With the first DSCSA deadline just two years away, pharmaceutical serialization and traceability is the hot topic and in this issue we offer some unique perspective.

Systech’s vice president of global strategic marketing, Darryl Brown, identifies trends reshaping the pharmaceutical and contract service industry including moving beyond compliance, better managing supply chain risk, brand protection as a global priority and how data driven analytics are becoming a major value play.

In “Trends in Contract Pharma Serialization and Supply Chain Security” beginning on page 62, he says here in America, the National Association of Boards of Pharmacy estimates that in 2010, the market for counterfeit product was valued at $75 billion—approximately 8% of the overall market. Some global estimates are as high as $200 billion.

Mr. Brown’s advice? Adapt or die.

“Advances in technology, regulation, counterfeiting, globalization and market demands for an increasing array of products have created an environment in which we must be more flexible and adaptable than ever before,” he says. “The ability to anticipate and adapt to change will be the hallmark of success.”

One company helping the pharma industry meet drug traceability regulations head on is France-based Adents. The serialization and track-and-trace specialist provides software solutions for the pharmaceutical and life sciences industries and recently opened its first U.S. location in Princeton, NJ. This opening comes just months after the company, which is headquartered near Paris, debuted its first North American subsidiary in Montreal, Canada.

Contract Pharma talked with Erik Bronander, senior director of sales, Americas for Adents, about recent news at the company as well as broader market trends. He says the multiple delays in previous mandates have created an atmosphere of delay, leading up to the realization that people who are waiting to the last minute are going to be putting their business at risk. Read his advice on how not to be left behind starting on page 40.

In addition to the content provided in this issue, serialization will also be one of the hot topics at the 14th Annual Contract Pharma Contracting & Outsourcing Conference and Tabletop Exhibition later this month. On the first day, Sept. 17, the Pfizer Keynote talk will address practical considerations for serialization implementation across a diverse network of internal sites and external suppliers. It will be delivered by Kurt Wieditz who is currently director of strategic projects within the external supply operating unit of Pfizer Global Supply.

With the current and pending regulatory requirements impacting product serialization and track and trace requirements, it is important to develop and execute appropriate compliance strategies and project governance to assure continued supply.

Mr. Wieditz will share some insights and learning’s from over 10 years of Pfizer’s experience with serialization pilots, recent deployments and active implementations. Along the way he will also examine and debunk some commonly held serialization myths. For full conference information and the complete agenda, turn to the Conference Preview beginning on page 118.

And if you haven’t registered there’s still time! Visit conference.contractpharma.com and 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