Annual SNM MI summit introduces the clinical tria...( RESTON Va.SNM will devote its annual...),Health

RESTON, Va.SNM will devote its annual Molecular Imaging Summit to introducing the new SNM Clinical Trials Network, Feb. 8𔃇, 2009, at the Hilton Clearwater Hotel, Clearwater, Fl. In part, the program will explain requirements of participation in the Clinical Trials Network, which was designed to facilitate cost-effective drug development through the integration of imaging biomarkers into Phase 1, 2, 3 and 4 therapeutics clinical trials. In addition, the workshop will explore key issues involved with imaging participation in multi-center trials.

"Attendance at this workshop is a must for imaging centers, pharmaceutical manufacturers and others who wish to be involved with the SNM's Clinical Trials Network," said Robert W. Atcher, Ph.D., M.B.A, president of SNM. "This intensive two-day program will outline the nuts and bolts of the network and requirements for participation."

The goal of SNM's Clinical Trials Network is to bring together the pharmaceutical industry, the imaging community, biomarker manufacturers and regulatory agencies and provide them with processes, standards and protocols to streamline the use of imaging in the development and testing processes for new pharmaceuticals. The use of imaging in clinical trials can help pharmaceutical developers determine earlier in the development process whether a new product is clinically promisingaccelerating the development of these promising drugs and eliminating those without apparent patient benefit. However, including these investigational imaging biomarkers in clinical trials for investigational therapeutics poses challenges for a drug development company, including a lack of standardized imaging methods and challenging regulatory approval or paperwork requirements for the imaging biomarker.

Several discussions between FDA and SNM have surfaced on this issue of limited harmonization of imaging protocols between multiple imaging centers. The use of a consistent methodology
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