Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges

This report explores the potential for applying genomic-based diagnostics to new drug developments, and the resultant implications for the pharma/biotech and diagnostic industries. It also reviews 28 collaborative agreements for the co-development of drug-diagnostics and determines which combinations can be expected to result in commercial products in the near future.

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There have been 28 Rx-Dx co-development projects identified, of which 17 are in the oncology area. The remainder have been found to cover cardiovascular, CNS, autoimmune, infectious diseases, HIV and growth factors.

There is a growing trend for co-development partnerships to be made during the early stages of drug development. An analysis of ongoing co-development projects indicates that more deals are being concluded well in advance of Phase II clinical trial completion.

Third-party studies will be a significant driver in gaining acceptance for the use of pharmacogenomic information to optimize drug usage. Work currently being done by US PBM Medco to generate data in the real-world setting will support manufacturers' own initiatives.

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