lims eln sharebiotech study diaporama · 2017-06-19 · 1 introduction study background ! objective...

Market study on LIMS and ELN in the Life Science Market SHAREBIOTECH

December 2011

1 INTRODUCTION §  Study background §  Objective of the study §  Methodology

2 ELN & LIMS MARKET §  ELN and LIMS definition §  Market context §  Market size and dynamics

3 FEEDBACK FROM SUPPLIERS §  LIMS and ELN suppliers §  Market segmentation §  Supplier interviews

4 FEEDBACK FROM USERS §  Academic Labs and core facilities §  Biotech/ CRO §  Corporate groups

5 ANALYSIS AND RECOMMENDATION §  Key learnings

from strategy to action PAGE 2

INTRODUCTION- Study background

PAGE 4

Study background

§  The aim of ShareBiotech is to develop knowledge transfer between companies and research centers

-  Strenghten the biotechnology sector within the Atlantic area (Ireland, France, Spain, Portugal)

§  In 2011, ShareBiotech conducted a market survey amongst their members (academic labs and core

facilities, biotech companies and CROs)

-  Aim: identify the technological needs

§  The survey revealed a need in Bioinformatics for data analysis and storage

§  ShareBiotech decided to initiate a survey to understand the current status and practices in Bioinformatics in the Life Science Market

from strategy to action

INTRODUCTION- Objective of the study

PAGE 5

Objective of the study

§  The main objective of the study is to identify the IT quality and data management tools implemented in the Life Science Market ➔  Which tools are implemented and how they are integrated ➔  What are the regulatory and quality constraints ➔  Understand the benefits for implementing such tools

Geography: France

Segment studied: Life Science Research §  Academic laboratories §  Academic core facilities §  Biotech and CROs


INTRODUCTION- Methodology

PAGE 6

MARKET RESEARCH

Web searches, published reports, studies Public and proprietary information

Macro economic data Overview of the market

trends and major players

FIELD BASED RESEARCH

Suppliers Current market situation

& segmentation

Users -  Acad Labs & Core Facilities -  Biotech/CRO

Status on quality and IT tools implementation

Corporate groups

PH

ON

E INTER

VIEW

S

WEB

S

UR

VEY

Expectations and prerequisites



2 ELN & LIMS MARKET §  Definition §  Market context §  Market size and dynamics





ELN & LIMS MARKET- Definition

PAGE 8

Electronic Lab Notebook (ELN)

§  What is an ELN? -  Paperless record of experimental data by connecting scientists, instruments and software in regulated and non-regulated environments - Used to document research, experiments and procedures performed in a laboratory

§  First ELN solution developed in the 1990s

§  2 types of ELN -  Generic

•  Not dedicated to any discipline/application •  Allow enterprise-wide deployment

-  Specific •  Developed for a particular discipline or application •  Allows department-wide deployment

§  Regulatory and legal aspects - ELN are expected to comply with FDA regulations related to software protection -  Often referred to patent prosecution and IP litigation


Structure searching

Publishing

Data mining

Workflow

IP

Chemical purchasing

Health & safety

Compund inventory

Instruments

File storage

Less then 20% of the pharmaceutical companies are equipped with ELN (data OVUM 2011, Atrium, 2010)


PAGE 9

Laboratory Information Management System (LIMS)


§  What is a LIMS? -  Designed to store data -  Useful for operational entities directly in the laboratory -  Samples and samples flow management

§  First LIMS solution appeared in the 1970s and the first commercial solution was launched in 1982

§  2 types of LIMS: -  Commercial solutions -  OpenSource solutions

§  Used for -  Quality control/quality assurance -  Manufacturing -  R&D labs (specifically genomic and genetic labs because LIMS is highly

configurable and scalable) -  Workflow and data tracking support, flexible architecture, and smart data

exchange interfaces

Stock management

Samples

Quality management

Dashboard

Data flow management

Equipment connections

Complaint management

Certificate reports

60 to 65% of the pharmaceutical companies are equipped with LIMS (data OVUM 2011, Atrium, 2010)


PAGE 10

Open source LIMS overview Open source vs commercial solutions


"   Advantages –  Massive flow of ideas & contributions

–  Flexibility

–  Well-defined software perimeter (no need to add expensive modules)

–  Ability to customize

–  Large support base for popular packages

–  “Push it forward” mentality of community

–  Open source LIMS can be free

"   Disadvantages –  Support not guaranteed

–  Unpredictable development cycles

–  FDA validation requirements

–  Many project starts, few reach the objectives, among them, yet few still alive 2 years later (see downloads in sourceforge.net)

"  Definition: Online LIMS allowing experienced users to modulate the software to adapt it to their specific needs and store data on the Cloud

"  Active communities with multiple solutions: –  Bika LIMS (by BikaLab system) –  FreeLIMS (by Labmatica) –  eyeLIMS (by eyeOS)

"  Applications specific to biology –  Structural Genomics

•  HalX

–  Microrarrays/microscopy •  Microarrays data Manager (MADAM, Dana Farber

Canacer Institute) •  Bioarray Software Environment ( Lund University) •  ScreenSaver (Harvard Medical school): HTS Small

molecules and RNAi •  Longhorn Array DB (Stanford) •  OpenLIMS (University Of Cologne)

–  Electrophoresis •  liPAGE

ELN & LIMS MARKET- Market size & dynamics

Analytical Life Science Instrumentation

$40 b

Lab automation

$2,8 b

LIMS, ELN

$440 M

Analytical Science

$37,2 b

PAGE 11

Market size Analytical Life Science Instrumentation


Source: Strategic Direction Inc, Instrument Business Outlook- Jan 2011

Volume (M$,

2010)

Growth rate (%)

Liquid handling 1208,4 4,6%

Microplate readers

837,2 6,5%

LIMS, ELN, SIDMS

439,6 4,7%

Robotics 302,4 3,9%

Volume (b$, 2010)

LS instrumenta-on 10,7

Separa-on instrumenta-on 6,9

Surface science 4,9

Molecular spectroscopy 3,7

Spectroscopy 3,2

Mass spectrometry 2,8

Lab equipment 2,6

Lab automa-on 2,8

Characteriza-on 2,2


PAGE 12

"   The ELN market is one of the fastest growing informatics market

–  37M$ in 2005 (Atrium) / Around 80M$ in 2010

–  Expected to grow by 25-30% in the upcoming 3 years

"   The ELN market is dominated by 5 major players (60% of total market)*

–  CambridgeSoft (Perkin)

–  Accelrys (Symyx ELN, Contur EN) (Thermo)

–  Independent •  Velquest

•  Waters

•  IDBS

"   ELN adoption drivers –  Compliance with external regulation

–  IP protection – from a peripheric to a core activity in labs

–  Instrument management ; workflow management and quality control inside the laboratory

*Atrium Research consulting, 2010

Source: Estimation from Atrium Research consulting (2010), «ELN: a global strategic business report » companies and markets.com (2011), « Laboratory informatics guide 2008 Europa Science LTD.

ELN - A fast growing market

World ELN revenues and projections



"   In 2010, the LIMS market was estimated around $380 - $450 M (ChemWare, 2011)

-  90% are generated by pharmaceutical, clinical trials, genomics and life science laboratories, chemical, petrochemical, other product quality/R&D testing

-  10% generated by other sectors

-  Expected to grow by 3-4% in the upcoming years

"   The LIMS market is dominated by a few players - Instrument Manufacturers

•  Perkin (LABWORKS)

•  Abbott (STARLIMS)

•  Thermo (Watson LIMS)

- IT players

•  LabLynx (Elab LIMS) (inc. 2000)

•  LabWare (partner Waters)

•  Labvantage (SQL LIMS & Sapphire LIMS)

•  AT Lab

PAGE 13

0

50

100

150

200

250

300

350

400

450

500

2002 2004 2006 2008 2010 2012 2014 M

$

Years

Source: Estimation from ControlGlobal.com (2009), Chemware (2011), ControlGlobal.com based on ARC Advisory Group report (2009)

LIMS – A steadily growing market

World LIMS revenues and projections


ELN & LIMS MARKET- Market penetration for ELN solution

2010-2015

2005-2010

2000-2005

2000

•  Life Sciences, QA/QC and R&D, Middle & Small Size Companies, Academics

•  Chemical, Academics

•  Life Sciences, QA/QC and R&D, CROs and Middle Size companies

•  Chemical, Middle Size companies

•  Life Sciences, R&D Drug discovery, Pharma

•  Chemical industry

PAGE 14

ELN has been implemented by the industry since 2000 - It is starting to be used in academic research


FEEDBACK FROM SUPPLIERS- LIMS & ELN suppliers

PAGE 16

§ Lab Analytics suppliers

§ Abbott § Perkin Elmer

§  IT players § Labware § Labvantage

.

BROAD RANGE SUPPLIERS

Applications, products

§ Thermo Fisher

§ Sapio Sciences

§ Loc@soft (LIMS.fr)

.

Generic Application

§ Linked to Analytical Tools § GenoLogics

§  IT players § ATLab § AgileBio § Baytek § Biomatters

(Cheesecake) § Stratocore (PPMS)

§ Open-Source § ActivX § OpenLIMS § BioArray Software

Environment

.

Specific Application

§ Specific § Accelrys (Symyx,

Contur) §  IDBS

§ Non Specific § QuattroResearch, § Kinematik, § NoteBook maker § SciLigence § RurO

.

Broad Range of Applications

§ Chem & Biology § ArxSpna § Cheminnovation § Agilab (fr)

§ Biology § Axiope § EZ Quant § ResCentris

§ Chemical § DeltaSoft § DotMatics

.

Niche Applications


LIMS SUPPLIERS ELN SUPPLIERS


PAGE 17

Basic research/ discovery Preclinical Development &

clinical Quality

Chemistry §  Cambridgesoft §  Cheminnovation §  Deltasoft §  Symyx §  Waters

Biology §  ChemInnovation §  ResCentris §  Agilebio §  Stratocore §  CoreLIMS

Animal facilities §  Cheesecake (Biomatters)

Study Management §  iAdvantage §  IDBS (BioBook)

Formulation §  Cambridgesoft §  DigiPharm §  MettlerToledo §  Symyx

Analytical §  LabTronics §  VelQuest

QA/QC §  Labtronics §  VelQuest §  Loc@soft



Abbott

STARLIMS

(123 M$, 2010)

Perkin (LABWORKS)

CambridgeSoft (220M$, 2011)

ArtusLab

(?, 2011)

Labtronics

(ELN, 2011)

GeoSpizza

(LIMS, 2011)

Thermo (WatsonLIMS)

Accelrys

Symyx

(186M$, 2010)

MDL Informations

Systems (2007)

Contur

(13M$, 2011)

InnaPhase

(26M$, 2004)

LMS inc

(11M$, 2003)

The market is crowded and going through M&A



PAGE 19

Targeted market Solu/on type

Supplier LIMS solu/on ELN solu/on Life sciences QA/QC

Life sciences R&D

Food Env Chem Comments Open

source Commercial

Agilebio Labcollector Labcollector ELN

Stratocore PPMS Specific to Core Facilities

Genologics Genologic Illumina configured

labLynx WebLIMS Generic

Labvantage LabVantage LIMS E-notebook Partner Waters,

Oracle, MS…

LabWare Labware LIMS LabWare ELN Waters, IBM

Perkin Elmer LabWorks Accelrys ELN

AbboN STARLIMS StarliMS ELN

Thermo Fisher LIMS Link Partner with

Accelrys, IDBS, Velquest


FEEDBACK FROM SUPPLIERS- LIMS & ELN solutions

PAGE 20

General information

Specificity

Product specifications & characteristics

§  Solution type: LIMS

§  Solution name: LIMS Link/Labtronics

§  Supplier: CambridgeSoft (Perkin Elmer)

§  Website: www.labtronics.com/lims_interfacing.htm

§  Automation of routine manual tasks §  Maintain control needed over sample data management §  Unique graphical configuration process eliminates the need for custom coding or scripting, simplifying implementation §  Security, audit trail and archiving features meet regulatory requirements §  Scalable architecture suits all requirements from single workstation to enterprise wide deployment


§  Type: Commercial

§  Targeted market: Life Science

§  Price estimation: annual fee per user 2000 to 4000€

Users - International

§  Undisclosed


PAGE 21

General information

Specificity



§  Solution name: STARLIMS

§  Supplier: Abbott

§  Website: www.starlims.com

§  Supports complex processes, ensure regulatory compliance and promote collaboration §  Award-winning off-the-shelf LIMS §  Integrated SDMS (Scientific Data Management System) and ELN (Electronic Laboratory Notebook) §  Enhanced laboratory process and data management, for improved data sharing within the laboratory and across the enterprise


§  Type: Commercial solution (100% web based)

§  Targeted market: Lifescience (including quality assurance and control, testing and monitoring, research and development, forensic, and clinical testing)

§  Price estimation: unknown


§  United Kingdom’s National Health Service

§  UK NHS Clinical Genetics Laboratories

§  NAACP

§  US Department of Defense Cyber Crime Center

§  Rutgers University, etc.


PAGE 22

General information

Specificity



§  Solution name: LabWorks LIMS

§  Supplier: Perkin Elmer

§  Website: www.perkinelmer.com/pages/010/labworks/ default.xhtml

§  Ultra-configurable to fit a wide variety of laboratory needs and workflows §  Collect, analyze and report on your processes and products §  High-level throughput and backlog reports, schedules and operational summaries §  Analysis providing highly detailed information about samples and their tests (performance history, comments, special information and documents) §  Industry-focused solutions, or possible to build own solution



§  Targeted market: Life Science (water, process, food,

green)

§  Price estimation: Unknown


§  Undisclosed


PAGE 23

General information

Specificity



§  Solution name: Labcollector

§  Supplier: AgileBio

§  Website: www.labcollector.com

§  Independent modules that can interact with each other §  Each scientist in the lab can manage quickly data and information and make it available to the rest of the lab community §  Intranet support §  Management of samples, storage and tracking of the activity and aliquots (biobanking)





Users – France mainly

§  Deinove

§  INRA - Centre Jouy en Jossas

§  IBCP

§  IFR 128 BioSciences Gerland – Lyon Sud


PAGE 24

General information

Specificity


§  Solution type: Type of LIMS

§  Solution name: PPMS (Pasteur Platform Management System)

§  Supplier: Stratocore

§  Website: http://stratocore.com/

§  Adapted to core facilities: developed from the “inside” of core facilities, by core facility staff, during 8 years §  All features are developed and tested on site to handle the very specific work-flow of core-facilities §  Web-based client interface §  Up to date information on maintenance, problems, and cancellations §  Management administrative documents, incident reporting, service history and maintenance §  Main advantage: scalability



§  Targeted market: Lifescience core facilities

(institutions)



§  Pasteur Institute

§  Curie Institute

§  Génopole

§  Rockefeller Institute


PAGE 25

General information

Specificity


§  Solution type: ELN

§  Solution name: E-Notebook

§  Supplier: CambridgeSoft (Perkin Elmer)

§  Website: www.cambridgesoft.com/software/details/?ds=9

§ Smooth web-based interface with a fully configurable, secure system for organizing the flow of generated information (such as reactions, Microsoft Office documents, spectra and other types of data) §  Possibility to search this data by text, substructure or meta data §  Organization of electronic pages by projects, experiments or any other classification conforming to a specific workflow §  Promote lab productivity and information sharing with procurement and inventory management systems to save time locating chemicals and entering structures §  21 CFR part 11 compliance §  High expertise worldwide leader in ELN solution for the past 20 years §  Advantage to be integrated to some equipment manufactured by Perkin Elmer




§  Price estimation: Annual fee per user: 1000 to 5000€


§  Undisclosed


PAGE 26

General information

Specificity


§  Solution type: LIMS/ELN

§  Solution name: Biobook

§  Supplier: IDBS

§  Website: www.idbs.com/products-and-services/e-workbook-suite/biobook/

§  Manage the entire lifecycle of complex biological experiments and studies §  From set-up and data capture, through analysis and graphing, to report creation, sign-off and publication §  21 CFR Part 11 compliant environment §  Real-time data sharing, analysis and rapid delivery of reports §  BioBook enhances productivity, reduces data transcription errors and protects corporate IP



§  Targeted market: Biology, mostly Pharma



§  Undisclosed


PAGE 27

General information

Specificity



§  Solution name: Contur

§  Supplier: Accelrys (Thermo Fisher)

§  Website: http://accelrys.com/

§  Supports experimental work and defend patents §  Capture, share and protect experimental thoughts, results and observations §  Enables users to insert text, images, analytical data, file attachments, chemical structures and reactions, company specific keywords, etc. §  IP-protection work-flow, featuring digital signatures based on industry standards, reminders and templates that ensure that the relevant information is captured, dated, signed and witnessed


§  Type: Commercial/Open source

§  Targeted market: Small and mi-size R&D organization (Biotech, Chemical, Food and Beverage and Academic Sectors)

§  Price estimation: annual fee per user 720€


§  Undisclosed


PAGE 28

General information

Specificity



§  Solution name: Symyx

§  Supplier: Accelrys (Thermo Fisher)

§  Website: http://accelrys.com/micro/notebook/

§  Allows scientists to plan, execute and analyse experiments while providing data and document transparency to the business §  Supports both regulated and non-regulated environments and both conventional and array-based experimentation §  Applicable to discovery and development functions and supports pharmaceutical, biotechnology, chemical, energy and other customers



§  Targeted market: Application-specific interfaces to

support discovery, process, formulations and analytical

functions



§  Elan Pharmaceuticals

§  Kalexsyn

§  Eli Lilly

§  Pfizer

§  Astrazeneca

FEEDBACK FROM SUPPLIERS- Suppliers interviews


Company ELN/LIMS

Thermo Fisher Both

Perkin Elmer Both

Agilebio Both

Loc@soft* LIMS

Stratocore LIMS

SPC consulting (2 contacts) Both

OVUM (Consulting firm) Both

* Not interviewed, information collected from the website

FEEDBACK FROM SUPPLIERS- Supplier interviews

PAGE 30

§ Industry: big Pharma/Biotech

§ Large budget dedicated to IT solutions

§ Medium-small Pharma, Biotech and Academic account

§ Low to no budget available for IT solutions

§  IT solution needs to be adapted since clients do not always have internal IT department, qualified staff and dedicated budget

§ Clusters: combining Pharma, Biotech and Academic account

§ Variable budget

.

FUNDING CAPACITY

§ R&D

§ Looking for flexible solutions since data, such as protocols, is constantly changing

§ ELN more adapted to R&D

§ Quality

§ Need a non flexible solution since quality involves routine data

§ LIMS more adapted to quality

.

USAGE

➔  Structure type, size, organization and amount of data generated are considered but the data management solution is basically the same before customizing it (different modules)

➔  Web based solutions, such as Contur (Thermo Fisher), Labcollector (Agilebio) and PPMS (Stratocore) are more adapted to academics and small biotechs

.



PAGE 31 from strategy to action

Market trends

"   ELN and LIMS are fast growing markets –  The LIMS market is reaching a consolidation stage: niche suppliers acquired by large and well established

companies

–  The ELN market is still emerging, growing faster in industry than academics/biotechs since it is difficult to implement a solution without qualified resources

–  The pharmaceutical industry has the biggest market share to meet the FDA requirements (such as 21CFR)

"   The market is represented by 3 major suppliers including Perkin Elmer, Thermo Fisher and Abbott –  Perkin Elmer owns 30% of the global LIMS market

–  Small suppliers on niche market (for example: Stratocore (positioned on core facility segment) and AgileBio (flexible solution adapted to academics and small biotechs)

–  The major suppliers are UK and US based (French suppliers offer niche solutions)

–  Academic research is better funded in US and UK allowing a faster adoption of such solutions



Advantages for adopting data management solutions

"  Key benefit for adoption is different between industry and academia –  INCREASE PRODUCTIVITY in industry (Perkin Elmer: +20% by scientist)

–  IP PROTECTION and DATA RECORD in academia

"  Common benefits –  Increase quality, traceability, efficiency

–  Keep the record of successful but also unsuccessful studies (avoid « Redo »)

–  Avoid loss of data (especially in academic labs where turnover is high)

–  Be able to prove data during a publication submission for example (ELN is ISO9001 compliant)

–  Compliance with regulations (ISO9001, 21CFR, etc.)




4 FEEDBACK FROM USERS §  Academic labs & core facilities §  Biotech & CRO §  Corporate groups



FEEDBACK FROM USERS- Overview

PAGE 34

QUALITATIVE STUDY

Status on quality and IT tools implementation


Requirements for external collaboration/outsourcing

Corporate groups

47 WEB SURVEYS (25 questions)

11 PHONE INTERVIEWS (14 questions)

Qualitative feedback from the market

4 PHONE INTERVIEWS (8 questions)

QUANTITATIVE STUDY



FEEDBACK FROM USERS- Overview


Typology of surveyed contacts

Academic lab & core facilities,

61%

Biotechs, 32%

Corporate groups,

6%

Distribution of interviewed and surveyed contacts A total of 62 people were contacted during the study: -  38 academic labs & core facilities -  20 biotechs -  4 corporate groups

0

5

10

15

20

25

30

Geographic distribution

N=62

BIOTECH & CRO 3 INTERVIEWS- 15 WEB SURVEYS


ACADEMIC LABORATORIES & CORE FACILITIES 8 INTERVIEWS- 30 WEB SURVEYS

CORPORATE GROUPS 4 INTERVIEWS

FEEDBACK FROM USERS- Academic Labs & core facilities



INTERVIEWS- N=8 Segments: 5 academic laboratories (100 to 500 FTEs), 3 academic core facilities (10 to 50 FTEs) Positions: 3 quality manager, 1 research engineer, 1 group leader, 1 lab head, 1 technical manager, 1 IT

➔ Most academic labs surveyed also belong to an academic core facility

Number of employees: 13 labs <10 7 labs between 10 and 50 9 labs between 50 and 500 1 lab >500

➔  Main typology of contacts: managers and engineers (Others: quality manager, professor)

N=30 N=30

0

5

10

15

20

25

Academic laboratory Core facilities

0 2 4 6 8

10 12 14



Detailed typology of surveyed contacts

➔ The majority of surveyed contacts are head of core facilities and managers (Quality Manager and Project Manager) (Others: Technical manager, head of bio-informatics, animal facility engineer)

0

2

4

6

8

10

12

14

N=30



Type of quality standards implemented

INTERVIEWS- N=8 Quality system: 5/5 academic labs and 2/3 core facilities have implemented a quality system (for at most 2 years) NB: No real full-time quality department in academic laboratories Types of certifications: 1/8 are ISO9001 and 2/8 in progress to adopt ISO9001 and 1/8 to adopt NFS96900

0

5

10

15

20

25

Yes No

➔ 70% (21/30) have implemented a quality system in the past 5 years

0 2 4 6 8

10 12 14 16 18

➔56% (17/30) are ISO9001. It is main the certification in academic labs. (Other: does not know) N=30 N=30



Type of computer data stored

INTERVIEWS- N=8 -  BioBank (records on strain lines and experiment results) -  Stock sequencing data -  Stock administrative documents, protocols, etc.

-  Management of stocks -  Equipment booking schedule

0

5

10

15

20

25

30

(Other: Scientific and experimental data) N=30



Awareness of data management solutions

INTERVIEWS- N=8 LIMS, and specifically ELN, are still early concepts explaining the low adoption

➔ 66% (20/30) surveyed academics are not aware of the LIMS nor the ELN solution

➔ 33% (10/30) have heard of LIMS and/or ELN

N=30

0

5

10

15

20

25

Laboratory management system/LIMS

ELN None



Current LIMS data management system

(Other: Does not know the answer to the question) Solutions: RedMine (open source), GLPI (open source), BASE (commercial)

Current ELN data management system

INTERVIEWS- N=8 -  In house data management system mostly (server back

up, classified folders, etc.) -  LIMS in use: Labcollector (Agilebio)

INTERVIEWS- N=8 -  ELN unknown by most academics, still in the process of

implementing paper laboratory notebook -  More adapted to corporate groups

0

2

4

6

8

10

12

14

Commercial solution

Open source solution

In house solution

None, but planned in short term

None Other 0

5

10

15

20

25

30

Commercial solution


In house solution


None Other

Solutions: undisclosed N=30

N=30



Factors triggering the adoption of a data management system

INTERVIEWS- N=8 -  Limitations of in house data management system -  Reinforce the internal organization -  Avoid wasting of reagents a biological matters

-  Traceability -  Normalization of data -  Data security

0

5

10

15

20

N=30



Factors limiting the adoption of a data management system

INTERVIEWS- N=8 -  Cost -  Complex to implement -  No dedicated team

Other(s): Limited access for employees to access the system, confidentiality management, remote access to data N=30

0

2

4

6

8

10

12

14

No identified need Existing solutions not adapted

Cost/lack of dedicated budget

Lack of available resources

Complex to implement

Workload linked to upgrade

Lack of interest by endusers

(before implementation)

Lack of implication (after implementation)

Other

0

2

4

6

8

10

12

14

16

18

20



Benefits of implementing a data management system

Other(s): No benefits N=30



Peers recommandations

"  Do not set-up solution not suited to your needs because you will end-up not using it. Avoid complicating the system by adding a difficult process. Beforehand, define a clear workplan to adapt the right tools regarding the needs you have

"  The data management system has to simplify the internal organization and functioning of the lab. If it is not the case, it is useless, inefficient and detrimental

"  Make the solution accessible to everyone and make it easy to use directly when the data is generated (avoid the reediting afterwards)

"  The paper laboratory notebook is not practical when offering services using numerous acquisition software, meaning separated and heterogeneous data. The paper notebook can also lead to multiplying the tasks, leaving little time to follow the procedures

"  Need for homogenization for inter-academics collaborations

"  Lack of qualified human resources so need to simplify the data management

"  Need to dedicate time to set-up the solutions, which is not always easy. Laboratory Heads are aware of some prerequisites they need in their labs for data management, so they start dedicating a budget as well as the human resources

"  We need to let researchers do their research and stop hassling them with unrealistic administrative obligations

FEEDBACK FROM USERS- Biotech & CRO



INTERVIEWS- N=3 Segments: 2 CRO, 1 biotech R&D (10 to 50 FTES) Positions: 1 quality manager, 1CEO, 1 research engineer

(Other: very small company)

Companies sizes: 5 companies <10 employees 10 companies between 10 and 50 employees 2 company between 50 and 100 employees

The majority of surveyed contacts were managers (10/17) Others: Technical-regulatory assistant, project leader, R&D pharmacist and CEO

0

2

4

6

8

10

Service company/CRO

Company (SME) Others

N=17 N=17

0

2

4

6

8

10

12



Detailed typology of surveyed contacts

Ø  Considering the size of the companies (SMEs), quality can be managed by CEOs (5/17), followed by quality managers (4/17) Others: In charge of GMP compliance, norms and regulations

0

1

2

3

4

5

6

N=17



Quality system status

INTERVIEWS- N=3 Quality system: 2/3 have implemented a quality system Types of certifications: 0/3 are ISO9001 and 1/3 is in progress to adopt ISO9001➔

➔ 70% (12/17) have implemented a quality system in the past 2 years

0

1

2

3

4

5

6

0

2

4

6

8

10

12

14

Yes No

➔ ISO9001 and GLP are the most common certificationss (Other: GBEA-Guide de bonne exécution des analyses)

N=17 N=17



Type of computer data stored

INTERVIEWS- N=3 -  BioBank (records on strain lines and experiment results) -  Stock sequencing data -  Stock administrative documents, protocols, etc.

-  Management of stocks -  Equipment booking schedule

0 2 4 6 8

10 12 14 16

N=17



Awareness of data management solutions

INTERVIEWS- N=3 LIMS, and especially ELN, are still early concepts explaining the low adoption

0

1

2

3

4

5

6

7

8

9

Laboratory management system/LIMS

ELN None

➔ 8/17 surveyed biotechs are not familiar with the terms LIMS and ELN solution ➔ 5/17 are aware of LIMS ➔ 5/17 are aware of ELN

N=17



Current LIMS data management system Current ELN data management system

INTERVIEWS- N=3 -  In house data management system mostly (server back

up, classified folders, etc.) -  LIMS in use: Labcollector (Agilebio)

INTERVIEWS- N=3 -  ELN known but not used because of its complexity,

currently using paper laboratory notebook -  More adapted to corporate groups

Commercial solutions: Modul-Bio

0

1

2

3

4

5

6

7

Commercial solution


In house solution


None Other

0

2

4

6

8

10

12

Commercial solution


In house solution


None Other

(Other: To comply with 21 CFR part 11, electronic signature is too complicated) N=17



Factors triggering the adoption of a data management system

INTERVIEWS- N=3 -  Limitations of in house data management

system -  Acquire accreditations faster (but not a

prerequisite)

-  Reinforce the internal organization -  Avoid wasting of reagents a biological

matters -  Traceability

-  Normalization of data -  Data security

0

2

4

6

8

10

N=17

0

2

4

6

8

10

12

14

16

No identified need Existing solutions not adapted

Cost/lack of dedicated budget

Lack of available resources

Complex to implement

Workload linked to upgrade

Lack of interest by endusers (before implementation)

Lack of implication (after

implementation)

Other



Factors limiting the adoption of a data management system

INTERVIEWS-N=3 -  Cost -  Lack of budget (not dedicated to IT but R&D) -  Complexity to implement

-  Not prerequisite for working with their clients -  No dedicated team -  No real need (not a “must have” but a “nice to have)

N=17

0

2

4

6

8

10

12



Benefits of implementing a data management system

N=17



Peers recommandations

"  Define a well established, well thought through and process documented workplan in order to obtain a satisfying and sustainable solution

"  Well define need and choose the most adapted solution

"  Solution needs homologation to be recognized by authorities for use in procedures and IP litigation

"  Multiplied data collection processes are time consuming and can become a limitation to adoption by users

"  Access to computer based solutions is difficult in confined areas/laboratories

"  In GLP and GMP environments, integrate the data validation process at the very start of the project (especially when editing the users’ needs) in order to define more easily the risk analysis, validation plan and tests datasheets, else it becomes very difficult to implement

FEEDBACK FROM USERS- Corporate groups


Typology of interviewed contacts

"   4 interviewed contacts

"   2 Pharmas, 1 Agrofood, 1 Cosmetics

Reasons for outsourcing

"   Expertise unavailable in-house

"   Lack of resources

"   Need for innovation -  design of new models

-  new or complementary products

-  widen the offer

"   Budget re-allocation

Company Contact /tle

GSK Director scientific affairs

Sanofi Scientific coordinator - Partnership &

external innovation

Cosmetic leader Outsourcing and partnerships in capillary

products

Danone Regulatory affairs and external affairs



Typology of collaborators Criteria to select collaborators

"   Following closely the workplan

"   Confidentiality management

"   High quality standards for results and deliverables (no need for accreditations)

"   Social ethics of collaborator compliant with the client’s expectations

"   Animal facilities compliant

N=4

0

1

2

3

4

5

Academic lab Core facilities Service providers/CRO

SMEs Corporate groups


"   No specific requirements for any of the interviewed contacts, however the collaborators must deliver: –  High level of confidentiality

–  Data traceability

–  Structured data management system (no preference over commercial or in-house, as long as it is reliable) •  Flexibility and reactivity to meet client’s need

•  No need to implement LIMS/ELN if too complex to use, loss of efficiency

–  No need for ELN if they have paper laboratory notebook

"   Ideally ISO9001, GLP and/or GMP –  Not a prerequisite

–  Must follow the quality standards

"   Standards and regulatory requirements are evolving. Large companies will raise their expectations

PAGE 62

Data management system and quality requirements for collaboration



15,8

13 12,2

9,5 9,1 8,5 7,2 7,1

4,8

0

2

4

6

8

10

12

14

16

18

Entreprise Resources

planning

LIMS Business Intelligence

Clinical trial management

systems

electronic data Capture

Supply Chain management

ELNs Customer Relationship management

Product life management

$100 of IT department are allocated as…

LIMS vs ELN expenditure in Pharma companies


Source: Ovum report 2010.

ANALYSIS & RECOMMENDATION- Key learnings

"   The IT tool solutions (LIMS/ELN) market is expanding –  The ELN market is set to grow strongly as knowledge management becomes a priority

–  Although the LIMS market is mature, new cases are emerging to face specific R&D needs

"   LIMS and ELN can be overlapping, however they have different aims and will most likely stay separate but will need to interface

–  Traditional LIMS handles samples and laboratory automation

–  ELN’s core function is to replace traditional lab notebooks and plays a key role in IP and knowledge management

"   The R&D LIMS and ELN space is crowded and fragmented but a few vendors stand out –  Small players positioned on niche markets are emerging

–  The market place has been M&A activities recently


ANALYSIS & RECOMMENDATION- Key learnings

"   The survey shows that for the Life Science research based organizations (biotech, CRO, core facilities and academic labs)

–  The awareness level for LIMS/ELN is rather low

–  The majority already have in place/will implement short term a quality strategy

"   The segment surveyed have different understanding of quality and are not at the same level –  Academic labs and core facilities have implemented a quality system (60%), but only 30% have accreditation

–  Biotech companies are more advanced with a high proportion (70%) ISO compliant

"   The motivation to implement a quality strategy is different between the segments –  Academic labs and core facilities follow a strategy focused on internal needs

–  Biotech companies are implementing tools in response to external constraints

"   The implementation level for LIMS/ELN is limited –  Solutions not adapted to the needs, too complex to implement, too expensive

–  Large corporate groups are not requesting specific tools because they are considered as too complex and even disruptive


ANALYSIS & RECOMMENDATION- Perspectives

"   For Suppliers –  Develop new products to meet users needs and enhance market entry

–  Create new business model (how to fund initial customer’s implementation cost )

"   For clusters –  Considered in the procurement process by suppliers

–  Involve Lab Managers through awareness and training

–  Connect with LS Corporate groups to assess current and future needs for Biotech companies and CROs

"   For academic labs & core facility –  IT tools knowledge will become a key competency in Corporate recruitment

–  Students need to be properly trained with up-to-date IT tools

"   For Biotech & CRO –  Adequate tools and market pressure are the key drivers for wider implementation

–  Foster close contact twith Corporate groups to keep abreast of IT evolution



Further information

Séverine Tamas-Lhoustau Managing Partner

[email protected] Tel : +33 1 39 30 60 30 Mobile: +33 6 74 49 0248

Jacques Cochard Managing Partner- Tematys

[email protected] Tel : +33 1 53 34 61 42 Mobile: +33 6 89 37 57 88

Dorothée Allard Marketing Consultant

[email protected] Tel : +33 1 39 30 60 43 Mobile: +33 6 10 150 730

Charlotte Lepère-Douard ShareBiotech project Manager

[email protected] Tel : +33 2 40 99 84 80 Mobile: +33 6 89 94 57 63

NOVOPTIM UNIVERSITY OF NANTES

lims eln sharebiotech study diaporama · 2017-06-19 · 1 introduction study background ! objective...

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