ABSTRACT
CONTENTS 31.1 Introduction ......................................................................................................................547 31.2 Drugs from Plants ..........................................................................................................548 31.3 Synthetic Drug Discovery ..............................................................................................550 31.4 Biotechnology, Genomics, and Proteomics ................................................................552 31.5 Gene Therapy ..................................................................................................................553 31.6 The Developers ................................................................................................................554 31.7 Small Development Companies ....................................................................................555 31.8 Academicians and Entrepreneurs ................................................................................556 31.9 Government, Regulation, and Drug Development ....................................................557 31.10 Government Research ....................................................................................................558 31.11 The FDA Regulators ........................................................................................................559 31.12 Conclusion ........................................................................................................................562 References ....................................................................................................................................562
The pharmaceutical industry is undergoing revolutionary change with the impact of new technologies, biotechnology, genomics, proteomics, and the effects of the most profound change in Medicare in the last 40 years — the prescription drug benefit. The forces of technology and government are like fast-running rivers, forever changing the topography of the landscape. Change is a part of the human condition that we often fail to notice. During the last 100 years, the drug development process has undergone considerable change, but all that has gone before will pale in comparison with the dramatic, new information era, which will markedly alter the environment we work in and the drug development process.
