Hot Topics

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.

Data Transparency Winter Event – 7-9 February 

The countdown is officially on for the 2023 Data Transparency Winter Event! We have 12 stimulating presentations from industry experts running across the three days. To find out exactly what it is in store, view the full agenda. Register here to ensure you don't miss out on this free, virtual event! 

Reimagining a Safety Submission – Aggregate Safety Assessment Planning – 16 February
The Safety Analytics Working Group will present their first ever Community Forum on 16 February 2023! Click here to register! 

Save the Date! – 27 March 2023

The Safety Analytics Working Group will host their second Community Forum, Reimagining a Safety Submission - Vision of Interactive Safety Reviews, on 27 March. Look out for registration opening soon. 

If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global. 

The Nonclinical Topics Working Group is on the lookout for members to join the Conformance with the Tumor.xpt Specification project. The aim of this project is to create a non-exhaustive first set of technical conformance rules with the tumor.xpt specification. This project will provide the first set of validator rules to be implemented by tools already used by the industry for verification of SEND datasets, thus removing part of the current manual burden of reviewing this file.

Management of ODS Regulatory Referenced Deliverables: Do you have experience in creating any of the four regulatory referenced deliverables (cSDRG, ADRG, BDRG, SDSP)? The Optimizing the Use of Data Standards Working Group is looking for you to be a part of a new project to ensure these deliverables are kept up-to-date with regulatory guidance's. You will work with the ODS Working Group leads to coordinate updates as needed. To apply for this project, click here to submit an application form.

An exciting opportunity has arisen within the PHUSE Nonclinical Scripts project to collaborate with BioClelerate, the FDA and CDER for assistance with implementing the sendigR open-source package at your company. Collaborative team meetings will take place Fridays 8-9am EDT. Ideally, volunteers will have some programming experience (ie, python, unix/R) and some knowledge of internal SEND data storage. Click here for more information on the sendigR package and the benefits of working collaboratively. 

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, biologic 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. 

Working Groups Latest Report Q3/4 2022: The report includes project updates, recent and upcoming deliverables and the future plans for each Working Group.

Monthly Mailings: Our monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE.