ChemBio 2013, Messukeskus

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1 Roche Personalised Healthcare - The Future has Arrived ChemBio 2013, Messukeskus GM, Dr Wolfram Schmidt and Dr Klaus Tamminen Diagnostics PERSONALISED HEALTHCARE Pharmaceuticals Affordable Innovation

2 Roche: A Global Leader in Personalised Healthcare Founded 1896 in Basel, Switzerland Founding families still hold majority stake Employing 82,000 people Global company represented in 150 countries Sales 2012: ~ $ 48 billion R&D Investment: >$ 9 bn World s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS Leadership in pharmaceuticals (#5)* Leadership in in vitro diagnostics (#1) and pioneer in diabetes management PERSONALISED HEALTHCARE Mission * Source: Decision Resources, Q3/2011

3 Personalised Healthcare (PHC) A Requirement Fitting the Treatment to Patients Healthcare Pressures: Benefit-Risk Ratio Economic Pressures: Benefit-Cost Ratio New Technologies: Expanded Capabilities Need for highly differentiated medicines that impact positively public health

4 Personalised Healthcare versus standard treatment Patients with same syndrome Standard Treatment: One-size-fits-all approach

5 Roche: Personalised Healthcare Tailor Made Solutions by Combining Pharma & Diagnostics Research Diagnostics Pharmaceuticals Combined Expertise: Diagnostics & Pharma Tailor Made Solutions = Affordable Innovation

6 Personalised Healthcare versus standard treatment Group of patients with the same syndrome Tailor Made Solutions

7 Personalised Healthcare benefits all stakeholders in healthcare Patients Best treatment at the right time Physicians & Providers Maximum benefit Minimum toxicity Payers & Reimbursers Efficient use of healthcare budgets PHC Regulators & Policy Makers Increased efficacy & safety

8 Personalised Healthcare: Collaboration Network Comprehensive Cancer Center National Biobank Patient Registries Academia & Clinics CollaborationNetwor k Industry & Private Patient Databases ehealth Program

9 Personalised Healthcare Benefits as seen by a patient The option of targeted treatment gave me hope and a better quality of life! Doretha Dee Burrell Philadelphia, USA (For full information see PHC brochure, page 32) Roche s Personalised Healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.

10 Personalised Healthcare Benefits as seen by scientist Combining diagnostic high-tech and cancer research under one roof this generates ideal conditions to translate science into efficient, targeted treatments for patients! Dr Suzana Vega Harring Head of Exploratory Pathology Translational Research Sciences, Penzberg, Germany (For full information see PHC brochure, page 36)

11 Personalised Healthcare Benefits as seen by experts The most effective way to save costs in Health Care today is to focus the therapy on those patients who really benefit. This is more and more possible with new diagnostics and new therapies. Dr, Jonathan K.C. Knowles FiDiPro Professor FIMM, Institute for Molecular Medicine Finland

12 Personalized Healthcare The Future Has Arrived Molekulaarisen tason tietämys sairauksista kasvaa valtavasti; esim DNA vauriot / geenimutaatiot syövässä ja muutokset solujen signaloinnissa

13 Globaali syöpägenomi projekti: tavoittena löytää kaikki ne mutaatiot, jotka aiheuttavat 50 tavallisinta syöpää - noin 350 eri geeniä osallisena syövän synnyssä.

14 Collaborations between Roche Diagnostics & Roche Pharma Majority of PHC activities are R&D collaborations June 2012 > 200 Total Roche PHC Collaborations 44 drug/test combo projects (out of 71 NMEs) in clinical development phases I III Disease Areas PHC Phase Oncology Virology Inflammation Metabolic CNS Multiple Testing hypothesis Confirming hypothesis Generating hypothesis other * e.g. experimental medicine projects, projects across disease areas, safety related projects

15 Diagnostics Organized around lifecycle teams to drive excellence in innovation Life Sciences In Vitro Diagnostics Applied Science Molecular Diagnostics Professional Diagnostics Tissue Diagnostics Diabetes Care* Academia/Pharma Molecular Lab Central Lab Doc. Office, Wards Pathology Lab Patient Biochemicals/IB Blood Screening SWA High/Mid Volume Platforms Workflow & IT Advanced Staining Assays Single Strip bgm qpcr/napi Genomics & Oncology SWA Low Volume Platforms Hospital POC Advanced Staining Platforms Integrated bgm Arrays HPV & Microbiology Clin Chem, ID, Onco, Endo Ambulatory Care Primary Staining Lancing Systems Sequencing Cellular NewGen Virology Cardio-Renal, Crit. Care & WH Specialty Testing Advanced Workflow Insulin Delivery Systems Insulin Delivery * Not organized by lifecycle teams

16 Personalised Healthcare The Future Has Arrived On tärkeämpää tietää minkälaisella ihmisellä on sairaus, kuin mikä sairaus ihmisellä on. Molekyylibiologiset tieteet; genetiikka, genomiikka ja proteomiikka - esim DNA vauriot / geenimutaatiot syövässä, molekyylibiologinen ymmärrys sairauden mekanismeista ja aiheuttajista - Parantunut diagnostiikka ja perustietämys sairauden alatyypistä, - esim olemassa yli 250 eri syöpää, jotka myöskin itsenäisiä tyypiltään ja muuntautuvia sairauden aikana. Taustalla kuitenkin aina karsinogeenien aiheuttama vaurio DNAssa Esimerkkejä: ihosyövässä : BRAF ja MEK, Rintasyövässä:BRCA1 ja 2, ErbB Keuhkosyövässä: esim. Adenokarsinoomat jaetaan kolmeen ryhmään: EGRF mutaatio positiiviset, ALK-fuusiogeeni positiiviset ja muut. - Tuumoreiden morfologinen muuttuminen hoidon aikana. (esim keuhkosyövässä PIK3 CA) - Yhden mutaation testaus vs. tieto koko signaaliketjun toiminnasta - Jotta syövän voi hoitaa, genetiikka sairauden takana pitää ymmärtää ensin.

17 Signaling pathways activated by HER2 (Human Epidermal Growth Factor Receptor 2) also known as Neu, ErbB-2, CD340 include: mitogen-activated protein kinase (MAPK) phosphoinositide 3-kinase (PI3K/Akt) phospholipase C γ protein kinase C (PKC) Signal transducer and activator of transcription (STAT) In summary, signaling through the ErbB family of receptors promotes cell proliferation and opposes apoptosis, must be tightly regulated to prevent uncontrolled cell growth from occurring.

18 Personalised Healthcare The Future Has Arrived Potilaan hoitoa voidaan kohdentaa monella eri tavalla: - Tietämys lisääntyy myös miten potilas metaboloi kyseistä lääkettä (esim. Multiplate ADP test) - Lukuisat uudet uudet teknologiat, joilla voidaan diagnosoida, profiloida, tehdä ennusteita jne tai valita hoitoja. Esim verenkiertoon vapautuvat mikrovesikkelit ( cmv) - Rekisterit, osaamiskeskukset ( CCC, FiMM), Instituutit - Biomarkkereiden lukumäärän ja molekyylibiologisen tietämyksen expentiaalinen kasvu Sairauden ymmärtäminen molekulaarisella tasolla lisääntyy tarvitaan parantunutta tiedonhallintaa ja saumatonta verkostoitumista hoitopäätösten tueksi. - biomarkereiden korrelaatio lääkevasteisiin - Esim. Caris Life Sciences Molecular Intelligence

19 Roche as a PHC pioneer Known examples 1998 FDA Approval for trastuzumab monoclonal antibody for HER2 positive breast cancer Development of Herceptin was a joint effort of UCLA's Jonsson Cancer Center and the biotechnology company Genentech, Inc., of South San Francisco Approval for vemurafenib an oral tablet for BRAF-mutation positive melanoma patients 2013 Pertuzumab for first line treatment of BC ( HER2/3) Trastuzumab-Emtansine, (T-DM1 ) a armored antibody for metastatic BC patients who have had previous tratment failures... Many more to come

20 New Medical Entities in product pipeline Progressing Personalised Healthcare pertuzumab Metastatic breast cancer HER-2/3 expression level T-DM1 trastuzumab- emtansine Metastatic breast cancer HER-2 expression level Lebrikizumab Asthma periostin level Mericitabine Hepatitis C HCV viral load, genotype Onartuzumab (MetMAb) Non-small cell lung cancer cmet status Danoprevir Hepatitis C HCV viral load, genotype

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22 Roche Personalised Healthcare

23 Doing now what patients need next