SNM and the International Partnership for Critical Markers of Disease (CMOD) are co-hosting an in-depth meeting on Friday, May 1, 2009, examining The US Food and Drug Administration (FDA) requirements for manufacturing positron emission tomography (PET) radiopharmaceuticals. The meeting, which takes place at the Natcher Auditorium, National Institutes of Health, Bethesda, Maryland, is scheduled to begin at 6:10 p.m. and conclude at 9:45 p.m.
“We are pleased to collaborate with the International Partnership for Critical Markers of Disease on this important meeting,” said Michael Graham,, SNM president-elect and director of nuclear medicine at the University of Iowa Carver College of Medicine. “New developments in molecular imaging technologies are dramatically improving the ways in which cardiovascular disease, neurological disorders and cancer are diagnosed and treated. It is essential that we work together as a scientific community to facilitate personalized medicine through the development of advanced imaging techniques and new radiopharmaceuticals that will enable physicians to determine early on the precise location of disease, and evaluate and monitor the effectiveness of therapy.”
“SNM and CMOD share a common interest in accelerating scientific research to bring the best in health care to patients today,” said Thérèse Heinonen, DVM, executive director of the International Partnership for Critical Markers of Disease. “With an active interest in the evaluation of potential cardiovascular biomarkers and their appropriate application in clinical trials, a partnership with SNM is a natural fit.”
Don Black, head of research and development at GE Healthcare’s Medical Diagnostics, Dwaine Rieves, director of medical imaging at the US Food and Drug Administration, and Michael Graham from SNM will kick off the special May 1 evening session. Dennis Swanson, University of Pittsburgh, and Sally Schwarz, Washington University, will survey the regulation history of PET and review current regulations for PET compounding. Joseph Hung, Mayo Clinic, along with other distinguished speakers, will address the critical necessity of developing new tracers and radiopharmaceuticals in compliance with FDA’s current good manufacturing practice (CGMP) and chemistry, manufacturing and control (CMC) regulations. Experts will then address the need for harmonization and standardization across multiple imaging sites and discuss the concept of a centralized IND and SNM’s new Clinical Trials Network. The meeting will conclude with an interactive question and answer session and panel discussion.
This meeting will take place immediately following SNM’s Multimodality Cardiovascular Molecular Imaging Symposium (CVMI), Apr. 30–May 1, also at the Natcher Auditorium of the National Institutes of Health.