Hot Topics
- Former user (Deleted)
- Alex Pearce
- Former user (Deleted)
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 Computational Science Symposium (CSS) 2025 |
|---|
In its 14th year, the PHUSE Computational Science Symposium (CSS) 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. Please visit the PHUSE website for more information. |
Data Transparency Autumn Event 2025 |
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. |
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. |
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:
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 10:00 (EDT) / 15:00 (BST) / 16:00 (CEST) |
|---|
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:
New projects can be submitted anytime during the year, click here to submit. |