Custom Laboratory Servicesfor Biomarkers, Esoteric Analysis and

Early Stage Studies

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LabConnect Overview• Global laboratory services

organization supporting studies across six continents

• Central laboratory services– Worldwide testing for clinical

studies– Project and data

management– Supplies and logistics

• Specialized laboratory services

– Leverage network to design solutions to match client needs

– Focus on specialized analysis and external R&D project management

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LabConnect Overview• Global network of

laboratories– Geographic coverage– Analytical capabilities

• Approximately 340 contracted studies since company’s inception in late 2002.

• 80-90 new projects per year.

• Diverse client base• Customized service

solutions• Comprehensive Laboratory

Project Management • Client Service/Follow

Up/Flexibility 3

Specialized Services Support

• Combines Scientific project management expertise with LabConnect network and infrastructure

• R&D and preclinical project management– Biomarker discovery – Full range of analytical platforms to support hypothesis

vetting– Assay development

• Early stage project support– Laboratory services project management– Custom collection and transport supplies– Logistics oversight– Site training materials and site support– Specimen processing and analysis– Specimen tracking

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Specialized Services MenuAssay

Development and Validation

Scientific Project Management

Sample Storage

Sample TrackingClinical trial

Project Management

Specialized and Exploratory

Analysis

Custom Supplies

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Client Challenges

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• Biomarker scientific support – Current staff stretched thin, hiring freeze– Academic collaborations difficult to manage– Difficulty coordinating with multiple different commercial

labs for preclinical R&D• Clinical trial specimen management

– No central lab, sites were shipping all over– Lots of complex sample collections– No monitoring of samples– Difficulty reconciling conflicting “sample trackers”

maintained by individuals• Early stage study support

– Services of current central laboratory provider not a good fit for early stage project requirements

– Need “go-to” lab services support team

Scientific Support

• Project Management– Academic institutions– Commercial laboratories & vendors

• Participates in study design and contract outlines• Maintaining contact with participating vendors• Responsible for daily/weekly project feedback: liaison between vendor

and sponsor groups

• Examples of projects:– Serum screening of RBM protein profiles in clinical samples to

identify new biomarkers– Analysis of SNP profiles in cytokine promoters in clinical cohorts to

determine which SNPs can serve as biomarkers (predictive)– Analysis of PTM profiles in cytokines of interest

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Technical capabilities

• Tissue Culture, bioactivity assays, most in vitro applications

• Immunoassays, neutralization assays, and ELISAs

• Immunology assays, ELISPOT• Flow Cytometry approaches (both

high specialized and routine)• Cytogenetics: FISH and Karyotyping• Genetics: Mutation analysis,

Sequencing, Microarray Analysis, SNP, splice variant analysis

• Mass spectroscopy• Western Blot, 2D gel analysis• Circulating Tumor Cell Analysis• Immunohistochemistry• Protein purification and

characterization• Antibody purification and

characterization

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Operational and Logistics Support• Developed sample tracker (multiple sites,

samples)• Provide reports regarding samples

(missing, shipped, received)• Developed forecast tool to monitor

samples not collected.• Developed automated sample tracking

tools (digital pen) for use within a study.

Sample tracking

• Developed standardized documentation for biomarker teams

• Assist with Biomarker study set up (protocol, manuals, collection, kits)

• Reconcile and/or update sample tracking information with other documentation (eCRF, result files, manifests, freezer inventories).

Documentation

• Web based training for biomarkers sample collection/processing and digital pen installation and use

• Provided study specific training materials for sample collections (manuals, flow charts, and leaflets).

• Work with scientific groups and vendor labs to verify study logistics and details

Training

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Custom Collection/Transport Supplies

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Custom Collection/Transport Supplies

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Current challenges in sample tracking

• Increase in esoteric testing requires more detailed sample management– Personalized medicine increases the need to look at samples during

the study and not at the end of the study.– Requires the knowledge of “where are my samples?”

• Difficult to get comprehensive sample reconciliation during on-going clinical trial– Sample tracking is often done manually by clinical operations group,

requires extra man hours and results in higher error rate• Limited visibility at sites

– Specimens can sit at sites for extended periods– No visibility until samples are shipped/received at a lab– Difficult to catch problems at a resolvable stage

• Hard to monitor sample quality– Sample collection/processing more intricate than safety sample

preparation.– No verification that sample was processed correctly until it is too

late• Difficult to identify samples in system based on clinical criteria• Result data is not associated with Subject/Sample information.

– Often done manually using different lists from different sources.12

There are gaps in current sample tracking systems

Sites Central lab

Lab 3

Lab 1

Lab 2Client or storage

Samples are not monitored until they are

received at a lab or by the client.

Labs (academia or specialized labs) frequently

do not have automated sample management

capabilities

Difficult to reconcile multiple outputs from

different locations. Increased error rate.

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LabConnect sample tracking system

Sites LabConnect

Lab 3

Lab 1

Lab 2Client or storage

Digital pen technology and data integration tools allows instant access to sample information and comprehensive real time

sample tracking.

Database

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Digital pen technology allows increased visibility without

changing behavior

Site personnel

Sample Collection

Site documentation

Sample stored, batched

shipped later

Sample shipped

1 2 3Lab receives

sample and enters into LIMS

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Digital pen captures site documentation instantly,

importing to database15

Case study: Sample tracking solution for large pharma company

Sites

Lab5

Lab4

Lab3

Lab2

Lab1

Client lab

Client storage

Sample types:Tumor

Cell pelletSkinCTCHair

BloodSerum

Plasma- 16 aliquots

Samples being tracked manually, by multiple people Data was inconsistent, full of errors, not complete

Samples were unaccounted for Difficult to determine number of missing samples

Difficult to determine what samples are available for analysis 16

LabConnect System Benefits

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• Real time tracking, starting at the time of collection• Instant accessioning • Better control on shipping logistics• Fast identification and correction of queries/issues• Multiple user web access (smart phone application

available)• Customizable reports• Solid chain of custody • Yields documented quality sample management and

saves time• Easy access to sample availability and information

for research and analysis determinations

www.labconnectllc.com