life science trends and the future role of laboratory automation · 2016. 9. 2. · flexible,...
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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