Test Development and Commercialization

The world leader in serving science

Drew Burch

Test Development and CommercializationProviding comprehensive solutions to help you prevail

VP, Strategy and Business DevelopmentLicensing and Commercial Supply

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A Unique Perspective on Diagnostic Test Development

Feeling lost?

We understand your challenges

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The Product Development Trade-Off

Scope

Cost

Time

Quality

Failure to maximize proprietary technology

Delays to market

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What if …

… you hit an obstacle?

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What We All Want

Create the best assays

In the shortest time

Cost effectively

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The Best Solution—Partnership

Leverage the knowledge, capabilities, and technology from an experienced supplier

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Why Choose Thermo Fisher Scientific as Your Partner?

Dedicated test development and contract manufacturing partner

Experience

Vast technological depth and breadth

Integrated and customized solutions

Innovation

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Brands You Can Trust for Diagnostic Test (or Assay) Development

We are a single supplier of these trusted brands to help you accelerateassay development and kit manufacturing.

For Research Use Only. Not for use in diagnostic procedures.

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Immunoassay Toolkit

Capture surface• Coated plates

• Streptavidin

• Thermo Scientific™

NeutrAvidin™ protein

• Invitrogen™ Dynabeads™

reagents

• Invitrogen™ Dynospheres™

microspheres

• Latex beads

1° and 2° antibodies

• Antibodies• Custom antibody

production• Custom conjugation• Invitrogen™ ABfinity™

antibodies• Thermo Scientific™

CaptureSelect™camelid antibodies

Nonspecific binding

• Detergents• PEGylation• Custom blocking buffers• Recombinant BSA• Synthetic blockers (AOF)

Conjugation

• Thermo Scientific™

Pierce™ crosslinkers• Biotinylation• PEGylation• Invitrogen™ SiteClick™

labeling system

Substrates and dyes

• Thermo Scientific™

SuperSignal™ (HRP) substrates

• Invitrogen™ DynaLight™(AP) substrates

• Thermo Scientific™

DyLight™ dyes• Invitrogen™ Alexa

Fluor™ dyes• Invitrogen™ Qdot™

nanocrystal• NBT/BCIP, TMB

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Molecular Diagnostic Toolkit

Run and analysis

3Assay prep

2Sample prep

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• Isolation

• Extraction

• Purification

• Labeling

• Dynabeads™ magnetic beads

• MagMAX™ nucleic acid isolation kits

• Fluorescent labeling dyes

• Assay components

• Applied Biosystems™ sequencing and fragment analysis reagents

• Applied Biosystems™ TaqMan® probes and primers

• Enzymes and master mixes

• Ion Torrent™ prep and sequencing reagents

• PCR/qPCR plastics

• Test execution • Data analysis

• Ion Torrent™ next-generation sequencers

• Applied Biosystems™ Sanger sequencers

• Applied Biosystems™ thermal cyclers and real-time PCR instruments

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Contract and OEM Manufacturing Toolkit

Manufacturing• Diagnostic reagents,

calibrators, controls

• High purity and reagent grade water

• Larger Volume formulation & filling capabilities

• Design & production of IVD instruments including expandable automation solutions for workflow efficiency

Regulatory / Quality

• ISO 13485 Certified• Canadian Medical Device

Regulations• 98/79 EC In-Vitro Diagnostics

Directive• FDA Medical Device IVD

Regulations• Clinical trial support

Technical Capabilities

• Assay development on partner proprietary instruments

• Clinical demand generation team

• Licensing of proprietary assays / IP

• Lyophilization Capabilities

Strategic Alliance Management

• Project management office with dedicated project managers

• Strategic Account management

• Dedicated Key Account Managers

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Global Manufacturing, Support, and Service

• Multiple levels of regulated manufacturing (cGMP, General Purpose Reagents, Research Use Only, Clean room, controlled environment), and advanced Quality Systems: ISO9001, ISO13485

• OEM product development, formulation, aseptic processing, kit assembly, and packaging

• Gain access to enabling technologies

• Decrease time to market

• Lower investments for manufacturing infrastructure

• Tap into Thermo Fisher Scientific’s manufacturing excellence

• Focus on your core expertise

• Consistent product performance

• Planning and logistics

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Our Partnership Examples

“The quality and performance of Applied Biosystems™ master mixes and custom oligos are key for our diagnostic kit development. The Thermo Fisher team provided us with a one-stop solution for the entire process—from assay test design, assay optimization, and kit validation, to partnering on the development of our commercialization strategy”

– Patrick Burke, PhD, Executive VP, Emerging Products, Myriad Genetics

“Adding the Applied Biosystems™ QuantStudio™ 5 Real-Time PCR System to the VERSANT™ kPCR Molecular Solution brings a new level of innovation to the market by providing more flexibility and customization to the molecular laboratory workflow. We are excited to strengthen our dedication to molecular laboratory innovations through our partnership with Thermo Fisher Scientific.”

-- Fernando Beils, Head of Molecular Diagnostics, Siemens Healthineers

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How to Benefit from Being Our Partner

ManufactureLicenseCustomizeSelectEvaluate

• Access to our problem-solving team of professionals, here to assist with all product development hurdles, big and small, all the time

• Supply of customized reagents, tailored to your specific needs

• Set product specifications to reduce product variability

• Confirm commercial rights

The world leader in serving science

For Research Use Only. Not for use in diagnostic procedures.© 2016–2017 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.

TaqMan is a registered trademark of Roche Molecular Systems, Inc., used under permission and license.

Let us know what you need, and we’ll find a solutionthermofisher.com/OEM