Mechanisms To Facilitate Imaging Biomarker Development

Despite the potential of imaging biomarkers as unique tools in drug development, the multidisciplinary nature and complexity of these technologies have somewhat hindered biomarker development. In addition, implementing and using imaging biomarkers has tended to be isolated to research institutions and centers with the necessary range of resources. The difficulties of imaging standardization and the expense of imaging biomarker qualification has also limited the incentive for commercialization of these technologies.

Many stakeholders in government and industry have recognized the inadequacy of traditional research and development approaches as applied to biomarker development. Other biomarkers in use today, such as blood pressure or plasma cholesterol, have taken decades to achieve their current utility [40]. In its Critical Path Initiative the FDA acknowledges the urgent need for new approaches and broad collaboration to address the unique challenges of biomarker development [179]. Two new approaches that are beginning to have a positive impact are public-private partnerships and the open-source development paradigm.

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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