Developing and investing in cDx
tools for Pharma
Peter Jones
Examining the way companion
diagnostics developers and Pharma
companies collaborate
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cDx: What is it?
Is a combination of a targeted therapeutic, a specific Dx and a defined patient population
Targeted therapeutics can:
• increases the chances of the drug’s approval
• aid in the streamlining of the drug development process resulting in
•
•
improved patient safety
increase in specificity and sensitivity of both drug and Dx
AKA
• Pharmacogentics
• Pharmcogenomics
• Personalised medicine
• Prognostics
• Theranostics
• Transcriptomics
• Metagenomics
• Patient Stratification
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© NuAge Vision 2014
Email: admin@nuage-vision.com
Web
www.nuage-vision.com
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© NuAge Vision 2014
Change the Model
Shift the emphasis in medicine from reaction to
prevention
Direct the selection of optimal therapy and reduce
trial-and-error prescribing
Help avoid adverse drug reactions
Increase patient adherence to treatment
Improve quality of life
Reveal additional or alternative uses for medicines
and drug candidates
Help control the overall cost of health care
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Drugs Don’t Work for Everyone
Email: admin@nuage-vision.com
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© NuAge Vision 2014
The Burden of Disease and the Changing Task of Medicine
David S. Jones, M.D., Ph.D., Scott H. Podolsky, M.D., and Jeremy A. Greene, M.D., Ph.D.
N Engl J Med 2012; 366:2333-2338June 21, 2012DOI: 10.1056/NEJMp1113569
Email: admin@nuage-vision.com
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© NuAge Vision 2014
Email: admin@nuage-vision.com
Web
www.nuage-vision.com
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+44 (0) 7803 122 583
+44 (0) 7553 040 928
© NuAge Vision 2014
Email: admin@nuage-vision.com
Web
www.nuage-vision.com
Tel:
+44 (0) 7803 122 583
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© NuAge Vision 2014
Technologies
histochemistry
immunohistochemistry
in situ hybridization (fluoroscent ISH and
chromogenic ISH),
polymerase chain reaction (PCR)
next-generation sequencing (NGS)-based
other…..
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• NICE
Must be linked to clinical data and show
sensitivity and well as specificity data
Costing determined as a total i.e. CDx + drug
Evaluation within NICE guidelines
 Medical Technologies Evaluation Programme (MTEP)
 Health Technology Adoption Programme (HTAP)
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FDA
• Ca 165 drugs with a cDx








ALK
BCR/ABL1
BRAF
CFTR
CYBR5R1-4
CYP2B6
CYP2C9,19
CYP2D6 etc etc etc
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The Players









Roche Diagnostics (Ventana Medical Systems)
Qiagen
Abbott Molecular
Agilent (Dako)
Myriad Genetics
bioMérieux
Siemens Healthcare
Thermo Fisher Scientific
Lab 21
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© NuAge Vision 2014
Roche
 Detect epidermal growth factor receptor
(EGFR) gene mutations in non-small cell lung
cancers (NSCLCs), treatment with erlotinib
(Tarceva),
 15 projects to develop cDx tests helping
 41 NCE with companion diagnostic in
pipeline
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Genomic
Profile
Clinical
Profile
Sequence
-Whole genome
-Targeted
- Array’s
Morphology
Presentation
Histology
Imaging
Rna levels
-Arrays
-Specific
Expression
Profile
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Analyte
Profile
Tel:
In vito/vivo analyte
-biomarkers
-antibodies
-proteins
-lipids
-metabolites
-ions
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© NuAge Vision 2014
Melanomer
B-RAFV600E gene
with Dabrafenib
treatment
Genomic
Profile
Clinical
Profile
Expression
Profile
Protein
Profile
Melanomer
B-RAFV600E gene
with Dabrafenib
treatment
Genomic
Profile
Clinical
Profile
Expression
Profile
Protein
Profile
Drug resistance
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Disease Profile
Genomic
Profile
Clinical
Profile
Complete
Classification
Expression
Profile
Protein
Profile