osthus-allotrope presents "laboratory informatics strategy" at smartlab 2015

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Building your laboratory informatics strategy The benefit of reference architectures & data standardization Wolfgang Colsman, OSTHUS Dana Vanderwall, Bristol-Myers Squibb

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Building your laboratory

informatics strategy

The benefit of reference architectures &

data standardization

Wolfgang Colsman, OSTHUS

Dana Vanderwall, Bristol-Myers Squibb

Slide 2

Abstract

Building your laboratory informatics strategy:

The benefit of reference architectures & data standardization

Modern laboratory processes have to deal with a multitude of

data sources originating from different instruments, systems,

sites and external resources. As a consequence data analytics is

severely limited by incomplete or inconsistent metadata and

different data formats. This complexity leads to inefficient

processes and high costs due to insufficient data integration and

accessibility.

Showing different use cases, we will present a successful data

and systems integration approach using reference architectures

and data standardization, resulting in increased cost efficiency

and improved decision making.

Slide 3

Why?

What should a Reference Architecture look like?

Which Standards to use?

Topics

Slide 4

Why?

Topics

Slide 5

Instrument Instrument

Why:

Example 1

LIMS

Data Mart

Instrument JMP

CRO

CSV Paper

Scripts

Data Cleansing and

Controlled Vocabularies

build into code

PDF

Method Transfer,

Manual Transcription

Data Incomplete,

Formatting, …

Manual Transcription,

Missing Context

Slide 6

Why:

Example 2

LIMS

Request Management

Data Analytics Compound

Logistics

ELN

LIMS Monolith, not best in class

Slide 7

Best of breed did not work in the past because of the lack of

standardization, but do we agree:

1. Everybody should do what he can do best?

2. Anybody should be able to talk to everybody?

Why:

Thesis

Slide 8

Topics

What should a

Reference Architecture

look like?

Slide 9

What should a Reference Architecture look like:

Lab Integration Requirements

ELN

CRO

CMO MDM

IMS

LES

HR

CDS

Data

Archive

Data Mining

Data Mart

SDMS

DMS

LIMS Instrument

Data

Warehouse

Registration

Controlled

Vocabularies

Data

Analytics

Predictive

Modeling

ERP

MES

Departments

Sites

Slide 10

Data Acquisition

Data Analytics Data Management

Master Data Lab Workflow

Collaboration

What should a Reference Architecture look like:

Lab Integration Requirements

ELN MDM CDS

DMS

Instrument

CRO Data

Warehouse

Data Mart

Data Mining

CMO

LIMS

LES

SDMS

Data

Archive

HR

IMS

Controlled

Vocabularies

Data

Analytics

Predictive

Modeling

Manufacturing

ERP

MES

LIMS

Departments

Sites

Registration

Slide 11

Data Acquisition:

CDS / Instrument

Data Analytics:

Data Warehouse / Data Mart / Data Mining / Data Analytics / Predictive Modeling

Data Management:

DMS / SDMS / Data Archive

Ma

ste

r D

ata

:

MD

M /

HR

/ I

MS

/ R

egis

tration /

Contr

. V

ocab

. Lab Workflow & Manufacturing:

ELN / LIMS / LES / MES / ERP

What should a Reference Architecture look like:

Lab Integration Requirements

Collaboration:

CRO / CMO

Slide 12

What should a Reference Architecture look like:

Two Worlds of Workflow

Lab Workflow

Experiment Report

Data Analytics

Data Knowledge

Where is my Data?

Slide 13

Data Analytics

Data Knowledge

Where is my Data?

What should a Reference Architecture look like:

Pain Points

Lab Workflow

Experiment Report

Document Preparation

• Finding data

•Copy/paste

•Transcribe/convert

•Combine multiple sources

Data Management & Archiving

• Searching/Finding data

•Data format conversion

•Data migration

•Maintenance and/or unavailability of legacy systems

Errors

•Manual text entry or transcription

•Manual calculations

•Wrong or missing metadata

•Need to reprocess data

Data Exchange

•Disparate data file formats

•Manual transcriptions

•Added cost & complexity to CROs, CMOs, partnerships

Regulatory Compliance

• Instrument & software validation

• SOPs

• System documentation

• Supporting questions/investigations (CAPA)

Extracting Knowledge & Value from Data

• Speed to answer/decision

•Data silos

•Constrained innovation

• Limited data mining & analytics

Slide 14

What should a Reference Architecture look like:

Root Cause

Lab Workflow

Experiment Report

Data Analytics

Data Knowledge

• Patchwork of software, helper applications, persistent gaps

• Lack of standard data file formats

• Lack of standard software interfaces (APIs)

• Lack of standard for metadata (the who, what, where, when, why, how)

Slide 15

What should a Reference Architecture look like:

Solution

Lab Workflow

Experiment Report

Data Analytics

Data Knowledge

• Open Document Standards

• Reusable Software Components and APIs

• Metadata Repository

Slide 16

Lab Workflow

Data Analytics

Reference Architecture & Data Standards

Data Management

Dashboards Metadata Browser Data Viewer

Plan

Analysis

Prepare

Samples

Submit

Samples

Acquire

Data

Process

Data

Store

Data

Analyze

Data

Reports

Results

Taxonomies Methods Instruments Samples Experiments Results Data

Allotrope Data Format Allotrope Metadata

Taxonomies

Allotrope Class

Libraries and APIs

Forecasting

& Capacity Planning

Request Management

& Tracking

Collaboration

& Distribution

Slide 17

APN webinars and information exchange with specific APN

members:

12 March 2015 APN Partner Led Committee Workshop, New

Orleans, LA

13 March 2015 APN General Meeting & Workshop, New

Orleans, LA

24 April 2015 Cross Industry Workshop, Cambridge, MA

15 Sept 2015 APN Workshop, Chicago, IL

16 Sept 2015 Cross Industry Workshop, Chicago, IL

Next Steps

©2015 Allotrope Foundation

Allotrope Foundation

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• Subject Matter Experts

• Project Funding

Pharmaceutical & Biotechnology

Companies

• Project Management

• Legal & Logistical Support

Secretariat

• Software Development

• Technical Leadership

Professional Software Firm

• Requirements & Specifications

• Contributions, PoC Applications

Partner Network

AbbVie Amgen Baxter Bayer Biogen Idec

Boehringer Ingelheim Bristol-Myers Squibb Eisai Eli Lilly Genentech/Roche

GlaxoSmithKline Merck Pfizer

ACD/Labs

Biovia

BSSN

IDBS

Mettler Toledo

Sartorius

Thermo Scientific

Waters

©2015 Allotrope Foundation

web: www.allotrope.org mail: [email protected]

web: www.osthus.com mail: [email protected]

Sign up to:

Allotrope Partner Network APN: partners.allotrope.org

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