Ventana-Bayer Strategic Partnership: Empowering high value companion diagnostics


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Discover best practices from a successful alliance between the Companion Diagnostics team at Ventana Medical Systems and the biomarker targeted pharmaceutical strategy team at Bayer.

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Ventana-Bayer Strategic Partnership: Empowering high value companion diagnostics

  1. 1. Ventana-Bayer strategic partnership November 2013 Daniel Forler, Bayer Matthew Nelson, Ventana Medical Systems, Inc.
  2. 2. Agenda Ventana and Bayer’s CDx background What and why is a strategic partnership needed? Keys to a successful alliance Case study: Alliance Health Check Building on additional capabilities between both parties
  3. 3. Ventana Medical Systems, Inc. At a glance Mission Statement: Total Avail. Market (TAM) “To improve the lives of all patients afflicted with cancer” Our Commitment: Our commitment to patients is guided by science, because we know that science is the foundation for delivering high medical value tests that ultimately improve patients’ lives Product Areas: Immunohistochemistry, in situ Hybridization, Hematoxylin and Eosin stain, Special Stains, Advanced Lab Workflow, Image Analysis Patents: 225 worldwide patents granted, 200 worldwide patents pending. Location: Tucson, Arizona
  4. 4. Cancer death rates remain stubbornly high 400 In spite of worsening obesity 300 200 100 Cancer In spite of decline in smoking 0 Mortality per 100,000 Population (US) Heart diseases Copyright: Bray, Freddie Dr. PhD, Jemal, Ahmedin PhD, Grey, Nathan PhD, Ferlay, Jacques ME, Forman, David PhD. Global cancer transitions according to the Human Development Index (2008—2030): a population-based study. The Lancet Oncology, Vol. 13 No. 8 pp 790-801. Image: copyright: Hoyert DL, Xu JQ. Deaths: Preliminary data for 2011. National vital statistics reports; vol 61 no 6. Hyattsville, MD: National Center for Health Statistics. 2012. Alzheimer’s
  5. 5. Personalized healthcare is real today From 670 diseases to > 16,000 in 37 years # of subtypes within disease states 18000 16000 14000 12000 10000 8000 6000 4000 2000 0 1891 1965 1975 2012 Copyright 2012 Aspinall. Do not distribute or reproduce Source: History of the Statistical Classification of Diseases and Causes of Death, I. Moroyama, et. Al, 2011; International Classification of Diseases, Tenth Revision, (ICD-10)
  6. 6. VENTANA assay portfolio overview >20 CDx in PMA development •  In vitro diagnostics -  -  -  -  -  -  Three CDx PMA approved tests (c-KIT, HER2 IHC, HER2 ISH) >20 Companion Dx (PMAs) in development Three 510(k) cleared tests (ER, PR, H. pylori) Over 220 Class I (exempt) IVD reagents and kits Over 220 CE IVD registrations Analyte Specific Reagents •  Research Use Only reagents (from Spring Bioscience) -  -  -  >175 Rabbit monoclonal antibodies > 400 Rabbit polyclonal antibodies > 60 ISH probes
  7. 7. Companion diagnostics leadership Growing portfolio of projects and partnerships All measures since 2007 | 1US CDx Commercial Value Study (PSB-2012) |
  8. 8. Ventana active CDx projects Unique new assays in multiple indications Companion Diagnostic Development Biomarker Evaluation Biomarker Discovery Companion Proof of Concept IVD Assay Development Late Stage Trial Support On Market PMA Submission IVD Launch > 20 PMAs in Development CD 30 CD 30 cMET Her2 Her2 x8 Her2 Her2 Her2 ALK Her2 cKIT x7 DDISH Renal Liver Breast Prostate Lung CRC Melan Gastric Lymp. Panc Gyno TBD IHC Represents signed project agreements with Pharma partners as of June 2013
  9. 9. Bayer – Mission statement
  10. 10. Global leader in specialty pharmaceuticals and consumer health Employees 2012: 55,300 Bayer HealthCare Sales 2012 Consumer Health Pharmaceuticals Animal Health Division € 1,303 million Consumer Care Division 7.0% 20.7% € 3,853 million Medical Care Division € 2,653 million Pharmaceuticals Division € 18,612 million 14.3% € 10,803 million 58.0%
  11. 11. Bayer Healthcare Pharmaceuticals Research focus
  12. 12. BHC pipeline by indication Oncology Cardiovascular Diseases Women’s Healthcare Hematology Ophthalmology Others Ø  Bayer is committed to become one of the top oncology companies Status July 2013 Selection of major Pharma pipeline projects in clinical Phase I to III
  13. 13. Bayer CDx background •  Recognized the enormous potential of personalized medicine to improve patients health and safety •  Multiple of Bayer’s oncology projects require companion diagnostics •  Bayer Healthcare's core competence is in drug development •  Improve effectiveness of the drugs by selecting the right patients
  14. 14. What is a strategic partnership? •  A formal contract that guarantees a number of available companion diagnostic development slots for the partner based on a retainer pricing model •  Stabilizes pricing for 3-5 years associated with both CDx and TDx activities •  Dedicated resources for each study guaranteed •  Early access to new technologies and sharing of technologies/clinical samples
  15. 15. Why is a strategic partnership needed? Drug & Biomarker Research Preclinical Drug & Biomarker Validation Clinical trials (Drug and CDx) Phase I – III: Drug testing for efficacy & adverse events in selected patient populations (CDx) Regulatory Approval Data review by regulatory authorities Market Access Joint Launch of Drug & CDx •  Long term commitment to support pharma during lengthy and complex development process (pre-clinical to market launch) •  Resources and support customized to the project and development stage •  Close collaboration during the whole drug development process
  16. 16. Why is a strategic partnership needed? •  Smooth out resource planning/demand and staffing •  Provide partner with guaranteed project slots •  Leverage partner’s experience over a sustained period to understand the partners next step and how we can best support that effort. •  Developing familiarity in relationship is important across many functional groups (i.e. discovery, development, clinical affairs, market planning and commercialization). •  Global footprint in terms of commercialization (wherever Pharma goes, CDx has to go, too)
  17. 17. Keys to a successful alliance •  Good understanding of the partners processes and decision •  Clear understanding of nomenclature (Diagnostic vs. Pharma) •  An open, clear and transparent communication •  Operational management excellence •  Open to learn from each other •  Strong feeling of trust in the working teams •  High flexibility
  18. 18. Alliance Health Check •  In addition to tracking the business goals, evaluation of the overall state of alliances on a regular basis to continuously and proactively optimize collaboration •  Partner survey to evaluate strength and weaknesses of the cooperation •  Action plans ensure optimization of partnerships
  19. 19. Case study: Alliance Health Check November 2013 Administrative Challenges – Master Collaboration Agreement (MCA) in 2011did not foresee wide variety of projects and studies - particularly early stage –Strategic Partnership Agreement (SPA) 2013 is an umbrella agreement that retains the MCA, but only for suitable projects  – Agreement in principle reached on an additional services agreement to supplement the MCA for projects unforeseen in 2011
  20. 20. Building on additional capabilities •  Deep insights into portfolio needs and clinical practice is beneficial for both partners. •  Early involvement in biomarker strategy •  Evaluating and testing of emerging technologies •  Access to clinical samples –  tissue sample management/requirements •  Global regulatory teams •  Global marketing and launch teams
  21. 21. Lessons learned •  Communication is key •  Face-to-face meetings are necessary on a regular basis. •  Alliance management is essential to streamline processes •  Consistently improve operational management
  22. 22. This presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forwardlooking statements or to conform them to future events or developments.
  23. 23. VENTANA Empowering | Innovation © 2013 Ventana Medical Systems, Inc. Copyright © Bayer AG VENTANA , Spring Bioscience and the VENTANA logo are trademarks of Roche. All other trademarks are the property of their respective owners. E5061-2 1113A