Hot Topics

Hot Topics

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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.

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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Data Transparency Autumn Event – Save the Date

Data Transparency Autumn Event – Save the Date

We’re looking forward to welcoming you back as the Data Transparency Working Group returns with another multi-day virtual event, taking place 15–17 September 2026.

Stay tuned for more details and registration information coming soon!

Real World Data Autumn Event – Save the Date

Real World Data Autumn Event – Save the Date

We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September–1 October 2026.

Stay tuned for more details and registration information coming soon!

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Optimizing the Use of Data Standards

Optimizing the Use of Data Standards

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new response to a question regarding SDTM/ADaM IG Nuances. View the team's response to the following question here.  

‘CTCAE Upversioning – When should a sponsor organisation decide to upversion CTCAE, DAIDS, or any other toxicity grading standards? How should sponsors handle pooled analyses with varying grading scales?'

Do you have a (FAQ project based) question? Send your questions to the team by emailing workinggroups@phuse.global. 

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Capturing Computational Workflows in Clinical Trials with BioCompute

Capturing Computational Workflows in Clinical Trials with BioCompute

The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & Innovation Working Group has published a new white paper, Capturing Computational Workflows in Clinical Trials with BioCompute which is now open for public review.

This white paper explores how the BioCompute standard is being applied in real-world clinical trials, showcasing practical case studies that demonstrate its role in improving reproducibility, transparency, and regulatory communication across complex computational workflows.

The team welcome feedback on the paper by 6 March . Please send responses to workinggroups@phuse.global.

Framework for Integrating Omics Data with Other Clinical and Non-Clinical Data Sources

Framework for Integrating Omics Data with Other Clinical and Non-Clinical Data Sources

The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & Innovation Working Group has published a new white paper, Framework for Integrating Omics Data with Other Clinical and Non-Clinical Data Sources which is now open for public review.

This white paper proposes a framework for integrating multi-omics data with clinical and non-clinical datasets, combining BioCompute for workflow documentation and MultiAssayExperiment (MAE) for data management. It aims to improve standardisation, interoperability, and reproducibility to better support personalised medicine and regulatory use. 

The team welcome feedback on the paper by 31 March . Please send responses to workinggroups@phuse.global.

PharmaForest: A Collaborative Repository of SAS Packages for Pharmaceutical Industry project team within the Data Visualisation & Open Source Technology Working Group, is calling for volunteers!

PharmaForest is a collaborative initiative focused on improving how SAS programming is developed and shared across the pharmaceutical industry. Built on the SAS Packages Framework (SPF), it promotes reusable, standardised SAS packages to reduce duplication, improve efficiency, and support compliance.

By combining an open package repository with community collaboration and practical guidance, PharmaForest helps move SAS programming from siloed approaches to a more scalable, industry-wide model.

If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 9 March ahead of the kick off meeting scheduled for Tuesday 10 March 08:00 EST / 13:00 GMT / 14:00 CET.

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. 

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. 

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: 

  • The projects must address significant research issues relevant to Computational Science

  • The project must not attempt to address FDA policy issues

  • There must be at least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here to submit.