PHUSE and the FDA have just held their annual PHUSE/FDA Computational Science Symposium, 13th–15th September. This year was extra special as it marked a decade of the event’s success, where the power of collaboration has helped drive innovation and advance computational and data science in medical research, delivering a lot of value to the industry.
The event kicked off with a celebration, reflecting on the amazing work that has taken place over the last 10 years, the powerful collaboration between PHUSE and the FDA, and what this has meant for the industry. This was followed by an FDA Plenary Session, ‘A Decade of PHUSE/FDA CSS Collaborations: An FDA Perspective’.
“The CSS is an incredibly successful enterprise that has brought together not only the science and the technology but also the ideation and ingenuity of all of us. And I think that has been the biggest accomplishment of the collaboration.” Lilliam Rosario, FDA
Take a trip down memory lane with us and watch 'A Trip Down Memory Lane – 10 Years of the PHUSE/FDA CSS' to see some CSS photos from the archives and where it all began!
With each year of the CSS, problems have been identified, solutions proposed and deliverables produced, ready to assist those working in the pharmaceutical industry. This is all thanks to PHUSE’s specialist Working Groups and their volunteers. Take a look below to see the Working Groups’ highlights of the 10th PHUSE/FDA CSS.
Data Transparency
“It was great to hear from the EMA about the joint work they are doing with Health Canada as well as the positive impact transparency has had on COVID data.”
Data Visualisation & Open Source Technology
“The potential for some of the work being done in the R Package Validation Framework and the valtools package is huge. I am really optimistic about the future positive impact that this will have for industry.”
Emerging Trends & Technologies
“It was really interesting to hear about FHIR and the involvement of PHUSE in the HL7 Vulcan Initiative. Learning about FHIR and discussing how HL7 resources can support clinical research was really enlightening.”
Nonclinical Topics
“It was great to have a shared session with the Safety Analytics Working Group exploring potential ways that nonclinical toxicology data and clinical trial data could be integrated to improve the evaluation of drug safety. PHUSE gives us the opportunity to have these discussions.”
Optimizing the Use of Data Standards
“There has been some fantastic progress made on the Bio-Research Monitoring Data Reviewer’s Guide (BIMO). Having the chance to review and comment on the latest version gave us a great opportunity to contribute to this topic.”
Risk-based Monitoring
“PHUSE has provided us a global platform for companies and people to collaborate, and truly share ideas, thoughts and future direction. We’ve made a great start on Centralized Monitoring Principles and Quality Tolerance Limits, and are looking forward to progressing these and where we go next.”
Safety Analytics
“Loved seeing the end-to-end connectivity of this Working Group, with discussions ranging from the impact of how data is collected for Adverse Events to how treatment emergence can be defined in analysis.”
If you would like to learn more about the recent CSS, and its Poster Winners, register your place at the PHUSE State of the Union in September, and at October’s Webinar Wednesday to hear from Chris Price, Working Groups Director.
To find out what’s happening in each of the Working Groups, watch their brief introductory videos here and contact workinggroups@phuse.global if you would like to get involved.
