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tensive therapy, a program that has defined hemodynamic action may naturally lead into the field of congestive heart failure. In the field of lipid-lowering therapy, one may have an agent that modulates vascular biology, that reduces second myocardial infarctions, and that might have a role in the prevention of death in ischemic heart disease. I think the time in the development process to plan out these further developmental strategies, which could lead to a far greater expansion of the market, would be after the NDA filing. |
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I have the impression there is a pervasive feeling that what one is looking for is the holy grail of approval and after that everything else will fall into place. Additional claims and additional indications are of dubious benefit. I think this is not correct. Experience has demonstrated that additional information in the medical literature leads to further indications for a drug. Having additional use of the drug may lead to further development and claims should be included in the product insert: physicians are more likely to use the product for the other indications when they have used it for the initial indication. In terms of costs, this is a far more economical means of promotion and a far more rational one. Depending upon off-label use rather than proceeding with additional studies is wrong, especially within our current regulatory framework that limits off label promotion. These types of studies are expensive, but I think industry could pursue a more collaborative approach with academia and government agencies. The need to monitor these studies as one would do for a pivotal trial, and for the same stipends to the investigators, is just not required. Still, the information may prove to be very useful and I think for collateral claims the FDA may depend more and more on published materials as long as they accurately contain the information necessary for review. |
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Drug development and discovery is a most exciting field. It is creative, intellectually taxing, and organizationally demanding. Those involved are to be congratulated for undertaking efforts that are usually anonymous but that impact on clinical therapeutics to a considerable degree. The drug discovery process has gone through the botanical phase, the synthetic chemistry phase, and is now into a most exciting era of biotechnology and gene manipulation. There is an awful lot of hoopla in this arena, but we must remember, it is just one of the rings of a three-ring circus. There is a tremendous evolution in our understanding of medicine, disease processes, and our statistical evaluation of clinical trials and these are important evolving arenas that dynamically interact with the drug discovery process. A third arena, the drug development program itself, is being markedly affected by the Third Wave, the information age. We can only think back to when a chapter like this would be handwritten, typed on a typewriter with carbon paper, corrections made, and then a copy sent off |
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