In this presentation I discuss why the application of context of use and some of the key parameters for efficacious assay development remain difficult to implement in an environment of bioanalysis. I clarify some of the concerns and resistance around application of the concepts. I know, I have been there and have lived the frustration. By reconnecting with our training as scientists, asking ourselves the right questions (and throwing out old habits) we can successfully communicate our strategies. First appeal to the scientist within, a data-driven evidence-based approach is a great start to persuasion and influence. Second, start with the why, ensure that we are clear on the concepts before presenting it to others. Third, remember that science is an iterative process and that failing to get it right is part of the process to getting it right so build debate into the process. I use parallelism as an example of demonstrating how new concepts can be introduced and embedded in a team. Furthermore, experience has demonstrated that when we empower the team to drive their own science they are more creative and receptive to new ideas.
Define and name the resistance to implementing CoU and other biomarker concepts in their organisations..
Explore how to overcome the resistance
Clarify some of their own strategies for overcoming obstacles