Advances in Imaging Biomarkers: Innovative technologies, applications in R&D and clinical practice, and informatics and regulatory requirements by Bus



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Imaging biomarkers, those quantified using imaging modalities including Magnetic Resonance Imaging and Positron Emission Tomography, are attractive for a variety of reasons: the methods of measurement used are non-invasive, and can provide information that cannot be obtained in other ways including a drug’s pharmacology and side effect profile, interaction of a drug and its target, delivery of a drug to its target, and the drug’s pharmacokinetic profile. In the clinical setting, imaging biomarkers can be used as a screening, diagnostic or prognostic tool as well as for monitoring treatment response.
Researchers have a vision that the introduction of imaging biomarkers will revolutionize basic research, drug development and treatment by providing non-invasive approaches that are translatable from the laboratory to the clinic and by allowing researchers and clinicians to see in great detail how drugs are behaving. The discovery and development of imaging biomarkers is an exciting and growing area and researchers across the globe are working to develop this vision. 

The imaging technologies available today offer a variety of methods that can be used to quantify information and thus create useful biomarkers. Discovering the biomarker is perhaps the easy step, whilst the clinical follow up studies required to gain a better understanding of the utility of the biomarker are more complex, time consuming and expensive. This report discusses advances in key technologies, the use of imaging biomarkers in drug discovery and development and current use in clinical practice. It also outlines key collaborative initiatives in standardizing imaging technologies and informatics, improving quantification and qualification without which the vision will not be realized.

Key features of this report

  • Highlight some of the key technologies for imaging biomarker development in different research or clinical settings, as well as pivotal technology developments.
  • Analysis of the potential for using these technologies to improve drug discovery and clinical trials. The different organizational structures within pharmaceutical companies are discussed.
  • Analysis of imaging biomarkers currently used in clinical practice as well as the future of imaging biomarkers in this setting.
  • Case studies of individual imaging biomarkers and the companies or research collaborations responsible for their development.

Scope of this report

  • Identify key technologies for development of imaging biomarkers to assist in biomarker discovery and development
  • Identify the relevance of imaging biomarkers to drug discovery and development and the different organization structures being adopted by pharmaceutical companies to the implement them
  • Learn about the important efforts of public-private consortia that are working to develop new imaging biomarkers, qualify existing imaging biomarkers and develop standards and clarify qualification processes
  • Understand the potential for imaging biomarkers to improve diagnostic processes, enabling earlier disease identification and promoting preventive medicine
  • Discover the potential of imaging biomarkers for improving decision making and terminating unsuitable drug projects at an early stage, as well as reducing costs in clinical care

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