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DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Supervisory Signature: C oncur ______________ Not Concur ______________ The primary study endpoint for leukoreduction was met for each SOLX group. Table 5-27 In vivo RBC Survival Studies for SOLX RBC Stored for 42 Days SOLX RBC demonstrated similar survival parameters for each analysis group. Table 2 presents the descriptive statistics for these Coagulation factors. I'm Anne Plant from NIST, National Institute of Standards and Technology.

Good morning. It's nice to see you?all here so early in the morning. We're looking more at systems biology?type approaches to tissue engineering.

And now since July of this year, we have what's called terms of reference. And now we have the strategic plan that was issued in June of this year. Tissue engineering could be used to produce vaccines and other complex drugs. And that's one of the areas that we see as important to carry out in research. We need to formulate better means of scaffolding and matrix environments. One of the other priority areas is assembling and maintaining complex tissues.

So we're talking about mixture of cells and how to design those cells, tissues. DR. PLANT: Thank you, Fred. We have time for one or two quick questions. DR. HOPKINS: Richard Hopkins from cardiac surgery, Children's Mercy Hospital.

It involves three agencies and six NIH institutes. So that is available. I think we heard a little bit yesterday about how these two fields intersect. And, in fact, there's a great deal of variability just in biological response.

And this is mainly where we work here at this interface, cells and tissues. But, again, the systems go all the way up to organs and whole animals. And we were looking at cells in a whole plate, in a well in a whole plate. So what are the tools then that we're using for the cellular systems biology? What we've done is validate this now to high throughput screening standards. What I've show you here are four different colors from the same field.

Stress pathway activation and cytoskeletal integrity again in this panel. That's shown in B here. We could then build heat maps out of this data. So now we have a known set of human toxicities on each of these compounds.

The way they're ranked across from left and right are what I told you. This is one way to look at the data in terms of just looking at one compound. So that's one way of visualizing the data to look at comparisons between them. For example, MTT which just shows you a cell loss or cell death assay. Then what we're really working on is this ranking, being able to rank them. DR. NEREM: Ken, over here, your last slide was sort of ?? triggered. For example, the array scan has an apotome, which we can do some sectioning. DR. GIULIANO: So, yes, so that's ?? there's two parts to that then.

And drugs of the similar mechanisms induce distinct cellular phenotypes. And for both of the studies, we use a same large dataset of microscopy data. And when we treat the drug, we use 16 titrations with 3, 4 dilutions. Then we treated ?? what we do is we put HeLa cell on 384?well plates. So in short, we have been able to capture four different types of features. And, of course, the very important feature everybody looks at is the intensity. With this in mind, I'm going to take you through our two different approaches. And then we can build a population's statistic for a control population.

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