Level: Beginner
【Presenter】
Ono Pharmaceutical Co., Ltd. Reliability Assurance Headquarters Pharmacovigilance Department PV Data Strategy Office Chikara Honda
Masashi Koyanagi, Statistical Analysis Department, PMS Center, Real World Evidence Business Division, EPS Corporation
[Presentation summary]
Pharmacovigilance (PV) is "the science and activities related to the detection, evaluation, understanding, and prevention of adverse effects of medicines or other problems associated with medicines."
This is an important task for pharmaceutical companies. Post-marketing surveillance (PMS) is a type of PV activity based on the characteristics of a drug, and is conducted based on an implementation plan.
In PMS, doctors fill out medical information on questionnaires and collect them in a database dedicated to the study. The information is coded, logically checked, re-examined, etc. in the data management (DM) process, and then compiled in the analysis department. The process from DM to analysis is multi-step, and when unexpected data comes in, a lot of time is spent investigating the cause and responding. In addition, it was difficult to confirm the results without creating a form using the SAS program. So we started using JMP. JMP's interactive visualization and analysis functions facilitated data monitoring (discovering irregularities) and factor analysis with non-analysis department personnel, contributing to smoother work. Currently, we are trying to automate preprocessing using Workflow Builder, with the aim of improving the data quality of the side effect information management database that collects all safety information including PMS data. In this presentation, I would like to introduce some of these and discuss the prospects for utilizing JMP.
[Presenter profile]
Mr. Honda: Ono Pharmaceutical Co., Ltd. Reliability Assurance Headquarters Pharmacovigilance Department PV Data Strategy Office
Joined Ono Pharmaceutical Co., Ltd. in 1998. Engaged in drug discovery target search, drug discovery theme planning, optimization research, and preclinical research at the Research Headquarters. Since 2007, he has been engaged in statistical consultation and educational activities in general non-clinical fields in the research management department, and since 2017 has been engaged in research and development in the oncology field, translational research, and construction of genomic information analysis infrastructure.
Since 2020, we have been conducting PV analysis in the data science department of Pharmacovigilance, and are currently exploring ways to effectively utilize the evidence obtained from the analysis results.
2010 Completed National Institute of Health and Medical Sciences Specialized Course II, Major in Biostatistics
2020 Completed doctoral course, Department of Social Medicine (Biostatistics), Kurume University Graduate School of Medicine
Masaru Koyanagi: EPS Corporation Real World Evidence Business Headquarters PMS Center Statistical Analysis Department
Joined EPS Corporation in 2018. Engaged in statistical analysis of post-marketing surveys in the Statistical Analysis Department. From June 2020, he was dispatched to the Pharmacovigilance Department of Ono Pharmaceutical Co., Ltd. and was in charge of analysis work.
