patented discovery. Since the law’s passage, patent licensing and other financial relationships linking medical researchers and research institutions with industry have expanded substantially (Schacht, 2008). Some scholars, however, have pointed to factors in addition to the legislation that may be associated with the historical increase in the numbers of patents, including a broadening of the criteria that allow materials to be patentable (particularly for life forms) and advances in biomedical research (see, e.g., Mowery et al. [2001, 2004] and Sampat ; see also Diamond v. Chakrabarty, 447 U.S. 303 ).
This chapter starts with a brief overview of some dimensions of university-industry collaborations in biomedical research and then summarizes data on the extent of the relationships between pharmaceutical, device, and biotechnology companies and academic research institutions and individual researchers. The next sections review concerns about these relationships and responses to those concerns. (Appendix E provides an additional discussion of the nature and importance of academic-industry collaboration in medical research.) Because many conflicts of interest at the institutional level emerge from research discoveries, the discussion of these conflicts and the responses to them presented in Chapter 8 is also relevant. The final section of this chapter offers recommendations.
The path from a scientific discovery to the marketing of a new drug, device, or biological product is typically long and complex and involves a diversity of expertise and resources. For example, basic researchers, often at academic medical centers and other research institutions, can identify new potential targets for therapies and new strategies for treatment, suggest additional diseases that may be able to be treated by existing and newly developed compounds, and suggest both how to target therapies to the patients who are the most likely to benefit and how to avoid particular treatments for patients at high risk for adverse events from those treatments. Scientists at the National Institutes of Health (NIH) also contribute to the discovery process, and important clinical research is undertaken at the NIH Clinical Center. In addition, basic scientists at biotechnology and pharmaceutical companies have made fundamental discoveries that have led to new therapies.
Scientists at pharmaceutical companies can help identify or develop drugs that may be active against new biological targets that have been identified by individuals who conduct basic research. These companies also have the critical ability to use good manufacturing practices to produce a candidate drug in sufficient quantities for clinical trials and then for large-scale commercial distribution, if the product is approved for marketing.