BIOTECH SUPPLY
CHAIN ACADEMY
October 8-9, 2012
Crowne Plaza, Foster City, CA
Leveraging Technology to Transform
the Clinical Trial Supply Chain
Leon Wyszkowski : Fisher Clinical Supplies
David Northrup : Accenture
Top ranked clinical trial supply chain pain points
The Problems Remain the Same
Short lead times
Poor Clinical & supply team communication
Protocol readiness / accuracy
Inaccurate forecast
Poor visibility
Source: Tufts CSDD
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What are we going to talk about today
 Technology in Clinical Development is evolving
 Fisher Clinical Services perspective
 Current biopharmaceutical supply chain landscape
 New ways to think about data visibility and collaboration
 Available technologies and an example
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“The sexy job in the
next 10 years will be
statisticians”
-- Hal Varian, Chief Economist at Google
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Clinical Development is recognizing the strategic
role of the clinical trial supply chain
In an Accenture survey of Development Directors and Study Managers:
 100% agreed clinical supply would be on their development critical path
 100% highlighted supply as an important pre-marketing differentiator
 90% cited drug supply as a key enabler of their development goals over the next 3
years
In many instances, the Clinical Trial Supply Chain is facing up to these pressures from
a position of weakness:
High level
of wastage
Not exploiting the
power of
collaboration
Disparate systems
Expected to be
available on-demand
Cottage Industry
Fragmented
marketplace
Industry wide opportunities
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Acceleration in Clinical Development
transformation is driving a change in clinical
trial supply chains
The Industry’s Strategic Focus...
Analytics
Technology
Data & information capabilities
Collaboration
Personalized
medicines
Patient focus
Recruitment
Globalization
Quality &
Compliance
is Driving Clinical Supply to….
 Invest in system infrastructure
 Understand the customer and
the patient
 Provide increased supply
flexibility with reduced process
lead-times, as the norm
 Deliver into ever expanding
markets
 Achieve higher performance
expectations
 Outsource, consolidate and
integrate with the wider supplyside operation
 Focus on efficiency and
standardization
 Adhere to stringent & evolving
regulatory requirements
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Complexity and Data Variability
Supply Chain Systems Current State
PROCESS
SYSTEM
API/MFG
Inventory
Packaging
Distribution
Site
SAP
SAP
SAP
IVRS
Oracle
Oracle
Oracle
(Multiple Providers)
IVRS & E-Pro
Systems
JD Edwards
JD Edwards
JD Edwards
Others
Others
Others
Self-Developed
Self-Developed
Self-Developed
Clinicopia
Clinicopia
Clin-Apps
Clin-Apps
 Number of systems becomes more complex as innovators use both in-house and external capacity
across supply chain
 Supply Chain professionals spend more time gathering data rather than analyzing it
 Broader trends on site performance, patient recruitment across therapeutic areas, and protocols
are harder to detect
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Current Solution
Inventory
Packaging
Distribution
Dispensing
Returns
Consumption
Customer
System
Visibility to some parts
of the Supply Chain to
enable optimization
Challenges:
 Not easy to bring on new systems
 All require a level of software development to connect to a data warehouse
 Some data is not transferred or system architecture does not allow for integration
– rules for data structure are not standard
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Traditional view of my network
Customers
Suppliers
Brand owner
Logistics Services Providers
Source: Pfizer @ Gartner SC Conference 2012
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Extending beyond the 4 Walls
Customers
Suppliers
Brand owner
Logistics Services Providers
Source: Pfizer @ Gartner SC Conference 2012
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Data management might get a little more
complicated
Amsterdam
Manufacturing
Plant
Russia
Import hold
Item
Invoice 425775
Grant Supplies
Pooled Supplies
External
Supplier
Complaint
Kit number
Quality Release
PO #4553245
Taiwan
China Hub
Stability date
Quality data
LIMS
Vendor Plant
BL# HJC 554545
Manual
intervention
Comparator
External
Supplier
US
Customs
Batch Record
Dose
Instructions
Randomization
FDA
Argentina
Market
Source: Pfizer @ Gartner SC Conference 2012
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Future Information Solution
How would data visibility with a single version of
the truth impact your day-to-day life?
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Example of technology solutions available today
CMO Collaboration
Analytics
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Over the past 18
months…
Pfizer Moves
Supply Chain
to the Cloud
a single version of
the truth against
which all
stakeholders operate
..allows supply chain network
participants to be added or removed
rapidly
Financial Times, Sept 11, 2012
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Access to data creates opportunities
for analytics…
Setting the Stage: What is
Big Data?
When the data size and
performance requirements
“become significant design
and decision factors for
implementing a data
management and analysis
system.”
Roger Magoulas & Ben Lorica
of O’Reilly Media
• Data sets that are big enough to obscure
underlying meaning or for which
traditional methods of storing, accessing,
and analyzing are breaking down (or
simply getting too expensive).
• Practically speaking big data is also about
adding unstructured or semi-structured
data to the mix
• Or creating hybrid environments that
perform while controlling cost.
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Analytics capabilities drive improved
decision making…
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…which provides opportunities for improved
business outcomes
Big Data is top of mind for virtually every industry, impacting core business processes
Resources
Health
Upstream Oil & Gas companies monitor
40K sensors per asset (combined with
4d seismic imagery) to drive real-time
production operations and
maintenance & reliability programs.
Public Sector
Electronic health records, home health
monitoring, telehealth, and new
medical imaging devices drive data
deluge in a connected health world.
Retail
USPS applies unique barcodes so it can
seamlessly induct and account for
postage. This results in ~1B pieces per
day, scanned multiple times throughout
the supply chain.
Financial Services
Emerging location based data, group
purchasing and online leads allow
Retailers to continuously listen, engage
and act on customer intent across the
purchasing cycle.
Communications
Pioneers in Big Data, Capital Markets
firms continue to innovate around low
latency systems to unlock trading
arbitrage opportunities.
Mobile usage data for Service Providers
unlock new business models and
revenue streams from Outdoor Ad
placement to medical adherence.
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Summary
To deliver enhanced patient outcomes, key components of business transformation emerge
Clinical Data
(via Collaborations)
Data Integration
Analytics
Mobility
Outcomes
Key Components
 Data visibility: Increasing amounts of data will be
available (e.g. via EMR, patient communities, digital
aids, etc.), making data sourcing and preparation an
essential foundation for the model.
 Data Integration: Raw data from many different
sources will need to be consolidated and connected
(e.g. via Master Data Management).
 Analytics: Predictive analytics must be developed to
leverage data for proactive insights
 Mobility: Data and insights must be accessible to
consumers, when and where they need it.
Visualization
 Visualization: Data and insights are meaningless if they
cannot be understood; Effective visualization is
required to support insight development.
 Outcomes: All supporting components and capabilities
must enable relevant, actionable insights in order to
deliver improved patient outcomes.
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Questions
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