Life Science Trends and The Future Role of Laboratory AutomationPeter Grandsard, Ph.D.Amgen R&D

September 20, 2011

For Internal Use Only. Amgen Confidential.

Industry in Crisis

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Paul et al., Nature Reviews Drug Discovery, March 2010

Productivity P in function of WIP = effort, work in progress; p(TS) = probability of technical success; V = value/impact; CT = cycle time; andC = cost

For Internal Use Only. Amgen Confidential.

Innovation – To increase Productivity by modulating the variables of P

(includes target discovery and validation)– To add new therapeutic modalities– To prolong commercial lifetime of therapeutics (e.g.

devices)

Internal R&D and Open Innovation: NOT exclusive

Industry and external research institutes need to collaborate to address the extreme multi-disciplinary challenge of discovery & development of therapeutics

Is there an Innovation Deficit in big Biopharma?

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For Internal Use Only. Amgen Confidential.

Cycle Time, Technical Success, and Impact are more Important than Throughput

Reduced CT increases R&D efficiency Processes within a laboratory Between functions Time-to-Market

P(TS) and V enabled by flexible, bench-top laboratory automation in all areas of R&D Study design trumps „HTS of many singletons‟, resolves

uncertainty and generates actionable output Automation with integrated DOE and informatics

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For Internal Use Only. Amgen Confidential.

Higher R&D Productivity at lower Cost

Flexible, “fit-to-purpose” laboratory automation– Modular functionality: from basic to fully equipped– Equally suited for „rewired‟ big biopharma, start-ups,

the average academic lab, and emerging markets

Consolidation of global management of instrumentation, consumables, and lab services– Driven by Finance and R&D management– Leased or second hand equipment– Performance analysis of equipment (Remote Advisor)– System integration as lab service– Same service level agreement for all global sites

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For Internal Use Only. Amgen Confidential. 6

For Internal Use Only. Amgen Confidential.

Cost Saving Opportunities & Applications

Advanced software architecture that encapsulates: – Control of modular, „plug-and-play‟ hardware– Data capture and management – Work flow management– Vendor-supported standardization of interfaces/formats?

Automation in Operations to reduce COGS, for instance:– Automated stability and release assays– Particle characterization to reduce scrap– Flow synthetic chemistry or continuous processing

Point-of-care analyses

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For Internal Use Only. Amgen Confidential.

Continuous Processing - “Numbering Up” may reduce CT and $

Batch Process: SCALE UP and changing protocol

Promise of Continuous Process: SCALE OUT –or- NUMBER UP and same protocol

For Internal Use Only. Amgen Confidential.

AMG 369 Cyclopropanation

Product is unstable under reaction conditions

GMP production required chromatographic purification

Continuous flow allows chemistry to be performed and quenched quickly, preventing decomposition

For Internal Use Only. Amgen Confidential.

For Internal Use Only. Amgen Confidential.

Value driven Opportunities

Automation in support of discovery of first-in-class therapeutics– Target discovery and validation– Elucidation of new MMOAs

In-vivo preclinical imaging benefiting translational science

Automation and instrumentation in support of new therapeutic modalities– Antibody Drug Conjugates (ADCs), oncolytic viruses

Research targeting a new generation of antibiotics to overcome multi-drug resistant bacterial infections

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For Internal Use Only. Amgen Confidential.

Animal Imaging may Refine Clinical Trial Design

Anatomy Physiology Metabolism MolecularOptical

MRIUS

PET/SPECTCT

(MRI)

Positron Emission Tomography (PET)

Single Photon Emission CT (SPECT)

(Computed Tomography)

(fluorescence, bioluminescence)

For Internal Use Only. Amgen Confidential.

The Quest for First-in-Class!

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Swinney & Anthony, Nature Reviews Drug Discovery, July 2011

• Period 1999 – 2008• 259 approved agents• 75 first-in-class with

new MMOA• 50 sm, 25 biologics• 28 from phenotypic

screening• Only 17 from target-

based approaches

For Internal Use Only. Amgen Confidential.

There are Rewards!

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For Internal Use Only. Amgen Confidential. 14

R&AT focuses on Core Activities

Capacity

Ca

pa

bil

ity /

Co

mp

ete

nce

Competitive Core Core of ExcellenceService

System Integration

Training

Technology Evaluations/Consulting

Prototyping

Signal processing

System Replication

Liquid HandlingCalibration

Testing

Troubleshooting

Maintenance

Outsourcing / Outreach

Protocol/process optimization Local IT

Project ManagementBusiness Analysis

System Specifications

(Agilent, …)

(Agilent, …)(x, y, z)

(Amgen Lab Services)

Software (Agilent, …)

Fit-for-Purpose Design

For Internal Use Only. Amgen Confidential. 15

The R&AT Triangle

R&AT

VendorAcademicInstitution

Validation of ideaRealization of ideaFunding

Concept

Prototype

Nth replicate -Commercialization

InnovationSolution to needTool research

System reproduction and versioningRecycle of resources, addition of application developersValidation of idea/prototype

Product line expansionApplication developmentInnovation

End user