NanoGuardian has struck a deal in which SDI will run the proactive, post-marketing monitoring portion of the Closed-Loop Protection program, an anticounterfeiting initiative of the Skokie, IL-based product-authentication technology company. SDI (Plymouth Meeting, PA) will capitalize on its worldwide clinical and institutional review board connections to select prescribers and retail locations from which drugs will be procured for authentication by NanoGuardian.
The Closed-Loop Protection program combines on-dose marking for authentication purposes with a proactive pharmacy-auditing program to identify counterfeit or illegally diverted pharmaceuticals in the global supply chain. Authentication is provided by NanoGuardian’s NanoEncryption technology, applied to drugs during manufacture and then used for verification at NanoGuardian facilities after post-marketing sampling. The technology provides both overt and covert security features through use of NanoCodes, which the company says can be associated with product, manufacturing, distribution, and other information.
The program amounts to an early warning system, allowing manufacturers to detect counterfeit and diverted products, says NanoGuardian, thereby mitigating risk to brands and patients. “To ensure the success of Closed-Loop Protection, it was vital to partner with an organization such as SDI, which has the regulatory experience in conducting proactive market monitoring services and that can manage networks of pharmacies and physicians,” says Dean Hart, EVP at NanoGuardian.
Clinical network access
In the NanoGuardian deal, SDI will set up networks of physicians who will write prescriptions to be filled at retail pharmacies, to then be picked up by security personnel and sent to NanoGuardian labs to be checked for authenticity. To establish the networks, SDI is extending existing efforts in which the company has developed surveillance systems for diseases using such sources as physician reports and lab and claims information gathered worldwide. “Because of these networks, we are able to access these folks reliably to provide information,” says Laurel Edelman, VP for clinical accounts. By working through IRBs, SDI ensure the medical community that its work is clinically relevant, protocols are established, and information is handled in conformance with HIPAA requirements.
Different NanoGuardian clients will have different drug brands requiring different surveillance networks. “What’s unique is finding the right participants—finding providers who are prescribing a certain kind of drug, which brings efficiency to the process,” says Edelman. “The networks will be tailored to the locations and sites where the drugs are being utilized. We want to target to get the highest volume in shortest time.”
First steps for SDI involve developing clinical protocols for IRB review. Doctor recruitment and background checks will follow.