ArchiMate as a Communication Tool in Launching an EA Effort fileand integration of business...

ArchiMate as a Communication Tool in Launching an EA Effort

Harmonizing and Promulgating a Vision forSupporting the Business Strategy

Open Group Conference Boston, July 2010

Andy Siegel, GenzymeRichard Ferrante, RDF SoftwareHemant Virkar, Digital Infuzion

Outline

21-July-2010 Open Group Boston 2010 2

Historical / Genzyme Context

Launching a Standards / EA Effort

Framework & Tooling• TOGAF• ArchiMate / Bizzdesign

Communication and Information Gathering

Accelerators

Conclusion & Questions

Historic Context

• IT / Informatics generally not a strategic focus of Biopharma– Some exceptions: early genomics companies– Includes academic & healthcare collaborations– Buy vs Build

• Industry standards are emerging– Primarily focused on immediate need data standards

• CDISC (Clinical Data Interchange Standards Consortium)– Regulatory authorities push for increased standardization in reporting

• Pharmacovigilance (detecting patterns of adverse events)• Marketing Authorizations • Product Labeling• Clinical Trials Transparency• Manufacturing Information

– Healthcare IT• HITSP (Healthcare IT Standards Panel)

Harmonization & Interoperability Specifications

• Difficult to maintain funding / LOE for strategic efforts– CDISC Life Sciences Industry Architecture (LSIA) effort was unable to

attract sufficient resources, given the turbulence in the industry

What differentiates us is our products and patient community focus not our enabling technologies

We are being pushed toward information standardization and integration of business processes across institutional boundaries

Genzyme Corporate Context• Global, diversified health care products company with

>12,000 employees worldwide

• Helping patients in 100 countries;85 locations in >40 countries;17 manufacturing sites

• 19 major marketed products;focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease

• 2009 revenue of $4.5 billionMarket cap > $13 billion10+ years of sustained 20% annual growth rate

• Henri Termeer: Chairman, CEO27 year tenure

21-July-2010 4Open Group Boston 2010

Major Marketed Products and Services

Personalized Genetic Health

Cerezyme®

Fabrazyme®

Aldurazyme®

Myozyme®

Lumizyme®

Renagel®Renvela®

Hectorol®Thyrogen®

Renal and Endocrinology

Mozobil®Clolar®

Campath®

Fludara®

Leukine®

Thymoglobulin®

Hematology and Oncology

GeneticsDiagnostics

Synvisc®

Synvisc-OneTM

Carticel®MACI®SepraTM Products

Biosurgery

Myozyme®

Lumizyme®

21-July-2010 5Open Group Boston 2010

Enterprise Architecture should allow Genzyme to answer some key strategic questions

do it better -do it faster -do it cheaper!

“We have far too many applications and it is getting worse. How do we

avoid re-inventing the wheel?”

“How do we best support and integrate with our outsourced

partners and suppliers?”

“Who should be the authoritative source for

customer, product, protocol, site, etc.?”

“How do we improve and optimize our

technology enabled business processes?”

“How do we get access to the right information to

run our business?”

“How do we support a future that takes advantage of

Cloud Computing?”

“How will this merger or licensing deal impact

our business?”

“What is the impact of implementing this new

standard on our existing systems and processes?”

• More value• Faster

service• Fewer errors

• More accurate information for more accurate decisions

• Maintain fewer applications

• Avoid duplication or work not aligned with transformation priorities

• Less redundant work

• More reuse

EA Transformation Must be Driven by Clear Business Benefit

Improved Customer

ExperienceGreater

Gross Margin

Cost Avoidance

Drive Efficiency

Reduced Total Cost of

Ownership

Adapted from PA Knowledge Ltd, EA Seminar, 2008.

Goals and Objectives• Provide support for

emerging Genzyme strategy and operating model:– Foster sharing of

information– Make outsourcing of

non-core processes easier

– Minimize data and systems redundancy

– Optimize use of existing and future assets

Where we are today

First Steps

• full end-to-end, metadata driven, standards based clinical development lifecycleCreate a vision

• GetSMART program• workstream projects

• EA practice• SMEs – early adopters / evangelists• BAT – engage the functional areas

Build teams to elaborate the vision

• RegistryNXT!

Engage in selected prospective & retrospective projects

Standards Program

Consistently define, use, and re-use clinical information globally through standards-based, metadata-driven processes

Strategic, Measurable, Achievable, Realistic and Timely Programto achieve efficiencies for clinical information processes

Standards-based, metadata-driven development data life cycle – Page 1

ProtocolDevelopment

SAPAuthoring &TLF Shell

Development

CRFRendering.

Studybook &Pre-DefineMetadata

Report

EditSpecifications

Clinical Data Mgmt System (CDMS)

and Electronic DataCapture (EDC)

Database Setup

Adverse Event &Medication Coding

Import of Central Laband Specialty Data to Genzyme’s

Statistical Computing Environment (SCE)

Standards-based, metadata-driven development data life cycle – Page 2

Load Study &Analysis Data

to ClinicalData Warehouse

Publication ofStudy and

Analysis Data

Publication ofSubmissionMetadata

Conversion of CollectedData to Raw Data

Standard

Creation of Analysis Datasets

Load CROStandards-based

Safety and EfficacyTables, Listings & Figures

(TLFs)

Framing Decisions

• “Enterprise Architecture” within a business area– Focused on

• Interchange/interoperability between systems• Facilitating scientific exploration/development• Facilitating regulatory compliance

– Less concerned with• Technical standards

Selecting A Framework

• Considered– Zachman, Gartner, TOGAF

• Quickly settled on TOGAF– Style fit

• Business oriented• Iterative• Examples of successful use in the

biopharmaceutical space

Initial Goals

• Support business strategy– Greater outsourcing– Collaboration – Transparency

• Data centric– Data is ~ forever– Science based

• Science is dynamic

Evolution

• Special purpose, locally optimized solutionsFrom• Replication• Shared best practices• Standards based approaches

• A Similar process is occurring in the regulatory agencies

Operating model

• EA Supporting a change in the business model– Going from the “local optimizations” represented by diversification– Going to some “global optimizations” represented by replication

primarily centered around data and process standards

Implications Going Forward

• Supporting Business Strategy– Requires communicating with the business strategists– Grounding communication with a technically accurate

representation.

• Other Portions of Genzyme Undergoing a similar evolution– Quickly, accurately revise and coordinate– Communication that is

• Rigorous• Simple• Not overly technical.

Tool Selection• Goals

– Communicate simply, but completely• Complete stack: business user hardware• Elide most detail• Highlight Interdependencies (current and planned)

– Data– Applications– Hardware

– Achieve consensus on a vision• Requires a sufficiently large context

– Spanning applications– Spanning business areas– Spanning the product lifecycle

Tool Selection: Graphic Representation

• Advantages• Communicates well with technical users

• Disadvantages• Overly detailed• Doesn’t lend itself to capturing the complete system on

• Advantages• No training required • Could communicate complete system on one page

• Disadvantages• Easy to become confused over time• Diagrams would require extensive documentation to be useful long term

Boxes & Arrows (ad hoc graphic

language)

• Advantages• Little training required • Could communicate complete system on one page

• Disadvantages• Recent standard not widely known• Some uncertainty as to its utility in meeting our needs.

ArchiMate

Tool Selection: Software Choice

• Advantages• Readily available

• Disadvantages• Doesn’t enforce notation• No tool support for naming consistency etc.

General Drawing tool (Visio, etc.)

• Advantages• Some were already in house• Broad Capabilities

• Disadvantages• Broad Capabilities == lack of focus• Examples not tuned to our needs.

General Modeling tool (EA oriented

solutions.)

• Advantages• Tuned to ArchiMate• Knowledgeable staff/consultants

• Disadvantages• Smaller Vendor

Bizzdesign Architect

Tool Evaluation via iteration

• Begin communication efforts• Evaluate graphical models

best able to communicate• Evaluate +/- of in house tools• Explore other tool options as

required

Use tools already in

Graphics Experiments

• Visio, Omnigraffle• If these work, we’re done

Use “Simple” Drawing Tools to Start

• Outreach to other efforts within Genzyme• Primarily around business process mapping

• Serve as a tool to harmonize divergent viewpoints• Primarily with the core stakeholders during the

experimental period

Initial drawings /discussions

What did we learn?

• Landscape map• High level interaction of business processes and functions• Avoids details in the first slide – steering between the Scylla

of “their eyes glaze over” and the Charybdis of “immediately doing the deep dive into detail” (typical of UML)

• Drug development lifecycle coding• Matches how people think about the process• Development lifecycle is the most salient overall process

driver

What works as a communication vehicle

• Using a simple drawing tool• Too easy to have name skew: same element having

different names on different drawingsWhat didn’t work

Experimental Results

• Functional Area SMEs• Executives• Technologists

ArchiMate communicates with the people we need to talk to

• BiZZdesign

Adoption of a new standard is facilitated by a using vendor involved in the development of the standard.

• Principles• Periods

• stage of the drug development process

Adequate communication of our situation required some enhancements (which were in process) to the current standard

IntroductoryPage

• Start Here

Introduction

• Drill down for EA principles

Guidelines

• Quick reference• Links for more detail

ArchiMate Language

EA Principles

• Drill down for Implications and Rationale

BusinessDataTechnology

LandscapeMap

• Scroll down for more areas

Business Areas

• Drill down for more detail

Business FunctionsBusiness Processes

Drill Down Detail

• Business information

Business Layer

• Application Data• Application Services• Application Components• Infrastructure

Application Services Layer

LifecycleStages

•Planning•Pre-Approval•Submission•Post-Approval

Development Lifecycle

•Current State•Future State

Architecture

•Evaluating•Prototyping/Piloting•Emerging•Core•Declining•Retired•Ruled Out

ITIL Lifecycle

Example: Gaucher Registry

• Established 1991– Largest cooperative, observational registry– Majority of the patients diagnosed between ages 4 and 30 years

(mean age, 19 years)

– Most (92%) patients diagnosed with type 1 Gaucher disease

– To date approximately 79% (3,598 patients) have received ERT with imiglucerase

• By Jan 2007– 4,585 patients– Across 56 countries

The New Platform

Architect, design and implement a standardized registry model across all 4 LSD registries using a common metadata driven framework

Implement new features and functions for data capture and data reporting into and out of the Registry to maintain the core scientific accuracy and credibility of the Registries

Implement a community knowledge base and online community that enhances and compliments the core scientific mission of the Registries with: Integrated data entry system and data reporting portal Single sign-on for data entry and reporting More flexible and efficient data collection partner (Medidata) New statistical reporting structure Interactive, real-time reports available to sites

Deliver value to our registry clinical care sites and their patients Provide a flexible set of tools for Genzyme’s registry managers

Is your architecture business ready?

How can EA deliver business benefit in its early stages?

The problem is most EAs are lagging behind projects!

EA Transformation Must be Driven by Clear Business Benefit

• Complete vs. Useful– Completion

• Do we really need to analyze and catalog every single attribute of every single entity?

– Useful• Should we wait for “completion” of

the EA before we use?– Results

• What is cost savings, cost avoidance and performance improvement attributed to EA

How “Complete” must the EA be before it can be

“Useful”?

Taking an Accelerated Approach

1. Start with an proven architecture– Is in use in the same or related domain (Clinical Research)

2. Utilizes industry standard information model and reference architecture– CDISC, HL7, Consolidate Health Informatics (CHI)– FEAF or TOGAF

3. Modeling methodology aligns with an industry standard– E.g., ArchiMate

4. Uses an SDLC that is supports modeling– RUP / UML

The DAIDS Platform Architecture

New Ideas Trial Design

Enrollment

TrialSet-up

Submission and Reporting

Evidence-basedReview

Enterprise System Components built to supportthe Clinical Trials Process

TrialConduct

What is the business of DAIDS?

DAIDS-ES Data Flow

FTP ListenerService

Patient Enrolled

CRFData Entry

XML FileTransfer

EnterpriseDataStore

Clinical Research Partners

DAIDS-ES Architecture Framework Abstract View

RUP 4+1 Architecture Views

Benefits of the Accelerated Approach

– Guides the implementation and integration without being prescriptive

– Exposes business improvement opportunities • E.g., Way we did our SAS analysis and reporting

– Supports the evaluation of alternatives in support of common business services

• E.g., Data-In via COTS or custom developed tool– Allows segment (Genzyme Registries program)

and solution (RegistryNXT! Platform) architecture with enough room for agility and scalability

• E.g., Other disease registries

So…while Genzyme EA was evolving

• Registries Program began implementing segment architecture– Adapting DAIDS-ES Architecture– Deriving the Information Model

based on industry standard (BRIDG)

– Adding Registry specific extensions

– Reusing components to minimize redundancy (MDR)

– Optimizing the re-use of information and data

– Developing new add-on components

Registry, Study, Agent

Patient, CRF Data

Reporting

People & Sites

Archive Mgmt

Standard’s based approach to data will allow:1) Easier standard reporting & reuse2) Easier database management3) Standardized data interchange/feeds from EHRs/PHRs4) Metadata driven system changes5) Promotes reuse into additional LSD registries

What got accelerated?

• Genzyme RegistryNXT! Platform– Solution is on target to be implemented in 15

months– NIH DAIDS-ES solution was architected and built

in 36 months– Genzyme will have saved 21 months

The bottom-up approach to Registries Architecture

• Use the RUP / UML models– Capture Use Cases– Abstract logical components– Abstract business objects

• Complete the ArchiMate Model

Platform Technology & Architecture -“Start Simple” but Be “Scalable”

Start SimpleThe Foundation

Avoid the Trap…Not spending time planning & architecting you may get this

ScalableSolid FoundationExpandable to support future

Simple Scalable

Avoid the Trap

Conclusion

Launching a business driven architecture function with TOGAF & ArchiMate supports the “top down” approach and is being well received by business & executive stakeholders

Can also be utilized “bottom-up” with COTS-like accelerators which support goals of increased use of standards, more reuse and lower costs

Business benefit can be achieved even while launching EA

Summary

Business Aligned:Enterprise Architecture is focused on aligning IT with Genzyme’s business strategy

Drive to Mature:Genzyme is very early in its EA maturity cycle but has a mandate to mature itself

Business Supported:EA needs business involvement and support to transform a legacy of fragmented applications and processes (both manual and automated) into an integrated environment with optimized processes

Emerging Operating Model:EA needs to work with the business areas to understand Genzyme’s emerging operating model and strategy

IT Governance:We still need to develop an IT governance practice optimized to Genzyme’s business strategies, desirable behaviors and corporate governance

Thank-you!Acknowledgements:

• Sue Dubman & BAT Team Members• The GetSMART Leadership Council, PMO and

Workstream Team Members• RegistryNXT! Team & Digital Infuzion Team Members• BiZZdesign

ArchiMate as a Communication Tool in Launching an EA Effort fileand integration of business...

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