Well I guess I'll throw my admittedly biased hat into the ring. I apologize for the lenght. I work for a small drug company. We have only 2 drugs on the US market.
Commonly accepted numbers are 550 to 750 million dollars to get a drug from a chemist's test tube to market over a period of 10 -12 years. This numbers are supllied by the PMA a business group representing drug companies but they are considered legitimate numbers.
I work in a dept call pharmacokinetics. We try to tell how much of a compound is in the body and what it is doing while it is in there. We mostly use triple quadropole mass spectrometers coupled to liquid chromatography systems (LC/MS/MS). These sytems average 300,000 dollars and I have 6. You need to add in scientists to operate them and operational costs to keep the instrument up and running. If we contracted this out the range is 100 - 150 dollars per SAMPLE. One small animal study will include 100 samples. We run 100 samples every night on at least 4 0f the LC/MS/MS 5 days a week. You can see the costs multiplying and I am just one small lab.
We need to pay for animals and facilities, we need chemists to synthesize the drug and then a process place to make quantities sufficient to perform the study. My lab is just ququantifying the compound. Similar teams are running tests for efficacy - does the drug even work. That is the big question and you never truly know until you are in the second clinical (human) trial.
We do at least two years of animal studies and test tube metabolism studies to see if we have a viable candidate to go into man. We file an IND with the FDA. They review all the data and will give us a go/no go to start clinical trials. Once we file the IND our patent protection kicks in. But we have another 8-10 years of FDA mandated testing before we can get to market. By time we hit the market our patent protection is nearly over. Then the generics run simple bio-equivalence studies and get approval.
FDA mandated studies include long term toxicological studies in two species. These can extend for two years. We also run 3 phases of clinical trials with a population pool large enough to make statistically significant differences noticable. We have depts of statisticians to interpret results.
We do all of this in a highly regulated environment know as cGxP - current Good Clinical or Manufacturing Practice as defined in the Code of Federal Regulations. I must calibrate bi-annually all of my instruments. Even my freezers are calibrated and monitored. The water I use is monitored and delivered from a calibrated filter. We spend 33 percent of our time on FDA paperwork. Sometimes I feel that if I
f@art I have to record where and when in some sort of log /forums/images/graemlins/laugh.gif I am overseeing the qualification/verification and calibration of all of the lab computers. For my small group we have spent 5 months so far working on this. We will pay consultants close to 1 million dollars to help us do this. That does not include my nor any other employees time plus lost "production time" as we can't run samples during the validation process.
We employ 160 people in the lab site. probably 100 are in the lab. Besides the HR group we have lawyers, patent people and regulatory people. That is here. In our Corp HQ are all the paper pushers that plan studies, deal with the feds, deal with the study physiicians, interpret data and file reports with the FDA. Our last NDA (last step for approval) filled 1 tractor trailer with paper reports for the FDA's review. Corp HQ employs more people than here. And we have a third production site with their own scientists, regulatory, HR, etc.
All of this to ensure a safe drug available for the market place.
Am I rich? No. Do I feel like I work for an evil company -NO. I feel that I do an important job that eventually will do good for society at large. I must admit I get tired of the drug companies being painted as the bad goes. I no longer vote for any politician that attempts to demonize the drug industry.
Well thanks for listening.
Phil
