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.
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
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
Drug and companion diagnostic development 12
Commercial potential 18
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