The third PharmaSUG Japan SDE turned into a virtual event this year, and was again very successful. Many thanks to all of those who attended, and to all of the presenter! Please send your feedback and ideas for future events via email to This email address is being protected from spambots. You need JavaScript enabled to view it.. The slides are available for download below.

Friday, November 6 Single-Day Event

Presentation (click for abstract)	Presenter (click for bio)	Slides
Collection, Analysis, Visualization, and Sharing for COVID-19 Insights: Cloud-based Data-driven Approach	Naoki Mashiko, Amazon Web Services	Slides (PDF, 45.8MB)
COVID-19 Update – Emerging Trends and Data about SARS-CoV-2 Epidemiology and Genetics from a Data Analytics Perspective, Practical Guidance and Insights from PerkinElmer and TIBCO® *	Dan Weaver, PerkinElmer Bioinformatics Michael O’Connell, TIBCO	Slides (PDF, 6.4MB)
Responding to COVID-19 Leveraging Analytics	Toru Tsunoda, SAS Institute Japan	Slides (PDF, 2.8MB)
CDISC Response to COVID-19 *	Bess LeRoy, CDISC	Slides (PDF, 3.1MB)
Skill Building of Modeling & Simulation and its Applications	Takamichi Baba, Shogo Miyazawa, Satoki Fujita and Yoshitake Kitanishi, Shionogi & Co., Ltd.	Slides (PDF, 2.7MB)

Seminar and Presentation Abstracts

Collection, Analysis, Visualization, and Sharing for COVID-19 Insights: Cloud-based Data-driven Approach
Naoki Mashiko, Amazon Web Services

Healthcare and life sciences organizations are accelerating global COVID-19 response from research, development, clinical care, and prevention. In order to find and share important insights in real-time, a data-driven approach - collecting, analyzing, and visualizing broad and large-scale data – is essential to be more agile, innovative, and effective.

AWS, among others, collaborate such organizations to host open data for COVID-19 response; anyone can experiment and analyze curated COVID-19 related data and share results and insights with other collaborators. In this session, we will share data-driven use cases and how the cloud solved and contributed the current issues with reference architectures and best practices.


COVID-19 Update – Emerging Trends and Data about SARS-CoV-2 Epidemiology and Genetics from a Data Analytics Perspective, Practical Guidance and Insights from PerkinElmer and TIBCO®
Dan Weaver, PerkinElmer Bioinformatics
Michael O’Connell, TIBCO

The COVID-19 situation continues to evolve with new and expanded data sets becoming available every day. The PerkinElmer and TIBCO teams continue to analyze this data to provide additional insights for the research community. Our Experts show how the TIBCO Spotfire platform and Lead Discovery Premium solution can help us to gain a better understanding of COVID-19. Topics include the history of Coronavirus (MERS, SARS and COVID-19) and what we currently know about its genetics, sequence and structure analysis. In addition analyses of COVID-19 associated proteins via Lead Discovery Premium will focus on how the disease has evolved as it has spread, and exploration of preliminary insights on human genetic factors that drive severity of COVID19 symptoms will be discussed.


Responding to COVID-19 Leveraging Analytics
Toru Tsunoda, SAS Institute Japan

SAS believe many social issues can be resolved leveraging analytics and is proud to be part of the Data for Good movement, which encourages using data in meaningful ways to solve humanitarian issues around poverty, health, human rights, education and the environment. To effectively mitigate the disruptions caused by COVID-19, various global and local initiatives have been taken within SAS. They include support to COVID-19 researches, prediction of patients and contact tracing. In this session, SAS’ belief and some initiatives / use cases will be shared.


CDISC Response to COVID-19
Bess LeRoy, Head of Standards Development, CDISC

In late March 2020, CDISC convened a Task Force to address challenges around standardizing COVID-19 data. Members of the Task Force included industry stakeholders, regulators, academia, and key CDISC data standards staff. The Task Force worked over a period of four weeks and on April 21st, 2020 published guidance on three areas of focus: a CDISC Interim User Guide for COVID-19 for studies developing treatments and vaccines for COVID-19, guidance for ongoing studies disrupted by the COVID-19 Pandemic, and resources for public health researches which included annotated case report forms and mapping spreadsheet for a tool developed by the World Health Organization (WHO) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). This presentation will describe the development process that was followed and the lessons since publication.


Skill Building of Modeling & Simulation and its Applications
Takamichi Baba, Biostatistics2 Group, Biostatistics Center, Global Development Division, Shionogi & Co., Ltd.
Shogo Miyazawa, Data Science Office, Integrated Disease Care Division, Shionogi & Co., Ltd.
Satoki Fujita, Data Science Office, Integrated Disease Care Division, Shionogi & Co., Ltd.
Yoshitake Kitanishi, Head of Data Science Office, Integrated Disease Care Division, Shionogi & Co., Ltd.

Modeling and simulation (M&S), which aims to predict future realities and make experimental inferences in a virtual setting from various and complex data, is not only used for evaluating pharmacokinetics but also for economics, hygiene and so on. The SIR model categorized under M&S, which has been used internationally due to the current Covid-19 epidemics, is highly contributory to decision making. Therefore, M&S is attracting more and more attention on a global scale. Shionogi has accumulated data on how to efficiently apply M&S in various critical decision making situations In this presentation, we would like to introduce our efforts by focusing on M&S in the field of infectious diseases. Through M&S, we have been promoting the understanding of the transmission of infectious diseases and the assessment of the impact of infectious diseases on society and the treatment there of. In order to carry out the evaluation efficiently, we have established an organization to utilize various analyses software ​​including Open Source Software such as SAS, MATLAB, R, Python, Berkeley Madonna, etc. We have applied M&S not only to respiratory infections but also to infections transmitted sexually or through mosquitoes. We have also been promoting discussions with each value chain. Throughout this talk, we will introduce our way of construction of organization for these analyses, and concrete and situational analysis examples. In addition, there are some cases in which the transmission of diseases is not limited to infectious diseases but is also applicable to other diseases, and the use of M&S is rapidly expanding. With that, we would like to share the latest cases.

Presenter Biographies

Takamichi Baba Takamichi Baba has been working for Shionogi for four and a half years. During his first three years, he was a statistical SAS programmer who made and reviewed ADaM/TLF, as well as planning real-world data analysis for exploring clinical hypotheses in Data Science Group. Since April of 2019, he has been working as a clinical trial statistician and data analyst of transmission of infection disease.
Satoki Fujita Satoki Fujita has been working for Shionogi for one and a half years as a Data Scientist. He is actively working on the application of artificial intelligence technology by using various analysis software.
Yoshitake Kitanishi Yoshitake Kitanishi is the Head of Data Science Office at Shionogi & Co., Ltd and has been using SAS/R/Spotfire for 15+ years.
Bess LeRoy Bess LeRoy is the Head of Standards Development at CDISC. Bess has been a CDISC team member since 2011 and has been involved in the development of 16 CDISC Therapeutic Area User Guides. She is a member of the CDISC Technical Leadership Team and leads the Global Governance Group. Bess has over 15 years' experience working in public health research and has held positions at the Framingham Heart Study, the Rotterdam Study, the Arizona Cancer Center, and the Critical Path Institute. Bess has a BS from the University of Michigan, an MPH from Boston University School of Public Health, and is currently pursuing a DrPH from Johns Hopkins Bloomberg School of Public Health.
Naoki Mashiko Naoki Mashiko is a Senior Solution Architect for enterprise healthcare and life sciences (HCLS) customers in Amazon Web Services (AWS) Japan, technically helping customers to build new businesses and services on AWS. He also leads the internal technical community for HCLS in Japan.
Shogo Miyazawa Shogo Miyazawa has been working for Shionogi for three and a half years as a Data Scientist. He explores the new value of real-world data by applying various methods to it.
Michael O’Connell Michael O'Connell is Chief Analytics Officer at TIBCO Software, helping clients with analytics software applications that drive extreme business value. Michael's passion involves identifying insights with visual and predictive analytics and turning these insights into actions across business operations. Michael has written more than 50 scientific papers and several software packages on visual analytics and statistical methodology. His current book, "A Picture is Worth a Thousand Tables," is published by Springer.
Toru Tsunoda Toru Tsunoda is a Customer Advisor from SAS Institute Japan. After working for several management consulting firms, he joined SAS Institute Japan. He is responsible for the health and life science industries.
Dan Weaver Dr. Daniel C. Weaver is the Senior Product Manager and Solutions Architect for Lead Discovery Solutions at PerkinElmer Informatics. Prior to joining PerkinElmer, Dr. Weaver was the Director of Scientific Computing at Array Biopharma, Inc. in Boulder, Colorado, where he led all aspects of scientific software development and acquisition. Over the course of the last decade, Dr. Weaver’s team delivered systems to support scientific endeavors ranging from target identification though drug discovery and into clinical development and translational medicine. In a previous life, Dr. Weaver was the Lead Scientist for Gene Expression Analysis at Genomica. He received his doctorate in developmental genetics from the University of Colorado, Boulder under the direction of Dr. William B. Wood where he studied patterning in early development.