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Hanming Tu is a highly experienced professional with over 25 years of expertise in information technology, information security, database administration, data integrity, data analytics and project management, with more than 20 years of experience in the pharmaceutical industry and CDISC standards. He is currently the Co-Founder and Chief Information Officer at Ashanda, having previously held positions such as Security Officer, VP of

IT and Database Administration (DBA) at Frontage Laboratories

, Director of Clinical IT

at Octagon Research

and DBA Manager at Accenture.

Hanming has participated in several CDISC standard development teams, where he has contributed to the initial development of CDISC standards such as the Study Data Tabulation Model (SDTM), the Operational Data Model (ODM) and the Protocol Representation Model (OPM). He has also been involved in e-submission and data conversion projects and architected the Automated Data Conversion Development (AutoDCD) program for a large FDA data conversion project at Octagon Research. Moreover, Hanming has developed a Define-XML generator and contributed to the CheckPoint application for SDTM data validation using Oracle PL/SQL language at Accenture.

In addition, Hanming has been a Co-Lead for the Standard Analyses and Coding Sharing Working Group at PHUSE since 2012. This Working Group merged with others to become the current Data Visualization and Open Source Technology Working Group in 2020. Through his participation in these Working Groups, Hanming has contributed to the discussion and presented numerous times on emerging technologies, data

standardisation, data

visualisation, data transformation and automation intelligence

at industry conferences such as DIA, CDISC,

PHUSE and PharmaSUG

. He

is also an active contributor to the open-source community, having published several R and R shiny packages in Comprehensive R Archive Network (CRAN), Perl modules in the Comprehensive Perl Archive Network (CPAN)

, and developed several Python packages.

Apart from his work in information technology and the pharmaceutical industry, Hanming holds a master’s degree in city and regional planning from Ohio State University and a

master’s degree in physical geography from Central China Normal University.

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mike.stackhouse@atorusresearch.com

Michael Stackhouse is the Chief Innovation Officer at Atorus Research. He has extensive CDISC experience, working with both Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards, and serving as a subject matter expert for Define.xml. He holds a bachelor’s degree from Arcadia University, where he studied business administration, economics, and statistics. He is a 2020 UC Berkeley School of Information Master of Information and Data Science (MIDS) program graduate, where he worked on projects involving computer vision, natural language processing, cluster computing, and deep learning. His special interests include automation, machine learning, big data technology, and mentoring rising programmers.

Previously, Michael was a senior manager of statistical programming at Covance, where he led U.S. innovation activities for the FSP department. Under his guidance, projects achieved data standardization according to SDTM standards on upwards of 75 studies, including database integration and data warehousing. He also managed programming activities through a multiagency submission for multiple studies across a single compound. In addition, he took on multiple automation projects, including the development of a tool capable of dynamically locating programming independence violations and automatically detecting protocol deviations, as well as the creation of data pipelines around tracking systems for programming deliverables. Michael and his team at Atorus have been actively developing and releasing open source R packages, such as pharmaRTF and Tplyr.

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nmasel@its.jnj.com

Nicholas Masel is the Associate Director Innovation Team Lead within Clinical & Statistical Programming at Janssen R&D. In this role, he is responsible for leading the design and implementation of technical solutions for global department use, as well as exploring emerging tools and technologies for potential practical application in support of portfolio needs. Some of his work relevant to the Data Visualization and Open Source Technologies scope of work include helping to lead the transition of Janssen R&D’s Statistical Programming group from an SAS-based environment to an environment that supports SAS, R and Python. Nicholas’s responsibilities include leading the R Implementation Team, developing internal and external R packages, validating R packages, and developing and deploying Shiny applications within the current ecosystem. He is also an active member and contributor to several external organisations beyond PHUSE. He is the Janssen representative for the pharmaverse Adoption Working Group and Technology and Templates Working Group, TransCelerate’s Modernization of Statistical Analytics project and a member of R Consortium’s Infrastructure Steering Committee. He also contributes as an R package developer to logrx, envsetup and tidytlg.