• There is a lack of consensus on what best practice is across various cultures.

• The regulations differ across countries.

• The regulations change.

• There are differences in cultural thinking.

For the last point, I would like to describe the main influences that drive differences in European versus American culture when it comes to animal research. In Europe, as opposed to the US, many things are uniform, because things are the equivalent of federally driven, whether it’s a speed limit that goes across the country, whether it’s VAT or sales tax across the country. In the US, every state is different. [For example,] the sales tax will be different—we all know the states that don’t have sales tax, and if you live near them you tend to visit them so you can get a break of 6 to 7 percent on whatever you are buying. There is a lot of diversity in the US as far as the way we expect things to happen. I’m originally from New Jersey; I travel back there a lot for family. I can use a cell phone in the state of Pennsylvania, and the minute I cross the New Jersey state border I put it away because I’m not allowed to use it unless I have a hands-free model. This is an example of differences.

Our way of living sometimes translates into the way we think about things. Generally speaking, in Europe, many things are consensus-driven—people say “let’s have a discussion.” Right now, there is the European Directive, driving similar practices in all EU countries. The US, for better or for worse, tends to work on threshold: We tolerate a lot, whether it’s national debt or handguns—whatever it happens to be—until a certain threshold is met, and then things happen. The good news is, when a threshold is met, something usually happens quickly. The bad news is that it generally takes a while to hit a threshold. The reverse would be in consensus: sometimes it takes a while to get to that outcome, but people are talking about a topic and thinking about it.

To me, the important question is, Do the variations that exist really result in a big difference in the way we care for animals in different parts of the world? Is it possible to align principles, independent of differing standards, which are the more prescriptive way of looking at animals in research?

Some of the differences, compared to academia:

• Industry usually has a very large internal capacity, there are many things we can do internally. [For example,] we generally have the option to buy equipment if we feel it’s needed and we can defend the budget for doing so.

• Industry tends to be a regulated environment. Even the earlier work has probably many more regulations than are normally seen in academia.

• Industry has many different requirements because it spans different countries and includes different types of studies, from efficacy models in transgenic animals to highly regulated GLP studies in macaques.

• Of course, timelines are extremely important.



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