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Reportlinker Adds Case Study: Personalized Cancer Therapy - The era of biomarker identification and companion diagnostic co-development
Date:4/28/2011

ant decisions regarding personalized therapy development. Selecting the correct time to begin companion diagnostic development will help improve the chances of approval and drive new drug uptake. Developers must also assess their position in the market before choosing internal or external development.

Drug developers are cautious of personalized therapies due to the small patient populations and associated commercial potential. However, Herceptin has been able to dominate a well defined segment of the breast cancer market and companion diagnostics have recovered the commercial potential of Erbitux and Vectibix.

Regulators have now realized that the regulatory framework must be altered to incorporate both drugs and companion diagnostics. The US, EU and Japanese authorities are all starting to change their guidelines to encourage personalized therapy development. However, there are still hurdles to overcome before co-development becomes common practice.

Key

Reasons to Purchase this research

• Identify key decisions when developing a drug and companion diagnostic, including internal or external development and when to start development

• Identify the commercial benefits of personalized cancer therapy by assessing drugs currently in development or approved

• Assess the changes in regulatory processes in the seven major markets as the paradigm of personalized cancer medicine grows

TABLE OF CONTENTS

Overview 1

Catalyst 1

Summary 1

About Datamonitor Healthcare 2

About the oncology pharmaceutical analysis team 2

Executive Summary 3

Strategic scoping and focus 3

Datamonitor key findings 3

Related reports 4

Case Study in Personalized Cancer Therapy 6

Introduction 6

Biomarkers 7

Drug and companion diagnostic development 12

Commercial potential 18

Regulators 22

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