One could say that supply chain security is the most critical issue facing drug manufacturers today—and perhaps facing our healthcare system as well. The supply chain is at the heart of healthcare’s greatest problems—drug counterfeiting and adulteration, shortages of key medicines, and of course escalating medical costs. Without security of supply, none of these challenges can be addressed.
What today's drug supply chain needs is a holistic approach beyond what’s been practiced traditionally. So say Pfizer senior director of supply chain security Brian Johnson and consultant Russ Somma—who, in a webcast yesterday on Supply Chain Threats, Strategies, and Successes, presented their versions of what a holistic approach to supply chain security looks like.
Johnson outlined Pfizer’s comprehensive approach. Pfizer is arguably the drug industry’s leader in this area—aggressively moving to pilot new security technologies and partner globally to thwart counterfeiters of Viagra and other key products. To its credit, it has been willing to share its expertise with other manufacturers. “We believe that supply chain security is something we’re all in together,” Johnson said.
“Where we buy our raw materials and manufacture and sell our products is changing,” he added. “I’ve been in this business for 28 years. Ten years ago we weren’t looking at the global, complex supply chain that we see today . . . so these trends everyone can recognize and appreciate. Given the increasing threats, we as a company said it’s time to step back and make sure we have a one-Pfizer strategy on supply chain security.”
In the webcast, Johnson maps out how supply chain security is tightly integrated throughout the organization. In their planning, he and colleagues identified over 100 different business processes and over 15 different organizations that needed to be woven into the program.
“Yes, but that’s Pfizer,” the industry often says. “What relevance does that have to my company, whether small, medium or large?”
“I hear that all the time,” noted Somma, who presented on how the principles of Quality by Design can, and should, be applied across the entire supply chain. “The pieces that you need in Quality by Design are precepts or principles for applying and accumulating knowledge. We use this information for startup, intermediate as well as large companies in the work we do. It’s not simply something that Pfizer does. That’s a misunderstanding. It’s a principle that should be applied, and it cuts across all sizes.”
Drug substance specifications and stability data collected early in development, for example, need to be leveraged to secure the supply chain throughout the product lifecycle, said Somma.
“If you are in the business of making medicines and delivering safe and authentic medicines to patients, you need to do the right thing,” said Johnson. “It doesn’t matter what the size of the company is. The systems and processes that I showed in my presentation are things that are pretty well understood and done in the industry . . . The size of the company does not matter. If you’re in this business, there is a baseline level of responsibility that you have.”
Here again is the link for the program. A brief registration is required.