Biopharma Climbs The Serialization Mountain

By Louis Garguilo, Chief Editor, Outsourced Pharma

The data associated with drug-product serialization will be Everest-like; accessing it may pose every bit the security risk. The difference is millions of people may be trying to access the summit … every day.

On the ground, biopharma and contract packaging organizations (CPO) will pile on hundreds of millions of unique serial numbers, matrix codes and other identifiers to enable the traceability of products. By the time we get into 2023, when the U.S. Drug Supply Chain Security Act (DSCSA) calls for a national system of “serialization,” we may already have petabytes of data associated with drug-product, supply-chain, store-location, and even consumer-behavior information. Perhaps biopharma will have partnered with Silicon-Valley for support.

What’s clear today is that a national program for drug serialization looms large on the horizon, and rises, if you will, high into the data clouds.

A Shared Resource

The U.S. Congress has mandated the FDA and biopharma industry come up with an “electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” In this case, it doesn’t feel like government overreach: Theft, counterfeiting and other safety threats to our drug supply need addressing.

Twenty-seven months into the DSCSA – over seven years to go – a major concern is the ultimate responsibility for securely maintaining all this data, while ideally allowing easy access for both producer and patient. Readers of OutsourcedPharma.com will also want to understand the role that contract packaging organizations will play.

In our first look at serialization, we learned how one CPO has already moved decisively in the direction of affixing GTIN [Global Trade Identification Number], serial numbers, lot numbers, expiry dates, and data-matrix coding, to ultimately allow for an aggregation of data from saleable units to pallets. In other words, enabling traceability from plant to patient.

“Digital copies of most the information will be accessible to CPOs, for at least reference purposes,” says Gaurav Banerjee, Director, Technical Services - US & EU, Sharp Packaging Solutions. “But to be clear, this is proprietary information that belongs to the drug manufacturer.”

Those brand-owners will need sophisticated and safe database and cloud solutions for data storage and access. By 2023, when complete supply-chain traceability is expected per the DSCSA, brand owners will need the ability to reference product as it is distributed throughout the supply chain, down to a question about a particular box that was sold in a drug store.

Since most biopharma will not want to build out digital infrastructure – or become IT companies anymore than they have to – this challenge might be outsourced to the clouds of the IBMs, or even Amazons, who have established themselves in this field. There’s also a growing number of IT companies with business models based solely on serving the biopharma industry and its data needs.

Back to the CPO, they need some form of digital copies for processing these unique identifiers to the extent customers track product and generate data today, and to the extent it will be required by regulators in future. However, as Banerjee makes clear, “We’re not in the business of generating that data, like a software company might be.

“We’re in the business of treating the data the same way we treat the pills,” he continues. “Our customer has a product, we process it, and we send it back to them. It’s the same concept with information. They send us numbers, we apply them to packaging as needed, process it, and send it back with the physical goods. We only hold on to a copy for our records and as per requirements.”

That particular data exchange sounds straightforward, but it introduces larger challenges. Not only will biopharma need to generate millions of unique identifying numbers and data-matrix codes (something we can’t get into here), but the industry will also be dealing with the challenge of a much broader and frequent exchange of drug-product data to multiple parties.

Can We Bank On It?

An important priority for the FDA and biopharma, then, is the setting of standards for how proprietary drug-related information is exchanged. Currently, at the most there are some emerging information-exchange standards, called EPCIS (electronic product code information service), which have been introduced by barcoding and labeling industry organizations.

Banerjee compares this situation with that of another industry. “If you think about the financial industry – specifically in banking – there are universally set rules for performing a secure and traceable inter-bank transfer of funds. How that communication happens from bank to bank is well established and regulated. As of today, there are no regulations governing how pharmaceutical product encoding needs to be captured, maintained, or transmitted.”

What we have – although for the most part biopharma is not yet open to discussing systems or plans – are companies and their IT service providers pursuing their own policies and procedures. Banerjee does see some organically occurring progress on this front, though. “In the absence of absolute clarity, I believe the branded-drug manufacturers are doing their best to follow emerging regulations on how this information is to be captured, manipulated and transmitted, and for the most part this helps drive the entire industry forward.”

The CPOs are also moving forward in conjunction with their biopharma customers, and as the FDA and industry overall continues to work toward ultimate regulation. Banerjee sees CPO who develop superior strategies and systems for handling this data potentially gaining significant competitive advantages. For now, he says, “We have secure databases where we access data that tells us we ran product X for customer A, lot number 123, and lists all the numbers that were applied. Only select individuals with permission to access that information at our company can get to it now. Again, to us it’s strictly the customer’s data, stored for the purpose of potential future query.” It remains to be seen how much “data-bank” transferring those customers will have to do in the future, and whether the CPO themselves will come to play a larger role.

Atop The Mountain

We’ll end this particular expedition with three thoughts: First, one has to wonder if biopharma – and/or the FDA – are employing Silicon Valley and other IT folks in the U.S. for data accumulation, storage, access/exchange, and security advice. Google and AbbVie, just to name one example, have started working together as drug development partners. Further tech-pharma relationships might turn serialization into a U.S.-based industry advantage.

Second, we said early in this article that this government-led push to serialization can be seen as a positive development. However, let’s hope that in practice the initiative is led by private-sector dynamism. And, as we’ve seen in both our articles on this subject, contract service providers will have a lot to offer. Finally, serialization should be yet another contributing factor in the growth of biopharma outsourcing overall. While it will require a coordinated effort to get there, “Mount Serialization” could offer everyone some great views.