Roadmapping offers a systematic approach for the pharmaceutical-biotechnology industry to target technology investments in the drug delivery process.
The field of genomics (the study of an organism's hereditary material, deoxyribonucleic acid) was created in 1990 when the Human Genome Project was initiated. The project has been compared in scope and complexity to the Manhattan project and the moon shot. However, genomics' greatest contribution will be to provide biologists new insights into the building blocks of life: genes and their corresponding products, proteins (1,2). This knowledge is obtained by sequencing DNA from human and model organisms (e.g., yeast, nematode, fruit fly, zebra fish). Comparing DNA sequences from a number of species enables scientists to study the function of a gene as it is expressed in different organisms (3,4). Similarities in gene function between these organisms and humans enable pharmaceutical researchers to use these organisms to analyze the effect of new therapeutic agents on the biological function of specific proteins, i.e., target molecules (5).
Genomics technology was initially adopted by the pharmaceutical industry in 1993, when SmithKline Beecham announced a strategic alliance with Human Genome Sciences to use genomic tools to find new drug targets (6). (See "Formation of a Pharmaceutical-Biotechnology Network," next page). Human Genome Sciences, founded in 1992, funded the non-profit organization, The Institute for Genomic Research, and in return, obtained exclusive marketing rights to its inventions. The Institute, led by Craig Ventner, leveraged Ventner's research at the National Institutes of Health which allowed researchers to rapidly identify the genes expressed by different cell populations (6,7). Differential gene expression enabled pharmaceutical researchers to identify potential drug targets by comparing expression profiles between different tissue or between diseased and "normal" cells (8,9).
The flood of genomic data has transformed biological research into an intensive information science. A new field was created, bioinformatics, to mine genomic data in public and private databases. Scientists in this field write programs to gain better insight into biological processes (10).
The completion of the "rough draft" of the human genome in February, 2001 (11) further accelerated this research by increased focus on the study of the structure and function of the proteins coded by genes (i.e., proteomics). Bioinformatics, linked to other new technologies, combinatorial chemistry and high throughput screening, has created a new paradigm for drug discovery. This technological change will move the industry from serendipitous discovery of new drugs to strategic management of markets and technology to improve healthcare for targeted diseases (12).
Technology management is critical to the pharmaceutical industry for a number of reasons. First, increased investment in pharmaceutical R&D has not resulted in a significant change in the number of new pharmaceutical agents introduced into the market (16,17). The cycle time for development of new drugs and R&D dollars spent per product has increased (9,16,18). This lack of R&D productivity is caused by many problems but among them are understanding the limitations of new drug discovery technologies (e.g., combinatorial chemistry, assays to validate targets), the unpredictable complexity of biological systems, and difficulty in making appropriate investments in technological areas that increase research productivity.
Second, many of the biotech companies that provide services to the pharmaceutical industry have moved to internal development of their own drugs either alone or in partnership with established companies (12). In a recent survey, it was estimated that approximately 50 percent of the drugs sold by the pharmaceutical industry were licensed in from other firms (9). Finally, the increase in the number of suppliers that provide services for specific aspects of the drug development value chain enables new entrants to partner with other companies to gain resources necessary for the commercialization process (19). …