Pharmaceutical Industry Information Management Opportunities and Challenges in Research, Development, Clinical, Sales, Marketing, Managed Markets, Manufacturing, Supply Chain and Distribution

1. INFORMATION MANAGEMENT IN
BIOPHARMA INDUSTRIES
CHALLENGES AND OPPORTUNITIES
Frank Wang

2. TOPICS
• Challenges of Pharmaceutical R&D and Clinical, Sales
and Marketing Productivity
• Evolving Biopharma Value Chain
• Information Management in Pharmaceutical R&D and
Clinical Value Chain
• Information Management in Pharmaceutical S&M and
Managed Care
• Information Management in Manufacturing and
Distribution (Supply Chain Optimization)
• Information Management to help IT Organization to run
like a Business

3. PHARMACEUTICAL INDUSTRY IS AT A CROSS-ROAD. WHILE R&D PRODUCTIVITY SAGS,
EMERGING MARKETS, RECESSIONS, HEALTHCARE REFORMS AND DEMOGRAPHICS
ARE FUNDAMENTALLY CHANGING THE LANDSCAPE.
Market and Industry Forces Impact
• Rising demographic pressures as populations age. Mature • R&D
countries large impact in 3-5 years, BRIC countries in 15-25
― Focus on precision medicine to find segmented populations for
years.
line extensions, off-label and new specialty drug uses; the rise of
disease management programs
• Large scale entry of developing nations with adequate
infrastructure leading to new market share opportunities ― Large scale pipeline renewal (process, organization, technology
(>50% of growth from emerging markets). and therapeutic area focus) through R&D reorgs and M&A to
refresh future funding sources. Shift R&D to developing nations
• Research productivity dropped significantly while R&D and outsource to reduce costs and efficiencies
expenses dramatically increased. Fewer blockbusters, more
extensions; patent cliffs with generics; precision medicine. • Manufacturing and Supply Chain
― Reduce manufacturing footprint; outsource more manufacturing
• The rise of biologics and genome-based therapies seen as
new source of innovation but genome based research has ― Revitalize supply chain by adopting best of the breed
not yet fulfilled its promise. manufacturing supply chain excellence such as lean
manufacturing, demand forecasting and inventory optimization
• Conflict of interest and fear of corporate influence driving
new regulations affecting corporate-physician relationships. • Sales and Marketing
• Recession and Healthcare Reform mandate require clear ― Differentiated sales and marketing strategies (segmentation)
required to reach emerging markets, mature vs. novel products
value prepositions of new molecular entities, new
and therapeutic-specific patients; tailored communications by
commercial business models and increased supply chain
segment by channel
agility.
― Socialized medicine cost pressures increase regulation in EMEA
and developed countries; price controls drives unified approach
to legal/safety, R&D and S&M
― Reduced access to Primary care as well as Specialty Physicians
and Managed care in US markets requires new S&M
approaches

4. HP’S VIEW OF FUTURE OF PHARMA VALUE CHAIN IN CORE
MARKETS
1 2 Development paradigm shifting to in-life monitoring
Discovery shifting away from blockbuster • New clinical model, from adaptive trial to enrichment strategies to screen and select
patients for targeted therapy will result in reduced costs and time needed for Phase III
• Targeted treatment based on biomarker & Px trial
• Focus on cure and prevention (convergence of Rx, Dx • Development Collaboration and offshoring: High % of development executed by CROs,
and devices) and more development conducted in emerging markets
• Research Collaboration and offshoring: High % of • Closer coupling with Providers, Payers, Government, Regulators to share clinical
Research executed through biotech and academia; high
% of research executed in emerging markets infrastructure
• EHR data mining, convergence of informatics of • Collaboration between Regulatory Bodies and Industry on an expedited drug
providers, payers and biopharma development pathway
3 Technical Operation modernizing
• Increased complexity due to precision medicine, combination
therapy, new delivery technologies
• Personalized dosage, lean principles, supply chain analytics
• New production sites and outsourcing to CMOs and
offshoring in emerging markets
• Continued emphasis on cGMP
4 Marketing transforming in core markets
• Evidence-based medicine marketing, pay for performance
pricing and reimbursement demanded by Managed Market
• Investment focus on initial product launch and post marketing
surveillance
• Post launch marketing shifts from physician-centric to
patient-centric
• Collaboration with Providers, Payers and Government to
improve patient outcomes
5 Sales transforming in core markets
6 Distribution partnering in core markets • Sales model changes from product driven to disease-management driven
• E-pedigree
• Bundled selling model emerge which may include Rx, Dx, Devices and
• Direct to pharmacy and newer channels supportive packages such as compliance monitoring and home delivery
• Patient-outcome based payment changes financial model • Smaller but more specialized sales force; different sales model for mature
and new products
• Collaboration with whole sales, specialty distributors, PBM
and pharmacies to increase patient adherence • Provides advisory, training and service roles
4

5. PHARMA R&D AND CLINICAL
• Business Processes
• Paradigm Shift
• Information Management Challenges and Maturity
Model
• Information Management Opportunities

6. Information Management and Knowledge Sharing along the
Pharmaceutical R&D Value Chain
Target ID Lead Identification Lead Preclinical Animal Non Clinical Clinical
Validation (Assay Dev/Screening) Optimization Testing Development Support
Genomics Compound Registration Tox LIMS Stability Clinical Trial Supply
Proteomics Compound Inventory Bioanalytics LIMS Scale-up Clinical PK
Bioinformatics Screening Databases Animal Pharmacology TotalChrom Manufacturing R&D
Images Project Mart PK/PD LIMS
Pathways Computational Chemistry Toxicogenomics Process Control
Systems Biology Cheminformaitcs (e-ADME) Metabonomics CMC Strategies
Rational Drug Design
Biology Therapeutic Centric DW IND Submission
Corp R&D Knowledge Managment GLP/GMP
Corp Compound Management Validation
Part 11 CRF 21
Content Management Documentum
Project Portfolio Managment
Collaboration, Portal, IP Management, CTI
Data Governance, Data Integration, Information Management and Knowledge Sharing

7. Information Management Along the Pharmaceutical Clinical Operation,
Regulatory Affairs and Post-marketing Surveillance
Regulatory
Phase I Phase II Phase III Phase IV
NDA Submission
Documentum Effectiveness of Medicine
Web-based EDC in traditional phases and adaptive trials
EDM Long-term Safety
Design and Plan
Document Life Cycle Life Cycle Management
Start-up (Distribute Drug info, Site Selection)
Management Patient Registry
Recruiting Patients/Investigators
eCTD Observational
Trial Management and Monitoring
E Submission Outcome Research
Conduct, Reports and Closeout
Sharepoint Pharmacoeconomics
Global Registery
CTDM
CTMS
Clinical Data Repository (SCE, eCDM)
Clinical Data Warehouse
Adverse Event Reporting System
Document Management, eCTD for IND/NDA
GCP/CFR 21 Part 11 Validation
Data Standards (HL7/CDISC/SPL/ICSR/RPS
eClinical (trial data management, trial supplier managemnet, statistics
ePRO, Clinical Trial Registry and Results Database
Data Governance, Data Integration, Information Management and Knowledge Sharing

8. PHARMA R&D BUSINESS PROCESS: TWO TYPES OF R&D. TRANSLATIONAL IS THE
INDUSTRY DIRECTION BUT PRESENTS THE GREATEST SET OF CHALLENGES.
Discovery and Manufacture and Health
Development Distribute Primary Management
Clinical Care
Basic Research Trials Payment
Acute Extended
Traditional R&D Translational R&D
• Silos between disciplines and within and • Integrates traditional discovery processes
between institutions with clinical practices
• A number of different disciplines: Chemical, • Breaks down boundaries between silos and
Biological, Clinical etc. organizations
• In many ways has hit a wall in terms of • Closes the cycle between research and the
efficiency and capacity for innovation clinic, and between different research
• Rich history of many applications and data- disciplines
providers • Requires collaborative infrastructures and
data access
• Process is circular (closed loop)
8

9. VIRTUAL R&D, COLLABORATION AMONG ACADEMIC MEDICINE, PHARMACEUTICAL
COMPANIES AND REGULATORY BODIES MANDATE EFFECTIVE INFORMATION
MANAGEMENT AND KNOWLEDGE MANAGEMENT
Drug Discovery Disease
Basic Science
Development Management
Clinical
Informatics
Clinical Care Research Payment
Hypothesis generation Statisticians develop tools
In vivo and in silico prospective to analyze and validate
and retrospective biomarker biomarkers
use in discovery
Basic Statistics
Science Informatician
Biopharma Companies
Clinical Care &
Biospecimen collection, clinical conduct and develop
Research
diagnosis and treatment to putative new treatment
assess biological activity and
hypothesis
Patient recruitment
Prospective biomarker • Receive current standard
therapy
screening in new
• On clinical trial of new therapy
patients
9

10. THE NEED FOR DEVELOPING A 360 VIEW OF BIOPHARMA PRECLINICAL AND
CLINICAL DEVELOPMENT ACTIVITIES – INFORMATION MANAGEMENT HUB AND
PHARMA R&D INTELLIGENCE SYSTEM
•Patient recruitment
•Site selection and monitoring
•Investigator relationship management
•Test sample logistics
•EDC
•Phase I safety study
•POC Study •Animal Tox Studies
•Clinical data reduction •Data to support phase 1 trials
•DRA •Dosing stability studies
•Tox analytical method development and validation
•INC support
•Clinical Supplies Manufacturing,QA/QC
•Analytical development •CMC section of NDA
•Pilot Manafacturing Clinical PK/PD •Dosage form Stability
•Technology Transfer
•Biomarker ID & Validation
•Clinical Compendium Dx kits development
•Phase I simulation, modeling and virtual patients
•Clinical protocol development
•IND Review
•Phase I trial review

11. INFORMATION MANAGEMENT OPPORTUNITY - CLINICAL TRIAL PROCESS
Design & Start-up Recruiting patients Closeout & Report
Trial Phases and Investigators,
Planning
managing trial
Key Activities • Designing protocols • Distributing drug information • Monitoring progress & adverse • Entering & verifying data
benefiting from events
• Creating regulatory docs. • Setting up data collection • Processing clinical response
information
• Managing drug supply forms
management • Planning, ordering drug • Selecting site
supply • Tracking patient enrollment • Addressing and reconciling
investigators’ queries
Information Management • Tracking clinical-response forms
1. Clinical Data Database of investigators and Standard interface to integrate Automated data checks to minimize
Management their preferences to support third party pay systems quickly queries
design of electronic forms and inexpensively
2. Safety Data Real-time monitoring and analysis of study data to spot adverse reactions.
Management
3. Document Single repository of data with version control, work flow management.
Management
4. Clinical-Trials Modular design, construction System to convert study Electronic invoicing Report Builder
Management of consent and case report designs to electronic forms and
Automated drug supply work flow
forms databases with minimal rework
and manual effort Study planning and budgeting
Patient Management
5. Project & Standard data models to work Ability to track and analyze cost, quality and speed
resource with third-party contractors
Management

12. INFORMATION MANAGEMENT OPPORTUNITY - CLINICAL
DATA REPOSITORY (CDR) BUSINESS CASES
• New R&D model requires extracting and use data and
metadata from all the transactional systems and aggregate
them into a comprehensive clinical trial management
environment.
• Definition of a Clinical Data Repository: a centralized metadata
repository fed by all the key systems (EDC, CTMS, IVRS, CDMS,
Labs, Genomics, Resource and Planning) to allow for retrieving,
combining, analyzing and reporting on operational data for
multiple purposes.

13. INFORMATION MANAGEMENT OPPORTUNITY – COMPREHENSIVE
PHARMACOVIGILANCE SYSTEM BUSINESS CASES FOR DRUG SAFETY
AND POST MARKET SURVEILLANCE SYSTEM
• Traditionally, Pharmacovigilance seen as drug adverse-event case
processing, relatedness assessment and regulatory compliance
reporting.
• Public safety concern and new R&D and commercial models
require a comprehensive benefit-risk analysis on drug
development and drug life cycle management.
• New bars on drug safety and post market surveillance require a
comprehensive pharmacovigilance system
• Definition of a comprehensive pharmacovigilance system:
possess ability to process safety data, to detect safety signals, to
assess preclinical and clinical potential safety concerns/risks.
The goal of the system is to enhance safety monitoring, to
communicate identified safety risks, to provide strategies for
implementing risk minimization

14. BUSINESS INTELLIGENCE: TRADITIONAL
CORPORATE BI VS. PHARMA R&D BI
 Traditional Corporate  R&D BI
BI Predictive Models
Number
ERP
Text
CRM
Visualization
Images R&D DW
Corp DW Reports
Gene
MRP
Interactive Reports
Structured DB
SFA
Compound Structure
• Heterogeneous data
• Structured texts
• Out-of-dated data
• Clear business rules
• Unstructured and structured
• Data residing in various dbs
• Data resides internally and externally

15. DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF INFORMATION
MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (1)
DATA INTEGRATION MATURITY
P3 P4
P10
P5 P8 P11
P7
P6 P2 P9
P12
No Minimally Integrated, Federated Querying, Full Discovery Full Integration Integration
Integration in Pilot Programs on EDC, within research (Targets to including with
Discovery, loosely harmanization discipline (Genomics, leads) Research, Commercial
standalone between CTDM and Medicinal Chemistry) Preclinical (Tox, Preclinical and (EBM,
LIMS, paper- AERS, separate and clinical (EDC, DMPK) and clinical data Personalized
based CRF research databases CTDM, CTMS and Clinical Medicine)
within therapeutic area AERS) as stop-gap Lifecycle
solutions Integration

16. DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF
INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (2)
DATA MINING AND ANALYTICS MATURITY
P3 P4
P10
P5 P8 P11
P7
P6 P2 P9
P12
No data Some data mining and Data repository Information Enterprise
mining and analytics capabilities, environment for Analytics Data Analytics
analytics SAS in biostatistics, informatics and environment and
capabilities. various loosely- analytics developed no longer Information
Heavy use of coupled informatics in discovery, specific to Workbench
Excel tools implemented in preclinical and single with
spreadsheets discovery, preclinical clinical. Analytic application customized
mostly associated results still and databases. dashboards
siloed applications application and Some
and some signal database specific. dashboards
detection in safety Siebel analytics capabilities
reports CRM reach of
frequency but not
marketing analytics

17. DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF
INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (3)
INFORMATION ARCHITECTURE AND DELIVERY
CAPABILITIES
P3 P4
P10
P5 P8 P11
P7
P6 P2 P9
P12
No information Information Siloed IT initiated Enterprise MDM Enterprise
architecture architecture built integration based on initiatives about MDM delivered
consideration. mostly based on SOA and portal. targets, on-demand.
Ad-hoc queries vendor supplied Example: Discovery compounds, Well thought-
as needed for standards. Siloed IT gene/compound products, out SOA in
groups develop databases integrated customers, place and
single
with project suppliers and enterprise web
application. SQL/database queries
patients along
Manual review strategies based on portfolios. Clinical services
the R&D+M
of multiple employee skillsets. data warehouses value chains.
groups in
queries to Information delivery being built to SOA and web place.
answer a single via window/Mac/web integrate EDC, CDMS services Information
question interfaces as needed based on industry adopted delivery based
standards customized
portal and
access control

18. DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF
INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (4)
LEVERAGING EXTERNAL
INFORMATION/COLLABORATION CAPABILITIES
P3 P4
P10
P5 P8 P11
P7
P6 P2 P9
P12
No external Access external Third party project Fully leverage
collaboration information via ftp, management tools industry
and no need to internet and VPN chosen. R&D and standards of
access external eROOM, sharepoints, Clinical implemented information and
document life cycle apply semantic
information – stand alone EDC,
strategies. webs and
non existent large scale R&D and
ontology
clinical project Documentum and
standards.
management based other content External
on MS projects and management tools information
visios chosen for integrated on-
information demand and
archiving and based on
regulatory business needs
submissions

19. PHARMA SALES, MARKETING AND
MANAGED CARE
• Business Challenges
• Evolving Business Models
• Information Management Opportunities

20. HARNESSING INFORMATION MANAGEMENT
FOR PHARMACEUTICAL S&M
Business Challenges Information Management Opportunities
• Global IM approach provides better insights and added value
• Emerging Market from core and emerging markets
• Global shared services allow robust integration of data sources
• Cost Containment and systems to drive efficiencies, support quality decisions and
• Generic Market reduce costs
• Consistent, and consolidated data improves performance
• Specialty Products and measurement such as launch success rate, product
Biologics penetration rate across regions, globally and therapeutics
areas.
• Managed Care • Integration of pharma, hospitals and payers data help realize
• New Distribution Channels the vision of EBM
• Integration of pharma, hospital, retails, PBM provide a more
• Evidence based medicine intelligent, integrated market view across national market, and
(EBM) alternative distribution channels
• DTC/Online Marketing • Comprehensive dashboards drive optimal brand management
at the global level and increase brand growth through
• eDetailing performance measurement
• Precision Medicine • Integration of marketing analytics allow for better measurement
of effectiveness of DTC and online marketing
• Consolidated reporting strategies reduce market research
reporting costs,

21. REFERENCE ARCHITECTURE FRAMEWORK FOR A TYPICAL
PHARMACEUTICAL SALES, MARKETING AND MANAGED CARE
ORGANIZATION
as influence field operations
yields insights that drive strategy and direction as well
Analysis performed on information from the field
Decision Support and Analytics
(Bus Intelligence/Scenario Planning/Predictive Analytics)
Information from the field is captured, filtered upward,
and used to make operational and strategic decisions
Managed Markets Sales Territory Alignment/ Marketing Segmentation
Formulary Strategy Management & Targeting
Primary Market Research /
Professional/Organization
Key Account Management
Incentive Compensation
Expense Management
Contract Management
Campaign Management
Literature Fulfillment
Sample Management
Competitive Intelligence
Key Opinion Leader
Speaker Programs
Regulatory Compliance
E-Channels
Detailing
Governance
HEOR
Master Data Management
(Customer, Product, Organization)
Data Warehousing/Information Management
Infrastructure

22. UNDERSTAND ANALYTICAL NEEDS: WHAT BUSINESS QUESTIONS
SALES AND MARKETING EXECUTIVES ASK LEAD TO DESIGN STRATEGY
OF INFORMATION MANAGEMENT
Entities
• Addresses • Market Hierarchy
S&M Analytical Areas: Groupings of KBQs into Analytical Areas to facilitate needs
• Affiliations • Patient
analysis.
Analytical KBQ Areas • Brand Hierarchy • People
(Employees, etc.)
• Market Performance
• What is segment script writing behavior by region, by brand, by geography?
• Compound
– The analysis of Client’s position in the marketplace
These Analytical Areas volume?
How do customers in various segments compare on scriptallow us to
analyze • Physical Assets
over time against competitors.•
current challenges and issues associated with • Customers
• Customer Segmentation • Which customers within a therapeutic classansweringmost per product
robustly have the KBQ’s that are similar in (Individual/ Org) • Product
– The analysis of Customer behavior using groupings with similar it?
market share and what is ways such as:
characteristics that allow Client to Whattheir communication
• tailor is the brand adaptability by graduation date or specific school?
and investments in an optimal fashion. • Data Capture. • Identifier • Product Hierarchy
• Data not captured in Client
How do we track segmentation of non-physician prescribers? systems
• Sales Tracking and Analysis
•
consistently. May point to process, application
What products have reached their saturation threshold with specific • Financial • Promotion
– The analysis of Script behavior across Customers and or organization issues or data does not exist.
customers both now and forecasted?
associated Sales Force activity and effectiveness.
• • practice and what are the demographics
How many patients are in a doctors Data Integration
• Healthcare Provider
• Lifecycle Management Data exists across multiple systems, e.g.
over time?
KOLs kept on multiple lists.
(HCP)
– The analysis and between the drugs in various stages and
Customer behaviors. • Which doctors influence the purchasing of which institutional entities for
example, nursing homes? • Information Access
• Event Analysis No direct access or Analytical tools available.
• What is the retention time of a prescriber towards Client over time by
– The analysis of the impact and effectiveness of Customer
product? • Data Quality
Event activities and other communication touchpoints.
• Patient Outcome Analysis
•
Issues include sufficiency, completeness,
How much does a customer cost to pursue and is there a significant
accuracy.
Product
variance in this by segment or region?
– The analysis of patient adherence to product
• How do we utilize segments at the household level for a practice entity?
prescription/regimen and the rate of outcome achieved. May
include comparisons to results expected from relationship between patient adherence and customer script
Other Vendor IMS
• Is there a clinical trial
systems.
growth? If so, what is it?
• Market Group
• Who are the Key Opinion Leaders (KOL) by therapeutic area, by • Market • Market
geography?
• Which customers are most profitable by segment, by region?
© Copyright 2007 HP
• Subclass • Sub Market
• How can the best segment based opportunities be identified?
• Sub Market a
• What is the lifetime value of a doctor?
• Franchise
• Sub Market b
• What is the brand switching behavior of products by customer, by segment,
by therapeutic class, by time, by geography?
• Brand
• Brand
• How can Client distinguish between brand switching and new scripting habits • Strength
when there are steep changes in market share (e.g. significant decrease • Product
within a short time period)?
• How does segmented customer level market share compare to competitors • Strength
within a product class? 22
• Packaging

23. THE TYPICAL MASTER DATA ENVIRONMENT IN THE INDUSTRY IS DIVERSE. A
THOUGHTFUL APPROACH IS NEEDED TO RATIONALIZE MDM WHILE STILL
MAINTAINING BUY-IN FROM USERS
Illustrative Pharma Mastering Environment
Customer Mastering Product Mastering
Siebel SFA Customer Master
Storage is in Visage. Production Hierarchy:
salesforce.com Siebel Compact and slowly
No history. Client In-house Developed System. IBM SAP ECC
Salesforce.com changing.
WebSphere QualityStage for
Customer List
standardization and miscellaneous tools for
matching.
Client
No true Product mastering
Customer List IMS WKH
process is in place
External ???
Manual especially for competitor
Data
Resolution for and switching analysis
IMS WKH more granular than
Rejects
External therapeutic class.
Data
Future Needs: Future Needs: Data vendor with competitor
products. Their data may be sourced at a more
Believed to drop • Internal Client Customer Lists, Medical granular level than today (today, at an
Customers for non- Affairs, KOLs, etc. aggregated and used at therapeutic class level).
core products, even • Track affiliations e.g. nurses with
competitor data. patients.
• Data vendor Customer level.
Geography/Territory Mastering Employee Mastering
Contains • Lacks all
Client In-house Developed System
contractors not Reps in field.
Siebel Custom in PeopleSoft. Siebel PeopleSoft
• Alignments have • Manages
Salesforce.com Alignment hierarchies for
different hierarchies e.g.
for Specialty, General HR purposes.
Siebel may both filter Custom
Practitioner and Primary
and transform CA
• Geography: State, FSA, Alignment
data.
postal groups etc.

24. PHARMACEUTICAL SALES, MARKETING AND DISTRIBUTION
MODEL IS EVOLVING
It was It is or will be
•Large sales forces •Smaller sales force per geography
•Captive sales forces •Fewer drugs in the bag, more targeted patient groups --
•Product focused all are equally important
•Broad detailing; often manual and push oriented •Contract sales forces that ramp up and down quickly
•Primary product with multiple other products •Specialist and clinical scientists focused, fewer
products to discuss, but deeper disease stage
•Single or few channels for product or disease
discussions
information
•Multiple channels/contact points; tiered contacts e.g.
•Single relationship based
MSLs, nurses, reps; Web, TV, wikis, physician and
•One size fits all consumer portals, social media
•Simple channels: Offices; educational seminars, •Disease management focused
hospitals
•Insight-led, Information based touchpoints e.g. knowing
•Physician or influence individual focus outcomes and safety issues
•Single company sales • Develop customer and prospect segmentation
•Direct to Consumer (DTC) nascent strategies that enable effective differentiation and
•Substantial sales force overhead time targeting of offerings.
•Empowered managed care account manager for payer
account management
•eDetailing, pull oriented, physician pull
•Collaborative sales; joint sales with multiple companies
•Sophisticated DTC to all demographics
•Reduced Rep overhead time

25. TO MEET EVOLVING BUSINESS NEEDS, INFORMATION MANAGEMENT
MATURITY LEVEL WILL NEED TO BE INCREASED AS WELL
Customer Centric View
Patient Centric View
360 Degree of All
Customers and Patients
limited IM maturity Intermediate IM maturity Future IM Maturity
• Start global • Integrated SFA and • Syndicated, global data • Support for flexible sales • Longitudinal patient
mastering with CRM feeds hubs force structures as # centric predictive models
local customer realignments increases. to predict outcomes
• Start to develop • Simplified Information
masters
integrated architecture and • Establish new • Electronic medical
• Start data quality marketing channels framework; standardized compensation plans records with integrated
programs and consolidated. genomic profiles.
• Start to develop • Automatic, integrated
• Start integration eDetailing POCs • Physician spend data safety reporting with
maps with integration with tight single point of data entry • Real-time S&M
standard • Gather new linkages to ERP systems. (e.g. harmonized effectiveness and ROI
definitions channel information vocabularies for clinical analytics
• Limited real-time S&M
• Start MDM to measure data)
data.
effectiveness. • Real-time analytics aids
shared service • Implement integrated
organizations • Larger amounts of diverse faster and frequent
eDetailing
data integration; data territory coverage
fusion; unstructured and • Off-the-label activities remaps
structured. completely automated • Integrated data mining
and tracked assists in pharma-
• Global master data
management systems as a • Region based IM covigilance and exploit in
value-add shared service. outcome based research
• Highly centralized and
standardized

26. PHARMACEUTICAL COMPANY IS CHANGING FASTER THAN BEFORE. MOST COMPANIES
LACK THE INFORMATION MANAGEMENT (IM) INFRASTRUCTURE TO SUPPORT CHANGE
AND ACCOMMODATE LOCAL COUNTRY NEEDS
Illustrative Informatics Value Stack
• Global platform and tools, local/regional • Standard tools typically used such as BO, Cognos. Other
Customer and Patient implementation tools not proven globally, e.g. Siebel Analytics, embedded
Analytics & Reporting • Master data and DI offers new analytic reporting apps.
possibilities • Different lens created regionally, globally and different
• Specialty data mining more outsourced. functional areas e.g. R&D and S&M.
• Governance is local and regional, very few global • Programming labor outsourced.
Data Integration, Quality
• Quality rules are being standardized at local • Standard tools, may be some regional
and Governance level, but local variations will remain • Volume demands different approach to infrastructure for
• Good master data and reference maps speed-up global scalability
data integrations • Different lens created for different groups is key
• DI and DQ are implemented as shared services; functionality; forced standardization has not worked well
success varies overall
• S&M Transaction data is configured regionally • Local data services are offered due to local regulations
Data
• Master Data is implemented regionally and • Efforts underway to standardize data for global analytics,
locally, some opportunities for global master primarily around disease
data • Maintenance is outsourced, not the content/quality
• Shared services model where possible (Master • Some definitions are being standardized
Data, analytics data, external data), some
regional and some global
• Regionally centralized; master data hubs • Uniform hardware and software, few regional/local
IT Infrastructure • Generally infrastructure not outsourced but variations
changing • Apps and db maintenance often out-sourced.
• Shared services oriented • Standard tools and platforms
• Some applications may be offered in SAAS
model for some countries

27. BRIDGING THE GAP BETWEEN
PHARMACEUTICAL MANUFACTURERS AND
HEALTHCARE PROVIDERS, PAYERS AND
GOVERNMENT
• Healthcare Economics and Outcome Research (HEOR)
• Quality Index of Medical Care and Evidence based Medicine mandated
by Center for Medicare and Medicaid and the Healthcare Reform Act
• Pay for Performance Reimbursement Model by Healthcare Payers
• Superior clinical benefits and longitudinal impact demanded by
Healthcare Providers

28. PHARMACEUTICAL MANUFACTURING
AND DRUG SUPPLY CHAIN
• Manufacturing Process and Challenges
• Drug Supply Chain Process and Challenges
• Federal and State Pedigree Legislation
• Information Management Opportunities

29. PHARMACEUTICAL MANUFACTURING (GMP)
Pharmaceutical Technology Commercial Product
Development Transfer Manufacturing Discontinuation
Investigational Products
cGMP
Quality Assurance (QA) and Quality Control (QA) System
Corrective Action/Preventive Action (CAPA) System
Knowledge Management and Information Management
29

30. PHARMACEUTICAL SUPPLY CHAIN PROCESS
Product Forward
Reverse
Shipments
Returns / Recalls
Returns / Recalls
Pharmaceutical Co
Shipments
Return Resale
Returns
Chargeback
Shipments
Returns / Recalls Credit Wholesaler
Order Payment
Order Payment
Returns / Recalls Credit
Pharmacy
Payment
Rebate PBM
Financial
Forward
Reverse 30

31. PHARMACEUTICAL SUPPLY CHAIN CHALLENGES
Counterfeiting / The level of pharmaceutical counterfeiting is
approximately 5-10% of world trade. This represents a
Product Diversion direct revenue loss of $24-$49B for the industry
Several states (California, Florida,etc) have state
Regulatory legislation on drug pedigree. Federal Government (FDA)
is considering adoption of track & trace technologies.
Compliance Customers are beginning to apply the technologies for
product recalls
Supply Chain Pharma experiences $2B in returns annually. The
Management estimated typical percentage of a facility’s total monthly
and Visibility Rx volume returned by customers is 4% for distributors
and 2% for manufacturers.
Improving Increasing FDA concern on contaminated or ineffective
Quality of Care products. 60% of counterfeits did not contain any active
ingredients; 19% contained a wrong dosage and 16%
contained inappropriate agents.
31

32. INFORMATION MANAGEMENT OPPORTUNITIES
Manufacturer Wholesaler Retail
Production DC DC Chain DC Retail Store
Pedigree Pedigree Pedigree
Pedigree Drug ID Info Drug ID Info Drug Id Info
Drug ID Info
Manufacturer MFR Pedigree MFRPedigree
Manufacturer
Wholesaler Wholesaler
Wholesaler
Re-packaging Hospitals/Doctor’s Office
Pedigree Pedigree Pedigree Pedigree
Drug ID Info Drug ID Info Drug ID Info
Drug ID Info
Manufacturer
Manufacturer MFR Pedigree MFR Pedigree
Re-packaging MFR Pedigree
MFR Pedigree
Re-packaging Repacker
TRACKING DRUG SUPPLY CHAIN DATA FLOW 32

33. PHARMACEUTICAL IT MANAGEMENT
• CIO Challenges
• Metrics that demonstrates aligns IT values to business priorities
• IT Innovation Metrics that tied to biopharmceutical companies
• Information Management Opportunities to help IT organization run
like a business

34. CIOS FACE A BALANCING ACT: CONTAIN IT COSTS, DELIVER HIGHER
QUALITY SERVICES AND APPLICATIONS AND LEAD INNOVATION IN A
FAST-PACED BUSINESS ENVIRONMENT.
Run IT ‘AS’ a business Run IT ‘FOR’ the business
Speed
Cost Quality
Average IT operational spending growing at 3x other systems costs.
$200 New server spending (USM$) 3% CAGR 30 minutes 5 seconds Trading analytics
Cost of mgmt. & admin. 10% CAGR 20 minutes 30 seconds Airline operations
$180
8 hours 10 seconds Call center inquiries
$160
1 day 5 minutes Track financial position
$140
1 day 15 minutes Supply chain updates
$120
3 days 30 seconds Mail/ express/ fax/ e-mail
$100
3 days 45 seconds Document transfer
$80
3 days 3 minutes Phone activation
$60 1 month 1 hour Refresh data warehouse
$40 5 days 1 day Trade settlement
$20 6 weeks 24 hours Build-to-order PC
$0 10 7 10 6 10 5 10 4 1,000 100 10 1 Seconds
’96 ’97 98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08
Your Average IT Operational spending
WW Spending (US$B) growing at 3x other systems costs

35. ILLUSTRATIVE METRICS: AN INTEGRATED SET
IS NEEDED TO UNDERSTAND IT VALUE.
IT Value Proposition Starts with:
Objective Metrics Actual Target Initiatives
IT Mission/Value – Optimize the return on IT – % of revenue spent on IT
investment – % of IT budget spent on new
1.2%
15%
2%
50%
– Value mgmt. program
– Program mgmt.
• Aligning IT objectives to
– Contribute value to
investments
– IT opinion survey/satisfaction N/A 75% – Infrastructure 2007 relevant business units goals
business processes rating
IT Customers – Optimize use of
enterprise services
– Infrastructure alignment index
– Post-acceptance satisfaction
0.85
2.5
2.0
4.0
– Program mgmt.
– Value mgmt. program
• Developing metrics to track
– Streamline business unit
services
score
– Application alignment index 0.50 2.0 – Program mgmt. progress
Internal IT
Processes
– Technology migration
– Establish value focus
– % of facilities at company
standards
– % of projects coming through
75%
50%
95%
100%
– Infrastructure 2007
– Value mgmt. program
• Launching key IT initiatives to
– Faster application dev.
value process
– On-time delivery 30% 90% – Infrastructure 2007 support those goals
Enabling – Improve moves, adds and – % of SLA requests to install met 70% 100% – Infrastructure 2007
Technologies changes (MAC) – No. of versions installed at same N/A <3 – Infrastructure 2007
management time
– No. of software releases and N/A max. 2 – Infrastructure 2007
dist. methods per platform
IT – Leverage ESP – % of noncore positions 25% 95% – Infrastructure 2007
Organizational – Attract and retain staff outsourced
Enablers with appropriate skills for – Attrition rate improvement -2% per 10% per – Employee development
services offered year year program
IT Value Proposition Targeted to Cost Containment Goals IT Value Proposition Oriented towards Innovation and Growth
Objective Metrics Actual Target Initiatives Objective Metrics Actual Target Initiatives
IT – Reduce IT Cost – % of reduction in CAPEX 1.5% 5% – 2006 “to the bone” IT – Support new sales – % of sales through new 9% 15% – Web/kiosk initiative
Mission/Value – Maximize ESP – Cost of service comparison N/A +/- 8% – Vendor management Mission/Value channels channel
Performance – Weighted % (by importance/ 75% 85% program – Improve time to market – % of project delivery on time N/A 90% – New products
cost) of contractual and on budget program
achievement
IT Customers – Sustain appropriate cust. – IT opinion survey/satisfaction 3.25 3.5 – IT customer sat. IT Customers – Better customer business – No. of IT-driven improvement 2 10 per – Value management
sat. levels through 2004 rating survey processes opportunities identified year program
– Provide a secure IT – % of compliance to policy 80% 100% – Enterprise security – No. of identified opportunities 1 8 per – Value management
environment – No. of monthly incidents 2 per <4 per program realized year program
month month
– Technology consolidation – No. of departmental servers 143 400 – 2006 “to the bone” Internal IT – Increase use of – % of projects using coll. tools 60% 90% – New products
Internal IT eliminated – Infrastructure 2007 Processes collaborative tools program
Processes – % of two-screen desks 9% 0% – Infrastructure 2007 – Contribute to business – % of projects with IT 70% 100% – Value management
– Standardization of – Change in IT development N/A -5% – Infrastructure 2007 case development contribution
development costs as proportion of total
– Technology refresh – Time spent vs. planned N/A +/-5% – Value management
Enabling – Thin-client simplification – % of conversion of possible 45% 95% – Infrastructure 2007 Enabling – % of desktops >3 years old 25% <5% – Infrastructure 2007
Technologies – Reduce app. dev. time – % of new projects using RAD 20% 80% – Development 2006
Technologies desktops
methods
– Personal – Better business – No. of bus. edu. forums N/A 10 per – Bus. education forum
IT – Keep and attract staff – % of staff with important N/A <15%
development program IT understanding year
Organizational training needs not addressed
– employee Organizational – Faster recruitment – Time to fill job requests 90 days 45 days – Employee dev. plan
Enablers – Improve hiring and – % of open requests unfilled in 15% 20%
development plan Enablers – Provide integrated – % of staff with business 10% 75% – Personal dev. plan
promotions >10 weeks
– employee performance criteria initiative measures in review
– No. of key positions with no 1 2
criteria
successor ready in < 6 months development plan

36. INNOVATION METRICS ARE PARTICULARLY IMPORTANT TO PHARMACEUTICAL CIO
AS MORE COMPANIES ARE FACING PATENT CLIFF AND REVENUE SHRINKAGE
Innovation Number of New Lag A measure indicating the uptake of new technologies (such Percent measure. For a given time period, the number new development projects using "strategic technologies" (as defined),
Technology Applications as RFID and so on, depending on the enterprise's divided by the total number of new development projects, expressed as a percent
requirement) Usually expressed as a proportion of projects
underway, there is a definitional issue that must be resolved:
to what extent does a new technology have to be part of the
project before it can be counted? 1% of budget? 10% of
budget...
Innovation # Of patents and other Lead Measure of the level of innovation exercised by the IT group Value measure over time. Every time a patent is rewarded or an award is received, this measure is incremented by one and
awards the date recorded
Innovation % new projects using Lead An architectural target measure charting the adoption rate of Percent measure. For a given time period, the number projects using Rapid Application Development tools and approaches
RAD Methods Rapid Application Development, an interactive prototyping (as defined), divided by the sum of projects using RAD tools plus projects not using RAD tools, expressed as a percent
approach to application development
Innovation % of new development Lead Measure of the degree to which IT budget can be directed Percent measure. For a given time period, the new development budget (for the month, for the quarter and year-to-date)
budget for strategic into new - and strategic or high pay off - projects allocated to strategic projects (as defined), divided by the total new development budget for the same period
projects
Innovation Average age of hardware Lead An aggregate measure of the age of hardware assets, Measure of age. For all assets, the sum of the number of days since each asset was first used (or purchased for unused
usually divided into categories (mainframe, servers, assets), divided by the number of assets whose age is being counted, expressed in days, months or years, depending on the
desktops). This measure is useful if demonstrating the asset type
impending need to replace assets or for planning asset
refresh cycles
Innovation Extent to which an Lead A measure that attempts to quantify the almost Percent measure. For a given period, during an employee satisfaction survey, the number of full-time equivalents giving a
environment is in place unquantifable. The only meaningful way of applying this score of high and very high to the question regarding 'This is a place that encourages innovation" , divided by the total number
which encourages measure is to seek the opinion of a competent authority and of full-time-employees completing the survey
innovation use this opinion to show the degree to which the
environment encourages innovation
Innovation Knowledge Sharing & Lead A (qualitative) measure of knowledge sharing - usually a Year to date measure. The total number of "learning events" held
Learning Events Held survey or surrogate measure such as documents referenced
or designs reused - scaled by the number of learning events:
meetings, teleconferences and so on, to gauge how effective
these learning events are
Innovation Level of activity in Lead A measure that attempts to quantify how much innovation is Percent measure. For a given time period, the new development budget (for the month, for the quarter and year-to-date)
innovation work. taking place. Since this is a notoriously difficult factor to allocated to strategic projects (as defined), divided by the total new development budget for the same period
manage, surrogate measures are usual: number of patents,
number of invitations to speak at conferences, number of
publications in peer reviewed journals.
Innovation Percentage of effort on Lag Effort normally gets split between Maintenance, Percent measure. Cumulative Project Workdays spent on new projects, divided by the Total number of workdays available,
new projects Enhancement, operations and new projects. Infrastructure, expressed as a percentage
M&E spending is largely non-discretionary and mostly not
value creating in the same way as new projects are. The
significance of this measure the larger the proportion I&M&E
spending is of the IT budget, the less proportionately there is
for new projects.

37. IT INFORMATION MANAGEMENT OPPORTUNITIES: FROM
STRATEGIC IT METRICS TO CIO SCORECARD
Business Impact
Financial
CIO Scorecard
IT Performance Indicators