Drug Development and Moving the Bottlenecks
I’ve read many articles recently about attempts to improve the whole drug development process and much of the focus seems to be on the drug discovery side. While I agree that drug discovery can be made more efficient, I think that this may just result in moving the bottleneck to the development arena, an area that in general from my experience gets somewhat overlooked in terms of how do we make development (making clinical trial materials) more efficient. I do think that the decoding of the human genome will eventually result in more potential target for drug discovery and help to focus their efforts in the future since most of the low lying fruit has already been picked. I think many people were overly optimistic as to how long it would be before the decoding of the human genome would lead to something concrete.
A large part of the problem is you don’t want to spend an inordinate amount of effort developing a great route to a compound, only to have it fail in the clinic. Determining failure in the clinic as soon as possible is imperative before they get into the large and expensive phase III trials. However, by the time it is clear that the drug will indeed succeed, it is usually determined (mainly by management and regulatory departments) to be too lately to make any changes to the route. This invariably leads to an inefficient processes being rolled out commercially. One of the reasons for that is the amount of work required to change a commercial route once it is validated and filed. I truly think more effort needs to be dedicated to getting a workable process in place for making changes to allow for
Process analytical technology (PAT) will help if it can be economically done by retrofitting current facilities. Expecting companies to scrap investment in facilities and equipment just to incorporate PAT is unlikely to happen. However, if PAT could be easily retrofitted into existing equipment it would certainly be more widely adopted.
Note that the bulk active post approval changes guidance has been removed from the FDA Guidance website since it was reported in the Federal Register on June 1, 2006 that they were “inconsistent with the agency’s initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative). However, looking through the CGMP Initiative nothing directly addresses the issue of what needs to be done if a change is to occur after approval. I for one sincerely hope this is an area of development that is looked at in more detail to allow for changes to occur which could improve the quality and efficiency of producing bulk active ingredients.
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