SMi Group's Inaugural Big Data in Pharma conference takes place in London this May

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Big Data in Pharma
SMi present their inaugural conference on…
Manage and analyse big data to enhance R&D
and clinical trials for the future!
12th - 13th
Holiday Inn Regents Park Hotel, London, UK
MAY
2014
chairman
simon holt, Vice President, Global Head HEOR,
novartis pharma AG
Prior to this position Simon was the Global Head of Market
Access for the franchise responsible for specialty medicines
at Novartis. He is based in Basel. Simon brings a background in strategy
and operations management consulting from A.T.Kearney with him to
his role as well as a wide reaching international network of seniors in the
medical device, healthcare, pharmaceutical and diagnostic industries.
Key speakers include:
• nick brown, Innovation & Technology Architect, Chief Technology
Office, AstraZeneca
• stephanie manson, Director Global Health Outcomes, GlaxosmithKline
• Rob thwaites, Vice President, Health Economics and Epidemiology,
evidera and Chair, Pharmaceutical industry Health Information Group,
Abpi
• Xavier olba, Digital Business Strategy, sanofi Aventis
• Jan hauß, Head of R&D Laboratory Information Management System
(LIMS), merck KGaA
• dr Athula herath, Statistical Director, R&D Statistics, medimmune
• Rachel uphill, Enterprise / Information Architect, R&D IT Solutions,
Delivery & Integration, GsK medicines Research centre
• Kerstin Kleese van dam, Associate Division Director, Leader Scientific
Data Management Group, pacific northwest national laboratory
benefits of attending:
• Attend the only event to focus specifically on the impact of big data in
the pharmaceutical industry - how can you exploit its potential to
create better medicine and generate new revenue streams?
• Hear from knowledgeable speakers - our carefully researched
programme includes several exclusive case-studies from pharma and
biotechnology experts. Watch this space as more are announced!
• Discover how big data analysis can positively impact clinical trials by
acting on information in real-time
• Gain up to date insight on applications for heoR data in pharma
plus tWo inteRActive hAlF-dAY post-conFeRence WoRKshop
Wednesday 14th may 2014, holiday inn Regents park hotel, london, uK
A: legal and practical Aspects of cloud
computing
Workshop Leader: Jan hauß, head of R&d laboratory information
management system (lims), merck KGaA
8.30am - 12.30pm
b: designing and commissioning studies using big data to
support drug development and marketing
Workshop Leadesr: Rob thwaites, Vice President, Health Economics and Epidemiology,
evidera and Chair, Pharmaceutical industry Health Information Group, Abpi
Andrew paul cox, phd, Senior Research Associate, evidera
Radoslaw (Radek) Wasiak, phd, mA, msc, EU Director and Senior Research Scientist in Health
Economics, evidera
www.pharmabigdata.co.uk
1.30pm – 5.30pm
1.30 pm - 5.30 pm
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
AcAdemic & GRoups discounts AvAilAble
#bigdatapharma2014

2. big data in pharma
www.pharmab
day one i monday 12th may 2014
8.30
Registration & coffee
9.00
chairman's opening Remarks
simon holt, Vice President, Global Head HEOR,
novartis pharma AG
biG dAtA in clinicAl tRiAls
11.40
personalized medicine: using big data to individualize treatment;
the cancer example
• Reviewing constitutional factors influencing reaction of the host
on a drug
• Discussing cancer/host factors predicting clinical course, i.e.
prognosis
• Tumour cell biology identifying validated tumor-driving genomic
aberrations in drug-targeted genes/pathways ('predictive'
biomarkers)
professor hubert caron, Paediatric Oncology, emma children’s
hospital Amc Academic medical centre, university of
Amsterdam
12.20
networking lunch
1.50
leveraging existing data from legacy clinical trials
• Discover a goldmine at your fingertips
• Understanding how to prepare it for use
• Choice of a (set of) standard(s)
• Evaluating future developments
pantaleo nacci, Head Statistical Safety and Epidemiology/PV,
novartis vaccines and diagnostics
2.30
developing a robust and effective patient reported outcomes
(pRo) strategy for clinical trials
• Understanding the essential elements required to create a
successful PRO strategy
• Ensuring best practice for PRO use in trials, to improve the
quality of PRO information collected for:
- clinical care
- decision-making
- predicting long-term outcomes
- informing health policy
professor melanie calvert, Professor of Outcomes Methodology,
Primary Care Clinical Sciences, birmingham university
3.10
Afternoon tea
mAnAGement And AnAlYsis (pARt 1)
9.10
9.50
openinG AddRess
big data analytics…enabling the "insights from the whole patient
populations to a sample
• On development of a framework that may enable the analysis
of clinical data/standard care in real-time to keep abreast of
latest clinical research related to drug development
• Introducing high-performance analytics to enable timely and
accurate insights using
- data mining
- predictive analytics
- modelling and simulation of the possible outcomes of a
therapeutic intervention to stratify patient populations to
sieve through the best interventions for a patient strata
dr Athula herath, Statistical Director, R&D Statistics, medimmune
big data and the pharmaceutical industry: understanding how
industry initiatives can move opportunities with big data forward
for individual companies
• How has industry championed big data?...Examples from
multiple countries
• Case study - a decade of initiatives by industry in the UK
• Collaborative developments that will open up opportunities for
companies in the future
• How can developments at an industry level help a company’s
RWD strategy
Rob thwaites, Vice President, Health Economics and
Epidemiology, Evidera and Chair, Pharmaceutical industry Health
Information Group, Abpi
looKinG AheAd
10.30
morning coffee
3.40
beyond the horizon… building the ‘blueprint’ for a data-led
pharmaceutical industry of the future
• Understanding how the plethora of new data and improved
analytical techniques can enhance future innovation and feed
the drug-development pipeline
• Implementing standards, strategies and collaborations to
enhance products and provide wider medical value
• Discovering what your peers are prioritizing as part of their own
Big Dip strategies
Rachel uphill, Enterprise / Information Architect, R&D IT Solutions,
Delivery & Integration, GsK medicines Research centre
11.00
leveraging big data to study comparative effectiveness
research (ceR): a case example in multiple sclerosis
• Developing a systematic approach for identifying CER
opportunities for pharma
• MS is a complex, chronic disease that requires monitoring of
real-world effectiveness to inform clinical and economic
decision-making
• The use of data from multiple sources can overcome the
limitations associated with assessing outcomes using a single
source of information, such as individual database or registry
studies
• This combination of data sources provides useful critical
information on real-world outcomes in a general MS population
that can be used to complement data from clinical trials and
observational studies in MS
niklas bergvall, Senior Director, Global HE&OR Neuroscience,
novartis pharma
4.20
An
lessons learned so far! understanding big data and
disc el
ussio
its uses for the pharmaceutical world
n
• What has been learned
• Evaluating what has and hasn’t worked
• What are the next steps in the big data strategy
dr Athula herath, Statistical Director, R&d statistics, medimmune
pantaleo nacci, Head Statistical Safety and Epidemiology/PV,
novartis vaccines and diagnostics
5.00
chairman's closing Remarks and close of day one
p
sponsoRship And eXhibition oppoRtunities
smi offer sponsorship, exhibition, advertising and branding packages, uniquely
tailored to complement your company’s marketing strategy. prime
networking opportunities exist to entertain, enhance and expand your client base
within the context of an independent discussion specific to your industry. should
you wish to join the increasing number of companies benefiting from sponsoring
our conferences please call: Alia malick, director on+44 (0) 20 7827 6168 or
email: amalick@smi-online.co.uk
*Subject to final confirmation
Want to know how you can get involved?
interested in promoting your services to this
market?
contact humaira Kaiser, smi marketing on
+44 20 7827 6197, or email:
hkaiser@smi-online.co.uk
Register online at: www.pharmabigdata.co.uk • Alternatively fax y

3. big data in pharma
bigdata.co.uk
8.30
9.00
day two i tuesday 13th may 2014
Registration & coffee
2.30
chairman's opening Remarks
dr Athula herath, Statistical Director, R&D Statistics,
medimmune
love thy neighbour - creating stakeholder partnerships to
maximize expertise capabilities and develop innovative
medicines
• Understanding how collaboration can enhance drug research,
development, commercialization and delivery
• Evaluating how collaborative “open space” initiatives can
enable specific questions or share insights to be addressed
• Learn how partnerships can harnessing Big Data for the
development of innovative medicines
• Lessons learned from successful pharmaceutical, academic
and CRO collaborations
• Building strategic relationships to maximize quality
improvements, economic value and cost effective outcomes
nick brown, Innovation & Technology Architect, Chief
Technology Office, AstraZeneca
pAn
Kerstin Kleese van dam, Associate Division Director,
disc el
ussio
n
Leader Scientific Data Management Group,
pacific northwest national laboratory
stephanie manson, Director Global Health Outcomes,
GlaxosmithKline
3.10
Afternoon tea
mAnAGement And AnAlYsis (pARt 2)
9.10
9.50
10.30
11.00
11.40
12.20
1.50
openinG AddRess
observational research and heoR in the big data arena
• Understanding the various applications for HEOR data in
pharmaceuticals – an introduction to the value of HEOR
• Reviewing examples of how HEOR data has proved important
and how this might be impacted by the use of big data
• Big data sources of real world observational data
• Embedding real-world data collection into clinical
development programmes
stephanie manson, Director Global Health Outcomes,
GlaxosmithKline
discussing advances in predictive analytics
• In-depth analysis – how to get at the hidden nuggets in your
data
• New approaches to distributed data analysis – analytics @ the
edge
• Continuous, automated synthesis of new knowledge and
dynamic control - analysis in motion
Kerstin Kleese van dam, Associate Division Director, Leader
Scientific Data Management Group, pacific northwest national
laboratory
morning coffee
mARKetinG & sociAl mediA
3.40
improving pharmaceutical marketing performance using big data
solutions
• Developing a digital marketing strategy in the data age
• Leveraging social media to communicate your key brand
messaging and intent
• Managing and optimising clinical data to stay ahead of the
complex and challenging market environment
• Generate more informative evidence across the product
lifecycle with observational data
christopher Keenan, Director, Governance & Operations, Global
Medical Information, bms*
4.20
delivering a definitive social media strategy and culture within
pharma to deliver optimal patient healthcare and treatment
awareness
• Realizing how social media can be used to meet the goals for
better understanding patients and to find out about:
- unmet need
- new adverse events
- patient compliance
• Evaluating available opportunities within social media for drug
marketing
• Understanding how to effectively market your drugs via social
media
• Deciphering how the various popular mediums can be used –
twitter, YouTube, LinkedIn and Facebook
• Preparing for the challenges of drug advertising compliance
within social media
Xavier olba, Digital Business Strategy, sanofi
5.00
chairman’s closing Remarks and close of day two
the impAct oF biG dAtA on ReseARch And development
making the right connections! integrating data to guarantee
consistency and reliability in R&d
• Managing and integrating data generated at all stages of the
value chain, from discovery to real-world use, to derive maximum
benefit from technology trends
• Implementing strategies to integrate external and internal
content
Jan hauß, Head of R&D, laboratory information management
system (LIMS), merck KGaA
unlocking the power of big data to transform R&d productivity
• Measuring the value of big data to pharmaceutical R&D
• How to Ensure you Select the Right ELN for your R&D
• Identifying the right patients for the right drug in Phase II trial
stage using Big Data
usman iqbal, Senior Director of Oncology, Global Evidence &
Value Development, R&d/ med Affairs, sanofi
networking lunch
cReAtinG A biG dAtA oRGAnisAtionAl cultuRe &
buildinG stRAteGic pARtneRships
big data, small steps…. insight into our innovation network and how
nurturing small pilots that deliver value, lead to big business change
• Realizing the importance of nurturing innovation
• Utilizing pilots and proof-of-concept
• Evaluating crowd-sourcing big data
nick brown, Innovation & Technology Architect, Chief Technology
Office, AstraZeneca
supported by
your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
*Subject to final confirmation

4. hAlF-dAY post-conFeRence WoRKshop A
Wednesday 14th may 2014 i 8.30am – 12.30pm
holiday inn Regents park hotel, london, uK
legal and practical Aspects of cloud
computing
Workshop Leader:
Jan hauß, Head of R&D Laboratory Information
Management System (LIMS), merck KGaA
overview of workshop:
After the latest scandals (e.g. PRISM) there should be
a focus on legal and economical traps and pitfalls in
cloud computing.
Legal aspects are:
• ISO 27K regulations
• Local and EU directives concerning privacy
Economical aspects are
• Data leakage prevention
• IP protection
This workshop will allow you to get a better
understanding of what to be aware of.
Why you should attend:
Gain practical and timely advice for anybody who is
involved in planning and implementation of software
and services that are Cloud based. In practice that
means that sharing data with an CRO via third party
services is sometimes for legal reasons not acceptable.
If you are involved in this area this workshop is for you.
programme:
8.30
Registration and coffee
9.00
9.10
9.50
10.30
11.00
11.40
12.20
12.30
opening remarks
session 1 iso 27K regulations
session 2 business relevant local and eu
directives concerning privacy
coffee break
session 3 data leakage prevention
session 4 ip protection
closing remarks
end of workshop
About the workshop host:
Jan was born in 1962. He achieved a
Ph.D. in Heidelberg in chemistry 1993, a
Post Doc. in Sussex in 1995 and has been
an IBM Fellow from 1996-1998. Since 1998
Jan has worked with Merck KGaA. He
joined the company initially as Lab. head NMR. He
has since moved onto different positions responsible
for the R&D LIMS and local IT Security Officer for Site
Operations.
About the merck Group
In 2012, the Merck Group generated total revenues
of €11.2 billion. The Merck Serono division accounted
for €6.4 billion, the Consumer Health division for €475
million, the Performance Materials division for €1.7
billion and the Merck Millipore division for € 2.6 billion
of that total. EBITDA pre, with which the earning
power of operating activities is measured, climbed to
€3 billion. Research and development spending
amounted to €1.5b illion. The operating result totaled
€964 million and free cash flow was €2 billion.
Important and current information on the company
can be found on the Web at www.merckgroup.com

5. hAlF-dAY post-conFeRence WoRKshop b
Wednesday 14th may 2014 i 1.30pm – 5.30pm
holiday inn Regents park hotel, london, uK
designing and commissioning studies
using big data to support drug
development and marketing
Workshop Leaders:
Rob thwaites, Vice President, Health Economics and
Epidemiology, evidera and Chair, Pharmaceutical industry
Health Information Group, Abpi
Andrew paul cox, PhD, Senior Research Associate, evidera
Radoslaw (Radek) Wasiak, phd, mA, msc, EU Director and
Senior Research Scientist in Health Economics, evidera
overview of workshop:
The purpose of the workshop is to give participants the basic
tools to evaluate whether and how to commission a big data
study. The topics that will have been presented at the
conference over the preceding two days will give all
attendees a picture of where studies using big data can
contribute in big pharma. This half day workshop will
concentrate on the “how”: how to decide when a study
using big data makes sense; how to commission a piece of
work using big data; and how to make the most of the
investment in a big data project.
Why you should attend:
Through a series of frameworks and case studies, the workshop
leaders will provide information and insights on:
• Reviewing different types of big data studies that can be
brought into support a new drug
• Planning for evidence generation: when can big data
studies best be brought in….and what are the
alternatives?
• Pitfalls to avoid in the design, conduct and analysis of big
data studies
• Newer methods and approaches to consider
• Selecting partners for a big data study
programme:
1.30
Registration and coffee
2.10
session 1 Reviewing the different types of big
2.00
2.50
3.20
3.50
4.30
4.50
5.20
5.30
opening remarks
data studies that can be brought into
support a new drug
session 2 planning for evidence generation:
when can big data studies best be brought
in…and what are the alternatives?
coffee break
session 3 pitfalls to avoid in the design,
conduct and analysis of big data studies
session 4 newer methods and approaches
to consider
session 5 selecting partners for a big data study
closing remarks
end of workshop
About the workshop hosts:
Rob thwaites, mA, mcom, is Vice President, Health
Economics and Epidemiology, for Evidera, a
leading global scientific consulting organisation.
Rob is been responsible for teams in Europe
conducting projects in the areas of health
economics, outcomes research, and market access. As
Chair of the UK Pharmaceutical industry Health Information
Group, Rob leads the team at the Association of the British
Pharmaceutical Industry responsible for activities at an
industry level to encourage the development and use of big
data and associated capabilities.
Andrew paul cox, phd, is a Senior Research
Associate at Evidera. In his role at Evidera, his main
area of expertise is Epidemiology, mathematical
modelling and data science.
Radoslaw (Radek) Wasiak, phd, mA, msc, is an EU
Director and Senior Research Scientist in Health
Economics at Evidera in London, UK. He has
extensive applied research experience in
designing and executing health economic,
health services, and multidisciplinary research.

6. biG dAtA in phARmA
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conference: monday 12th – tuesday 13th may 2014, holiday inn Regents park hotel, london, uK i Workshops: Wednesday 14th may 2014, london
4 WAYs to ReGisteR
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