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The Pharmaceutical Industry's Approach to the Problem of Resistance

For the pharmaceutical industry, identifying primary targets of those representing the toughest resistant ones is a high priority. Clearly the effort of essentially all pharmaceutical companies is to discover and develop agents that are safe and effective against clinical pathogens that are resistant to most antibacterials. In other words, right now, we're focused our discovery efforts to meet an unmet medical need. We can't deal with developing a new drug for a disease for which there is quite adequate therapy. We've got to go after the tough guys, meet that unmet medical need, whether we like it or not. And I think we do like it. We do want to follow that. That's a requirement now to be accepted by FDA. You have to meet unmet medical needs.

Basic research to recognize emerging mechanisms of resistance. I went through some mechanisms of resistance earlier, but as we develop, for instance, a new drug--and we're working on some right now-- before we even get to the point of placing the agent in humans, we start doing studies to see how rapidly emergence might occur with organisms that we're getting from clinics. These studies include a tremendous number of clinical isolates. We have to find out what the frequency might be of resistance. What the nature of the resistance might be with some expectations that our drug is going to last out there for some time and not be compromised by rapid development of resistance to it. In fact, we are constantly seeking a drug that's better than the agent in development before we even get final approval. By knowing something about the resistance patterns that might develop to a new agent and going ahead to discover an agent that will avoid that resistance mechanism, that's the optimum.

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