Transcript Service Management (SM) Implementation

Clinical Technology and Information Management
Modernize Clinical Development through New Technology
Using social software to accelerate clinical development
DIA China 2011
May17th 2011, Beijing
Outline
The clinical challenges and opportunity
What is social software and how are we connected
The case for Clinical
Sanofi approach
2
The current clinical development model is unsustainable
but the opportunity to transform it is available
2/3 of R&D
costs spent
in clinical
trials
8% R&D cost
increase per
year with -5%
probability of
success
3
Convergence
of Healthcare
and Life
sciences
Increasing
complexity of
trials to
support
requirements
for safety and
efficacy
Virtualiz
ation of
work
“Web 2.0”
enables
distributed cocreation and
activism
Cloud
Computing
accelerates
the IT
commoditiza
tion
Opportunity to
become a part
of the
continuum of
care of the
patient.
The healthcare digital transformation
We will all be connected
Social networks will enable far-reaching and immediate exchange of
clinical/anecdotal experience and information among key healthcare
stakeholder communities that have been and will continue to be
established.
Mobile will reign
Mobile devices and patient records will be the standard for recording,
tracking, transmitting and receiving healthcare data.
Portability = new lifestyle
It will be a Digital world
The complete migration to digital healthcare technology for healthcare
practitioners and patients will enable improved exchange, sharing, and
integration of information.
Data will be integrated and shared
Information across all health data platforms including electronic medical
records, patient health records, and “smart” monitoring and diagnostic
devices and will be seamlessly integrated.
4
From Consumer to Prosumer - Web 2.0
Web 2.0 is associated with web applications that facilitate participatory
information sharing, interoperability, user-centered design, and
collaboration on the World Wide Web.
A Web 2.0 site allows users to interact and collaborate with
each other in a social media dialogue as creators (prosumers) of
user-generated content in a virtual community, in contrast to
websites where users (consumers) are limited to the passive
viewing of content that was created for them.
Examples of Web 2.0 include social networking sites, blogs,
wikis, video sharing sites, hosted services, web applications,
mashups and folksonomies.
5
Defining social software – connecting people
the social Web is about conversations, interpersonal
networking, personalization and individualism…It is
the ‘People-centric Web’.
Its content can be more easily generated and
published by users, and the collective intelligence of
users encourages more democratic use
Online social interaction has been enriched through
the use of wikis, blogs and podcasts
Encourages a more human approach to interactivity
on the Web, better supports group interaction and
fosters a greater sense of community
6
Social Software enable the
creation of communities
Creating communities: patients like me
www.patientslikeme.com
Health data-sharing website with more
than 100,000 patients and 500+
conditions
Online communities in which patients
monitor and submit data on the effects
of novel drugs
Enables a matched control group
MySpace ‘CURE DiABETES group’ - run by patients and supporters
Patient.co.uk - readers can record and rate existing ‘Patient Experience’ entries
Online resources for educated patients
LibraryThing Medicine Group
A library social network site promoting social interactions,
book recommendations, self-classification, and monitoring
of new books
A community of 1.3M book lovers
A virtual Library w/ more than 61 million books catalogued
in 50+ languages
Tweeting for trials
Due to the posting of clinical trial information publicly, patients are taking a more active role in
their health care decisions. Through public registries and public sites such as ClinicalTrials.gov
(NIH trial registry) many patients are seeking their own trial participation.
As looking for trial manually can be overwhelming, a new Twitter application by TrialX
(http://trialx.com/) allows patients to use do-it-yourself social media to find clinical studies that
match their health and disease profile.
TrialX also lets patients with electronic personal health records like Microsoft HealthVault or
Google Health import their information instead of filling out online pre-screening forms to be
matched for trials.
Tweet examples…
@trialx CT find studies for my father, 62 with pancreatic cancer in
Raleigh area
@trialx CT 55 YO female with multiple sclerosis in Chicago, Illinois
After sending the Tweet the TrialX application will send a reply
Tweet in about 1-2 minutes with a link to the TrialX page listing
matching clinical trials. If patients prefer not to divulge their health
profile for privacy reasons they can simply "Follow" the @trialx on
Twitter and send the Tweet as a direct message. They will then
receive a private reply with their matching trials.
Content partially extracted from http://medicinedigest.blogspot.com/
9
Moving toward integrated patient centric Information
Google Health
(https://www.google.com/accounts/ServiceLogin?service=health&nui=1&continue=https://health.g
oogle.com/health/p/&followup=https://health.google.com/health/p/&rm=hide)
Manage your health history online
Set personal health and wellness goals
Track and monitor your progress
MicroSoft Health Vault
(http://www.microsoft.com/en-us/healthvault/)
Electronic Medical Records are in use by
40% of US physicians
Source: Taking the Pulse® US v10.0.
10
How social software can be a differentiator?
11
Collaboration and social media: one of the pillars of sanofi clinical
technology strategy
Sanofi Clinical Team is developing 9 technology domains to accelerate Development Collaboration and Social Media is one major pillar.
Advanced scientific techniques
Innovation
-Use of omics
-Adaptive Trials
-Translational medicine
- Modeling and simulations
Service Orientation
Enabling Technologies
-Mobility, eHR, devices
-Natural language query and processing
- Visualization, Image Interoperability
Process Excellence
Analytical Excellence
Collaboration
Operational Excellence
(Compliance, Performance, Cost)
Global Sourcing Model
Collaboration
Analytical Excellence
Process Excellence
High Performance Team
Innovation
-Process modeling and
optimization
-Process automation
-Business activity monitoring
-Data integration and mining
-Data visualization and analytics
-Predictive analytics and
simulation
-Portal and mobility
-B2B
- Knowledge Management
- Social Software/Media
System Integration & Interoperability
-Scalability
-Flexibility, Agility with SOA, CBA
- Standardization (HL7, CDISC, BRIDG, CMR)
TIM
Operational Excellence
Enhancing Existing Capabilities
-Invoice checking; remote site monitoring;
study optimization
-Patient Enrollment optimization
- Portfolio mgmt and capacity planning
12
Cost and Risk Control
Performance Management
-Dashboards available for
management (dept, CSU), site,
vendor/lab, partners
-Cloud computing
-Application landscape rationalization
- Application lifecycle management
- Strategic partners (technology,
sourcing)
Sanofi global clinical collaboration platform
Strengthening the investigator-sponsor collaboration
Training &
Investigator
Meetings
Collection of 1572,
CV, Financial
Disclosure, etc.
IRB Approval
Documentation
Budget &
Contract
Negotiation
Finalize
Outstanding
Recruitment
Study Library
Materials with Items, Calendar, (key reference
Sites / IRBs Messages/Alerts, documents) Dear Investigator
Enrollment
Letters, newsletters,
Performance
communications
eTMF /
Documentu
m
Clinical
Team
Documents
Select Sites /
Investigators
Feasibility
Surveys
(Trial, EDC)
New Trial
Information
13
IWRS Integration, Drug
Shipment & Reconciliation,
Patient Visit Schedules
Pharma
Collaboration
Portal
Interim safety
reviews, queries,
drill-down reports
Study Planning &
Management (CTMS)
Sponsor
Activities Only
Select
Countries
Contact
Management
Potential
Investigator
Registration
Electronic Data
Capture (EDC)
Payment
Detail
Reports
Collaboration,
Study-Specific
Site Personnel Tools, Other
changes, lab
licenses, etc.
(ongoing)
Clinical Trial Portal – a new approach to Trial Management
Building patient centricity and connecting healthcare and life
sciences with mobile apps
Eases the work of scheduling meds, measurements, and
healthy habits
Daily view of scheduled medications, measurements and
diet/exercise routines
Detailed logs of patient measurements
Patients access to all medical records
View health status of family and dependents
Information shared with Doctors
Browser and all mobile platform support
Integrate with Online Records
Application integrates with both Google Health and Microsoft
HealthVault. These services are leading the way in putting medical
records online -- everything from X-rays and prescriptions to hospital
visits and blood tests.
15
Take away: at sanofi, social software is expected to be an
accelerator of clinical development
Social software is setting the way forward
For faster patient recruitment
For patients to find the right trials
For sponsors to move into a service mode and increase patient retention
As part of this environment, collaborative portals in particular
increase the productivity of the sponsor-investigator working
relationships and will continue to be an important investment area
over the next few years
Mobile apps are a new norm and a key vehicle in this new digital
social environment. These apps will contribute to:
Strengthen the patient-investigator relationship
The healthcare and life sciences convergence
Improve overall the quality of healthcare hence, contribute to cost reduction
16
Thank you !
17