Team:Manchester/Implementation
UriGel's proposed end users are hospital inpatients who require catheterization due to various factors, such as recurring UTIs, surgery, or urinary incontinence. The number of these end users is likely to grow in the future, as medical factors like the number of surgeries requiring post-op catheterization is increasing and is projected to grow into the future.
However, UriGel cannot directly sell to these end users, as they very likely do not possess the technical skillset nor the know-how to perform catheterization. As such, we aim to reach our proposed end users via our proposed customers, namely hospitals, hospital trusts, and other point-of-care medical facilities that have an inventory of catheters as part of their medical device portfolio.
We think that UriGel can be used as a springboard for other researchers to use in prevention of CAUTIs. Given that UriGel explores a novel application for synthetic biology in the medical realm, further research is likely to benefit not only UriGel but the medical and scientific community to further understand the basis of biofilm formation, and how to combat it using novel techniques.
Similarly, the commensal coating can also be extended to other areas of the body/technology as well. This ties into the earlier notion of extended research by the scientific community, as UriGel can be used as a basis of innovation to combat biofilm formation in other types of catheters or other types of medical devices altogether.
We would require further research into the mechanisms we have explored here to their feasibility at preventing CAUTIs in vitro and eventually in vivo. As such, our first step for real-world implementation would be to launch Phase I of UriGel (detailed on our Entrepreneurship page).
Phase I UriGel largely revolves around the translation of computational models and data into tangible, viable mechanisms and systems. The main aim, as stated earlier, is to see whether the computation models and data hold true in a real-life setting, and if so, to what extent. An additional aim of this phase would be test out various iterations of the product, including the development of a minimum viable product.
If this phase is successful, we would accelerate UriGel into Phase II studies, wherein we give significant focus to product safety and evaluate it for potential issues that may lead to engineered bacteria escaping into the natural environment. One of the most important features of this phase would be to study the product and its true safety when present in a simulated environment. The preliminary safety data we gather here would directly feed into future evaluation studies and support our plans for the next stage of implementation: in vivo studies and regulated clinical trials on human volunteers.
A key consideration before clinical trials is UriGel's mode of delivery. The prevailing idea discussed over the iGEM season was a two-step process: a hydrogel coating application step, and a dipping step which lines the hydrogel with the engineered bacteria (from a culture). A major issue with this delivery approach is the need for storing large quantities of the cell culture without it 'going bad', which would require the integration of additional mechanisms and/or chemical/biological compounds in the culture media that prolonged the culture's shelf-life. It is important to note that this is just a prevailing idea, and it is almost certain that this delivery method would be adapted based on the additional data we would generate in Phase I and II of UriGel's implementation plan. Additionally, research and considerations would have to be made for the large-scale manufacturing of UriGel.
Following positive results in Phase II, the next step on the road to real-life implementation is clinical trials. UriGel would be subjected to rigorous clinical trials overseen by stakeholders such as public watchdog groups and medical regulators (FDA, EMA, etc.). At this stage, we do not have enough data to hypothesize what a clinical trial would look like for UriGel, but we would consider the safety data, public perception, and regulatory guidance of the time pertaining to synthetic biology applications when designing a trial.
The final stage for UriGel's implementation would market entry, which is discussed here.
With engineered bacteria, there is always the assumed risk of escape into the environment even when strict control measures are in place. As such, one of the main aims of Phase I and II of UriGel is to study not only the safety of the product itself, but also test the mechanisms which disable its function if its leaves its optimal environment, such as that caused by accidental release into the natural environment.
Likewise, the biocompatibility of the engineered pathways must also be tested extensively, as there is potential to lead to allergic reactions in users if the compounds are not biocompatible.
As such, UriGel's safety concerns can be largely classified into two categories:
These two concerns will be tested extensively in our initial research towards a minimum viable product, and be accelerated to the forefront of safety data once the first prototype for UriGel is prepared and further safety tests can begin to accelerate the product into clinical trials and beyond.
One of the most significant challenges would the public perception of UriGel. A living bacterial coating designed for medicinal use is likely to be a world-first in terms of synthetic biology applications. Recent trends around vaccines suggest that novel applications are followed very closely and scrutinized extensively for potential drawbacks or mishaps, and UriGel would need to engage and invest in a large-scale media campaign to inform and help shape public opinion of this novel application of synthetic biology. More information about UriGel's marketing strategy can be found here.
Historically, companies exploring niche novel applications rarely get past the first stage of funding as they are a very high risk investment for investors. As such, funding may also be a challenge for the very same reason as public perception. However, the rise of companies with deep roots in the iGEM competition (like Twist Biosciences and Ginkgo Bioworks) may provide some of the historical basis needed to alleviate some of the pressure on obtaining funding.
Another challenge would be obtaining regulatory approval for UriGel. The lack of regulatory guidance on synthetic biology products for medical use means that a lot of what UriGel does would be on a "make-as-you-go" basis when it comes to regulatory protocols, which may lead to delays as they would require additional scrutiny from both UriGel and the relevant regulator.