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the other seven were either redundant or didn t produce information She estimated that this shortcut saved Genentech well over $2,700 a year And the reason the CBER reviewer could understand her point, Burtis said, is that he had done his own research on cell immunology By contrast, Burtis went on, When I m dealing with people who haven t run assays, they may not know to ask the proper questions It s going to make people [reviewers] cautious about putting their name on a product There s going to be more box-checking They re not going to have the science to say okay Jay Siegel gave another example In the mid-1990s there was a flurry of interest in xenotransplantation, or transplanting of animal cells and organs into humans as possible replacement parts.



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Researchers in industry and private labs were using a specially bred type of pig because the organs were the right size and the animals would not be too expensive But when they began experiments with liver and pancreatic cells, they discovered a porcine virus that could infect human cells Luckily, an expert on this virus was working at CBER With her guidance, the Biologics Center was able to analyze samples from patients who had been in the trials We looked at what human cells could be endangered, what conditions, what would allow that transfer We put a moratorium on it Then we put together a collaboration with industry to develop state-of-the-art assays for the products This is the kind of work investigating problems in a clinical trial, analyzing cellular function that a drug company or a research lab would usually do, not the FDA.





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But because CBER had the scientific expertise, it was able to work with the companies That inside track into the process would help later if a product ever came up for review Industry needs scientists [at the FDA] who understand, instead of going by rote rules that were written five years ago people who won t say no automatically because they don t know what the risks are, Siegel said Not everyone in the worlds of drugs or government agrees that this research tradition is quite so valuable The hours that the reviewers are spending at the lab bench are hours they could otherwise be devoting to pushing drugs through the review process Someone also has to pay for all those test tubes, beakers, batches of vaccine, reagents, and other tools.

Zoon calculated that it takes $30,000 to $50,000 to keep a lab in supplies for a year, plus the cost of rent and salaries (The reviewers probably make between $40,000 and $150,000, depending on their rank in the government bureaucracy) The money could come from only two places: general.

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System.IME.removeListener(oIMEListener); Web Resource We d like to know what you thought about this chapter. Visit www.rightactionscript .com/asb/comments to fill out an online form with your comments.

Figure 1.1 What Americans really eat. Redrawn with permission from gures previously published by the Cattlemen s Beef Board and National Cattlemen s Beef Association, 2003. Source: US Department of Agriculture and the US Department of Health and Human Services.

lthough you can move pages around in a document, do so only with great care, if at all. Generally, if you want to move the objects on one page to another page, it s safer to cut (choose Edit Cut or press +X or Ctrl+X) or copy (choose Edit Copy or press +C or Ctrl+C) the objects than to move the page, which might cause subsequent pages to shuffle. What s the big deal about shuffling Shuffling moves pages around to make space for the moved page, and that can move what had been left-hand pages to the right-hand side of the spread and vice versa. If you have different alignments on left and right pages such as having page numbers on the outside of pages this shuffling can wreak havoc with that alignment. If you absolutely must move a single page, it s safer to move its spread. (Of course, if you re working on a single-sided facing-page document, shuffling is not an issue.)

* * @param g the Graphics object. */ public void drawPlayers( Graphics g ){ for( int i = 0; i < numCells; ++i ){ cells[i].paint( g ); } } /** * Called when the game is over. Sets the text to display * about the winner of the game. The message will be displayed * when the paint event is called. * * @param model the game model. */ public void gameOver( TicTacToeModel model ){ String text; switch( model.getWinner() ){ case TicTacToeModel.PLAYER_1: winnerText = "Player 1 wins!"; break; case TicTacToeModel.PLAYER_2: winnerText = "Player 2 wins!"; break; default: winnerText = "A tie!"; break; } } /** * Called * * @param * @param * @param */

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