Team:Stanford/Entrepreneurship
Entrepreneurship
As our team looked deeper into the implications of a cell-based diagnostic, our goals quickly grew beyond the iGEM competition. We were building a future where the diagnostic test could be scaled faster than the virus; and we were driven by the conviction that centralized diagnostics would inevitably be replaced by microbes that live with and around us. For us, this project evolved from something that could be done to something that must be done. The iGEM deadline is arbitrary. We’re not stopping until we have a diagnostic that grows faster than the virus.
Our Entrepreneurial Journey
We started our project full-time in June of 2020, virtually, focused on the iGEM competition. We reviewed the literature, designed and refined constructs, and laid out protocols to use once we could get access to a lab. After months of coordinating remote work with each other over Zoom and scrambling for off-campus lab space, we stumbled across BioCurious, a community lab in San Jose that is home to many a startup. In September, we began experiments there: the first steps to turn SEED into more than just an idea, and make it real.
By August, we had started to run out of money from our initial summer funding. But we could not give up on the project. So we searched for investors. Although most team members had zero business experience, we reached out to companies like Quest Diagnostics and Gingko Bioworks, attempting to establish partnerships. These leads were ultimately unsuccessful.
Then we found Stanford Med Catalyst - an organization whose mission is to bridge the gap between academia and industry, by investing in academic projects. We submitted a proposal of our idea to them, in the hopes of being asked to pitch the project to investors. We were the only undergraduate team accepted to the presentation round. We spent two weeks preparing to pitch our project and, out of roughly 90 teams, were 1 of 3 chosen to receive funding. Now with $40K in capital and an excited team of investors, we were ready to make our proof of concept.
Filing For a Provisional Patent
There are many aspects of our invention, the SEED system, that are novel. This includes, but is not limited to, the use of recombination for in vivo detection of nucleic acids, the use of toeholds in vivo inside of Bacillus subtilis, and the use of live cell colonies as a clinical diagnostic test. In October - after securing funding, but before the iGEM competition - our team worked closely with Stanford's Office of Technology Licensing in order to file a provisional patent on our biotechnology. We officially filed our provisional patent on October 22nd, 2020 for our invention and its future use cases.
A lot of thought and consideration went into deciding whether or not it would even be worth it to file the patent, and whether the act of filing a patent and protecting our intellectual property is in-line with our long-term ethical goals. Will obtaining a patent take us closer to or farther from the vision that we want to see realized? We decided that filing the patent and moving towards a startup phase was the best decision for us. At least through March 2021, we will be focused on furthering lab research to get to the proof-of-concept while developing a commercialization strategy.
Developing A Commercial Strategy
We plan to develop a standard-environment kit for SEED called BacPac (a play on words related to our organism's genus, Bacillus) to be deployed in clinical and at-home settings. This would involve not only producing the engineered cells themselves, but manufacturing them along with supplies needed to culture them and administer tests. The commercial product, then, will be BacPac as a whole - while the cells will be made open-source to anyone who wants to trouble themselves with the culturing and preparation process. In terms of building a commercial pipeline, we’re currently in conversation with Culture Biosciences, who specialize in cloud-lab bioreactors, to form a partnership for the mass production of our cells, and we hope to partner with Vera to power our distribution pipeline. We’ve also recently been in talks with representatives from Ginkgo Bioworks to support us to reach Series A funding.
Developing SEED itself further, we have many next steps in place that we want to test and optimize experimentally. To do this, we will finalize proof-of-concept research in BioCurious by the end of the 2020 year, utilizing funding from Stanford Med Catalyst. After proof-of-concept has been established, we will move on to optimization steps and planning for clinical trials. By partnering with the Stanford Medical School, Stanford Med Catalyst, and Ginkgo BioWorks, we will be able to optimize our research plans to prepare for clinical trials, and form connections with experts to help design our trial implementation plans. Depending on the state of the current pandemic, we will finalize pre-clinical experimentation either in BioCurious, or in a lab at Stanford, before moving on to stage 1 clinical trials in partnership with the Stanford Medical School. From there, we are unsure what the strategy looks like for getting FDA approval or for publishing - but with property rights already secured, and commercial partnerships already beginning to form, we see a way to transition from approval to market as quickly and efficiently as SEED detects DNA.
Our Target Customers: Hospitals, Companies, Then Individuals
In the immediate future, with the development of BacPac, SEED would be utilized largely in clinical settings, enabling medical professionals to test patients without fear of testing shortages. For less that 57 cents per test, SEED would help ease the burden of viral testing in healthcare by providing cheap, fast, and scalable testing solutions. In the future, our fully developed invention could be used by anyone on Earth. Our cells can easily be sporulated for shipping around the world, and can be stored at room temperature for months or even years. They can be produced so quickly, cheaply, and easily, that anyone is able to test for any nucleic acid sequence they desire. Companies and individuals would be able to order cells engineered to target a sequence of their specifications, with a customizable readout.
A Customization and Approval Service
After developing a proof-of-concept generally, and then for a specific virus that exists, we would want to continue to develop more tests that can detect a vast array of target sequences. But what we are offering is powerful, and one of the primary reasons we want to retain property rights is to allow this technology to be widely distributed, while also protecting it from being abused. We are planning on allowing SEED to be open-source for approved bioengineers to modify it to suit their uses. This is important to us within the ethics we have been guided by. The approval process for customization requests is not entirely sorted out yet, but it will be based on plan descriptions, network verifications, and questionnaires for psychological evaluation. We’re cautious because this technology could theoretically be weaponized to release a toxin upon detection of a person’s unique SNP sequence, for example. This technology could also conceivably be adopted by a government to track dissidents with known DNA profiles and suppress democracy. We would prefer for these things to not happen, which is why we believe it is a necessity to retain intellectual property and verify customization requests. Developing this service would be the next step after getting approval as a test for one kind of virus, such as COVID-19, in order to broaden the scope of the diseases we are able to detect.
Considering Future Directions
There are many future directions that we can see SEED evolving into, whether it is done commercially or academically. There are a wide variety of ways in which the technology could change the current economy; and it can shift our entire perspective on human health and the way that we interact with microbes. These future applications are described in detail on the Future Applications page (click button to go there).
Conclusion
We think we are eligible for this prize because our entire journey has been defined by entrepreneurship. While being barred from working on campus, living all over the country, and possessing very little resources, we managed to find public lab space and win a $40K grant through the Stanford Medicine Catalyst to fund our proof-of-concept. We’ve kept an eye on our long-term vision for the world, while flexibly adapting and improvising to the short-term challenges and opportunities. We all have a conviction that SEED must be made real, so we’ve taken steps to form key partnerships for the manufacturing, distribution, and acceleration of our invention. We plan to continue working until SEED in commercially available.
