Challenges and Opportunities in Molecular Imaging

Molecular imaging research has been focused on identification of tumor specific markers and the application of these markers for evaluation of patient response to radiation therapy, chemotherapy or chemo/radiotherapy. Though the opportunities are involved in molecule in licensing, yet, the challenges involves in regulatory compliance in investigative new drugs such as chemistry, manufacturing, control, pre-clinical pharmacology/toxicology and clinic protocol management. In this article, we reviewed the opportunities and challenges in molecular imaging using generator produced isotopes. 99mTc (technetium-99m), 68Ga (gallium-68) and 188Re (rhenium-188) are generator-produced isotopes which are readily-accessible and affordable. These generator produced isotopes were developed to label molecular targets for prediction of therapeutic response, monitoring tumor response to treatment and differential diagnosis. 188Re is a therapeutic radionuclide which can be used to target tumors and deliver lethal radiation due to high-energy β- emissions. Challenges and opportunities in molecular imaging involving drug discovery, validation, intellectual property in licensing and regulatory compliance are discussed.