Companion Biomarkers in Drug Development

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Companion Biomarkers in Drug Development
One-Stop Shop for Business Information
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Summary
Companion biomarkers are diagnostic tests that
are specifically linked to a therapeutic drug
either during its development or in the clinic.
This linkage can be an important component of the
drug development process alternatively, the
companion biomarker can be useful in ameliorating
the regulatory process for the drug, or acting as
an aid to therapeutic use in the clinic. Market
opportunities for companion biomarkers are
focused in drug development targets, drug
development efficacy and clinical end points in
four main therapeutic areas oncology,
cardiovascular, neurology and autoimmune. Using
companion biomarkers yields safer and more
efficacious drug products, reduces clinical trial
and development costs, improves post-marketing
safety profiles and salvages therapies that
otherwise would not be granted approval.  This
TriMark Publications report focuses on the role
of companion diagnostic tests in drug
development.
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It provides an in-depth discussion and analysis
of the application of companion biomarkers to
drug development and targeted therapeutics, as
well as their use in clinical trials and the
regulatory forum. The examination emphasizes new
and developing technology platforms meant to aid
in development of drugs for therapeutic use, and
sometimes to be available as companion tests for
these drugs in the clinic. This report also
examines companies that are actively developing
and marketing companion biomarkers around the
world. Detailed tables and charts with sales
forecasts and marketshare data are also
included.
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Table Of Content

1. Overview 16
2. Introduction Companion Diagnostics in Drug
   Development 25
3. Biomarker Development Tools 78
4. Market for Biomarkers in Drug Development 132
5. Imaging Biomarkers in Drug Discovery 153
6. Clinical Biomarkers Improving Trial Design 160
7. Biomarkers as Surrogate Endpoints 164
8. Market Size, Collaborations and Future Directions
   for Companion Diagnostics in Drug Development 166
9. Regulatory Issues for Biomarkers in Drug
   Development 171
10. Business Decisions Using Companion Biomarkers in
    Drug Development 217

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