of Clinical Research: Methodologies and Scientific Quality Controls and Safety Monitoring (Speaker TBD)

Challenges of Clinical Trials in International Settings Dr. Christine Grady, RN, Ph.D., NIH Clinical Center Department of Bioethics

9:30 – 10:15 2030 Health Care: Medical Practice — Early Diagnosis and Prevention of Heart diseases by Dr. Yang, Yuejin, Professor and Vice President of Fuwai Hospital, the CAMS, PUMC

Epidemiology as a Tool to Study Cardiac Disease

Dan Levy, M.D., Boston Univ. School of Medicine, Director for Framingham Heart Study, National Heart, Lung, & Blood Institute

10:30 – 11:15 Health Education and Communication Network for physicians to assure quality in clinical research practice by Dr. Ke, Yang, Deputy President of Peking Univ. and Medical Center

Physician Communication and Network—benefit for clinical research and practice Dr Harvey Fineburg, MD. Chairman of Institute of Medicine, the U.S.

11:15 – 12:00 Recognition of the Contributions of the Pioneer Contributors in the Development of the Sino-American clinical research initiative: The Special Awards for the Nominees (presented by Vice Minister of Health)

12:00 – 12:30 Closing Remarks: Conclusions & Future Plans By Dr. Zhan, qimin, M,D. Ph.D. Vice President of the Chinese Academy of Medical Sciences.

13:30—16:00 Special Meeting: The first meeting for the Society of Chinese Clinical and Translational Research: Seeking the Collaboration and Action Plan between the U.S. counterpart and the NIH grant support. Around Table Meetings: Focusing groups: The SFDA authorized Clinical Trial Centers, Bio-Industrial Park, Pharma R&D, and CROs On Translational collaboration in the near future to boost the research and to ensure the quality of control.

AFTERNOON SECTION:

June 17th: Converting the vision into reality: Plans, Opportunities and Tools

13:00 – 16:00 Symposia: Concurrent Clinical Research Specialty

• Clinical translational research on Cancer Clinical Trials (Moderator by Dr. Jing, Zhenyu, Professor and Director of Dept. of Radiology, Peking Union Hospital)

• Drug development and clinical trial safety monitoring (Moderator by Dr. Ding, Jian, Director of Shanghai Drug Research Institute, Chinese Academy of Sciences)

• Clinical research for infectious and transmitted diseases (Moderator by Dr. Jin, qi, Chief Scientist and Director for the National Virology Laboratory)

• Stem Cell Translational Research: highlight the scientific, clinical, regulatory, ethical and social issues. (Moderator Dr. Cao, yiling, President of Plastic Surgery Hospital Institute, CAMS, PUMC)

• Translational Research for Brain and Cardio-vascular Diseases (Moderator Dr. Yang, yuejin, Professor and Vice President of Beijing Fuwai Hospital, CAMS, PUMC)

• Clinical Research for Endocrine-metabolism and Auto-immune Diseases (Moderator Dr. Wang, Hongyang, Professor and the member of CAE, the 2nd Military University)

• Respiratory system and environmental related health care issues (Moderator TBD)

16:00 – 17:00 Round Table Meeting: New Drug Development and Clinical Trials for Cardiovascular Diseases 17:00 – 18:00 Poster session

18:30 – 20:00: Special Dinner Lecture: BioBank—In Personalized Cancer Therapy

by Dr. Anna Barker, M.D. Deputy Director of the NCI, NIH

Preliminary Agenda Sino-American Symposium on Clinical and Translational Research in China

Keynote Speakers and Distinguished Leaders from the U.S. NIH and Health Agencies At the Sino-American Symposium in June 16-18th, Beijing, China

NIH Senior Directors:

Dr. Francis Collins, M.D., Ph.D.,

Director

The U.S. National Institutes of Health(NIH)

Dr. Anthony S. Fauci, M.D.,

Director for the NIAID, NIH

Dr. Roger Glass, M.D., Ph.D.,

Director for the NIH Fogarty Int’l Center

Dr. John I. Gallin, M.D.,

Director for the NIH Clinical Center

Co-Chair for the Sino-America Symposium

On Clinical and Translational Research

Dr. Anna Barker, M.D.,

Deputy Director for

The National Cancer Center , NIH

Dr. Barbara Alving, M.D.,

Director for the National Cancer of

Research Resources, NIH

Dr. Christine Grady, RN, Ph.D.,

Deputy and Acting Director

Dept. of Bioethics at the NIH Clinical Center

Dr. Jerry Menikoff, M.D., J.D.,

Director, Office for Human Research

Protections, Office of Public Health and Science, OS, DHHS

Department of Human Health Service (DHHS):

The U.S. FDA:

Dr. Margaret Hamburg, M.D.,

Director and Commissioner for

the U.S. Food and Drug Administration

Dr. Harvey Fineburg, M.D.,

President for the Institute of Medicine, USA

Dr. Robert Califf, M.D.,

Associate Dean for the Duke University

Chairman for the Clinical and Translational

Research Center, Duke University.

Dr. Dan Levy, M.D.

Director for Framingham Heart Study,

National Heart, Lung, and Blood Institute

Dr. Marjorie Speers, PhD.

President of AAHRPP,

Former Associate Director of CDC

The U.S. National Institutes of Health

中美临床和转化医学研究高峰论坛 中美临床和转化医学研究高峰论坛 中美临床和转化医学研究高峰论坛 中美临床和转化医学研究高峰论坛 2010年6月16-18日, 北京

中国医学科学院特邀专家学者中国医学科学院特邀专家学者中国医学科学院特邀专家学者中国医学科学院特邀专家学者((((部分名单部分名单部分名单部分名单))))

魏于全教授

科学院院士,华西医学院

四川大学副校长 胡大一教授

北京大学人民医院

心血管疾病研究所所长

金征宇教授,主任医师

北京协和医院放射科

曹谊林教授

中国医科院附属

整形医院院长

程涛教授

医学科学院血液学研究所

血液病医院常务副所院长

丁键研究员 中国科学院 上海药物研究所所长

蒋建东教授

中国医学科学院

医药生物技术研究所所长

陈士林教授

中国医学科学院

药用植物研究所所长

杨跃进教授

中国医学科学院

附属阜外医院副院长

刘德培教授 中国医学科学院院长 中国工程院院士 中美临床和转化医学 高峰论坛中方主席

桑国卫教授

中国医药研发总框架师

中国工程院院士

戴尅戎教授

上海第九人民医院

中国工程院院士

邵明立卫生部副部长

兼中国SFDA局长

刘谦卫生部副部长

主管科技司,科技发展规化

钟南山教授 广州医学院呼吸 疾病研究所所长 中国工程院院士

陈智南教授

第四军医大学

中国工程院院士

杨宝峰教授

中国工程院院士

哈尔滨医科大学校长

曾益新教授

中山大学肿瘤防治中心

所长,中国科学院院士

付小兵教授

中国工程院院士,

解放军总医院

生命学院院长 程书均教授

中国工程院院士

医学科学院

肿瘤研究所

金奇教授,主任

病毒基因工程国家重点实验室

管又飞教授,主任

北京大学医学部

基础医学院副院长

柯阳教授

北京大学常务副校长

北京大学医学部副主任

王红阳教授

中国工程院院士

第二军医大学附属

东方肝胆外科研究所

Dr. Sang, guowei, M.D. Chief for China National Drug Development Strategy Plan

The member of CAE

Dr. Shao, mingli, M.D. Deputy Minister of MOH, and Commissioner of China SFDA

Dr. Liu, Qian, M.D. Deputy Minister of MOH, in charge of Med Science and technology development

Prof. Yang, baofeng, M.D. President of Haerbing Medical Univ. the member of CAE

Dr. Zeng, xingyi, M.D. Cancer Research Center, Zhongzhan University

The Member of CAE

Prof. Fu, xiaobing, M.D. PLA General Hospital, Life Sciences Institute, the member of CAE

Dr. Wei, yuquan, M.D. Vice Dean of Sichuan Univ. the member of CAS

Prof. Ke, Yang, M.D. Vice President of Peking Univ. Deputy Director of Med. Center

Peking Univ.

Dr. Chen, shiling, PhD. Director of Drug & Plant Institute, Academy of Sciences

Prof. Yang, yuejin, M.D. Vice President of Fuwai Cardiovascular Hospital, CAMS

Dr. Cheng, tao, M.D. V.P. of Hematology Institute & Hospital, CAMS

Dr.Jiang, Jiandong, PhD.

Drug and Bio-products Institute, CAMS

Dr. Liu,Depei, MD,PhD President of CAMS Vice President of CAE Co-Chair for Sino-American Symposium on CTR

Dr. Dai, Kerong,M.D. Shanghai No. 9 Hospital,

The member of CAE

Dr. Chen, zhinan, M.D. The 4th Military Medical University, The member of CAE

Dr. Zhong, Nanshan, M.D. Director for the Institute of Respiratory Disease, Ghuang Zhou Med. College the member of CAE

Dr. Wang Hongyang, MD The 2nd Military Medical University, the member of CAE

Dr. Cheng, Shujin, MD

Cancer Institute, CAMS the member of CAE

Dr. Hu, Dayi, M.D. Director of Heart Disease Res. Institute, the People’s hospital

Dr. Jin, zhengyu, MD

Chief of Dept. of Radiology, PUMC, CAMS

Dr. Cao,yinling, M.D.

President of Plastic Surgery Hospital, CAMS

Dr. Ding, Jian, PhD. Director of Drug Res. Institute, China Academy of Sciences

Dr. Guan, youfei, MD, PhD

Deputy President of Basic

Med. Research Institute,

Peking Univ. Med. Center

Dr. Jin, Qi, PhD. Chief for the National Lab. of Virology

“中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛”简介简介简介简介 联合主办单位联合主办单位联合主办单位联合主办单位::::中国医学科学院中国医学科学院中国医学科学院中国医学科学院((((CAMS), , , , 美国国立卫生研究院美国国立卫生研究院美国国立卫生研究院美国国立卫生研究院((((NIH)临床研究中心临床研究中心临床研究中心临床研究中心, , , , 全球医生组织全球医生组织全球医生组织全球医生组织((((GlobalMD))))

引言引言引言引言:

“中美临床和转化医学研究高峰论坛”作为中美医学科研和临床实践合作的新平台。把临床医生, 基础和临床科研人员,

以及医药卫生专家学者所共同关心的医学研究及成果转化的国际合作提到日程上来, 并基于此平台开展广泛而有成效的

交流。转化医学研究的核心是加快研究成果转化成为更有益的临床诊治实践, 以及全面地认知疾病对人类健康的影响。

临床和转化医学研究也关系到人类社会整体的稳定与和谐发展, 贯注到医院的人体临床科研, 新药研发和方向, 更涉及

到从实验室的成果转化成为患者病床前的临床诊治应用全部过程。临床转化医学研究是我们所共同关心的提高健康和

医疗质量的前提和保障。科学地研究并积极地开展临床实践应用是真正提高医学科学水平的源泉。

目的目的目的目的: 促进中、美医学在临床和转化医学研究, 药物研发创新与临床应用的深入和广泛性交流合作。

“论坛论坛论坛论坛”重点探讨问题重点探讨问题重点探讨问题重点探讨问题:

• 全球健康和临床研究未来展望和新方向 - 转化医学研究;

• 感染传染性疾病以及突发传染性疾病问题和临床研究;

• 临床药物研究的规范和准则, 以及受试者保护的伦理观念和科学管理;

• 基因学和基因突变性疾病 - 基因工程,细胞学技术转化治疗疾病的进展;

• 心脑血管疾病的早期诊断和预防以及心脏疾病的临床治疗进展;

• 解析药物审评机构的政策与法规, 新药研发方向和人体临床试验和科学管理;

• 从罕见或疑难疾病研究领悟常见性疾病临床研究如神经系统、内分泌代谢、以及呼吸系统等疾病临床科研等,

• 肿瘤的临床和转化医学研究;

• 干细胞临床治疗方法和临床试验的指南及规范.

邀请参加者邀请参加者邀请参加者邀请参加者:

临床医生, 基础和临床科研人员, 临床药物研究和科研管理人员, 各个临床专科专家和医药研发技术及管理人员等;

以及曾参加过美国国立卫生研究院(NIH)临床培训班的学员或曾在NIH及附属机构学习、进修过的专家学者等。

获益获益获益获益:

除获得相关专业领域最新临床和转化科研信息, 最前沿的医药研究课题发展状况之外, 参加论坛本身对您的专业知识,

科研理念和管理, 直接与NIH开展国际项目研究合作都将会有获益, 包括如下:

• 了解和把握国际和国内临床和转化医学研究的现状和发展趋势,

• 了解相关领域的临床科研合作资源和把握NIH转化研究基金支持的机会,

• 关注和拓展中、美医学科学家和临床医生之间可行性的临床科研合作,

• 探讨和交流包括从罕见或疑难疾病到慢性疾病的临床研究和进展等, 包括肿瘤, 心脑血管疾病和干细胞技术等等,

• 了解和关注国际新药转化研究领域的最前沿技术和应用,

• 借鉴国际公认的临床研究规范和准则, 在共同遵循的医学伦理原则下, 开展临床人体和临床药物实验和研发。

中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛

_________________________________ _________________________________

刘德培教授, MD. Dr. John I. Gallin, MD.

中美论坛共同主席 (Co-Chair) 中美论坛共同主席 (Co-Chair)

中国医学科学院院长,中国工程院院士 美国NIH临床研究中心院长,美国国家医学院院士

论坛筹备委员会负责人 论坛筹备委员会负责人 论坛筹备委员会负责人 论坛筹备委员会负责人

詹启敏教授, MD, PhD. 时占祥博士(Tim Shi), MD, PhD.

中国医学科学院副院长 全球医生组织-NIH中国项目负责人

Dr. Frederick P. Ognibene, M.D. NIH临床研究中心副院长,主管教育与国际战略合作

拓展中美临床和转化医学交流合作的新篇章拓展中美临床和转化医学交流合作的新篇章拓展中美临床和转化医学交流合作的新篇章拓展中美临床和转化医学交流合作的新篇章

中国医学科学院,国际合作处联系人:孙集宽主任, 东城区东单三条9号, 邮编100730

全球医生组织,中国办事处联系人:Tim Shi, 海淀区复兴路65号,10层1020号,邮编100036

电子信箱: tim@GlobalMD.org 和 dakuansun@yahoo.com.cn

官方网站:www.Chinacts.org 或 www.ChinaGlobalMD.cn

2010年年年年6月月月月16日日日日:Setting the vision: Global, Sino-American and Institutional

8:00 – 9:00 开幕式开幕式开幕式开幕式::::大会共同主席致欢迎词, 卫生部领导致开幕词.

9:00 – 10:00 主题演讲主题演讲主题演讲主题演讲::::临床和转化医学研究全球化发展趋势 – 中美临床研究合作现状和发展;NIH全球医学研究合作模式

特邀嘉宾特邀嘉宾特邀嘉宾特邀嘉宾::::桑国卫副委员长,中国工程院院士(特邀); Dr. Francis Collins, 美国国立卫生研究院(NIH)院长

10:00 – 11:00 2009年医学诺贝尔医学奖专题报告: 从基础研究到临床转化应用: 基础科研, 兴趣引导医学实际应用的发现 –

端粒, 端粒酶与癌症和衰老发生机制的关系-2009年诺贝尔医学奖获得者Dr. Carol Greider,美国霍普金斯医学院

11:15 – 12:00 全球所关注的问题—感染传染病疾病的变迁和临床研究 – Dr. Anthony S. Fauci, 美国科学院院士,NIH NIAID所长

从SARS到H1N1全球流感–呼吸系统感染传染性疾病的预防 – 钟南山院士,中华医学会会长

12:00 – 13:00 午餐会/休息

13:00 – 16:00 专题论坛专题论坛专题论坛专题论坛((((Panel Discussion)))): 临床和转化医学研究学科专题研讨会临床和转化医学研究学科专题研讨会临床和转化医学研究学科专题研讨会临床和转化医学研究学科专题研讨会

肿瘤临床和转化医学研究进展及热点问题 (曾益新教授,工程院院士主持)

药物研发和临床转化科技的应用;人体临床药物试验的安全性与科学管理 (魏于全教授,中科院院士主持)

感染性和传染性疾病的临床研究及转化研究的热点问题 (陈智南教授,工程院院士主持)

干细胞临床转化研究的科学规范及临床应用准则,基础医学研究和临床应用领域 (付小兵教授,工程院院士主持)

脑,心血管疾病的临床研究和转化医学应用,包括心血管新药,药物基因和微创影像学技术 (胡大一教授主持)

临床代谢和内分泌系统疾病, 以及免疫性疾病的临床研究 (管又飞教授,副院长主持)

呼吸系统疾病, 及与环境相关因素疾病的临床研究和公共卫生课题(钟南山院士主持)

16:00 – 17:00 专家圆桌会议专家圆桌会议专家圆桌会议专家圆桌会议::::肿瘤临床研究和新药试验专题讨论

17:00 – 18:00 Poster Section: 论文专题和研究交流

18:30 – 20:00: 欢迎晚宴欢迎晚宴欢迎晚宴欢迎晚宴: : : :

特邀演讲特邀演讲特邀演讲特邀演讲: 干细胞分离技术的突破和其临床应用的前瞻性探讨 —Dr Curt Civin, 马里兰大学干细胞研究中心主任

2010年年年年6月月月月17日日日日: Converting the vision into reality: plans, opportunities and tools

8:30 – 9:30 中、美临床医学研究合作的各自优势:临床科研合作的机遇

如何研究罕见或疑难疾病 –更好地理解和解决普遍的临床医学问题—NIH临床研究模式

特邀嘉宾特邀嘉宾特邀嘉宾特邀嘉宾::::刘德培教授,中国医学科学院院长,工程院院士;Dr John I. Gallin, Director, NIH Clinical Center

9:30 – 10:15 发展临床研究型医院和临床转化研究中心机构对接国际临床转化医学研究飞速发展

国际临床研究的规范和标准建立的挑战和困难 - 疫苗研制的临床试验

特邀嘉宾特邀嘉宾特邀嘉宾特邀嘉宾::::戴尅戎教授,上海第九人民医院,工程院院士,Dr Roger Glass, Director for the NIH Fogarty Int’l Center

10:15 – 11:15 药物研发和临床人体试验:对比和诠释中国SFDA和美国FDA关于药品临床试验的管理和市场准入规范

特邀嘉宾特邀嘉宾特邀嘉宾特邀嘉宾::::邵明立副部长兼中国SFDA局长和 Dr. Margaret Hamburg, MD, 美国FDA局长

11:15 – 11:45 心血管疾病的大型临床试验研究成果-早期诊断和预防心血管疾病的手段—Dr. Robert Califf, MD, 杜克大学副校长

心血管疾病的防治和基础转化研究进展–杨宝峰教授, 工程院院长,哈尔滨医科大学校长

11:45 – 12:30 临床试验机构的国际认证: 评估临床研究过程中对受试者的保护及合法权益。国际多中心临床合作中所涉及

医学伦理及相关文化国情背景的研究.Dr. Jerry Menikoff, 美国DHHS医学伦理IRB监察委员会主席和

Dr Marjorie Speers, PhD. 国际人类临床研究认证委员会主席, 前任美国CDC副主任

12:30 – 13:30 午餐会/休息

13:30 – 16:00 专题论坛专题论坛专题论坛专题论坛: 临床转化医学研究 临床转化医学研究 临床转化医学研究 临床转化医学研究 ———— 学科专题研讨学科专题研讨学科专题研讨学科专题研讨

肿瘤临床转化医学研究和个体化治疗 (程书均教授,工程院院士和程涛教授主持)

药物研发和临床转化科技的应用,及临床药物试验的设计和数据管理(陈士林教授主持)

感染性和传染性疾病的临床研究及目前的热点(金奇教授和蒋建东教授主持)

干细胞临床和转化研究热点和应用发展(曹谊林教授,中国医科院整形医院院长主持)

脑,心血管疾病的临床研究和转化医学应用(杨跃进教授,阜外医院副院长主持)

临床代谢和内分泌系统疾病,以及免疫性疾病的临床研究 (王红阳院士主持)

呼吸系统疾病,及与环境相关的疾病的临床研究和公共卫生课题 (TBD)

中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛————日程安排日程安排日程安排日程安排

16:00 – 17:00 专家圆桌会议专家圆桌会议专家圆桌会议专家圆桌会议::::心血管疾病的临床研究和新药试验专题讨论

17:00 – 18:00 Poster section: 论文专题和研究交流

18:30 – 20:00: 晚宴演讲晚宴演讲晚宴演讲晚宴演讲: 个体基因库(BioBank) 在肿瘤治疗中的应用 — 美国国家癌症研究中心副主任Anna Barker

2010年年年年6月月月月18日日日日: Making it happen: management and knowledge for quality Clinical Research

8:30 – 9:30 NIH临床研究资源整合—临床和转化医学奖奖励基金的支持项目和申请; 美国NIH对于临床试验的科学管理,

Dr. Barbara Alving, M.D., NIH国家医学研究资源中心主任,临床医学和转化研究项目总负责人.

临床药物试验的安全性的监测 —丁键研究员, 上海药物研究所所长

9:30 – 10:15 2030年健康医疗服务: 未来医学实践和诊治—心血管疾病的临床和转化医学进展及方向; 心血管疾病的流行病学

特邀嘉宾特邀嘉宾特邀嘉宾特邀嘉宾:杨跃进教授,中国医学科学院附属阜外心血管医院副院长, Dr. Dan Levy, NIH NHLBI

10:30 – 11:15 继续教育与国际交流:提高临床研究兴趣和诊治服务质量-NIH视频网络交流平台在中国医院的示范

特邀嘉宾特邀嘉宾特邀嘉宾特邀嘉宾:Dr Harvey Fineburg, MD. 美国国家医学院院长, 医学院院士

11:15 – 12:00 GlobalMD特别荣誉奖仪式:推动和发展中美临床研究和交流的拓荒者: by Rep. from the Ministry of Health

12:00 – 12:30 闭幕式闭幕式闭幕式闭幕式: 总结和展望未来的中美临床和转化医学研究的合作前景 总结和展望未来的中美临床和转化医学研究的合作前景 总结和展望未来的中美临床和转化医学研究的合作前景 总结和展望未来的中美临床和转化医学研究的合作前景 - 詹启敏教授,中国医学科学院副院长

13:30 – 15:30 “中国临床和转化医学学会”成立大会(筹委会): 探讨与美国NIH和美国“临床和转化医学”学会的长期交流合作机制

圆桌专题会议圆桌专题会议圆桌专题会议圆桌专题会议: 临床研究多中心合作-SDFA认证的临床试验机构,生命科学园区的R&D, CRO, 企业研发机构等

中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛————活动日程安排活动日程安排活动日程安排活动日程安排

注册报名表 注册报名表 注册报名表 注册报名表 - 中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛中美临床和转化医学研究高峰论坛, 2010年年年年6月月月月16-18日日日日, 北京 北京 北京 北京

Last Name(姓) First Name(名) Degree(学位) Title/Position(职务/职称)

Hospital/Institution (医院/机构)

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Tele(电话): Mobile(手机): E-Mail(电子邮箱): Personal Blog(个人博客):

注册费: 2500元/每人 2000元/每人(NIH培训班学员) 1500元/每人(研究生) (不包括特邀晚宴费用,另议)

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是否提交论文(Submit Abstract / Research): YES是( ), NO没有( ), 还在准备好( )

1. 临床研究领域:_______________________________________________________________________________________________

2. 临床课题资助:( )医院; ( )国家基金; ( )企业资助; ( )国际合作; ( )其他资助

3. 希望申请GlobalMD-NIH Challenge Fund ( ) Yes; ( ) No.

联系方式联系方式联系方式联系方式:中国医学科学院,国际合作处,孙老师,电话:65105938 , 传真:65124876, 电子邮箱:dakuansun@yahoo.com.cn

地址:北京东城区东单三条9号, 邮政编码:100730

全球医生组织中国办事处,周老师, 电话:(010)65058815; 传真:(010)65058852, 电子邮箱:Admin@GlobalMD.org

地址:北京海淀区复兴路65号, 10层20-22, 邮政编码:100730 官方网站:www.ChinaCTS.org