Project Description

I would like to tackle a disease that has been labelled as Poverty disease, snakebite envenoming, because it majorly affects poverty stricken rural communities in Sub-Saharan Africa, Asia, Latin America and other places. The only treatment for SBE is administration of the right antivenom, in the right doses and in a timely manner.  Antivenom is developed through a tedious process of injecting large mammals with low amounts of snake venom, then harvesting the antibodies that the animal develops over time. This process is not only time consuming and labour intensive, animal rights activists have questioned the ethics of injecting animals with venom and harvesting the antibodies from their serum. In Africa, the problem is compounded by the fact that no antivenom is manufactured there, therefore, the available antivenoms are developed using venom from Indian snakes and other parts of the world significantly reducing the effectiveness of the antivenom. Another major challenge is availability of these antivenoms. As i had indicated early on, this is a disease that mainly affects rural, poor community therefore in most of the dispensaries and hospitals in those areas antivenom are not available and even when available they are not affordable to the most vulnerable communities that need them the most.

I am suggesting therefore to use the power of synthetic biology and try and solve this problem by applying a three thronged approach:

1. Diagnostics – I hope to develop a genetic circuit that can detect and accurately report the biting snake species using the DNA left on the victims bitemarks. In order to do this, I suggest a toehold switch that intakes the DNA from the Snake and report the species responsible. This will help a great deal in helping healthcare providers in deciding quickly what antivenom to administer in order to save the lives of the victims since a SBE is a serious medical emergency and time is essential factor.

2. Therapeutic

   Develop a gene circuti that neutralizes the variouos snake venom toxins in the circulating blood of vicitms. This will reguire an understading of the toxins and their corresponding proteins that neutralizes them after recognizing them

3. Develop a potential vaccine through a virus like particles that has the epitomes of snake venom toxins inorder to elicit an immune response that can then helo victims in their next encounter with snakes. .

Q2 Next, describe one or more governance/policy goals related to ensuring that this application or tool contributes to an "ethical" future, like ensuring non-malfeasance (preventing harm). Break big goals down into two or more specific sub-goals.

For this project, there should be policy and governance guidelines that must be put in place. This will enable the adoption of this new technology and acceptance to the general population as a viable addition and complement to the current methods of handling SBE. Let s explore the current synthetic biology policy in Kenya as a basis for what needs to be done.

Synthetic Biology policy in Kenya

There is no standalone policy for Synthetic Biology in Kenya currently, however, there are several charters and policies that Kenya is a signatory to which provide guidance and direction and can be adopted and used in this case. Kenya is was among the first countries in Africa to sign the Nagoya protocol which gives a direction for fair use and sharing of biological materials between countries. Kenya passed the Biosafety act of 2009 which established the Biosafety Authority of Kenya which is a body mandated with developing policies and guidelines that guide the adoption and utilization of all biotechnology applications in Kenya. So, building on this, i would propose the following policy and governance guidelines for this project to be fully adopts and accepted.

1. Stand alone policy in Bioengineering and Synthetic Biology

Synthetic Biology is rapidly evolving and changing and therefore there is need for the government of Kenya to establish a standalone policy on Synthetic Biology addressing areas like biosafety and biosecurity, permits and permission of engaging in Synthetic Biology work, and govern dual use policies.

This framework will be important is addressing the and defining the difference in synthetic biology products and Synthetic Biology tool deployment and adoption. I would suggest for example that the products that come from engineered microbes should not be categorized in the same way as deploying an engineered bacteria to the environment.

1. Develop guidelines on environmental protection and avoidance of gene transfer

We need a policy and guidelines on Synthetic Biology ensuring that we do not transfer transgenic genes into the environment and preserve the biological diversity while enjoying the benefits of Synthetic Biology. In this case, policy we could adopt that will be beneficial is insistence on use of cell free system that freeze fried on paper and other material for diagnostic work for all the products that will be deployed to the general public and only use whole cell sensors under controlled environment. Every organization and university engaging in Synthetic Biology must have a proper guideline on how to avoid leakages and a containments plan in case of accident. This will help in building confidence in the general public and other industry players to focus on the potential benefits of Synthetic Biology in Kenya.

1. Intellectual property and benefit sharing in Synthetic Biology

This is a very touchy subject in cases where Synthetic biology products are developed in conjunction with the local and international University. I propose a clear guidelines and framework in the country that guides benefit sharing of the benefits of Synthetic Biology. If this project were to succeed and be deployed for the benefit of the majority of the rural farmers and the moist vulnerable of our communities, it should be clear who own the intellectual properties and how that benefits the local community.

Q3. Next, describe at least three different potential governance "actions" by considering the four aspects below (Purpose, Design, Assumptions, Risks of Failure & “Success”). Try to outline a mix of actions (e.g. a new requirement/rule, incentive, or technical strategy) pursued by different "actors" (e.g. academic researchers, companies, federal regulators, law enforcement, etc). Draw upon your existing knowledge and a little additional digging, and feel free to use analogies to other domains (e.g. 3D printing, drones, financial systems, etc.).

• Purpose: What is done now and what changes are you proposing?
• Design: What is needed to make it “work”? (including the actor(s) involved - who must opt-in, fund, approve, or implement, etc)
• Assumptions: What could you have wrong (incorrect assumptions, uncertainties)?
• Risks of Failure & “Success”: How might this fail, including any unintended consequences of the “success” of your proposed actions?

Purpose

Currently, the process of developing anti snake venom is tedious and risky that involves first extracting venom form the venomous snakes which requires that the snakes be kept in captivity and milked periodically. Then a large mammal, like horses or cows are immunized with the venom at various time intervals over a period of time and allowed to produce antivenom against the venom which is then harvested in blood. These antibodies are purified from the serum of the animals, and packaged as antivenom against the original venom that was used to immunize animal. In order to get a cocktail of antivenom, the animals have to be immunized with a mixture of venom from various snake species.  This is a very tedious and expensive process that Synthetic Biology can easily intervene and make it easier and less expensive and more efficient.