The Role of Biomarkers and Companion / Complementary Diagnostics in Immuno-Oncology Trials

•

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Xtalks Webinars

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

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

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

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

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

Copyright © 2016 Honeycomb Worldwide Inc.
Click here to watch the
complete webinar:
or
Click here for more information on this presentation:
http://xtalks.com/biomarkers-and-companion-complementary-diagnostics.ashx
POWERED BY HONEYCOMB
Copyright © 2016 Honeycomb Worldwide Inc.

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PEPSICO Presentation to CAGNY Conference Feb 2024

PEPSICO Presentation to CAGNY Conference Feb 2024

Content Methodology: A Best Practices Report (Webinar)

Content Methodology: A Best Practices Report (Webinar)

Content Methodology: A Best Practices Report (Webinar)

How to Prepare For a Successful Job Search for 2024

How to Prepare For a Successful Job Search for 2024

How to Prepare For a Successful Job Search for 2024

Social Media Marketing Trends 2024 // The Global Indie Insights

Social Media Marketing Trends 2024 // The Global Indie Insights

Social Media Marketing Trends 2024 // The Global Indie Insights

Trends In Paid Search: Navigating The Digital Landscape In 2024

Trends In Paid Search: Navigating The Digital Landscape In 2024

Trends In Paid Search: Navigating The Digital Landscape In 2024

5 Public speaking tips from TED - Visualized summary

5 Public speaking tips from TED - Visualized summary

5 Public speaking tips from TED - Visualized summary

ChatGPT and the Future of Work - Clark Boyd

ChatGPT and the Future of Work - Clark Boyd

ChatGPT and the Future of Work - Clark Boyd

Getting into the tech field. what next

Getting into the tech field. what next

Getting into the tech field. what next

Google's Just Not That Into You: Understanding Core Updates & Search Intent

Google's Just Not That Into You: Understanding Core Updates & Search Intent

Google's Just Not That Into You: Understanding Core Updates & Search Intent

How to have difficult conversations

How to have difficult conversations

How to have difficult conversations

Introduction to Data Science

Introduction to Data Science

Introduction to Data Science

Time Management & Productivity - Best Practices

Time Management & Productivity - Best Practices

Time Management & Productivity - Best Practices

The six step guide to practical project management

The six step guide to practical project management

The six step guide to practical project management

Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...

Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...

Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...

Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...

Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...

Unlocking the Power of ChatGPT and AI in Testing - A Real-World Look, present...

12 Ways to Increase Your Influence at Work

12 Ways to Increase Your Influence at Work

12 Ways to Increase Your Influence at Work

ChatGPT webinar slides

ChatGPT webinar slides

ChatGPT webinar slides

More than Just Lines on a Map: Best Practices for U.S Bike Routes

More than Just Lines on a Map: Best Practices for U.S Bike Routes

More than Just Lines on a Map: Best Practices for U.S Bike Routes

The Role of Biomarkers and Companion / Complementary Diagnostics in Immuno-Oncology Trials

1.

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

6. Copyright © 2016 Honeycomb Worldwide Inc. Click here to watch the complete webinar: or Click here for more information on this presentation: http://xtalks.com/biomarkers-and-companion-complementary-diagnostics.ashx POWERED BY HONEYCOMB Copyright © 2016 Honeycomb Worldwide Inc.