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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
21-July-2010 Open Group Boston 2010 3
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
Other
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
21-July-2010 Open Group Boston 2010 7
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
21-July-2010 Open Group Boston 2010 9
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
Data
Safety and EfficacyTables, Listings & Figures
(TLFs)
21-July-2010 Open Group Boston 2010 13
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
21-July-2010 Open Group Boston 2010 14
Selecting A Framework
• Considered– Zachman, Gartner, TOGAF
• Quickly settled on TOGAF– Style fit
• Business oriented• Iterative• Examples of successful use in the
biopharmaceutical space
21-July-2010 Open Group Boston 2010 15
Initial Goals
• Support business strategy– Greater outsourcing– Collaboration – Transparency
• Data centric– Data is ~ forever– Science based
• Science is dynamic
Evolution
21-July-2010 Open Group Boston 2010 16
• Special purpose, locally optimized solutionsFrom• Replication• Shared best practices• Standards based approaches
To
• A Similar process is occurring in the regulatory agencies
Operating model
21-July-2010 Open Group Boston 2010 17
• 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.
21-July-2010 Open Group Boston 2010 18
21-July-2010 Open Group Boston 2010 19
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
21-July-2010 Open Group Boston 2010 20
• Advantages• Communicates well with technical users
• Disadvantages• Overly detailed• Doesn’t lend itself to capturing the complete system on
UML
• 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
21-July-2010 Open Group Boston 2010 21
• 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
21-July-2010 Open Group Boston 2010 22
• 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
house
Graphics Experiments
21-July-2010 Open Group Boston 2010 23
• 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
21-July-2010 Open Group Boston 2010 24
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
21-July-2010 Open Group Boston 2010 25
• 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
21-July-2010 Open Group Boston 2010 26
IntroductoryPage
• Start Here
Introduction
• Drill down for EA principles
Guidelines
• Quick reference• Links for more detail
ArchiMate Language
21-July-2010 Open Group Boston 2010 27
EA Principles
• Drill down for Implications and Rationale
BusinessDataTechnology
21-July-2010 Open Group Boston 2010 28
LandscapeMap
• Scroll down for more areas
Business Areas
• Drill down for more detail
Business FunctionsBusiness Processes
21-July-2010 Open Group Boston 2010 29
Drill Down Detail
• Business information
Business Layer
• Application Data• Application Services• Application Components• Infrastructure
Application Services Layer
21-July-2010 Open Group Boston 2010 30
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)
21-July-2010 Open Group Boston 2010 32
– 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
21-July-2010 Open Group Boston 2010 33
Is your architecture business ready?
21-July-2010 Open Group Boston 2010 34
How can EA deliver business benefit in its early stages?
The problem is most EAs are lagging behind projects!
21-July-2010 Open Group Boston 2010 35
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”?
21-July-2010 Open Group Boston 2010 36
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
21-July-2010 Open Group Boston 2010 37
The DAIDS Platform Architecture
21-July-2010 Open Group Boston 2010 38
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?
21-July-2010 Open Group Boston 2010 39
DAIDS-ES Data Flow
FTP ListenerService
Patient Enrolled
CRFData Entry
XML FileTransfer
EnterpriseDataStore
1
2
3 4
5
21-July-2010 Open Group Boston 2010 40
Clinical Research Partners
Sites
DAIDS-ES Architecture Framework Abstract View
21-July-2010 Open Group Boston 2010 41
RUP 4+1 Architecture Views
21-July-2010 Open Group Boston 2010 42
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
21-July-2010 Open Group Boston 2010 43
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
21-July-2010 Open Group Boston 2010 44
Registry, Study, Agent
Patient, CRF Data
Reporting
People & Sites
Archive Mgmt
21-July-2010 Open Group Boston 2010 45
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
21-July-2010 Open Group Boston 2010 46
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
21-July-2010 Open Group Boston 2010 47
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
21-July-2010 Open Group Boston 2010 48
Platform Technology & Architecture -“Start Simple” but Be “Scalable”
Start SimpleThe Foundation
21-July-2010 Open Group Boston 2010 49
Platform Technology & Architecture -“Start Simple” but Be “Scalable”
Avoid the Trap…Not spending time planning & architecting you may get this
21-July-2010 Open Group Boston 2010 50
Platform Technology & Architecture -“Start Simple” but Be “Scalable”
ScalableSolid FoundationExpandable to support future
needs
21-July-2010 Open Group Boston 2010 51
Platform Technology & Architecture -“Start Simple” but Be “Scalable”
21-July-2010 Open Group Boston 2010 52
Simple Scalable
Avoid the Trap
Conclusion
21-July-2010 Open Group Boston 2010 54
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
21-July-2010 Open Group Boston 2010 55
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
21-July-2010 Open Group Boston 2010 56