Introduction

Elucidation of the Periodic Table of elements was in no small part a driving force in the creation of the modern chemical industry and a subsequent chemistry-driven pharmaceutical industry. Similarly, elucidating the genetic code and the subsequent determination of the structure of the entire human genome has created a biotechnology industry and a biology driven biotherapeutics industry. Taken together, the branded prescription drug products from the combined biopharmaceutical industry and the nonbranded generics industry enjoyed 2005 worldwide sales of over $600 billion, about half of those sales in the United States.

Successful development and commercialization of therapeutic drugs requires constant innovation, creativity, endurance, and strong patent protection (IP). It also requires sound management, deep pockets, and an uncanny element of plain old-fashioned luck in the many steps from bench to bedside. Unlike few other industries, success or failure only becomes evident eight to ten years and hundreds of millions of dollars into the development process. Uniquely, the drug developer does not have the ultimate say in triggering entry of a new product to market. The final arbiter is an independent government regulatory authority that is vested with the right to give a thumbs up or a thumbs down for approval of a new chemical entity (NCE) to move forward to the marketplace. Furthermore, unlike many consumer products, there is no margin of error that allows a pharmaceutical ...

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