Annual Conference 2016

Fast Track to Approval: Speed and Efficiency

9th - 12th October 2016

Conference Summary:

PHUSE 2016 was held at the Princesa Sofia Gran Hotel from the 9th to the 12th October and was chaired by Åsa Carlsheimer (Trialbee) and was a great success. With nearly 600 attendees, 44 exhibitors, 15 streams including > 120 papers, six Hands-on Workshops and Discussion Clubs, this was the biggest PHUSE conference ever. Both the venue and the location in beautiful Barcelona were perfectly suited for PHUSE.

The conference kicked-off on Sunday evening with the poster session followed by a buffet dinner and drinks. This was a perfect opportunity for networking and catching up with friends in other companies. Earlier on Sunday there was an opportunity to contribute to PHUSE in the Scriptathon.

Each day of the conference started with an inspirational talk by a keynote speaker. This year we were very fortunate to have a good mix of scientific topics presented by Alok Jah, Aseem Malhotra and Jack Lewis. Alok Jah (journalist and broadcaster) spoke about using story telling as a tool for presenting complicated topics. Dr Aseem Malhotra told us about over use of medicines and the importance of informing patients about alternative options to standard treatment. Finally Dr Jack Lewis gave a very inspirational talk about our brains and how we can train them to make better decisions. I think everyone who listened and wakes up at night knows what to do – go clean the oven! Don’t reward the brain by doing something nice. Both doctors touched upon the importance of a healthy diet without sugar. 

The theme of the conference was “Fast Track to Approval: Speed and Efficiency”. Many of the workshops and presentations discussed how we as data scientists can standardize, automatize and become more efficient in order to reduce the time to approval for our drugs. This year two new streams were introduced “Real World Evidence” and ”Data Visualization”, both were well attended and received positive feedback from the audience. The management stream continued on the interactive path with three different topics that were presented by senior leaders and lively and fruitful discussions.

All the Hands-on Workshops and Discussion Clubs were sold out and very well received as they interactively engaged and brought relevant information to the attendees. The topics featured this year were: Semantic Technology, SAS Life Science Analytics framework, CDISC, R, Computational Science Symposium and Good Programming Practice.

In addition to industry presentations, this year the regulatory stream included presentations from three different regulatory authorities. During the FDA presentation by Lilliam Rosario all seats were filled and people were standing in the back to hear the view and expertise of one of our key stakeholders.

The Conference Committee faced a significant challenge this year in selecting only the very best abstracts, and this was reflected in the high quality of all the presentations and posters at the conference. During the closing session, we had the pleasure to announce the Best Paper Awards for each stream.

We are looking forward to meeting many of you again at PHUSE events during 2016 and, of course, in Edinburgh for the next Annual Conference.


Papers & Presentations: 

Keynote Presentations: (Audio files)

Monday 10th October - Alok Jha

Tuesday 11th October - Aseem Malhotra (available December 2016)

Wednesday 12th October - Jack Lewis (shortened version)


Semantics Workshop

Semantics 101 for Pharma

Best in Stream Winners are highlighted in bold text.


Applications and Software Development

AD01: The TFL Workbench: Tools to Standardise and Accelerate Table, Figure and Listing (TFL) Programming

Iain Humphreys & Hansjörg Frenzel, PRA Health Sciences
Download Presentation

AD02: ICON's DIAMOND, or an Enhanced Way to Automate Statistical Reporting

Nathalie Fuchs, ICON

Download Presentation

AD03: QC of the aCRF Using SAS

Rune Pedersen & Niels Both, S-cubed

Download Presentation

AD04: How to Create your Define-XML as Early as Possible with the Click of a Button

Roman Radelicki, SGS Life Sciences Services

Download Presentation

AD05: Efficiency and Delivery Driven by Metadata

Magnus Mengelbier, Limelogic

Download Presentation

WINNER AD06: Making the Leap from Excel to a Database Used for Reporting

Shafi Chowdhury, Marco Ackermann & Md Zobair, Shafi Consultancy

Download Presentation

AD07: A Tool to Automate TFL Bundling

Mark Crangle, ICON

Download Presentation

AD08: Peaceful Co-existence: R and SAS

Martin Gregory & Manuel Cornes, Merck

Download Presentation

AD09: Programmed Patient Narratives Using SAS

Prafulla Girase & Daniel Boisvert, Biogen

Download Presentation

AD10: SAS Environment Upgrade: The PRA Experience

Gary Stevens, PRA Health Sciences

Download Presentation

AD11: Clinical SAS Application Development in a GRID environment

Giri Balasubramanian & Edwin Ponraj Thangarajan, PRA Health Sciences

Download Presentation

AD12: ValidR Enterprise: Developing an R Validation Framework

Andy Nicholls, Mango Solutions

Download Presentation


Coder's Corner

CC01: Compress It More

Linda Palm Simonsson, I-Mind

Download Presentation

CC02: Unicode Characters in a Table of Contents

John Hendrickx, Danone Nutricia Research

Download Presentation

CC03: Macro-free Parsing of Multiple Text Files with SAS

Adam Amborski, inVentiv Health

Download Presentation

CC04: Colour Me Useful

Robert de Gois, Veramed

Download Presentation

CC05: Writing Reusable Macros

Philip Holland, Holland Numerics

Download Presentation

CC06: How Macro Design and Program Structure Impact GPP (Good Programming Practice) in TFL Coding

Galyna Repetatska, Chiltern

Download Presentation

CC07: Add Derived Parameters with Multi-dimensional Arrays

Siddharth Kumar, GCE Solutions

Download Presentation

CC08: Perish the Sort: Using Indexes and Hash Objects for Efficient Programming

Jason Smith, Argo Analytics

Download Presentation

WINNER CC09: Fundamental Advice to Save Time in SAS Programming

Mickael Borne, 4Clinics

Download Presentation

CC10: Keeping Track of Database Changes During Database Lock

Sanjiv Ramalingam, Biogen
Download Presentation


CDISC Workshops

What's New

Exercise: Define v2.0 and the Need for Value Level Metadata

Standards Conceptual Model - Understanding the Potential and Possibilities

Live Demo
Peter Van Reusel and Nick De Donder, Business & Decision Life Sciences, David Iberson-Hurst, Assero


CDISC & Industry Standards

CD01: Protocol Representation: The Forgotten CDISC Model

Jeff Abolafia, Rho & Frank Dilorio, CodeCrafters

Download Presentation

CD02: CDASH V2.0: What is it Good For?
Éanna Kiely, inVentiv Health

Download Presentation

CD03: DIY: Create Your Own SDTM Mapping Framework

Bas van Bakel, OCS Consulting

Download Presentation

CD04: Assessing CDISC Therapeutic Area User Guides in a Machine Readable Format

Johannes Ulander & Niels Both, S-cubed

Download Presentation

CD05: Device Domains: Examples of their Use in Clinical Trials

Oksana Voevutska, Chiltern

Download Presentation

CD06: Analysis Datasets for Baseline Characteristics and Exposure Time for Multi-stage Clinical Trials

Kimberly Umans, Katherine Riester, Manjit McNeil, Wei Liu & Lukasz Kniola, Biogen

Download Presentation

CD07: OCCS - Creating Flags or Records

Rob Wartenhorst, GSK

Download Presentation

CD08: Increasing Work Group Transparency: ADaMIG v1.2 Update and New Team Working Process Review

Terek Peterson, Chiltern & Brian Harris, MedImmune

Download Presentation

CD09: Constructing a Clinical Data Warehouse for Nutrition Studies

Paul Vervuren, Danone Nutricia Research

Download Presentation

CD10: Linking Metadata from CDASH to ADaM

João Gonçalves, Business & Decision Life Sciences

Download Presentation

WINNER CD11: Analysis Results Metadata...Are We There Yet?

Carla Santillán, Chiltern

Download Presentation

CD12: Pattern-based MDR: Towards High-quality Data Standards

Alan Cantrell & Julius Kusserow, PAREXEL

Download Presentation

CD13: To Create Define-XML Using -XML and the OpenCDISC Validator

Murali Neela, GCE Solutions

Download Presentation

CD14: Out-of-the-box %Define-XML – Just a Simple SAS Macro

Katja Glass, Bayer Pharma

Download Presentation

CD15: How to Handle Different Versions of SDTM & Define Generation in a Single Day

Edwin Ponraj Thangarajan & Giri Balasubramanian, PRA Health Sciences

Download Presentation

CD16: Placing a Moratorium on the Madness

Scott Bahlavooni, d-Wise

Download Presentation

CD17: Understanding the Potential of Share: A Visual Business Case and Technical Use Case

Peter Van Reusel, Business & Decision Life Sciences

Download Presentation


Coding Solutions

CS01: Boosting the Efficiency of Data Review by using SAS Integration Technologies and VBA

Giuseppe Di Monaco, UCB Biosciences

Download Presentation

CS02: SAS, Java & Excel: A Ménage á Trois

Dana Vinzelberg, Bay Pharma

Download Presentation

CS03: Exploring Newer Techniques in SAS to Enhance Interactive Web Applications

Volker Harm, Bayer Pharma

Download Presentation

CS04: Reducing Build Time of Integrated Clinical Databases with SAS Grid and SAS/OR

Eric Brinsfield, Meridian Analytics

Download Presentation

CS05: Dictionary Tables – A Programmer's Friend?

Marcin Pracz, Quintiles

Download Presentation

CS06: Coding WHO-DDE: An Automatic, Easy and Powerful SAS Tool

Gianluca Mortari, CROS NT

Download Presentation

CS07: Get a JumpStart on Clinical Data Analysis and Visualisation with Standard Scripts

Jared Slain, MPI Research & Hanming Tu, Accenture

Download Presentation

WINNER CS08: CompareDirectory – Macro Bits and Pieces in Action

Lawrence Heaton-Wright, Quintiles

Download Presentation

CS09: Top 10 Uses of Macro %VARLIST – In Proc SQL, Data Step and Elsewhere

Jean-Michel Bodart, Business & Decision Life Sciences

Download Presentation


Data Handling

DH01: Effective Use of a Metadata Repository Across Data Operations: The Need for a Machine Readable Form

Isabelle de Zegher, PAREXEL

Download Presentation

DH02: Data De-identification Made Simple
Jørgen Mangor Iversen, LEO Pharma

Download Presentation

DH03: Grading Lab Toxicities using NCI Common Terminology Criteria for Adverse Events (CTCAE)

Srinivas Veeragoni & Ankur Mathur, Bayer Healthcare

Download Presentation

DH04: Integrating the New EMA Requirements on Public Disclosure in the Study Conduct (Back-up presentation, no paper available).

Jean-Marc Ferran, Qualiance

Download Presentation

DH05: How a Metadata Repository Enables Dynamism and Automation in SDTM-like SAS Dataset Generation

Judith Goud, Akana & Priya Shetty, Intelent Inc.

Download Presentation

DH06: A Standardised Approach to De-identification

Chris Hurley, MMS Holdings

Download Presentation

DH07: How to Review a CRF – A Statistical Programmer's Perspective

Elsa Lozachmeur, Novartis

Download Presentation

DH08: Efficiency comes From Reusability and Repeatability

Hanming Tu & Dave Evans, Accenture

Download Presentation

WINNER DH09: Calculating the Risk of Re-identification of Patient-level Data Using a Quantitative Approach

Lukasz Kniola, Biogen

Download Presentation

DH10: Metadata on the Go: Achieving Metadata Accuracy and Consistency Continually

Swapna Pothula, SGS Life Sciences Services

Download Presentation

DH11: How to Effectively Deal with Hard-coding and CDISC Controlled Terminology in Clinical Studies

Lennert van der Zee, OCS Consulting

Download Presentation

DH12: Data Sharing 3 Years on – From Baby to Toddler...

Katherine Tucker, Roche

Download Presentation

DH13: From SDTM to Displays, through ADaM & Analysis Results Metadata, a Flight on Board Metadata Airlines

Omar Sefiani & Stéphane Bouget, Boehringer Ingelheim
Download Presentation


Data Visualisation

DV01: Interactive Visualisation for Precision and Translational Medicine
Christof Gaenzler, PerkinElmer
Download Presentation

DV02: Communicating Results with R & Shiny
Mika Mäkinen, Roche
Download Presentation

DV03: Interactive Data Visualisation and Exploration Using the Loon R Package
Adrian Waddell, Roche
Download Presentation

DV04: Clinical Graphs Using SAS
Sanjay Matange, SAS
Download Presentation

DV05: A Cost-effective Data Visualisation Using Base SAS
Kevin Kane, PHASTAR
Download Presentation

WINNER DV06: Interactive Visualisation of Linked Data
Tim Williams, UCB
Download Presentation

DV07: Clinical Data in Business Intelligence
Mike Collinson, Oracle Health Sciences Consulting
Download Presentation

DV08: End-to-end Data and Metadata: It’s Not Only a Dream, It’s a Reality
Gerald Neveu, Danone Research
Download Presentation

DV09: Concepts and Strategies for Developing Effective Data Visualisation
Rebecca Bates, GCE Solutions
Download Presentation


Industry Starters

IS01: Adventures in Data Science
Kieran Martin, Roche
Download Presentation

IS02: The Hardships of Finding your Way in Biometrics
Evi Creebsburg, OCS Consulting
Download Presentation

IS03: How Well Can you Speak SAS or is What you See What you Get?
Bahatska Yuliia, inVentiv Health
Download Presentation

WINNER IS04: The Data Detective: Hints and Tips for Independent Programming QC
Bethan Thomas, PRA Health Sciences
Download Presentation

IS05: Good Programming Practice and its Importance in Metadata
Jennifer Chin, Eisai, Mark Foxwell, PRA & Shafi Chowdhury, Shafi Consultancy
Download Presentation

IS06: Get Kitted Out – A Practical Guide to SAS Certifications, MOOCs and Hands-on Experience
Hannes Engberg Raeder, PRA Health Sciences
Download Presentation

IS07: Developing Better Training Guides
Alastair Scarlett, d-Wise
Download Presentation



MA01: Developing Agile and Adaptive Processes in the Modern Fast-packed Data Rich World
Sam Warden, d-Wise, Chris Price, Roche & Shafi Chowdhury, Shafi Consultancy

MA02: Dancing with the Grizzly – An interactive workshop to define the perfect SCE (Statistical Computing Environment) Implementation Project for a Global Biopharmaceutical Company
James McDermott, Ab Tartarus & Jean-Marc Ferran, Qualiance

MA03: Enhanced Data Analytics: A Reality Check of Aspiration, Current Progress and Organisational Implementation
Christian Mueller, Roche, Sascah Ahrweiler, Bayer, Leo Valms, Quintiles & Jari Ahvenainen, Aastat


Professional Development & Training

PD01: The Process and Development of the SAS/STAT® Programmer Role from a Retroactive Perspective
Jonathan Bishop, PRA Health Sciences
Download Presentation

PD02: Size Doesn't Matter – Little Fish Can be Leaders Too
Jennifer Dootson, d-Wise
Download Presentation

PD03: Why Programmers Make the Best Functional Leads: Do Statisticians Really Know Best?
Tom Ward, PPD
Download Presentation

PD04: Continuous Improvement for TFL Production
Caroline Terrill, CROS NT
Download Presentation

PD05: How to Enjoy Working in Virtual Teams
Petra Auclair & Antje Rossmanith, Roche
Download Presentation

PD06: Program-level Programming Strategy – Oh, I Wish I’d Thought of That Beforehand!
Jennie McGuirk, ICON
Download Presentation

PD07: Desired Competencies for Speed and Efficiency (in the Drug Approval Process)
Ramesh Satyavarapu, inVentiv Health
Download Presentation

WINNER PD08: So You’re a Superstar Programmer…Why You Still Might Not Be Picked for the Team
Diana Stuart, Veramed
Download Presentation

PD09: On the Fast Lane to a Successful Submission – A Lead Programmer’s Guide to Efficient, High-quality Submission Programming Deliverables
Michael Reich, Hannes Engberg Raeder, James Witt & Doris Kolb, PRA Health Sciences
Download Presentation

PD10: Is the Statistical Programming Process Lean Enough?
Simon Jennings, ICON
Download Presentation

PD11: Integration & Innovation: Pharma-CRO Relationship
Nalin Gupta, GCE Solutions
Download Presentation


Poster Presentations

PP01: SAS Grid Migration – Challenges, Solutions and Learnings
Amol Waykar, Eric Brinsfield & Alistar Dootson, d-Wise
Download Presentation

PP02: Efficiently Converting Datasets to Vertical Structure using Metadata
Thevaki Mahadevan, ICON
Download Presentation

PP03: CONSORT Diagram: Doing it with SAS
Anusha Mallavarapu & Dean Shults, Cytel
Download Presentation

PP04: Using Metadata to Drive Standards, Speed, Consistency and Quality in Reporting
Shafi Chowdhury, Shafi Consultancy & Daniel Boisvert, Biogen
Download Presentation

PP05: Early Data Review
Graham Oakley, ICON
Download Presentation

PP06: Developing MDR Metadata Requirements for Operational Implementation
Andy Richardson & Scott Bahlavooni, d-Wise
Download Presentation

WINNER PP08: The Tortoise Versus the Hare – And the Winner is...
Meena Rahman, AstraZeneca & Rebecca Leivers, PAREXEL
Download Presentation

PP09: Creating a PDF File Containing Multiple Outputs
Spencer Renyard, PHASTAR
Download Presentation

PP10: Non-printable and Special Characters? BYTE Me!
Louise Sims, PHASTAR
Download Presentation

PP11: Automating ADaM
Helen Hart & Christof Binder, Roche
Download Presentation

PP12: Implementation Effort Estimation: Important Aspects
Patrick Warnat, HMS Analytical Software
Download Presentation

PP13: Shopping for your CRF: Combining Sources for a Simple Data Collection Browser
Rod Bower, Roche
Download Presentation

PP15: Automating Frequency Tables with ClinXport SAS Macro Package
Loizos Nicolaou & Julien Vanwinsberghe, ClinBAY
Download Presentation

PP16: Crossover to High-quality Graphics
Simon Clancy, Sue McKendrick & Martin Clancy, Quanticate
Download Presentation

PP17: Stylising your SAS graph – A Needs-based Approach
Jérôme Lechere, Novartis
Download Presentation

PP18: Fast and High-quality Validation Process
Andrea Parodi, Dmitri Petratchenko & Alessia Sacco, Valos
Download Presentation

PP19: The Development of Standards Management Using EntimICE-AZ
Shyamprasad Perisetla & Per-Arne Stahl, AstraZeneca
Download Presentation

PP20: Fast Track to Domain: SDTM.PC and SDTM.PP
Lina Ulkjær Jørgensen, Novo Nordisk
Download Presentation

PP21: Reflections on the Effects of Data Pooling
Catharina Dahlbo, Capish Nordic
Download Presentation

PP22: KeyDan – A Data Anonymisation Tool
Cathy Scoupe, Stéphane Chollet & Mathilde Laffitte, Keyrus Biopharma
Download Presentation

PP23: Constructing Interoperable Study Documents From A Semantic Technology-based Repository
Colin de Klerk, UCB Biosciences
Download Presentation

PP24: Scientific Data Curation: Efficiently Extracting Structured Data from Publications
Rupali Desai & Nand Kishore Rawat, Cytel
Download Presentation


Regulatory Agencies

Electronic Submissions, Study Data Standardization Efforts, and the Impact on Regulatory Review in CDER, FDA
Lilliam Rosario, FDA

Regulatory Statistical Implications of "Fast Track Approval"
Ferran Torres, IDIBAPS (Hospital Cliníc de Barcelona)

IDMP/SPOR Project: A New Way of Conducting Business
Francisco Peñaranda, EMA



RG01: What is High-quality Study Metadata?
Sergiy Sirichenko & Max Kanevsky, Pinnacle 21
Download Presentation

WINNER RG02: Planning for Data-reporting Processes for Submission: Key Considerations
Parag Shiralkar, Interdependent Consultant
Download Presentation

RG03: Japanese Electronic Submission in CDISC Formats
Takashi Kitahara, Novartis
Download Presentation

RG04: What Auditors Want
Angelo Tinazzi & Cédric Marchand, Cytel
Download Presentation

RG05: Case Study in Support of German Payer Evidence
Frank Senk, AstraZeneca
Download Presentation


Real-world Evidence

RW01: The Playbook: Real-world Data to Real-world Intelligence
Laurie Rose & Robert Collins, SAS
Download Presentation

WINNER RW02: Real-world Evidence: A Comparison Between Countries
Edith Heintjes & Jetty Overbeek, PHARMO Institute
Download Presentation

RW03: Proposal of a General Macro Framework for Propensity-score Matching
Holger Langkabel, Roche
Download Presentation

RW04: An Algorithm to Distinguish Between COPD and Asthma
Berber Snoeijer & Jetty Overbeek, PHARMO Institute
Download Presentation

RW05: Considerations in the Use of Propensity Scoresin Observational Studies
Lawrence Rasouliyan, Estel Plana & Jaume Aguado, RTI Health Solutions
Download Presentation

RW06: What Have I Done? Analysis Specifications Document for Retrospective Database Studies
Knut Mueller, UCB Biosciences
Download Presentation


Software Demonstrations

SD01: Data Standards Governance
João Gonçalves, Business & Decision Life Sciences
Download Presentation

SD02: Fast Track to Define-XML v2.0 – SDTM and ADaM
Jörn Bilow, Entimo
Download Presentation

SD03: Pinnacle 21 Enterprise – Facilitating eSubmission Preparation
Max Kanevsky, Pinnacle 21
Download Presentation

SD04:  EnForeSys – An Advanced Patient Enrolment Forecaster with Monte Carlo Simulations
Ritika Yadav & Swechhya Bista, Cytel
Download Presentation

SD05: Blur Software Demonstration
Cathal Gallagher, d-Wise
Download Presentation

SD06: encapsia™ – Providing Real-time, Interactive Visualisations of Clinical Data
Jon Carter, Cmed
Download Presentation

SD07: SAS Studio – Getting to Know SAS Studio
Andy Bayliss, SAS
Download Presentation

SD08: Standard Safety Visualisation Set-up Using Spotfire
Michaela Mertes, Roche
Download Presentation


Statistics & Pharmacokinetics Programming

SP01: Standard Methods for Analysis and Reporting of VAS or NRS Derived Pain Relief Response Scores
James Johnson, Flexion Therapeutics
Download Presentation

SP02: Probability Plots as an Instrument for Comparing Distributions
Holger Langkabel, Roche
Download Presentation

WINNER SP03: Upstream with Your Statistician and a Data Visualisation Paddle
Nick Cowans, Veramed
Download Presentation

SP04: Multiplicity Issues in Clinical Trials – Look at it with a Magnifying Glass!
Madhusudhan Bandi, Cytel
Download Presentation

SP05: Using Graphics to Review and Present PK/PD Data for Maximum Impact
Shafi Chowdhury, Rajwanur Rahman & Marco Ackermann, Shafi Consultancy
Download Presentation


Trends & Technology

TT01: Does the Concept of a ‘Sentient Enterprise’ Apply to the Clinical Trial Execution Process?
Peter Grolimund, Teradata
Download Presentation

TT02: SCAPROC Impact Analysis – Providing QA and Compliance Insights
Sandeep Juneja, Ben Bocchicchio & Stijn Rogiers, SAS
Download Presentation

TT03: An Update from the PHUSE Working Group on Cloud Adoption in the Regulated Life Sciences Industry
Tony Hewer, Medidata Solutions
Download Presentation

TT04: Challenges and Opportunities with the Implementation of a Single-instance Cloud Research Platform
Doug Bain, eClinicalHealth
Download Presentation

TT05: Generating Analysis Results and Metadata – Report from a PHUSE CS Project
Marc Andersen, StatGroup & Marcelina Hungria, DIcore Group
Download Presentation

TT06: Reflect on Your Data
Peter Tormay & Henrik Drews, Capish Nordic
Download Presentation

WINNER TT07: R Beyond Statistics
Namrata Deshpande, Cytel
Download Presentation

Back to Stream Overview

Back to Conference Archive

Back to Main Archive


Thinking of joining PHUSE?

Already a member but not sure how you can benefit?

PHUSE is an expanding, global society with a global membership of clinical data scientists. It requires a large pool of resources to help with its running, and so there are many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly online newsletter, we are always keen to hear from volunteers.

Find Out More