Information Management in Pharmaceutical Industry

INFORMATION MANAGEMENT IN BIOPHARMA INDUSTRIES CHALLENGES AND OPPORTUNITIES

Frank Wang [email protected], www.linkedin.com/in/frankfangwang

mailto:[email protected]

• 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

Extended Acute

Health Management

Payment

Translational R&D Traditional 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 Stability

Clinical 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 speed Standard 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)

P2 P6

P5

P4 P3

P8

P7 P9

P10

P12

P11


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

P2 P6

P5

P4 P3

P8

P7 P9

P10

P12

P11

DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF

INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (3)

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

P2 P6

P5

P4 P3

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

P2 P6

P5

P4 P3

P8

P7 P9

P10

P12

P11

PHARMA SALES, MARKETING AND MANAGED CARE

• Business Challenges

• Evolving Business Models

• Information Management Opportunities

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

Gov

erna

nce

Infrastructure

Data Warehousing/Information Management

Master Data Management

(Customer, Product, Organization)

REFERENCE ARCHITECTURE FRAMEWORK FOR A TYPICAL PHARMACEUTICAL SALES, MARKETING AND MANAGED CARE ORGANIZATION

Info

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upw

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Analysis performed on inform

ation from the field

yields insights that drive strategy and direction as well

as influence field operations

Cont

ract

Mana

gem

ent

HEO

R

Key

Acc

ount

Mana

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E-Cha

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Prof

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Ince

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Expen

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ana

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Decision Support and Analytics (Bus Intelligence/Scenario Planning/Predictive Analytics)

Regula

tory Comp

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Spea

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Prog

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s

Cam

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Key

Op

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Int

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UNDERSTAND ANALYTICAL NEEDS: WHAT BUSINESS QUESTIONS SALES AND MARKETING EXECUTIVES ASK LEAD TO DESIGN STRATEGY OF INFORMATION MANAGEMENT

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© 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 IntegrationData exists across multiple systems, e.g. KOLs kept on multiple lists.

• Information AccessNo direct access or Analytical tools available.

• Data QualityIssues 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

PeopleSoft Siebel

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 • Information Management Opportunities

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

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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% CAGRTrading 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.

Presenter

Presentation Notes

The only constant is change, and one of the things that has changed most, is the role of the CIO Cost of IT – Has to be right, not too low, otherwise we stifle investment, not too high, otherwise IT becomes part of the problem rather than part of the solution. What is the right cost for IT for your business, and how do you know? Quality of Service – Managing internal and external expectations, understanding availability, managing Risk, this again are critical areas for IT, and one which has increased in importance over the past 10 years. IT is now embedded in every business transaction, so when IT stops, the business stops, and this is the same for all businesses. So the Cost vs. Quality balance is a continued challenge for you all today, and one which has become ‘business as usual’… So lets now add to the mix Agility, or speed of execution. In a recent Global survey of 456 CEO’s only 13% regarded IT as responsive to change within the business, 80% were partially responsive, and the rest were incapable of change. Over half of these CEO’s expect the future to be one of ‘continued discontinuity’ where change, and the ability to change quickly, is a major business advantage. So what of tomorrow, well CIO’s today are struggling with not only running IT as a business, with proper service levels, accountability, risk management, and cost effective operations and infrastructure, but also running IT for the business, where IT is used by the business for competitive advantage, and has become an enabler to their future growth. For example, where would the Telco’s be with IT, how could the automotive manufactures manage global supply chains with a global IT network and complex IT systems. How could the banks bring financial services into the homes of their customers with IT systems to support them. These are not back office IT functions, but complex business processes, enabled by IT.

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/A25%20%

N/A

90 days10%

15%

90%

10 per year8 per year

90%

100%

+/-5%<5%80%

10 per year45 days75%

– Web/kiosk initiative

– New products program

– Value management program



– Value management

– Value management– Infrastructure 2007– Development 2006

– Bus. education forum

– Employee dev. plan– Personal dev. plan

Initiatives

IT Mission/Value

IT Customers

























9%

N/A

2

1

60%

70%

N/A25%20%

N/A

90 days10%

15%

90%


90%

100%

+/-5%<5%80%


IT Mission/Value

IT Customers

























9%

N/A

2

1

60%

70%

N/A25%20%

N/A

90 days10%

15%

90%


90%

100%

+/-5%<5%80%


– Web/kiosk initiative





– Value management

– Value management– Infrastructure 2007– Development 2006

– Bus. education forum

– Employee dev. plan– Personal dev. plan

InitiativesInitiatives

IT Mission/Value

IT Customers




– 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/A75%

3.25

80%2 per month143

9%N/A

45%

N/A

15%

1

– 2006 “to the bone”– Vendor management

program

– IT customer sat. survey

– Enterprise security program

– 2006 “to the bone”– Infrastructure 2007– Infrastructure 2007– Infrastructure 2007

– Infrastructure 2007

– Personal development program

– employee development plan


5%+/- 8%85%

3.5

100%<4 per month400

0%-5%

95%

<15%

20%

2

Initiatives

IT Mission/Value

IT Customers





Performance




















1.5%N/A75%

3.25

80%2 per month143

9%N/A

45%

N/A

15%

1

IT Mission/Value

IT Customers





Performance




















1.5%N/A75%

3.25

80%2 per month143

9%N/A

45%

N/A

15%

1

– 2006 “to the bone”– Vendor management

program

– IT customer sat. survey

– Enterprise security program

– 2006 “to the bone”– Infrastructure 2007– Infrastructure 2007– Infrastructure 2007


– Personal development program



5%+/- 8%85%

3.5

100%<4 per month400

0%-5%

95%

<15%

20%

2

IT Value Proposition Starts with:

IT Value Proposition Oriented towards Innovation and Growth IT Value Proposition Targeted to Cost Containment Goals

IT Mission/Value

IT Customers




–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– IT opinion survey/satisfaction

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

0.852.5

0.50

75%

50%

30%

70%N/A

N/A

25%

-2% per year

Initiatives

2%50%

75%

2.04.0

2.0

95%

100%

90%

100%<3

max. 2

95%

10% per year

– Value mgmt. program– Program mgmt.


– Program mgmt. – Value mgmt. program

– Program mgmt.


– Value mgmt. program


– Infrastructure 2007– Infrastructure 2007



– Employee development program

IT Mission/Value

IT Customers




–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– IT opinion survey/satisfaction

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

0.852.5

0.50

75%

50%

30%

70%N/A

N/A

25%

-2% per year

Initiatives

2%50%

75%

2.04.0

2.0

95%

100%

90%

100%<3

max. 2

95%

10% per year

– Value mgmt. program– Program mgmt.


– Program mgmt. – Value mgmt. program

– Program mgmt.


– Value mgmt. program


– Infrastructure 2007– Infrastructure 2007



– 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 numberof 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 numberof 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 BusinessValue Model

MarketResponsiveness

SupplierEffectiveness

ProductDevelopmentEffectiveness

OperationalEfficiency

Financeand Regulatory

Responsiveness

CustomerResponsiveness

SalesEffectiveness

InformationTechnology

Responsiveness

Sales OpportunityIndex

ForecastAccuracy

ClientRetention Index

Sales CycleIndex

Sales PriceIndex

Sales CloseIndex

On-TimeDeliveryService

Performance

Order FillRate

AgreementEffectiveness

TransformationRatio

MaterialQuality

SystemsPerformance

New ProjectsIndex

IT Total CostIndex

IT SupportPerformance

PartnershipRatio

Service LevelEffectiveness

Human Resources

Responsiveness

Demand Management

Supply Management

Support Services


SalesEffectiveness


Responsiveness

Identify Relevant Metrics to be Tracked and Communicated

Gartner BusinessValue Model






Responsiveness


SalesEffectiveness


Responsiveness

Sales OpportunityIndex

ForecastAccuracy

ClientRetention Index

Sales CycleIndex

Sales PriceIndex

Sales CloseIndex

On-TimeDeliveryService

Performance

Order FillRate

AgreementEffectiveness

TransformationRatio

MaterialQuality

SystemsPerformance

New ProjectsIndex

IT Total CostIndex

IT SupportPerformance

PartnershipRatio

Service LevelEffectiveness

Human Resources

Responsiveness

Demand Management

Supply Management

Support Services


SalesEffectiveness


Responsiveness

1 2

3 4

The ITThe ITView View CSFsCSFs

The BusinessThe BusinessView View KOIsKOIs Increase

customer loyalty

Cross-selling

Billing accuracy

Faster product/serviceintroduction

Market retention

Revenue percustomer

Reduce rework

Market share

Make it easier to do businesswith the corporation

Knowledge mgmt.

Legacy sys. maint.

Reducecycle time

Customers accessingthe Web site

Cust. files Billing-error

rate Auto. test

process

No. of staff members trained on Java

DBMSstandardization

Consolidatebilling systems

Select/implement new tools

The BusinessThe BusinessView View CSFsCSFs

The ITThe ITView View KOIsKOIs

The ITThe ITView View KPIsKPIs

CSF = Critical success factorKOI = Key outcome indicatorKPI = 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 ITView View CSFsCSFs

The BusinessThe BusinessView View KOIsKOIs Increase

customer loyalty

Cross-selling

Billing accuracy

Faster product/serviceintroduction

Market retention

Revenue percustomer

Reduce rework

Market share

Make it easier to do businesswith the corporation

Knowledge mgmt.

Legacy sys. maint.

Reducecycle time

Customers accessingthe Web site

Cust. files Billing-error

rate Auto. test

process

No. of staff members trained on Java

DBMSstandardization

Consolidatebilling systems

Select/implement new tools

The BusinessThe BusinessView View CSFsCSFs

The ITThe ITView View KOIsKOIs

The ITThe ITView View 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



Gartner Business Value Model

Business CaseBenefits: $3.2 m

Costs: 2.3 mNet: $0.9 mROI: 39%

Payback: 11 Months



Payback: 11 Months





Responsiveness

Human Resources

Responsiveness

DemandDemandManagementManagement

SupplySupplyManagementManagement

SupportSupportServicesServices



SalesEffectiveness


Responsiveness





Gartner Business Value Model



Payback: 11 Months



Payback: 11 Months





Responsiveness

Human Resources

Responsiveness

DemandDemandManagementManagement

SupplySupplyManagementManagement

SupportSupportServicesServices



SalesEffectiveness


Responsiveness

Target

Market ResponsivenessChannel Profitability Index 68% 76%

Sales Effectiveness70% 73% 75%

IT Responsiveness

Baseline ExternalBenchmark

66% 72%

Sales Opportunity Index 41% 55%Sales Close Index

Client Retention Index

43% 46% 50%40% NA25% 35%26% 28% 31%25% NA55% 65%57% 60% 63%53% 63%

Systems PerformanceIT 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 RatioService-Level Effectiveness

28% 50%33% 35% 38%29% 45%79% 85%82% 85% 84%80% 84%

New Projects IndexIT 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 ResponsivenessChannel Profitability Index 68% 76%

Sales Effectiveness70% 73% 75%

IT Responsiveness

Baseline ExternalBenchmark

66% 72%

Sales Opportunity Index 41% 55%Sales Close Index

Client Retention Index

43% 46% 50%40% NA25% 35%26% 28% 31%25% NA55% 65%57% 60% 63%53% 63%

Systems PerformanceIT 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 RatioService-Level Effectiveness

28% 50%33% 35% 38%29% 45%79% 85%82% 85% 84%80% 84%

New Projects IndexIT 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 & Authoring Services

Distribution Services

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

Data & Analytics

Information Management in Pharmaceutical Industry