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Genentech is considered an extraordinary success story in the biotechnology sector. The industry has been on the rise and is extremely profitable with notably over $70 billion in 2015 (Giovanetti & Spence, 2017). According to Hardymon and Nicholas (2019), venture capital was a turning point for the biotechnology sector when Robert Swanson and biochemistry Herbert Boyer sourced finances in the private sector to run DNA molecules customization research. This research paper delves into the case study under analysis and presents the issues and solutions available as well as the best recommendations.
Summary of the Case
The case setting is in the field of biotechnology and the main stakeholders were the founders Robert Swanson and Herbert Boyer who did not have the financial capabilities to establish the project. The two invited Tom Perkins, who was the co-founder of Kleiner-Perkins as a venture capitalist to invest in the project. These investors established Genentech in 1976 with Boyer and Swanson spearheading advancement in recombinant DNA science. It aimed at producing a viable therapeutic drug; an achievement many scientists believed was decades away from being accomplished. In addition, it allowed venture capital to influence the approaches to financing in this sector. Hardymon and Nicholas (2019) note that by 1978 Genentech had produced Humulin from their laboratories, a product that was a result of recombinant DNA. Humulin is a name acquired from the process of developing the drug; it means human insulin.
In addition, Humulin positively contributed to improving the lives of those suffering from diabetes. The extraction of human DNA to clone human insulin, synthesizing a given gene, and introducing a gene into a bacterium for duplication did not dowse the arguments against DNA molecule customization (Hardymon & Nicholas, 2019). There were questions on the potential threat posed by reproducing genes that were not supposed to replicate. At the time of this significant achievement, many thought that recombinant DNA products would unknowingly and unintentionally contain harmful substances, which could destroy human health.
There are several issues that are evident in this case; first, the use of recombinant DNA poses a threat to human life as one could easily manipulate the nature of human DNA. In addition, it is noted that the commercialization of genetically engineered products was on-demand, yet, there were no proper laws and guidelines for such research (Hardymon & Nicholas, 2019). Finally, it is a major concern that the manipulation of DNA could unintentionally and unknowingly introduce a harmful substance that might affect the quality of human health. The secondary issue, in this case, is the possible environmental safety as a result of biohazards from the manufacture of this drug. All these issues are interrelated as they all focus on ensuring that human beings are safe from the development of recombinant DNA. Singer (2016) asserts that laymen were worried about the effect of manipulating DNA. The main concern over recombinant DNA was the danger it could cause to human health, alter the environment and change the path of evolution.
The solution to Address the Issues
In order to address the concern that genetic engineering could have potential biohazards, Biotechnology Company should continue researching in ways that promote the advancement of the industry and achieve significant progress in gene customization. Gene engineering needs to be done in a manner that does not harm the environment. The National Institute of Health proposed a guideline for recombinant DNA molecularization that follows specific practice when it comes to cells, viruses, organisms, or DNA that contains such molecules (National Institutes of Health, 2016). It also stipulates the need for comprehensive risk assessment, biological safety techniques that set standards of practice and laboratory implementations that offer physical protection based on the estimated levels of biohazard.
The strength of this solution is that it introduces regulations that are an important part of controlling the manufacture and distribution of genetically engineered products thereby preventing potential biohazards from harming the population. In addition, the regulations should have an impact on both companies that rely on the National Institute of Health for funding and those that are privately funded. This would be the best option as it gives precautionary measures for the processes involved in the production of recombinant DNA. However, the weakness of this proposed solution is the logistics involved in coming up with laws and regulations. A venture capitalist might lobby and ensure that such laws are not passed.
The alternative solution is pegged to the hearing of the Recombinant DNA Research Act of 1977 by congress. It showed that while there were regulations and guidelines for research, they were not mandatory unless it was government-funded (Singer, 2016). Therefore, the Act tries to solve this challenge by extending these regulations to research conducted by private firms. This is because of the unknown nature of genetic engineering, the set regulations would have to be applied in all genetic tests.
To evaluate the effectiveness of the main proposed solution, the government would cross-check experimentation, thereby, allowing a deeper understanding of human genotype. In addition, limit the researcher’s ability to decide how to use data to identify and prevent hereditary illnesses such as diabetes. Consequently, this implies that the outcome of the research is determined through various regulations set by the government and met by the research institutions.
In conclusion, recombinant DNA research is important in finding solutions that are based on human genes and have the potential in aiding the treatment of serious diseases. Research firms using venture capital such as Genentech have the capabilities to bypass the current National Institute of Health regulations because they are privately funded. Although this is the case, safety and ethical concerns about biohazards and the intended purpose of the study need to be met by these firms.
Giovanetti, G., & Spence, P., (2017). Beyond borders 2016: Biotech financing. EY. Web.
Hardymon, F., & Nicholas, T. (2019). Kleiner-Perkins and Genentech: When venture capital met science. Harvard Business School. Web.
National Institutes of Health. (2016). NIH guidelines for research involving recombinant or synthetic nucleic acid molecules. Department of Health and Human Services. Web.
Singer, M. (2016). Risk, regulation, and scientific citizenship: The controversy over recombinant DNA research. U.S. National Library of Medicine. Web.