Serialization Challenges Facing Pharma Manufacturers

Rajesh Singh, senior manager, and Brad Pedrow, manager, S&O Supply Chain Strategy, both at Deloitte Consulting, spoke with Pharmaceutical Technology about the challenges of serialization implementation, and how to improve processes ahead of the Drug Supply Chain Security Act (DSCSA) deadlines. To learn more about this and other topics, attend Singh and Pedrow’s presentation, “The Role of Track and Trace in a Post-Serialized World”, at CPhI North America on May 17, 2017 from 10:30 am to 12:00 pm.

An approaching deadline

PharmTech: What are some typical challenges facing pharma manufacturers as the November 2017 date for serialization approaches?

Singh and Pedrow: What we see in the market is multifold. Large pharma [companies] are mostly on track for meeting their obligations, mid-pharma tends to be a mixed bag, and small/virtual pharma seems to be behind. Most of the issues are organizational in nature (e.g., contract manufacturing organization dependency, over-dependence on consulting partner resources, lack of internal expertise, and a general reluctance by some upper management to do this the right way). Quite a few companies underestimated the complex nature of the effort it takes to do this correctly, especially the ones who did not do anything for the ePedigree law in CA. Additionally, we also see some companies, especially those who are late to the game, face some late-stage integration challenges due to lack of expertise and resources.

PharmTech: What kind of advice would you give a company that is unprepared for the DSCSA deadline?

Singh and Pedrow: Well, it is spring of 2017 already. If a company is in initial stages for November 2017, it is probably very late, not in terms of technology but finding the right resources. My advice would be not to delay any further and either outsource your serialization requirements to a third party or immediately initiate a program internally.

New technologies

PharmTech: What kinds of new technologies are making serialization easier for pharma manufacturers? Are there new technologies in development for serialization?

Singh and Pedrow: Companies that are late to the game tend to go for easier-to-set-up technologies that are cloud-based. The lead time for such solutions is far less than traditional on-premise (and perhaps more expensive) solutions. There are several vendors who offer this service. There are also talks in the industry on mechanisms to exchange serialization data with trading partners, considering some of the large wholesalers have already issued memos to run pilots with manufacturers. Interesting conversations are currently taking place in this regard.

The value of investing in serialization

PharmTech: Aside from the regulatory requirements, what is the value to pharma manufacturers investing in serialization and track and trace?

Singh and Pedrow: We see value in serialization as a by-product of this investment and not really the driver. However, had this regulation not been in place, few of these companies would have thought of leveraging the vast amount of data that can be used for efficiencies. We typically see conversations, pilots, and other efforts inside companies to improve inventory visibility, tracking of control substances, rebate and chargeback accuracy, and recall accuracy as main value drivers. Some companies are also investigating the value of block chain, which has an interesting place in this use case. All these trends will take some time to come to fruition. Lastly, we have seen quite a few cases of companies looking to leverage this investment for clinical trial supply management as well.

What to expect at CPhI North America

PharmTech: What will participants learn about serialization and track and trace during your CPhI North America session?

Singh and Pedrow: We will share what we are seeing in the market, some tactical aspects on how to get ready, and what the future looks like.