We are exploring satellite or community infusion centers for weekly administration of an investigational IV therapy in the U.S., Australia and New Zealand. The goal is to reduce patient travel, improve retention and potentially establish a commercially viable infusion pathway as we keep patients on IP during OLE. This is for a rare genetic disease where subjects have mobility challenges and often become fatigued.

The primary site and PI would retain oversight, while the satellite location manages IP receipt, storage, preparation, administration, temperature control, accountability and documentation.

Has anyone implemented a similar model? If so, are there companies or organizations you recommend?

How were the satellite locations structured and overseen?
Which infusion networks or vendors did you use?
What regulatory or supply-chain challenges occurred?
Could the model transition to commercial use?
Did it improve patient retention?

Any experiences or recommendations would be appreciated.