Roche, Roche Molecular Diagnostics and more

Patients have

questions.

We provide

answers.

[Monte Wetzel, PhD]

2

Roche Group – Clear focus on Healthcare Innovation with two strong pillars

2

Pharma

Roche

Pharma

Genentech Chugai

Diagnostics

Roche

Molecular

Diagnostics

Roche

Professional

Diagnostics

Roche

Tissue

Diagnostics

Roche

Applied

Science

Roche

Diabetes

Care

3

Roche Group – Clear focus on Healthcare Innovation with two strong pillars

3

Pharma

Roche

Pharma

Genentech Chugai

Diagnostics

Roche

Molecular

Diagnostics

Roche

Professional

Diagnostics

Roche

Tissue

Diagnostics

Roche

Sequencing

Roche

Diabetes

Care

4

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

5 5

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

6

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

7

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

8

provide rapid, precise,

reliable actionable

information

to guide treatment for

better patient outcome

Roche Molecular Diagnostics

MOLECULAR

DIAGNOSTICS

TESTS

9

RMD: Focused on developing and marketing

Molecular Diagnostic tests

9

• >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

11

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

12 12

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]

13

14

Pharma Needs

14

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

15 15

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

16

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

tod.bedilion@roche.com

925-730-8375

www.roche.com

21

Doing now what patients need next