challenges ahead! a fast-growing business landscape 3rd ... 2017 sde presentations/final... · a...

Frankfurt 2017 | PhUSE Single Day Event | 1

FrankfurtSingle Day Event

Challenges Ahead! A Fast-growing Business Landscape3rd May 2017Marriott Hotel, Frankfurt

2 | PhUSE Single Day Event | Frankfurt 2017www.sas.com/phuse-de

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SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration.

SAS® Life Sciences Analytics Framework

Better trials.Less error.

Frankfurt 2017 | PhUSE Single Day Event | 3www.sas.com/phuse-de



SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration.

SAS® Life Sciences Analytics Framework

Better trials.Less error.

4 | PhUSE Single Day Event | Frankfurt 2017

Your guide to the day

AgendaTime Title and Speaker

08:45–09:30 Registration and coffee

09:30–09:40 Welcome

Beate Hientzsch, HMS Analytical Software & Boris Grimm, Boehringer Ingelheim

09:40–10:20 PhUSE Overview – 100 SDEs and Counting

Stephen Bamford, PhUSE Events Director

10:20–11:00 SDSP – Study Data Standardization Plan: A First Insight

Claudia Meurer, Merck

11:00–11:30 Morning break

11:30–12:10 New Roles and Challenges for Statistical Programming –

Examples from Boehringer Ingelheim

Jürgen Böhl, Boehringer Ingelheim

12:10–12:50 Ever Programmed a PowerPoint Presentation with SAS?

Steffen Müller, HMS Analytical Software

12:50–13:50 Lunch and networking

13:50–14:25 Running CDISC Conformance Checking in SAS

Frank Biedermann, Grünenthal

14:25–15:00 SAS Studio – Overview and Usage in Clinical Development

Beate Prellwitz, SAS

15:00–15:30 Afternoon break

15:30–16:05 Navigating Cloud Computing in the Fast-growing Clinical Landscape

Sam Warden, d-Wise

16:05–16:15 PhUSE European Annual Conference 2017

Jules van der Zalm, PhUSE

16:15–17:00 Closing and get-together


Dear Single Day Event Attendees,

It is our pleasure to welcome you to a special PhUSE Single Day Event

(SDE). This year’s SDE in Frankfurt is the 100th SDE in the PhUSE history

and we are very proud to be part of this important milestone.

We will celebrate this anniversary by painting a picture from the very

beginning as a European user group to what is now a global non-profit

organisation shaping the business landscape. We will have insight into the

various ongoing initiatives and activities today and our vision for the future.

At the end of the day, you are invited to stay for a drink.

As for all Single Day Events, the goal is to exchange ideas and create value

for participants as well as for the PhUSE Future Forum, a strategic PhUSE

initiative aiming to drive forward the industry thinking on key topics around

technology, data, processes and collaboration.

Out of a broad range of topics addressing future challenges, we have

selected the newly established Study Data Standardization Plan, CDISC

conformance checking, SAS Studio applied in clinical development, creation

of PowerPoint presentations using SAS, cloud computing, new roles and

challenges for statistical programming and last but not least the PhUSE

organisation itself. The agenda encourages intense discussions after each

presentation and provides time between the sessions for networking.

We would like to thank all of you for attending this event and especially our

presenters for their commitment.

Join us and make the 100th PhUSE SDE an enjoyable and productive

experience!

Best regards,

Beate & Boris

Frankfurt Single Day Event Chairs 2017

Introduction

Beate HientzschHMS Analytical Software

Boris GrimmBoehringer Ingelheim

Welcome to Frankfurt


Speakers and abstracts

Stephen Bamford, PhUSE Events Director

Claudia Meurer, MerckAbstract

Frankfurt 2017 will be the 100th PhUSE Single Day Event. What

a milestone! As part of designing PhUSE membership, the Board

knew that to create a global membership base, we had to appeal

in more ways than a single conference occurring in a different

European country each year. We needed something that would

benefit members in different regions. At the same time, a large

number of presentations were being created each year at the

Annual Conference, so we thought about ways to share the best

papers from each stream. In 2008, the PhUSE SDE was born:

events held in different regions, which would be free for PhUSE

members. Today we will take a journey back through the SDEs

and where PhUSE is heading as we move forward. There will be

an opportunity to ask questions regarding any aspect of PhUSE.

Biography

Stephen was nominated to the position of EU Events Director in

2013 and now holds the position of Global Events Director.

Stephen started his career in clinical biometrics at Pfizer in 1995.

During his 12 years at Pfizer, he took on biometrics leadership

roles of increasing responsibility, led the analysis and reporting

of numerous international clinical trials and worked as a key

member on six global NCE submissions. After leaving Pfizer,

Stephen joined Quanticate in a senior biometrics management

role until he left in 2011 to set up Cerafor, where responsibilities

included the provision of technical leadership, management of

business operations and strategic business development.

In 2014, Cerafor was acquired by Business & Decision Life

Sciences and Stephen became Director of Biometrics

Consultancy. In 2016, Stephen joined Janssen Research &

Development, where, as Director of Information and Knowledge

Management, he heads up the Central Statistical Surveillance

unit as well as being the business owner for data privacy for

data sharing as well as for regulatory requirements such as EMA

Policy 0070.

Stephen founded PhUSE in 2004 and held the position of

President until 2011 when he moved into an advisory capacity

before returning to the Board as EU Events Director in 2013. He

holds a BSc in Statistics from Coventry University and is married

with two children. He lives in Kent and is a keen supporter of

Welsh rugby.

Abstract

This presentation gives an overview of the Study Data

Standardization Plan, a cross-functional document which shall be

used for discussions with the FDA before submission. Covered

topics are: Why do we need a SDSP? Who is responsible? Who

contributes? Which templates are available? When should you

start the SDSP? This presentation describes our lessons learned

during the creation of the SDSP and the experience we gained

during a submission.

Biography

In 1986, Claudia joined the pharmaceutical industry as a SAS

programmer. She gained a lot of experience in the biostatistical

departments of several pharmaceutical companies in the Rhine-

Main area, working on analysis and reporting of Phase I to Phase

III trials and creating SAS macro libraries.

In addition, she worked on data management tasks, such as

database set-up, editing checks, query management, coding

activities and standardisation of these tasks. In 2003, she came

into contact with SDTM for the first time, which she then became

greatly interested in.

Since November 2010 she has worked in the Data

Standardization Team of Merck, Data Management. There, she

leads the SDTM team which is responsible for the Merck-SDTM

standard, its governance and maintenance. In addition, the SDTM

team supports the project data managers at Merck to ensure

submission-readiness of SDTM data.

PhUSE Overview – 100 SDEs and Counting

SDSP – Study Data Standardization Plan: A First Insight

09:40–10:20 10:20–11:00



Jürgen Böhl, Boehringer Ingelheim

Steffen Müller, HMS Analytical Software

Abstract

This presentation will consist of a small recap of the history of

statistical programming at Boehringer Ingelheim (BI) and how

the role of a programmer at BI has developed since the mid-90s.

The presentation will then describe the current situation and

characterise a new programming role created at BI.

Last but not least there will be a look into the crystal ball as to

what the future of statistical programming may look like and what

talents will be needed. We will touch upon topics like big data, R

programming language and the data scientist, with an attempt

to outline exactly what is meant by these popular keywords and

how they may influence the future of statistical programming.

Biography

Jürgen’s first exposure to SAS was in 2000 as a student at the

University of Göttingen. After five years at the Swiss Federal

Institute for Forest, Snow and Landscape Research, where

he analysed data from forest inventories and built a SAS-

based reporting system, he joined the statistical programming

department at Boehringer Ingelheim in 2007. He has worked on

the reporting of clinical studies, the preparation of submission

documents and the development of standard reporting macros.

Over the years, Jürgen has worked in different roles from

associate programmer to lead project programmer; he took over

a team lead position within statistical programming at BI in 2012.

Abstract

Transferring and updating your SAS results in a PowerPoint

presentation can be time-consuming and error-prone if done

manually. Why not use ODS PowerPoint to generate your

presentation with SAS?

This presentation describes the features of the ODS PowerPoint

functionality. Standard formatting and layout options will be

shown, as well as how to customise your layout. Advantages and

limitations will be discussed, concluding with when it is beneficial

to use ODS PowerPoint and when it’s better to stick to the

classic way of presentation creation.

As a proof of concept, this presentation will be created as far as

possible with ODS PowerPoint.

Biography

Steffen started working as a statistical programmer in 2003,

after finishing his education as a computer scientist for Aventis.

His daily work covers project leader activities, CDISC application

in clinical trials for all major indications, as well as technical tasks

such as generation and maintenance of complex generic macro

systems. Always open for new technologies, Steffen is also

interested in how R can be implemented in clinical analysis.

New Roles and Challenges for Statistical Programming – Examples from Boehringer Ingelheim

Ever Programmed a PowerPoint Presentation with SAS?

11:30–12:10 12:10–12:50



Frank Biedermann, Grünenthal Beate Prellwitz, SAS

Abstract

Pinnacle 21 is an easy point-and-click software solution for

CDISC conformance checking. SAS programmers and persons

working with CDISC standards usually run Pinnacle 21 as an

independent executable application during and after the CDISC

dataset creation process. But there are possibilities to execute

Pinnacle 21 from within a SAS program.

This presentation will show how to run Pinnacle 21 from within

a SAS program, how to assign required parameters such as

type of standard, input and output files, version of checks and

so on. It will also show how to create a Java package of the

Pinnacle 21 installation and how to run this package on a SAS

Linux/Unix system or in a hosted environment, like the SAS Drug

Development.

Biography

Frank works as an Analytical Programmer at Grünenthal, a

midsize pharmaceutical company with headquarters in Aachen,

Germany. He has worked in different technical, programming and

project management roles. With more than 15 years’ experience

in SAS programming in the pharmaceutical industry, he has a

deep technical and architectural knowledge of different SAS

solutions, for example SAS Life Science Analytics Framework,

SAS EBI, JMP Clinical.

Abstract

SAS provides a number of programming interfaces. One of these

is SAS® Studio – a developer environment that runs in a web

browser, enabling developers to program in SAS wherever and

whenever they want. SAS® Studio offers capabilities that can

help busy users easily access programs, data files and libraries.

With its customisable interface and flexible task framework, SAS®

Studio allows users to create their own tasks by easily designing

an input form to support a set of code.

Biography

Beate Prellwitz is an Account Advisor, and has been working

for the pharmaceutical and life sciences industry in Germany

for more than 10 years. She started at SAS as a Technical

Consultant working on data warehouse projects, requirement

workshops, programming, proof of concept and coordination of

project implementation.

Running CDISC Conformance Checking in SAS

SAS Studio – Overview and Usage in Clinical Development

13:50–14:25 14:25–15:00


Thanks

Sam Warden, d-Wise

Abstract

Cloud computing potentially offers many advantages to sponsors

and CROs seeking to benefit from greater flexibility, disaster

recovery, automatic updates, reduced capital expenditure,

collaboration, document control and security.

While cloud computing potentially offers many benefits, there

are also considerations and potential pitfalls that need to be

navigated, not least validation, compliance and support. The

burden of providing clinical computing in small and medium-sized

organizations often increases sharply compared with companies

that benefit from significant IT budgets and/or dedicated support

teams.

d-Wise will provide an overview of the opportunities and

challenges facing resource-challenged companies seeking to

benefit from cloud computing in clinical research and operations.

Biography

Sam has over 20 years of successfully delivering global life

sciences project and operations consulting. She holds an MBA

and is a Chartered Manager. She is experienced in facilitation,

process improvement and project management and has a life

sciences degree. Prior to joining d-Wise Sam held leadership

positions with Covance, Merck Serono and GlaxoSmithKline.

She has been involved in leading large-scale technology

implementation projects focused on data for the past 20 years.

These projects have related to research as well as development,

seeing the complete research and development life cycle from

molecule discovery through to registration.

At d-Wise, Sam leads both European and US teams of life

sciences consultants, bringing her extensive experience to

analysing external and internal drivers and creating strategies

that forge organisational design, process improvements and

embrace technology to deliver innovative solutions.

Navigating Cloud Computing in the Fast-growing Clinical Landscape

15:30–16:05 ContributorsThank you to all our contributors for their generous support


Things to come

Looking forward

Visit the PhUSE website for dates and further information –

phuse.eu/single-day-events-2017

India SDE

Mumbai

China SDE

Shanghai

November USA SDE

Chapel Hill, NC

Belgium SDE

Beerse

June Denmark SDE

Copenhagen

USA SDE

Raritan, NJ

India SDE

Hyderabad

CSS EU

London, UK

Mon 19th-Tues 20th

July USA SDE

North Chicago, IL

May Switzerland SDE

Basel

China SDE

Beijing

UK SDE

London

August USA SDE

Whippany, NJ

Japan SDE

Tokyo

October PhUSE Annual

Conference

Edinburgh, UK

Sun 8th–Wed 11th

September France SDE

Chilly-Mazarin

ANALYTICAL CRO-SERVICES BY HMS Your excellent and reliable partner

Analysis of Clinical Studies Data Integration CDISC Services Regulatory & eSubmission Support Training & Consultancy

Join our Team: www.analytical-software.de/en/


ANALYTICAL CRO-SERVICES BY HMS Your excellent and reliable partner

Analysis of Clinical Studies Data Integration CDISC Services Regulatory & eSubmission Support Training & Consultancy

Join our Team: www.analytical-software.de/en/


Conference Chair Jules van der Zalm, OCS ConsultingConference Co-Chair Katja Glaß, Bayer PharmaFor more information visit the PhUSE website phuse.eu/annual-conference.aspx

Annual Conference

Edinburgh Castle

Digital Innovation in Healthcare8th–11th OctoberEdinburgh International Conference Centre

Edinburgh 2017

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