eln deployment planning, deployment, lessons...

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


•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


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


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


• Chazy, New York

• Andover, Massachusetts

• Pearl River, New York

• Collegeville, Pennsylvania

• Catania, Italy

• Tokyo, Japan

Delivery Organization Model


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


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


• “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


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


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


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


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


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


Pilot


•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


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


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


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


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 ?


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


Scope


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


Design & Communication Model


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


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


GxP


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


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.
