Is it hard or the hardest?

The quirks that make drug development so hard:
[Via business|bytes|genes|molecules]

People outside the pharma industry rarely realize how difficult a task the drug discovery process is. But perhaps, even among scientists, there is a significant lack of knowledge of the complexities of the drug development process. Part of the reason is that this process happens behind the closed walls of pharma and is rarely published, but it’s also not the sexy part of bringing a therapeutic to market.

Derek Lowe’s post on a patent dispute between Novartis and the Government of India speaks to this complexity (in this case polymorphs).
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I would make the argument that the full panoply of techniques, tools and innovations required to get a drug to market represent some of the most difficult processes our society deals with on a regular basis.

We start with a system that we barely understand – a living human being. An individual has so many cellular and chemical reactions going on, all evolved to be very resilient. Figuring out how to fix a single broken process is hard. Now imagine that there seldom is just one process involved, that not only are there a wide variety of other reactions that take part, but that multiple reactions that will be affected by any single fix.

Then realize that is just in one individual. Genetic and epigenetic differences mean that there are millions (billions?) of different combinations of reactions, each slightly different with slightly different properties, as we move from an individual to a population.

And that is just the discovery side. Then the drug has to be made in quantities that can be effective, it has to be produced in a reproducible fashion, it has to be delivered in the correct form and must not have any really deleterious effects in any of the population.

Frankly, I think going to the Moon is easier. Not only were we working with pretty defined systems, the physics was also well known. The ease of the Moon shot compared to drug development can be seen in the fact that we got to the Moon with 8 years after we decided to try.

A recent study suggests a much longer timeframe for drugs. For many of the most important drugs, it took closer to 24 years from initial discovery in the lab to an approved drug. Just the time from the start of clinical trials to approval can take 8 years, as long as it took us to get to the moon.

That drug companies can accomplish as many ‘Moon programs’ as they do is remarkable.

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