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ELN DeploymentA lifecycle review
Jim King
IDBS User Group Meeting, Budapest
June 25th & 26th, 2009
Objective & Context
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/20092
Objective Communicate the process for a successful ELN
selection, implementation, validation and deployment.
Context Presented from a solution architect,
relationship manager and business strategist perspective
Target Audience Scientific & Business Leadership &
Implementation
Agenda
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/20093
•About Wyeth – Who we are
•Context for project
Introduction to Wyeth
•Research
•Need / Driver
•Pilot
•Partner
•Communication
•Execution
The Process•Pilot
•Production
Lessons Learned
Q & A
About Wyeth Global
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/20094
Mission
We bring to the world pharmaceutical and health care products that improve lives and deliver outstanding value to our customers and shareholders.
Vision
Our vision is to lead the way to a healthier world. By carrying out this vision at every level of our organization, we will be recognized by our employees, customers and shareholders as the best pharmaceutical company in the world, resulting in value for all.
We will achieve this by being accountable for:
Leading the world in innovation through pharmaceutical, biotech and vaccine technologies
Making trust, quality, integrity and excellence hallmarks of the way we do business
Attracting, developing and motivating our people
Continually growing and improving our business
Demonstrating efficiency in how we use resources and make decisions
Wyeth is a global leader in pharmaceuticals, consumer health care products, and animal health care products.
Fast FactsFounded in 1926 under the name American Home Products CorporationHeadquartered in Madison, NJOperating in more than 100 countries47,500 employees worldwide
Major DivisionsWyeth PharmaceuticalsWyeth Consumer HealthcareFort Dodge Animal Health
Wyeth Pharmaceuticals
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/20095
Headquartered in Collegeville, Pennsylvania, U.S.A.
Wyeth Pharmaceuticals has global operations consisting
of:
37 manufacturing facilities
17 countries
markets products in over 60 nations
Geographic Scope - DSM
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/20096
• Chazy, New York
• Andover, Massachusetts
• Pearl River, New York
• Collegeville, Pennsylvania
• Catania, Italy
• Tokyo, Japan
Delivery Organization Model
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/20097
Acco
unt
Man
agem
ent
Team
s
Preclinical
Development -CPD
Preclinical
Development -DSM
Vaccines
Busin
ess A
nalysts
System
s Deve
lopm
ent /
Support
PM
O
Strategy &
Operatio
ns
Business Systems & Processes Business Areas
Shared Services – Common Infrastructure
Discovery
Role – Project Focus
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/20098
Jim King
• Strategy & Operations, Business Systems & Processes
• Discovery, Preclinical Development & Vaccines
• Senior Account Manager, Drug Safety & Metabolism
• Program Manager for ELN initiatives
• Project Manager for Drug Metabolism ELN
ELN Project
• Preclinical Development
• Drug Safety & Metabolism
• Bioanalytical & Drug Metabolism
Project Background
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/20099
• “De-Excelify”, consolidate & manage workflow
• Automate processes for increased efficiencyStarted in 2007 with initial
need to:
• Addresses Excel everywhere issue with control and context as well as replacement workflow.
• Provides process management
Selected ELN as best fit solution
• Existing ELN implementation in Medicinal Chemistry
• Corporate Monolithic StrategyBegan with head to head
against “corporate standard”
• Small scope, @ 30 participants at 3 sites
• Built business casePilot Project
• Began in 2008 and went live in June of 2009
• 3 sites, 170 initial users
• GLP & Non-GLPProduction Rollout
Risks / Motivators
11/3/201810
Regulatory Compliance
Competitive Advantage
Targeted Efficiency Gains
Quality Science Improvements
KPI availability and management
Need for collaboration
Internal and external
Risk Management
IP Protection and Development
Risk of Inaction
ELN Deployment, Jim King for IDBS UGM 6/2009
Business Challenges - Context
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200911
Challenge Response
Multiple Client Management Chains Build shared vision & strategy at the top
IT Lacks a voice / Seat at the table Using an account team approach, amplifying
existing Business partner activity to be more
organized and focused
Client dissatisfaction with delivery history Rationalized portfolio, provided clear focus on
delivery and built trust through execution.
Added client voice in steering committees and
oversight.
Disconnected workflows and systems, no
consistency across areas
Created an umbrella program to address
disconnect and begin tying foundation systems
into a published strategy
Integrated Strategy
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200912
Business Executive Sponsors BSP Executive Sponsor
Steering GroupBusiness Leads BSP Leads
Program Core TeamAll Sub-Team Leads and Business Leads Shared Services/DBA
Support TeamVendor Services
Program ManagementBSP Program MgrBusiness Program Mgr
Lab Data Storage
Integration Architecture Models and Standards P100
Data Acquisition Systems
Program Management OfficePMO Services: Communications, Change Mgmt, Business Process Analysis, Training, Support Operating Model
Process Analysis
Data Models and Standards
Tra
nsa
ctio
nA
cqu
isit
ion
/ A
rch
iva
l
Da
ta S
tra
teg
y
an
d E
AI
ELN Program
Modeling
LIMS Consolidation Program
ELN Project ELN ProjectLIMS ProjectLIMS Project LIMS Project
Integration
Project Server
R&D Common Data Architecture
Pro
gra
m M
an
ag
emen
tO
ver
sig
ht
ELN Project
Process Overview
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200913
Research Robust understanding of business opportunities and requirements is critical and the foundation for all other
activities
Partner Identify key sponsors and supporters at all levels Identify potential detractors and actively work to understand their position and bring them into the team
Communicate Socialize the ideas, vet the approach, involve Science / QA / IT Ongoing activity
Execute
Researc
h
Partner
Communicate
Execute
Research
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200914
Build your business case early
Why an ELN?
What are you trying to solve / improve?
What will change?
Will I save money, time, improve quality? Do any of these
matter to me? (Business Drivers)
Why the ELN you are looking at?
Develop and verify Strong Requirements
Rese
arc
h
Partner
Communicate
Execute
Mapping the Processes
11/3/201815
Interactions between business units.
Collaboration across
organizational boundaries
Regulatory Compliance
ELN Deployment, Jim King for IDBS UGM 6/2009
Building the Business CaseNote: This slide illustrates a simplified view of observed lab processes
Scientist Enters experiment data into Paper lab notebook
Supervisor requests notebook for review
Scientist opens 2nd
notebook to continue working, cross referencing
to first
Notebook requested for Audit
Scientist opens 3rd notebook to continue working, cross referencing to previous 2
Scientist B Enters experiment data into Paper lab notebook
Scientist cross references experiment in associates notebook
Scientist B opens 2nd
notebook to continue working, cross referencing to first
Manager accumulates notebooks to review, and manually sign
Scientist begin to accumulate notebooks
locally to reference past work
Notebooks are sent offsite for
scanning and archiving
Data not put into Paper notebook is stored in physical study file
Microfiche copies of notebooks are stored
Scientist review Microfiche to identify what notebooks
might need pulled for review
Notebooks are returned to Scientist for review as
needed
Lost notebook impacts entire web of references
Potential FDA Auditors must review all linked / referenced notebooks, dramatically increasing potential for findings across multiple notebooks
1
Research across life of experiment now spans many physical notebooks, increasing risk of errors and compliance while significantly increasing complexity of information retrieval 11/3/201816 ELN Deployment, Jim King for IDBS UGM 6/2009
Simplification through an ELN
ELN
Scientist A enters data into ELNSupervisor gets
automated notification to review active notebook
Auditors log into ELN with restricted account that allows them access only to relevant records to review
Scientist B enters data into ELN, referencing associates experiments as needed within the ELN
11/3/201817 ELN Deployment, Jim King for IDBS UGM 6/2009
Process for Selection / Deployment
Selection process
Research, including the Atrium Report (IDBS was ranked in top 3 across
the board)
Real world installations & customer validation
Workshops > Pilot implementation
Demonstrated Results
Deployment Process
Prioritized with LIMS initiative
3 Sites initially in scope, all US based
Collegeville, Andover & Pearl River
Workshop based requirements
Business led build teams
11/3/201818 ELN Deployment, Jim King for IDBS UGM 6/2009
Pilot
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200919
•Ensure you have a strong relationship with your sponsors and key stake holders and build a team around them.
•Understand the space you are working in, rarely is there a once size fits all
•Create a clear and measurable objective / defined end state
•Strong business requirements are critical before proceeding to a technology selection
Business Problem Definition / Requirements
•Understand the parameters you have to work within, but do not sacrifice scientific need for technologic expediency.
• Set as a goal to maximize interoperability and standards complianceTechnology Selection
•Develop relationships with vendors early on.
•A vendor confident in the product and the claims made will be willing to co-invest in a strong evaluation
Vendor Selection
•Revisit the objectives. Ensure they are achievable.
•Set clear metrics and communicate the objectives to the team. Wherever possible, make the team a part of the objective setting exercise.
Scope & Objectives
• Stick to the defined scope
• Check your requirements with a focus on the key / critical ones
• Check your metrics against expectations and vendor claims
• Publish the results, socialize the summary report and use it to build momentum. Make pilot participants allies for the next phase.
Execution & Wrap Up
Partner
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200920
Identify executive sponsors
Ideally, the project is driven out of the gate by a key executive.
Make them a part of the discussion, give them ownership.
Build a team that represents key areas
Science
Quality
IT
Rese
arc
h
Partner
Communicate
Execute
Understanding the Information Layer
11/3/201821
Need for information at
varying levels of detail.
Need for information
sharing at varying levels
Internal to Business unit
Internal to Company
External
Variable role of ELN in
the information
management process
ELN Deployment, Jim King for IDBS UGM 6/2009
Summary Data
Reports
Results Data
Compiled Data
Raw Data
Concept Source: CHA Presentation,
Tox Web conference 3/31/2005
Store
Generate
Generate /
Store
Store /
Generate
Source
Communicate
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200922
Form working teams early
Meet Regularly
Empower key people to lead to the over all plan
Use Steering committee meetings to proactively inform
key individuals of progress and request assistance
Should be follow up to private dialogs
Rese
arc
h
Partner
Communicate
Execute
Type Received From Sent To When How
Task status Project team members Project manager As tasks are updated project server
Project status Project manager Sponsor Montly Teleconference
Identification of an issue Any team member Project manager weekly team meetings verbal and email on occurrence
Resolution of an issue Any team member Project manager weekly team meetings verbal and email on occurrence
Status of a deliverable Owner (see Responsibility Matrix) Whoever needs status (Responsibility Matrix) weekly team meetings email & weekly meeting update
Requests for changes or
additional work
Requestor Project manager Weekly team meetings & on
occurrence
Scope change document
Identification of a risk event Any team member Project manager weekly team meetings unless high
priority
email & weekly meeting update
Change in resources Resource manager Project manager As far in advance as possible verbal and email on occurrence
Project #: 45
Date: 9/22/2008 Last update
Communication Plan
Project Name: DM ELN
Project Manager: Jim King
Execution
Create and Gain approval on Strategic plan
ELN is not a once and done application
Sustained commitment and oversight is needed to be
successful
Rese
arc
h
Partner
Communicate
Execute
11/3/201823 ELN Deployment, Jim King for IDBS UGM 6/2009
Best-in-class Strategy for ELNs
11/3/201824
The unique needs of the
various scientific disciplines
across Wyeth R&D requires
that more than one vendor
product be considered and/or
implemented during early
adoption of ELNs.
BSP Research proposed a
“short-list” strategy, limiting
the number of ELN products
to 3 or 4 best-in-class
products for consideration
across Wyeth R&D
Today, there are a small
number of major ELN
suppliers, covering different
areas of the market.
Chemical and
Pharmaceutical
Development
Discovery Research Drug Safety and
Metabolism
Analytical and Quality Sciences
Bioprocess Development
Chemical Development
Pharmaceutical Development
Biological Technologies
Translational Medicine
Chemical and Screening Sciences
Biotransformation
Bioanalytical
Drug Safety
Vendor C
Vendor A
Vendor A
Vendor B or Vendor
A ?
None
Required ?
Vaccines
Early Phase Programs
Late Phase Programs
Vendor A ?
ELN Deployment, Jim King for IDBS UGM 6/2009
Intersecting Capabilities
11/3/201825
There is overlapping
functionality across Lab
Systems, specifically what
can/will be in done in an
ELN and a LIMS
Many of the functionality
gaps in the current Lab
Systems landscape can
either be addressed through
upgrading our LIMS, or by
implementing an ELN
Unstructured Structured
Automated
Manual
ELN
LIMSAddresses structured data management and limited data analysis
Workflow Automation ProjectsAddresses limited scope, one off int
E-WorkBook BioBook
Da
ta A
na
lysis –
Ga
p in
LIM
S
ELN Deployment, Jim King for IDBS UGM 6/2009
Scope
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200926
170 Users, 3 Sites, 2 Groups
Bioanalytical Collegeville
BA Chromatography - Small Molecule
Andover
Ligand Binding – Large Molecule
Pearl River
Ligand Binding – Large Molecule
Chromatography (Small Molecule)
BA PK Group (GLP PK)
Drug Metabolism Collegeville / Andover
Discovery PK
Collegeville
Mass Spec
Exploratory Metabolism
Development
Implementing an ELN
11/3/201827
What and Why
Focus on Drug Safety and Metabolism area
E-Workbook and BioBook from IDBS
Used to replace traditional paper notebooks as primary
evidence of experiment and patent defense.
Used as “Organizing Principle” for laboratory information
management
Significantly increase efficiency in targeted areas
Decrease compliance risk
Enhance collaboration & Integration
ELN Deployment, Jim King for IDBS UGM 6/2009
Design & Communication Model
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200928
Shared Assets GLP
Regulated
Ca
talo
g -
Dic
tion
ary
Se
cu
rity &
Hie
rarc
hy
Stru
ctu
re T
em
pla
tes
Forms
Content TemplatesQuick Text, Boiler Plate Text Box, etc …
BioBook Spreadsheets
Structure TemplatesExperiment Templates including content
Forms
Content
Templates
BioBook
Spreadsheets
Structure
TemplatesBioBook Module
E-Workbook FrameworkShared
Assets GLP
Regulated
Ca
talo
g -
Dic
tion
ary
Se
cu
rity &
Hie
rarc
hy
Stru
ctu
re T
em
pla
tes
Forms
Content TemplatesQuick Text, Boiler Plate Text Box, etc …
BioBook Spreadsheets
Structure TemplatesExperiment Templates including content
Forms
Content
Templates
BioBook
Spreadsheets
Structure
TemplatesBioBook Module
E-Workbook Framework
Project Timeline – High Level
11/3/201829 ELN Deployment, Jim King for IDBS UGM 6/2009
20092008 2010
Discover
Analyze
Design
Develop
Validate/Test
Deploy
Initiation $$
50%SD
BA
Tester
75%
60 –
100%
26 –
59%1 – 25%
Pro
ject A
ctiv
ities
Reso
urc
es
10%Support
Pla
nn
ing
Exe
cu
tion
Clo
se
ou
t
PM
Closeout
100%
100%
Go Live - Implementation
June July August September
1 8 15 22 29 6 13 20 27 3 10 17 24 31 7 14 21 28
Dru
g M
eta
bo
lism
Dev MS & Discovery Bioanalytical
Disc Mass Spec / EXM
Insilco, DM Bio-Resources
Development Metabolism 1&2
Bio
an
aly
tica
l
Andover
CVL / PRL Small Molecule
PRL GLP & Non GLP
Training
BA Small Molecule (PR & COL) 6/12
BA Lg Molecule / PK / BioResources (PR)
6/30
BA Lg Molecule (And) 7/2
Valid
atio
n
Com
ple
te
Go -
Liv
e
Regulated UseNon-Regulate Use
Paper NB Closed OutNo New Paper Study / Experiment
11/3/201830
Applying Lessons Learned
11/3/201831
Partnership is critical to success
Client
Vendor
Integration points & opportunities clearly defined
Will impact business value
Harmonization - Process & Documents
Performance Metrics
Define early
Measure
pre, mid, post
Report
ELN Deployment, Jim King for IDBS UGM 6/2009
GxP
11/3/2018ELN Deployment, Jim King for IDBS UGM 6/200932
Involve validation teams and QA / QC from the very
beginning
Develop Complete and Clear requirements
Test requirements against workshops and update as
needed
Work with ELN vendor for any validation accelerator
packs
IDBS has opportunity here to improve offerings and packaging
Future State – Where to go
Evolve and Grow Partnership model, transition control to
a Scientific Governance group
Make sure it is clear how systems deployed support the
strategic vision and foster collaboration.
Robust process definition and workflow optimization is
an ongoing effort – make it a part of the “way of doing
business”
Build in growth and integration as a part of the regular
budget
11/3/201833 ELN Deployment, Jim King for IDBS UGM 6/2009
Final Take Away Points
11/3/201834
Business partnership is critical to success
Strategic alignment is not enough, a seat at the table and a
leadership role is imperative.
Flexibility and adaptability are the gold standard for
systems architecture and data integration
The technology is the last concern. The business strategy
is the primary concern.
ELN Deployment, Jim King for IDBS UGM 6/2009