Strategies For Developing Biomarkers 487

disease pathogenesis through the development of animal models that recapitulate the hallmarks of human disease. These basic science exploratory studies can be difficult and time consuming. However, the value of these studies is realized when testing reveals that a therapy can modulate levels of the identified biomarkers and this correlates with a positive effect of the drug on disease endpoints in a clinically relevant animal model. Additional studies that investigate the effect of dose and regimen of a given therapy on modulation of these biomarkers are ultimately the key experiments that will inform on the dosing regimen to be used in human clinical trials. This information is critical, as it is a valuable component in the value chain of drug development.

It is now clear that the effort spent on biomarker development in preclinical animal models at the front end of the drug development process facilitates a more informed approach to clinical trial design in humans. This ultimately translates into a higher success rate for therapies tested in the clinic.

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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