Time Agenda Session Moderator 08:30 - 08:50
08:50 - 09:10 Opening Remarks Wen Jin Cherng,Chairman,Chang Gung Steering Committee, TW
Yang Chih Shih,Counselor,Ministry of Health and Welfare, TW Ming Hsun Liu,Chief Executive Officer, Center for Drug Evaluation, Keynote Speech 1
9:10 - 10:00
Prof. Shein Chung Chow
Biostatistics and Bioinformatics, Duke University, USA Topic：Innovative Approach on Rare Disease Drug Development
Chin Fu Hsiao,Investigator,National Health Research Institutes, TW Chyong Huey Lai,Vice Superintendent, Linkou Chang Gung Memorial Hospital, TW
10:00 - 10:10
10:10 - 10:50
Prof. Toshimitsu Hamasaki
Biostatistics Center and the Department of Biostatistics and Bioinformatics, George Washington University, USA Topic：Statistical opportunities and challenges in using real-world data for medical product development
10:50 - 11:30
Prof. Chin Fu Hsiao
Institute of Population Health Sciences, National Health Research Institutes, TW
Topic：Is real world evidence real?
11:30 - 11:50 Disscuion 11:50 - 12:50
Keynote Speech 2
12:50 - 13:30
Prof. Haruko Yamamoto
Pharmaceutical and Medical Devices Agency, JP Topic：PMDA perspective on the utilization of RWD/RWE for regulatory
Tsang Wu Liu, Investigator, National Institute of Cancer Research, TW
Session 2 : Precision Medicine
13:30 - 14:10 Prof. Chien Feng Li
Chi Mei Medical Center, TW
Topic：Precision Medicine driven by Cancer Genomics 14:10 - 14:30 Discussion
14:30 - 15:00 Prof. Guei Feng Tsai
Center for Drug Evaluation, TW
Topic：Adaptive design in clinical trials 15:00 - 15:20 Discussion
15:20 - 15:40
15:40 - 16:20
Prof. Wen Yi Shau
Senior Medical Director of Taiwan, Pfizer Inc.
Topic：RWD/RWE general introduction, experiences, and difficulties
16:20 - 17:00 Prof. Ya Lei Wang
Center for Drug Evaluation, TW
Topic RWE for use in regulatory perspective of view
Churn Shiouh Gau,Director,Preparatory Office of International Research Platform of Regulatory Science and Administration for Medicinal Products, TW
2021 Conference of Critical Clinical Initiatives in Drug Development- Adaptive Designs, Precision medicine, and RWD/RWE
2021藥物開發之關鍵臨床計畫國際研討會 調適性設計、精準醫療及真實世界資料/證據
Date: 2021/9/17
Registration
Break Session1: RWD/RWE
Chee Jen Chang, Distinguished Professor, Chang Gung University, TW Lunch
Tsang Wu Liu,Investigator,National Institute of Cancer Research, TW
Session 3: Adaptive Design
Yung Chang Lin, Director, Clinical Trial Center, Linkou Chang Gung Memorial Hospital, TW
Break Session 4: RWD/RWE
Opening Guest 開幕致詞
Wen Jin Cherng(程文俊), MD., FACC., FAHA, FESC.
Chairman
Chang Gung Steering Committee, Taiwan Superintendent
Linkou Chang Gung Memorial Hospital, Taiwan
Education Kaohsiung Medical University, College of Medicine, Taiwan
Post-Graduate Education Cardiology Dep, National Cardiovascular Center, Japan (Scholarship of Japan Society of Ultrasonics in
Medicine)
Cardiology Dep, Strong Memorial Hospital, University of Rochester, Rochester, New York, USA (Scholarship of Paul N. Yu Fellowship)
Fulltime Employments 1994 – 1998 Chairman, Department of Medicine, Chang Gung Memorial Hospital, Keelung.
1997 – 2003 Chairman, Department of Medicine, Chang Gung Memorial Hospital, Linkou, Taoyuan.
2001 – 2003 Vice-Superintendent, Chang Gung Memorial Hospital, Keelung.
2003 – 2016 Superintendent, Chang Gung Memorial Hospital, Keelung.
2016 – present Director of Board, Chang Gung Medical Foundation.
2017 – present Chairman, Chang Gung Steering Committee.
2017 – present Superintendent, Chang Gung Memorial Hospital, Linkou, Taoyuan.
Academic Appointments 1999 – present Professor of Medicine, Chang Gung Memorial Hospital.
2004 – present Professor of Medicine, Chang Gung Medical College, Chang Gung University.
Opening Guest 開幕致詞
Yang Chih Shih(施養志), Ph.D.
Counselor
Ministry of Health and Welfare, Taiwan
Academic Qualifications 1985-1989 Ph.D: Department of Food Science, Rutgers, State University, USA
Present Appointments -present Counselor, Ministry of Health and Welfare
-present Adjunct Professor, Department of Food Science, Fu Jen Catholic -present Executive Director, AOAC International, Taiwan Section
-present Director, Agricultural Chemical Society of Taiwan
-present Managing Director, Agricultural Technology Research Institute -present Director, Taiwan Association for Food Science and Technology
Previous Appointments 2011-2014 Director, Division of Research and analysis, TFDA
Opening Guest 開幕致詞
Ming Hsun Liu(劉明勳) Chief Executive Officer
Center for Drug Evaluation, Taiwan Tel:886-2-81706000
Email: mhliu941@cde.org.tw
Education & Training 2007 Elite Leadership Program
John F. Kennedy School of Government, Harvard Kennedy School, USA 1994 Master of Pharmacy and Health Sciences
Long Island University, NY, USA 1989 Bachelor of Department of Pharmacy
Kaohsiung Medical College, Taiwan
Summary of Career 2020.03~now Chief Executive Officer
Center for Drug Evaluation
2018.10~2020.02 Director, Division of Medicinal Products
Food and Drug Administration, Ministry of Health and Welfare 2016.7~ 2018.10 Director, Office of Public Relations
Ministry of Health and Welfare
2013.7~ 2016.7 Senior Specialist, Department of Medical Affairs, Ministry of Health and Welfare 2009.12~2013.7 Senior Specialist, Bureau of Medical Affairs
Department of Health
2004.11~2009.12 Section Chief, Bureau of Medical Affairs Department of Health
2000.7~2004.11 Section Chief, Centers for Disease Control Department of Health
1998.10~2000.7 Specialist, Office of Public Relations Department of Health
1996.12~1998.10 Specialist, NHI Medical Expenditure Negotiation Committee 1996.7~1996.12 Specialist, Bureau of Pharmacy
Department of Health
1995.2~1996.7 Researcher, Bureau of Medical Affairs Department of Health
Moderator 主持人
Chin Fu Hsiao (蕭金福), Ph.D.
Investigator
Institute of Population Health Sciences National Health Research Institutes, Taiwan 35 Keyan Rd. Zhunan Town Miaoli 350, Taiwan Tel: 037-246166 ext. 36106
Email: chinfu@nhri.org.tw
Education University of Wisconsin-Madison, Wisconsin, U.S.A.: Ph.D. in Statistics, August 1997.
National Central University, Taiwan, R.O.C.: M.S. in Mathematics, June 1989.
National Central University, Taiwan, R.O.C.: B.S. in Mathematics, June 1987.
Experience 10/2011–Present Investigator
Institute of Population Health Sciences, National Health Research Institutes 8/2014 –8/2020 Deputy Director,
Institute of Population Health Sciences, National Health Research Institutes 1/2011 – 7/2014 Director,
Division of Clinical Trial Statistics,
Institute of Population Health Sciences, National Health Research Institutes 8/2012–Present Adjunct Professor, National Yang Ming University
8/2011–Present Adjunct Professor, National Chiao Tung University 2/2006–Present Adjunct Associate Professor, National Taiwan University 9/2004–9/2011 Associate Investigator,
Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes
2/2001–9/2004 Assistant Investigator, Division of Biostatistics and Bioinformatics, National Health Research Institutes
Moderator 主持人
Chyong Huey Lai (賴瓊慧), M.D.
Vice Superintendent
Linkou Chang Gung Memorial Hospital, Taiwan Distinguished Professor
Chang Gung University College of Medicine, Taiwan
Dr. Chyong-Huey Lai is Professor and Vice Superintendent of Chang Gung Memorial Hospital, and Distinguished Professor of Chang Gung University College of Medicine,Taiwan. She was President of Taiwan Medical Women’s Association (2014-2017). Dr. Lai obtained her M.D. degree from College of Medicine, National Taiwan University in 1982. She was President of the Taiwan Association of Gynecologic Oncologists(2002-2004) and a Council Member of International Gynecologic Cancer Society (2002-2006). Dr. Lai served the founding President of Asian Gynecologic Oncology Group(AGOG) 2005 to 2015, and has continuedher service as Honorary Chairperson and Advisor of the AGOG since November 2015. Dr. Lai served the founding President of Taiwanese Gynecologic Oncology Group since April 2021. She serves several editorial boards, such as “Gynecologic Oncology” (2005 till present), Biomedical Journal (1996 till present), Journal of Formosan Medical Association (since 2014), and
“International Journal of Gynecological Cancer” (2001-2008).Dr. Lai served the founding President of Taiwanese Gynecologic Oncology Group since April 2021.Dr. Lai's areas of research are cervical cancer prognosis, screening, HPV molecular epidemiology, molecular imaging, genomic medicine, and gynecologic cancer biology and therapeutics.She received Excellence Award from the National Science Council, Taiwan in 2007 and 2010, respectively,Outstanding Professionalism Award, Ministry of Health and Welfare, Taiwan in 2018, Medical Doctor's Role Model Award of Taiwan Medical Association, and We Innovators Awardin 2020, respectively for her contribution in medical research.She serves several editorial boards, such as “Gynecologic Oncology” (2005 till present), Biomedical Journal (1996 till present), Journal of Formosan Medical Association (2014-2020), and“International Journal of Gynecological Cancer” (2001-2008).
Moderator 主持人
Churn Shiouh Gau (高純琇), Ph.D.
Director
Preparatory Office of International Research Platform of Regulatory Science and Administration for Medicinal Products, Taiwan
Dr. Gau is now the adjunct professor and the director of the Platform for Research and Inspiration in Regulatory Science, School of Pharmacy, National Taiwan University, and the distinguished senior specialist at the Ching- Kang Foundation for pharmacy Promotion. Dr. Gau also serves as the project director for the Office of Sustainable Platform for Big Data in Health, a program sponsored by the Ministry of Health and Welfare, Taiwan in 2021.
Dr. Gau had been the Chief Executive Director of Center for Drug Evaluation (CDE), Taiwan for 9 years, from April 1, 2011 to Feb. 29, 2020. CDE was established by Department of Health (DOH, now MOHW) in 1998, to assist the technical evaluation for market approval of drugs and medical devices. Dr. Gau was appointed as the Deputy Executive Director of CDE from June 2006 to Aug. 2009.
Dr. Gau received her Ph.D. degree in Pharmaceutics from the School of Pharmacy, University of Wisconsin- Madison, USA, in 1992. After that she returned to the School of Pharmacy, National Taiwan University (NTU) as a faculty member. During Aug. 1996 to July 2000, she was appointed as the Director of the Department of Pharmacy, NTU Hospital, one of the largest university-affiliated medical centers in Taiwan.
Prior to joining CDE, Dr. Gau served as expert/advisor in many Committees for MOHW, specializing in the evaluation of new drug application, assessment of drug safety, and accreditation of teaching hospital. Dr. Gau had led the projects for establishing the National ADR Reporting System in Taiwan for many years. Dr. Gau’s researches focus on the use of claim database of the National Health Insurance program of Taiwan to study the prescription pattern of drug utilization, the adherence of drug usage to the professional practice guidelines, and the association of adverse reactions and clinical outcomes with the drug used. She has published more than sixty research papers in the fields of pharmaceutical sciences, drug safety, and pharmaceutical regulation in internationally recognized medical journals.
Moderator 主持人
Tsang Wu Liu (劉滄梧), M.D.
Investigator
National Institute of Cancer Research, NHRI, Taiwan
Education 1974-1981 M.D, Medical College National Taiwan University
Academic Appointments 2020.01 – present Investigator & Attending Physician, National Institute of Cancer Research, NHRI, Taiwan 2014.08 – present Deputy Director, National Institute of Cancer Research, NHRI, Taiwan
2002.07 – present Director, Taiwan Cooperative Oncology Group, NICR, NHRI, Taiwan
2006.03 – 2019.12 Associate Investigator & Attending Physician, National Institute of Cancer Research, NHRI, 1996.02 – 2006.02 Assistant Investigator & Attending Physician, National Institute of Cancer Research, NHRI,
Taiwan
1996.05 – 1997.08 Research Associate, Department of Pharmacology, School of Medicine, Yale University, USA
Hospital Appointments 2008.01 – present Adjunct Attending Physician, National Taiwan University Hospital, Taiwan
1996.02 – 2007.12 Adjunct Attending Physician, Taipei Veterans General Hospital, Taiwan
1989.07 – 1996.01 Director, Resident and Fellow Training Program, Koo Foundation Sun Yat-Sen Cancer Center, Taiwan
1989.07 – 1996.01 Senior Staff, Medical Oncology, Koo Foundation Sun Yat-Sen Cancer Center, Taiwan Professional Appointments and Activities 2017.01 – present Member, National Health Insurance Dispute Mediation Committee, MOHW
2016.01 – 2019.12 Chairman, The subcommittee for Review and Approval of Orphan Drugs, Committee for the Review and Examination of Rare Diseases and Orphan Drugs, FDA, MOHW
2008.01 – present Board member & council member, Asian Oncology Society (AOS) (formed from Asian Clinical Oncology Society)
2005.1 – present Member and Principal Investigator, Accreditation of Cancer Care Program, Health Promotion Administration, Ministry of Health and Welfare
2015.01 – 2016.12 Member, Central Board of Cancer prevention and Control, Executive Yuan 2011.05 – 2015.05 President, The Taiwan Oncology Society
2008.09 – 2011.08 Head, Department of Research Planning and Development, National Health Research Institutes
2005.08 – 2008.12 Chairman, Drug Evaluation Committee, the Bureau of Pharmaceutical Affairs, Department of Health
2000.07 – 2006.06 Executive Secretary, Medical Ethics Committee, National Health Research Institutes
Moderator 主持人
Yung Chang Lin(林永昌), M.D.
Director
Clinical Trial Center
Linkou Chang Gung Memorial Hospital, Taiwan Email: yclinof@adm.cgmh.org.tw
Education 1980-1987, Bachelor of Medicine, Taipei Medical College, Taipei, Taiwan
Post-Graduate Education July 1989 - June 1992 Resident, Department of Internal Medicine, Chang Gung Memorial Hospital
(CGMH)
July 1992 - June 1993 Clinical Fellow, Division of Medical Oncology, Department of Internal Medicine, CGMH
July 1993 - June 1995 Fellow, Department of Medical Oncology, Division of Medicine, UT MD Anderson Cancer Center, Houston, USA
Academic Appointment August 1995 - 1998 Clinical lecturer, Chang Gung University.
August 2002 -2011 Clinical Assistant professor, Chang Gung University August 2011- Clinical Associate professor, Chang Gung University
Employment Record 2018- Director, Clinical Trial Center
2014 -2018 Deputy Director, Clinical Trial Center
2013 -2020 Director, Cancer Center, CGMH LinKou branch
2011 Feb-2017 June Director, Division of Hematology/Oncology, Department of Internal Medicine, CGMH, LinKou
July 1995 - Attending Physician, Division of Medical Oncology, Department of Internal Medicine, CGMH, LinKou
IRB Member/Staff 2000- Member of Chang Gung Medical Foundation IRB
2003- Member of Joint IRB
2010- Secretary, Chang Gung Medical Foundation IRB
Moderator 主持人
Chee Jen Chang (張啟仁), Ph.D.
Distinguished Professor
Graduate Institute of Clinical Medical Sciences;
Department of Biomedical Sciences;
Clinical Informatics and Medical Statistics Research Center;
Research Services Center for Health Informatics Chang Gung University, Taiwan
Professor Chang is a biostatistics-trained methodologist, expert in design and analysis of clinical trial and HTA research and development, focus on methodologies, harmacoeconomics modeling and big data analysis. He is a Distinguished Full Professor in Graduate Institute of Clinical Medical Sciences; Department of Biomedical Sciences; Director of Clinical Informatics and Medical Statistics Research Center; and Research Services Center for Health Informatics in Chang Gung University, Taiwan.
Professor Chang receives his PhD in Statistics from University of Iowa in USA. Then he became a faculty member in Department of Epidemiology and Social Medicine at Albert Einstein College of Medicine, Yeshiva University in New York City where he served as a faculty in teaching, research and research services in many clinical related researches.
During his service in AECOM, he helped to establish the General Clinical Research Center and Biostatistical Core of Cancer Center. In 1999, he returned to his birth country in Taiwan and helped to establish Clinical Trial Center in National Taiwan University Hospital. Later in 2006, he was invited to Chang Gung University as a Full Professor and continue his career in teaching and research. He also established a RCT/HTA master program in 2019 to educate the master students who are interested in pursuing their career in these areas.
His interests cover the areas in methodology development and study design of Randomized Clinical Trials (RCT), modeling approaches in pharmacecoeconomics (PE), real world data/evidence (RWD/RWE) derivations in health economics and outcome research (HEOR), which is applicable to health technology assessment (HTA) process of pharmaceutical industries and government agency. He also serves in many government committee members related to new drug approval in TFDA and health insurance reimbursement in NHIA. He was the president of Taiwan Society for Pharmacoeconomics and Outcome Research (TaSPOR), 2012 ~ 2017, and the chairperson of ISPOR, Taiwan chapter. Now, he is the chair-elect for ISPOR Asia Consortium advisory board.
Prof. Chang is a statistical reviewer of many peer review journals and advisor editorial board. He has published more than 250 papers as author or co-author in many peer-reviewed journals.
Keynote Speaker 主題演講人
Shein Chung Chow(周賢忠), Ph.D.
Professor
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, USA
Shein-Chung Chow, Ph.D. is currently a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA. Dr. Chow is also a special government employee (SGE) appointed by the United States Food and Drug Administration (FDA) as an Oncologic Drug Advisory Committee (ODAC) voting member and Statistical Advisor to the FDA. Between 2017 and 2019, Dr. Chow was on-leave for FDA as Associate Director of the Office of Biostatistics responsible for statistical methodology research within FDA. Dr. Chow was the Editor-in-Chief of the Journal of Biopharmaceutical Statistics (1992-2020) and the Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall/CRC Press of Taylor & Francis Group. He was elected Fellow of the American Statistical Association in 1995 and an elected member of the ISI (International Statistical Institute) in 1999. Dr. Chow has published more than 320 methodology papers and 32 books including Design and Analysis of Clinical Trials, Adaptive Design Methods in Clinical Trials, and most recently Innovative Methods for Rare Diseases Drug Development.
Speaker 主講人
Toshimitsu Hamasaki, Ph.D.
Research Professor
Biostatistics Center and the Department of Biostatistics and Bioinformatics, George Washington University, USA
Toshimitsu Hamasaki is a Research Professor of the George Washington University (GWU) Biostatistics Center and the Department of Biostatistics and Bioinformatics. He is the Associate Director of the Statistical and Data Management Center (SDMC) for the Antibacterial Resistance Leadership Group (ARLG), a collaborative clinical research network that prioritizes, designs, and executes clinical research to reduce the public health threat of antibacterial resistance. Prior to joining GWU, he worked at Shiogoni, Pfizer, Osaka University_ and National Cerebral and Cardiovascular Center. His research interests include the design, monitoring, analyses, and reporting of clinical trials. He is the author of more than 200 peer-reviewed publications and four textbooks on statistical methods in clinical trials including "Sample Size Determination in Clinical Trials with Multiple Endpoints"
and "Group-Sequential Clinical Trials with Multiple Co-Objectives".
Dr. Hamasaki is the Editor-in-Chief of Statistics in Biopharmaceutical Research, an Official Publication of the American Statistical Association (ASA). He also currently serves as an Editor for Statistical Communications in Infectious Diseases and an Editorial Board Member for Contemporary Clinical Trials. He served as an Associate Editor or Editor for several journals including Statistics in Biopharmaceutical Research, Journal of Biopharmaceutical Statistics, Japanese Journal of Statistics and Data Science, CHANCE, and Journal of the Japanese Society of Computational Statistics. He is co-chair of the Society for Clinical Trials (SCT) Program Committee. He was the chair of the ASA Committee on International Relation in Statistics, a member of the Steering Committee for the Adaptive designs CONSORT Extension (ACE) Project, an extension to the CONsolidated Standards of Reporting Trials (CONSORT) Statement for adaptive clinical trials, and a member of Implementation Working Group on ICH-E5 Guideline “Ethnic Factors in the Acceptability of Foreign Clinical Data”
as a representative of Japan Pharmaceutical Manufacturers Association.
Dr. Hamasaki is an elected member of International Statistical Institute (ISI) and a fellow of the ASA. He received the Distinguished Article Award from the Japanese Society of Computational Statistics and Hida-Mizuno Prize from the Behaviormetric Society of Japan.
Speaker 主講人
Chin Fu Hsiao (蕭金福), Ph.D.
Investigator
Institute of Population Health Sciences National Health Research Institutes, Taiwan 35 Keyan Rd. Zhunan Town Miaoli 350, Taiwan Tel: 037-246166 ext. 36106
Email: chinfu@nhri.org.tw
Education University of Wisconsin-Madison, Wisconsin, U.S.A.: Ph.D. in Statistics, August 1997.
National Central University, Taiwan, R.O.C.: M.S. in Mathematics, June 1989.
National Central University, Taiwan, R.O.C.: B.S. in Mathematics, June 1987.
Experience 10/2011–Present Investigator
Institute of Population Health Sciences, National Health Research Institutes 8/2014 –8/2020 Deputy Director,
Institute of Population Health Sciences, National Health Research Institutes 1/2011 – 7/2014 Director,
Division of Clinical Trial Statistics,
Institute of Population Health Sciences, National Health Research Institutes 8/2012–Present Adjunct Professor, National Yang Ming University
8/2011–Present Adjunct Professor, National Chiao Tung University 2/2006–Present Adjunct Associate Professor, National Taiwan University 9/2004–9/2011 Associate Investigator,
Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes
2/2001–9/2004 Assistant Investigator, Division of Biostatistics and Bioinformatics, National Health Research Institutes
Keynote Speaker 主題演講人
Haruko Yamamoto, M.D., Ph.D.
Chief Medical Officer, Associate Executive Director Pharmaceutical and Medical Devices Agency, Japan
Since graduating from Osaka University School of Medicine, Dr. Haruko Yamamoto has worked for many years at the National Cardiovascular Center as a specialist in neurology, notably cerebrovascular accidents (acute stroke) and higher brain dysfunction. While playing an active role as a medical doctor on the front lines, Dr Yamamoto directed the research and development of new drugs and medical devices, and the creation of innovation. She also contributed widely to the promotion of the development of new drugs and medical devices in the planning, management, and education of clinical trials and clinical research in her role as Director, Center for Advancing Clinical and Translational. Since October 2020, she has been working for Pharmaceutical and Medical Devices Agency, the Japanese regulatory agency, as the Chief Medical Officer and the Associate Executive Director. She has been one of the 210 Council Members of the Science Council of Japan since October 2020. She received a Ph.D. from Osaka University School of Medicine.
Speaker 主講人
Chien Feng Li (李健逢), M.D., Ph.D.
Chair
Department of Medical Research, Chi Mei Medical Center, Taiwan
Education 1995-2002 Kaohsiung Medical University, Kaohsiung, Taiwan: M.D. in Medicine
2009-2012 National Sun Yat-sen University, Kaohsiung, Taiwan: Ph.D. in Biomedical Sciences
Positions and Employment 2002-2007 Resident, Department of Pathology, Chi Mei Medical Center, Taiwan
2007-2009 Attending physician, Department of Pathology, Chi Mei Medical Center, Taiwan 2009-2019 Chief, Division of Clinical Pathology, Department of Pathology, Chi Mei Medical Center,
Taiwan
2010-2013 Adjunct attending physician, National Institute of Cancer Research, National Health Research Institutes, Taiwan
2010-Present Principal Investigator, Translational Research Laboratory of Human Cancers, Department of Medical Research, Chi Mei Medical Center, Taiwan
2012-2015 Assistant professor, Department of Biotechnology, Southern Taiwan University of Science and Technology, Taiwan
2013-2018 Joint-Appointment Assistant Investigator, National Institute of Cancer Research, National Health Research Institutes, Taiwan
2015-2018 Associate Professor, Department of Biotechnology, Southern Taiwan University of Science and Technology, Taiwan
2017-2021 Chair, Department of Pathology, Chi Mei Medical Center, Taiwan
2018-Present Joint-Appointment Associate Investigator, National Institute of Cancer Research, National Health Research Institutes, Taiwan
2018-2019 Professor, Department of Biotechnology, Southern Taiwan University of Science and Technology, Taiwan
2019-Present Joint-Appointment Professor, Institute of Medical Science and Technology, National Sun Yat-sen University
2020-Present Joint-Appointment Investigator, National Institute of Cancer Research, National Health
2021-Present Chair, Department of Medical Research, Chi Mei Medical Center, Taiwan
Other Experience and Professional Memberships 2004- United States and Canadian Academy of Pathology
2015- International Society of Bone and Soft Tissue Pathology 2019- American Associations for Cancer Research
Honors 2006 IACP best abstract award
2009 Best research paper (Taiwan Academy of Pathology)
2011 Outstanding poster award, Asia-Pacific Congress on Pancreas and Biliary Tract Cancer, 14th TCOG Annual Meeting & 2010 International Conference on Translational Cancer Research 2012 IACP best abstract award (corresponding author)
2012 National Innovation Award (Teamed with National Cheng-Kung University) 2014 IACP best abstract award (corresponding author)
2014 Young Investigator (Encouragement) Award, Japanese Society of Medical Oncology (JSMO) 2014 Travel Award, Japanese Society of Medical Oncology (JSMO)
2014 National Innovation Award (Teamed with Kun Shan University)
2015 Best Poster Award (Multi-national Alliant Gastro-Intestinal Cancer Symposium, 2015) 2015 Travel Award (Multi-national Alliant Gastro-Intestinal Cancer Symposium, 2015) 2015 National Innovation Award (Teamed with Kun Shan University)
2015 National Innovation Award (Teamed with National Cheng-Kung University) 2016 Academic Research Award-Wu-Da-You Memorial Award
2016 Outstanding Alumni Award, National Sun Yat-sen University
2020 Young Investigator Outstanding Cancer Research Award, Taiwan Oncology Society
Journal Editorial Board (SCI) 2010-Present Editorial board, Oncology letters (Spandidos publication)
2018-Present Associate Editor-in-Chief, Cancer Management of Research (Dove Medical Press) 2020-Present Associate Editor, Frontiers in Cell and Developmental Biology (Frontiers Media S.A.) 2020-Present Associate Editor, Frontiers in Oncology (Frontiers Media S.A.)
2020-Present Academic Editor, Medicine (Lippincott Williams & Wilkins)
2021-Present Editorial board, International Journal of Molecular Sciences (MDPI)
Grant Review (International) 2015,2018,2020 Ministry of Health, Italy
2015 Netherlands Organisation for Scientific Research (NWO), Netherlands
Speaker 主講人
Guei Feng Tsai (蔡貴鳳), Ph.D.
Statistical Team Leader
Center for Drug Evaluation, Taiwan Email: gftsai@cde.org.tw
Education Ph.D. Statistics Oregon State University, USA
MS Biometry Division, Dep. of Agronomy National Taiwan University BS Department of Agronomy National Taiwan University
Work Experience 2014 – Current Statistical Team Leader, Division of New Drugs, Center for Drug Evaluation, Taiwan
2006 – 2014 Statistical Reviewer, Division of New Drugs, Center for Drug Evaluation, Taiwan 2005 – 2006 Post-doc fellow, Department of Statistics, Northwestern University, USA
Key Skills Clinical trial design Interpretational skills
Sample size calculation Consultation
Statistical inference and modeling Regulatory guidance knowledge
Speaker 主講人
Wen Yi Shau (邵文逸) M.D., Ph.D.
Senior Medical Director of Taiwan Pfizer Inc.
Work Experience 2015-present Senior Medical Director of Taiwan, Pfizer Inc.
2014-2016 PEH (Pfizer Essential Pharma Business) Medial Lead of Taiwan & APAC Mature Market (Taiwan, Hong Kong & Singapore), Pfizer Inc.
2012-2015 Medical Director of Taiwan, Pfizer Inc.
2008-2012 Principal Researcher, Health Technology Assessment, Center for Drug Evaluation, Taiwan.
2005-2007 Epidemiology Director of Asia Pacific Region, GlaxoSmithKline Pharmaceuticals R&D.
2003-2005 Medical Director, GlaxoSmithKline Pharmaceuticals Taiwan Branch.
2001-2003 Clinical Development Manager, GlaxoSmithKline Pharmaceuticals Taiwan Branch.
1992-1993 Resident, department of surgeon, Hospital of Kaohsiung Medical College, Kaohsiung.
1990-1991 Resident, department of surgeon, Kee-Long Naval Hospital, Kee-Long.
Profession experience 2019-present Adjunct associate professor, Graduate Institute of Clinical Pharmacy, College of Medicine,
National Taiwan University.
2012-present Adjunct associate professor, Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University.
2002-2012 Adjunct assistant professor, Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University.
1998-2001 Teaching assistant, Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University.
Education 1995-2000 Ph.D., Graduate Institute of Epidemiology, College of Public Health, National Taiwan University.
1994-1996 Postgraduate Training Program in Applied Epidemiology, Field Epidemiology Training Program (FETP) of ROC, also certificated by Centers for Disease Control and Prevention, USA.
1994-1995 M.Ph., Graduate Institute of Epidemiology, College of Public Health, National Taiwan University.
1983-1990 M.D., Department of Medicine, Kaohsiung Medical College.
Research interest Epidemiology and Clinical research methodology, Pharmacoeconomic, Health care Database analysis.
Speaker 主講人
Ya Lei Wang (王亞蕾), M.D.
Senior Reviewer
Center for Drug Evaluation, Taiwan E-mail: ylwang448@cde.org.tw
Current Position Section Chief, Division of new drugs.
Professional Experience 2021 - now1 Senior Reviewer. Center of Consultation, Center for Drug Evaluation (CDE), Taiwan.
2018 - 2021 Section Chief. Division of new drugs, Center for Drug Evaluation (CDE), Taiwan.
2013 - 2018 Medical Reviewer. Division of new drugs, Center for Drug Evaluation (CDE), Taiwan.
2013 - now1 Adjunct Physician, Department of Pediatric, Far Eastern Memorial Hospital.
2010 - 2012 Research Fellow in Neonatology. Department of Pediatric, National Taiwan University Hospital.
2007 - 2010 Resident and Chief Resident. Department of Pediatric, National Taiwan University Hospital.
Highest Education 2000-2007 Medical Doctor. Department of Medicine, College of Medicine, National Taiwan University.
