Presentations & Posters

Summary:

Over the last five years, the CSS has grown from its infant years, passed through adolescence and matured into a successful collaboration leading to innovation within our industry. This years Symposium commenced on the Sunday evening with a welcome and introduction to the great work being done across the Working Groups and all the projects. Working Group volunteers had opportunities to network with their fellow colleagues, put names to faces, and look forward to the next two days.  

The first-ever 'Semantics 101 for Pharma' workshop helped bridge the gap between legacy clinical data processes and the introduction of innovative ways to look at clinical information. Thirty people registered and over 50 attended, showing the significant interest in this topic.

The annual FDA session on Monday, introduced us to real things happening within the FDA, including an update on the guidance, the reality of what is being seen in the CDISC data being received, and the importance of the data reviewer guides published by PhUSE projects. Over 30 posters were presented on a variety of topics and a number of Working Groups proposed new projects.

By the end of the event, there was significant excitement around current and new projects and while all attendees understood the challenges identified are not easy to solve, everyone was eager to roll up their sleeves and execute what could be achieved through collaboration. As one new attendee said after the event, "the collaboration among industry, regulatory agencies, and standards organisations was a formula for success. I could see everyone working together to solve problems and explore new concepts, and the amount of progress the groups made in a short time frame was extraordinary".

Thank you to everyone that contributed to yet another extremely successful Symposium, and we look forward to seeing you all in 2017.

 


 

Presentations: 

PresentationPresenter

Welcome

Crystal Allard, Office of Computational Science, CDER, FDA

e-Study Guidance and Technical Conformance Guide: Are you Ready?

Colleen Ratliffe, MS, PMP, FDA/CDER/OSP/Data Standards Team

How Good is Your Data? Perspectives from the Trenches:

SDTM


ADaM



SEND




Mary Doi, Office of Computational Science, CDER, FDA


Steve Wilson, USPHS Director, Division of Biometrics III, CDER, FDA

Tim Kropp, Deputy Director, Office of Computational Science, CDER,FDA

The State of the Data Reviewer's Guide

Helena Sviglin, Office of Computational Science, CDER, FDA

 


 

Posters:

Winners are highlighted in bold text

Poster No.Poster TitleAuthors

PP01

Using CDISC Standards and Semantic Technology to Drive the Automation of Study Database Build                         

Chris Price, Roche & Jonthan Chainey, Genentech

PP02

Proposal for Streamlining the SDRG and ADRG Authoring Process

Stanely Wei, Novartis

PP03

Tough Start? Don't Panic! Your Submission Can Still Be Successful: Regulatory eSubmission Lessons Learned for a Late-stage Acquisition

Jiaan Illidge & Chris Williams, Alexion Pharmaceuticals

PP04

NoSQL Database in Healthcare Industry

Kevin Lee, Consultant

PP05

Graphical Display of Histopathology Data from Toxicology Studies: An Industry Survey

Alan Brown, Novartis & Philip Drew, PDS Consultants

PP06 

Common Errors in Loading SDTM Data to the Clinical Trials Repository - Why Getting it Right Matters

Crystal Allard & John Slattery, FDA

PP07

Open-NCA - R Scripts for CDISC-based Pharmacokinetics Analysis

Peter Schaefer, Validated Cloud Applications

PP08

PhUSE De-identification Working Group: Providing
De-identification Standards to CDISC Data Models

Jean-Marc Ferran, Qualiance & Kelly Mewes, Roche

PP10

The Car is in the Shop but Where are the Mechanics? The Future of Standard Scripts for Analysis and Reporting

Dirk Spruck, Clinipace Worldwide, Hanming Tu, Accenture & Dante Di Tommaso, Roche

PP11

Achieving Clarity through Proper Study Documentation: An Introduction to the Study Data Reviewer's Guide

Terek Peterson & Michael Stackhouse, Chiltern

PP12

Implementing NONMEM POP PK Specifications and Data Standards through the use of a Browser-based Form

Robert Fox & Huan Liu, AstraZeneca

PP13

Let's Visit "The Visits" Scheduled/Unscheduled: Windowing and Clinical Encounters

Himajarani Surapaneni & Rama Devi Kudaravalli, Chiltern

PP14

CDISC Standards End-to-End Transitional Hurdles

Alyssa Wittle, Christine McNichol & Antony Cardozo, Chiltern

PP15

The Nonclinical SDRG

Gitte Frausing, Data Standards Decisions & Catherine Roy, Merck

PP16

Standard Analyses and Displays for Common Data in Clinical Trials - Socialize the Deliverables!

Mary Nillson, Eli Lilly & Nhi Beasley, FDA

PP17

Making 21 CRF a Linkable Resource for Semantic Web Applications

Yu Lin, Rashedul Hasan & Mitra Rocca, FDA

PP18

Enhanced Visualization of Treatment Emergent Liver Effects in Integrated eDSH & Baseline Shift Plot

Crystal Allard, Tejaskumar Patel & Nicholas Fleischer, FDA

PP19

Standard Endpoints, Standardized Data and Subgroup Outcomes in Diabetes: A Patient-Level Meta-analysis

Crystal Allard, Tejaskumar Patel & Helena Sviglin, FDA

PP20

Common Data Quality Issues Identified During the JumpStart Process

Crystal Allard, FDA & Kathryn Matto, IBM

PP21

Screen-failure Data Provides Insight into Subgroup Representation in Diabetes Clinical Trials

Crystal Allard, Tejaskumar Patel & Ana Szarfman, FDA

PP22

Challenges in Legacy Data Mapping to SDTM Exposure Domains for Topical Drug Studies

Aijun (Lillian) Qui & Hon Sum Ko, FDA

PP23

Collaboration with Safety Scientists Using Interactive Data Displays

Xiangyun Wang & Josephine Fong, Genentech

PP24

Good Programming Practices at Every Level

Maria Dalton, GSK

PP25

Investigating Endpoint Modeling for SEND Datasets

Christy Kubin & Brian Argo, MPI Research

PP26

FDA SEND Submissions: Does the Pinnacle 21 Open-source Community Validator Predict FDA Findings?

Laura Kaufman & Mike Wasko, PDS Life Sciences

PP27

Using Ebola Experiences to Highlight Standards Implementation in Outbreak Settings and Observational Studies

Maura Kush, PharmaStat

PP28

Statistical Computing Environments in the FDA's Center for Drug Evaluation and Research

Paul Schuette, FDA

PP29

Piloting Post-market Surveillance of Saxagliptin with FDA Adverse Event Reporting System and MedDRA-based Adverse Event Diagnostics

Daniel Choi & Austin Taylor, FDA

PP30

The SEND Implementation Wiki- Crowd-sourced Practical SEND Information

Christy Kubin, MPI Research & Lynda Sands, Independent Consultant

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