Introduction

The decision to select and develop a new drug candidate is complex. It is dictated by the interplay between the potential markets and the scientific advances being made in basic, translational, and applied research. The drug development process, from the inception of a therapeutic strategy to the approval and introduction of the therapeutic compound for human use, involves investments, sharing of knowledge, and collaboration among govern ment agencies, pharmaceutical companies, universities, and other research organizations (Figure 3.1). When successful, these interactions lead to the development of drugs that provide cure, treatment, or prevention of disease.

Since the development in the 1970s of molecular tools enabling the production of proteins and peptides in sufficient quantities for therapeutic purposes, dedicated biotechnology companies have been examining, refining, and developing these technologies for commercialization. This

Biotechnology and Biopharmaceuticals, by Rodney J. Y. Ho and Milo Gibaldi ISBN 0-471-20690-3 Copyright © 2003 by John Wiley & Sons, Inc.

Basic research

Generating

Knowledge

Government

NIH, PHS NSF

Private

Universities and

Research

Organizations

Pharmaceutical Companies

Translational Research

Applied Research

Patient Benefits

Integrating Knowledge

Knowledge\ about disease etiology, mechanisms, , and potential/ points of attack

Government

NIH, PHS

Private

Pharmaceutical Companies

Universities and

Research

Organizations

Developing molecular entities for therapeutic use

Cure, Treatment, Prevention, or better disease management

Private

Pharmaceutical Companies

Figure 3.1. The process of pharmaceutical drug discovery and development—an integrated science that draws on the collective knowledge and resources from both government and private sectors. Abbreviations: NIH, National Institute of Health; NSF, National Science Foundation; PHS, Public Health Service.

0 0

Post a comment