Biotech filter - what are the major steps

March 7, 2008 7:26 PM

Normally I would go back to my university (aka Wikipedia) for this question but I'm not getting the full picture... can you help me understand the whole pharma/biotech value chain and the major inputs and outputs of each major phase (R&D, development, clinical trials, pharmacokinetics, manufacturing, distribution (guessing)) and the risks that threaten each step. Thanks
posted by Barrows to technology (8 comments total)

Brief overview from Hoovers

How to Learn About an Industry or a Specific Company

Answer to a question about a different industry but the how-to may be helpful.
posted by MLIS at 8:58 PM on March 7 [2 favorites]

Can you be more specific? As written your question is so broad as to require pages of response to be even slightly thorough. The microanswer:

R&D - lots of money chasing unknowns. try a bazillion different molecules and see if any of them do something. when you get something interesting try all analogues. biotech is more like the last part, find some interesting pathway or marker and try to manipulate it. End result a new molecular entity or biologic that looks like it works in the test tube and in a limited animal model.

Development - take the results from R&D and try to make something you might be able to sell. end result, it seems to work well in a large animal model, you haven't given it to humans yet, except perhaps to yourself (yes, it happens).

Clinical trials - dig a huge hole and dump in $30 to $100 million. Every once in awhile one of those holes will start spouting billions, if that NME is safe and efficacious. End result - FDA approval (although you might get foreign approvals first and start selling overseas).

Manufacturing and distribution - boring, next

Selling - a cadre of young and beautiful detailers descend upon doctors to convince them of the wonderful new drug's benefits, and why it is better (less side effects, more efficacious) than your competitors similar new drug.

Patent challenges - after you have invested hundreds of millions in development, clinical trials, and marketing, a generic manufacturer will come along to challenge your patent as invalid. they challenge every patent, every single one. every three or four times they do this (for about $5 million a pop) they get a winner and have six months of exclusivity to market their generic version of your drug. They make $50 million or so and build up a fund to do it all over, your profits dry up.
posted by caddis at 6:22 AM on March 8

The risks that threaten the first three of your "steps" are summed nicely (and quantified to some degree) in this seminal work.

If you want facts and figures, this guy writes one of the industry's annual bibles, which you can probably find at a big city library. Or you could shell out $300 for your own copy.
posted by Kwantsar at 8:51 AM on March 8

I'm not sure if this is what you want exactly but I can explain about clincal trials..
Usually there are three phases. The first phase has a small amount of people. If that phase succeeds it moves to Phase Two which has more people, then to phase three which has a lot of people. Sometimes drugs can skip phase three if they have proven themselves and are an important drug (eg something that could prevent heart attacks or clean arteries).. Most studies are double-blinded. That means that half of the group is getting a placebo and the other half isn't. No one knows what the patient is getting except for a computer (and maybe a few people). After the study period they break the code and find out who was getting what. Most study medications have a literal black box on them that in case of emergency can be removed so that if say they have to go to a hospital they can find out what they were getting.

Hope that helps!
posted by majikstreet at 10:19 AM on March 8

Layman here, probably stating the obvious, but take care not to think of it too immutably as a chain - it isn't just a linear process through the steps. For example, obviously, data from the trials (and other steps) also feeds back into R&D (and other steps). The prize example would be a potential new product emerging from noticing a common side-effect of a drug in trials, a side-effect which in another context, would be useful in and of itself.
posted by -harlequin- at 10:53 AM on March 8

majikstreet's explanation of clinical trial blinding is good, but kind of glosses over what the purpose of the phases are:

Phase 0: Doesn't gather data on whether the drug is safe of if it works. Only used to compare if the drug is processed by the human body in the same way that one would expect from the animal data obtained.

Phase 1: Is the drug safe when tested on about fifty people? How much of the drug dose is too little to be processed by the body or too much to produce intolerable side-effects. Whether or not the drug "works" or is therapeutic is not the purpose of this phase either.

Phase 2: Does the drug work at all on about 200 people? Phase 1 safety issues are also looked in addition to whether there is any benefit at all (however small) to patients taking the drug.

Phase 3: Is the drug any better than what's already available? Usually over 1,000 patients are tested in this phase. If the new drug does not result in a therapy better than what's currently prescribed, then the drug fails the clinical trial in this phase.

Phase 4: Post approval surveillance. After the drug reaches the market, trials are done to verify that no additional side-effects or drawbacks are present from taking the medication.

These are pretty big hurdles to overcome and should suggest why pharma corps. require very large budgets, produce very expensive medicines, and have extremely daunting challenges to overcome to complete their mission.
posted by dendrite at 2:05 PM on March 8

Thanks guys this is great stuff
posted by Barrows at 2:11 PM on March 10

Let us know if you need more specifics in some areas. It is a complex and interesting industry. I think it is more interesting than the computer industry, but it reaches less folk on a day to day basis so gets lets press. The energy industry is even more arcane, yet worthy of study. Anyway, there are a few of us here who study this one, so if you have specific questions let em' fly. We might have answers.
posted by caddis at 7:59 PM on March 10