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.


Become an FDA Reviewer for the Day

View the video presentation here.



Winners are highlighted in bold text.

Poster No.Poster TitleAuthors


SEND CT-Compatible Simulated Study – Process Streamlining and Implementation

Takayuki Anzai & Michael Wasko, PDS Life Sciences 


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


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


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


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


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


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


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


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


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


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


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


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



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



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


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


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


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


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

Margo Cohen, IBM & Peter Glass, FDA


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


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


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


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


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


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

Hanming Tu, Frontage & Gustav Bernard, IQVIA


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

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


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


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


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


Introduction of Machine Learning

Kevin Lee, Clindata Insight


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



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


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

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