BIOTECH SUPPLYBIOTECH SUPPLYBIOTECH SUPPLYBIOTECH SUPPLYOctober 8-9, 2012

Crowne Plaza, Foster City, CA

Leveraging Technology to Transform the Clinical Trial Supply Chain

Leon Wyszkowski : Fisher Clinical SuppliesDavid Northrup : Accenture

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Top ranked clinical trial supply chain pain points

Source: Tufts CSDD

Short lead times

Poor Clinical & supply team communication

Protocol readiness / accuracy

Inaccurate forecast

Poor visibility

The Problems Remain the Same

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

What are we going to talk about today

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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 path100% highlighted supply as an important pre-marketing differentiator90% cited drug supply as a key enabler of their development goals over the next 3 yearsIn many instances, the Clinical Trial Supply Chain is facing up to these pressures from a position of weakness:

5Industry wide opportunities

Cottage Industry

Not exploiting the power of

collaboration

Expected to be available on-demand

High level of wastage Disparate systems

Fragmented marketplace

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Acceleration in Clinical Development transformation is driving a change in clinical trial supply chains

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 supply-side operation

Focus on efficiency and standardization

Adhere to stringent & evolving regulatory requirements

The Industry’s Strategic Focus...

Analytics

Collaboration Recruitment

Patient focus

Personalized medicines Globalization

Quality & Compliance

Technology

Data & information capabilities

is Driving Clinical Supply to….

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Complexity and Data VariabilitySupply Chain Systems Current State

PROCESS

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

SYSTEM

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Current Solution

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

Customer System

Visibility to some parts of the Supply Chain to enable optimization

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Traditional view of my network

Brand owner

Logistics Services Providers

Suppliers Customers

Source: Pfizer @ Gartner SC Conference 2012 9

Extending beyond the 4 Walls

Brand owner

Logistics Services Providers

Suppliers Customers

10Source: Pfizer @ Gartner SC Conference 2012

Randomization

External Supplier

Taiwan China Hub

PO #4553245

External SupplierComparator

BL# HJC 554545

Item

LIMS

Pooled Supplies

Russia

Argentina Market

Vendor Plant

Import hold

FDA

Batch Record

Quality data

Amsterdam

US Customs

Dose Instructions

Grant Supplies

Kit numberQuality Release

Complaint

Manual intervention

Stability date

Invoice 425775

Manufacturing Plant

Data management might get a little more complicated

Source: Pfizer @ Gartner SC Conference 2012 11

Future Information Solution

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How would data visibility with a single version of the truth impact your day-to-day life?

Example of technology solutions available today

CMO Collaboration

Analytics

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Pfizer Moves Supply Chain to the Cloud

Financial Times, Sept 11, 2012

Over the past 18 months…

a single version of the truth against

which all stakeholders operate

..allows supply chain network participants to be added or removed

rapidly

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Access to data creates opportunities for analytics…

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.

Setting the Stage: What is Big Data?

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Analytics capabilities drive improved decision making…

…which provides opportunities for improved business outcomes

Big Data is top of mind for virtually every industry, impacting core business processes

Upstream Oil & Gas companies monitor 40K sensors per asset (combined with 4d seismic imagery) to drive real-time production operations and maintenance & reliability programs.

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.

Electronic health records, home health monitoring, telehealth, and new medical imaging devices drive data deluge in a connected health world.

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.

Emerging location based data, group purchasing and online leads allow Retailers to continuously listen, engage and act on customer intent across the purchasing cycle.

Resources Health

Public Sector Retail

Financial Services Communications

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Summary

To deliver enhanced patient outcomes, key components of business transformation emerge

Outcomes

Visualization

MobilityAnalytics

Data Integration

Clinical Data(via Collaborations)

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: 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