From discovering and developing a new drug, testing to ensure its safety & effectiveness, determining how the drug should be delivered, and the demanding regulatory environment, most drugs take years before they are introduced into a market. Add in the fact that 7 in 10 products that reach market never recover the cost of development, and the challenging nature of the pharmaceutical industry becomes clear.
For as long as I can remember, one thing has always stood out to me about pharma—the razor-sharp focus on speed & flexibility is a way of life. After all, being the first to offer a promising new treatment can go a long way to galvanize a drug’s success. Speed is critical because drug makers need to start making money as soon as they can to not only recover what they have already invested, but also to ensure profitability. Flexibility is also incredibly important, and particularly relevant to the supplier side of drug development.
Three Ways Packaging Suppliers Can Support Fast & Flexible Turnarounds
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Meet with your customer early … I try to do an initial “discovery” meeting at least 10 months in advance of launch to understand the specific project needs. Once you know this, plan out how you will ensure your team’s attention and accessibility. Then convey this assurance to your pharmaceutical client—they demand it and depend on it. With your internal team, build trust … and don’t be afraid to call in a favor to hit a deadline.
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Memorize the Prescription Drug User Fee Act (PDUFA) date. It is critically important and determines all other timelines. I use this date and work backwards to establish key deadlines for packaging needs, including materials and artwork. In essence, the PDUFA date is the official launch date from the FDA for US products.
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Artwork matters. Package labeling, print, and artwork may seem ancillary, but they are not, especially in pharma. The FDA must approve the final artwork before it is turned over to packaging. Also, know your materials. Pharma companies are looking for perfect and consistent printing, and this does not exist on certain materials. There are many characteristics that may need to be changed to produce the level of printing they require. Therefore, always ask for preliminary artwork—an iterative process begun early is a best practice.
The pharmaceutical industry is no doubt different from the medical device industry—it’s demanding, colorful, quicker. Pharmaceutical products are meant to be packaged immediately; they don’t sit on a shelf the same way a medical device might. Therefore, speed and flexibility are nonnegotiable when working with pharmaceutical clients. If you can deliver on those, you’ll succeed as a trusted supplier. I’ve been a part of the pharma industry for more than 20 years, and there’s nowhere else I’d rather be!
