Animal Research in a Global Environment Meeting the Challenges: Proceedings of the November 2008 International Workshop (2011) / Chapter Skim
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Animal Research in a Global Environment: Meeting the Challenges--John Baldoni
Animal Research in a Global Environment: Meeting the Challenges--John Baldoni
Pages 81-92
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From page 81... ...
I thought for this talk I would go through a bit of scene setting first, describe what it is to work in a core function such as preclinical development in the pharmaceutical industry. Give you some examples of the challenges to drug development on a global footprint on a generic basis, not only in terms of the care and use of animals but also both in geographic terms and what it takes to develop a drug.
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From page 82... ...
There are other pharmaceutical companies looking at how we organize, and going from big R&D units to small R&D units, essentially taking advantage of the wisdom of a crowd of discovery units as opposed to that of a single monolithic discovery unit. With regard to our R&D units, there is a great deal of complexity related to the core processes that we use in conducting our work and delivering our products.
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From page 83... ...
We now assess the risk of developing a drug from a biochemical pathway target, all the way through to the animal model, all the way through to the manufacturing, all the way through the commercialization and the system to distribute and sell the drug. Our ability to sell a drug 15 years from now depends absolutely critically on the scientific rigor used to identify a target and its pathway, and picking the right molecule to affect the target.
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From page 84... ...
Those retained ask questions like where is the quality in the product, what is the animal model, how are you ascertaining the efficacy of the drug. I already talked about integrating quality into the drug discovery and development process.
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From page 85... ...
The one I am most interested in and the one I am most proud of is preclinical development. In preclinical development we have five major departments: drug metabolism, which investigates the absorption, distribution, metabolism, and excretion of our molecules; pharmaceutical development, which develops the dosage form and the manufacturing processes for those dosage forms; safety assessment, which assesses the hazards and identifies the risks of molecules; chemical development, which actually makes the drug substance and scales it up and transfers it to factory; and laboratory animal sciences, which you
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From page 86... ...
One is to understand the risks from a biological perspective, which involves in vitro work, and to understand how our drug behaves in in vitro systems and ultimately in in vivo settings. Preclinical in vivo studies involve conducting animal model efficacy studies with discovery scientists, regulatory-required preclinical studies required to demonstrate the safety of a molecule and, importantly, investigative toxicology studies, which constitute a lot of what we do.
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From page 87... ...
We ensure, as we go through our drug development process, that we build quality into our product so that if and when that product launches, we have some assurance that it is going to be sustainable in the market from a quality perspective. Transparency and Regulation There are many stories around the safety of our drugs.
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From page 88... ...
There are societal expectations: people expect that with all the money they are spending on drugs, the return on that expenditure is better drugs. There is activism -- in the animal world, in the patient world, and in the political world, people asking of pharmaceutical companies: What are you doing?
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From page 89... ...
What do I mean? If there is a dietinduced obese model being used to explore diabetes, and one of the biochemical pathways they are exploring is insulin sensitization, justify that diet-induced obese model.
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From page 90... ...
If we have scientists working in an academic laboratory doing animal work, we assess that academic laboratory for adherence to our core principles. LAS drives consensus on best practice around the organization, which creates a lot of constructive dynamics and constructive debate in our organization.
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From page 91... ...
We use GSK core principles, which are independent, as I said before, of location, an outside company's relationship with us, or the study size. Importantly, we get world-class experts in laboratory animal sciences and we make them influential.
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From page 92... ...
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.
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