Overcoming difficulties shipping a Named Patient Program product to Belarus

Condition

Cancer

Drug Type

Approved

Where Approved

US

About Sponsor

The sponsor is a biopharmaceutical company accelerating the development of new and improved medical products for various types of cancer. Its goal is to create targeted, effective therapies that make a significant impact to the lives of patients and their caregivers around the world.

Challenge

The sponsor partnered with WEP Clinical to set-up a Named Patient Program (NPP) to supply its approved product to ex-clinical trial patients living in countries where the company does not plan to commercialize. Because the product is not approved in these countries, our team must follow appropriate regulatory channels to import the drug on an unlicensed basis. This requires support and cooperation from local physicians, who are expected to act on their patient’s behalf. However, we faced particular difficulty shipping product to Belarus, as the treating physician there was largely unresponsive to our communication and was hesitant to complete the necessary paperwork.

WEP Solution

The lead WEP Clinical Project Manager (PM) for this NPP decided to enlist the help of the CRO who had managed the company’s clinical trial efforts in Belarus, as they had experience working with the physicians during the trial. The CRO team was able to encourage the physician to compete the necessary quality forms and supported the physician through the process. However, the physician refused to complete the paperwork to apply for the import permits from the the Belarusian Ministry of Health. To overcome this issue, our PM team contracted with a local logistics company, that could apply on the physician’s behalf. The negotiations, contracts, quality technical agreements and regulatory import permits took 5 months to collect and complete, but the patient did receive treatment and the sponsor company was extremely grateful to our team for their efforts in overcoming all the challenges.

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