Imaging Diagnostics and Theranostics: Meeting Clinical Development Challenges

Publish Date:
June 27, 2017
Authors:
Prithul Bom, MBA, RAC, ASQ-CSQE, Senior Director, Scientific Affairs, Medical Device & Diagnostics; Lisa Moore, PhD, RN, Executive Director, Medical Device and Diagnostics; Jeffrey Joseph, MS, Executive Director, Statistics

Molecular imaging has become increasingly important in the diagnosis, detection and treatment of cardiovascular, oncologic and other diseases. Advances that provide new radionuclide molecules, contrast agents, novel therapeutic devices, targeted delivery and increased patient safety are occurring at an incredibly fast pace. The human genome project, combined with bioinformatics and mining of big data, has led to the identification of key biomarkers in cancer and other diseases. Furthermore, with advancements in physics and engineering, the field of theranostics has emerged, bringing together predictive, diagnostic and therapeutic agents to detect and treat highly specific diseases.

It is an exciting time in the research and clinical development of new molecular imaging radionuclides. By demonstrating safety and efficacy, real-world evidence and a good risk-benefit profile, many new products are currently being marketed.

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