Frankfurt Single Day Event Challenges Ahead! A Fast-growing Business Landscape 3rd May 2017 Marriott Hotel, Frankfurt
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
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. Other brand and product names are trademarks of their respective companies. © 2016 SAS Institute Inc. All rights reserved. G28381US.0516
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. Other brand and product names are trademarks of their respective companies. © 2016 SAS Institute Inc. All rights reserved. G28381US.0516
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. Other brand and product names are trademarks of their respective companies. © 2016 SAS Institute Inc. All rights reserved. G28381US.0516
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. Other brand and product names are trademarks of their respective companies. © 2016 SAS Institute Inc. All rights reserved. G28381US.0516
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
Frankfurt 2017 | PhUSE Single Day Event | 5
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
6 | PhUSE Single Day Event | Frankfurt 2017
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
Frankfurt 2017 | PhUSE Single Day Event | 7
Speakers and abstracts
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
8 | PhUSE Single Day Event | Frankfurt 2017
Speakers and abstracts
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
Frankfurt 2017 | PhUSE Single Day Event | 9
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
10 | PhUSE Single Day Event | Frankfurt 2017
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/
Frankfurt 2017 | PhUSE Single Day Event | 11
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/
12 | PhUSE Single Day Event | Frankfurt 2017
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