48

2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Academicians/Experts

Vice President of the Chinese Academy of Engineering, President of the

Chinese Academy of Medical Sciences and Peking Union Medical College

Wang Chen

An expert in respiratory medicine and critical care medicine. He is Academician of the

Chinese Academy of Engineering, foreign member of the National Academy of Medicine

of the US and the Academy of Europe, fellow of European Academy of Sciences and

Arts, and divisional committee member of the Chinese Academy of Medical Sciences,

and Director of National Respiratory Clinical Research Center. He holds multiple

important professional posts in the WHO. He is the editor-in-chief of Chinese Medical

Journal and member of the Lancet COVID-19 Commission. He has long been engaged in

clinical, teaching and research work in respiratory and critical care medicine. His main

research areas include respiratory pathology, population medicine and public health.

He has made several important innovations and improved healthcare practices in the

areas of chronic airway diseases, pulmonary embolism, respiratory failure, emerging

respiratory infectious diseases, and smoking control. He has published more than

290 papers in prestigious international journals such as New Engl J Med and Lancet.

He has received the Special Prize, First Prize and Second Prize of the National Science

and Technology Progress Award. He has taken leadership and managerial roles in the

Chinese Academy of Engineering, Chinese Academy of Medical Sciences, Peking Union

Medical College, China-Japan Friendship Hospital, Department of Science and Education

of the Ministry of Health, Beijing Hospital, Chaoyang Hospital and Beijing Institute of

Respiratory Diseases, and has achieved remarkable performance in discipline building

and administration. He has faciliated the creation of the standardized training and \"4+4\"

medical education system for resident and specialist physicians in China.

President of Hainan University, Honorary President of Hainan

Institute of Real World Data

Luo Qingming

Academician of the Chinese Academy of Sciences; Fellow of the Chinese Academy of

Medical Sciences; Chairman of Hainan Association for Science and Technology; and

Director of the Steering Committee of Biomedical Engineering Teaching in Institutions

of Higher Education, Ministry of Education. He has won the second prizes of the

National Natural Science Award (2010) and the National Technology Invention Award

(2014), and the first prize of Huang Jiasi Biomedical Engineering Award (2021), and

was selected for China Top Ten Science and Technology Progresses (2011).

Main Forum

49

Executive President of Hainan Institute of Real World Data

Chen Pingyan

Doctoral Supervisor, Cooperative Postdoctoral Supervisor, and Former Director of the

Department of Biostatistics, Southern Medical University (1997-2019). He is the first in

China to establish the department of biostatistics (2004), and the undergraduate major

in biostatistics (2005). Chen is Executive President of Hainan Institute of Real World

Data; Director of the Biostatistics Branch of Chinese Preventive Medicine Association;

Vice Chairman of the International Biometric Society-Chinese Region; Chairman of

Guangdong Biostatistics Association; and an expert in argumentation of administrative

policies in Guangzhou. Chen published more than 280 papers on SMMR, SIM, NEJM,

JAMA, JCO, JAMA-IN, ERJ, JASN and Radiology, among which 80 papers are published

on SCI journals with a cumulative impact factor over 500. He is Editor-in-chief of the

postgraduate textbook SPSS Statistical Software Application.

President of Ruijin Hospital Affiliated to Shanghai Jiao Tong University

School of Medicine

Ning Guang

Academician of the Chinese Academy of Engineering, tenured professor of Ruijin

Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; President of

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine; Director

of National Clinical Medicine Research Center for Metabolic Diseases; Honorary

Director of the Branch of Physicians in Endocrinology and Metabolism, Chinese Medical

Doctor Association; former director of the Branch of Endocrinology, Chinese Medical

Association; Editor-in-chief of Chinese Journal of Endocrinology and Metabolism; Editor

of Journal of Diabetes. He is also the Changjiang distinguished professor of the Ministry

of Education and chief scientist of the 973 program (National Basic Research Program).

He has long been engaged in the clinical treatment of endocrine and metabolic

diseases, and secured innovative outcomes in the diagnosis, treatment and research of

endocrine tumors and diabetes. He has published 500 papers in SCI-indexed journals

such as Science and JAMA. He has won 4 second prizes of the National Science and

Technology Progress Award, 3 first prizes of the Shanghai Science and Technology

Progress Award, the 2017 Shulan Medical Award, the 2014 Chinese Physician Award,

Wu Jieping Medical Innovation Award, the second Bethune Doctor Award; he also

claimed the Israel Diabetes Alliance Lifetime Achievement Award and International

Endocrinology Award from the American Association of Clinical Endocrinology and the

Yutaka Seino Distinguished Leadership Award.

50

2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Scientific administrator of Data Analytics and Methods Task Force,

European Medicines Agency

Andrej Segec

Pharmacist by training (Comenius University, Bratislava, Slovakia) with an MSc in

Epidemiology (London School of Hygiene and Tropical Medicine, London, UK). He has

worked for the European Medicines Agency (EMA) since 2008, holding a number of roles

in pharmacovigilance, from signal detection and signal management, monitoring of the

performance of the EMA pharmacovigilance system, in surveillance and epidemiology,

as committee manager for the operations of the Pharmacovigilance Risk Assessment

Committee (PRAC) and as a risk management specialist for anti-infective therapies and

vaccines. In the current role, Andrej’s focus is on the generation and use of real world

evidence in regulatory decision making and the establishment of the Data Analysis and

Real World Interrogation Network (DARWIN EU).

Director of the China Office in the FDA’s Office of Global Policy and

Strategy (OGPS)

Vanessa Shaw-Dore

Vanessa Shaw-Dore joined FDA in April 2020 as Director of the China Office. Ms. ShawDore previously served as Deputy Program Director of the Center for Disease Control’s

(CDC) Division of Global Health Protection (DGHP) overseeing CDC’s Global Health

Security Agenda (GHSA) work in Vietnam. Prior to her time in Vietnam, Ms. Shaw-Dore

served in the same office as Deputy Program Director for CDC’s Democratic Republic

of the Congo country office, and Branch Chief in the Health Resources and Services

Administration HIV/ AIDS Bureau, Division of State HIV/AIDS Programs. In that role,

Ms. Shaw-Dore oversaw $490 million in federal funds in support of Ryan White Part B

and AIDS Drug Assistance Program grants for 20 states and U.S. territories, including

Washington D.C. Ms. Shaw-Dore has 15- plus years of operations and management

experience with international public health programs. She has also led the coordination

of high-level interagency programs.

WHO Representative in China

Gauden GALEA

Public health physician, currently working as the WHO Representative in China, based in

Beijing since April 2018. He has been coordinating the collaboration between WHO and

China across all health concerns, with a primary focus on: the COVID-19 response, the

review of a decade of health sector reform, advocacy for tobacco and alcohol control,

and exploring the digital health landscape of China. On behalf of the Western Pacific

Region of WHO, he has been coordinating an effort promoting innovation in public

health within the \"For the Future\" vision of the Region. Dr Galea has worked for WHO

since 1998. Before assuming his current post, he worked in WHO/Europe. He previously

held posts in Suva, Manila, and Geneva as technical officer, regional adviser, and

coordinator respectively in areas related to NCDs and Health Promotion.

Guests from International Organizations and

Foreign Regulatory Institutions

Main Forum

51

Pharmaceuticals and Medical Devices Agency (PMDA)

Hanako MORIKAWA

Principal Reviewer of Office of Medical Devices II, Pharmaceuticals and Medical Devices

Agency (PMDA).

52

2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Expert medical Assessor of the Medicines and Healthcare products

Regulatory Agency, the UK (MHRA)

Daniel O'Connor

His PhD in the field of tumour suppressor genes was awarded from Imperial College

London. He joined the Medicines and Healthcare products Regulatory Agency (MHRA) as

a Medical Assessor in 2006 from a clinical lecturer post at UCL/UCH/Ludwig Institute for

Cancer Research. He works in the licensing division of the MHRA with special interests

in rare diseases, early access and patient reported outcomes and engagement. He is

editor author of the first edition Oxford Specialist Handbook of Pharmaceutical Medicine

and on the editorial board of the journals Expert Opinion on Orphan Drugs and Rare

Disease and Orphan Drugs Journal.

Director of Key Laboratory of Cardiovascular Remodeling-related

Diseases, Ministry of Education, Capital Medical University

Du Jie

Deputy Director of Beijing Institute of Heart, Lung and Blood Vessel Diseases. Chief

Scientist of National Key Research and Development Program, Beijing Scholar. He is

committed to the early diagnosis, risk assessment and precise diagnosis and treatment

of cardiovascular diseases as well as the related commercialization issue. He has

conducted a series of clinical translational research and advanced commercialization of

self-developed clinical diagnostic products.

Distinguished Professor, School of Life Sciences, Beijing University of

Chinese Medicine

Han Dongran

Distinguished Professor of School of Life Sciences, Beijing University of Chinese

Medicine, Deputy Director of Education and Information Center, Academic Leader of Big

Data of Traditional Chinese Medicine in the Basic Professional of Integrated Traditional

Chinese and Western Medicine. Focusing on the top-level design and standardization

construction of the big data ecosystem of traditional Chinese medicine, he led a number

of original work in the direction of big data and informatization in the university, and

was responsible for a number of national key R&D projects, which were cited more than

3,400 times by Google Scholar. 2 invention patents in the United States and 8 domestic

invention patents, all of which are the primary inventors.

Sub-Forums

Hosts/Speakers from Government

Departments and Academia

53

President of Children’s Hospital of Chongqing Medical University

Li Qiu

Professor, doctoral supervisor, director of the National Children's Clinical Medical

Research Center, Young and Middle-aged Experts with Outstanding Contributions of

the National Health and Family Planning Commission of China, and experts eligible

for special government allowances from the State Council. The first batch of leading

medical talents in Chongqing, chief expert of Chongqing Chief Expert Studio, member of

the Standing Committee of the Central Committee of the Democratic League and deputy

to the National People's Congress. Member of the Standing Committee and Secretary

General of the Pediatrics Branch of the Chinese Medical Association, Vice Chairman of

the Children's Hospital Management Branch of the Chinese Hospital Association, Vice

Chairman of the Pediatrics Professional Instructor Committee of the Higher Education

Guidance Committee of the Ministry of Education, and Deputy Head of the Nephrology

Group of the Pediatrics Branch of the Chinese Medical Association. He has presided

over more than 10 national projects, won the first prize of Chongqing Science and

Technology Progress Award, the second prize of Science and Technology Progress

Award of the Ministry of Education, the first prize of Chongqing Teaching Achievement

Award, the Song Qingling Pediatric Medicine Award and many other awards, and served

as the chief editor and deputy editor of the textbook of People’s medical publishing

house.

Hainan Medical Products Administration

Li Yali

Deputy Director of Hainan Medical Products Administration.

Associate Director for Real-World Evidence Analytics in the Office

of Medical Policy (OMP), Center for Drug Evaluation and Research

(CDER), U.S. Food and Drug Administration (FDA)

John Concato

As an internist and epidemiologist, Dr. Concato seeks to enhance policies related to

drug development and regulatory review. His responsibilities include a focus on realworld evidence (RWE) and involve work developing internal Agency processes for

evaluating RWE, interacting with external stakeholders regarding RWE, supporting RWE

demonstration projects and guidance development, and serving as the Chair of the

RWE Subcommittee. Prior to joining FDA, his career focused on generating research

as an independent investigator, research center director, and Professor of Medicine at

Yale University School of Medicine and the U.S. Department of Veterans Affairs (VA); he

also was one of two founding principal investigators of the VA Million Veteran Program

genomic mega-biobank. He received M.D. and M.S. degrees from New York University

and an M.P.H. degree from Yale University.

54

2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Director of the First Department of Clinical and Biostatistics of Center

for Medical Device Evaluation (CMDE) of NMPA

Liu Yinghui

Doctor of Medicine, Chairman of the medical device clinical evaluation working group

of the International Medical Device Regulators Forum (IMDRF), the deputy leader of the

national medical device clinical evaluation standardization technology NFP (national

focal point).

Executive Dean of International Evidence-based Chinese Medicine

Research Institute, Director of Evidence-based Medicine Center,

Beijing University of Chinese Medicine

Liu Jianping

Doctor of Medicine, Distinguished Professor of the Chang Jiang Scholars Program, the

Ministry of Education, and Doctoral Supervisor. He is granted the special government

allowance of the State Council.He ever studied abroad and worked at the University of

Liverpool in the UK.He holds the following academic positions: President of International

Society of Complementary and Integrative Medicine Research (ISCMR) (ISCMR 2017-

2019); Advisor on Traditional Medicine of World Health Organization; Member of the 7th

Integrated Chinese and Western Medicines Discipline Evaluation Group of the Academic

Degrees Committee of the State Council; and Honorary Director of the Evidence-based

Medicine Professional Committee of Chinese Association of Integrative Medicine. He

is Editor-in-chief of 10 textbooks and monographs, and publishes more than 650

academic papers at home and abroad, 229 of which are included in SCI.

Executive President of Hospital for Skin Diseases, the Chinese

Academy of Medical Sciences

Lu Qianjin

Chief Physician, Professor, and Doctoral Supervisor, granted with special government

allowances of the State Council. He is Executive President of Hospital for Skin

Diseases and Executive Director of Institute of Dermatology, the Chinese Academy of

Medical Sciences; Director of the Key Laboratory of Basic and Translational Research

in Immunodermatology, the Chinese Academy of Medical Sciences; Director of the

Dermatology Branch, Chinese Medical Association; member of Asian Dermatological

Association; Deputy Director of the Dermatology Branch, World Association Of

Chinese Doctors; Deputy Director of the Dermatology Branch, Chinese Medical Doctor

Association; Executive Director of Chinese Society for Immunology, and Chief Scientist of

the Lupus Erythematosus Research Center of the Dermatology Branch, Chinese Medical

Association. Associate Editor of Clinical Immunology.

55

Optometry Director of the School of Ophthalmology and Optometry, Wenzhou

Medical University, Executive President of Hainan Institute of Real World Data

Qu Jia

Professor, chief physician and doctoral supervisor. President of Wenzhou Medical

University Eye Hospital Group. Qu is Director of National Key Laboratory in

Ophthalmology, Optometry and Visual Science, Director of National Ophthalmology &

Optometry Engineering Technology Research Center; member of the Clinical Medicine

Discipline Evaluation Group of the Academic Degrees Committee of the State Council;

Director of the Steering Committee of Ophthalmology and Optometry Medical Education

of Institutions of Higher Learning, Ministry of Education; Vice Chairman, and Director

of the Ophthalmological Branch, Chinese Geriatrics Society; and Deputy Director of

Chinese Ophthalmological Branch, Chinese Medical Association. He ever served as Chief

Scientist of the “973” Programme and undertook more than 100 research projects.

He has won 2 second prizes of National Science and Technology Progress Award, 3

National Teaching Achievement Awards, and more than 10 provincial and ministerial

level awards including the first prize of Chinese Medical Science and Technology Award.

Executive vice president of Dongzhimen Hospital, Beijing University

of Chinese Medicine

Shang Hongcai

Researcher and Doctoral Supervisor. He is winner of the National Science Fund for

Distinguished Young Scholars. He is Director of the Key Laboratory of Chinese Internal

Medicine of Ministry of Education (Beijing University of Chinese Medicine); Deputy

President of Dongzhimen Hospital of Beijing University of Chinese Medicine; and

Deputy Director of Institute of Cardiovascular Diseases of Beijing University of Chinese

Medicine. His research interests are the evaluation of clinical evidence of traditional

Chinese medicine, the characteristics of the effect and its mechanism. He is leading

a number of national projects such as those under the National Key Research and

Development Program, and the National Science Fund for Distinguished Young Scholars

of the National Natural Science Foundation. He has won 3 second prizes of National

Science and Technology Progress Award and 6 first prizes of provincial and ministeriallevel awards. He has published more than 200 papers, among which 70 are SCI papers,

with the total impact factor at 247. His papers have been cited more than 600 times by

SCI papers and 1,121 times by Chinese papers, and cited by internationally renowned

journals such as Nature Reviews Cardiology. He has been granted 6 invention patents

and 2 software copyrights.

56

2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Professor of School of Pharmacy, Peking University

Shi Luwen

Doctoral Supervisor. Director of International Research Center for Medicinal

Administration, Peking University. Deputy Director of the Pharmaceutical Policy

Professional Committee, China Pharmaceutical Innovation and Research Development

Association. Director of the Pharmacoeconomics Professional Committee, Chinese

Research Hospital Association. Director of the Pharmacoeconomics Professional

Committee, Beijing Pharmaceutical Association. Deputy Director of the Rare Diseases

Branch, Beijing Medical Association. Deputy Director of the Drug Clinical Evaluation

Research Professional Committee, China Association of Traditional Chinese Medicine.

Deputy Director of the Pharmaceutical Management Branch, Committee of Experts on

Modern Hospital Management Capacity Building. Member of Committee of Experts

on Consistency Evaluation of Generic Drug Quality and Efficacy. Member of the 2nd

Committee of Experts on Rare Disease Diagnosis, Treatment and Medical Security,

National Health Commission. Member of the Expert Team, Drug Price, Bidding and

Procurement Guidance Center, National Healthcare Security Administration. Associate

Editor-in-chief of Chinese Pharmaceutical Journal (English edition).

International Program and Policy Analyst (IPPA) - Medical Devices at

the United States Food and Drug Administration (FDA) China Office

Scott Gonzalez

Before being named the Acting International Program and Policy Analyst, Mr. Gonzalez

spent 9 years in the FDA’s Center for Devices and Radiological Health (CDRH) including

the Office of In Vitro Diagnostics and Radiological Health (OIR) and the Office of

Strategic Partnerships and Technology Innovation (OST). During his tenure at the FDA

he has also served as a pre-market/post-market Lead Reviewer and Acting Chief of the

Diagnostic X-Ray Systems Branch as well as a Senior Technical Advisor to the Office of

In Vitro Diagnostics and Radiological Health. Mr. Gonzalez is a subject matter expert

regarding the regulation of electronic product radiation emitting devices and is a

contributor to many international consensus standards relating to the testing as well as

the basic safety and essential performance of diagnostic x-ray systems and their major

components.

57

Head of Department of Biostatistics, Georgetown University Medical Center

Tan Ming

Doctoral degree in statistics. Tenured professor of Biomathematics at School of

Medicine, Georgetown University and Georgetown Lombardi National Comprehensive

Cancer Center. He is a Committee Member or Chairman of Data and Safety Monitoring

Committees for Clinical Trials of New Drug at NIH and pharmaceutical companies,

Member of FDA Expert Committee and many National Institutes of Health Project Review

Committees, and Expert Consultant of many pharmaceutical R&D and investment

companies. He is the Executive Editor of Molecular Carcinogenesis. He has long studied

experimental design and statistical methods for new drug development, and has

published more than 200 academic papers in prestigious international journals.

Director of China Evidence-based Medicine Center, West China Hospital,

Sichuan University and Deputy President of Hainan Institute of Real World Data

Sun Xin

Researcher and doctoral supervisor. Director of NMPA Key Laboratory for Real

World Data Research and Evaluation in Hainan. Director of Sichuan Real World Data

Technology Innovation Center. Director of Cochrane China Center. Director of MAGIC

China Center. Executive Editor-in-Chief of the Chinese Journal of Evidence-based

Medicine and Journal of Evidence-based Medicine. Director of the Real World Research

Professional Committee, China Association of Traditional Chinese Medicine. His research

interests are theoretical innovation and applications of the RWD research system and

the R&D, evaluation and application of the modern efficacy-oriented TCM. He has

presided over more than 20 vertical projects of National Natural Science Foundation

of China and National Key R&D Program of China, and published 119 SCI papers in

JAMA, BMJ, International Journal of Epidemiology, Critical Care Medicine, etc., with an H

index of 36. He is Chief Editor of postgraduate program textbooks of \"Evidence-Based

Medicine\" and the monograph of \"Evidence-Based Traditional Chinese Medicine\". He

won the first prize of Sichuan Science and Technology Progress Award, the second prize

of Science and Technology Progress Award of the Ministry of Education, and the BMJ

Outstanding Research Achievement Award.

58

2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Vice Director of Institute of Hematology & Blood Diseases Hospital,

Chinese Academy of Medical Sciences

Wang Jianxiang

Professor, PhD Supervisor, Chief Physician. He is Director of Leukemia Treatment Center

of Blood Diseases Hospital, Chinese Academy of Medical Sciences, Director of Institute

of Hematology, the Vice President of Internal Medicine Branch of Chinese Medical

Doctor Association, the Vice President of Hematology Branch of Chinese Medical Doctor

Association, the Associate Chief Editor of J Hematol & Oncol, and a member of the

Editorial Board of Blood. He once served as Director of Hematology Branch of Chinese

Medical Association, Chief Editor of Chinese Journal of Hematology (2012-2016), and

Director of China Anti-Cancer Association Hematology Oncology Special Committee

(2012-2015). He was selected as \"Distinguished Young Scholars\" and the National Talent

of \"New Century Hundred-Thousand-Ten Thousand Talent Project\". He is a special expert

of the Ministry of Health and is specially funded by the State Council. He is the main

developer of CD19 and CD33 CAR-T, a leader in leukemia treatment, with prognostic

stratification, intensive induction, and full management significantly improving the

outcome of treating acute leukemia. He has led the development of several guidelines

for the treatment of acute myeloid leukemia, acute lymphoblastic leukemia, and chronic

myeloid.

Director of the Department of Statistics and Clinical Pharmacology,

Center for Drug Evaluation, NMPA

Wang Jun

Doctor, Researcher, Director of the Department of Statistics and Clinical Pharmacology of

Center for Drug Evaluation, National Medical Products Administration. Wang graduated

from the Chinese Center for Disease Control and Prevention (CDC) and started working

at the CDC Information Center in 2005. He joined the Center for Drug Evaluation in 2011,

mainly engaging in new drug statistical evaluation, clinical pharmacology evaluation

and consistency evaluation. Besides, he presided over or participated in the revision of

many guidelines related to clinical trial statistics, and was the main author of guidelines

such as Guidelines for Real World Evidence to Support Drug Research, Development and

Evaluation and Guidelines for Real World Data Used to Generate Real World Evidence.

He is also a member of the ICH E9(R1) and M14 Expert Working Group and is responsible

for the translation and implementation of ICH E17 and other guidelines in China.

59

Deputy Director of Life Sciences and Medicine Department,

University of Science and Technology of China

Weng Jianping

Doctor of Medicine, Distinguished Professor of Ministry of Education of the People's

Republic of China, Executive Dean of School of Clinical Medicine, University of Science

and Technology of China; Deputy Dean of the First Affiliated Hospital of USTC (Anhui

Provincial Hospital), Dean of Bengbu Medical College. His research areas include the

early prevention and treatment of type 2 diabetes and its complications, molecular

genetic mechanism of special types of diabetes, the development and application of

artificial pancreas, new pathogenesis of diabetes susceptibility genes, and chronic noncommunicable disease cohorts and its application. He has undertaken two Projects

for Innovative Research Team in University of Ministry of Education of the PRC, and

led large-scale projects such as National Key R&D Program, the 12th Five-Year Major

Science and Technology Project.

Deputy Dean of School of Pharmaceutical Science and Technology,

Tianjin University

Wu Jing

Professor. She received a Ph.D. degree in pharmacoeconomics jointly issued by

Shenyang Pharmaceutical University and Peking University in 2007. From 2013 to

2014, She was a visiting scholar at the Leonard D. Schaeffer Center for Health Policy

& Economics, University of Southern California. Dr. Wu holds the following part-time

positions: Deputy Director of the Pharmaceutical Economics Professional Committee

of Chinese Pharmaceutical Association; Deputy Director of the Pharmaceutical

Economics Professional Committee of Chinese Research Hospital Association; Vice

Chairman of Tianjin Medical Insurance Research Association; and Executive Director of

Tianjin Health Economics Association. Her research interests are in health economics

and pharmacoeconomics. In the past five years, Dr. Wu has published more than 40

papers in English (SSCI&SCI) and more than 60 papers in Chinese. She presided over

three programs sponsored by the National Natural Science Foundation of China.

She co-authored Pharmacoeconomics (China Medical Science and Technology

Press), Pharmacoeconomics (Higher Education Press), and China Guidelines on

Pharmacoeconomic Evaluation and Manual 2015, and National Essential Medicine

System: Theories and Experiences. She is one of the lead authors of 2020 China

Guidelines on Pharmacoeconomic Evaluation and Manual.

60

2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Professor of School of Traditional Chinese Medicine, Hainan Medical University

Xie Yiqiang

Doctoral Supervisor, School of Traditional Chinese Medicine, Hainan Medical University.

Professor Xie is on the Steering Committee of Integrated Traditional Chinese and

Western Medicines Education in Institutions of Higher Education, Ministry of Education.

He is head of the team in the first batch of Hainan Province “Double Hundred” talent

teams, on the lists of Leading Talents, Nanhai Masters, and Outstanding Experts in

Hainan province, and a candidate for first-level talents in 515 Talent Project in Hainan

province. He is Final Review Expert of the National Natural Science Foundation of

China; Deputy Director of the health maintenance and Rehabilitation Branch, China

Association of Chinese Medicine; Deputy Youth Director of the Committee of Experts

on the Basic Research Platform for Prevention and Treatment of Major Diseases with

Traditional Chinese Medicine, China Association of Chinese Medicine; Deputy Chairman

of the Endocrinology Branch, World Federation of Chinese Medicine Societies; Standing

Member of the Diabetes Branch, China Association of Chinese Medicine; Vice President

of Hainan Provincial Association of Chinese Medicine. He is on the editorial board of TMR

Modern Herbal Medicine, International Journal of Chinese Medicine. He has undertaken

3 projects of National Natural Science Foundation of China, and 3 projects of Hainan

Province, with a total research fund of more than 5 million yuan. He has published more

than 150 papers. He authored or participated in the writing of 13 books. He has won 2

prizes of Hainan Provincial Science and Technology Progress Award, 1 Hainan Provincial

Research Achievement Award for Institution of Higher Education, and been granted 14

invention patents.

Professor of the University of Texas, USA

Xu Hua

Professor and Director, Center for Computational Biomedicine. Associate Dean for

Innovation. School of Biomedical Informatics. The University of Texas Health Science

Center at Houston. Dr. Hua Xu is a Professor and Associate Dean for Innovation at the

School of Biomedical Informatics in The University of Texas Health Science Center at

Houston (UTHealth), as well as an elected fellow of the American College of Medical

Informatics. He directs the Center for Computational Biomedicine at UTHealth. Dr. Xu

received his Ph.D. in Biomedical Informatics from Columbia University. His primary

research interests include biomedical natural language processing (NLP) and data

mining, as well as their applications in secondary use of electronic health records data

for clinical and translational research. His research is funded by multiple agencies (i.e.,

NLM, NCI, NIGMS, AHA, and CPRIT), and methods/tools developed in his lab have been

top ranked in a number of biomedical NLP shared tasks and widely used to support

diverse biomedical researches.

61

Researcher of the School of Pharmaceutical Sciences,Tsinghua University

Yang Yue

Researcher and Doctoral Supervisor at the School of Pharmaceutical Sciences,

Tsinghua University. As the first one in China to obtain a PhD degree in pharmaceutical

management, she focuses on pharmaceutical regulations, policies and regulation.

She is a member of NMPA’s communication team for Drug Administration Law, Vaccine

Administration Law and Regulations for the Supervision and Administration of Medical

Devices. Her representative works include Scientific Research on Drug Regulation in the

United States, Introduction to the Drug Marketing Authorization Holder System, and 21st

Century Cures Act.

Professor of School of Pharmaceutical Sciences, Sun Yat-Sen University

Xuan Jianwei

Director of the Institute of Pharmaceutical Economics, School of Pharmaceutical

Sciences, Sun Yat-Sen University. Researcher of the Research Center of National Drug

Policy & Ecosystem (NDPE), expert of Shanghai Thousand Talents Program. He has

published more than 300 academic articles in the fields of clinical research, health

economics, medical big data, and policy research. He has cooperated with China's

National Development and Reform Commission, China's National Health Commission,

and the National Healthcare Security Administration for many times to conduct policy

research, and has led global clinical research in many multinational companies. His

research results have been applied in many countries for medical decision-making.

Director of the Medical Statistics Department of Peking University First

Hospital, Deputy President of Hainan Institute of Real World Data

Yao Chen

Doctoral Supervisor and professor;Director of the Medical Statistics Department of

Peking University First Hospital, Deputy President of Hainan Institute of Real World

Data，Deputy Director of Peking University Clinical Research Institute. He holds the

following academic positions: Director of the Evidence-based Medicine Professional

Committee of Chinese Medical Doctor Association; Deputy Director of the Statistical

Theory and Methods Professional Committee of Chinese Health Statistics Association;

Deputy Director of the Real World Research Professional Committee of World Federation

of Chinese Medicine Societies; Deputy Director of the Department of Oncology of Wu

Jieping Medical Foundation; and Expert of Drug and Device Review, National Food

and Drug Administration. Professor Yao participated in Johnson & Johnson’s real-world

research project on Catalys precision laser cataract surgery in Lecheng, Boao, and

applied the real-world data in the research in the automated collection process. The

paper on this methodological research has been published in China Food and Drug

Administration Magazine.

62

2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Deputy Chief Engineer, Institute of Automation, Chinese Academy of Sciences

Zhang Wensheng

Researcher, doctoral supervisor, chair professor of artificial intelligence at the University

of Chinese Academy of Sciences, dean of Cmdi Artificial Intelligence Research Institute

(Suzhou) Co., Ltd., chief scientist of the major project of Strategy for Science, Technology

and Innovation Development until 2030-\"new generation artificial intelligence\";

member of the group of experts in “Cloud Computing and Big Data sector” and “Internet

of Things and Smart Cities” of the National Science and Technology Major Project,

vice chairman of the Internet of Things Working Committee of China Instrument and

Control Society, deputy director of the Intelligence Services Committee of the Chinese

Association for Artificial Intelligence. He previously took on such posts as head of the

science and technology section, head of major projects, member of the institute affairs

committee, and assistant to the institute head. Recent fields of research include: big

data and data mining, Artificial Intelligence, Machine Learning, pattern recognition,

3D physical simulation, embedded video image processing. He has published more

than 200 papers, secured more than 50 foreign and domestic inventions and patents, 1

national second prize, and 5 provincial and ministerial second prizes.

Dean of School of Public Health,Peking University, Director of the Department

of Epidemiology and Biostatistics of School of Public Health, Peking University

Zhan Siyan

Professor, Doctoral Supervisor; Director of Clinical Epidemiology Research Center,

Peking University Third Hospital. She is also Executive Director, and Director of

the Pharmacoepidemiology Professional Committee, Association of Chinese

Pharmaceutical Association; and Director of the Epidemiology Branch of Chinese

Preventive Medicine Association. Professor Zhan is Editor-in-chief of Chinese Journal of

Pharmacoepidemiology, Associate Editor-in-chief of Chinese Journal of Epidemiology

and the medical edition of Science Bulletin, Editor-in-chief of the 7th and 8th editions

of the textbook Epidemiology, and Editor-in-chief of the 2nd edition of the textbook

Clinical Epidemiology. Her research interests are in pharmacoepidemiology, clinical

epidemiology and evidence-based medicine. Professor Zhan has undertaken a number

of projects funded by the Ministry of Science and Technology and National Natural

Science Fund, published more than 200 papers as the first or responsible author. She

won the 17th Wu Jieping-Paul Janssen Medical & Pharmaceutical Award in 2016, and

was awarded the title of Beijing Excellent Teacher in 2017, and the tile of Outstanding

Individual in Beijing’s Fight against COVID-19 in 2020. She is granted special government

allowance of the State Council.

Scientific Advisor of Canadian Agency for Drugs and Technologies in

Health (CADTH)

Yuan Hongbo

Board of Director, and past Chair of the Comparative Efficacy Research Group of the

International Society of Pharmacoepidemiology (ISPE). He obtained his doctoral degree

in the Department of Epidemiology and Biostatistics, McGill University in 2002. Since

2010, Dr. Yuan has provided scientific support to the evaluation of efficacy and safety

(HTA) for over 200 various new drug applications.

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Vanke School of Public Health, Tsinghua University

Zhao Kun

Distinguished Visiting Professor, Vanke School of Public Health, Tsinghua University.

Deputy Director of the Center for Comprehensive Drugs and Health Technology

Assessment. Deputy Director of the Committee of Experts on Rare Disease Diagnosis,

Treatment and Protection, National Health Commission. Deputy Chairman/

Secretary-General of the Health Technology Assessment Professional Committee,

Chinese Health Economics Association. Deputy Director of the Early Measurement

and Evaluation Professional Committee, Chinese Preventive Medicine Association.

Deputy Director of the Medical Policy Professional Committee, China Pharmaceutical

Innovation and Research Development Association. Director of China Health Insurance

Research Association. Director of China Alliance for Rare Disease. Chairman of ISPOR

Asia Pacific Conference Program Committee (2018-2020).Chairman of Asian Health

Technology Assessment Alliance (2021-2022). Professor Zhao has led the third-party

evaluation on the construction of a tiered diagnosis and treatment system, National

Health Commission. The evaluation on the project of the national key disciplines in

clinical medicine. Professor Zhao is responsible for advancing the comprehensive

drug clinical evaluation, and has participated in the writing of the National

Guidelines on Managing the Comprehensive Drug Clinical Evaluation, Guidelines on

Comprehensive Clinical Evaluation of Anti-tumor Drugs, Guidelines on Comprehensive

Clinical Evaluation of Cardiovascular Drugs, Guidelines on Comprehensive Clinical

Evaluation on Children’s Drugs, and Guidelines on Comprehensive Clinical Evaluation

of Rare Disease Drugs. Professor Zhao has published more than 80 papers in core

journals as the first author and corresponding author. She is Editor-in-chief of Health

Technology Assessment and Policy Evaluation-Theory and Methodology and Health

Technology Assessment and Policy Evaluation-Empirical Study.

Professor of Eye Hospital, Wenzhou Medical University

Zhou Xiangtian

Prof.Zhou mainly engaged in research on the pathogenesis and clinical prevention

and control of myopia, and proposed the theory of scleral hypoxia in the formation

of myopia. He has received National Science Fund for Distinguished Young Scholars,

and National Natural Science Fund for Outstanding Young Scholars. Besides, he was

selected as Young Top-level Talents of the Organization Department of the Central

Committee of the People's Republic of China (Ten Thousand Talents Program) and

won honors such as Leading Healthcare Talents of Zhejiang Province. He currently

serves as Vice Chairman of the Youth Committee of Chinese Ophthalmological

Society, Chinese Medical Association. He is Deputy Group Leader of Visual Physiology

Group of Chinese Society of Ophthalmology, Expert Member of Chinese Society of

Ophthalmology, Chinese Medical Association, Fellow of Asia-Pacific Academy of

Ophthalmology, Member of ARVO Global Committee, and Editor Board Member

of prestigious journals such as Experimental Eye Research, BJO, Eye & Contact

Lens, Chinese Journal of Ophthalmology, and Chinese Journal of Optometry &

Ophthalmology and Visual Science. He has published more than 100 SCI articles in

mainstream academic journals in ophthalmology and visual science, such as PNAS,

IOVS, etc., and more than 20 articles in mainstream journals in the field, such as

Investigative Ophthalmology & Visual Science. He has been granted 9 invention

patents, including 2 international patents; he received the second prize of National

Science and Technology Progress in 2007 and 2009 (ranking the third and the fourth

respectively).

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2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration

Lyu Xiaolei

Executive Deputy Director of Hainan Boao Lecheng International Medical Tourism Pilot

Zone Administration.

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Global Head of Evidence and Launch Excellence, Global Drug

Development at Novartis Pharmaceuticals Corporation

Amy Rudolph

Amy has been in the industry since 1999, dedicated to research design innovation,

science implementation and evidence integration. She previously held positions as

Head of US HE&OR (Health Economics and Outcomes Research) and Medical Access, as

well as leading positions in HE&OR, digital medicine, early products, CER (comparative

effect research) and communication. Amy also previously held two other roles in

medical affairs with a focus on hypertension with Novartis, and on atherosclerosis and

stroke with Pfizer, Inc. Amy has also been granted 13 patents and published numerous

articles spanning preclinical research, drug development, and outcomes research.

Chief Scientific Officer at Elixir Clinical Research (ECR Global) and

Senior Vice President at Overland Pharmaceuticals

Chen Jie

Doctoral degree in statistics. Dr. Chen Jie is also the head of Biometrics at Overland

Pharmaceuticals. He is a visiting scholar at the Center for Design Research at Stanford

University. Dr. Chen has over 27 years of biopharmaceutical R&D experience and is on

the editorial board of Contemporary Clinical Trials and Journal of Biopharmaceutical

Statistics. He is currently co-chair for the project of the American Statistical Association

(ASA) BIOP Real-World Evidence Scientific Working Group (SWG). Dr. Chen authored a

book on Medical Product Safety Evaluation: Biological Models and Statistical Methods

and published over 50 papers in journals.

RWD policy lead and Chapter Lead within the Global Regulatory

Policy team at Roche

Gracy Crane

Gracy Crane is a cancer biologist by training with a Master in Biomedical Research and a

Ph.D. in Cancer Biology. She has also completed post-doctoral training fellowships

at Oxford University (UK) and Massachusetts Institute of Technology (USA). She has

over 12 years of years of experience in the pharmaceutical industry, in varying roles

including medical and scientific affairs, clinical development, health outcomes research

and real world data. For the past 5 years, she has worked on leading the real world

evidence strategy for molecules within the rare cancer space as part of the global Data

Science team of the personalized health care department at Roche. Currently, she is

the RWD policy lead and Chapter Lead within the Global Regulatory Policy team at

Roche. She has authored many publications on this topic and has presented in many

international conferences.

Speakers from the Corporate Sector

Sub-Forums

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2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Chief Strategy Officer and Chief Medical Officer of 3D Medicines

Xiao Shen

Ph.D., West Virginia University, Dr. Xiao completed postdoctoral research at Johns

Hopkins University and the University of North Carolina. He has worked in the FDA

for nearly 20 years, responsible for hundreds of New Drug Development and Review

Process, and as a clinical reviewer and/or multi-discipline review team leader,

responsible for the marketing approval of more than ten new drugs. He is also

responsible for the consultation work related to nephrotoxicity in new drug approval at

the Center for Drug Evaluation and Research (CDER). In addition, he consulted on kidney

disease for the FDA's Center for Devices and Radiological Health (CDRH), the Center for

Biologics Evaluation and Research (CBER), and the U.S. Department of Justice. Dr. Xiao

was responsible for and participated in the drafting and development of multiple FDA

new drug development guidelines; discussing drug-specific regulatory standards, ICH

guidelines, etc. with European and Canadian drug regulatory agencies (EMA, Health

Canada), etc. He worked in Nanjing General Hospital of Nanjing Military Region and the

All-Army Nephrology Research Center. He won the third prize of the National Science

and Technological Progress Prize and the second prize of the All-Army Science and

Technological Progress Prize.

Executive director of biostatistics at Pfizer Inc.

Joseph C. Cappelleri

He earned his MS in statistics from the City University of New York (Baruch College),

PhD in psychometrics from Cornell University, and MPH in epidemiology from Harvard

University. Dr. Cappelleri is an elected Fellow of the American Statistical Association.

He has coauthored approximately 1,200 external presentations and 600 publications

on clinical and methodological topics, including on regression-discontinuity designs,

meta- analysis, and health measurement scales. He is the 2021 recipient of the ISPOR

Avedis Donabedian Outcomes Research Lifetime Achievement Award.

Senior Vice President of Medtronic

Laura Mauri

M.D., Harvard Medical School; B.A., M.S., Harvard University; Senior Vice President and

Chief Clinical & Regulatory Officer at Medtronic, Member of the Executive Committee

of Medtronic. In 2018, Dr. Mauri became Vice President of Global Clinical Research and

Analytics at Medtronic. In 2020, she became Member of Global Executive Committee

at Medtronic. Before joining Medtronic, she has been working as an interventional

cardiologist at Brigham and Women's Hospital for 15 years. With a Bachelor of Arts and

Master of Science from Harvard University, and a PhD of Medicine from Harvard Medical

College, she completed her training at Brigham and Women's Hospital. She is Member

of reputed associations such as American Association of Clinical Research and American

College of Cardiology and Senior Editor of Circulation. She has published about 200

papers and received the Joseph A. Vita Award from American Heart Association in 2017.

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Head of Global Epidemiology & RWE CoE, Boehringer Ingelheim

Laura Wallace

An epidemiologist with a background in Epidemiology, Psychology and Public Health

who trained at Brown University, Southern Connecticut State, and the University of

Alaska, Fairbanks in the United States. She joined the pharmaceutical industry in

2002, working in multiple roles in epidemiology, real world evidence, safety and

risk management, drug development, and Medical Affairs. She came to Boehringer

Ingelheim in 2016, and since 2020 has worked as the Head of Global Epidemiology &

RWE CoE, based in Ingelheim, Germany.

Senior Director of Medical and Payer Evidence Statistics, AstraZeneca

Mario Ouwens

Dr. Ouwens leads a medical and payer evidence statistics group of 11 statisticians

at AstraZeneca who have been highly involved in COVID-19-related research over

the past two years. His workshop in Brazil was one of the two workshops leading to

ANVISA opening for the use of RWE. In 2022, Dr. Ouwens presented the comprehensive

evidence and expert opinion of RCTs combined with RWS at the PPMA, and published

6 articles, including “Best Practice Recommendations for Practical Clinical Trial Design

and Statistical Analysis: Improved Delphi Methods”. Within AstraZeneca, Dr. Ouwens

developed the guidelines for pragmatic clinical trials and the SIDE-L framework,

being a framework to assess the quality of observational studies related to Statistical

Interpretation Design External and Labeling criteria. In the past 5 years, Dr. Ouwens

frequently presented at The International Society for Pharmacoeconomics and

Outcomes Research (ISPOR) Europe in oral presentations and workshops and presented

yearly at PPMA, Europe’s largest congress in market access, pricing and evidence. His

work is referenced in technical support documents of NICE (UK).

Chief Data Science Officer and the Global Head of Strategy &

Operations for Janssen Research & Development

Najat Khan, Ph.D.

Doctoral degree in organic chemistry from the University of Pennsylvania, a B.S. in

chemistry and a B.A. in economics from Colgate University; she is co-chair of the

Johnson & Johnson Data Science Council, and a core member of the Development and

Investment Committees, overseeing Janssen's R&D strategy, pipeline and portfolio

optimization and investments, and seeking to fully integrate data science and digital

health into the overall pipeline to drive transformational innovation for patients. Her

team leverages artificial intelligence (AI), machine learning, digital health and realworld evidence (RWE) to bring transformative value to patients. Najat was previously a

partner at the Boston Consulting Group (BCG). In 2022, Najat was listed among the Top

20 Leaders under 40 in biopharma and biotech by Endpoints News.

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2022 年 12 月 8 日  Dec.8, 2022    中国 • 博鳌  Boao • China

Vice President of Epidemiology and Real-World Data Sciences for

Medical Devices at Johnson and Johnson

Paul Coplan

Paul leads a team of epidemiologists, data programmers and biostatisticians. Paul

has been a pioneer in using epidemiology and real-world evidence to develop new

vaccines, medicines and medical technology and to assess their postmarket safety and

effectiveness. He has participated in the postmarket surveillance of several devices.

He has also helped develop 8 widely used vaccines and 9 medicines. In addition, He

has authored over 90 peer-reviewed scientific articles and 500 international medical

conference presentations, and has worked with the FDA, EMA and other national

regulatory authorities. Paul is a member of the National Evaluation System for Health

Technology’s Active Surveillance Workgroup (of which FDA is the regulatory chairman)

and the Medical Device Innovation Consortium Science of Patient Input Steering

Committee. He has led pre-competitive initiatives for collaboration between companies,

regulators and academics in creating benefit-risk frameworks for medical product

evaluations, assessing the safety of HIV medications, vaccines, opioid analgesics.

Chief Scientific Officer Emerita IQVIA Real World Solutions

Nancy A.Dreyer

Adjunct Professor of Epidemiology at the University of North Carolina at Chapel

Hill, President of Dreyer Strategies LLC, a Fellow of both the International Society

of Pharmacoepidemiology and the Drug Information Association, and a Trustee

of Brandeis University. She has helped advance the use of real-world evidence for

regulatory purposes, influencing the content of recent guidelines by regulators in the

US, Europe, and China, each of which cite one or more of her publications.

Vice President of Global Data Science and Analytics Function at

Abbott medical devices

Nirav Dalal

He has more than twenty years of experience in medical device industry. Nirav is

interested in methods and tools to improve healthcare and create value using “Big

Data” and machine learning. He received MS in Electrical Engineering from the

California Polytechnic State University, San Luis Obispo and an MBA from the Pepperdine

University. He has published more than fifty peer-reviewed journal articles, conference

abstracts, and US patents. He is a frequent speaker on medical devices, real-world

evidence, digital health, health economics, and data science. His past speaking

engagements include talks at the FDA, AdvaMed, Big Data in Healthcare, American

Chamber of Commerce, Medical Design & Manufacturing, Global Cardiovascular Clinical

Trialists Forum.

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Head of Real World Data Strategy & Alliances, Astellas Pharma

Sandeep SANGA

A data-minded biomedical scientist, innovate business leader, product-focused

executive and problem-solver. Dr. Sandeep Sanga is Head of Real World Data Strategy

& Alliances at Astellas Pharma. He has a deep understanding of health and life science

industry with his rich working experience in science, business and product. Sandeep's

team has established and brought to the market lots of industry-specific SaaS products,

which helps clients quckily obtain useful information from abundant data ranging

from vertical and horizontal clinical, phenotypic, genomics, to imaging. He was a

postdoctoral fellow at Cardiovascular Institute, University of California where he was

trained in medical genomics and applied data science with a focus on asthma and

sarcoidosis.

Director and Executive Director of Health Economics and Outcomes

Research (HEOR) at Department of Medicine, BeiGene USA Inc.

Tang Boxiong

Dr. Tang established the Global Health Economics and Outcomes Research Team at

BeiGene. As Head of HEOR, he is responsible for the implementation of Global Health

Economics and Outcomes Research Strategy. Before joining BeiGene, he has worked in

Teva, Pfizer, Johnson & Johnson and GlaxoSmithKline. Dr. Tang was Visiting Professor

at Fudan University and Visiting Researcher at Zhejiang University School of Medicine

and serves as President of Asia Consortium Industry Committee, International Society

for Pharmacoeconomics and Outcomes Research (ISPOR). He has been engaged in

medicine, health economics and outcome research for over 20 years with publication of

over 30 papers, over 100 scientific manuscripts, abstracts and speeches at many largescale international scientific conferences.

Senior Director of Real World Evidence Analytics, AbbVie

Yonghua Jing

He obtained his Ph.D. degree from University of Cincinnati, Master of Pharmacology

from Ohio Medical School and Bachelor of Pharmacy from China Pharmaceutical

University. Over the past 15 years, Dr. Jing has worked in AbbVie and led his team in

discovering real-world evidence supportive of bestselling drugs (i.e. aripiprazole,

Eliquis, Plavix, and Humira). He himeself is also an expert on the design and application

of real-world evidence. Since 2014, his team has developed a real-world data platform

and capabilities to integrate real-world evidence within AbbVie, and he joined PhRMA

Real-World Evidence Working Group on behalf of AbbVie. Dr. Jing is a long-time Member

of ISPOR Asia Consortium and has a good relationship with experts in real-world

evidence worldwide.

Vice President and Chief Medical Officer, Medical Affairs and Health

Economics Asia Pacific (APAC) Boston Scientific Corporation

Zhang Mingdong

Research Fellow and Staff Scientist at the US National Institutes of Health. Doctoral

degree from the Department of Molecular Virology and Microbiology at Baylor College

of Medicine. He previously worked at the Chinese University of Hong Kong as a

professor, and at CDRH, FDA as medical officer and epidemiologist. He published 40

papers in high impact journals. During his service in CDRH, FDA, Dr. Zhang provided

medical reviews for multiple original PMA and 510k submissions on medical devices

including in vitro diagnostic tests; led designs of post-approval studies; and performed

risk assessment and health hazard evaluations of medical devices.

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