39 FDA drug approvals in 2012: everything is back to normal(?)

FDA approved 39 new drugs last year. This is great news no question about it. First thought is for celebration. Indeed. We needed this, and that's good news for all of us working in the drug discovery industry. Taking the large lay-offs, especially in the US, affecting thousands of people, I think this gives back something, at least the hope that this trend is about to change. But is it? I think it is worth digging a bit deeper and see what were the keys for this success. As demonstrated at BioSpring, 50% of the approved drugs were basically in-licensed by big pharma and 100% involved some SME (small/medium-sized enterprise) as a partner during discovery/development. What does this mean? If I would work for a big pharma company, I would probably not feel assured about future, as these numbers suggest as least for me that innovation is coming from SME and it is acquired or in-licensed by big pharma. One might also see trends like big pharma becoming investors and it is the SME that is focusing on discovery. I think this is normal and have nothing to do against great scientists working at big pharma. This is really not about which scientists have better capabilities, are they innovative or not, so don't take this personally. I think this is about what Steve Blank said once (can't remember the exact words, sorry). Imagine someone working at McDonalds coming up with the idea on a nice, sunny morning to prepare the burgers based on a new recipe. What would happen? He would be convinced to stop this non-sense and get back to work, and if he is still not getting it, he will be soon on the road to seek a new job (or starting his new shop based on the new recipe). I think there is an analogy to the pharma industry. Big pharma is good in execution, but that is probably not enough and is not the reason for the high number of new approved drugs on the market. Opinions?

Chemical probes vs. drugs

I came across this nice blog post on Chemical probes vs. drugs, and I think it touches an important issue. Several (mainly academic) groups identifying hits on novel targets with a suboptimal property profile. Some hits contain reactive functional groups or have an extreme lipophilicity. In these cases, it is always advisable to check the specificity of the hits as the compounds can actually bind to many targets and for example phenotypic effects might be due to other mechanism of action than the target in focus. Both reactive functional groups and high lipophilicity can be associated with selectivity issues and therefore they are less favored for further exploration. But there is a commonly used excuse for "ugly" compounds: that even though they are not fulfilling the criteria for entering into a drug discovery project, they are still useful "tool compounds" or "chemical probes". In the light of the cited Nature paper (very nice title btw: "Stay on target"), this should be reconsidered, as a chemical probe should be even more selective than drug candidates. I think this is worth remembering when dealing with results obtained with less nice compounds. Specificity should be tested at least on a basic level.