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"In a clear presentation it gave a perfect insight into our struggle with SDTM and legacy data"

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Conference 2009

The 2009 PhUSE conference was held in Basel, Switzerland on the 19th to 21st October and was chaired by Benjamin Szilagyi.

 

Basel Conference 2009

 

The conference contained more than 100 papers and posters and was attended by more than 400 people, so the biggest PhUSE yet.

 

Opening this year was Diane Jorkasky with the keynote speech.  I highly recommend for you to review the video on our website as it's packed with relevant information and challenges for the status quo. Throughout the whole conference both the presenters and the audience kept referencing Diane's speech and related their own experiences or aspirations to hers.

 

New this year was the PhUSE Discussion Clubs.  Through a series of interviews and feedback sessions the three topics below were discussed. All of these are considered critical to our profession:

 

  • Open Source Code
  • CDISC
  • Accelerating Clinical Development 

The Management Stream expanded on the success of previous year's presentations and subsequent discussions.  The topics covered this year were:

 

  • Lean / Six Sigma.... The 5 Y's
  • Does a Sponsor Clinical Trial Reporting System fit into a Sponsor / CRO alliance?
  • Juggling balls and resource management strategies from a CRO perspective
  • Future Skills & emerging markets
  • Considerations for Process development
  • Managing and working effectively in a globally dispersed team across different time zones

2009 Papers

Best paper winners are highlighted in bold text.

 

Applications and Software Development

AD01: Techniques for writing robust SAS macros
Martin Gregory, Merck Serono (Size: 126 Kb)
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AD02: ModSpace: Promoting Modeling Dissemination and Reuse
Jonathan Chard, Mango Solutions & Henning Schmidt, Novartis (Size: 147 Kb)

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AD03: Web-Based Application for the Reporting of Population PKPD Models
Richard Pugh, Mango Solutions & Justin Wilkins, Novartis (Size: 530 Kb)
 
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AD04: Effective Scripting in JMP
Patrick Warnat, HMS Analytical Software (Size: 41 Kb)

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AD05: (Inter)facing SAS
Raymond Ebben, OCS Consulting (Size: 784 Kb)
 
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AD06: Medical Data Review Exploratory Drug Development
Michaela Jahn, Roche (Size: 579 Kb)
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AD07: Metadata and Standard Programs
Marianne Carames, Novo Nordisk & Martin Lindhard, Novo Nordisk (Size: 316 Kb)

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AD08: Nuts and Bolts of SAS Patient Safety User Interface 
Eric Brinsfield, SAS Institute & Jeff Sun, SAS Institute  (Size: 288 Kb)
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AD09: SBPOP - A Computational Tool Supporting Model Based Drug Development - Application to the Renin-Angiotensin System 
Bruno Bieth, Novartis, Henning Schmidt, Novartis & Antoine Soubret, Novartis (Size:171  Kb)
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AD10: Clinical DI Studio - will we need new MetaProgrammers?
Simon Wilcock, ICON & Sireesha Potula, ICON  (Size: 375 Kb)

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AD11: Automation using SAS & C#.NET for CROs and Pharmaceuticals 
Giri Balasubramanina, Kinsheep Technology & Gopinath Viswanathan, Kinsheep Technology (Size: 646  Kb)
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AD12: What you get and what you lose when you switch to SAS Enterprise Guide 
Andreas Mangold, HMS Analytical Software  (Size: 497 Kb)
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AD13: Compliant Agile Development - using iterative approaches to develop and/implement computer systems 
Christopher Cieslok, Independent Consultant, Ian Francis, Business & Decision Life Sciences & Eckhart Hanser, University of Cooperative Education  (Size: 996 Kb)
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AD14: Crossing the Chasm: Simplifying Data Management with Perl and Metadata 
Stephen Baker, d-Wise Technologies  (Size: 215 Kb)
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AD15: Main challenges for a SAS programmer stepping in the SAS developers's shoes 
Sebastien Jolivet, Novartis  (Size: 63 Kb)
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CDISC and Industry Standards

CD01: SDTM Validation: How can we do it right?
Peter Van Reusel, Business & Decision Life Sciences (Size: 854 Kb)
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CD02: Generate Define.xml & Define.pdf from Metadata Environment
Rohit Banga, Business & Decision Life Sciences (Size: 247 Kb)
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CD03: An Evaluation of the ADaM Implementation Guide v1.0 and the Analysis Data Mode v2.1
Chris Price, Roche (Size: 1054 Kb)
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CD04: Insights into ADaM
Matthew Becker, PharmaNet (Size: 527 Kb)
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CD05: Using SAS Clinical Data Integration Server to Implement and Manage CDISC Standards
Julie Maddox, SAS Institute (Size: 433 Kb)
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CD06: The SAS Clinical Standards Toolkit
David Smith, SAS Institute (Size: 2465 Kb)
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CD07: The CDISC/FDA Integrated Data Pilot:  A Case Study in Implementing CDISC Standards to support an Integrated Review
Chris Decker, d-Wise Technologies (Size: 219 Kb)
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CD08: From raw data to submission: A metadata-driven, repository-based process of data conversion to CDISC
Dimitri Kutsenko, Entimo (Size: 428 Kb)
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CD09: Standardization of data base: interaction between Biostatistics and Clinical Data Management
Céline Tendero, Sanof-Aventis (Size:  Kb)
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CD10: Converting the define.xml to a Relational Database to Enable Printing and Validation
Lex Jansen, Octagon Research Solutions (Size: 888 Kb)
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CD11: Using SAS Macros to simplify preparation and validation of SDTM data, Annotated CRFs and Define.xml in a metadata driven environment
Niels Both, S-cubed (Size: 516 Kb)
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CD12: Kendle Implementation of CDASH
Elke Sennewald, Kendle & Gill Lawrence, Kendle (Size:  Kb)
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CD13: Implementation of ADaM standards NOT driven by a submission
Karin Fleischer, Ferring Pharmaceuticals (Size: 222 Kb)
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CD14: Experiences and lessons learned from a first SDTM submission project
Paul Vervuren, Schering-Plough & Bas van Bakel, OCS Consulting (Size: 491 Kb)
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Coders Corner

CC01: Can I CALL EXECUTE here?
Vinod Kaippillil Mukundapra, Roche (Size: 23 Kb)

CC03: Sudoku's resolution Using SAS Arrays
Michael Gauthier, Novartis (Size: 69 Kb)

CC04: Timezone correction of data
John van Bemmelen, Schering-Plough (Size: 155 Kb)

CC05: Using Screen Control Language - without a  screen!
Steve Prust, Independent Consultant (Size: 256 Kb)

CC06: How to create an S-Plus graph from SAS
Ronan Knab, Novartis Oncology (Size: 146 Kb)

 

Coding Solutions

CS01: User friendly management of continuously improving standard macro systems
Katja Glass, Bayer Schering (Size: 1148 Kb)
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CS02: Macro to manage the PCSA
Claude Guyot, Sanofi Aventis (Size: 883 Kb)

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CS03: Coding dictionaries information: How to manage? How to use?
Guimard Herve, Sanofi Aventis & Eric Sorel, Sanofi Aventis (Size: 868 Kb)
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CS04: Zooming in on graphics
Armin Gemperli, BIOP (Size: 1227 Kb)

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CS05: How to standardize solutions to recurrent issues
Tangi Sanseau, ICON & Giuseppe Di Monaco, ICON (Size: 166 Kb)

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Data Handling

DH01: Accelerate Clinical Development through Management of Data Quality
David Smith, SAS Institute (Size: 1022 Kb)
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DH02: Clinical Database acceptance: what statistical review checks are necessary to validate a database?
Genevieve Jehl, Qunitiles (Size: 704 Kb)

DH04: Validate it Again?! Get SAS to do it!
Carol Matthews, United BioSource Corporation, Ginger Lewis, United BioSource Corporation & Olga  Belotserkovsky, United BioSource Corporation (Size: 86 Kb)

DH05:This study is essentially just like that other one
Louise Mazzeo, Quanticate (Size: 97 Kb)

 

Management

MA01: Lean/Six Sigma..the 5 why's
Michael Whitworth, AstraZeneca (Size:  Kb)
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MA02: Does a Sponsor Clinical Trial Reporting System Fit Into a Sponsor/CRO Alliance?
Kerry Gordon, Quintiles & John Salkeld, Pfizer (Size:  Kb)
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MA03: Juggling Balls and Resource Management: Strategies From a CRO Perspective
Yvonne Moores, Quanticate & Alison McDonald, Quanticate (Size:27  Kb)
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MA04: Building and maintaining a clinical data warehouse - challenges and opportunities for pharmaceutical programmers
Juergen Kuebler, Novartis
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MA05: Experiences of Offshoring Statisical Programming - The Pros and Cons
Francis Kendall, Roche (Size: 280 Kb)
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MA06: Managing and Working Effectively in a Globally Dispersed Team
Gary Hearfield, Amgen (Size: 910 Kb)

 

 

Posters

P001: Using SAS to Automate the Production of Medical Writing Narratives
Andrew York, Covance & Joe Martin, Covance (Size: 50 Kb) 

P003: The MEDCODE mcacro and the PRXCHANGE function 
Gary Stevens, Biogen (Size: 307 Kb) 

P004: Suggestions for coding standards 
Russ Lavery, Independent Contractor (Size: 62 Kb)

P005: PROC TRANSPOSE for Better Listing View
Jules van der Zalm, OCS Consulting (Size: 55 Kb)

P006: The Perfect Match - an appreciation of the functionality of the dataset MERGE 
Diana Stuart, Takeda (Size: 36 Kb)

P007: Techniques for Assigning NCI CTC Grades to Laboratory Results 
Carol Matthews, United BioSource Corporation (Size: 67 Kb)  

P009: Open Source SAS® Software Applications: the OS3A Program for Community Programming 
Dante di Tommaso, Roche, Paul OldenKamp, Seattle Children's Res.Inst. & Paul Hamilton, Amgen (Size:  195 Kb) 

P010: A Framework for Acheiving an Industry-Driven, Open-Source Clinical Reporting System 
Dante  diTommaso, Roche, Ann Martin, UCB Pharma s.a. & Paul OlkenKamp, Seattle Children's Res.Inst. (Size: 96 Kb)  

P011: Concepts Learned from our Programming Cousins 
Dante DiTommaso, Roche & Christoph Binder, Roche (Size: 85 Kb)

P012: A Year in Pharma 
Gemma Bishop, Quanticate (Size: 30 Kb)

P013: Automatic Conversion of  SAS "Enhanced Programs" to PDF 
Dirk Spruck, Accovion & Piia-Piret Enomis, German Cancer Research Centre  (Size: 42 Kb)

P015: Call Symput-Global or Local 
Littish Dominic, Roche (Size: 30 Kb) 

P016: Software validation in clinical trials: strategy, implementation and experiences in the MAKS project
Jessica Wisniewski, IZKS  Mainz, Daniel Wachtlin, IZKS Mainz & Rolf Meinert, DATAMAP (Size: 20 Kb)

P017: Validating the Use of R in a Commercial Environment
Olivier Kimberlin, Mango Solutions  (Size:  Kb)
  

P018: After a new CDISC SDTM version, how to update and manage ADS/SDS DEFINE files at company team level 
Nathalie Moro, Sanofi-Aventis (Size: 202 Kb)  

P020: An Animated Guide: the logical cascade through the --Orres variable 
Russ Lavery, Independent Contractor (Size: 120 Kb)

 

 

Professional Development and Training

PD01:Home or Away - Who has the Advantage?
Kathryn Wright, Kendle (Size: 120 Kb)

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PD02: Model of interaction between China and Europe on a B&P project 
Johanna Mursic, Sanofi-Aventis & Martine Madec, Sanofi-Aventis (Size: 120 Kb)

PD03: Preventing the "Bad Hire" - Behavioural Interview Techniques for SAS Programming Candidates 
Pamela Giese, i3 Statprobe (Size: 1081 Kb) 

PD04: Medical Research: What should Programmers prepare for? 
Emilie Brennion, Roche (Size: 115 Kb)

PD05: The Pharmaceutical Industry is under pressure to evolve for many reasons.  How does this impact on the role of the Statistician and Statistical Programmers?
Gail Kniveton, i3 Pharma Resourcing (Size: 281 Kb)

PD06: Global working - Rotation to India experience 
Gwenaelle de Borne de Grandpre, Novartis (Size: 33 Kb)

PD07: Road to Rome or Roaming to... 
Francis Kendall, Roche & Christian Mueller, Roche (Size: 1082 Kb)  

PD09: Moving from Full Development to Translational Medicine
Nassim Sleiman, Novartis (Size: 283 Kb)

PD10: Challenges in running a virtual department through outsourcing 
Silvana Cappi, Ferring Pharmaceuticals (Size: 51 Kb)

PD11: Working in a global team
David Barrett, Amgen (Size: 151 Kb)

PD12: Getting Your Point Across - Efficiency in QC Programming across Virtual Teams 
James Bidwell, Amgen (Size: 281 Kb)

PD13: Team Expansion Through External Training 
Kamila Duniec, Quanticate (Size: 41 Kb)

PD14: Creating Articulate and Captivating e-Learning Courses 
Tony Cooper, GlaxoSmithKline (Size: 341 Kb)

 

Regulatory

RG01: 24 Hour Challenge
Michael Whitworth, AstraZeneca (Size: 134 Kb)
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RG04: Acceleration through Collaboration 
Carrie Eason, Quintiles (Size: 86 Kb)
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RG06: CRT for eCTD submission 
Aurelien Guillouche, Novartis (Size: 339 Kb)
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RG07: Data review: To see or not to see.. 
Estelle Tiemtore, Quintiles (Size: 153 Kb)
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RG08: Health Authority questions: how to deal with the diversity 
Annabelle Millischer-Foulon, Novartis (Size: 46 Kb)
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RG09: ClinicalTrials.gov- a programmers perspective 
Ralf Minkenberg, Boehringer-Ingelheim (Size: 271 Kb)
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RG10: Industry Standard Good Programming Practice for Clinical Trials (using SAS)
Mark Foxwell, AstraZeneca (Size :40 Kb)
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Statistics and Pharmacokinetics

SP01: An Animated Guide: Matching Test and Control Subjects 
Russ Lavery, Independent Contractor (Size: 164 Kb)

SP02: Comparing Kaplan-Meier curves - what are the (SAS) options?
Rob Allis, Amgen (Size: 187 Kb)

SP03: The role of the statistician in data monitoring committees 
Fritz Schindel, Accovion (Size: 255 Kb)

SP05: An Application of SAS in Model Based Drug Development 
Imelda Parker, Quintiles & Michael O'Kelly, Quintiles (Size: 74 Kb)

SP06: On the use of spreadsheets for statistical analysis 
Martin Gregory, Merck Serono (Size: 111 Kb)

 

Technical Solutions

TS01: XML Managment Using SAS
Marco Bertolino, Actelion (Size: 619 Kb)

TS02: Improving Biometrics Processes with Six-Sigma 
Andrew York, Covance (Size: 4459 Kb)

TS03:  A Regular Expression is a Healthy Expression
Paul Shannon, RTI Health Solutions (Size: 202 Kb)

TS04: Solving the Source Control Issue 
David Shannon, Amadeus Software (Size: 143 Kb)

TS05:  Using the ODS Graphics Designer to Create Your Own Template 
Philip Holland, Holland Numerics (Size: 511 Kb)

TS06: Managing your metadata efficiently 
Kirsten Langendorf, Novo Nordisk & Mikkel Traun, Novo Nordisk (Size: 774  Kb)

TS08: Providing Historical Control Data for Toxicology With the SAS Stored Processes Web Application 
Volker Harm, Bayer-Schering (Size: 402 Kb)

TS09: Migrating the 4GL SAS Code to SAS 9 EBI and Enterprise Guide
Sandra Farrow, Amadeus Software & Mike Needham, Amadeus Software (Size: 2513 Kb)

TS11: Clinical Trial Reporting with SAS ODS Graphics
David Garbutt, Business and Decision & Hans-Rainer Pauli, SAS (Size: 1988 Kb)

 

 

Tutorials

TU01: Practical Uses of the DOW Logo in Pharmaceutical Programming 
Richard Allen, Peak Statistical Services (Size: 139 Kb)

TU02: MACRO PROCESSOR -The Masked Warrior 
Salaja Akkadan, Quanticate (Size: 379 Kb)

TU04: Works as Designed (?) 
Heinrich von Lips, Ecron Acunova (Size: 50 Kb)

TU05: A Visual Revolution: Statistical Graphics in SAS 9.2
Ian Amaranayake, Amadeus Software & Bob Newman, Amadeus Software (Size: 1839 Kb)

TU06: Accessing SAS metadata and using it to help us develop data-driven SAS programs 
Iain Humphreys, PRA International (Size:150  Kb)

TU07: Take me for a test drive 
Christof Binder, Roche (Size: 146 K