Abstract

Stated simply, the term “innovation” implies a new way ofdoing something. It may refer to incremental, radical, andrevolutionary changes in thinking, products, processes, ororganizations (Wikipedia, the free encyclopedia, http://en.wikipedia.org/wiki/Innovation). The American HeritageDictionary (Fourth Edition, 2000) defines innovation as“the action of beginning or introducing something new”.Innovation is important to many fields, most notably, butnot limited to, economics, sociology, business, and engi-neering. In a colloquial manner, innovation refers to theoutput of a process or system invented or devised toaccomplish a goal. Those who are responsible for theadoption of innovation are often called pioneers, whetherthey are individuals or organizations.When tied to organizations or the products or output theyachieve, innovation is typically linked to performance andimprovement in efficiency, productivity, quality, cycle time,competitive position, and/or market share. If one looks atthe course of history, all organizations and industries haveexhibited the ability to practice innovation. History has alsoshowed us that organizations or companies that innovategain a competitive edge over those that do not, sometimesto the extent that those that choose not to innovate aredestroyed by those that do. A convenient definition ofinnovation is given by Webster where it is stated thatinnovation is “the introduction of something new, as in adevice, method, or idea”. In the pharmaceutical industry,innovation has been driven by the evolution of ideas,technology, regulations, and economics. Over the past50 years, the concepts of trial, error, and serendipity indrug discovery have given way to the use of rational drugdesign, combinatorial chemistry, high-throughput screen-ing, bioinformatics, and genomics. In the area of drugdevelopment, the performance of clinical trials in countriesother than the USA and the European Union, the adoptionof the Quality by Design paradigm by the US FDA, theregulatory expectations in the toxicology area with regardto genotoxic impurities, and the increased utility ofmodeling and design as an alternative to empirical thinkinghave altered the way in which active molecular species aretransformed into marketable dosage forms.While innovation is difficult to accurately quantify, it canbe large or small. As an example of a small innovation,studies of the location of equipment and reagents in ananalytical laboratory have been shown to expedite work andlead to increased productivity, which is one way in whichinnovation may be measured. If one evaluates their ownwork performance and asks “Am I accomplishing morethan I did 10 or 20 years ago?” The answer is usually yes. Ifso, we might then ask, “Am I working sixteen hours insteadof eight?” The answer to that questions is usually no,leading to the additional question, “How am I doing mywork differently?” The reply to this is tied directly to theconcept of innovation, although many scientists will notadmit that their approach is innovative in nature. Many ofus raised in science confuse innovation with invention.Invention is the first occurrence of an idea for a newproduct or process while innovation is the first attempt tocarry it out into practice [1]. Based on this definition,Thomas Edison might be better remembered as an

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