Guest Speakers – Day Two

Professor Taixiang Wu

(Professor, Administrator, CEO, Head of ChiCTR/中国临床试验注册心)

Taixiang_Wu

A/Professor Taixiang Wu, is the Administrator of the Chinese Clinical Trial Registry, one of the Primary Registry of WHO ICTRP. He initiated and is activating on the clinical trial transparency, established the Chinese Clinical Trial Registry, Chinese Ethics Committee of Registering Clinical Trials, Chinese Clinical Trial Registration and Publication Collaboration, Publication Ethics Committee of Chinese Medical Journals, he is a pioneer and practitioner of initiative the theory of clinical trial transparency, organizations and service system in China.

吴泰相,中国临床试验注册中心主管,缔造了中国临床试验注册中心、中国注册临床试验伦理审查委员会、中国临床试验注册与发表协作网、推动建立中国医学期刊编辑与发表伦理委员会,是形成我国临床试验透明化理论、组织和服务完整体系的开拓和践行者。

 

Maria Ming-Po LAI

(Nursing Officer/Executive Officer of CCRB, CUHK/ Administrator of WHO Clinical Trials Partner Registry)

IMG_Lai

Executive Officer/ Nursing Officer, Centre for Clinical Research and Biostatistics, Division of Biostatistics, Faculty of Medicine, The Chinese University of Hong Kong.

Ms. Lai obtained her Bachelor of Nursing Degree from University of Manitoba (Canada) in 1994 and her Master Degree in Public Health from the Chinese University of Hong Kong in 2004. In 2001, she completed training in “Protocol Development and Cancer Epidemiology” at the McGill University (Canada). Ms. Lai is a Certified Clinical Research Professional of the Society of Clinical Research Association (SoCRA) in US 2004. She received training on “Practical GCP compliance auditing of trials and system” from DIA in UK. In April 2008, she was accredited as the approved trainer of Association of Clinical Research Professionals (ACRP) in US, and also served as the By-law Chair of ACRP Asia-Pacific Region Chapter 2012-14. Ms. Lai also is the primary administrator of the WHO Clinical Trials Partner Registry taking on the lead to meet international standard for clinical trials registry in Hong Kong.

Ms. Lai has over 20 years of clinical research experiences. She was the Head Study Nurse in the Department of Clinical Oncology of CUHK. She coordinated and managed research activities within the Department with a multi-disciplinary team, and has experience in managing multi-centre trials. Ms. Lai later extended her works to research areas other than Clinical Oncology, especially focus in the implementation of quality control and quality assurance process. In 2005, she worked with 10 disciplines at the Prince of Wales Hospital and the Department of Health of Hong Kong, for the preparation of SFDA (now CFDA) inspection and obtained the accreditation in 2006. Later she also successfully completed 2009 and 2012 re-inspections and obtained accreditations. Ms. Lai has the opportunity to build and establish the CUHK Phase I Clinical Trials Centre in 2013. Since 2014, she continues to extend her interest in the field of medical devices and computer assisted device (CAD) development.

Ms Lai also has experience in research nurses/clinical research coordinators training and investigators training conducted in Hong Kong SAR, Guangzhou and Shanghai (Mainland China), Taiwan, Singapore, Korea and Australia (Sydney). She has strong interests in establishing Clinical Research Professionals and GCP trainings for clinical staff in research centers of different countries and interested in innovative health care technology development.

黎明宝
香港中文大学医学院生物统计学部临床研究及生物统计中心执行官及护士长
黎女士于1994年在加拿大Manitoba大学获护理学学士,2004年在香港中文大学获公共卫生硕士学位。2001年,她于加拿大McGill大学接 受“Protocol Development and Cancer Epidemiology”项目培训。她在2004年获得美国临床研究协会(SoCRA)认证临床研究专业资格。2008年,她接受药物信息协会在英国举 办的“Practical GCP compliance auditing of trials and system”项目培训。同年4月,她被认证为美国临床研究协会核准培训师,之后于2012-2014 担任该协会亚太区章程起草委员会主席。黎女士同时也是世界卫生组织临床试验合作注册(Partner Registry)主要行政主管。
黎女士从事临床研究超过20年,曾担任香港中文学肿瘤学系研究护理主任。期间她以协调员及项目经理身份参与了多项该部门组织的跨学科临床研究项目和多中心 试验项目。之后黎女士转为从事临床研究特别是质量控制和质量认证方面的研究。2005年,她与香港威尔斯亲王医院的10个学科以及香港卫生署一起合作顺利 通过国家食品药品监督管理总局的审查,并于2006年获得认证,之后于2009年及2012再次成功通过审查并获得认证。黎女士在2013年参与了香港中 文大学一期临床试验中心的筹建。从2014年开始,她开始从事医疗器械和计算机辅助设备(CAD)的研发。
黎女士在护理研究及临床研究领域有丰富的面向协调员和项目主持人的培训经验,成功组织了多次在香港,广州,上海,台湾,新加坡,韩国及悉尼的培训项目。她 非常关注在不同国家的研究中心,培训临床试验专业人员及对临床工作人员进行GCP训练,同时对健康护理技术方面的研发也有浓厚兴趣。

Dr. Marc Chong

(Research Assistant Professor , CUHK/香港中文大学)

MARC

Dr. Chong received his MSc in Statistics and PhD in Public Health from the Chinese University of Hong Kong (CUHK) in 2006 and 2011 respectively. He is a biostatistician and SAS programmer in Centre for Clinical Research and Biostatistics (CCRB, former Centre for Clinical Trials) since 2006. He is involved in various study design, data management, and statistical analysis for academic and industrial clinical trials of different phases. Dr. Chong is also a postdoctoral fellow in the JC School of Public Health and Primary Care, CUHK. His main research interest is system dynamic modelling in infectious diseases transmission (e.g. influenza and measles) and healthcare system (e.g. elderly care, accident and emergency services).

庄家俊

香港中文大学公共卫生及基层医疗学院研究助理教授

庄博士于2006年在香港中文大学获统计学硕士学位,随后于2011年获公共卫生博士学位。自2006,他一直在香港中文大学临床研究和生物统计中心(CCRB, 前身为临床试验中心 CCT)从事生物统计和SAS编程工作,参与了多项学术及业界的临床试验项目,所作工作涵盖试验设计,数据管理,统计分析等。庄博士曾于2014-2015担任香港中文大学的博士后研究员。他的研究兴趣为传染性疾病传播的动态系统模型(例如,流感和麻疹)以及卫生保健系统(例如, 老年医疗保健,急症服务)

 

Dr. Lai Xin

(Assistant Lecturer, CUHK/香港中文大学)

XinLai

Dr Lai received his PhD degree in Statistics from University of Science and Technology of China. Meanwhile, he also received a joint-PhD degree from City University of Hong Kong. Currently, he is an Instructor of the School of Public Health and Primary Care under Division of Biostatistics, responsible for teaching, tutorial and research which are related to statistical methods in clinical trials and public health. Prior to joining CUHK, Dr Lai was a Research Associate in City University of Hong Kong from 2007 to 2009.

His research interests are primarily in the areas of the statistical methods for clinical trial data, including long-term survivor models in multi-centre clinical studies and applications of generalised linear mixed models. Since 2010, he has been the investigator of serval research projects conducted in both mainland China and Hong Kong, focusing on clinical trial design, statistical monitoring of surgical outcomes. Dr Lai is currently working with industry to design and carry out clinical trials that satisfy both academic and industry interests.

赖欣博士毕业于中国科学技术大学和香港城市大学(联合博士项目),现 工作于香港中文大学公共卫生学院生物统计学部。他主要负责与临床实验和公共卫生相关的统计教学,咨询和科研。他的研究兴趣为临床实验数据的统计建模,包括 带治愈项的长期生存模型,广义线性混合模型。自2010以来,他已经主持或参与了多项在香港和内地的国家和政府研究项目,主要集中在临床实验设计和手术数 据的统计监控等方面。

 

Dr. Jack Lee

(Co-founder of Health View Bioanalytics Limited, HK/康讯生物分析有限公司)

JACK

Dr. Jack Lee, a co-founder of Health View Bioanalytics Limited in Hong Kong and the chief researcher for the medical device development related projects. He worked in Chinese University of Hong Kong as a biostatistician/bioinformatics scientist since 2004 till now. His main research area at the early stage was the methodology developing in Bioinformatics and then focusing on methods development in Biostatistics related to image processing for retinal images associated to diseases such as Diabetic and etc. He has a long-term experience as a Statistical Consultant, Teaching staff and Researcher during the studying periods in Canada. At the same time he has supervised or consulted for more than hundreds of projects or papers in CUHK since 2004. With other core member Professor Benny Zee have accomplished a number of patent applications, and developed a fully automated retinal image analysis system as well.

李作为博士,香港康讯生物分析有限公司联合创始人之一,医学软件项目研发首席研究员, 生物信息学和生物医学图像分析学的研究专家。留学美加多年,积累了丰富的统计咨询经验。研究领域包括开发生物信息学的计算方法及利用生物统计学方法检测与 图像分析相关的疾病等。大学工作至今, 合作或独立完成超过上百个研究项目,并与团队核心成员徐仲锳教授等合作完成了多项专利的申请,及研发了全自动视网膜图像分析系统。

 

Prof. Benny Zee

(Professor, Head of Division of Biostatistics, CUHK/香港中文大学)

ZEE

Prof. Benny Zee is Assistant Dean of Research for the Faculty of Medicine and also Professor and Director of the Centre for Clinical Research and Biostatistics and Head of the Division of Biostatistics in the JC School of Public Health and Primary Care, Chinese University of Hong Kong (CUHK). He holds honorary appointments in the Department of Clinical Oncology and the Department of Statistics of CUHK. He is also the Chairman of the Joint CUHK-NTEC Clinical Research Ethics Committee since 2006.

Professor Zee has strong interest in various aspects of multi-center clinical trials, including statistical methods, data management, drug and medical device development. On the methodological side, he is active in Biostatistics research, especially in the area of clinical trials design, bioinformatics, quality of life, data & safety monitoring and other statistical issues. He has experience in the development of efficient data management procedure using advanced computer technology, plus ample experience in working with industry to design and to carry out clinical trials that satisfy both academic interest and industry objectives. He has tremendous experience in the development of hospital infrastructure such as Ethics Committee, GCP Centre and quality assurance team to carry out clinical research in hospitals that satisfies regulatory and international requirements. He is also active in medical devices development such as “automatic retinal imaging analysis system (ARIAS)” and serves in the Centre for Entrepreneurship of CUHK. He had published more than 172 international peer reviewed journal articles and serves in various committees including advisory committees for drug development and data & safety monitoring committees for international drug trials.

徐仲锳教授是香港中文大学医学院助理院长(研究)也是公共卫生学院生物统计学教授/临床研究及生物统计中心的中心主任及香港中文大学临床肿瘤学和统计系的名誉委任教授。自2006 年以来,他也是香港中文大学及医管局新界东联网临床研究伦理委员会主席。
徐教授对多中心临床试验拥有浓厚的兴趣,其中包括统计方法,数据管理以及新药及医疗器材的研发。在科研上他的专长在生物统计,特别是在临床试验设计学,生 物信息学,生活质量问题,数据和安全监测和其他统计的问题积极研究。他在高效率的数据管理程序方面发展,善于采用先进的计算器技术与设计,在临床试验设计 上,既能达到学术上的目标也能满足业界的要求。徐教授在建立医院管理结构上,尤其是在伦理委员会,国家药物临床试验管理架构,及质量管理上有丰富经验且能 达至国际水平。他也投入医疗器械的研发,例如「全自动视网膜分析系统」,也参与中文大学创业研究中心的工作。徐教授发表了超过一百六十六篇国际论文,曾参 与商界的药物研发当顾问和统筹数据及安全监测小组。