Conference 2010

PhUSE 2010, the sixth annual conference was held at the Radisson Blu Hotel in Berlin on the 17th to 20th October and was chaired by Heidi Curinckx (Janssen R&D).

 
The conference contained more than 100 presentations and posters and was attended by 368 people.  Presentations ranged from simple but useful programming tips, to the latest on integrating available technology with industry requirements. Between presentations there was the opportunity to wander around the exhibition area where CROs, solution providers and software vendors featured their products and solutions.

 

This year we organized pre-conference training on Sunday afternoon, and a welcome drink and dinner in the evening, which meant the Sunday provided an opportunity for early arrivals to catch up with old friends and colleagues.  It also allowed a prompt start at 9am on Monday morning for the opening address, followed by the keynote speeches, this year given by Dr Rebecca Kush (CDISC) and Dr Charles Jaffe (HL7), who outlined the future challenges facing the industry.  On Tuesday we again started with a plenary session, with Dr Ed Conley (Cardiff University) as our 3rd keynote speaker.  The remainder of our 3-day event was given over to presentations on Industry Standards, Coding Solutions, Technical Solutions and many other hot topics in our industry. We also organized 3 Discussion clubs (CDISC and Industry Standards, Outsourcing and Innovation Driven by Technology) for a more interactive session with the audience, and 7 Regional Discussion Clubs to find out specific needs and wishes in different regions (UK, Switzerland, Germany, Benelux, Scandinavia, Rest of Europe and Rest of World).  On Wednesday morning we invited University students and saw the last of the presentations.  Following this we ended with a closing speech, which included prize giving for the best papers in each stream and the lucky winners of the various exhibitor prizes.  This speech also introduced Yvonne Moores, who will chair next year's conference.

 

 

 

 

 

 

2010 Papers / Presentations

Best paper winners are highlighted in bold text and will be featured in the next edition of Pharmaceutical Programming.

Applications and Software Development

AD01: Why "Context Driven Content Management" should be considered by the pharmaceutical industry
Karsten Fogh Ho-Lanng, NNIT A/S

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AD02: Analysis software in.NET and SAS
Jules van der Zalm, OCS Consulting
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AD03:Exploratory Data Analysis in Pharmacogenomics Using SAS JMP and Windows WF Workflows
Robert Eric Huisden, OCS Consulting
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AD04: Interactive Clinical Data Review for Safety Assesment and Trial Operations Management
Michael O'Connell, Tibco Spotfire
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AD05: A dynamic reporting system: Catering to the needs of many
Pascal Hanssens, Business & Decision
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AD06: Project management (Dashboard and Metrics) with QlickView
Stéphane Pirault, Keyrus BioPharma
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AD07: What makes a "good program"
Dean Grundy, Roche Products Ltd
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AD08: Using web service technologies for incremental, real-time transfers
Andrew Newbigging, Medidata
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AD09: Phase III Macro-System
Wolf Dieter Batz, Phenix-MTK GmbH
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AD10: iPad - Innovation or Gadget
Niels Mathiesen, Mathiesen & Mathiessen
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AD11: AstraZENeca and the ART of metadata maintenance
Paul Frost, AstraZeneca
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CDISC and Industry Standards

CD01: Initial Investment in CDISC Data Standards in Clinical Organisations
Kenneth Stolzfus, Octagon Research Solutions
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CD02: How Do I Map That? - SDTM Implementation Challenges
Chris Price, Roche Products Ltd
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CD03: From ACE to ZINC
Paul Vervuren, MSD/NV Organon

CD04: New CDISC migration strategies and tools: determining the best approach and employing automated data mapping
Michael Weitz, Cytel  & Lauren Spiess, Cytel 
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CD05: How to go From an SDTM Findings Domain to an ADaM-Compliant Analysis Dataset: An Example
Carl Heremans, Merck  Sharp & Dohme (Europe)
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CD06: Traceability between SDTM and ADaM converted analysis datasets
Florence Somers,  Business & Decision Life Sciences & Michael Knoessl, Boehringer Ingelheim Pharma GmbH & Co. KG
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CD07: Defining "Compliance" for Analysis Data
Chris Decker, d-Wise Technologies & Randall Austin, GlaxoSmithKline
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CD08: The Use of Meta Data in Creating, Transforming and Transporting Clinical Data
Gregory Steffens,  ICON
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CD09: Define.xml - Tips and Techniques for Creating CRT-DDS
Julie Maddox, SAS Institute &  Mark Lambrecht, SAS Institute (Size)
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CD10: Accessing the metadata from the define.xml using XSLT transformations
Lex Jansen, Octagon Research Solutions
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CD12: Bridging the communication gap: implementing metadata standards in trial protocols
Annabel Acs, Novo Nordisk
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CD13: CDISC integration in a clinical data management system
Peter Van Reusel, Business & Decision Life Sciences
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CD14: Implementing, Managing and Validating a Clinical Standard
Gene Lightfoot, SAS Institute
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Coders Corner

CC01: An Animated Guide: Sending SAS file to Excel
Russ Lavery, Independent
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CC02: Convert dataset variables into macro variables: a new approach with CALL SET and the SCL FETCH
Patrice Agator, Sanofi
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CC03:Working Efficiently with Large SAS Datasets
Vishal  Jain, Quanticate 
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CC04: Updating an MS SQL database from SAS
Jim Groeneveld, OCS Biometric Support
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CC05: APPEND, EXECUTE and MACRO
Jim Groeneveld, OCS Biometric Support
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CC06: PCKG: Managing SAS Macro Libraries
Magnus Mengelbier, Limelogic Ltd
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CC07: Generate ATTRIB and FORMAT statements from the SAP
Shafi Chowdhury, Shafi Consultancy Ltd
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CC08: Let me "Google" that for you - Google Labs Code Search
James Bidwell, Amgen 
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Coding Solutions

CS01: SAS® Drug Development Program Portability
Ben Bocchicchio, SAS Institute & James McDermott, Quanticate
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CS02: Identifying medications that are protocol violations
John van Bemmelen, MSD
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CS03: SAS Graph to help data Dose/Concentration consistency review
Patrick Lupien, Novartis
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CS04:Developing ODS Templates for Non-Standard Graphs in SAS 9.2
Philip Holland,  Holland Numerics
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CS05: For a programming more efficient
Claude Guyot, Sanofi-Aventis
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Data Handling

DH01: Facilitating Data Integration for Regulatory Submissions
John Gerlach, Independent Consultant & John Bowen, Independent Consultant
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DH02: How to clean up dirty data in Patient reported outcomes?
Knut Mueller, Schwarz Biosciences
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DH03: How to improve quality control in a data conversion process?  By extended usage of metadata!
Dimitri Kutsenko, Entimo AG
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DH04: From Data Capturing to Decision Making - Innovation and Standardization
Michaela Jahn, F. Hoffmann-La  Roche  & Stepan Laage-Witt, F. Hoffmann-La Roche Download Presentation

DH06: The Ultimate Integration Challenge
Jennifer Choon-Moi Chin, Covance CAPS & Hester Schoeman, Covance CAPS
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DH07: How to process data from clinical trails and their open label extensions
Thomas Grupe, Bayer Vital GmbH & Stephanie Bartsch, Bayer Vital GmbH
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DH08: Clinetics Data Merge - A Platform for Exchange of Pharmacokinetic Data
Ralf Schefer-Pregi, Bayer Schering Pharma & Andreas Schwarzer, M.A.R.C.O
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DH09: Electronic transfer of sAE to Global Pharmacovigilance
Eva Bervar, Bayer Vital GmbH
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DH10: Converting Data to CDISC Models: Research Project on Metadata Extraction, Exploration and Pooling
Ronald Steinhau, Entimo AG & Dimitri Kutsenko, Entimo
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DH11: Data Warehousing for the Reporting and Management of Clinical Data
Robert Ellison, ICON Clinical Research
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Management

MA01: Challenges of Clinical projects shared between Pharma Companies
Oliver Leconte, F. Hoffmann-La Roche
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MA02: Driving value through Standardization - Industry Challenges and Best Practices
Henry Levy, Accenture
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MA03: GSTARS a complete strategy for the reporting
Alain Vasseur, Sanofi Aventis
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MA04: Simplifying the Clinical Information Environment for the Planning and Execution of Clinical Trials
Anup Patel, GlaxoSmithKline & Matt Lamming, GlaxoSmithKline
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MA05: Modeling and Simulation: challenges for the clinical programmer and for the group leader
Vincent Buchheit, Novartis
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MA06: The Innovative Medicines Initiative Knowledge Management
Ann Martin, IMI
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Posters

P001: The MEDCODE macro and the PRXCHANGE Function
Gary Stevens, Biogen Idec
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P002: An Animated Guide: Coding Standards for SAS® Production Programs
Russ Lavery, Independent
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P003: Statistical Graphics for Review and Reporting in Clinical Development
Kerstin Pietzko, TIBCO Spotfire & Michael O'Connell, TIBCO Spotfire
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P004: Back to the future
Kristiina Puustusmaa, Roche 
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P005: Autocall Macros - A Quick Overview
Vinod Panangattiri  Parambil, Roche
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P006: How can we do things better: A SAS Java Library Proposal and other stories
Michael Auld, Michael Auld Consulting
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P007: Data Migration from Oracle Clinical® to .XML using SAS®
Valeria Visona, CROS NT & Matteo Ferrari, CROS NT (Size)
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P009: AstraZeneca and Quintiles Prgramming Groups - working collaboratively
Elizabeth Latta, AstraZeneca & Paul Westley, Quintiles
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P010: Forest Plots and SAS
Anne Barfield, Quanticate
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P011: Automatic Conversion of SAS "Enchanced Programs" to PDF
Dirk Spruck, Accovion & Piia-Piret Eomois, German Cancer Research Centre
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P012: An Animated Guide: the logical cascade throught the - Orres variable
Russ Lavery, Independent
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P013: PROC TRANSPOSE for Better Listings View
Jules Van der Zalm, OCS Consulting
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P014: Anticipating User Issues with Macros
Lawrence Heaton-Wright, Quintiles
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P015: Improving the Quality of Data
Ester Schoeman, Covance
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P016: A graphical approach to examine the completeness of epidemiological data: Patient Profile Plots (PPPs) and Centre Profile Plots (CPPs)
Methodios Typou, Independent Consultant
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P017: Lean Six Sigma:Measure and Improve
Jinesh Patel, Quanticate
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P018: Concepts learned From Our Programming Cousins
Dante diTommaso, Roche & Christof Binder, Hoffmann-La Roche
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Professional Development and Training

PD01: Recruitment, Retention and Motivation of your team
Louise Webber, i3 Statprobe 
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PD02: Qualities of a Project Manager
Jon-Paul Mewes, Roche 
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PD03: The Anaylst Mindset in Statistical Programming
Ryan Copping, Roche & Ross Farrugia Roche
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PD04: The Challenges of Implementing New Technology on the Business Process 
Chris Decker, d-Wise Technologies
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PD05: Skills Required for a Project  Programmer and a guess at what the future holds!
Roy Ward, Novartis
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PD07: Accreditation of Professional Statisticians: Current Perspectives and Challenges
Katherine Hutchinson, Quanticate
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PD08: Assessing Applications Training
Edel Hogan, ICON Clinical Research
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PD09: Theory U-Social Technology for Innovation
Colin Brown, Roche
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Regulatory

RG01: A Case Study in Using Unit Testing as a Method of Primary Validation
Ross Farrugia, Roche Products Limited
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RG02: Vendor Selection & Management in GxP critical IT projects - a validation perspective (based on actual case)
Claus le Fevre, NNIT
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RG03: How much is it?  Validation of Open-Source Software using the example of R
Peter Bewerunge, HMS Analytical Software
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RG04: Validation Strategies for Report Objects and Programs - Challenges and Obstacles in a Risk Based World
Christoph Ziegler, Roche & Beate Hientzsch, Accovion
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RG06:Risk Radar for the Outsourcing of Clinical Trials: The Best Guide for Success
Randy Ramin-Wright, ii4sm & Raffael Jovine, ii4sm
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RG07: Good Clinical Practices or "Why we do What we do the Way we do it"
Elaine Dempsey, Paraxel
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Statistics and Pharmacokinetics

SP01: An Animated Guide: An introduction to Poisson Regression
Russ Lavery, Independent

SP02: Using Data and Text Mining to drive Innovation
David Smith, SAS Institute
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SP04: Inference for the Location Shift in 3x3 Crossover Studies: the Median-Scaling Method
Stefano Vezzoli, CROS NT
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SP05: Assesment of Cox Proportional Hazard Model Adequacy Using PROC PHREG and PROC GPLOT
Jadwiga Borucka, Quanticate
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SP06: Useful Tips for Analysis of  Variance (ANOVA) in Multicentre, Placebo Controlled Clinical Trials
Joanna Romaniuk, Quanticate
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SP07: Getting your data in good shape for Non Linear Mixed Effects Modeling
Vincent Buchheit,, Novartis
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SP08: Waterfall plots: A beautiful and easy way of showing a whole picture of an interesting outcome
Antonio Nieto, PharmaMar & Javier Gomez, PharaMar
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SP10: BeST- BIOEQUIVALENCE STUDY TEMPLATE
Pekka Heikkila, StatFinn
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Technical Solutions

TS01: Migrating a SAS Programming Environment to a Virtual Linux Server
Dirk Spruck, Accovion & Judith Kanz, Accovion
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TS02: SAS GTL - Injecting New Life into Graphs
Lawrence Heaton-Wright, Quintiles
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TS04: PDF Multi-Level  Bookmarks via SAS
Steve Griffiths, GlaxoSmithKline
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TS05: Unit Testing and Code Coverage Assessment with SASUnit
Patrick Warnat, HMS Analytical Software GbmH
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TS06: An Open Source Reporting System for Life Sciences
Magnus Mengelbier, Limelogic Ltd
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TS07: Uncover Useful Patterns in Clinical Trials Safety Data with JMP® Clinical
Valérie Nedbal, SAS Institute
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TS08: Development and implementation of a statistical programming environment in a biotechnology company
Albert Chau, Antisoma Research Limited & David Shannon, Amadeus Software Limited
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TS09: Capturing Tabular Data from Graphical Output: Web and Windows-Based Tools
Brian Fairfield-Carter, ICON Clinical Research & Stephen Hunt, ICON Clinical Research
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TS10: Study conduct in a global integrated SAS environment
Martin Probach, Bayer Schering Pharma
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Tutorials

TU01: Tools for supporting the development of robust SAS macros
Martin Gregory, Merck Serono
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TU02: SAS/AF Frame in programmer toolkit
Patrick Lupien, Novartis
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TU04: Code evolution: how programs are developed and refined over time
Pantaleo Nacci, Novartis Vaccines and Diagnostics Srl
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TU06: Introduction to SAS® Clinical Standards Toolkit
Andreas Mangold, HMS Analytical Software GmbH & Nicole Waechter, HMS Analytical Software GmbH
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TU07: EG as an IDE, how PC is that?
John Moone, ICON Clinical Research
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