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Symposium 9: Three approaches to conduct real-world studies across multiple healthcare systems: common research question, common protocol, and common data model

Tracks
Track 1
Monday, October 14, 2024
8:30 - 10:00
Yasuda Auditorium

Details

It is vital for rationale drug development and assessment of medicines to understand the diversity of patient phenotypes and of delivery of care among healthcare systems across Asia. In addition, there is an opportunity to learn from the similarities and differences in population biology and in the use of healthcare services within the region. The challenge to executing and interpreting such pan-region or pan-global observational studies is coordinating multiple investigators using diverse data systems within a heterogeneity of operating environments.  Enhancing Methodological and Interpretative Skills: This session will provide a framework for in-depth discussions on research methodologies and the interpretation of results, enhancing the analytical skills and knowledge base of ISPE members.  Expanding Research Networks: This session will offer ISPE members a valuable opportunity to broaden their research connections, fostering collaborations and partnerships within the pharmacoepidemiology community.  Fostering a Growth-Oriented Scientific Community: This session will share the experience from analyzing various Asian healthcare database, to cultivate a scientific community that has a growth mindset, and to encourage continuous learning, innovation, and progress in pharmacoepidemiology.


Speaker

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Chin Yao Shen
Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University

Presenter

Biography

Mr. Chin-Yao Shen is a senior PhD student at National Cheng Kung University in Tainan, Taiwan. He has a particular interest in cardiovascular diseases, rheumatoid arthritis, and urology, with several publications in these fields. As a pharmacoepidemiologist, his aim is to generate real-world evidence by integrating diverse datasets from Asian countries to support decision-making in regulatory contexts. Chin-Yao focuses on the design and development of distributed data networks in Asia, particularly using the Common Data Model, to produce reliable evidence through descriptive studies, drug surveillance, and comparative effectiveness research."
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A/Prof Ching Lung Cheung
The University of Hong Kong

Presenter

Biography

Dr. Cheung is an associate professor of Department of Pharmacology and Pharmacy at the University of Hong Kong (HKU). Dr. Cheung obtained his PhD in HKU and post-doctoral training in the Harvard Medical School. His research focuses on the epidemiology and genetics of osteoporosis and related endocrine diseases.
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Jeff Lange
Observational Research Senior Director
Amgen

Presenter

Biography

Jeff Lange earned his PhD from the University of Iowa, serves as an adjunct professor at Hong Kong University, and has been a research scientist with Amgen since 2011. With over 25 years dedicated to advancing the use of real-world evidence to inform healthcare decisions, his career includes research at the Walter Reed Institute of Research, Procter & Gamble, and Amgen. Since relocating to Hong Kong in 2019, he has collaborated with teams and academic partners across East Asia using pharmacoepidemiology to understand the geographic heterogeneity of disease and standards of care to accelerate clinical trials, and to evaluate the benefits and risks of medicines to support regulatory decisions.
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Hojoon Lee
Observational Research Senior Manager
Amgen Korea

Presenter

Biography

Hojoon Lee is an epidemiologist at Amgen, driven by a fervent passion for translational epidemiology. He excels in leveraging real-world evidence (RWE) to inform critical decision-making processes, with a particular focus on regulatory approvals, medical communication, and reimbursement procedures. Hojoon is also dedicated to expanding the role of RWE in early drug development and shaping study designs for clinical trials. Outside of his professional pursuits, he is an avid long-distance runner who enjoys exploring both roads and trails.
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Dr Suzu Chia-Hsien Chang
Observational Research Senior Manager
Amgen Japan

Presenter

Biography

Suzu Chia-Hsien Chang serves as a trained pharmacoepidemiologist at Amgen, where her role is to conduct epidemiological research and analyze real-world data to support the drug development process from clinical phase to post-market stages. Her enthusiasm lies in exploring new data resources, employing robust research methods, and working in teams to address clinical and regulatory questions.

Moderator

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Chieko Ishiguro
Section Chief
National Center for Global Health and Medicine

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Chi-chuan Wang
National Taiwan University

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