1. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 Developing and investing in cDx tools for Pharma Peter Jones Examining the way companion diagnostics developers and Pharma companies collaborate

2. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 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

3. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928

4. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 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

5. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 Drugs Don’t Work for Everyone

6. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 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/NEJMp1113569June 21, 2012

7. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928

8. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928

9. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 Technologies  histochemistry  immunohistochemistry  in situ hybridization (fluoroscent ISH and chromogenic ISH),  polymerase chain reaction (PCR)  next-generation sequencing (NGS)-based  other…..

10. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 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)

11. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 FDA Ca 165 drugs with a cDx  ALK  BCR/ABL1  BRAF  CFTR  CYBR5R1-4  CYP2B6  CYP2C9,19  CYP2D6 etc etc etc

12. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 The Players  Roche Diagnostics (Ventana Medical Systems)  Qiagen  Abbott Molecular  Agilent (Dako)  Myriad Genetics  bioMérieux  Siemens Healthcare  Thermo Fisher Scientific  Lab 21

13. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 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

14. © NuAge Vision 2014 Email: admin@nuage-vision.comadmin@nuage-vision.com Webwww.nuage-vision.com Tel:+44 (0) 7803 122 583 +44 (0) 7553 040 928 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

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

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

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