Event Summary

Having just concluded our 7th Computational Science Symposium it continues to highlight the great work that the PhUSE community can achieve through collaboration. The innovation, teamwork and output from our PhUSE projects is also strengthened by having the opportunity to come together and share our thoughts, ideas and progress.

This year, we ran three workshops, the FDA held an interactive session on the JumpStart Process, there was a plenary session on integrating PhUSE, CDISC and regulatory stakeholders, as well as the traditional Poster Session.

Sunday began with registration opening and an overview from all the Working Group Leads on project status. The evening was brought to a close with the first of our workshops – Linked Data for Clinical Trials – which was a full house.

Be an FDA Reviewer for the Day: Take an Interactive Journey through the JumpStart Process kicked off Monday’s events. Members from the FDA walked us through the reviewer process from data arriving at the FDA through to approval. Following lunch, the Working Groups then went into their breakout sessions, which involved discussions around project progress to date. 

Our Poster Sessions always achieve a great turnout. With nearly 300 members networking, interacting and collaborating, the efforts from the Poster presenters is always appreciated. 

We finished off the evening with the other two workshops: GitHub Environment: From White Paper Targets (TFL) to Shareable Scripts and Maintaining the Clinical and Nonclinical Study Data Reviewer’s Guides. Many members stayed on to ensure they had the opportunity to listen, learn and engage. 

On Tuesday, the Working Groups continued with their breakouts, followed by a wrap-up session on progress made over the last couple of days. We then all came together as one to listen to how PhUSE, CDISC and the regulatory authorities integrate, in a panel discussion. The audience were provided with three pre-determined questions and then each table had discussions around these topics. The ideas and suggestions were captured live, condensed and shared with the panel. Each member of the panel then provided their thoughts on the comments received. It was a very interesting, thought-provoking and interactive session.

To conclude the conference, we celebrated the achievements of some of our members by congratulating them on their dedication over the past year. Our Achievement Award was given to seven attendees, and five attendees received the Poster Award.

In summary, the Computational Science Symposium was yet another great success. Currently running at 48 projects, with new projects in the pipeline, PhUSE is the premier community to ensure we continue to connect, advance, share.

Thank you to everyone that contributed, and we look forward to seeing you once again in 2019.


Presentations

Become an FDA Reviewer for the Day

View the video presentation here.

 

Posters

Winners are highlighted in bold text.

Poster No.Poster TitleAuthors

PP01

SEND CT-Compatible Simulated Study – Process Streamlining and Implementation

Takayuki Anzai & Michael Wasko, PDS Life Sciences 

PP02

Results of the Third Annual SEND Industry Readiness Survey George Kahlbaugh, Boehringer Ingelheim,  Lou Ann Kramer, CDISC & Bob Friedman, Xybion 

PP03

Modeling of Anti-Drug Antibodies in SEND Leslie Lorello & Gretchen Dean, Pfizer 

PP04

Ensuring Consistency of SEND Datasets with Study Reports, Using Machine Learning Algorithms Suresh Madhavan, Kurien Abraham & Venkatesh Krishnan, PointCross

PP05

Automating CDISC Conformance Issue Management Eric Crockett & Mario Widel, Covance

PP06 

Data Consistency: SEND Datasets and the Study Report Maria Francomacaro, Merck, Wenxian Wang, Xybion & Michael Rosentreter, Bayer

PP07

Optimizing SDTM Specification Development with Auto-population Cori Kramer, Ryan Adalbert & Deborah Goodfellow, Covance 

PP08

CDISC SDTM/ADaM Dataset Generation Using R Presanna Murugesan, AstraZeneca

PP09

Introducing the ADaM Implementation Guide v1.2 Terek Peterson, Covance & Brian Harris, MedImmune

PP10

An R Pipeline to Efficiently Access, Explore and Visualize Data in SDTM and ADaM Standards Changhong Shi & Yilong Zhang, Merck 

PP11

CDISC Compliance Issue Prevention: ADaM Planning Meeting Mario Widel & Steven Kirby, Covance

PP12

SDTM: Model or Implementation Guide? Michael Wise, Soumya Rajesh & Kapila Patel, Syneos Health

PP13

Body Weight Gain Analysis Based on the BW Domain Using an R Shiny Application Bob Friedman, Xybion & Anthony Fata, SNBL USA

PP14

*Winner*

Global View of Clinical Trial Transparency and Disclosure Events for a Single Study and Product Submissions Julie Holtzople, AstraZeneca

PP15  

*Winner*

BioCelerate Toxicology Data Sharing Initiative: Development of a Centralized Searchable Preclinical Thomas Bjerregaard, Novo Nordisk & William Houser, Bristol-Myers Squibb 

PP16

Traditional vs Adaptive Design Phase I/II Hybrid Trials in Model-based Drug Development Krishna Gopal, Quintiles & Vishnu Dabbiru, PSCI  

PP17

Event Adjudication: End-to-end Traceability Umair Ijaz Dar, Novo Nordisk

PP18

Evaluation of a Novel Graphical Display Tool for Visualizing and Analyzing Histopathology Data from Multiple Toxicology Studies

Alan Brown, Novartis, Kevin Snyder, FDA & Philip Drew, PDS Consultants

PP19

Common Define-XML File Issues Seen During the FDA’s JumpStart Service

Margo Cohen, IBM & Peter Glass, FDA

PP20

FDA Assessment Process of TA-specific Clinical Data Extensions to CDISC Foundational Standards Alisa Khomyanina, IBM

PP22

Data Visualization Working Group Subject-level Data Review & Visualization Ingeborg Holt, Commonwealth Informatics & Jasmine Sen, Bayer US LLC

PP23

Standard Analyses and Displays for Common Data in Clinical Trials: The Journey Continues Mary Nilson, Eli Lilly & Nhi Beasley, FDA

PP24

One Year Later: Results of the Test Data Factory (TDF) Project Peter Schaefer, VCA-Plus

PP25

One Vision, Six Different Needs: CPE Plan for Standard Analyses & Code Sharing Jared Slain, MPI Research

PP26

Streamlining the Collaboration – From White Paper Targets (TFL) to Sharable Scripts

Hanming Tu, Frontage & Gustav Bernard, IQVIA

PP27

High-performance Integrated Virtual Environment (HIVE): A Robust Infrastructure for NGS Data Analysis

Elaine Thompson, FDA, Raja Mazumder & Vahan Simonyan, FDA/CBER

PP28

BioCompute: A Framework for Community Harmonization of Sequencing Computational Pipelines Elaine Thompson, FDA, Raja Mazumder, George Washington University, Vahan Simonyan, FDA/CBER

PP29

Utilizing Visualizations Developed in R Shiny for Exploratory Safety Analysis Austin Taylor & Daniel Choi, FDA 

PP30

The Clinical Research Tragedy Chris Decker & Scott Bahlavooni, d-Wise

PP31

Introduction of Machine Learning

Kevin Lee, Clindata Insight

PP32

eTRANSAFE: A New Player in the Translational Safety Assessment William Drewe, Lhasa Limited, Thomas Steger-Hartmann, Bayer & Montserrat Cases, Synapse Research Management Partners

PP33

*Winner*

FDA Study Data Technical Conformance Guide Updates for Software Program Submissions Paul Schuette & Weiya Zhang, FDA

PP35

What’s Rules Got to Do With It? Helena Sviglin, FDA

Thinking of joining PhUSE?

Already a member but not sure how you can benefit?

PhUSE is an expanding, global society with a membership of more than 8,000 clinical data scientists. It requires a large pool of resources to help with its running so offers many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly newsletter, we are always keen to hear from volunteers.

Find Out More