QDIS Blog

Occasionally my reading material stacks up and I have to set aside some time to go over it and read through all the various trade journals and magazines I get. In the course of that exercise, I came across a good article on HIV/AIDS in Drug Discovery and Development.

A Quarter Century of Battling HIV/AIDS

Since the XVI International AIDS Conference is occurring in Toronto, Canada this week, I though it was a good time to alert folks to this.

Basically 21 drugs have been approved since 1987 or about one per year. And this doesn’t include the recent approval of Atripla, the three drug combo for once a day dosing. I’ll post more about some developments on Atripla later this week.

Technorati Tags: aids drugs, HIV drugs

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Healthworld IT is reporting that Steven Paul, executive vice president at Eli Lilly is stating that the cost to develop drugs could top $2 BILLION by 2010 if changes are not made.

Drug Costs Nearing $2 Billion, Warns Lilly Executive

Other than mentioning the FDA’s Critical Path Initiative there isn’t much else new here. The one point that always seems to get mention is the need to reduce the attrition rate in phase II. Currently only 20% make it to phase III studies (one on five). Biomarkers may help with this but I still think that your are always going to have phase II as the place to make go-no go decisions. This makes sense if you stop and think about it. This is the first place where it is tested in humans for the disease indication and the first time it is tested in more than a few people. It should be expected that this is where potential drugs are going to fail. Until we develop much better animal models, this will continue to be the case.

I do think the talk of allowing the use of biomarkers and possibly allowing drugs to go onto market for those identified with certain biomarkers after a successful phase II study could help. However, I don’t see this happening anytime soon as a lot of processes and procedures would need to be put into place before it could be eliminated.

I do find the following quote from the article to be interesting:

The effective patent life of blockbuster drugs is approaching 10 years, said Paul, who contrasted that short lifespan with the 50 years of copyright protection enjoyed by Mickey Mouse! “We should start the clock when the drug reaches market,” Paul suggested.

I think pharmaceutical executives tend to forget or overlook the current attitudes of consumers. There is already much talk about how expensive drugs are and this seems to play right into the view of some consumers of pharmaceutical companies being greedy. While increasing potential income is one approach, I think there is much more room for improvement with the lead discovery to phase II stages.

Technorati Tags: drug development, drug cost

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