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

 

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