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Data Transparency Winter Event 2025

Active since 2014, PHUSE’s 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 PHUSE Data Transparency Autumn Event took place on 4–6 February 2025. 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. During this virtual event, presentations were delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There was also a panel discussion and Q&A session focused on the day's themes. Links to the event presentations and daily recordings can be found here.

Join the webinar to learn why change is not only an idea but a necessity. We will explore where old habits need to be retired and where new initiatives have proven to increase efficiency and reduce cost without impacting on quality.

This Webinar will be taking place virtually on 20 February at 15:00-14:00 (GMT) / 8:00-9:00 (EST) / 14:00-15:00 (CET)

We're thrilled to announce a new Working Group event coming your way in 2025 – the PHUSE Real World Data Spring Event!

"It will bring together engaged speakers from the field ranging from data vendor and data registry representatives to pharmaceutical and biotech industry representatives who are sharing their knowledge and ideas around Real World Data utilisation in a fast-moving and challenging environment." 

-Berber Snoeijer, ClinLine – PHUSE Real World Evidence Working Group Lead

The Real World Data Spring Event will take place on 9–10 April 2025 14:00-16:30(GMT) / 9:00-11:30(EST) / 15:00-17.30(CET)

In its 14th year, the PHUSE Computational Science Symposium (CSS) will be in Utrecht, the Netherlands 20-21 May.

Please visit the PHUSE website for more information.

If you have groundbreaking research, innovative methodologies or impactful case studies, we've got an exciting opportunity for you!

Poster Presentations provides an opportunity to cover any of the Stream topics in a visual and engaging manner. The Poster Session is an opportune time for networking and asking fellow CSS attendees for feedback on your work. Posters are ideal for presentations that include graphics, source code, statistical or thought-provoking concepts, novel data management or handling techniques, and innovative ways to implement data standards. Posters increase visibility, allow participants to review at their own pace and enable conversation about the topics presented.

The Poster Session is taking place on 20 May and will offer an unparalleled platform to showcase your work, receive valuable feedback and engage in Q&A with attendees. Submit a 150-word abstract by 28 February. 

Please Welcome Jennifer Khron as a new Risk Based Quality Management lead.

Jennifer Krohn, MS, currently serves as Associate Director, RBQM at Gilead Sciences. In her role, Jenn advises study teams on implementing risk-based monitoring strategies and leads initiatives working to develop enhanced technology and processes for centralised monitoring, risk assessments and site monitoring approaches. This role expands upon her 16 years’ experience in the CRO sector, where she spent a decade helping build centralised monitoring, leading data analyst teams and serving as QTL BPO. Prior to the RBQM space, Jenn worked in a variety of clinical trial roles across a wide range of therapeutic areas, from the site level as study coordinator, to the CRO side in clinical operations (CRA), data management and feasibility. 

Jenn previously co-led the Central Monitoring project, under the PHUSE RBQM Working Group. She holds a master’s degree in biology with a focus in biochemistry and physiology from the University of North Carolina Wilmington. 

There’s been an exciting change in PHUSE Working Groups recently…

The Emerging Trends and Technologies Working Group has officially evolved into the Emerging Trends and Innovation Working Group!

Why the change? Working Group Lead Mike Hamidi shares what brought about this change of name and scope:

"The name change from Emerging Trends & Technologies to Emerging Trends & Innovation reflects a broader focus beyond technological enablement. This shift encompasses ongoing developments in areas such as AI/ML, digital health technologies and healthcare standards and aims to provide deeper insights into these and other evolving topics. This adjustment will preserve the emphasis on emerging trends while enhancing our commitment to delivering valuable industry insights and innovations.”

PHUSE is equally excited to welcome Mark Bynens, the new Working Group Lead. He joins Mike Hamidi and Stuart Malcolm, expanding the team’s expertise and capacity.

Mark Bynens brings a wealth of experience as Director and Scientific Computing Operations (SCO) Head within Statistics & Decision Sciences (SDS), Global Development at Johnson & Johnson. Mark leads initiatives in change management, project management, education, high-performance computing, and statistical research.

Learn more about the Working Group Leads and their efforts here.

Would you like to get involved in Working Groups? Check out the new Advance Hub page to view all opportunities.

We have just published the last Working Group Report for 2024! You can view the Quarter 4 summary here, including the project reports and some of the highlights across our Working Groups for this final quarter. Don’t forget to check out the Working Group Events Report too, which provides a breakdown of the data collected from the Working Group Events for 2024.

Well done to all our Working Groups who have had a fantastic 2024!

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published two new FAQs! They have answered a FAQ with Data Submission, the FAQ answered looks at the ‘Correct Implementation of the Define-XML Standard for Submission Purposes – ADaM and SDTM Variable Alignment’ and ‘Correct Implementation of the Define-XML Standard for Submission Purposes – Clarifications Needed’.

You can view this question and see the FAQ's this project has answered so far here. 

Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global. 

The Submitting Real World Data project within the Real World Evidence Working Group, has published a Blog. This Blog post explores possible approaches for submission of real world data to regulatory bodies. Real world data, as defined by the Food and Drug Administration in their guidance, comprises data collected from non-interventional study designs. (1) From project group discussions, ‘claims’ and ‘electronic health records’ comprise most real world data used in providing clinical evidence. Fast Health Interoperability Resources, or FHIR, is a platform used by HL7 for health information exchange. (2) This platform is widely used to exchange healthcare information, as far as claims and EHR data is concerned. As a result, a significant portion of real world data used by the pharma/biotech industry follows HL7-FHIR.

The AE Groupings in Safety (AEGiS) project within the Safety Analytics Working Group has published a new white paper. This white paper outlines why using standard AE groupings for queries is key to understanding a drug’s safety profile, discusses assumptions underlying the use of standard queries for estimation and outlines the benefits of standard queries when available. When standard queries are not available, but detailed analysis of a specific medical condition is needed, this document recommends a process to develop and maintain a custom query that can be replicated by regulatory authorities. 

The Estimands in Safety Analytics, a new project within the Safety Analytics Working Group, is calling for volunteers. The value of well-defined safety estimands is not generally appreciated and has not been communicated well to safety scientists. 

• Safety analyses are often ambiguous and, in some cases, carry the risk of being misinterpreted.

• A better understanding and consequently a more consistent application of a robust estimand framework in the analysis of safety data would eliminate this ambiguity and drive clarity on both the specific question an analysis addresses, as well as the answer to that question.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 14 February.

The Kick-Off Meeting for this project was held on 18 February at 14:00-15:00 (GMT) / 9:00-10:00 (EST).

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.