Abstract
Today’s revolution in imaging technologies in the biomedical sciences has raised much needed hope for improved diagnostics, therapeutics, and the eventual cure of many debilitating illnesses. Imaging itself has become the seed technology that has fostered the development of many novel diagnostic approaches as well as helping point the way to witnessing the mechanism of action of drugs and biologics. The advancement of new drugs and biologics will be undertaken in the future with surrogate biomarkers, and many of these will be in the form of imaging. Imaging of pharmacodynamic responses to therapies such as changes in RECIST, cerebral glucose utilization, MRI BOLD changes reflecting neurologic activity, and many other novel approaches are opportunities for the imaging community to work with the regulatory community to contribute to the advancement of novel agents. As stated by Dr Steven Larson (2007) “We are experiencing a paradigm shift from anatomic towards biomarker (molecular imaging) as the primary means for assessing treatment response in oncology” and as such the regulatory environment for this to happen must be considered and developed to maximize the potential which imaging brings to medical diagnosis and to clinical decision making.
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Notes
- 1.
CDER has developed DDT Qualification Programs directed toward the following types of DDTs: biomarkers, clinical outcome assessments (COAs), and animal models.
- 2.
Biomarker qualification program: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284076.htm; The Biomarker Qualification Process is described fully in this link: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284621.htm.
- 3.
Concept paper from the FDA: Animal Models—Essential Elements to Address Efficacy Under the Animal Rule http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072214.pdf.
- 4.
Clinical Outcomes Assessment Qualification Program (COAQ): http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm.
- 5.
FDA CMC Guidance documents can be found at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm064979.htm.
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Moyer, B.R., Cheruvu, N.P.S., Hu, T.CC. (2014). Regulatory Considerations Involved in Imaging. In: Moyer, B., Cheruvu, N., Hu, TC. (eds) Pharmaco-Imaging in Drug and Biologics Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 8. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-8247-5_13
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