Integrated Human Practices

Finding an innovative and reliable solution to a problem does not happen in a vacuum, on the contrary, there is a continuous relationship between our work and the world. On how our work affects the world and how the world affects our work. Acknowledging this, we went out into the world to get feedback on many aspects of our diagnostics.

To review the feasibility of our project, and to continually improve our final product, we contacted stakeholders either invested or interested in the issue of snake envenomings.

Here we summarize the feedback that is of both technical and economic nature:

1. - Rapid identification of snake species will give valuable insight into the proper course of treatment
2. - Our approach on choosing a project has been a pragmatic one that is, avoiding having a solution without a problem.
3. - We looked into how we could meet the requirements for our solution to be viable for treating snake envenoming.)

We looked into how we could meet the requirements for our solution to be viable for treating snake envenoming.

Andreas Lausten postdoc, VenomAb, an entrepreneur and researcher, is using a rapid and effective manufacturing process which includes human phage display libraries and synthetic biology, to produce monovalent antivenoms, targeting specific snakes. He has given us feedback on several aspects of our project, including the design of our snake detection device. The concrete technical feedback relates to rapidity of our prototype, means of lowering costs and issues surrounding a device employing a single variant of an oligopeptide for screening.

1. - Rapidity: He deliberated the importance on the rapidity of the response. This led us to investigate the amplification mechanism of the signal. This is important, as certain snakes have more potent venoms and that detecting the type of envenoming prior to symptoms begins to show would be valuable. In this case, the earlier the treatment, the better. Hence, we went ahead and modelled the amplification mechanism using x-Gal.
2. - Low cost: Furthermore, he emphasized on the importance of our device being a low-cost detection system.

We met this requirement in two ways:

1. - Disposable lab equipment: Our prototype consists of modules that all are based on standard disposable tubes and vials. This is to ensure that the prototype can be used across clinics, countries and continents. It will also enable the rural clinics, or those with restricted access to state of the art lab equipment, to use the device as a means of detecting snake envenoming.
2. - Complexity of venom: Our device is measuring the proteolytic activity of the venom. This could be either phospholipase 2A, metalloprotease or other proteases in the venom. This means that the linkers used should encompass multiple activities of the venom. This effectively means that the device should enable for multiple oligopeptide variants that are known to be targets for the enzymatic activity in the venom. In order to take this point into account, we have developed an application for discriminating between snakes species using logic gates.

Angela A. Amadeu, Instituto Butantan, Brazil: This institute is well known for it’s large collection of venomous snakes. We got in contact with the research group under Wilmar Dias da Silva professor of the immunological lab in Sao Paulo, who works with snakes native to Sub-Saharan Africa. From the group. Angela A. Amadeu, who is studying the venom of Bitis arietans, was able to give us information on the venomics of Bitis venom. Furthermore, she provided inputs to how our team could test our proposed biosensor and imitating blood samples by adding serum and blood thinners such as Heparine to our venom when testing our device.

Gernot, J. Abel Novozymes Novozymes is a big player in biotechnology, working with enzyme products. Their feedback reflects their opinion on the requirement for a viable solution for the market. We discussed the importance of certification, robustness and specificity of our prototype in addition to the user experience. We had time to incorporate the feedback on:

1. - User experience Simplify the user platform
2. - For the lowest common denominator by applying simple visuals
3. - Give option to access snakes envenoming relevant resources.

This is especially relevant if the rural clinics lack expertise, both professionally (lacking doctors) or knowledge on the subject. We have a simple and intuitive color-scheme on the smartphone interface. In addition, we have incorporated the option to get more information on the snake, when and which antidote is needed and the geographic area, where the snake is found. This information is facilitated by WHO snake database, which also has pictures of the snakes and maps of where they are found. In addition, it provides a list of antivenom suppliers. This would enable the treatment facility to offer a better course of treatment.

Feedback and endorsements on economics, market and distribution

Extending on the feedback received by Andreas Laustsen on the need for the diagnostic device to be low-cost, we assessed for how we could create revenue. We identified the challenge to reaching the end users of rural sub saharan africa to be impacted by challenged infrastructure and distribution channels.

We further learned, from Guidelines for the management of snake bites, David A. Warrell: that prices of all types of medication rise due to the challenged infrastructure and the high demand for these medications. This leads certain suppliers to increase the prices for the products.
From communication and a meeting with Mette Louise Larsen from the Danish NGO, InnoAid, we were told about revenue streams that could be achieved given the nature of our project.

We communicated with Bernadette Abela-Ridder, the team leader for Neglected Zoonotic diseases at Department of the Control of Neglected Tropical Diseases at The World Health Organization, who encouraged our incentive:
“Your research is interesting and valuable and may be able to support the WHO Roadmap which we will be developing in the next months.
We will be developing a research agenda that support the roadmap and these type of tools will be considered” 8. October 2017

We believe getting endorsement from respectable organization such as the World Health organization increases our chances of being a viable solution on the market in the future.

In order to assess for viability of our prototype on the market, we made a preliminary Canvas business plan to identify resources and challenges.

Business canvas

We believe a sequential approach of breaking through on the market is necessary. We have a challenge before us with certification, which we would have to achieve through multiple rounds of experiments, and test for robustness and specificity of our device.

We would like to develop the prototype further. We identify the University environment to be the most sensible solution, partly due to the high cost of research and development, and due to managing expenses on labor and facilities.

Strategically, we have two markets we have taken into consideration

1. - Australia
2. - Expand range to fit a bigger market, with the end-user having similar diagnostic needs but more means to pay for a diagnostic device and its use
3. - Expand range to fit a bigger market, with the end-user having similar diagnostic needs but more means to pay for a diagnostic device and its use
4. - Expand to more challenging market (i.e Africa)
5. - Africa
6. - Utilize already existing distribution and logistical channels set in place by
7. - Humanitarian aid organizations such as UNICEF and Doctors without Borders.
8. - Governmental Health Authorities and Antivenom supplies

As long as research and development can be done within the University framework, utilizing students - the cost on laboratory use can be lowered tremendously.

Revenue streams for this kind of solution has been a challenge to establish. We have, so far, identified that we could pay back investor or stakeholder by either selling the patenting information, or by establishing a subscription model for the application access of the costumer, who is identified here, to be the Rural clinics, UNICEF, or Antivenom Suppliers.

The incentive for antivenom suppliers to invest in our device would be to raise their value proposition by offering a package, containing both their antivenom and the diagnostic solution.
They would be the only supplier on the market doing this, raising their competitiveness, considerably. Ideally the target for this strategy should be a monovalent antivenom manufacturer, as polyvalent manufacturer have the benefit of being able to market their product for multiple snakes, where detection between closely related snake species would not have much effect on the administration of antivenom.

We also identify an opportunities to gather and sell metadata for epidemiological research. This is facilitated through the use of the application. The challenge here is that we would ensure that there is data coverage at either the treatment facility, or at the envenoming incidence site. However, this can prove useful in assessing morbidity in certain areas.

If diagnosis is subsidized by Humanitarian Aid organization, such as Doctors without Borders or UNICEF we could offer the end user to use the diagnostic and channel cost for its use to these organizations.

This to be necessary as we can not expect the average Ugandan working the fields to pay the cost for both diagnosis and treatment.

Our unique value-proposition is the rapid diagnosis of snake envenoming to potentially save lives and cost of treatment. We do the latter to exclude use of antivenoms identified to be less effective against the type of envenoming present in the patient. This is valuable to more effectively use the limited stock of antivenom to patients that have more need for it.