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Re: stoprun post# 13525

Thursday, 04/19/2012 9:01:16 PM

Thursday, April 19, 2012 9:01:16 PM

Post# of 29254
Thanks and good luck to you too. You may be half right about the power struggle. But with whom? Their chairperson? It is possible. if that's the case and that is why the shareholders are getting hurt, if I was on their board, I would do a Donald Trump on the chair: "You're fired!" As i said in an earlier posting, I don't think she has a clue about how the biotech industry works, or even what a protein is or what it does. I was trying to recollect my interaction with Viropro's CEO when I first met him at Genentech in the 80s and we were working on getting tPA approved. Here's a story to share with you all if you have some patience to read it. He was a crazy determined character - I mean that in a good sense. Dont' know if any of you guys remember G'tech had a 6 month delay in getting a FDA approval. At issue was an unsteady impurity profile of the product. This guy was a hot biochem eng guy out of MIT. He proposed a diametrically opposite solution to what some of the best purification experts in the world were suggesting at G'tech. Nobody believed that could have been the source of the problem. There was unbelievable pressure to get it solved as each day late meant a couple of million bucks in lost revenues. My boss gave him a shot at it. The damn thing worked! You know what this guy told us? I'll never forget it because I switched my thinking about proteins after that - he seemed to have some sort of a gut feel about proteins. He said: "You've got to come down to the level of a protein and think like a protein. Imagine you are a wobbly, microscopic 3-D structure. Look at that pH change coming, feel it, it's going to broadside you; watch the bend in the pipe coming, because that shear is going to tear you up if you're not protected properly; look out for the salt gradient, it's like an invisible wind shear - if you can't navigate around it, it is bye-bye to the C-terminus, and so on (by the way, the guy was at that time a high performance sailplane pilot-used to talk endlessly about the joys of flying silently with the birds-that's why the wind shear comparison). And guess what? it was fluid shear in several areas of the piping that was creating an unsteady impurity profile, which is what the FDA had questioned. Saved G'tech a lot of bucks, I can tell you that for sure!