Paths In Codevelopment

There are several major paths of co-developing a drug and associated test: (1) drug and test are developed in parallel (true co- development); (2) drug is developed first, followed by the diagnostic test(s) development (drug rescue in case there are safety issues discovered in phase IV); and (3) the already existing test can be used for drug(s) selection (patient enrichment/stratification). Multiple tests may be developed for the selection of a certain drug, either in parallel with the drug or at a later date. Figure 2 illustrates major drug diagnostics collaboration scenarios.

In the end, regardless of the path taken, co-development results in cross-labeling/relabeling of drug and/or the diagnostics. FDA drug package inserts frequently cite the relevant in vitro diagnostic test(s), and FDA cleared/ approved devices reference the targeted drug(s). Table 1 presents current

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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