Personalized Healthcare Diagnostik und Therapie aus einer Hand

Transcription

1 Personalized Healthcare Diagnostik und Therapie aus einer Hand Priv.-Doz. Dr. med. Christian Meisel DVFA Life Science Conference, 17 June The Challenge Personalised healthcare Roche s unique position Summary 2

2 The healthcare market Market dynamics Unlimited demand Two-thirds of diseases untreatable Existing treatments often inadequate 3 Inadequate treatment Efficacy Safety 80 Drug response rate [%] Analgesics Oncology 20 0 Spear et al., Trends Mol Med, 2001; Lazarou et al., JAMA,

3 The healthcare market Market dynamics Unlimited demand Two-thirds of diseases untreatable Existing treatments often inadequate Limited resources Spiralling costs Budgets increasingly under pressure 5 Limited Resources Increasing pressure on healthcare budgets U.S. Healthcare Spending, US$ Billions U.S. Healthcare Spend as % of GDP % % 16% Source: Centers for Medicare and Medicaid, Office of the Actuary, National Health Statistics Group 6

4 The healthcare market Market dynamics Unlimited demand Two-thirds of diseases untreatable Existing treatments often inadequate Limited resources Spiralling costs Budgets increasingly under pressure 7 The Challenge Personalized healthcare Roche s unique position Summary 8

5 Personalised healthcare An evolving idea, not a brand new one For over 10,000 years Treatment decisions were based on smell, taste, touch In the last 100 years Better understanding of how the body works Today Advances in molecular biology and genetics 9 Personalised Healthcare Increasing demand of stakeholders Patients & Physicians Best treatment Regulators Better efficacy & safety profile Payers Better cost / benefit Industry More competitive 10

6 Biomarker Development Why? Most likely to benefit / most effective treatment Healthy Asymptomatic disease Symptomatic disease Chronic disease cured Risk assessment Screening/ Diagnosis Prognostic Predictive Monitoring Predisposition for developing disease Early detection Predict probable disease course Predict likely response to a drug Monitor efficacy/ recurrence Patient stratification / Therapy selection Therapy adaptation 11 Complexity of Science A biomarker might be more difficult to find than a drug 1 Clinical use 10 s Potentially valuable 100 s Early stage assessment 1000 s biomarkers Exploratory Biomarker = Any biological parameter used as indicator of disease process or drug response 12

7 Biomarker Development What it Takes A plethora of tools, skills and capabilities Samples, Clinical trials, Patient data Highly linked information network Diagnostic skills & Expertise Successful biomarker programs Portfolio of Dx platforms and tools Understanding of molecular biology 13 Biomarker Development Capabilities Significant hurdles Validation Commercialisation Clinician/Lab education Auditing for result consistency Distribution to laboratories Discovery Regulatory test approval Assay refinement & development IVD test Clinical validation of candidate markers using assay Develop prototype assay Identification of candidate markers Generation of a biomarker hypothesis 14

8 Biomarker Development Roche s Distinctiveness Roche s competitive edge is driving PHC in-house and with selected partners Validation Commercialisation Leading IVD company Label defined on launch Established clinician/ Lab network Discovery IVD development expertise Large clinical trial programs with outcomes Clinical sample databank Joint research at molecular biology level Full availability of technological expertise & platforms Open exchange of knowledge & IP 15 Personalised Healthcare Better understanding of molecular biology requires early stage collaboration with Diagnostics Research Development Commercialisation Evolving Diagnostics tools Traditional Diagnostics tools Improved target selection More targeted clinical trials Safer, more efficacious medicine 16

9 The Challenge Personalised healthcare Roche s unique position Summary 17 Personalised healthcare Basis: Understanding molecular biology 18

10 Roche Uniquely Positioned to Drive PHC Two pillars of strength Diagnostics Pharmaceuticals Roche Applied Science Roche Molecular Diagnostics Roche Professional Diagnostics Roche Tissue Diagnostics Roche Diabetes Care Roche Pharma Genentech Chugai Expertise in molecular biology and technologies 19 PHC is at the core of our organisation Diagnostics input - from discovery to market Target Selection Discovery Research Lead Generation/ Optimisation Phase Exploratory Phase Develop Commercialise Phase 0 Phase I Phase II Phase III Filing PoC Confirmatory Phase Market Phase IV Biomarker development Target identification Companion diagnostic feasibility & attractiveness Patient selection Dx launch/ Post-launch assessment Tailored prescribing & monitoring Research assay Technically validated assay Clinically validated IVD assay 20

11 Collaboration Pharma and Diagnostics Benefits of in-house collaboration Research Development Commercialisation Technically validated Research assay assay Evolving Diagnostics tools Clinically validated IVD assay Unrestricted knowhow and IP exchange Seamless platform transition Flexible pricing drug vs. test 21 Over 800 drugs are in development in oncology Paradigms in Cancer Therapy must change Tumor Site Tumor Histology Molecular Biology Molecular Profile Old Paradigm Toxic, non-selective, chemotherapy drugs Targeted Therapies Wider therapeutic index, derived from molecular biology discoveries of the 80s Future Paradigm Integration of molecular diagnostics with targeted therapies for integrated cancer care22

12 PHC as Key Driver of Change Key to enabling highly differentiated medicines Healthcare Pressures: Benefit-Risk Ratio Economic Pressures: Benefit-Cost Ratio New Technologies: Expanded Capabilities Need for highly differentiated medicines that impact positively public health Payors will reward innovation 23 Molecular Diagnostics in Cancer - The Future is here Unprecedented opportunities to characterize tumors and patient characteristics Testing after extraction Tissue dissection to enrich cancer cells manual Tissue NA extraction Protein extraction semiautomated semiautomated Cancer cells Normal cells H&E stain morphological analysis e.g. MagNA Lyser & MagNA Pure manual Linear DNA or RNA amplification & labeling IHC protein markers FISH/CISH/SISH NA markers Mass spectrometry on tissue DNA mutation RNA expression via microarray RNA expression via multiple RT- PCR or mutation detection RNA expression via multiple RT- PCR or mutation detection Protein expression via microarray Protein expression via IC system microwell plate or microfluidic array AmpliChip LC480 TaqMan IMPACT Elecsys 24

13 Targeting BRAF mutations in cancer One promising early phase example BRAF gene mutations detected in ~7% of all cancers Up to 70% of malignant melanomas Up to 53% of papillary thyroid carcinomas Up to 15% of colorectal tumors Most common mutation by far: V600E in exon 15 ~ 70% melanomas, thyroid and colorectal cancers with mutated BRAF RAF activates the MAPK signaling pathway BRAF can be activated by a single mutation (V600E) J Clin Oncol 23:6771 (2005) M Beeram et al.; Cancer Cell 6:313 (2004) MJ Garnett and R Marais R 7204: Novel small-molecule inhibitor from Plexxikon CoDx need: Taqman PCR-based V600E mutation detection 25 Identifying the cancers that harbor the drug targets Which cancers are likely to respond? Oncologist Surgeon 4 5 BRAF V600E Targeted Positive PLX4032 Therapy 1 Tumor Pathologist V600E Status returned to Oncologist 3 Tumor block FF/FFPET Sections 2 Molecular Testing Center H&E Staining Tissue sections Nucleic acid extraction PCR-based V600E Test 26

14 Roche s unique strategy Driving personalised healthcare High Medical Differentiation Roche Focus Generics Pharma Dia MedTech OTC Focus on our two core businesses Pharma and Dia Leveraging collaboration: - along entire value chain - broad range of technologies Low Premium for Innovation High 27 The Challenge Personalised healthcare Roche s unique position Summary 28

15 We Innovate Healthcare