An Interview With Brian Thompson (Vice President Demand Supply Chain and Purchasing DSM Pharmaceuticals, Inc. a unit of DSM Pharmaceutical Products)

Tuesday, August 27, 2013

Brian Thompson Vice President Demand Supply Chain and Purchasing DSM Pharmaceuticals, Inc. a unit of DSM Pharmaceutical Products

1. How does serialization mitigate risk in the pharmaceutical supply chain?

From a CMO’s perspective, serialization should help prevent fraud and help DSM as well as its customers’ research any issues reported downstream in the supply chain. Through serialization and other technologies like video surveillance, DSM will have the ability to investigate primary and secondary packaging units to the exact time they were packaged during a standard packaging run.

As a CMO, DSM is implementing serialization solutions in order to help customers achieve regulatory compliance. As it relates to security and business, serialization should reduce the risk of fraud and improve the efficiency of investigating issues reported downstream in the supply chain.

2. What are the challenges associated with serialization?

The primary challenges related to serialization are the uncertainty of HR1919 getting passed by the US Senate and the short timeline for implementation required by the state of California. DSM is seeing varying degrees of activity in the market regarding serialization. Some pharmaceutical companies are taking more of a wait-and-see approach while others are actively implementing serialization in order to meet the California requirements. DSM is aligned with the latter of these and currently plans to have a solution in place before 2015. The uncertainty around HR1919 creates challenges for DSM and its customers related to building business cases for investment in serialization. This becomes particularly challenging given the California requirement to have solutions in place before 2015.

Technical challenges related to serialization include:

Multiple customers with multiple requirements, for example:
Push or pull serial numbers
Location of serial numbers on packaging units
Differences in data transfer methods
Lack of industry best practices and standards
Different requirements in different regions of the world

There are also significant challenges for the marketers related to tracking numbers and lack of downstream technology to fully utilize the serial numbers.

3. How do you assess new technologies for trackand- trace capabilities?

For more than five years DSM, along with its partners, has been preparing for the upcoming serialization requirement though the use of a pilot scale packaging lab. Because of this, DSM feels it is wellpositioned to deliver on a serialization solution that is flexible enough to meet the challenges mentioned above. Below is a comprehensive list of factors that DSM used to evaluate potential solutions.