Q&A: The Impact and Benefit of Serialization on Rare Disease Therapies

At FutureLink Barcelona 2019 in June, the serialization discussion will focus on the value of digital information sharing Can healthcare manufacturers use data to help patients and physicians?

With the EU Falsified Medicines Directive (FMD) and Drug Supply Chain Security Act (DSCSA) deadlines now passed, many companies are looking for the value beyond compliance.

At FutureLink Barcelona 2019 in June, the discussion around serialization will shift from a focus on compliance and discuss the value of digital information sharing and how serialized data can be used to improve communications with partners and patients.

The event takes place June 11-13, where leaders from across the life sciences industry will gather to explore the future of healthcare delivery and how serialized data can drive innovation, transform business operations and improve patient outcomes.

We spoke to one of the members of the event’s advisory board, Naseem Amin, CEO at GMP-Orphan (as well as a qualified medical doctor, a graduate from the Royal Free & University College Medical School, London) and asked him a few questions about serialization compliance and how he thinks the industry will change in the coming years.

Healthcare Packaging (HCP): What have been some of the challenges for your organization when it comes to the FMD?

Naseem Amin: We’re a niche player working with incredibly small volumes of drugs when compared to some of the ‘big’ pharmaceutical manufacturers. Our most advanced product candidate is Cuprior for the treatment of Wilson’s Disease and we only have around 1,000 patients across Europe at any one time. As such, we’re manufacturing very small volumes of a drug.

While the implementation of an FMD-compliant solution with the support of vendors such as TraceLink was necessary, it was also a resource- and capital-heavy investment so we’ve had to figure out ways to make more of our investment.

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