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Biotech / Medical : momo-T/FIF -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (5918)	4/8/2007 12:43:04 PM
From: former_pgs	Read Replies (1) \| Respond to of 12215

>but absent some biomarker, I am (like you) unclear what else they can do.< They do have a surface biomarker (CD54) that is upregulated and the extent of upregulation appears to correlate with clinical efficacy. However, it is quite evident that the company does not have control over the extent of upregulation. Therefore, I don't think the FDA could reasonably demand that CD54 upregulation pass a certain threshold for every patient since the company can't make it happen at this stage. I think the manufacturing on this one comes down to "we do it this way and it appears to work", and the danger of trying to micromanage the steps of the preparation may inadvertantly "lose" or downregulate the factor that drives the efficacy. So if the FDA approves, they're going to have to be generally "off-hands" from the manufacturing, short of demanding sterility and mechanical reproducibility of the process. I agree that this seems to be the kind of process that the FDA has nightmares about insofar as their ability to control and validate. The additional factor is that the more burden you put on the sponsor of these methods, the more likely you are to lose potency imo. Since they are using live cells, most will inevitably begin to differentiate with time in culture. I don't know exactly how amenable these antigen presenting cells are to maintaining their phenotype ex vivo (rick?), but I'd want to keep the processing time to a minimum.