Transcript (PPTX, 3.17MB) - Ventana Medical Systems, Inc.

Ventana-Bayer strategic partnership
November 2013
Daniel Forler, Bayer
Matthew Nelson, Ventana Medical Systems, Inc.
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
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
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
Personalized healthcare is real today
From 670 diseases to > 16,000 in 37 years
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)
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
Companion diagnostics leadership
Growing portfolio of projects and partnerships
All measures since 2007 | 1US CDx Commercial Value Study (PSB-2012) |
Ventana active CDx projects
Unique new assays in multiple indications
Companion Diagnostic Development
Biomarker Evaluation
Biomarker
Discovery
Companion Proof of
Concept
IVD Assay Development
On Market
Late Stage Trial
Support
PMA
Submission
IVD
Launch
> 20 PMAs in Development
CD 30
CD 30
x8
Her2
cMET
Her2
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
Bayer – Mission statement
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%
Bayer Healthcare Pharmaceuticals
Research focus
BHC pipeline by indication
Oncology
Cardiovascular Diseases
Women’s Healthcare
Hematology
Ophthalmology
Others
 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
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
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
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
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)
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
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
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
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
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
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 www.bayer.com.
The company assumes no liability whatsoever to update these forwardlooking statements or to conform them to future events or developments.
VENTANA
Empowering | Innovation
www.ventana.com
© 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.
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