Reducing Excess Production of the Active Pharmaceutical Ingredient during Early-Phase Development
Table of Contents
1. Introduction 1
1.1 Background 1
1.2 GSK Supply Chain 2
1.3 Demand Generation Process 4
1.4 Objective and Scope of Work 6
2. Literature Review 7
3. Methodology 11
4. Future Work 12
Figure 1 Clinical Development Process (Source: PhRMA) 1
Figure 2 GSK clinical trials supply chain 3
Figure 3 GSK clinical trial demand generation process
1. Introduction
1.1 Background
In the pharmaceutical industry, the development process that required to bring a new drug to market involve significant expense (up to $1 billion) and can take as long as 10 years. The development of new drug follows sequence of steps including discovery, Food and Drugs Administration (FDA) application, product and process development, clinical trials, approval by FDA and finally launch. Nevertheless clinical trials constitute an important and expensive part of the development process.
Figure 1 Clinical Development Process (Source: PhRMA)
The figure below shows the entire clinical development process. Before FDA approval of a new drug, testing of a drug patient in clinical trial is conducted to ensure safety and effectiveness of the treatment in human. In addition the clinical trial usually requires three phases and takes on average six to seven years. With the aim of finding successful treatments, drug companies in United States spend about 20% of their sales on research and development (R&D). According to Pharmaceutical Research and Manufacturers of America (2009) and Thomson CenterWatch (2007), it is estimated that "the R&D spending exceeds $65 billion per year with some estimates topping $100 billion in wo...
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