The Parenteral Drug Association recently held its first global conference on emerging manufacturing technologies. Among the
presentations were those discussing the latest in disposable technologies, aseptic filling and closing, and barrier systems.
Clearly, technology vendors have stepped up efforts to streamline processes and better handle complex drug products.
Whether manufacturers are ready to implement these technologies, however, wasn't so obvious. During a luncheon, my tablemates
debated over whether drug makers will ever be able to provide personalized medicine. In the end, they generally agreed this
was a long way from fruition. But the conversation prompted a PDA official to pose an even tougher question: Faced with two
compounds, one that is simple, easy to manufacture, but must be administered monthly, and another that is much more complex
but can be taken only once a year, which would you pursue to market?
What was so surprising was that, unlike the personalized-medicines issue, no one offered an immediate and definitive opinion.
After a seemingly long silence, the pros and cons were weighed: How long would the simpler formulation sustain a reasonable
market share before a competitive product was marketed that required less frequent dosing? Would the inconvenience of more
frequent dosing have a higher risk for patient noncompliance? The complex formulation would cost more and carry a higher risk
of error during development, but it offered a preferred dosage regimen and patient compliance would (theoretically) be greater.
The general consensus was that, all points considered, manufacturers could not afford not to pursue the once-per-year dose. Patient-focused healthcare is here and now, ready or not. Sooner rather than later, technologies
will have to be updated, not only, as one speaker stated, because "the aggressive use of technology makes good business sense,"
but also because it will soon be common sense.
is a senior editor of Pharmaceutical Technology,