PhUSE 2019
Computational Science Symposium Summary

Silver Spring, Maryland
June, 9th–11th 2019

With a record number of Poster submissions for our 8th Computational Science Symposium, it was clear to see that this would be yet another successful PhUSE event. Nearly 260 attendees congregated at the Civic Center in Silver Spring to hear 7 keynote speakers from the FDA, to participate in 4 workshops, and to learn and share their experiences in over 30 breakout sessions.

New additions to this year’s format included a change in schedule from a wintry March to a wet June! The Symposium featured an interactive networking session where all the Working Groups projects had the opportunity to share their project updates and forward-thinking projections over a delicious BBQ, and the introduction of a new recognition reward from the Working Groups Board of Directors in appreciation for a ‘job well done’ supporting the Steering Committee.

Sunday commenced with an overview of the CSS for first-timers and followed with a warm welcome from Lilliam Rosario, Director of the Office of Computational Science at the FDA. Participants then engaged in discussions with Working Groups Leads and project members alike at their booths and were introduced to new project tools such as Squarespace, thought-provoking questions such as When you close your eyes, what do you think about data standards?, together with the opportunity to review the Key Performance Indicators Phase I survey findings.

Three workshops drew the evening to a close: Safety Analytics, Let’s Make a Knowledge Graph! and Design Thinking Focus Group. Attendees discussed gaps in safety analytics knowledge across all functions, the current level of learning in the industry and how to use a web application to diagram relationships for clinical trial processes and data and then convert your whiteboard drawing to Resource Description Framework (RDF).

Monday morning kicked off with a two-hour plenary session hosted by the FDA on CDER/CBER Perspectives in the Use of Study Data for Regulatory Reviews. Topics presented included (1) Technical Rejection Criteria (TRC) for study data; (2) the use of standardised SEND study data in nonclinical regulatory review in CDER; (3) the use of standardised study data and analytical tools for clinical safety evaluation in CDER; (4) study data traceability, transformation, mapping, consistency, and challenges for clinical reviews in CDER; and (5) study data considerations from a CBER perspective.

The six Working Groups then went into their breakout sessions and information sharing. Experiences centred around SEND Implementation, Cloud Adoption, SDTM ADaM FAQs, Data Visualisation, CDISC Implementation Primer, and many more.

Monday concluded with the traditional Poster Session and a Machine Learning Programming Workshop.

Following the continued Working Groups breakouts and the summary wrap-up, Tuesday’s Closing Session looked at defining the next opportunities for the CSS in the format of a panel. The audience then took to a table discussion to provide their thoughts on:

Which “disruptive technologies” are of the most relevance to clinical data scientists and why? Which challenges could these disruptive technologies help address?

What can the PhUSE Working Groups do to bring these technologies to a wider audience? What can industry and regulators do to bring these technologies into day-to-day operations?

What do the PhUSE Working Groups need to do to expand, engage and energise the volunteer base?

Responses were then summarised and each panellist had the opportunity to provide their personal thoughts on where we should focus our efforts to help the growth of PhUSE and to fill the gaps in the market. Watch this space!

Finally, during a ceremony of certificates and gifts, project members, poster presenters and a Working Group Lead were congratulated and thanked for their contributions to PhUSE over the past year. We reflected on the hard work and dedication of our members to make PhUSE what it is today, a global organisation with an international membership of more than 9,000 clinical data scientists.

All presentations, together with a list of our winners, can be found here. There is still time to provide your CSS feedback by following this link to our survey.

Thank you to each and every one of you who has made this possible. We truly did Connect, Share, Advance. Now on to the EU Connect!


 

 

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