Information Management in Pharmaceutical Industry

INFORMATION MANAGEMENT IN
BIOPHARMA INDUSTRIES
CHALLENGES AND OPPORTUNITIES
Frank Wang
frankfangwang@yahoo.com, www.linkedin.com/in/frankfangwang

• 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
TOPICS

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

1
3
5
6
4
FUTURE OF PHARMA VALUE CHAIN IN CORE MARKETS
Discovery shifting away from blockbuster
• Targeted treatment based on biomarker & Px
• Focus on cure and prevention (convergence of Rx, Dx
and devices)
• Research Collaboration and offshoring: High % of
Research executed through biotech and academia; high
% of research executed in emerging markets
• EHR data mining, convergence of informatics of
providers, payers and biopharma
Development paradigm shifting to in-life monitoring
• 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 trial
• Development Collaboration and offshoring: High % of development executed by CROs, and
more development conducted in emerging markets
• Closer coupling with Providers, Payers, Government, Regulators to share clinical
infrastructure
• Collaboration between Regulatory Bodies and Industry on an expedited drug development
pathway
4
2
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
Sales transforming in core markets
• Sales model changes from product driven to disease-management driven
• Bundled selling model emerge which may include Rx, Dx, Devices and
supportive packages such as compliance monitoring and home delivery
• Smaller but more specialized sales force; different sales model for mature
and new products
• Provides advisory, training and service roles
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
Distribution partnering in core
markets
• E-pedigree
• Direct to pharmacy and newer channels
• Patient-outcome based payment changes financial model
• Collaboration with whole sales, specialty distributors, PBM
and pharmacies to increase patient adherence

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

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

Phase I Phase II Phase III
Regulatory
NDA Submission
Phase IV
Information Management Along the Pharmaceutical Clinical Operation,
Regulatory Affairs and Post-marketing Surveillance
Web-based EDC in traditional phases and adaptive trials
Design and Plan
Start-up (Distribute Drug info, Site Selection)
Recruiting Patients/Investigators
Trial Management and Monitoring
Conduct, Reports and Closeout
CTDM
CTMS
Clinical Data Repository (SCE, eCDM)
Clinical Data Warehouse
Adverse Event Reporting System
Documentum
EDM
Document Life Cycle
Management
eCTD
E Submission
Sharepoint
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
Effectiveness of Medicine
Long-term Safety
Life Cycle Management
Patient Registry
Observational
Outcome Research
Pharmacoeconomics
Global Registery
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.
• Silos between disciplines and within and
between institutions
• A number of different disciplines: Chemical,
Biological, Clinical etc.
• In many ways has hit a wall in terms of
efficiency and capacity for innovation
• Rich history of many applications and data-
providers
• Integrates traditional discovery processes
with clinical practices
• Breaks down boundaries between silos and
organizations
• Closes the cycle between research and the
clinic, and between different research
disciplines
• Requires collaborative infrastructures and
data access
• Process is circular (closed loop)
Basic Research
Discovery and
Development
Clinical
Trials
Manufacture and
Distribute Primary
Care
ExtendedAcute
Health
Management
Payment
Translational R&DTraditional R&D

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

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

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

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.

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

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

DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF INFORMATION
MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (1)
DATA INTEGRATION MATURITY
No
Integration in
Discovery,
standalone
LIMS, paper-
based CRF
Minimally Integrated,
Pilot Programs on EDC,
loosely harmonization
between CTDM and
AERS, separate
research databases
within therapeutic area
Federated Querying,
within research
discipline (Genomics,
Medicinal Chemistry)
and clinical (EDC,
CTDM, CTMS and
AERS) as stop-gap
solutions
Full Discovery
(Targets to
leads)
Preclinical (Tox,
DMPK) and
Clinical
Lifecycle
Integration
Full Integration
including
Research,
Preclinical and
clinical data
Integration
with
Commercial
(EBM,
Personalized
Medicine)
P2P6
P5
P4P3
P8
P7
P9
P10
P12
P11

DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF
INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (2)
DATA MINING AND ANALYTICS MATURITY
No data
mining and
analytics
capabilities.
Heavy use of
Excel
spreadsheets
Some data mining and
analytics capabilities,
SAS in biostatistics,
various loosely-
coupled informatics
tools implemented in
discovery, preclinical
mostly associated
siloed applications
and some signal
detection in safety
Data repository
environment for
informatics and
analytics developed
in discovery,
preclinical and
clinical. Analytic
results still
application and
database specific.
Siebel analytics
reports CRM reach of
frequency but not
marketing analytics
Information
Analytics
environment
no longer
specific to
single
application
and databases.
Some
dashboards
capabilities
Enterprise
Data Analytics
and
Information
Workbench
with
customized
dashboards
P2P6
P5
P4P3
P8
P7
P9
P10
P12
P11

INFORMATION ARCHITECTURE AND DELIVERY
CAPABILITIES
No information
architecture
consideration.
Ad-hoc queries
as needed for
single
application.
Manual review
of multiple
queries to
answer a single
question
Information
architecture built
mostly based on
vendor supplied
standards. Siloed IT
groups develop
SQL/database queries
strategies based on
employee skillsets.
Information delivery
via window/Mac/web
interfaces as needed
Siloed IT initiated
integration based on
SOA and portal.
Example: Discovery
gene/compound
databases integrated
with project
portfolios. Clinical
data warehouses
being built to
integrate EDC, CDMS
based on industry
standards
Enterprise MDM
initiatives about
targets,
compounds,
products,
customers,
suppliers and
patients along
the R&D+M
value chains.
SOA and web
services
adopted
Enterprise
MDM delivered
on-demand.
Well thought-
out SOA in
place and
enterprise web
services
groups in
place.
Information
delivery based
customized
portal and
access control
P2P6
P5
P4P3
P8
P7
P9
P10
P12
P11

LEVERAGING EXTERNAL
INFORMATION/COLLABORATION CAPABILITIES
No external
collaboration
and no need to
access external
information –
non existent
Access external
information via ftp,
internet and VPN
eROOM, SharePoint,
stand alone EDC,
large scale R&D and
clinical project
management based
on MS projects and
visios
Third party project
management tools
chosen. R&D and
Clinical implemented
document life cycle
strategies.
Documentum and
other content
management tools
chosen for
information
archiving and
regulatory
submissions
Fully leverage
industry
standards of
information and
apply semantic
webs and
ontology
standards.
External
information
integrated on-
demand and
based on
business needs
P2P6
P5
P4P3
P8
P7
P9
P10
P12
P11

PHARMA SALES, MARKETING AND
MANAGED CARE
• Business Challenges
• Evolving Business Models

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

Managed Markets
Formulary Strategy
Sales Territory Alignment/
Management
Marketing Segmentation
& Targeting
Governance
Infrastructure
Data Warehousing/Information Management
Master Data Management
(Customer, Product, Organization)
REFERENCE ARCHITECTURE FRAMEWORK FOR A TYPICAL
PHARMACEUTICAL SALES, MARKETING AND MANAGED CARE
ORGANIZATION
Informationfromthefieldiscaptured,filteredupward,
andusedtomakeoperationalandstrategicdecisions
Analysisperformedoninformationfromthefield
yieldsinsightsthatdrivestrategyanddirectionaswell
asinfluencefieldoperations
ContractManagement
HEOR
KeyAccountManagement
E-Channels
Professional/Organization
Detailing
SampleManagement
LiteratureFulfillment
IncentiveCompensation
ExpenseManagement
Decision Support and Analytics
(Bus Intelligence/Scenario Planning/Predictive Analytics)
RegulatoryCompliance
SpeakerPrograms
CampaignManagement
KeyOpinionLeader
PrimaryMarketResearch/
CompetitiveIntelligence

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

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

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

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

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

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

PHARMACEUTICAL MANUFACTURING
AND DRUG SUPPLY CHAIN
• Manufacturing Process and Challenges
• Drug Supply Chain Process and Challenges
• Federal and State Pedigree Legislation

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

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

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

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

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

CIOS FACE A BALANCING ACT: CONTAIN IT COSTS, DELIVER HIGHER
QUALITY SERVICES AND APPLICATIONS AND LEAD INNOVATION IN A
FAST-PACED BUSINESS ENVIRONMENT.
$0
$20
$40
$60
$80
$100
$120
$140
$160
$180
$200 New server spending (USM$) 3% CAGR
’96 ’97 98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08
Cost of mgmt. & admin. 10% CAGR
$0
$20
$40
$60
$80
$100
$120
$140
$160
$180
$200 New server spending (USM$) 3% CAGR
’96 ’97 98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08
Cost of mgmt. & admin. 10% CAGRCost of mgmt. & admin. 10% CAGR
Trading analytics
Document transfer
Call center inquiries
Airline operations
Track financial position
Supply chain updates
Phone activation
Trade settlement
Build-to-order PC
Refresh data warehouse
107 106 105 104 1,000 100 10 1 Seconds
3 days 45 seconds
30 minutes 5 seconds
8 hours 10 seconds
1 day 5 minutes
1 day 15 minutes
3 days 3 minutes
1 month 1 hour
6 weeks 24 hours
5 days 1 day
Mail/express/fax/e-mail30 seconds3 days
Trading analytics
Document transfer
Call center inquiries
Airline operations
Track financial position
Supply chain updates
Phone activation
Trade settlement
Build-to-order PC
Refresh data warehouse
107 106 105 104 1,000 100 10 1 Seconds
3 days 45 seconds
8 hours 10 seconds
1 day 5 minutes
1 day 15 minutes
3 days 3 minutes
1 month 1 hour
6 weeks 24 hours
5 days 1 day
Mail/express/fax/e-mail30 seconds3 days
Speed
Cost Quality
Run IT ‘AS’ a business Run IT ‘FOR’ the business
Average IT operational spending growing at 3x other systems costs.

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

INNOVATION METRICS ARE PARTICULARLY IMPORTANT TO PHARMACEUTICAL CIO
AS MORE COMPANIES ARE FACING PATENT CLIFF AND REVENUE SHRINKAGE
Percent measure. Cumulative Project Workdays spent on new projects, divided by the Total number of workdays available,
expressed as a percentage
Effort normally gets split between Maintenance,
Enhancement, operations and new projects. Infrastructure,
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.
LagPercentage of effort on
new projects
Innovation
Percent measure. For a given time period, the new development budget (for the month, for the quarter and year-to-date)
allocated to strategic projects (as defined), divided by the total new development budget for the same period
A measure that attempts to quantify how much innovation is
taking place. Since this is a notoriously difficult factor to
manage, surrogate measures are usual: number of patents,
number of invitations to speak at conferences, number of
publications in peer reviewed journals.
LeadLevel of activity in
innovation work.
Innovation
Year to date measure. The total number of "learning events" heldA (qualitative) measure of knowledge sharing - usually a
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
LeadKnowledge Sharing &
Learning Events Held
Innovation
Percent measure. For a given period, during an employee satisfaction survey, the number of full-time equivalents giving a
score of high and very high to the question regarding 'This is a place that encourages innovation" , divided by the total number
of full-time-employees completing the survey
A measure that attempts to quantify the almost
unquantifable. The only meaningful way of applying this
measure is to seek the opinion of a competent authority and
use this opinion to show the degree to which the
environment encourages innovation
LeadExtent to which an
environment is in place
which encourages
innovation
Innovation
Measure of age. For all assets, the sum of the number of days since each asset was first used (or purchased for unused
assets), divided by the number of assets whose age is being counted, expressed in days, months or years, depending on the
asset type
An aggregate measure of the age of hardware assets,
usually divided into categories (mainframe, servers,
desktops). This measure is useful if demonstrating the
impending need to replace assets or for planning asset
refresh cycles
LeadAverage age of hardwareInnovation
Measure of the degree to which IT budget can be directed
into new - and strategic or high pay off - projects
Lead% of new development
budget for strategic
projects
Innovation
Percent measure. For a given time period, the number projects using Rapid Application Development tools and approaches
(as defined), divided by the sum of projects using RAD tools plus projects not using RAD tools, expressed as a percent
An architectural target measure charting the adoption rate of
Rapid Application Development, an interactive prototyping
approach to application development
Lead% new projects using
RAD Methods
Innovation
Value measure over time. Every time a patent is rewarded or an award is received, this measure is incremented by one and
the date recorded
Measure of the level of innovation exercised by the IT groupLead# Of patents and other
awards
Innovation
Percent measure. For a given time period, the number new development projects using "strategic technologies" (as defined),
divided by the total number of new development projects, expressed as a percent
A measure indicating the uptake of new technologies (such
as RFID and so on, depending on the enterprise's
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...
LagNumber of New
Technology Applications
Innovation
Percent measure. Cumulative Project Workdays spent on new projects, divided by the Total number of workdays available,
expressed as a percentage
Effort normally gets split between Maintenance,
Enhancement, operations and new projects. Infrastructure,
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.
LagPercentage of effort on
new projects
Innovation
A measure that attempts to quantify how much innovation is
taking place. Since this is a notoriously difficult factor to
manage, surrogate measures are usual: number of patents,
number of invitations to speak at conferences, number of
publications in peer reviewed journals.
LeadLevel of activity in
innovation work.
Innovation
Year to date measure. The total number of "learning events" heldA (qualitative) measure of knowledge sharing - usually a
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
LeadKnowledge Sharing &
Learning Events Held
Innovation
Percent measure. For a given period, during an employee satisfaction survey, the number of full-time equivalents giving a
score of high and very high to the question regarding 'This is a place that encourages innovation" , divided by the total number
of full-time-employees completing the survey
A measure that attempts to quantify the almost
unquantifable. The only meaningful way of applying this
measure is to seek the opinion of a competent authority and
use this opinion to show the degree to which the
environment encourages innovation
LeadExtent to which an
environment is in place
which encourages
innovation
Innovation
Measure of age. For all assets, the sum of the number of days since each asset was first used (or purchased for unused
assets), divided by the number of assets whose age is being counted, expressed in days, months or years, depending on the
asset type
An aggregate measure of the age of hardware assets,
usually divided into categories (mainframe, servers,
desktops). This measure is useful if demonstrating the
impending need to replace assets or for planning asset
refresh cycles
LeadAverage age of hardwareInnovation
Measure of the degree to which IT budget can be directed
into new - and strategic or high pay off - projects
Lead% of new development
budget for strategic
projects
Innovation
Percent measure. For a given time period, the number projects using Rapid Application Development tools and approaches
(as defined), divided by the sum of projects using RAD tools plus projects not using RAD tools, expressed as a percent
An architectural target measure charting the adoption rate of
Rapid Application Development, an interactive prototyping
approach to application development
Lead% new projects using
RAD Methods
Innovation
Value measure over time. Every time a patent is rewarded or an award is received, this measure is incremented by one and
the date recorded
Measure of the level of innovation exercised by the IT groupLead# Of patents and other
awards
Innovation
Percent measure. For a given time period, the number new development projects using "strategic technologies" (as defined),
divided by the total number of new development projects, expressed as a percent
A measure indicating the uptake of new technologies (such
as RFID and so on, depending on the enterprise's
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...
LagNumber of New
Technology Applications
Innovation

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

INFORMATION MANAGEMENT OPPORTUNITY USE CASE: LEVERAGE IT
METRICS TO HELP YOU DEVELOP A PROVEN IT VALUATION MODEL
Identify
Relevant
Metrics to be
Tracked and
Communicated
Gartner
Business
Value Model
Market
Responsiveness
Supplier
Effectiveness
Product
Development
Effectiveness
Operational
Efficiency
Finance
and Regulatory
Responsiveness
Customer
Responsiveness
Sales
Effectiveness
Information
Technology
Responsiveness
Sales Opportunity
Index
Forecast
Accuracy
Client
Retention Index
Sales Cycle
Index
Sales Price
Index
Sales Close
Index
On-Time
Delivery
Service
Performance
Order Fill
Rate
Agreement
Effectiveness
Transformation
Ratio
Material
Quality
Systems
Performance
New Projects
Index
IT Total Cost
Index
IT Support
Performance
Partnership
Ratio
Service Level
Effectiveness
Human
Resources
Responsiveness
Demand Management
Supply Management
Support Services
Customer
Responsiveness
Sales
Effectiveness
Information
Technology
Responsiveness
Identify
Relevant
Metrics to be
Tracked and
Communicated
Gartner
Business
Value Model
Market
Responsiveness
Supplier
Effectiveness
Product
Development
Effectiveness
Operational
Efficiency
Finance
and Regulatory
Responsiveness
Customer
Responsiveness
Sales
Effectiveness
Information
Technology
Responsiveness
Sales Opportunity
Index
Forecast
Accuracy
Client
Retention Index
Sales Cycle
Index
Sales Price
Index
Sales Close
Index
On-Time
Delivery
Service
Performance
Order Fill
Rate
Agreement
Effectiveness
Transformation
Ratio
Material
Quality
Systems
Performance
New Projects
Index
IT Total Cost
Index
IT Support
Performance
Partnership
Ratio
Service Level
Effectiveness
Human
Resources
Responsiveness
Demand Management
Supply Management
Support Services
Customer
Responsiveness
Sales
Effectiveness
Information
Technology
Responsiveness
1 2
34
The ITThe IT
ViewView CSFsCSFs
The BusinessThe Business
ViewView KOIsKOIs Increase
customer
loyalty
 Cross-
selling
 Billing
accuracy
 Faster
product/
service
introduction
 Market
retention
 Revenue per
customer
 Reduce
rework
 Market
share
 Make it
easier to
do business
with the
corporation
 Knowledge
mgmt.
 Legacy
sys. maint.
 Reduce
cycle time
 Customers
accessing
the Web site
 Cust. files
 Billing-error
rate
 Auto. test
process
 No. of staff
members trained
on Java
 DBMS
standardization
 Consolidate
billing systems
 Select/implement
new tools
ViewView CSFsCSFs
The ITThe IT
ViewView KOIsKOIs
The ITThe IT
ViewView KPIsKPIs
CSF = Critical success factor
KOI = Key outcome indicator
KPI = Key performance indicator
How the
business
must succeed Outcomes
of business
processes How
IT must
succeed Outcomes
of IT
processes Measures
of IT
performance
The ITThe IT
ViewView CSFsCSFs
ViewView KOIsKOIs Increase
customer
loyalty
 Cross-
selling
 Billing
accuracy
 Faster
product/
service
introduction
 Market
retention
 Revenue per
customer
 Reduce
rework
 Market
share
 Make it
easier to
do business
with the
corporation
 Knowledge
mgmt.
 Legacy
sys. maint.
 Reduce
cycle time
 Customers
accessing
the Web site
 Cust. files
 Billing-error
rate
 Auto. test
process
 No. of staff
members trained
on Java
 DBMS
standardization
 Consolidate
billing systems
 Select/implement
new tools
ViewView CSFsCSFs
The ITThe IT
ViewView KOIsKOIs
The ITThe IT
ViewView KPIsKPIs
How the
business
must succeed Outcomes
of business
processes How
IT must
succeed Outcomes
of IT
processes Measures
of IT
performance
Challenge: Reduce dependence
on agents and lower
cost of sales
Initiative: Web-based selling
on agents and lower
cost of sales
Gartner Business Value Model
Business Case
Benefits: $3.2 m
Costs: 2.3 m
Net: $0.9 m
ROI: 39%
Payback: 11 Months
Business Case
Benefits: $3.2 m
Costs: 2.3 m
Net: $0.9 m
ROI: 39%
Payback: 11 Months
Supplier
Effectiveness
Product
Development
Effectiveness
Operational
Efficiency
Finance
and Regulatory
Responsiveness
Human
Resources
Responsiveness
DemandDemand
ManagementManagement
SupplySupply
SupportSupport
ServicesServices
Customer
Responsiveness
Market
Responsiveness
Sales
Effectiveness
Information
Technology
Responsiveness
on agents and lower
cost of sales
on agents and lower
cost of sales
Gartner Business Value Model
Business Case
Benefits: $3.2 m
Costs: 2.3 m
Net: $0.9 m
ROI: 39%
Payback: 11 Months
Business Case
Benefits: $3.2 m
Costs: 2.3 m
Net: $0.9 m
ROI: 39%
Payback: 11 Months
Supplier
Effectiveness
Product
Development
Effectiveness
Operational
Efficiency
Finance
and Regulatory
Responsiveness
Human
Resources
Responsiveness
DemandDemand
SupplySupply
SupportSupport
ServicesServices
Customer
Responsiveness
Market
Responsiveness
Sales
Effectiveness
Information
Technology
Responsiveness
Target
Market Responsiveness
Channel Profitability Index 68% 76%
Sales Effectiveness
70% 73% 75%
IT Responsiveness
Baseline External
Benchmark
66% 72%
Sales Opportunity Index 41% 55%
Sales Close Index
Client Retention Index
43% 46% 50%40% NA
25% 35%26% 28% 31%25% NA
55% 65%57% 60% 63%53% 63%
Systems Performance
IT Support Performance
98.5% 99%98.7% 98.9% 98.6%98.2% 99%
90% 95%91% 93% 93%90% 94%
Time
Q 4Q 3Q 2Q 1
How is the Web initiative going?
Partnership Ratio
Service-Level Effectiveness
28% 50%33% 35% 38%29% 45%
79% 85%82% 85% 84%80% 84%
New Projects Index
IT Total Costs Index
47% 60%50% 54% 59%48% 57%
3.2% 3.1%3.3% 3.1% 3.2%3.2% 3%
Target
Market Responsiveness
Channel Profitability Index 68% 76%
Sales Effectiveness
70% 73% 75%
IT Responsiveness
Baseline External
Benchmark
66% 72%
Sales Opportunity Index 41% 55%
Sales Close Index
Client Retention Index
43% 46% 50%40% NA
25% 35%26% 28% 31%25% NA
55% 65%57% 60% 63%53% 63%
Systems Performance
IT Support Performance
98.5% 99%98.7% 98.9% 98.6%98.2% 99%
90% 95%91% 93% 93%90% 94%
Time
Q 4Q 3Q 2Q 1
How is the Web initiative going?
Partnership Ratio
Service-Level Effectiveness
28% 50%33% 35% 38%29% 45%
79% 85%82% 85% 84%80% 84%
New Projects Index
IT Total Costs Index
47% 60%50% 54% 59%48% 57%
3.2% 3.1%3.3% 3.1% 3.2%3.2% 3%
Link business to IT performance management… …using business metrics to attract business interests…
…Provide post-implementation tracking
using metrics agreed with Business.
…linking IT initiatives to business metrics and
ROI…

INFORMATION MANAGEMENT FRAMEWORK
39

ESTABLISHING INFORMATION MANAGEMENT ARCHITECTURAL
FRAMEWORK AND BUILDING THE CAPABILITIES WILL BE
CRUCIAL TO SUPPORT THE CHANGING BUSINESS LANDSCAPE
• Master and Reference
Data
• Business Intelligence
Data
• Transaction Data
• External Data
• Semi-Structured Data
• Unstructured Data
• Data Access
• Data Delivery
• Data Integration
• Process Integration
• Transformations
• Business Rules
• Meta Data Repository
• Enterprise Data Models
• Service Registry
• Directories
• BI Definitions and
configurations
• Integration Definitions
• Access Definitions
• Delivery Definitions
• Transformation Definitions
• Process Definitions
• Business Rules Repository
IM Framework components… …defined by…
• Business Goals & Principles
• IT Goals and Principles
• IM Organization
• Enterprise Governance
• Information Governance
• Service Governance
• Process Governance
• Application Governance
• Infrastructure Governance
• Change Management
• Information Lifecycle Management
• Compliance & Risk Management
• Enterprise Architectural Standards
…and driven by:
Typical IM Strategy Process map
Information Access
Information Architecture &
Integration
Information Quality (MDM)
• IM Governance
• Technical
Architecture
• Service
Definition

MASTER DATA MANAGEMENT SOLUTION FRAMEWORK: THINK LOCALLY,
STANDARDIZE REGIONALLY, ANALYZE GLOBALLY. DO NOT “OVER MASTER.”
EDM Governance & Stewardship–
Acquisition&AuthoringServices
DistributionServices
Metadata Services
Master Data
Management
Services
Data Quality Services
Administration
Services
Maintenance
Services
Master Data Consumers
Acquisition & Authoring
• Real-time/Near
• Batch
• Change Capture
Distribution
• Self-service (pull) interface
• Publishing (push) interface
• Messaging-oriented interface
Data Quality
• Validation
• Audit, balance & control
• Quality Tracking
Metadata
• Metadata shopping
• Impact analysis
• Operations Monitoring
• Quality Investigations
Administration and Maintenance
• Change management
• Security management
• Operational support
• Process monitoring
• Performance management
Stewardship Process
• Distribution Request
• New/changed Master Data Request
• Quality Improvement Initiative
• Operations & Quality Monitoring
Master Data Management
• Historical Data Management
• Storage services
• Schema services
• Mapping/alignment Services
• Hierarchy Management
Suppliers
• Authoritative Sources
• End-user Authoring
Master Data Suppliers
Workflow Services
Workflow Services
• Review and Correction
• Approval and Publishing
• Exception escalation

Information Management in Pharmaceutical Industry

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