Three European providers of PET radiopharmaceuticals--Advanced Accelerator Applications, Erigal Limited and IBA Molecular--have registered their manufacturing sites with SNM's Clinical Trials Network.
The SNM network is an initiative designed to address the need for streamlined drug discovery through the integration of imaging biomarkers into multicenter clinical trials.
According to Michael M. Graham, MD, PhD, SNM's president and co-chair of the Clinical Trials Network, the companies' "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."
The three commercial manufacturers represent 27 PET radiopharmaceutical 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 society said that 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, sites will have the option to purchase investigational biomarkers from a commercial manufacturer with a drug master file on file with the FDA.
Advanced Accelerator Applications, Erigal and IBA have all expressed interest in participating in future multicenter clinical trials under SNM INDs, the society reported. Participation in any specific trial will require that these manufacturers have chemistry, manufacturing and control information on file with the FDA for the investigational imaging biomarker being used in that trial.
There are currently 201 manufacturing sites registered with the network worldwide, with 23 percent located in European regions.