The PHUSE US Connect conference in North Bethesda, Maryland in February proved to be another insightful and fun conference, presenting us with some great keynote speakers and inspiring talks. As Premier Supporters of PHUSE, it was great to meet up with fellow industry leaders and innovators to share, learn, and discuss where the bio-pharma space and world of biostatistics is heading.
We hosted live demonstrations at our booth and expanded upon these subjects through our workshops, posters, and presentations. Stuart Malcolm, our Head of Standards, Efficiency, and Automation, co-hosted a Dataset-JSON Submission Pilot Workshop facilitated by PHUSE, CDISC, and the FDA and presented a poster on ‘Software Product Lines Framework: How to manage end-to-end metadata-driven automation at scale’. Amy Booth, Senior Programmer, co-presented on ‘Standards Library: Getting started – A Medical Device Case Study (DS06)’ with Instem. Using a Medical Device case study, they covered library structure, process flows for submission deliverables, validation, metrics reporting, lessons learned, and future automation goals.
Many other presentations covered a variety of topics and discussions, including R-Submissions, AI/ML use cases, Digital Protocol, OMO, and much more! Discover our key highlights at PHUSE US Connect this year:
The Clinical Trials Process is still Fundamentally Broken!
Peter Ronco, Chief Executive Officer at Emmes, kicked-off proceedings with a barn-stormer of a keynote! Reflecting on 30 years of experience, Peter challenged us to change, asking “What are you going to be responsible for changing?” and reflected upon the PHUSE motto to “Connect. Share. Advance”.
CDSIC Analysis Results Standards
Bess LeRoy, Head of Standards Innovation at CDISC, gave an update on the development of the CDISC Analysis Results Standard, where she talked about the Genentech {cards} package which also had a great summary poster by Daniel Sjoberg, Senior Principal Data Scientist at Genentech. The {cards} project is a perfect example of the power of open-standards meets open-source.
Automating the Creation of ADaM
Building on last year’s presentation on automating SDTM and ADaM, Lyubov Sushchenko, Senior Submission Data Standards Leader at Sanofi, presented on automating VLM for ADaM. ADaM automation is late to the party so it’s great to see this being shared; it is just as possible as SDTM and TFL, and arguably has a bigger impact on quality!
The Many Use Cases of Metadata
Sanjiv Ramalingam, Director, Statistical Programming at Biogen, first discussed the metadata repository that they have developed, which has matured to the point where there is real value in having the source metadata. For example:
- The new IVDR In-vitro device regulation meant that there is a need to identify all assessments done in European sites.
- The repository can be used to accelerate activities such as specification creation, and provide management oversight such as what % compliance to standards is being achieved.
Overall, the objective is to reduce timelines – a message which resonates with the Day 1 keynote.
Statistical Programming Using Synthetic Data
Faezeh Moshfeghifar, Data Management Process & Innovation Specialist at Novo Nordisk, presented an innovative project to generate synthetic test data by ‘driving’ the EDC, to allow programming to be tested end-to-end before ‘real’ data is available.
This is a different approach than the one that Matt Travell, Head of Innovative Technologies and Analytics at Jazz Pharmaceuticals, presented at PHUSE EU Connect 2023 on generating realistic SDTM data. It’s great to see activity in this space as it holds the promise of significantly reduced timelines and increased quality – what’s not to like?!
Open-source and Visualisation
Michael Rimler, Strategic Integration Lead at GSK, and Ross Farrugia, Data Engineering Product Family Lead, Data Science Acceleration, Pharma Development Data Sciences at Roche kicked off Day 2 with an entertaining and interactive Keynote on Open-Source. They shared many good points, but the main takeaway for me was the benefit of collaborative working across the industry. R-Shiny is perhaps the best example of how Open-Source projects can allow us to create innovative solutions more quickly and easily.
Steve Wade, Senior Principal Analytics Programmer, and Sudhir Kedare, Senior Principal Analytics Programmer, both from Jazz Pharmaceuticals, presented an R-Shiny interactive clinical study report (iCSR) application that demonstrated real-time dynamic data exploration that improves the data review process compared with using static TFL.
And much, much more!
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