The Impact of Global Integration on Drug Development and Clinical Research
- PDF / 278,672 Bytes
- 4 Pages / 504 x 720 pts Page_size
- 95 Downloads / 157 Views
0092-86 15/99 Copyright 0 1999 Drug Information Association Inc.
THE IMPACT OF GLOBAL INTEGRATION ON DRUG DEVELOPMENT AND CLINICAL RESEARCH IGNACIOCHRISTIAN MARQUEZ,DDS, MS Medical Editor, Mundo Medico Publisher, Mexico City, Mexico; Formerly, Clinical Research Associate, Zeneca Pharmaceuticals and Parke-Davis, Mexico City, Mexico
Global integration has brought sweeping changes in the pharmaceutical industry due to cost constraints that have forced the industry to negotiate for lower “bottom line” costs. The pharmaceutical industry is constantly and rapidly changing because of changes in technology, research and development (R&D), regulations, competition, and demand for pharmaceuticals. Increased competition will drive industry change as the use of less expensive generic and over-the-counter drugs increases because of the rise in managed health care. Companies will focus on streamlining production methods, reducing product development cycles, and reducing costs. Key Words: Global integration; Cost constraints; R&D; Drug discovery; Overhead
INTRODUCTION EFFECTIVE STRATEGIES AND management techniques, especially those relating to investment, are essential for success in research and development in the global research-based pharmaceutical industry. An analysis of the drug discovery and clinical research potentials of the pharmaceutical industry concluded that the industry was facing an innovation deficit that will be severe enough to incite further consolidations within the industry (1). At present, pharmaceutical companies are attempting to balance portfolios by the opportunistic licensing-in of new chemical entities (NCEs). They are making use of contract organizations as they downsize and alter the focus of R&D to fewer therapeutic areas (2).
Reprint address: Ignacio Christian Marquez, DDS, MS, Amores 2011, Colonia Del Vaile, Delegacion Benito Juarez, Mexico City, Mexico 03 100.
DRUG DISCOVERY-AN INNOVATION DEFICIT? Suspicions that the pharmaceutical industry might be charging too much for what it delivers to the health care systems of the industrialized world have been lingering for some time. More specifically, the industry has been criticized for turning out too many drugs that did not represent significant advances over existing treatment (3), for making inappropriately high profits (4), and for being only moderately innovative (5,6). The validity of these criticisms became clearer as the conditions under which the industry operated grew harsher. Health care systems have become rather intolerant of drug redundancy. The legislative and political manifestations of this intolerance differ from country to country, but they all convey the following message: 0
725
Only drugs that carry substantial advantage over existing therapeutics can command premium prices upon introduction. In this
Downloaded from dij.sagepub.com at NANYANG TECH UNIV LIBRARY on April 25, 2015
726
Ignacio Christian Marquez
context, the term “advantage” denotes new therapeutic possibilities that can prolong life, save lives, or increa
Data Loading...
