Feinstein Institute Gains Federal Approval to Manufacture State-of-the-Art Radiopharmaceuticals for PET Imaging
September 10, 2007
| For decades, scientists at The Feinstein Institute for Medical Research have been using positron emission tomography, or PET scanning, to help diagnose cancer and diseases of the heart and brain. Throughout the development and use of PET scanning, chemists in the basement of the premier research facility in Manhasset have been making the radiopharmaceuticals necessary to get a clearer look inside the human body. All the while, Thomas Chaly, PhD, chief of cyclotron radiochemistry, has made sure that the manufacturing of these substances is safe and effective. Now, Dr. Chaly’s work has paid off: The Feinstein is the nation’s first research institute to receive two new drug approvals from the US Food and Drug Administration (FDA). Last week, the FDA gave its seal of approval on Ammonia N 13 injections and two years ago, the use of fludeoxyglucose F18 injections for cancer and heart disease was given a thumbs-up. There are 65 other PET scanning centers throughout the country, and without such federal oversight, scientists can make their imaging pharmaceuticals without relying on exact standards set by the government. “Ultimately, new drug approval, or NDA status, makes it safer for patients,” Dr. Chaly said. The new approval for Ammonia N 13 is for PET imaging of the myocardium to diagnose suspected or existing coronary heart disease. Scans may be ordered before surgery to ensure the viability of the myocardium, the muscular tissue of the heart. Radiopharmaceuticals have a very short window of activity, called a half-life. In the case of Ammonia N 13, it’s about 10 minutes. A cyclotron is a particle accelerator that makes the radioactive tracer and tags it to a pharmaceutical, also known as a ligand. These substances mimic the body’s own physiological chemicals. The radiopharmaceutical follows a certain pathway in the body. Ammonia N 13 follows the route of the body’s blood system and so it’s used as a blood flow agent. Any breaches along this pathway – for instance a blockage in the heart, will be picked up by the scan. FDA approval for use of the radiopharmaceuticals also means that insurance companies are more likely to reimburse for a diagnostic test. Dr. Chaly and his colleagues now use 10 ligands in a number of imaging tests. Five federal drug regulators spent a week at the The Feinstein’s Manhasset, NY headquarters to ensure that the manufacturing process meets the rigorous federal standard. Patients from all over world travel to The Feinstein to undergo this state-of-the-art diagnostic imaging. About The Feinstein Headquartered in Manhasset, NY, The Feinstein Institute for Medical Research is home to international scientific leaders in Parkinson's disease, Alzheimer’s disease, psychiatric disorders, rheumatoid arthritis, lupus, sepsis, inflammatory bowel disease, diabetes, human genetics, leukemia, lymphoma, neuroimmunology, and medicinal chemistry. The Feinstein Institute, part of the North Shore-LIJ Health System, ranks in the top 6th percentile of all National Institutes of Health grants awarded to research centers. Feinstein researchers are developing new drugs and drug targets, and producing results where science meets the patient. For more information, please visit www.FeinsteinInstitute.org or http://feinsteininstitute.typepad.com/feinsteinweblog Media Contact: Jamie Talan 516-562-1232 |