1.7. Summary

Statistics, as a discipline, has broadened its scope significantly over the past 20 years. Wherever there is a need for quantification, statistics has a role. The abilityto think in terms of variability, to separate signals from noises, to control sources ofbias and variation, and to optimize under given conditions, makes statisticians a valuable partner in the development of a new pharmaceutical and biological products.

Mining historical data to add to our cumulative knowledge is a low-cost and high-yield activity. Many companies realize the value of this activity and are actively pursueit. For example, Bristol-Myers Squibb (Pink Sheet, December 13, 2004) formed a discoverytoxicology group and retrospectively analyzed approximately 100 development compounds that failed during a 12-year period. Bristol-Myers Squibb hoped to use the acquired knowledge to decide what assays and technology to implement early to reduce compound attrition. Bristol-Myers Squibb concluded that a combination of in vitro, in vivo, and in silico techniques was needed to improve productivity and reduce attrition. According to the same report in the Pink Sheet (December 13, 2004), other pharmaceutical companies have reached similar conclusions.

Data mining is also expected to help us look for better predictors for hepatotoxicity and cardiovascular toxicity such as Torsade de Pointes. Data mining examples can go on and on. We can't think of any scientists who are more poised and qualified to lead this data-based learning, endeavor than statisticians!

The challenge is definitely on us, statisticians!