| More like an automotive hobbyist who has enough of a machine shop in the garage to (barely) be able to do any of the engine work they need themself. Other hobbyists have this too, about half the equipment or less compared to an established hot-rod shop. But this guy is designing and building his own radically different engine, optimized to be better performing than anything else out there no matter how big the established alternative teams, including multinationals. Nothing else even qualifies as a milestone in this garage. People across-the-board give such minuscule credit to the way some individuals can accomplish what the biggest teams can't. In this case one of the key elements is that the product needs to be more easily manufactured profitably and reliably" compared to potential competitive materials or it will not be more attractive to approve and deploy compared to what other choices there are. Not only that but it needs to be more attractive financially, period, compared to all other drugs of any kind* considering costs of technical challenges, raw materials, energy, etc. Otherwise it is less likely to have a chance at enough backing to ascend from the benchtop to anybody's pharmacopoeia to begin with. At the Contract Drug Manufacturing Organization (CDMO) the factory productivity itself is the main feature, which makes the shareholders break out the Champagne when milligrams are the effective dose and it's cheap enough to make kilos, beyond a certain point. One of the things about industrial processes is that it takes a team to carry out the operation, but often mainly only because it is operating at industrial scale. So that is taken for granted at the top of the mind always. In relation to that, people usually think that developing the process itself from "nothing to something" also requires a team of researchers and experimenters in about the same way, at laboratory scale. Because that's what usually happens and has been known to work as well as it has, which is pretty good. It just doesn't cover all the bases, plus over the decades most of the places where lab teams have overgrown it's from directors' firm grasp of how long it takes to reach any decent milestone at all. And their response too often has been to "speed things up" when resources allow by crowding the labs a bit in spite of how many mythical-man-months accrue over the decades :\ Herd mentality can trump individual greatness, and it can be a slippery slope. Leaving better-than-ever greenfields for the ambitions individual, but it takes guts like few others. Here, one of the pillars of manufacturing success, ease of production, is pushed to the far side of the long tail to be within reach of a single-handed operator. The easier the better for everybody, but this is a severe focus-inducing limitation to allow going without a team which could otherwise help build things that one person just can not do. But sometimes there's no other choice if you're going to get something accomplished on your own using very limited resources anyway, and you want to start sooner rather that later. If you can make a viable prototype in a garage it may very well be the kind that is more financially feasible to mass-produce compared to things that could never even get off the ground no matter how advanced the "conventional" team is with their orders-of-magnitude greater resources. Ownership structure could make the difference too, as a blurb I'd say ask a few PhD medicinal chemists what they would do to own 100% of their own inventions ;) And this garage is not ugly. If you've seen what's in back at a random FDA-approved manufacturing facility, that can be. Ug. Ly. Garage did pretty good for a couple of notable companies like Hewlett-Packard and Apple too :) |