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PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please email workinggroups@phuse.global. |
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PHUSE Computational Science Symposium (CSS) 2025
In its 14th year, the /wiki/spaces/WEL/pages/38993921 will be in Utrecht, the Netherlands 20-21 May.
At the heart of the event is the PHUSE Working Groups’ mission to tackle 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 CSS agenda will feature a variety of activities, including expert-led plenary sessions, interactive workshops and dedicated Working Group Breakout Sessions that drive forward existing initiatives and explore new ones. Attendees will also have the chance to attend the Poster Session, providing the opportunity to share knowledge and engage in discussions on various computational science topics.
PHUSE is excited to welcome attendees from across pharma, CROs, academia, health authorities, technology vendors and SDOs to come together for this collaborative and forward-thinking experience.
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Real World Evidence | ||
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Community Forum: Capturing the Patients Voice Through Lived Experience Across Diaries and Social Media 23 April 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)
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Data Transparency Autumn Event – Call For Speakers | |
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The Data Transparency Working Group invites abstract submissions for its upcoming multi‑day virtual event, taking place 15–17 September 2026 at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST). The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data. Focus your submission on these central themes and submit an abstract by 8 May to contribute to the discussion. Click here for more information.
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Real World Data |
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Autumn Event |
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Active since 2014, Data Transparency Working Group has provided subject matter expertise for the review of draft deliverables and guidance documents from regulatory bodies (such as the EMA and Health Canada), as well as other industry organisations (such as TransCelerate) and academia. Since their inception in 2020, the free-to-attend Data Transparency Events have gone from strength to strength. These virtual events have created an unrestricted space where questions can be asked and challenges addressed. Individuals passionate about the area can come together to share vital knowledge, develop new ideas and spark innovation through presentations, panel discussions and Q&A sessions alongside experts in the data-sharing field.
The Data Transparency Autumn Event 2025 will take place on 16-18 September. Data Transparency Events offer you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with experts from a variety of companies and backgrounds. Registration for this event will open in July.
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The Analyses & Displays for Hepatotoxicity project within the Safety Analytics Working Group have published a new White Paper!
This White Paper provides recommendations for displaying, summarising and analysing measures of hepatotoxicity in tables, figures and listings (TFLs). The suggested TFLs will have implications for what and how liver-related data should be collected. If the data required to populate these TFLs is not collected, then there may be insufficient information to adequately assess the potential for a drug to cause or contribute to the cause of hepatotoxicity.
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The Optimizing the Use of Data Standards Working Group has a new project FDA Requests Public Comment on CDISC Dataset-JSON Standard and is calling for volunteers! The U.S. Food and Drug Administration (FDA) has recently published a Federal Register Notice exploring the potential adoption of CDISC Dataset-JSON v1.1 as a new exchange standard for electronic study data submissions potentially replace the SAS v5 XPORT Transport Format (XPT) in the long term. The FDA is seeking comments on whether to accept Dataset-JSON for regulatory applications in the future, specifically regarding:
PHUSE, given its expertise and commitment to advancing the implementation of data standards within the pharmaceutical industry, and its recent PHUSE/CDISC pilot, is launching a short-term project to collect and synthesize comments from its members on this Federal Register Notice. Building on the PHUSE/CDISC pilot this is an opportunity to:
We are seeking volunteers to participate in this project. The timeline for this project will be relatively short, aligning with the FDA's comment period. We anticipate the main activities to take place during May. If you are interested in volunteering for this important project and contributing your expertise, please express your interest by completing this Working Group Project Membership Form. |
The clinical study analysis and reporting QC process has not changed in decades. It is widely agreed that there is significant overhead in using double programming, and that this may need to be revisited to accelerate and optimally use programming resources. This process has not been revisited or analysed within a modern context. The purpose of this Working Group project would be to perform this analysis and report findings.
The QC process has significant impact on the adoption of Git in statistical programming, specifically in the complexity in using Git in a way that does not disrupt the QC process. This will also impact on what is perceived as acceptable level of QC for submissions by the industry, including regulators.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 29 April 2025.
The Kick-Off Meeting for this project will be held 30 April 2025 9:00 (EDT) / 13:00 (BST) / 14:00 (CEST)
Integration of Omics Data into Clinical Drug Development, a new project within the Emerging Trends & Innovation Working Group, is calling for volunteers.
Omics data has the promise of bringing precision medicine and targeted drug discovery to life. However, its use in clinical drug development has been quite limited due to challenges that span technical, practical, ethical and regulatory domains. The team proposes an initial short-term smaller scope of the WG focused on BioCompute and its implementation. This would ensure a focused short to mid-term delivery. The scope would entail:
Establishing best practices when working with BioCompute
A guide for creating and validating BioCompute Objects
Submission considerations for BioCompute Objects
Sharing of BioCompute Objects across the industry.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 May.
The Kick-Off Meeting for this project will be held 6 May 2025 10:00 (EDT) / 15:00 (BST) / 16:00 (CEST)– Call For Speakers | ||
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We’re excited to announce Call for Speakers for the Real World Evidence Working Group’s second multi‑day virtual event is now open! Taking place 30 September – 1 October 2026, from 09:00–11:30 (EDT) / 14:00–16:30 (BST) / 15:00–17:30 (CEST). Submit your abstract by 8 May for the chance to present. Focus your submission on these central themes:
Click here for more information.
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Emerging Trends & Innovation |
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The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & InnovationWorking Group has published a new White Paper titled “Capturing Computational Workflows in Clinical Trials with BioCompute” This white paper explores how the BioCompute framework can transform the way computational workflows are captured and communicated in clinical trials. As bioinformatics analyses become increasingly complex, consistent and transparent documentation is essential for reproducibility and regulatory confidence. Through practical case studies, the paper demonstrates how BioCompute enables structured, auditable workflows across diverse data types, including omics and imaging, while supporting more efficient collaboration and regulatory submissions. |
Real World Evidence |
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The RWD Guideline for Programming and Analysis Processes Project within the Real World Evidence Working Group has published a new White Paper. This paper offers practical guidance for statistical programmers on applying real‑world data (RWD) to produce regulatory‑grade real‑world evidence (RWE), covering study design, data fitness, governance, ethics, vendor engagement, bias management, and regulatory submission considerations. |
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Real World Evidence – Calling For Feedback |
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The Quality and Reusability of Real World Data Project within the Real World Evidence Working Group has produced a White Paper ‘Real-World Data Reliability and Integrity: Ensuring Real-World Data is Fit for Use for Regulatory Submissions’. This White Paper focuses on the usability of real-world data sources for regulatory submission purposes. To assess the fit for use of this data, we need to assess the relevance and the reliability of the data. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 24 April 2026. |
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If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
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Working Group Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group. | |
Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE. | |
PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. |
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Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
New projects can be submitted anytime during the year, click here to submit. |