This webinar will address the spectrum of immunotherapy development considerations and their implications for drug developers.

2. Confidential
Companion Diagnostics Overview
Approximately 30 applications in clinical use today
► Usually involve the assessment of a single gene or protein
► Lab platforms include molecular biology, immunohistochemistry,
FISH and cell-based assays
Majority of CDx applications in Oncology
► Expansion of applications beyond Oncology
Considerations for CDx development earlier
in the drug development process
► Involvement in early clinical development process
New technologies and applications
► Liquid biopsy (CTC, cfDNA); Next Generation Sequencing (NGS);
Gene Expression Profiling (GEP)
Challenges have included:
► Timing of diagnostic and therapy development processes;
Adoption rate of CDx assays; Value based reimbursement
| The Role of Biomarkers, Companion and Complementary Diagnostics to Support Immuno-Oncology Trials, October 5, 20162

3. Confidential
Animal and Cell
Models
Mechanism of
Action
Immuno-toxicology
Market Access
Patient Data
Central Labs &
Specialty Labs
Alliance
Management
Companion
Diagnostics
MarketplaceInvestigator Quality
Clinical Monitoring
Trial
Experience
Health
Economics
Biomarkers
Competition
vs
Collaboration
Trial Design &
Execution
SafetyPreclinical
Immuno-Oncology Drug Development
REQUIRES UNIQUE AND COMPREHENSIVE SOLUTIONS
Key
Immuno-
Oncology
Features
3

4. Confidential
Companion vs Complementary
Dx Assays
UTILIZATION AND CLIENT ORDERING TRENDS
Client orders 22C3 Client orders 28-8
16%
84%
% Specimens
22C3 28-8
| The Role of Biomarkers, Companion and Complementary Diagnostics to Support Immuno-Oncology Trials, October 5, 20164

5. Confidential
Genomics of Lung Adenocarcinoma -
Targeted DNA Sequence Analysis
KRAS
22%
EGFR
15%
AKT1
1%
ALK
3%
BRAF
2%
DDR2
4%
FGFR1
10%
HER2
2%
MEK1
1%
MET
3%
NRAS1
1%
PIK3CA
2%
PTEN
5%
RET
1%
ROS
2%
Unknown
26%
Spectrum of Mutations Number of Mutations/Sample
36%
| The Role of Biomarkers, Companion and Complementary Diagnostics to Support Immuno-Oncology Trials, October 5, 20165
External Data

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