Held 20–21 May in Utrecht, the Netherlands, the PHUSE Computational Science Symposium (CSS) 2025 brought together a vibrant community of passionate individuals for a collaborative and engaging event.

With two regulatory Plenary Sessions, 21 poster presentations and 29 Breakout Sessions driving Working Group momentum, the CSS delivered connection, clarity and plenty to take forward.

Keep reading for full summaries of each day.

Tuesday – Day 1

The CSS opened with a thought-provoking Plenary Session, with great presentations from Anne-Sophie Henry-Eude and Daniel Morales (both EMA). We heard about the evolution over the past decade of the EMA Transparency Department and how they are addressing the challenges of the future by providing many aspects of EMA activities. Our second presentation introduced developments in the use of RWE in regulatory decision-making, covering aspects from RWE generation, data quality, the vision of HealthData@EU and how the EMA is developing methodological guidance.

We then took a moment to recognise standout contributions through our Plane Builder Awards. Details of our award winners can be found below.

Attendees enjoyed a rich variety of Working Group Breakout Sessions – 16 in total – covering a wide spectrum of topics, from data submission and transparency to nonclinical data, AI in clinical trials, open-source tools and real-world applications of the teal framework. The Working Groups also held update sessions, evaluating ongoing projects and identifying new opportunities for collaboration.

The day also included a Poster Session, where attendees explored emerging ideas and research findings in an informal setting. Many enjoyed the chance to connect with our poster presenters face-to-face and continue conversations sparked by the morning’s sessions.

Wednesday – Day 2

Day 2 of the CSS featured another engaging line-up of Working Group Breakout Sessions and a compelling Plenary Session.

Across 13 Working Group Breakout Sessions, attendees explored a range of topics, from anonymisation trends and the use of SEND data, to advancing innovation in pharma, image de-identification and the application of Dataset-JSON and CDISC concepts.

In the Plenary Session, we heard from three EMA speakers: Frank Pétavy, Noémie Manent and Luis Pinheiro. They shared forward-looking perspectives on how the EMA are embracing data analytics, the digitalisation of the protocol and the opportunities that presents as part of ICH M11. They also discussed how the EMA are both considering what appropriate AI regulation may look like as part of medicine development and how they might make use of these tools to facilitate review.

The day concluded with the Poster Awards, where we proudly recognised our best Industry and Collaboration posters. You can find details of our winners below.

Thank You

PHUSE would like to thank all those who attended the CSS for their open-mindedness and innovative spirit, many of them having the opportunity to attend a PHUSE Working Group meeting for the first time. The energy and enthusiasm across both the Breakout Sessions and the coffee and lunch breaks is a testament to the value of in-person collaboration in advancing the efforts of the PHUSE Working Groups.

Particular thanks go to Danone Research & Innovation, our venue host, and to Paul Vervuren and Jean-Marc Ferran, our CSS Chairs, who have worked tirelessly over the last few months to bring such an exciting agenda to the attendees. We’d also like to acknowledge the poster judges for their contributions in encouraging and supporting the development of content for the event, as well as those who led sessions on behalf of the Working Groups driving the conversations in the Breakout Sessions.

Finally, we would like to recognise the many knowledgeable and enthusiastic volunteers who make significant contributions throughout the year to 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.

The Plenary Session slides and Posters will be available to access via the PHUSE Archive by the end of the month.

Plane Builder Award Winners

Every year at the CSS, PHUSE recognises individuals from each Working Group who have been a key contributor over the previous 12 months. PHUSE would like to acknowledge this year’s Plane Builder award winners and thank them for their continued contribution.

Data Transparency – Helen Spotswood, Roche

Helen Spotswood regularly attends and contributes to the PHUSE Data Transparency Events, and this year made impactful changes in the Rare Disease/Small Population Data Sharing project. Helen’s approach to navigating the challenging nature of this area has helped push forward creating a deliverable for anonymising and sharing rare disease/small population data.

Data Visualisation & Open Source Technology – Peyman Eshghi, Johnson & Johnson

Peyman has been recognised with the Plane Builder Award for his exceptional contributions to the Data Visualization & Open Source Technology PHUSE Working Group. His outstanding organisational skills have been instrumental in coordinating the teal efforts and fostering a collaborative environment that encourages innovation. Peyman proposed creating the Teal Enhancements for Cross-Industry Adoption project, which has significantly enhanced cross-industry collaboration. His dedication is also evident in his efforts to organise the CSS workshop, where he facilitates meaningful discussions and learning with regulatory and sponsors.

Emerging Trends & Innovation – Vijay Pasapula, Cerus & Unnat Patel, AnalysisMate

Vijay Pasapula and Unnat Patel, Co-Leads of the Digital Health Technologies Working Group project, have demonstrated outstanding leadership and dedication in advancing the landscape analysis of this space. Their multi-part white paper strategy provides a solid foundation for understanding this complex domain. By contributing expert insights and fostering knowledge sharing, Vijay and Unnat are driving industry education, awareness and innovation. The Emerging Trends & Innovation Working Group Leads sincerely acknowledge and recognise Vijay and Unnat’s continued efforts.

Nonclinical Topics – Christy Kubin, Charles River Laboratories

We want to recognise work Christy Kubin has done as a lead on the project team: Supporting the Use of SEND for the Implementation of Virtual Control Groups. Virtual controls are one of the hottest topics in nonclinical, and there are a multitude of questions surrounding how they will be incorporated into the SEND standard. With SEND 4.0 already in the internal review process, there will not be an opportunity to address virtual controls with the upcoming release of the SEND IG. Under Christy’s leadership, the project team has drafted guidance for how to implement virtual control groups in the existing standard and recommendations for CDISC on possible ways to update the standards to model these data in the future. Her work on the project team, which is currently being prepared for publication, will provide a bridge for SEND generators to approach these data in the coming years as well as a framework for how the standards may adapt in the future. The Nonclinical Topics Working Group is very pleased to present this year’s Nonclinical Plane Builder Award to Christy Kubin.

Optimizing the Use of Data Standards – Sopan Kaith, Alexion AstraZeneca Rare Disease

Sopan Kaith is celebrated for his exceptional collaborative efforts in the BIMO FAQ project. As an active member of the Optimizing the Use of Data Standards Working Group since 2020, Sopan Kaith has consistently demonstrated his commitment to teamwork and collective success. His volunteer work with PHUSE has been instrumental in shaping the Bioresearch Monitoring Reviewer’s Guide (BDRG), where he has partnered with his Co-Lead, cross-industry teams and regulatory representatives.

Together, they gathered valuable public review comments on the BDRG, which highlighted the need for a new initiative – the BIMO FAQ project. This multi-year collaboration focused on addressing commonly asked questions and themes that emerged during the feedback period, showcasing Sopan’s ability to unite diverse stakeholders towards a common goal. His leadership and strong organisational skills have been pivotal in driving the BIMO FAQ’s objectives forward.

Please join us in congratulating Sopan for receiving this year’s 2025 Plane Builder Award, a testament to his dedication to fostering collaboration and teamwork in the PHUSE Community!

Real World Evidence – Matt Baldwin, Amgen

We are pleased to nominate Matt Baldwin for the Plane Builder Award in recognition of his exceptional contributions to the Quality and Reusability of Real World Data and Estimands for RWD/RWE projects within the Real World Evidence Working Group. Matt played a key role in contributing to a high-impact white paper that outlines practical frameworks to improve data quality and reusability across studies – work that is poised to become a valuable industry reference. He also leads the Estimands for RWD/RWE initiative, addressing methodological challenges and promoting the consistent application of estimands principles in observational research.

Matt’s leadership and active involvement in the PHUSE Community have significantly advanced collaboration, innovation and best practice sharing across the industry.

Risk Based Quality Management – Jennifer Krohn & Jeremy Wildfire, Gilead Sciences

Jennifer Krohn and Jeremy Wildfire have demonstrated exceptional commitment to developing and delivering innovative solutions in risk-based quality management (RBQM). Their leadership in the RBQM Hands-on Workshop at the US Connect 2025 showcased their dedication to advancing open-source tools paired with central monitoring best practices. Their approach and expertise provided attendees with invaluable insights and practical skills, contributing significantly to the success of the largest annual US Connect conference to date. With over 670 members from 162 organisations in attendance, Jennifer and Jeremy's contributions helped to foster collaboration, learning and the sharing of industry-leading practices, making them deserving nominees for the 2025 PHUSE Plane Builder Award.

Safety Analytics – Peg Fletcher, MedAssessment

Peg Fletcher was a Co-Lead of the very successful and impactful AEGiS (AE Groupings in Safety) project team. During her leadership, Peg offered clinical expertise and experience that was integral in the development of the white paper and final recommendations. She has a wealth of knowledge and was a very effective leader of the project, ensuring engagement and collaboration throughout the development of the White Paper. Additionally, Peg has taken another leadership role as the co-lead of the PrOACTS (Process for Ongoing Assessment of Clinical Trial Safety Data). Peg continues to bring her experience and expertise in pharmacovigilance to PHUSE and has and continues to be critical in the project teams where she is involved.

Poster Winners

Industry – Amaya Opalka, Roche

PP05: GitLab vs GitHub: The Battle of the Repositories

Explore the world of repository management with GitLab vs GitHub: The Battle of the Repositories. When I first started in the industry, GitHub was widely used at Roche, but shifting to GitLab sparked interest.
This poster will delve into the differences and capabilities of both tools. We will look at key distinctions in project management tools such as issue tracking, project boards, issue weights, burn-down charts and collaboration. We will provide a detailed comparison, showcasing which offers a more comprehensive solution for project management, appealing to those requiring granular detail. Additionally, we will evaluate CI/CD implementations and scalability. While both platforms efficiently support continuous integration pipelines, our analysis highlights which might be better suited to specific needs. The poster will also include some of the basic commands to get you started, as well as hints and tips!

Collaboration – Gitte Frausing, Data Standards Decisions, Frank Bringezu, Merck, Christy Kubin, Charles River Laboratories & William Houser, Bristol Myers Squibb

PP19: Representing Virtual Control Animal Data in SEND

The PHUSE Nonclinical Topics Working Group project Supporting the Use of SEND for the Implementation of Virtual Control Groups proposes a method for including virtual control data as part of a study’s SEND dataset package. The proposal includes suggestions for incorporating trial design information for experimental designs that use virtual control groups (VCGs) and include individual virtual control animal (VCA) data. VCGs can be incorporated into the trial design using trial sets. Each trial set should contain only virtual animals or concurrent animals. Trial set parameters should identify that the trial set includes VCA and describe the selection criteria for the VCA. Each VCA’s experimental conditions can be described using the Subject Characteristic domain. Individual VCA data can be included in interventions, findings and special purpose domains, and specific guidelines are included for these domains (e.g. how to represent dosing events in EX).

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