News
News Release
Cyclomedical Applications Group, LLC
Broadens its Regulatory Expertise
Contact: James F. Lamb, Ph.D.
+1-865-670-9021
jlamb@cyclomedical.com
KNOXVILLE, Tennessee,
2006 May 15—Cyclomedical Applications Group is proud to announce that a regulatory expert recognized in both the United States and Canada has joined its team of Associates. Cyclomedical will now be in a position to assist a larger number of clients with their regulatory needs related to PET (positron emission tomography) accelerator operations, on both sides of the border.
Michael Jamieson has built an international reputation around his ability to develop innovative solutions which enable companies to get their products and facilities through regulatory channels in a timely fashion. He is an experienced senior manager with over twenty years of diverse international research and development, regulatory approval and regulatory compliance expertise. Mike has been involved in numerous nuclear medicine projects including the regulatory approval of a number of therapeutic and diagnostic radiopharmaceuticals. In recent years Mike has spent a significant portion of his time in South America overseeing the building of GMP-compliant manufacturing facilities. For the last five years he has been a member of the Academic Advisory Board for the Masters Program in Regulatory Science at the University of Southern California. He also lectures on International Regulatory issues within the program. Michael Jamieson’s operational base is in Ottawa, Canada, and he has worked effectively with regulatory bodies in both Canada and the United States. He founded Pharmacon Research Inc. which is now known as InSource Innovations Inc.
David Drummond, Vice President of International Marketing for Cyclomedical, stated, “We are excited to add Mike to our team of experts. As PET imaging begins to expand rapidly in Canada, with several new cyclotron facilities planned, Cyclomedical is well positioned to address the regulatory requirements of those operations.”
Dr. James Lamb, President of Cyclomedical, added, “Mike Jamieson will be a valuable addition to our team of regulatory experts. Licensing and regulatory compliance are areas in which Cyclomedical can provide critical support to our clients.”
Cyclomedical Applications Group is an organization of experienced radiopharmaceutical experts serving the nuclear medicine industry, especially owners and operators of medical accelerators dedicated to the production of positron emitting radioisotopes. It works primarily with facilities producing and distributing F-18 FDG—the most widely used positron-emitting radiopharmaceutical in PET scanning. Consulting services offered by the company range from short-term consultation to longer-term retainer arrangements and assistance with regulatory agencies as well as cyclotron operation and FDG production problems. Contract management services range from full responsibility for a cyclotron/FDG production facility to a monitoring posture in support of an in-place management team. Cyclomedical’s goal is to provide a full range of support expertise including FDG market research and development, facility financing, facility planning and operation, licensing and safety, and FDA regulatory issues. The company currently has operational responsibility for several cyclotron/FDG facilities and is providing consultation services to a number of accelerator-operating companies. For more information, see the Cyclomedical web site at www.cyclomedical.com.