From this morning's Chemical and Engineering News, Rudy Baum's comment on a panel discussion he hosted between John LaMattina (former Pfizer R&D head) and Professor Ronald Breslow (emphasis CJ's):
I hope things change, and soon. Best wishes for all of us.
Breslow said that the chemistry enterprise faces a “morale” problem. “We used to tell students that, if you take an advanced degree in chemistry, your career will be secure. That’s not true anymore.” Like LaMattina, Breslow took aim at the consolidation of the pharmaceutical industry. “Mergers may make great financial sense, but they are very destructive,” he said. “And not just to the pharmaceutical industry, but to the chemistry community in general.”
Mergers and acquisitions in the pharmaceutical industry aren’t going away, of course, and LaMattina observed that the biotech industry isn’t immune to the trend. Breslow insisted that the economic strength of the U.S. “is largely based on the strength of our science and technology. Government must continue to recognize that support for science is important.”
Although the discussions and the question-and-answer follow-up were lively and informative, they did not offer much in the way of reassurance for U.S. chemists in the pharmaceutical industry who fear for their futures.I don't know where Ron Breslow has stood in the past, but I think it's very important that senior members of the academic chemical community recognize the economic picture facing current generations of American chemists. I don't know if it's too much to ask senior members of the pharmaceutical industry to be able to make similar statements about our employment futures; Dr. LaMattina doesn't seem to have directly addressed the issue at the forum.
I hope things change, and soon. Best wishes for all of us.
This tripe: "decline in R&D spend is coupled with an increasingly tough regulatory environment, making it more difficult for drugs to progress through pipelines: 55 drugs failed at the Phase III stage during 2008–2010, more than double the number of failures during 2005–2007."
ReplyDeleteAlways annoys me, as it assumes all NDA/BLA filings are of equal value. I do not think this is true.
There was a paper published a few years back in J Clin Oncol discussing how smaller companies are incented to file NDAs even on compounds they know have 0 shot at approval, especially if the company doesn't have anything else in the clinic. For execs no downside, and waiting for NDA decision means more salary.
OREX's recent announcement of a 10,000 clinical study for its pointless drug contrave is a good example. No chance that turd gets approved, but CEO buys himself 2 more years at $1 mill/yr + (I'm pretty sure) a decent expense account.
bboooooya I am unclear what you consider as "tripe" about the statement? Subsequent comments suggest you view doubling Phase III failures is primarily due to inadequate projects motivated by self-serving financing. While I am sure that does happen, particularly now where predominately investors mandate having Clinical data not just POC studies, would expect overall that is not a significant number and further such mostly would likely not make it in to Phase III.
ReplyDeleteAt the same time although I concur there has been a decline in R&D spend and the regulatory process tougher (and not all NDA/BLA equivalent with a few bad ones) hence fewer total numbers and higher barriers to overcome those seem as partial contributors so any attempted correlations or causation discussion that only includes those does not explain these results. I don't recall anything that provides completely reasonable answers on direction Pharma has taken in past few decades however from LaMattina statements I have read he does offer good insights on certain aspects.
CMCguy
"you view doubling Phase III failures is primarily due to inadequate projects motivated by self-serving financing."
ReplyDeleteI do.
To be fair, I have no data to back this up and it's not even clear to me what data one could acquire: i.e. I'm not sure there is a way to quantify the adequacy of NDA filings beyond the current pass/fail. Even among NDAs that do get a pass, many are for crap drugs that don't generate even enough revenue to begin to pay taxes (looking at you, SOMX/AVNR/VNDA).
Morale problem? That's like saying someone with a broken arm has a "discomfort" problem...
ReplyDeleteYes, morale problem indeed. Personally, I suspect that a lot of the comments we see like this -coming from some big shot, expressing concern over the situation while also grossly diminishing the problem -are just a way of putting people off. I feel like they want me to believe they want to solve the problem and that it's manageable, but I don't believe it. I think that they're just trying to keep the status quo intact for as long as possible.
ReplyDelete