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Reston, Va.-SNM and the International Partnership for Critical Markers of Disease (CMOD) organized a special joint session the evening of May 1, 2009, at the National Institutes of Health. The meeting was designed to share presentations and engage in discussion about the manufacturing of PET radiopharmaceuticals.
To kick off the evening, Peter Libby, M.D., co-founder of CMOD, and Michael M. Graham, Ph.D., M.D., president-elect of SNM, welcomed the group to a special session examining FDA requirements for manufacturing PET radiopharmaceuticals.
"We are delighted to bring everyone together tonight to facilitate discussion among various stakeholders-including pharmaceutical developers, regulatory agencies, the imaging community and others," said Dr. Graham, director of nuclear medicine at the University of Iowa Carver College of Medicine, to the packed audience. "In conversations with these partners, we continue to hear that there is a real need in the community for information about issues of current good manufacturing practice (CGMP), chemistry, manufacturing and control (CMC) and associated regulatory issues for the manufacturing of PET radiopharmaceuticals. SNM's new centralized IND provides to the community an opportunity to enable the implementation of investigational and approved PET imaging in multicenter clinical trials."
Throughout the evening, speakers surveyed the regulatory history of positron emission tomography (PET), reviewed current guidelines for PET radiopharmaceutical compounding and discussed challenges and opportunities from both the commercial as well as the academic perspective. Invited speakers also addressed the critical necessity of developing new tracers and radiopharmaceuticals in compliance with FDA's current cGMP and CMC regulations. Sally Schwarz, Washington University, provided a detailed overview of the requirements of U.S. Pharmacopeia (USP) General Chapter <823>, "Radiopharmaceuticals for Positron Emission Tomography: Compounding," and the proposed draft §212.5(b) FDA rule. Following Sally Schwarz, Eldon Leutzinger, Ph.D., chemistry team leader at FDA, presented an overview of the current draft FDA regulations, issued in 2005. Dr. Leutzinger noted that "the evenings' presentations had covered the multiple aspects and regulatory issues facing PET imaging at this time, but when the forthcoming guidance is published with the final rule, we believe it will be helpful to PET producers in understanding how to come into compliance with the PET requirements."
"We are so pleased that CMOD and SNM were able to put together this in-depth and engaging joint session," said Thérèse Heinonen, D.V.M., executive director of CMOD. "With the topics of PET manufacturing, regulatory compliance and pharmaceutical development of critical importance to both our organizations, teaming up seemed like a natural fit."
"It was really a team effort," added Graham. "That is how we approach our collaboration with various partners-as a joint effort that brings together multiple partners. SNM's goal is to provide a framework and a forum for these discussions to occur."
The evening concluded with a lively, interactive panel discussion. Because of the ongoing need to address standardization and harmonization across imaging sites, SNM plans to host a number of Webinars later this year on compliance with USP Chapter 823 and draft FDA guidelines. Additionally, CMOD and SNM will host a joint session at CMOD's upcoming annual meeting in October. A file of the talks given at the May 1 meeting will be available for download from the SNM and CMOD Web sites later this week. Please visit www.snm.org or www.cmod.org to access these files.
SNM is an international scientific and medical organization dedicated to raising public awareness about what molecular imaging is and how it can help provide patients with the best health care possible. SNM members specialize in molecular imaging, a vital element of today's medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated.
SNM's more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit www.snm.org.
About the International Partnership for Critical Markers of Disease (CMOD)
The mission of the International Partnership for Critical Markers of Disease (CMOD) is to accelerate the identification, validation and appropriate application of biomarkers in cardiovascular and related diseases.
CMOD works to: provide scientifically rigorous and balanced information on established and novel biomarkers and imaging technologies; facilitate the cooperative exchange of ideas and information about critical biomarkers among clinical and basic scientists, governmental regulatory agencies, pharmaceutical, biotech and diagnostic companies, health care providers, and patient groups; identify issues in biomarker identification and offer educational programs that provide access to the most current information on biomarker and related sciences to meet educational needs; and promote and support collaborative initiatives to advance the identification, validation and application of biomarkers most efficiently. For more information, visit www.cmod.org.