The Computational Science Symposium (CSS) is a powerful collaboration in support of health product development and regulatory review. The event enables us to work together and share experiences to solve problems and explore new concepts which are critical in driving future innovation.

Last year, we celebrated 10 years of the PHUSE/FDA Computational Science Symposium, albeit virtually. This year, we are thrilled to have been able to welcome you all back to reconnect and rediscover – in person – for our first physical CSS since 2019.

During this year’s event we had 200+ attendees, 23 poster presentations and over 30 Working Group breakout sessions!

Monday – Day 1

Monday kicked off with an FDA-led Plenary Session, with the theme of inspiring attendees to ‘Reconnect and Rediscover’. This was hosted by Lilliam Rosario and Catherine Li from the FDA, who presented on innovation. Each of the PHUSE Working Groups provided us with an update on their activities over the past two years.

This session concluded with the Plane Builder Awards, which recognises all those who have made a significant contribution to the Working Groups over the past 12 months – view the winners below!

After the Plenary Session, attendees enjoyed a Welcome Event sponsored by TrialTwin, which consisted of drinks, canapés and the opportunity for some informal networking! It was clear our attendees loved being able to rekindle connections and collaborate in person. The atmosphere was testament to the fantastic start to the CSS.

Day 1 concluded with a Safety Analytics Workshop centred around Designing EDC for Efficient Adverse Event Collection.

Tuesday – Day 2

Tuesday was a busy day for breakout sessions! Eighteen breakouts took place across six of the Working Groups to advance current projects and explore new ones. This information sharing focused on research, analysis and collaboration.

Replica Analytics delivered an excellent interactive session during the Synthetic Data Hands-on Workshop – ‘An Introduction to Privacy-preserving Synthetic Data’. They covered topics on generating synthetic health data, understanding and evaluating the privacy benefits and risks of synthetic data, and evaluating the utility of synthetic data.

The day concluded with the much-loved CSS Poster Session, sponsored by Entimo. This is a great opportunity for both Working Group and computational science topics to be displayed in a visual manner, with presenters on hand to engage in Q&A.

Wednesday – Day 3

Wednesday began with a Regulatory Update Plenary Session, where attendees heard from health authority speakers on current hot topics related to computational science and took part in a Q&A/interactive discussion.

Anne-Sophie Henry-Eude, EMA, began the session by sharing information on the EMA Raw Data Pilot, a project which PHUSE, in partnership with the EFPIA and the EFSPI, have been providing industry feedback to. Next, the FDA’s John Concato provided an overview of their Real-world Evidence (RWE) Program for drugs and biological products within FDA CDER.

Vaishali Popat, MD, MPH, Associate Director of Biomedical Informatics and Regulatory Review Science, OND, CDER, FDA, closed the session by sharing information on the Office of New Drugs FDA CDER recent release of documents for public review on standard adverse event groupings and queries for evaluation of biologic/new drug applications. This built on the 2020 CSS presentation by Dr Popat – ‘Updates from the Office of New Drugs Pre-Market Safety Analytics Program’. View the presentation recording and slides here.

A further 12 breakout sessions took place on Day 3, including Safety Analytics’ ‘Public Review Advancing Pre-market Safety Analytics’, which discussed initial feedback on the Office of New Drugs Standard Safety Tables and Figures Integrated Guide (STF-IG) and the FDA Medical Queries (FMQ) approach to grouping preferred terms.

Thank You

We would like to thank all those who attended the CSS in person this year for their enthusiasm, open-mindedness and spirit. The value of returning to in-person collaboration was evident in the number of constructive conversations taking place within both the breakout sessions and the coffee and lunch breaks. Particular thanks go to the Working Group Leads and Project Leads, who drove the conversations in the breakout sessions.

While the CSS takes place just once a year, we would like to recognise the many knowledgeable and enthusiastic volunteers who make significant contributions throughout the year. We are very grateful for the efforts of all those involved in advancing the PHUSE Working Groups’ mission to address unmet computational science needs in support of health product development and regulatory review, ultimately bringing safe and effective medical products to those who need them.

We would also like to thank our contributors and exhibitors for their time and dedication in contributing to this event, which truly enabled us to ‘Reconnect and Rediscover’.

A full summary of the CSS was presented in October’s Webinar Wednesday, click the link to watch on demand. Plenary Session recordings and Posters are also now available to access via the PHUSE Archive.

CSS 2022 Plane Builder Award Winners

Every year at the CSS, PHUSE recognises an individual in each Working Group who has been a key contributor over the previous 12 months. PHUSE would like to acknowledge this year’s CSS 2022 Plane Builder Award Winners and thank them for their continued contribution.

Data Transparency – Devaki Thavarajah

Devaki is a long-time contributor to the Data Transparency Working Group and over the past year has shown great dedication to her role. Devaki leads the Educate the General Population on Data Privacy and Data Sharing project, which is in the final stages of producing their first two videos to share with the wider public while being a significant aid to multiple other projects. Devaki has also recently joined the Working Group’s leadership team.

Data Visualisation & Open Source Technology – Melvin Munsaka

Melvin leads the R Shiny Interactive Forest Plot team in conjunction with the American Statistical Association (ASA) to develop R Shiny applications which enable the generation of identified plots for direct inclusion in submission packages for regulatory agencies. The team has achieved the initial goal of developing the tools to generate forest plots for inclusion in submission to the FDA.

Emerging Trends & Technologies – Berber Snoeijer

Berber has been an active member of the Emerging Trends & Technologies Working Group and has contributed her significant expertise to the Real World Evidence project.

Nonclinical Topics – Michael Rosentreter

Michael has contributed valuable ideas, project leadership and preclinical data expertise to the Nonclinical Topics Working Group for many years. Michael conceived, and is currently leading, the SEND Dataset QC Best Practices project. This project has actively surveyed industry, generated an excellent white paper, provided meaningful posters and has prompted ideation across other areas of nonclinical data challenges, such as conformance rule validation and automation scripting. He is also a long-time active expert contributing to the Nonclinical Scripts NSDRG project. Michael is a Preclinical Data Manager at Bayer, and is actively contributing to the Preclinical Development Expert Group (PDEG) for the European Federation of Pharmaceutical Industries and Associations (EFPIA)’s exploration of the use of electronic data for regulatory review of drug applications in Europe.

Optimizing the Use of Data Standards – Ellen Asam and Sandy VanPelt Nguyen

Ellen and Sandy co-lead the Best Practices for Data Standards Governance Implementation project. They have demonstrated a positive impact to the project direction and the volunteers by coordinating and managing the industry survey, poster presentation and drafting of the white paper. Both Ellen and Sandy are equal contributors to the success of the Working Group.

Risk Based Monitoring – Anne Lawrence and Ann Fleenor

Anne Lawrence and Ann Fleenor have led the new project approved this year, Centralised Monitoring Capabilities. They have both been invaluable in organising the project and coordinating the prompt publication of its first deliverable.

Safety Analytics – Mercy Navarro

Mercy has been a co-lead for the Safety Analytics Listings for Clinical Study Reports project team. She has co-led the development of a published white paper and a manuscript to Pharmaceutical Statistics. Mercy has also been very active in presenting at conferences to share the viewpoints and recommendations as described in the publications.

Poster Winners

Industry – Anthony Chow (CDISC) and Nicholas Haydel (CDISC)

PP08 – CDISC Implementation Guides Going Beyond PDF: Full Digital Transformation with Access Through CDISC Library and API

CDISC has been making our data standards available for general consumption in PDF format. CDISC Library is a single, trusted, authoritative source of CDISC standards metadata. Through its Data Standards Browser and API, users have been able to browse and retrieve normative metadata such as SDTM domain specifications, and ADaM variables and data structures. CDISC increasingly focuses on enabling end-to-end process automation and simplifying data transformation throughout the data life cycle. The CDISC Data Science team embarked on a proof of concept project to digitally transform a few implementation guides and make all the content machine-readable, including, but not limited to, informative text, biomedical concepts and conformance rules. This poster aims to discuss technical details such as infrastructure, technology stack and access, plus lessons learned.

Collaboration – Wenxian Wang (BMS) and Brianna Paisley (Eli Lilly)

PP13 – SENDing Toxicology Study Data Analysis into the 21st Century with a New R Package: sendigR

The CDISC-SEND data standard created new opportunities for collaborative development of open-source software solutions to facilitate cross-study analyses of toxicology study data. A public–private partnership between BioCelerate and the FDA/CDER works to develop and publicise novel methods of extracting value from SEND datasets. In collaboration with PHUSE, R package sendigR has been developed to enable harmonisation and visualisation of SEND datasets as variation in application of the SEND standards hampers cross-study analysis. sendigR includes 1) a Python package to harmonise SEND datasets using SEND CT and extensible terminology 2) an R script to construct a relational database from any collection of SEND datasets 3) an R Shiny application with a graphical user interface, allowing users who are not familiar with programming to perform cross-study analyses. sendigR enables experienced R programmers to integrate the package functions into their own custom scripts/packages, enabling continued improvements to the functionality of these tools.

FDA – Jim Wedge (FDA) and Matthew Wiley (FDA)

PP24 – Data Central: Study Data at the Right Time, in the Right Place, in the Right Format

Quick, innovative and adaptive, Data Central is an automated solution used by CDER to acquire, process and deliver reviewer-ready study data from the FDA’s Electronic Data Repository (EDR) to downstream systems and services, for easy and efficient access to clean, usable data. Data Central is comprised of four key components: Data Management/Data Quality Microservices, Workflow Automation, Data Repository/Database and Web-based Application. Built on a hybrid cloud environment, developed using Microservices Architecture and following Agile Methodology, Data Central is designed to be flexible and adaptive to business needs. Since go-live in the autumn of 2020, Data Central expanded its automation capabilities, validation services and metadata offerings (e.g. clinical data checks) by increasing the number of APIs (4+) and connectivity (12+) to downstream systems and service teams.