© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) Developing and investing in cDx tools for Pharma Peter Jones Examining the way companion diagnostics developers and Pharma companies collaborate

© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) 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 Webwww.nuage-vision.com Tel:+44 (0) (0) 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

© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) Drugs Don’t Work for Everyone

© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) 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: June 21, 2012DOI: /NEJMp June 21, 2012

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© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) Technologies  histochemistry  immunohistochemistry  in situ hybridization (fluoroscent ISH and chromogenic ISH),  polymerase chain reaction (PCR)  next-generation sequencing (NGS)-based  other…..

© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) 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)

© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) FDA Ca 165 drugs with a cDx  ALK  BCR/ABL1  BRAF  CFTR  CYBR5R1-4  CYP2B6  CYP2C9,19  CYP2D6 etc etc etc

© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) The Players  Roche Diagnostics (Ventana Medical Systems)  Qiagen  Abbott Molecular  Agilent (Dako)  Myriad Genetics  bioMérieux  Siemens Healthcare  Thermo Fisher Scientific  Lab 21

© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) 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

© NuAge Vision Webwww.nuage-vision.com Tel:+44 (0) (0) Genomic Profile Analyte Profile Expression Profile Clinical Profile Sequence -Whole genome -Targeted - Array’s Morphology Presentation Histology Imaging In vito/vivo analyte -biomarkers -antibodies -proteins -lipids -metabolites -ions Rna levels -Arrays -Specific

Genomic Profile Protein Profile Expression Profile Clinical Profile Melanomer B-RAF V600E gene with Dabrafenib treatment

Clinical Profile Genomic Profile Protein Profile Expression Profile Melanomer B-RAF V600E gene with Dabrafenib treatment Drug resistance

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Genomic Profile Protein Profile Expression Profile Clinical Profile Disease Profile Complete Classification