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Optimal Solution team selected for FDA DSCSA Pilot Program
PRINCETON, N.J., April 24, 2019 /PRNewswire/ -- After a rigorous screening process, a team comprising six strategic technology partners has been selected to participate in a new Food and Drug Administration (FDA) pilot program aimed at making it easier for pharmaceutical companies to comply with the Drug Supply Chain Security Act (DSCSA). The pilot team includes supply chain technology leaders RXTransparent, Systech, T-Systems, FarmaTrust, Cryptowerk, and CalQLogic.
"The DSCSA is the shield that protects Americans from counterfeit and suspect drug supply. When it was first ratified, a fully interoperable drug supply chain was an aspirational goal. The pilot program is a multi-vendor, synergistic team formed to translate the DSCSA's vision into reality," says Dwight deVera, founder and CEO at RXTransparent.
The pilot builds upon the team's earlier work with the Center For Supply Chain Studies, a non-profit industry research and educational organization. Called "The Optimal Solution - a Federated Approach to Trusted Transactions in the Interoperable DSCSA," the program will provide the FDA and the industry with a fully interoperable solution that can be used to identify, track and trace prescription pharmaceuticals throughout the US supply chain.
Given the foundational technical challenge posed by interoperability in the supply chain, Ara Ohanian, CEO of Systech observes: "The Optimal Solution pilot intends to demonstrate what is possible using a variety of technologies to support the industry's goal of 'interoperability' in addition to showcasing new capabilities that will provide further solutions to ensure that the US Drug Supply Chain is the safest in world."
Addressing the unique, founding philosophy of the team, Jim Sabogal, Head of Healthcare & Life Sciences at T-Systems notes: "No single company provides an end to end solution that meets every DSCSA requirement while providing enhanced security and safety for pharmaceutical products. The Optimal Solution pilot will show what is possible using innovative technologies and showcasing capabilities from a team of vendors collaborating toward a common goal."
But, what would achieving "interoperability" mean for stakeholders in the supply chain? Discussing this question, Shahnawaz Aziz, CTO at FarmaTrust asserts: "In the DSCSA domain, "interoperability" translates directly into dramatically improving the health outcomes for individuals and populations. Therefore, The Optimal Solution pilot program will address interoperability as a central objective."
"By leveraging our advanced technologies in a fully interoperable fashion, this pilot approach addresses product safety and trust issues beyond compliance. We believe we are creating a unique solution with an unmatched combination of partners as a viable blueprint for the whole industry," says Peter Ebert, SVP at Cryptowerk.
The collective approach is designed to meet and excel regulatory requirements with a solution that includes:
- Utilizing a digital e-Fingerprint® layer of security to create an immutable track and trace ledger that improves visibility and enhances counterfeiting detection at the product level
- Capturing the Internet of Things (IOT) and Cold Chain information to leverage data for additional consumer insight and analytics
- Deploying blockchain as the infrastructure to enable interoperability providing a reliable foundation for trust in data that has been elusive with other technologies
The formation of this cooperative team is no accident. As Swamy Narayanaswamy, CTO of CalQLogic relates: "The technology providers that comprise The Optimal Solution team represent a combination of best of breed vendors from a cross section of the industry that have been collaborating for several years to answer the DSCSA challenge for supply chain stakeholders."
The pilot duration is proposed as six months with the final FDA presentation anticipated for Fall 2019.
Dwight deVera, CEO
Jefferson Barr, VP Marketing
SOURCE Systech International