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and what I would like to do is sort of walk through the future state that we think is a desired state and then try to link yesterday's discussion and today's discussion to that and hopefully connect those dots.

I think the drug discovery development paradigm is shifting, and one anticipated outcome is that the trend would be more towards targeted small populations and drugs developed for those, and I think that itself creates a challenge, and manufacturing would have to be flexible to adapt to that.  At the same time, I think efficiency of manufacturing processes need to be at a much higher level for many different reasons.

So in the drug quality system for the 21st century, we essentially want to recognize that pharmaceutical manufacturing is evolving from an art form to one that is now science- and engineering-based.  Effectively using this knowledge in regulatory decisions, not only for establishing specifications but also for evaluating manufacturing processes, can substantially improve the efficiency of both manufacturing and regulatory processes.

This initiative is designed to do just that,

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