This plenary session examines the evolving landscape of Real-World Evidence (RWE) across the Asia Pacific region, where adoption varies significantly between countries despite growing interest. Speakers will explore how RWD/RWE is increasingly supporting decision-making in life sciences, regulatory approvals, and reimbursement. The session will highlight regional efforts while addressing critical challenges including data availability, data quality, interoperability, privacy concerns, and potential biases. Attendees will gain insights into how RWE can play a role in decision-making process and discover practical lessons for infrastructure development and capacity building specific to Asia Pacific healthcare environments.
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Mahendra Kumar Rai, PhD
EVERSANA, Singapore, Singapore
Dr. Mahendra Rai is a Regional thought leader in HEOR & RWE with over 20 years of experience. At EVERSANA, he heads the HEOR, RWE and Medical Affairs for the APAC region. Mahendra’s core responsibility is to provide actionable insights to healthcare companies, based on real world data, in the process facilitating informed decision-making at both strategic and tactical levels. He has experience in pricing and market access, outcomes research, health economics, real world insights and observational research spanning across the healthcare spectrum covering pharmaceuticals, medical devices and diagnostics and OTC categories. Mahendra has been part of various HTA engagement programs and has successfully managed over 50+ HTA submission globally including US, EU, APAC and ME markets. He has been instrumental in generating local evidence in APAC and ME markets and is an expert on TLR/SLR methodologies and PE Modelling. Mahendra’s academic training includes a M. Pharma in Hospital Pharmacy (DISPAR) and a PhD in Clinical Research. Mahendra is currently the President for ISPOR India, Mumbai chapter and Ex-Chair for the RWE Council of Indian Society for Clinical Research (ISCR).
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Sallie Pearson, PhD
The University of New South Wales, Sydney, Australia
Professor Sallie-Anne Pearson is a leading Australian pharmacoepidemiologist renowned for her pioneering work in population-based research using routinely collected health data. She currently serves as Professor of Health Systems at the School of Population Health, UNSW Sydney, where she heads the Medicines Intelligence Research Program and is the Theme Principal for Health Systems Research within the Faculty of Medicine and Health. Professor Pearson’s research focuses on generating real-world evidence on the use, benefits, and safety of prescribed medicines. She has led numerous national and international studies leveraging big health data to inform medicines policy and improve healthcare delivery. As Director of the NHMRC Medicines Intelligence Centre of Research Excellence (MI-CRE), she coordinates a collaborative network of researchers from nine Australian universities and six leading international institutions, aiming to accelerate evidence development for policy decision-makers. A passionate advocate for the ethical and effective use of health data, Professor Pearson has played a pivotal role in shaping governance frameworks for data linkage in research. She chaired the NSW Population Health Service Research Ethics Committee for over a decade and continues to serve on several high-level advisory bodies, including the Drug Utilisation Sub-Committee of the PBAC, the Australian Commission for Safety and Quality in Health Care, and the National Data Advisory Council. Her contributions have been recognised with numerous accolades, including the Distinguished Investigator Lifetime Achievement Award from the Health Services Research Association of Australia and New Zealand, and the New South Wales Premier’s Award for Outstanding Cancer Research. Professor Pearson is also a committed mentor and educator, celebrated for her leadership in higher degree research supervision and her involvement in global initiatives such as the Homeward Bound program for women in STEMM.
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Bor-Sheng Ko, PhD, MD
National Taiwan University Hospital, New Taipei City, Taiwan
Dr. Bor-Sheng Ko is currently serving as an associate professor in National Taiwan University College of Medicine (NTUMC), and the director of the Department of Hematological Oncology at the National Taiwan University Cancer Center. Additionally, he works also as an attending physician in the Division of Hematology at the Department of Internal Medicine in the National Taiwan University Hospital (NTUH), and holds the position of director at the Tai-Cheng Cell Therapy Center at National Taiwan University. He obtained his medical degree from the NTUMC in 1995 and completed his clinical training in internal medicine and Hematology/Hematopoietic stem cell transplant (HSCT) fellowship at the NTUH. In 2011, he earned his PhD from the Institute of Clinical Medicine at NTUMC. Dr. Ko spent a year as a visiting research scholar at The University of Texas Health Science Center and MD Anderson Cancer Center in Houston, Texas, USA from 2006 to 2007. He also worked as a joint investigator at the National Health Research Institute in Taiwan from 2010 to 2014. Dr. Ko was elected as the President of Taiwan Society of Blood and Marrow Transplantation from 2019 to 2022. He also served as the president of the Taiwan Society of Pharmacoeconomics and Outcome Research (TaSPOR/ISPOR Taiwan Chapter) from 2018 to 2023, and currently is still the executive director; in addition, he is member of Executive Committee of Asian-Pacific Blood and Marrow Transplantation (APBMT) Group. Currently he is the president of the Hematology Society of Taiwan (HST). His research interests focus on hematopoietic diseases and HSCT, and pharmaco-economics. Recently, he has been involved in establishing databanks, conducting big data analysis, and integrating machine learning and deep learning algorithm into medical practice. Dr. Ko is an active scholar who has published numerous works in reputable international journals within his areas of interest.
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Boxiong Tang, PhD, MD
TZ Health, Collegeville, PA, United States
Dr. Tang brings over 27 years’ experience in medicine, public health, and health economics & outcomes research (HEOR). Currently, he is a founder and principal of TZ Health providing leadership and consulting service to healthcare organizations. Previously, he served as an AVP of HEOR at Agenus, responsible for HEOR strategies globally. He established HEOR function to support the product launches and reimbursement globally. Before joining Agenus, Dr. Tang was the Executive Director/Head of HEOR at BeiGene, Sr. Director of Global HEOR at Teva Pharmaceutical. Senior Director of Health Outcomes Research at Pfizer Emerging Markets, Director of HEOR in JNJ and GSK. He was also an adjuvant professor of China Fudan University and faculty of Zhejiang University Medical School. Meanwhile, Dr. Tang was the 2016-2018 Chair of the HTA (Industry) Committee, Asia Consortium of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), and a current member of Asia Consortium Executive Committee. Also, he served as a Sr. Fellow at Thomas Jefferson University, School of Population Health. Dr. Tang’s training includes an MD in Preventive Medicine, a PhD in Health Services Research, and an MPH in Health Planning and International Health. He has published more than 40 manuscripts in peer review journals, 100+ abstracts, speeches, and presentations in major scientific congresses. He is knowledgeable in the development of Health Technology Assessment around the world. In addition, he served at the Scientific Committees of International Health Economics Association (iHEA/ASHE), Society for Medical Decision Making (SMDM), and a Peer Reviewer of America Journal of Managed Care, and Cancer Research Journal.
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Yoshiaki Uyama, PhD
Pharmaceuticals & Medical Devices Agency (PMDA), Tokyo, Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH E15, E16 and E17 Expert Working Groups, and Pharmacoepidemiology Discussion Group. He is also served as a member of the DIA Council of Regulators and a board member of the international society for pharmacoepidemiology as well as a visiting professor in Chiba University (Graduate School of Medicine), Nagoya University (Graduate School of Medicine) and Nagoya City University (Graduate School of Pharmaceutical Science).
The use of real-world evidence (RWE) continues to increase but has yet to reach its potential and maximize value. There is a long history of RWE in post-market reviews to monitor drug safety, effectiveness, and value-based pricing; however, RWE for decision-making such as drug approvals, health technology assessment and clinical practice remains in its development. Access to large – population level - real world databases is fundamental as is developing robust methods for standardized analysis of data and collaboration across jurisdictions remains in its infancy.
This plenary panel explores the future for RWE in HEOR and addresses questions around what do we, as HEOR experts, need to do to develop and optimize the use of RWE? How should we go about getting RWE into decision-making and clinical practice? What should we be doing to foster the development and use of RWE? Is there a place for using AI in RWE? If a harmonized HTA ecosystem was sought, can RW data and RWE provide the uplift needed to harmonize systems?
