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SNM's Clinical Trials Network expands European membership of PET biomarker manufacturers
Date:7/23/2009

Reston, Va.SNM's Clinical Trials Network today announced that several leading commercial providers of PET radiopharmaceuticals in Europe have registered their manufacturing sites with the network. SNM's Clinical Trials Network is an initiative designed to address the need for streamlined drug discovery through the integration of imaging biomarkers into multi-center clinical trials.

According to Michael M. Graham, M.D., Ph.D., SNM President and co-chair of the Clinical Trials Network, "SNM is very pleased to have the support of Advanced Accelerator Applications, Erigal Limited and IBA Molecular. Their participation in the network will afford European clinical trial sites the option to obtain investigational imaging agents like FLT from a commercial provider instead of having to produce it themselves." These commercial manufacturers represent 27 PET manufacturing sites in Europe.

The SNM Clinical Trials Network has received investigational new drug (IND) status for the use of FLT in multicenter studies. The goal of the network is to receive multicenter IND status for additional imaging biomarkers over time. Each imaging site that participates in a study using an SNM multicenter IND will need to demonstrate that the biomarker for the study is manufactured in a manner consistent with FDA standards. Now, in place of submitting detailed information about in-house production methods, sites will have the option to purchase investigational biomarkers from a commercial manufacturer with a drug master file (DMF) on file with the FDA. Advanced Accelerator Applications, Erigal Limited and IBA Molecular have all expressed interest in participating in future multicenter clinical trials under SNM INDs. Participation in any specific trial will require that these manufacturers have chemistry, manufacturing and control (CMC) information on file with the FDA for the investigational imaging biomarker being used in that trial.

"We hope that having commerci
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Contact: Amy Shaw
ashaw@snm.org
703-652-6773
Society of Nuclear Medicine
Source:Eurekalert

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