This year was the 10th anniversary of the PHUSE/FDA Computational Science Symposium, better known as the CSS. Once again, we met virtually for three highly productive days, which gave us an opportunity to both reflect on the last 10 years and to look towards the future. For both those who attended and those who were unable to attend, the presentations are now available on the PHUSE archive.

Over the course of the event, we heard updates from the FDA, watched 15 poster presentations, held a fascinating panel discussion on open-source technology in clinical research, not to mention over 50 Working Groups breakout sessions and a design thinking session to develop the next PHUSE/FDA Innovation Challenge, which is now open for submitting abstracts.

The PHUSE Working Groups and projects are made up of many knowledgeable and enthusiastic volunteers who make significant contributions throughout the year. We are very grateful for the efforts of all of those involved to advance the PHUSE Working Groups’ mission to address 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.

We would like to thank everyone involved for their time and dedication in contributing to what was an extremely successful event. A full summary of the CSS was presented at the October Webinar Wednesday, which is now available to watch on demand.

CSS 2021 Plane Builder Awards

Data Transparency – George Allan

George is a long-time contributor to this Working Group and shows great passion for all the projects he has joined. Currently, George is leading the EU CTR Implementation project and contributing to the Terminology Harmonization project.

Data Visualization & Open-Source Technologies – Ellis Hughes

Ellis has led the R Package Validation Framework project, which has not only delivered a white paper but an R package that has the potential to carry a lot of influence for the industry.

Emerging Trends & Technologies – Geoff Low

Geoff has been active in many PHUSE projects over the years and, particularly in the last year, has championed, guided and contributed significant technical expertise to the Investigating the Use of FHIR in Clinical Research project. Geoff has played a key role at PHUSE in joining the HL7 Vulcan Accelerator.

Nonclinical Topics – Mark Carfagna

As a more recent member of the Nonclinical Working Group, Mark has been a key driver of our collaboration with BioCelerate, with his co-leadership of the Harmonization of SEND Implementation to Enable Historical Control Data Analysis project. They have already delivered two white papers this year and are poised for another.

Optimizing the Use of Data Standards – Julie Maynard

Julie co-leads the Bio-research Monitoring Data Reviewer’s Guide project. She has been invaluable in organising the project and getting the project deliverables for review in a timely manner. Julie’s commitment (along with her co-leads) to this project is a great example of their passion to participate in and contribute to PHUSE.

Safety Analytics – Bill Palo

As another more recent contributor to our PHUSE Working Groups, Bill has quickly become very active. He is co-leading the Treatment Emergent project team and the Safety Analytics education project. Both projects are progressing well, largely due to Bill’s leadership.

Poster Winners

Industry – Timothy Bergsma, qPharmetra & Qiaobing Bergsma, UCB

PP11 – Mesa: A Shiny-based Web Application for Drag-and-Drop Creation of Metadata-driven Statistical Summary Tables

This poster was selected as the Industry winner as it showcased the use of an open-source tool to expedite the production of statistical summary tables. It demonstrated a unique yet very practical approach to solving a problem which can otherwise be tedious and repetitive.

Collaboration – William Houser, Bristol Myers Squibb & Michael DeNieu, Labcorp Drug Development

PP18 – Testing Simplified TS Examples Against FDA Technical Rejection Criteria for Nonclinical Studies

Poster PP18 was selected as the Collaboration winner as it succinctly described the results of an expediently executed PHUSE project that generated a concrete resource to help sponsors successfully navigate the FDA/CDER technical rejection criteria with respect to the inclusion of standardised electronic study datasets for IND submissions containing nonclinical toxicology study reports.

FDA – Alan Shapiro, FDA & Sarah Rodgers, IBM

PP13 – The JumpStart Flag Validator Tool

Poster PP13 shared the use of an open-source application (FDA Validator Tool) within the FDA to check for commonly used analyses flags in ADaM datasets. This presentation was impactful as it provided examples and usage of a simple open-source tool to check for analyses flags to help reviewers and sponsors understand the importance of confirming the accuracy of the flags submitted.