I sit on the R&D Executive Committee, and on a regular basis we have a session where we talk about the use of animals in R&D. We keep metrics on the use of animals and we act on those metrics.

Externally, we engage stakeholders in meetings such as this. We endeavor to understand the local regulations and, importantly, the environments in which our people are working, so that we can understand the culture in which they work and the stress they are under and how we can help them, through mutual education and exploration of differing views, and, as I mentioned, we encourage audits by external and internal groups.

Conclusion

In summary, the pharmaceutical environment has changed and will change in the future. Standardization across geographic regions and cultures and jurisdictions is not realistic now, because it is too dynamic. We will rely on core policy, principles, and values.

One of the most important principles is that of peer review. This creates the challenge we want to understand of the scientific hypotheses to be tested in animals and to question how replacement, reduction, and refinement are being considered. The first few times we went through this, it was difficult. Now we have our CEDD heads engaging our people and asking them to justify their experimental models. That is the transformation we are looking for, the kind of drive we are looking for in an organization.

It comes only with deep expertise in comparative biology. These people are going to be with some of the world-class scientists in the therapeutic area discussing a biochemical pathway in an animal model. Our comparative biologists have to go toe to toe with them. They have to be just as world-class in their discipline. And they have to have courage, if I could use that word, because they are put in challenging situations.

Diligence ensures adherence to principles and dissemination of learning. It is not good enough to just audit. We have to audit, we have to talk about it, we have to put it out there, we have to air findings and share corrective actions, and we have to make people understand when things have to change.

Finally and importantly, operations based on publicized core principles and continuous improvement enable geographic flexibility in where work is conducted. The standard creates the corporate way of working. We have assurance that, through our policy and processes, through the science that we emphasize, and through our audit functions, we will meet our standard anywhere in the world. If the standards cannot be met, we don’t do work there. That drives good behavior in our organization and in those organizations with whom we work.



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