As we go to press the deadline to comply with the U.S. Drug Supply Chain Security Act (DSCSA) is only 90 days away! Yikes. As you are all aware, with the first deadline so close, serialization/traceability is one of the most talked about topics across the industry. In this issue we’ve gathered some expert perspectives from across the supply chain.

Daniela Geiger, product and service manager at the CDMO Vetter, talks about the problem of drug counterfeiting, which has led regulatory agencies around the world to implement safety measures, such as the U.S. DSCSA. She says the economic impact of fake drugs ranges anywhere from $75-$200 billion and can make up between 8-15% of all drugs sold in lower income nations. While drug counterfeiting is costing the industry tens of millions of dollars annually it is more importantly endangering the lives of people taking them.

In, “The Psychology of DSCSA: Four Stages of Serialization,” Larry Hotz, marketing manager WDPrx, says it’s imperative for manufacturers to adopt post-serialization efficiencies now. Citing a 2016 survey he says that only 13.5% of respondents said their companies had their full serialization program in operation! Obviously, those who have adopted a proactive approach are now in the ideal position. For those manufacturers that have postponed serialization plans, Mr. Hotz offers some practical how-to advice on how they can get ahead with their serialization compliance strategy.

From the manufacturer’s perspective, Linda Kristoffersen and Dave Colombo from KPMG’s Life Sciences Advisory talk about serialization validation and right fitting your strategy with a CMO. The authors say that in order to define an appropriate validation strategy with the right balance of risk, three key factors should be evaluated: the CMOs serialization experience; IT integration model; and packaging line capabilities.

In addition to the articles provided in this issue, we have assembled an expert panel to discuss serialization at the 16th Annual Contract Pharma Contracting & Outsourcing Conference and Tabletop Exhibition taking place Sept. 14-15. On the morning of Sept. 14, from 11:15-12:00, the panel, entitled, “Serialization Strategies for Success,” will offer several manufacturers’ perspectives on serialization and the impacts to the organization, technology and operational processes. The panel features experts from Allergan; Sandoz/Novartis; Regeneron; and will be moderated by KPMG’s Mr. Colombo, co-author of the previously mentioned article.

For full conference information and the complete agenda, turn to the Conference Preview beginning on page 102. If you haven’t registered there’s still time! Visit conference.contractpharma.com and/or come to the Hyatt in New Brunswick to sign up on-site. Either way, make sure you’re a part of the industry’s leading event dedicated to Pharma and Biopharma Outsourcing. Hope to see you there!

Tim Wright, Editor
twright@rodmanmedia.com