Symposium 5: Use of real-world evidence (RWE) in
regulatory decision-making: Regulatory guidance andexamples from Asia and the US
Moderator
Darren Toh FISPE, Harvard Medical School and Harvard Pilgrim Health Care Institute,USA
Darren Toh, ScD is an Associate Professor in the Department ofPopulation Medicine at Harvard Medical School and Harvard Pilgrim
Health Care Institute. He is a pharmacoepidemiologist with an interest in
the comparative safety and effectiveness research of medical products.
His research focuses on 1) assessing the risks and benefits of medicalproducts using electronic data collected as part of routine healthcaredelivery, and 2) developing and applying privacy-protecting analytic
methods to conduct multi-center studies in distributed data networks. Darren is Associate
Director of the Therapeutics Research and Infectious Disease Epidemiology (TIDE) group in
the Department of Population Medicine. He is also Chief Scientist at the Operations Center ofthe FDA-funded Sentinel System, a congressionally mandated national medical product safetysurveillance system. Darren received his doctoral degree in Epidemiology from the Harvard
School of Public Health.

Speakers
Darren Toh FISPE, Harvard Medical School and Harvard Pilgrim Health Care Institute,USA
Darren Toh, ScD is an Associate Professor in the Department ofPopulation Medicine at Harvard Medical School and Harvard Pilgrim
Health Care Institute. He is a pharmacoepidemiologist with an interest in
the comparative safety and effectiveness research of medical products.
His research focuses on 1) assessing the risks and benefits of medical
products using electronic data collected as part of routine healthcaredelivery, and 2) developing and applying privacy-protecting analytic
methods to conduct multi-center studies in distributed data networks. Darren is AssociateDirector of the Therapeutics Research and Infectious Disease Epidemiology (TIDE) group in
the Department of Population Medicine. He is also Chief Scientist at the Operations Center ofthe FDA-funded Sentinel System, a congressionally mandated national medical product safetysurveillance system. Darren received his doctoral degree in Epidemiology from the Harvard
School of Public Health.

Jeremy Rassen, Aetion, Inc., USA
Jeremy A. Rassen, MS, ScD is a pharmacoepidemiologist with 25 yearsof academic and industry experience. He is co-founder, president, andchief science officer at Aetion, a health care technology company thatdelivers real-world evidence for life sciences companies, payers, andregulatory agencies. Prior to founding Aetion, Dr. Rassen was AssistantProfessor of Medicine at Harvard Medical School, where he focused on
methods to improve the quality and validity of real-world data studies. He
also worked in Silicon Valley in a variety of tech companies. Dr. Rassen
received his bachelor’s degree in Computer Science from Harvard College and his master’sand doctorate degrees in Epidemiology from the Harvard T.H. Chan School of Public Health.
Yusuke Okada, Pharmaceuticals and Medical Devices Agency (PMDA), JapanMr. Yusuke Okada is a safety reviewer in the Office of Medical
Informatics and Epidemiology at the Pharmaceuticals and Medical
Devices Agency (PMDA) in Japan. He joined PMDA in 2015 and he had
worked in office of generic drugs as a reviewer for 3 years. Then, hetransferred to office of medical informatics and epidemiology. He
currently reviews post marketing database study protocols and conducts
pharmacoepidemiological database studies using healthcare information
databases like MID-NET®. He also has experience in working for qualitycontrol of MID-NET® database.

Jasmanda Wu, Sanofi, USA and ChinaDr. Jasmanda Wu is currently the Board of Director for industry/service
provider for Asia-Pacific region and Chair of Rare Disease Special Interest
Group for ISPE. She became the fellow of the ISPE in 2016. She has over
17 years of experience with pharmaceutical industry spanning real-world
evidence generation, pharmacoepidemiology, pharmacovigilance andbenefit risk assessment for activities across product life cycle.
Jasmanda is currently a Senior Director in the Real-World Evidence &Clinical Outcomes Department, as part of Global Medical within thepharmaceutical company Sanofi. In this role, she leads the development
and execution of real-world research projects applying conventional andadvanced epidemiological methods across a variety of therapeutic areas. Prior to that, she
had expatriation assignment in Asia-Pacific Region and was based in Shanghai, China from2015 to 2017. She served as a real-world evidence/pharmacoepidemiology expert for AsiaPacific R&D and Regional Medical Affair team to support products in development andlaunches.
She obtained her doctoral degree in epidemiology from the University of Michigan Departmentof Epidemiology and obtained a Master of Public Health degree from the University of TexasHouston School of Public Health.
Chi-Chuan Wang, National Taiwan University, Taiwan
Dr. Chi‐Chuan (Emma) Wang, is an Associate Professor at the Schoolof Pharmacy, National Taiwan University. Dr. Wang had herundergraduate pharmacy training from National Taiwan University, andreceived her Masters’ degree in Health Policy and Administration fromWashington State University at Spokane, and her Ph.D. degree in
Pharmaceutical Outcomes and Policy at UNC Chapel Hill. Prior tojoining NTU, Dr. Wang worked as a senior health economist at RTI
Health Solutions. Dr. Wang has particular expertise in study design andextensive experience working on large databases, including

administrative claims data, electronic health records, and national survey data. She has
published several studies evaluating the effectiveness, safety, and costs associated withpharmaceutical products. Dr. Wang’s current work focuses on the integration and applicationof real-world data and was awarded the MOST Young Scholar Fellowship by the Ministry ofScience and Technology in Taiwan in 2018.