Oscillate is completely different from any project we have undertaken. This year, we have engineered a new way for cells to interact with external stimuli. With this groundbreaking creation and new biotechnology, we wanted to explore the legal and ethical consequences of emerging biological technologies. To achieve this, we tasked ourselves with deeply analyzing the ethics of sharing knowledge about emerging technologies, different business development paths, and intellectual property. Through research articles, interviews with researchers, consultation with legal experts, and thoughtful discussion, we developed a full view of our project. We were able to gain perspective from innovation to implementation.
Because of its novelty and inherent foundational value, the Oscillate platform presents our team with a unique set of considerations when thinking of its implications in biotechnology and beyond. Therefore, we decided to contact the rapidly growing, intensely innovative synthetic biology company Ginkgo Bioworks, which as been pushing at the vanguard of what synthetic biology can accomplish.
Based in Boston, Massachusetts, Ginkgo Bioworks specializes in organismal engineering, especially with yeast. We had the pleasure of speaking with Grace Chuang, who works on the creative and outreach team in the company, on how Ginkgo approaches the synthetic biology, and the challenges and considerations that come with innovating at the cutting edge.
Ginkgo’s workflow is divided into three fundamental stages - designing, building, and testing newly engineered organism - with the ultimate goal of making biology faster and efficient to engineer. This process is based in their ‘foundry’, which is unique, high throughput, horizontally integrated platform for organismal engineering that takes projects from clients in diverse areas of applications. This has interesting implications for Oscillate, and has compelled us to potentially frame our advancements as a mini-platform, a basis for many applications.
With Ginkgo’s pioneering work, we wondered about the concomitant growing pains within the company. One interesting problem was the lack of visibility in understanding the regulatory standards surrounding biotechnology, especially commercial industries. Ms. Chuang delineated that most of their work was situated at the intermediate position in the production of a product, that their yeast strains were not the final product and so were not subject to the same regulatory guidelines. This informed us of the need for defining more visible guidelines for safe and responsible synthetic biology, as a the field grows, so will the need for the public arena to engage synbio comprehensively.
Another takeaway was Ginkgo’s framing of the field of synthetic biology. Because it is so young, Ms. Chuang stated that it is difficult to define exactly what synthetic biology encompasses. However, one way to look at the field is its ways of translating the principles of computer science into equivalent ways we engineer and ‘code’ organisms, by using predetermined building blocks to create emergent properties not possible otherwise. The most immediate way we saw to apply this was to our outreach, through communicating what synthetic biology truly is to the public and to educate, especially the students, on the relevant building blocks of synthetic biology. This became part of the inspiration for our plasmid education kit endeavor.
With these new insights, we saw correlations from their large scale operations to our small but ambitious mission in Oscillate. This helped inform how we perceive regulations and the growth of our project in the long run, and how we are to frame synthetic biology to the public and to ourselves as scientist and engineers.
The possibilities with Oscillate are boundless. As we developed our frequency-dependent genetic circuit and discussed it with researchers from around the world, we heard about so many exciting potential applications for Oscillate. What follows are a list of these application suggestions:
- Dr. Hasan Baig, an Assistant Professor of Computer Science at Habib University in Karachi, Pakistan, suggested we use Oscillate to perform cellular computations within a desired period of time. In this way, cellular computations would mimic digital computations. Dr. Baig even suggested we use tools that he developed to analyze our genetic logic gate.
- Dr. Guillaume Lambert, The Gordon Lankton Sesquicentennial Faculty Fellow in the Applied and Engineering Physics Department at Cornell University, had many suggestions. Some of his suggestions include using Oscillate in co-culturing and differential control of complex microbiomes.
- Dr. John March, a Professor and Chair of Biological and Environmental Engineering at Cornell University, suggested using Oscillate for co-culturing, as well. He mentioned that Oscillate could work to control ferritin nanoparticles if there was an environment of sustained heat or fluctuations in temperature.
We want to create a product which has the greatest positive effect on the largest number of people. These potential applications suggest we could make an impact through biomedical sciences, biological computers, or microbiology research, among other fields. With these possibilities in mind, we continue to optimize Oscillate and our frequency-dependent genetic circuit so researchers from many fields might one day use this emerging technology to affect real change in the world.
Before moving forward with our project, we must take into consideration the laws and regulations in place that deal with intellectual property. Our product was created using our university’s resources with the input of several team members and professional experts. As a result, concerns regarding the distribution of intellectual property rights must be addressed and clarified.
First, we contacted Dr. Mariagiovanna Baccara, an Associate Professor of Economics at Washington University in St. Louis with research experience in innovation and intellectual property rights. Our interview with Dr. Baccara was a great launching point for further delving into the specific rules governing the distribution of rights among participants in the ideation and execution process. As a preventative measure for intellectual property disputes, Dr. Baccara suggested looking into non-disclosure agreements as a way to protect the ideas of our team as we continue our discussions with experts from relevant fields.
In a separate meeting with Dr. Nicholas Argyres, a faculty professor of the Olin Business School at Washington University in St. Louis, Dr. Argyres brought up the importance of obtaining a patent as a safety measure before heavily promoting our project idea. Though Dr. Argyres acknowledged that the process of actually obtaining a patent is difficult and expensive, he also reasoned that the university may provide a means of funding the process, in which case the patent would belong to the school.
Since our project has yet to go through the entire commercialization process, we felt that it was too early to obtain a patent as mentioned in our conversation with Dr. Argyres. Additionally, the scale of our project was fairly limited, so we decided against the use of non-disclosure agreements. However, there is real potential for our project to eventually reach the stage of commercialization in which these suggestions would play a key role, so we plan to explore these options further in the future.
One major consideration when working on our project was the eventual commercialization of our product. Questions of business ethics were raised as we got deeper into discussions about the potential applications of our foundational advance. Since the technology we are proposing has a limited number of contenders, if any, we were afforded a decent amount of liberty when deciding in which direction to further develop our idea. For this reason, we turned to experts in the business field to discuss our concerns.
During our meeting with Dr. Nicholas Argyres, the Vernon W. & Marion K. Piper Professor of Strategy at Washington University in St. Louis, we discussed possible strategies for narrowing our search for the best application. Dr. Argyres made an interesting suggestion to assess the commercial viability of each application idea by looking at market sizes and potential tradeoffs. However, he brought up another important consideration to keep in mind when using this approach: the most viable applications might help fewer people than a less viable option that might benefit a greater percentage of the population.
For our team, our goal is to create a product that will have the most effective impact on the greatest number of people. With this in mind, we decided to focus our ideas to applications that directly affect people. However, this decision led to another ethical concern that frequently comes up in the debate around synthetic biology. We would be genetically modifying organisms, specifically E. coli, with the intention of introducing it to the general population.
We brought up this concern when consulting Dr. Lamar Pierce, Professor of Strategy and Faculty Director for Masters of Science in Leadership at Washington University in St. Louis. Dr. Pierce mentioned that there would indeed be potential concerns with the Food and Drug Administration and advised us to provide ample evidence of its safety and efficacy in vitro as well as in humans.
We kept these important considerations of ethics, purpose, and design in mind as we continued our work to ensure that we can make the most desired impact.