The Perfect Storm: Separation,

changing CRO and

implementing a workflow driven

compound management supply

What you’ll learn

• Challenges of implementing a hybrid

compound management workflow

– Transitioning from legacy systems

– Implementing new workflow

– Meeting timelines

• Opportunities of workflow approach

• Experiences from delivery

Overview

Customer

Problem

Approach

• New company launched as spin out

• Operates across 120 Countries

• Multiple research sites

• Separation

• New systems

• Improved workflow

• COTS Platform

• Integrations

• Enhancements

• Customizations

Key Challenges

Separating physical inventory

• Changing CRO

• Managing dispatch and receipt process

Transition from legacy systems

• Retraining

• Changing expectations

Building new processes

• Project driven workflow

• Tactical workflow with CRO

Separation

• Zoetis Recent spin-out from Pfizer

• Separate compound collection

• Need to clearly designate IP ownership

• Transition from CRO powder store to

another CRO powder store with a fixed

date and financial penalties

Transition from legacy systems

• Legacy systems

– In house built only for inventory tracking

and ordering

– Orders associated with projects so limited

metrics reporting

• Deadlines

– Must be ready for transition from CRO

– Hard system retirement dates

Building new processes

Compound Management

• Powder process

– Dispatch

– Receipt

– Solubilization

• Liquid process

– Ordering

– Stamping

– Dilutions (ARPs)

Assay workflow

• Assay Request

– Screening

– In vivo

– Integrated supply

chain

• Project Cascades

– Progression

– Automation

Tracking demand from project teams & evaluating availability

Assay Planning

Ordering and Delivery

Task management and scheduling

Workflow Requirements

Confidential

Time challenges

Powders

Liquids

Requests

Results

Workflow

2014

Powders live

at new CRO

2015

Legacy

Software Off

Project Phases

Powders

Liquids

Requests

Results

Workflow

BioRails Selection

Commercial Off-The-Shelf platform

• PTO – Assay Requesting

• AP – Assay Planning & Ordering

• DM – Data management

• Inventory – Plate and vial operations

Integration with Biovia

• ELN & Chemreg

Delivery experience

Confidential

Powders

From offsite CRO

• Search

• Evaluate

• Order powder tubes

from CRO

Dispatch & Receive Orders

With Barcode scanner integration

Migration Challenges

• Inaccurate inventory

• Legacy naming conventions (aliases and synonyms)

• Transfer all the physical inventory

from one CRO to another and get

registered in the allotted time

• Coordinating integration

– CRO – wrapping 3rd Party CM Software

– Customer – onsite testing and validation

Assay Workflow

Request Plan Execute Decision

Orders from assay workflow

Local Compound Management

• Tubes

• Racks

• Plates

Racks and Plates

Liquid

Workflow

Workflow Challenges

• Interface to Hamilton robotics

– Leveraged Morphit and web services

– Quick uptake by scientists

• Managing updates and keeping virtual

and real inventory synchronized

• Support for barcoding and physical

transfer

Inventory operations

• Dissolution

• Plate transfers

• Quad mapping

• Stamping

• Dilution series

Assay and Study Request

Compound progression

Requesting

Confidential

Request workflow

• Required careful thought about how to

setup assays

• Review concepts of protocol and assay

• Think differently about the tools and

workflow used to execute assays

– Compound management

– Assay scientists

– Project teams

Requesting results for assays to drive

progression

Experiences

1. Successfully applied an agile approach

to meeting deadlines

2. Realized integrated laboratory

workflows

3. Mutual strong “partnership”

4. Allowed a more strategic approach to

workflow focused on project goals

– Look beyond tactical issues

– Keeps everyone engaged

KPI

Acknowledgements

Website: http://www.edge-ka.com/

The Edge Head Quarters, Guildford, Surrey, UK

Email: info@edge-ka.com Telephone: +44 (0) 2380 411 098

Zoetis team

• Annie Janssen

• Eric Norby

• Daniel Stamp

• John Ott

• David Opdycke

Edge Team • Andrew Lemon • Heiko Webers • Emma Wallace