Accelerating the Adoption of Companion Diagnostics

Transcription

1 Accelerating the Adoption of Companion Diagnostics

2 Our mission: to improve the lives of all patients afflicted with cancer Our vision: to empower our customers by providing the highest quality, most innovative cancer diagnostic solutions 50+ collaborative agreements with 30+ pharmaceutical partners 200 ongoing biomarker projects 13 years experience in Companion Diagnostics Leading the CDx market with ALK, PD-L1, HER2 and other cutting-edge assays.

3 Development overview CDx development and co-launch strategy Biomarker evaluation Design and develop robust assay with in-house clinical testing on pharmaceutical partner s patient tissue samples Pre-Clinical Phase I Phase II Develop assay kit, scoring algorithm, control slides and training materials Phase III Traditional and accelerated adoption models available Patient Access 3

4 RTD Companion Diagnostics (CDx) We identify and develop innovative predictive diagnostics to target patients more likely to respond to specific therapies Medical value Testing efficiency Partnership Improve risk-benefit ratio in guided treatment. Right test, right patient at the right time. Standardized, fully automated and easy-to-use predictive assays. More availability to labs and patients. Internal & external pharma partners. Development & commercialization. Unmatched experience and global reach. Partner with Roche CDx because assay choice matters. Personalization matters. Experience matters. Reach matters.

5 Traditional launch model* Traditional support yields sales readiness Traditional support 1. Value proposition 2. Interpretation guide 3. Regulatory requirements 4. Communication plan and sales alert 5. Internal sales training 6. Sales brochure 7. Biomarker product page online 8. Poster or abstract Sales readiness Launch 5

6 Global leader in automated tissue staining 9,000+ systems in 55 countries 3,025 3, ,755 Source: Internal business intelligence survey data,

7 Acceleration Agreement Day one readiness and patient access Critical assumptions: Class I assay and platform migration studies 7

8 Rapid adoption Ensure patient access to predictive testing at launch Bridge the gap between traditional and accelerated launches for day one patient access Bridge the communication gap with predictive education, training and engagement with pathologists Bridge the gap to day one patient access by engaging earlier with key opinion leaders (KOLs) and Centers of Excellence (COEs); prepare labs for testing Bridge the medical value gap with medical affairs and marketing support to create an effective value proposition and diagnostic value tools 8

9 Align efforts to accelerate adoption Pharmaceutical rep role Value proposition for therapy targeted to oncologists and patients Diagnostic rep role Value proposition for testing targeted to AP lab leaders and pathologists Oncologist Day one patient access Pathologist Study shows engaged pathologists are key influencers in choice of therapy: Oncologists and pathologists interact during test ordering process and intra-hospital events (e.g. tumor boards) Oncologists and pathologists are synergistically educated to align appropriate patient treatment decisions Pathologists engage oncologists in understanding test interpretation, differentiation factors and the impact on patient outcomes Regulatory conditions in different countries affect the level of autonomy a physician may have in the selection of a test or therapy Source: Internal report: Pathologist/Oncologist Interactions in PD-LI CDx Testing, March

10 Your bridge to day one patient access Formulate acceleration strategy. In partnership with pharmaceutical partners, co-create the strategy, define the market, conduct research and create materials prior to market launch. Activate early adopters. Engage with medical affairs and facilitate early delivery of KOLs and COEs. Proactively develop proof sources and ensure strong support of clinical trials throughout the co-launch process Dominate market preference. Continue to create market awareness, drive preference and accelerate global reach 10

11 Global and country-level commitment Local implementation approach varies by country Global Acceleration Goal Secure day one patient access + Affiliate Country Planning and development Local implementation Co-creation of strategy Development of education, training and marketing materials KOL and COE engagement Direct marketing Media support Individually targeted training 11

12 Access to subject matter experts Accelerate global adoption Disease state portfolio experts Disease state portfolio experts drive incorporation of critical information into disease state panels and deliver knowledge/expertise for our pharmaceutical partners. Exceptional opportunities to build awareness Medical affairs leaders Leaders in medical affairs champion medical value messaging and support: Pathologist training Initiation of COE and KOL studies Publication strategy Unparalleled local market access to lab leaders and pathologists across the globe is essential for accelerated adoption. Lab leaders across local markets Unparalleled local market access to lab leaders and pathologists across the globe is essential for accelerated adoption. Access to tools and resources to assist in validation set up in testing laboratories through partners such as Horizon Discovery 12

13 Conduct market research Formulate acceleration strategy? What Conduct market research to fill key information gaps related to biomarker awareness Define pathologist attitudes, perceptions and practice in diagnosing indication Gain early insight into pathologist awareness of biomarker expression in target indication and clinical trial data Identify products pathologists use to test for biomarker expression! Results + Benefits Data informs acceleration strategy about pathologists awareness and use More targeted launch package assures day one readiness

14 Conduct market mapping Formulate acceleration strategy? What Determine primary testing sites in key markets and map to install base Competitive landscape assessment Identifies key testing sites for diagnosing indication in countries of interest Determines if key sites have VENTANA BenchMark ULTRA device (Europe: BenchMark XT and Benchmark GX devices) Country-level competitive landscape high level of market share! Results + Benefits Data provide input into launch strategy Identifies key targets for Class I and COE sites

15 Market mapping Identifies labs with high testing volume, most likely to adopt Timing: Pre-launch - 24 months prior to launch to select labs, target contracts and training

16 Define value proposition Formulate acceleration strategy? What Dedicated working sessions with internal subject matter experts Value proposition and budget impact models for use in educational and promotional material! Results Provides payers, labs, hospitals and pathologists with critical decision-making information + Benefits Alignment with adoption strategy Identification of data (beyond clinical study) required for additional proof sources Improved decision-making by customers Pre-launch - 24 months prior to launch to select labs, target contracts and training

17 Define value proposition Identifies data for HTAs*; medical value messaging required to drive adoption Clinical Value False negative/false positive rate Patient response rate Analytic Value Sensitivity, comparison to on-market IVD clones Specificity, comparison to on-market IVD clones Economic Value Improved outcome of patients using CDx compared to on-market IVD clones False negative/false positive rates of on-market IVD clones *Health Technology Assessments 17

18 Establish Centers of Excellence Activate early adopters in AP labs? What Establish two testing COEs that will be ready to receive and test samples at launch! Results Medical affairs set up lab and train to scoring algorithm prior to launch Labs validated for assay within 24 hours of FDA approval + Benefits Increase day one patient access for testing COE consults with other labs, drives adoption COE can provide reference services COE promoted on biomarker microsite

19 Centers of Excellence provide access Ensures no delays in delivering effective therapies Strategic goal Secure day one access to high-quality CDx testing in partnership with market mapping efforts + Pathologist training Provide standardized pathologist training Lab validation Establish high-quality testing through a standardized approach Ensures pathologists can assess and interpret CDx assay accurately and consistently Provides adequate time for labs to validate assay on their platforms Ensures that patients can receive CDx testing at launch Enables optimal turnaround time at launch

20 Conduct studies with KOL Activate early adoption and medical value discussions Prevalence studies Robustness studies Quality reproducibility studies Comparative studies Ad boards? What! Results External and inter-laboratory reproducibility studies Understanding of total addressable market Performance against on-market IVD clones KOL champions + Benefits Market access Thought leader access Quality and performance data Medical value proof sources Early adopter promotion of assay

21 Develop CDx e-learning tool for pathologists Activate early adopters in AP labs? What e-learning tool with assessment that facilitates consistent interpretation of the assay Robust tool to mimic peerto-peer pathologist training at the microscope Pathologists gain confidence in their ability to interpret the results Pathologists learn on their own time in a simulated training environment! Results + Benefits Increases adoption rate rapidly Broad reach for effective training Enables decentralized testing

22 ALK interactive e-learning training tool Provides broad training to create confidence and drive adoption Key activity for adoption ALK online training: technical overview of ALK staining, scoring algorithm, instructive clinical cases with a proficiency exam Web5875A-1_Module 1: Introduction and ALK Basics Narrator Driven ALK Lecture Web5875A-2_Module 2: Cases 1-10, Guided demonstration, known ALK status Narrator Driven ALK Case Review Web5875A-3_Module 3: Cases 11-20, Guided demonstration, unknown ALK status Student Driven ALK Case Review Web5875A-4_Module 4: Cases 21-30, Practice session Student Driven ALK Case Review Web5875A-5_Module 5: Test Cases 31-70, Test set and certification Student Driven Test Set and Certification Score actual cases using virtual microscopy with opportunities for corrective feedback Pre-launch to launch Module 1 with analytical assay

23 CDx e-learning tool for pathologists Viewing similar to microscope with corrective feedback on interpretation 23

24 e-learning vs. Interpretation Guide Interactive tool offers broad training, creates confidence and drives adoption *Static images without the opportunity for feedback 24

25 Create microsite for biomarker assay Activate early adopters in AP labs? What Design of a microsite dedicated to the biomarker Microsite aggregates information specific to the assay, including e-learning tools, links to COEs and information about therapy e-learning tool ALKIHC.eu Link to COEs PD-L1 Therapy information ALK! Results + Benefits Single point of reference for all biomarker-related materials Ongoing awareness and education of customers Customer-facing sales tools and relevant industry articles

26 ALKIHC.eu and ALKIHC.com Visual branding and additional messaging on biomarker microsite

27 PDL1IHC.com and Product Page Visual branding and additional messaging on biomarker microsite The VENTANA PD-L1 (SP263) Assay Biomarker Biomarker Microsite Microsite Delivering the new option for identifying NSCLC patients most likely to benefit from OPDIVO (nivolumab). CE marked. FDA approved to predict NSCLC patient response to OPDIVO Providing robust PD-L1 staining in both tumor cells (TC) and tumor-infiltrating immune cells (IC) The VENTANA PD-L1 (SP263) Assay Pre-launch with Class I and update at CDx launch

28 Deploy global media plan Dominate market preference? What Co-developed plan between Ventana and pharmaceutical partner for joint plan Symposia coverage Publications Marketing messages! Results Partnership awareness Companion status differentiation Joint education efforts with pathologists and oncologists Value propositioning + Benefits Partnership benefit Companion status differentiation Visibility across the two organizations Value proposition

29 In-depth assay and therapy training Increase confidence and knowledge to drive sales? What Joint pharmaceutical and local Roche sales education and tactical promotional strategies specific to region Promote therapy and CDx assay to oncologists and pathologists via joint pharma/diagnostic sales team seminars, training, presentations to tumor boards, etc. Globally facilitated but locally driven agreements! Results + Benefits Sales promotions increase day one patient access Increase adoption Increase confidence and knowledge regarding assay and therapy for sales reps

30 In-depth assay and therapy training Increase confidence and knowledge to drive sales 30

31 Promote posters/white papers/webinars Dominate market preference? What Educational, customerfacing webinar promoted via blast Sales team participates in webinar to promote awareness of assay! Results blast to customers drives awareness and supports market position + Benefits Ongoing customer engagement Market leadership and positioning Offers ongoing education to build customer relationships and spur buy-in

32 Congresses/symposia and publications Dominate market preference? What Abstract/poster at one major conference for launch! Results Topics may include: Development of biomarker Assay and scoring algorithm and use in clinical trial Performance of biomarker Comparison of on-market clones Conferences may include CAP, US-CAP, etc. + Benefits Supports early scoring algorithm usage with biomarker Supports increase in enrollment and day one patient access to clinical trials Provides proof source for value proposition

33 Poster: PD-L1 and MEDI4736 With analytical assay enables early adoption and market readiness Background: A high quality PD-L1 companion diagnostic may help predict which patients are more likely to respond to PD-1/PD-L1 antibody-based therapy. Here we describe a PD-L1 immunohistochemical (IHC) diagnostic test developed by Ventana Medical Systems, Inc. for use with MEDI4736. Source: 2015 ASCO Poster # 355 Results: The VENTANA PD-L1 IHC (SP263) Assay met all pre-defined acceptance criteria. The scoring algorithm was defined Samples of both cancer types are considered test positive when the membrane of 25% of tumor cells stain for PD-L1 at any intensity....for both NSCLC and SCCHN, PD-L1+ patients identified by the scoring algorithm had a higher response rate than PD-L1 patients. Conclusions: These results highlight the robustness and reproducibility of the PD-L1 (SP263) IHC Assay in a clinical setting. In NSCLC and SCCHN patients treated with MEDI4736, PD-L1+ patients identified by the scoring algorithm had a higher response rate than PD-L1 patients. The clinical utility of the PD-L1 diagnostic assay will be further validated in a prospective manner using additional patients in this study and in other MEDI4736 studies. Clinical trial information: NCT

34 Your partner for day one patient access We accelerate adoption to ensure market preference Formulate acceleration strategy. We are your committed partner together we will co-create an aggressive strategy to assure day one patient access. Activate early adopters. We activate early by engaging with medical affairs and facilitating early delivery of KOLs and COEs; we proactively develop proof sources and ensure strong support of clinical trials throughout the co-launch process. Dominate market preference. We will continue to create market awareness, drive preference, and accelerate global reach. 34

35

36 Ventana Medical Systems, Inc. VENTANA and BENCHMARK are trademarks of Roche. All other trademarks are the property of their respective owners. 7391A 116 RTDPC-CDx-0155