Symposium 7: Government-Industry-Academia Collaboration in Postmarket Outcome Validation Studies in the Era of Real-World Data: Design Considerations, Challenges and Future Opportunities
Tracks
Track 3
| Sunday, October 13, 2024 |
| 14:45 - 16:15 |
| Ito International Research Centre |
Details
In the United States and Europe, real-world data (RWD), including claims data and electronic health record data, are commonly used for post-approval observational studies, with real-world evidence algorithms developed and validated to identify various disease outcomes. In Japan, the Good Post-marketing Study Practice (GPSP) has been revised to allow the use of RWD for post-market safety studies, requiring an outcome validation study beforehand. However, there are still few examples of validation studies in Japan and even fewer examples of government-industry-academia collaboration.
This symposium will summarize on regulatory expectation, design considerations, and challenges in designing and conducing outcome validation studies. It will also offer additional insights and suggestions for future opportunities.
Validation studies in general and especially the challenges in conducting them are of great interest to ISPE’s membership, particularly in the Asia-Pacific region, due to the unique challenges and opportunities it presents. And the majority of RWE algorithms and methodological advancements have primarily been developed using data sources from the United States or Europe. Asian countries often have stricter privacy laws that prohibit direct access to patient identifiers in RWD, necessitating multi-institutional efforts for data sampling and analysis. Additionally, there is limited funding for clinical research, which requires robust government-industry-academia collaboration involving clinical and method experts, government support, and industry innovation. This symposium aims to address these challenges and foster a better environment for high-quality postmarket studies, including validation studies, by leveraging diverse resources and expertise.
Speaker
Prof Naoki Nakashima
Kyushu University
Presenter
Biography
Kensuke Kataoka
Tosei General Hospital
Presenter
Biography
Mari Matsui
Pfizer R&D Japan
Presenter
Biography
Ms. Mari Matsui is a senior manager of PMS Affairs, Pfizer R&D Japan. In this position, Ms. Matsui is responsible for planning and operation of post marketing surveillance and has over 15 years’ experience in the pharmaceutical industry.
Dr. Yujing Huang
Eli Lilly and Company
Presenter
Biography
Yujing is currently a Senior Director in the Global Patient Safety-Pharmacoepidemiology group at Eli Lilly and Company. A trained epidemiologist with over 10 years of research experience in the pharmaceutical industry, she specializes in designing and executing RWE/observational studies, with a strong focus on drug safety. In her role, she provides strategic epidemiological support and risk management planning to support global product development across its lifecycle. She has experience working with RWD from both US and Japan.
Hotaka Maruyama
Pharmaceuticals and Medical Devices Agency
Presenter
Biography
Mr. Hotaka Maruyama is a reviewer in the division of Pharmacoepidemiology, Office of Pharmacovigilance I at PMDA.
In this position, he is mainly engaged in plan and analysis of post-marketing DB studies.
He also has experience conducting outcome validation studies using MID-NET® collaborated with academia.
Moderator
Kazuto Nomura
Pfizer
Soko Setoguchi
Rutgers University
