Roche, Roche Molecular Diagnostics and more

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1 , Molecular and more [Monte Wetzel, PhD] Patients have questions. We provide answers.

2 Group Clear focus on Healthcare Innovation with two strong pillars Pharma Pharma Genentech Chugai Molecular Professional Tissue Applied Science Diabetes Care 2

3 Group Clear focus on Healthcare Innovation with two strong pillars Pharma Pharma Genentech Chugai Molecular Professional Tissue Sequencing Diabetes Care 3

4 Group Pharma Group - Structure Diversity gred pred Partnering Chugai Global Scale / Reach Pharma Medicines Business Areas Global Functions Regions Diabetes Care Finance, IT, Legal, HR, Communications Cohesion 4

5 worldwide Reykjavik Pleasanton Tucson Madison Branford Branchburg Indianapolis Ponce Burgdorf Mannheim Penzberg Rotkreuz Graz Sites Major R&D/ Manufacturing Other R&D/ Manufacturing 5

6 Group What makes us distinctive Optimally positioned for the future Combined strengths of Pharmaceuticals and Leader in Pharma Leader in Synergies in research, development and marketing Unique global network of alliances Pioneering personalized medicine Early detection Prevention Diagnose Therapy Therapy monitoring 6

7 Organized around lifecycle teams to drive innovation Life Sciences In Vitro Sequencing Molecular Professional Tissue Diabetes Care* Molecular Lab Central Lab Doc. Office, Wards Pathology Lab Patient Academia/Pharma Sequencing Blood Screening Genomics & Oncology SWA High/Mid Volume Platforms SWA Low Volume Platforms Workflow & IT Hospital POC Advanced Staining Assays Advanced Staining Platforms Single Strip bgm Integrated bgm HPV & Microbiology Clin Chem, ID, Onco, Endo Ambulatory Care Primary Staining Lancing Systems NewGen Cardio-Renal, Crit. Care & WH Advanced Workflow Insulin Delivery Systems Virology Specialty Testing qpcr/napi * Not organized by lifecycle teams Biochemicals/IB 7

8 Molecular MOLECULAR DIAGNOSTICS TESTS provide rapid, precise, reliable actionable information to guide treatment for better patient outcome 8

9 RMD: Focused on developing and marketing Molecular Diagnostic tests Pleasanton, CA >800 Employees R&D RMD Headquarters Strategic Marketing Rotkreuz, CH 170 Employees Development RMD Manufacturing Branchburg, NJ 500 Employees Manufacturing 9

10 Molecular : Product portfolio Leading innovation for molecular testing Virology Blood Screening Women s Health Genomics & Oncology Microbiology RMD Assays HIV Hepatitis C, B CMV Multiplex HIV, HCV, HBV West Nile Virus B19V, HAV Human Papillomavirus Chlamydia & Gonorrhea BRAF KRAS EGFR MRSA Sepsis Tuberculosis Herpes Current RMD Platforms COBAS AmpliPrep/ COBAS TaqMan / cobas p 630 cobas s 201 System cobas s 401 System cobas 4800 System cobas 4800 System LightCycler 2.0 / COBAS TaqMan 48 Future RMD Platforms NewGen cobas 4800 System

11 Our goal for Genomics & Oncology Improving therapy selection Personalised Healthcare Biomarker BRAF V600 Initial applications Select metastatic melanoma patients for RG7204 therapy KRAS EGFR PIK3CA Identify colorectal cancer patients appropriate for anti-egfr monoclonal antibody therapies Identify NSCLC patients appropriate for earlier TKI therapy Research collaboration with /Genentech Breast, colorectal & other indications p53 Research collaboration with Merck and Sarcoma, ovarian & other indications 11

12 Demonstrating value through Personalized Healthcare Healthcare Pressures: Benefit-Risk Ratio Economic Pressures: Benefit-Cost Ratio New Technologies: Expanded Capabilities Highly differentiated medicines will positively impact public health Payors will reward innovation 12

13 Companion Diagnostic Tests are Tied Inextricably to Therapeutic Drugs The success of the program is tied to both the drug and the diagnostic test performance Drug approval in the US will require approval of a Companion Diagnostic test (IVD test) Approval of the Companion Diagnostic IVD test will require Clinical Utility data collected in the drug trial(s) In-Phase Development of Both parts IVD approval for a Dx is for a system [sample prep, DNA isolation, RT-PCR reagents and kit, IVD compliant hardware and software, automated algorithms, result analysis and reporting] 13

14 Enabling Personalized Healthcare Provide relevant capabilities to address Pharma needs Pharma Needs Capabilities Full range technologies Tools & Technologies Breadth & depth IVD transferable Incorporation into clinical trials Clinical Expertise Clinical validation Clinical adoption Broadly available commercial test Commercial Presence Installed base Customer access 14

15 IVDs play a central role in PHC Disease screening Risk of developing disease Diagnosis rule-in and rule-out Institute therapy Adjust therapy Stop or change therapy Assess therapeutic effectiveness Assess therapeutic compliance Personalized Medicine (PHC) 15

16 IVDs can play role along the treatment pathway Biomarkers and diagnostics development are key to PHC Healthy Asymptomatic disease Symptomatic disease Chronic disease Risk Assessment Screening/ Diagnosis Prognostic Predictive Monitoring Predisposition for developing disease Early detection Predict probable disease course Predict likely drug response Monitor efficacy/ recurrence Difficult to prove medical value Few markers have acceptable sensitivity or specificity Patient Stratification / Therapy Selection Therapy adaptation 16

17 Biomarker Evaluation Criteria Consider clinical and market factors Key Questions Clinical Utility Degree of Validation Competitive Freedom Pricing Flexibility Is there a clear unmet medical need? Does the marker answer the clinical question? Will the test enable a superior clinical management outcome? Is there a sufficient level of clinical evidence (>100 cases) to support the clinical utility claims? To what extent has the test been accepted by the clinical community? What evidence exists that the test represents novel clinical content? How likely is this test to be the best-in-class? Is there market exclusivity? Can gain commercial access to physicians and patients for this test? What evidence exists that this test can be priced for the value it creates? What potential exists for the test to create savings in the healthcare system? Is pricing likely to be limited due to the presence of competitors?

18 What is being Licensed Patents, applications, know-how Therapeutic agent (protein, small molecule) Long, risky and expensive development Tool technology (e.g. PCR) Broadly useful, many fields, encourage access Therapeutic target Biomarker Diagnostic application Disease identification or confirmation Predictor of outcome - theranostics

19 How PHC Biomarkers are Licensed Knowledge mobilization Financials Consider fitness for purpose how well is it characterized for its intended purpose: what remains, what risks Who best can make this determination Value: How to optimize to licensor, licensee and patients/medical community Exclusivity Who best can develop and distribute: value, dissemination Interfacing the therapeutic and diagnostic is critical Diligence standards Who best can develop and distribute: what are the motivations Clinical trials (access to medical community and resources), endpoints, regulatory submissions (experience), manufacturing, distribution and marketing capabilities (worldwide)

20 Partnering with Molecular (RMD) understands that pivotal early data and intellectual property that govern the next generation IVDs are often available. We have created the following decision tree to help guide tech transfer professionals toward the opportunities we seek. We hope that the community finds this useful, and thinks of first as their partner of choice to develop and commercialize diagnostics Technology Disclosure Flowchart: In Vitro Assays Does the diagnostic technology specify human cells, tissue or sample? Yes Is either screening, diagnosing, prognosing, therapy predicting or monitoring the diagnostic application of the technology? Yes Is the disease area either infectious diseases, oncology or inflammatory? Yes Does the diagnostic application involve Nucleic Acid Testing (NAT)? Yes High priority for Molecular Send to contact below Tod Bedilion No (e.g. Food) No (e.g. predisposition) No (e.g. CVD) No (e.g. non-nat) Low priority for Interested Send to:

21 Doing now what patients need next 21