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Building onto SNM's Clinical Trials Network is the recent addition of several leading commercial providers of PET radiopharmaceuticals in Europe that have registered their manufacturing sites with the network.
Michael M. Graham, MD, PhD, 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 commercial PET radiopharmaceutical producers supply investigational agents will further improve the level of standardization in imaging biomarker production. But this in no way reduces the need for single site produced biomarkers. We need both," said Dr. Graham.
Having commercial availability of IND PET drugs for use in clinical trials for future therapeutic agents will also greatly enhance the number of sites that have access to biomarkers like FLT and may increase the number of sites able to participate in these studies.
There are currently 201 manufacturing sites registered with the network worldwide, with 23% located in European regions.