Costly Cost-Cutting Conundrum

We have a well-established/legacy drug product—an oral anti-viral medication—that is registered in over 70 countries. We’re under a lot of pressure to find cost savings on the stability side which we could achieve on the testing side by modernizing with lower variability and faster throughput test methods, like UHPLC, for example. We could also cut costs through reduction of intervals and bracketing across similar packaging types and sizes. Overall, we’re looking at the potential for $2.5 million in savings over five years of testing.

The problem, though, is that those numbers are purely hypothetical with extreme upfront costs for method development, validation and establishing new specifications, not to mention the cost of updating registrations in all those countries. I’m not even sure we have the manpower to achieve this without going on a mini hiring spree in the analytical chemistry and regulatory groups. If we carelessly dive in and try to speedily modernize everything, I’m afraid we’ll never actually break even before this product is ultimately retired.

What are some strategies and advice we could follow to make this modernization project profitable and not just the “cool new thing”?

One way to cost-justify these changes is if they are tacked on to other significant product improvements; something like a packaging improvement, reformulation or process improvement, or perhaps all three. The costs of implementing these analytical/stability improvements could easily outweigh future stability savings. For example, you will end up with so many registration stability studies that they alone could dwarf the cost of your status quo annual stability over the next 5 years.