Commercializing Successful Biomedical Technologies Basic Principles for the Development of Drugs, Diagnostics and Devices SHREEFAL S. MEHTA

Commercializing Successful Biomedical Technologies Basic Principles for the Development of Drugs, Diagnostics and Devices SHREEFAL S. MEHTA

The deciphering of the human genome at the dawn of our twenty-first century not only fueled expectation of an increase in speed of developing therapies for many diseases but also exploded some cherished myths. Among the myths exploded was the belief that there were about 100 000 genes in the human genome and that this would lead to thousands of new ‘targets’ (receptors, enzymes, transporters, ion channels, etc.) for the discovery of new drugs. Although still somewhat in question, the number of genes in the human genome is felt to be about 30 000, thus dampening considerably some of the initial euphoria over the anticipated results of this outstanding achievement: the deciphering of the human genome. Another disappointing projection is that the number of druggable targets will only increase some threefold, from about 550 to 1500. Nonetheless, this incredible achievement, enabled by many technologies associated with genome sequencing, has fueled additional technologies, such as proteomics and metabolomics, for the innovation of new drugs and diagnostics.

Commercializing Successful Biomedical Technologies Basic Principles for the Development of Drugs, Diagnostics and Devices SHREEFAL S. MEHTA

Contents:
 
1. The biomedical drug, diagnostic, and devices industries and their markets
2.Markets of interest and market research steps

3. Intellectual property, licensing, and business models

4.New product development (NPD)

5.The regulated market: gateway through the FDA

6.Manufacturing

7.Reimbursement, marketing, sales, and product liability 264