This document discusses new needs for interoperability in clinical research. It outlines global trends driving changes in the pharmaceutical industry towards more collaboration and use of external data sources. Interoperability is needed to exploit information from clinical trials, databases, literature and electronic health records. The Innovative Medicine Initiative and its EHR reuse project aim to develop a model for accessing and analyzing healthcare data to improve research through standardized platforms. The goal is to establish sustainable organizations to bridge levels of interoperability between healthcare and research.

1. New needs for
interoperability in Clinical
Research
Mats Sundgren
Global Clinical Development AstraZeneca

2. What this lecture is all about
”Discuss aspects of interoperability needs to
realise added value of health information -
linking patient care, clinical research
and public health”
New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 2

3. Outline
• Global trends in science & medicine
• The changing face of pharma industry
• Drivers & interoperability needs for the pharma
industry in the next years
• In context – health data and the case of Innovative Medicine
Initiative (IMI) and the EHR re-use project
• Conclusions
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4. The changing face of unmet medical need
• The need to improve on available therapy
• Tailored for the individual
• Very early diagnosis
• Modification of disease
• Ageing – diseases and symptoms
• “Old” and new infections
• Sedentary life style – in all ages,
throughout the world
• Improved health care generates new
demands

5. Pharma Industry Trends
R&D spend Dev. times NMEs Sales
rma
250
pha
for iety
Indexed to 1997
e
eng or soc
200
R&D spend
150
hall rn f
A c ce
A con
100
50 NME
0
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007*
• Much more complex • Regulatory requirements
• From “Art to Science” • Safety & efficacy
• Multidisciplinary • Much larger programs
• Parallel work at risk • Hard end-points (outcome
• Superior properties required studies)
• Safety concerns greater • Value demonstration
Source: CMR International & IMS Health

6. Drivers for Life Science Innovation
• Advances in computer science
• Shift in scientific method (Systems biology)
• Information & Communication Technologies
(ICT)
• Explosion in information & data availability
• New tools for understanding biology &
medicine
• Redefining Knowledge Management
• New collaboration models for bridging
connections for innovation

7. The changing face of pharma industry
• Moving from traditional R&D model towards a collaborative
model
• Externalization, Transparency, Public – Private – Partnerships
• Were knowledge management and information
interoperability are key capabilities
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8. Why is information interoperability
important?
• The use of health information generated in the external
environment (e.g. EHR) will become central to new drug
development business model:
Traditional pharma R&D: creation, control and dissemination of information
Huge increase in information from the patient population; accessible by many parties
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9. Challenges
• The challenge for the industry is no longer how to
capture and manage data in clinical trials.
• But to exploit all the information that is available without running
clinical trials: legacy data from our clinical research, external
research databases, biomedical literature and, not the least,
electronic health records.
• Build capabilities through collaboration to address
interoperability needs (semantic, organisational etc) to
connect health data with clinical research
• is a multi facet, multi stakeholders undertaking with regulatory,
organizational and technical components. These components are
inter-related; all of them are needed
• Impact on both new drug development and
health care and patients
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10. New Information Landscape
For the Pharmaceutical Industry
For the Pharmaceutical Industry
New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca

11. The Internal Information Domain - AZ
• Company generated scientific
information in new drug development
such as:
• Clincal Study data – on going projects
• Clincal Legacy data (terminated projects)
• Textual information (e.g. reports, protocol)
• Pre-clinical information and data, etc.
• High need of make optimal re-use of information,
• Increased demand to share information
externally
• Pace of Information production and supporting
technology: high speed
New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca

12. The External Regulated Information Domain
• Access controlled information
sources such as:
• Academic data bases
• Health care (EHR, PHR)
• Scientific data bases
• National Disease Registers
• Scientific Journals
• Real World Data.....
• Represent “validated” scientific information
with very high relevance for clinical
research
• Pace of Information production and
supporting technology: high speed
New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca

13. The External Open Information Domain
• Free access information
sources such as:
• Open accessible data bases
• Patient communities
• Blogs
• Conferences
• Represent a mix of “validated”
scientific information with
potential high relevance for
clinical research
• Pace of Information production
and supporting technology:
ultra high speed
New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca

14. New Information Landscape
For the Pharmaceutical Industry
For the Pharmaceutical Industry
”Un-Linked” Data
Linked
Open
Data
Linked
”Un-Linked” Data Open Drug
Data
Linked Data
”Un-Linked” Data
New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca

15. Impact areas – e.g. Health data integration on drug
development
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16. Example Pharma perspective
Organization: today, with EDCs
1 6
5
2
3 4
EDC without data standards, courtesy Charles Jaffe
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17. Patient recruitment
• In 2006, the US based Mayo Clinic used EHRs for
rapid prospective recruitment of patients with heart
failure
• In one study, more than 2900 (2904) heart failure
cases were identified in less than 24 hours using
language contained in the EHRs
• These results were also used for predictive modelling
and clinical trial design
Ref. (Pakhomov et al. “Electronic Medical Records for Clinical Research:
Application to the Identification of Heart Failure”, Am J Management Care. June, 2007)
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18. Demands of interoperability
Means to share information between disparate
information systems in such a way that the
information can be used in a meaningful way
• Functional
• Semantic
• Privacy & Security
• Legal
• Business
• Organisational
New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca

19. Example of moving forward for
coordinated action
The case of Innovative Medicine Initiative (IMI) and
the EHR re-use project
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20. What is IMI?
• Long term public-private partnerships in research
at European level (2007-2017)
• Aims
• Removing major bottlenecks in drug development,
where research is the key,
• Re-invigorate the European bio-pharmaceutical
sector
• Coordinated research efforts responding to industry
needs
• Focus on fields of high industrial and policy
relevance
• Building on European Technology Platforms
• Implemented through new legal entities – Joint
Undertakings (JU)
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21. IMI Call topic no 9 - EHR to Support &
Enhance Medical Research
Problem statement
• A sustainable “business model” for the
re-using EHRs in Europe is required
• to realize the potential of enhanced research,
development, and safety through the expanded use
and interoperability of health information technology
• There is gap between
• technology solutions, regional diversity, individual
approaches and the lack of a common viable model
across Europe
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22. IMI Call topic no 9 - EHR to Support &
Enhance Medical Research
Project objective
The applicant consortium is expected to bring forward innovative
approaches to develop:
A model to access, share, and analyze electronic healthcare data
to improve medical research and efficiently connect patients to
research and development opportunities
through standardised and scalable platform(s)
that may include globally accepted standards, processes, systems, technology, organisation
models, and principles of governance
that enables healthcare professionals and medical researchers in
academia and industry to re-use healthcare databases
for new discoveries not possible in existing scientific repositories
ensuring that Information is shared in an ethical and safe way,
complying with all necessary legal requirements designed to protect patient rights and interests
In a sustainable and scalable way
across European regions and/or countries
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23. Key deliverables of the project
• A sustainable framework to provide interoperability of EHR data
between primary patient care and medical research contexts
• focusing on the specific areas of clinical trial protocol feasibility,
patient recruitment, drug safety, and cost effectiveness
• A clear value demonstration through the execution of pilot
projects
• in the above areas to demonstrate the integrity, security,
performance, and scalability of the platform across European
regions and/or countries in an ethical and safe way, complying
with all necessary legal requirements designed to protect patient
confidentiality
• Providing a forum for emerging EHR initiatives across Europe
by enabling the consistent adoption of best practices for the
convergence of clinical research and clinical care across Europe
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24. Aim of the IMI EHR project - Sustainable and
Scalable Organizational Model
• Goal - accredited ”Third party” organisations running on a new
scalable and sustainable organisational model to provide services
bridging different levels of interoperability between health care and
research
Third Party
Functional Privacy & security
(e.g. Technology, architecture, tools) (e.g. legal, sharing, governance)
Semantic Business
(e.g. ontology's, standards, languages) (e.g. organisational, accreditation, roles)
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25. New organisational model
Pharma R&D
Third Party
Business Security Pharma R&D
Health care
Functional Semantic
Health care
Academic
Health care
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26. Scalable Organisational model for EHR re-use
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27. Benefits of re-use of EHRs
Providers/Health Community
Patients
• Enhance patient safety •Faster drug to market
• Improve quality of • Enhance access to drug
healthcare information
• Reduce healthcare costs • Improved personalized
treatment capability
Empower consumers to manage their own health and to work collaboratively with their
Empower consumers to manage their own health and to work collaboratively with their
physicians to prevent illness and to adhere to treatment regimens
physicians to prevent illness and to adhere to treatment regimens
Pharma industry
Payers
• Improve targeting the right patient
• Addresses wellness, disease population & indication
prevention, & disease management
• Increase number effective sites &
• Prevent illness & to adhere to enrollment rate, shorten trial time & cost
treatment regimens
• Enhance patient safety
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28. Joint undertaking
EFPIA consortia Applicant consortia
Participants may come from:
• Academia
• SMEs
• Healthcare institutions
Sustainable
• Patient organisations
Sustainable
Organisational model
Organisational model
• Legal & European
for
for legislative expertise
EHR re-use
EHR re-use • Regulatory representatives
to Support
to Support
Medical Research • Ethics representation
Medical Research
• IT companies/vendors
• Privacy enhancing technology
One project vendors
consortia • ….
5 years
Initiation 2010 • ….
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29. Bridging a gap & perfect pitch
One of the key messages in PriceWaterCooper report on
Transforming Healthcare through Secondary Use of Health
Data (Oct, 2009)
What it means for your business?
“Industry stakeholders are calling for a
framework to define public and private
sector roles in secondary data use”!
Which is exactly what the IMI EHR project is
all about!
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30. CONCLUSION
• EHR and health information integration for medical research is opening
on
new possibilities to be a real win-win-win situation for patients, health
win
care and life science industry
• It is a complex undertaking with demands of organizational, legal and
technical, semantic, and geographical interoperability requirements
• Technology, is here and integration is feasible to solve many cross-EU
issues
• BUT it requires a public private partnership model with an industry
wide approach, strong political support, where pharma industry plays an
important role
Turning health data into actionable information
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31. Thank you for your attention
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