roche, roche molecular diagnostics and more -...
TRANSCRIPT
Roche, Roche Molecular Diagnostics and more
Patients have
questions.
We provide
answers.
[Monte Wetzel, PhD]
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Roche Group – Clear focus on Healthcare Innovation with two strong pillars
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Pharma
Roche
Pharma
Genentech Chugai
Diagnostics
Roche
Molecular
Diagnostics
Roche
Professional
Diagnostics
Roche
Tissue
Diagnostics
Roche
Applied
Science
Roche
Diabetes
Care
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Roche Group – Clear focus on Healthcare Innovation with two strong pillars
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Pharma
Roche
Pharma
Genentech Chugai
Diagnostics
Roche
Molecular
Diagnostics
Roche
Professional
Diagnostics
Roche
Tissue
Diagnostics
Roche
Sequencing
Roche
Diabetes
Care
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Diversity Global Scale / Reach
Ph
arm
a
Dia
gn
osti
cs
Cohesion
Gro
up
Finance, IT, Legal, HR, Communications
Pharma Medicines
Global Functions
Diabetes Care
Business Areas
Roche Group - Structure
Partnering
pRED
gRED
Chugai
Diagnostics
Regions
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Roche Diagnostics worldwide
Penzberg
Mannheim
Rotkreuz Pleasanton
Tucson Ponce
Graz Burgdorf
Indianapolis
Branchburg
Reykjavik
Branford Madison
Diagnostics Sites
Major R&D/
Manufacturing
Other R&D/
Manufacturing
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Roche Group — What makes us distinctive Optimally positioned for the future
• Combined strengths of Pharmaceuticals
and Diagnostics
• Synergies in research, development
and marketing
• Unique global network of alliances
• Pioneering personalized medicine
Early detection
Leader in Diagnostics
Leader in Pharma
Prevention Diagnose Therapy Therapy
monitoring
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Roche Diagnostics Organized around lifecycle teams to drive innovation
* Not organized by lifecycle teams
Molecular Lab
Molecular Diagnostics
Genomics & Oncology
HPV & Microbiology
NewGen
Blood Screening
Virology
In Vitro Diagnostics Life Sciences
Academia/Pharma
Sequencing
Sequencing
Biochemicals/IB
qPCR/NAPI
Pathology Lab
Tissue Diagnostics
Advanced Staining Assays
Primary Staining
Advanced Workflow
Professional Diagnostics
Central Lab
SWA High/Mid Volume Platforms
Cardio-Renal, Crit. Care & WH
SWA Low Volume Platforms
Clin Chem, ID, Onco, Endo
Ambulatory Care
Doc. Office, Wards
Workflow & IT
Specialty Testing
Hospital POC
Patient
Diabetes Care*
Integrated bGM
Single Strip bGM
Lancing Systems
Insulin Delivery Systems
Advanced Staining
Platforms
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provide rapid, precise,
reliable actionable
information
to guide treatment for
better patient outcome
Roche Molecular Diagnostics
MOLECULAR
DIAGNOSTICS
TESTS
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RMD: Focused on developing and marketing
Molecular Diagnostic tests
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• >800 Employees
• R&D
• RMD Headquarters
• Strategic Marketing
Pleasanton, CA
• 170 Employees
• Development
• RMD Manufacturing
Rotkreuz, CH
• 500 Employees
• Manufacturing
Branchburg, NJ
Roche Molecular Diagnostics: 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
cobas® 4800 System NewGen
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Our goal for Genomics & Oncology
Improving therapy selection Personalised Healthcare
Biomarker Initial applications
BRAF V600 Select metastatic melanoma patients for RG7204
therapy
KRAS Identify colorectal cancer patients appropriate
for anti-EGFR monoclonal antibody therapies
EGFR Identify NSCLC patients appropriate for earlier
TKI therapy
PIK3CA Research collaboration with Roche/Genentech
Breast, colorectal & other indications
p53 Research collaboration with Merck and Roche
Sarcoma, ovarian & other indications
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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
Demonstrating value through Personalized
Healthcare
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]
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Pharma Needs
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Enabling Personalized Healthcare Provide relevant capabilities to address Pharma needs
Full range technologies
Broadly available commercial test
Commercial Presence • Installed base
• Customer access
• Breadth & depth
• IVD transferable Tools & Technologies
• Clinical validation
• Clinical adoption Clinical Expertise Incorporation into
clinical trials
Roche Diagnostics Capabilities
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IVDs play a central role in PHC
• Disease screening
• Risk of developing disease
• Diagnosis “rule-in” and “rule-out”
Personalized
Medicine (PHC)
• Institute therapy
• Adjust therapy
• Stop or change therapy
• Assess therapeutic effectiveness
• Assess therapeutic compliance
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Risk Assessment
Predisposition for developing
disease
Therapy
adaptation
Patient Stratification / Therapy Selection
Screening/ Diagnosis Prognostic Predictive Monitoring
Early detection Predict probable disease course
Predict likely drug response
Monitor efficacy/ recurrence
Healthy Asymptomatic
disease Chronic disease Symptomatic disease
Difficult to prove
medical value
IVDs can play role along the treatment pathway Biomarkers and diagnostics development are key to PHC
Few markers
have acceptable
sensitivity or
specificity
Biomarker Evaluation Criteria Consider clinical and market factors
Clinical Utility
Degree of Validation
Competitive Freedom
Pricing Flexibility
Key Questions
• 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 Roche 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?
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
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)
Partnering with Roche Molecular Diagnostics
(RMD)
Does the diagnostic technology specify human
cells, tissue or sample? No
(e.g. Food)
Is the disease area either infectious diseases,
oncology or inflammatory?
No
(e.g. CVD)
Yes
Is either screening, diagnosing, prognosing,
therapy predicting or monitoring the diagnostic
application of the technology?
No
(e.g. predisposition)
Yes
Does the diagnostic application involve Nucleic
Acid Testing (NAT)? No
(e.g. non-NAT)
Yes
High priority for Roche Molecular Diagnostics
Send to contact below
Yes
Low priority
for Roche
Diagnostics
Roche
Diagnostics
Interested
Send to:
Dx.Biomarkers
@roche.com
Roche 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 Roche first as their partner of choice to develop and commercialize
diagnostics
Technology Disclosure Flowchart: In Vitro Diagnostics Assays
Tod Bedilion
925-730-8375
www.roche.com
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Doing now what patients need next