Abstract

In the past few years it has been hard to pick up a copy of Nature, Science or many preclinical biomedical research journals without seeing an article on the issue of non-reproducible research. They all acknowledge that research is plagued by findings that are not reliable and just cannot be reproduced. The pharmaceutical industry is not immune to these issues. Replication of published research findings is a key component of drug target identification and provides confidence to progress internal drug projects into the discovery pipeline. We also use data from internal assays to assess the biological and pharmacokinetic activity, selectivity and safety of novel compounds and make decisions which impact their progression towards clinical development. Many pharmaceutical companies have statisticians engaging with research scientists however the ratio of statisticians to scientists is typically low. This talk will describe the role of a preclinical statistician, outline the key challenges they face and focus on how Pfizer is implementing the Assay Capability Tool. The ACT was created by Research Statistics within Pfizer to guide the development of drug discovery assays and to address issues of robustness and reproducibility in research. It promotes easy to follow but absolutely essential experimental design strategies and represents the distilled experience of the provision of over three decades of statistical support to laboratory scientists.