Just one month remains until the PHUSE/FDA Computational Science Symposium! If you haven’t already registered, there is still time to secure your place.

The CSS brings together regulators, standard development organisations, sponsors, vendors, CROs and academia, each with their own perspective for advancing the future of life sciences through the ongoing efforts of the Working Groups.

If you are passionate about making real change within the industry and tapping into a hub of collaborative innovation, then this event is for you! View the full event details below to find out what's in store. 

Be sure to read the Working Groups Quarterly Report in preparation for the CSS event and for information on upcoming outputs.

The Office of New Drugs (OND) in the FDA Center for Drug Evaluation and Research (CDER) will release documents for public review on standard adverse event groupings and queries for evaluation of biologic/new drug applications. 

FDA Presentation

PHUSE is pleased to announce that Vaishali Popat MD, MPH, Associate Director of Biomedical Informatics and Regulatory Review Science, OND, CDER, FDA, will speak on this topic during the regulatory plenary session. This session will also allow attendees to pose questions to our presenters from the FDA and EMA.

Safety Analytics Breakout Session

The PHUSE Safety Analytics Working Group will discuss initial feedback on these documents as part of the breakout sessions at PHUSE/FDA CSS 2022. The Working Group will also form a project to provide consolidated PHUSE feedback on the standard tables and figures and standard adverse event groupings and queries packages. Those interested in joining this project should contact workinggroups@phuse.global.

Hear from Chris Price, PHUSE Working Groups Director, in the short video below where he talks about the value the in-person event experience holds, and the importance of the CSS in bringing individuals together to collaborate for a collective goal – the greater good of the patients.

“The CSS has been virtual for the past two years, so we’re excited to welcome you all back in person to continue to drive all these important projects forward.

We are enhancing the in-person experience with new twists that drive that high level of engagement – this appointment to collaborate is a must for your diary.”

– Chris Price, PHUSE Working Groups Director

FDA Plenary: Reconnect & Rediscover  

We will hear from each of the Working Groups, who will provide an update on their activities over the last two years. This will be followed by a presentation and panel discussion from the FDA on Innovation. You are invited to approach collaboration from a new space that leaves behind predisposed judgments and opinions on how it should be done. Be open to approaching people with curiosity about who they have become in the last two years, what drives them and how we can work together.

Regulatory Update & Q&A

In addition to Dr Popat's presentation on FDA OND Public Review on Standard Tables and Figures, Standard Adverse Event Groupings and Queries for Evaluation of Biologic/New Drug Application, we will be joined on Wednesday by Dr Concato who will provide an overview of FDA’s Real-World Evidence (RWE) Program for drugs and biological products. 

The presentation will focus on efforts related to internal agency processes, external stakeholder engagement, demonstration projects and guidance development; examples of regulatory approvals based on RWE will also be described. Our final speaker in this exciting regulatory session will be Anne-Sophie Henry-Eude, who will provide an update on the EMA pilot project on the analysis of raw data from clinical trials.

An Introduction to Privacy-preserving Synthetic Data

Synthetic Data Generation (SDG) is gaining rapid interest and adoption as a privacy-enhancing technology that solves many data access, reuse and sharing problems, and requires fewer additional controls to manage overall risks.

Delivered by Replica Analytics, this interactive workshop will cover the following topics: generating synthetic health data, understanding and evaluating the privacy benefits and risks of synthetic data, and evaluating the utility of synthetic data. It will be a mixture of lectures and hands-on exercises using an online SDG tool – programming experience is not required!

Designing EDC for Efficient Adverse Event Collection

PHUSE's Adverse Event Collection Recommendations Project Team of the Safety Analytics Working Group executed a survey in 2020 which indicated that fewer respondents are collecting improvements, rather than worsening, to adverse events (63% vs. 83%). One of the reasons cited for not collecting improvements to AEs is the burden on the sites and the difficulty of entering all changes in EDC.

This workshop will review several designs for AE eCRFs in the most common EDC systems to show how to reduce data entry burden. Specifically, we will show how to build the eCRFs in Rave, InForm and Veeva EDC systems and how data would be entered for the different designs.

This is your final opportunity to become a CSS contributor as just two exhibition spaces remain! View the prospectus for full details and don’t miss your chance to contribute to the important work of a PHUSE/FDA CSS.