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 se-
rialization 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 pack-
aging line capabilities.
In addition to the articles provided in this issue, we have assem-
bled an expert panel to discuss serialization at the 16th Annual Con-
tract 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; Regen-
eron; 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
DSCSA Deadline Approaches
An expert panel will convene at Contract Pharma’s upcoming conference to discuss key serialization
issues, challenges and trends
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