Team:CCU Taiwan/Human Practices








Choice of research method

We don’t want to rely only on intuition without thinking about the needs of end users and vested interests. Therefore, the interaction between product and social connections is vitally important. Hence, we choose to use the following methods.



Three stages in choice of our method


Observation is one of the most basic and best ways to begin scientific inquiry. To elaborate, observation can be subjective or objective, about what affects us directly or what affects others. There are no restrictions on observation because it can be about anything from the large-scale environment to details. Therefore, we began by observing what was going on in our surroundings, and the incidence of African swine fever caught our attention.
In practice

In 2018, ASF outbroke in many Asian countries near Taiwan. Statistics showed that 57 countries have recently given notice of ASF to the World Organization for Animal Health (OIE), and the cases continued to increase.


In the next stage, we have to consider whether the problem really needed to be solved. For this part, we need to define our observations precisely, then consider the seriousness of this matter and whether it is urgent. As a result, we began to study how our surroundings were affected by this problem, seeking a holistic understanding of it, which might involve a huge system of underlying social, cultural, and structural factors. After understanding how this problem affected our surroundings, we tried to find the root of the problem by investigating the larger social structure and potential impact on our area.
In practice

After realizing the worldwide importance of ASF, our team conducted extensive market research and business analysis to confirm the seriousness and impact if ASF were detected in Taiwan.


Once we defined the problem, we considered possible solutions through brainstorming, interview workshops, field research, etc. After determining a potential solution, we began conversations with various social groups, since our goal was to solve a societal problem. As a result, we actively kept in touch with others, including experts, scholars, end users, government agencies, etc. Based on these interactions, we continued to test, verify, and modify the method.
In practice

After determining our topic, we began to brainstorm feasible solutions and asked experts for their opinions. Finally, we decided to develop a rapid detector for ASF and started to design the experimental procedure and device. Moreover, we continued to contact our stakeholders such as government agencies, stock farmers, meat processing houses, consumers, etc. We solicited their feedback and continuously improved our product to ensure that it would meet the needs of society.



ASF is spreading rapidly in Asian countries

In 2018, a dead pig infected with African swine fever (ASF) drifted across the ocean from China to Kinmen (a Taiwan outlying island). ASF has rapidly become a worldwide problem. The African swine fever virus (ASFV) first appeared in Kenya, then spread from Africa to Europe, South America, and Russia, and had spread to 17 countries in Europe in just 61 years.

In the past, ASF spread at a rate of 100 to 200 km per year in Europe, and 47 countries have reported the ASF epidemic since 2005. ASF started spreading from north China in August 2018, and by September 2019, nine countries in the region were confirmed to have ASF.

According to research, only two countries in East Asia are “clear” now, Taiwan and Japan. Since almost all of Asia has fallen to the invasion of ASF, we were inspired by this risk. Hence, we hope to make an effort to prevent ASF in Taiwan.



Potential risk to Taiwan by ASF

To understand the potential risk Taiwan faces, we should first clarify how the supply chain of the pork industry works. When a pig owner is going to sell a batch of pigs, those pigs will be sent to the slaughterhouse by a transporter. After slaughter, a transporter will send the pork to the downstream meat company, which will then wholesale the units to the markets which sell pork. Finally, pork will enter the market and eventually our stomachs.



The above schematic diagram illustrates how the pork industry chain works.





Pork industry is out of control

We got a useful frame for the references from a disease outbreak in Taiwan in 1997, Foot and Mouth Disease (FMD, Aphthous fever). When the tragedy of FMD occurred in Taiwan, the pig farmers didn’t know how to react, which led to many pigs being infected with FMD.

On top of that, pigs that were not symptomatic were sent from southern Taiwan to northern Taiwan, which resulted in the spreading of FMD throughout Taiwan. Suddenly, the entire pork industry collapsed. This severe incident caused Taiwan to lose nearly 7 billion US dollars, and pork exports have suffered a great setback for the past 22 years.

From pig farms to consumers, pork will be transported to many venues during this process, which means the whole supply chain can be a route of infection for ASF. ASFV is stable and difficult to be destroyed, so there will be an uncontrollable disaster if pork infected with ASFV is sent away from pig farms. Therefore, only a few countries are able to control an epidemic effectively after the invasion of ASF.

The same three problems exist, whether when the FMD outbreak occurred 20 years ago or if an ASF outbreak happens now.
  1. Lack of a reliable detecting system
  2. Lack of institutionalization of an epidemic-reporting system
  3. Lack of domestic planning for epidemic prevention before the epidemic outbreaks




Value proposition for ASFAST

To prevent an ASF epidemic, we have developed “ASFAST”, focusing on these three problems while designing our product. The value of our product is that it can detect infected pigs immediately, on-site, report the results to management units, and thus assist in reporting and management of an epidemic. We are devoted to establishing a complete ASF health check system, from detection to prevention management, in order to guarantee a reduction of future risk. (Taiwan is considered a high-risk country but not currently an infected area.)



Given the threat of ASF, a passive defense is insufficient

However, you may still wonder why we want to do this since Taiwan is not an ASF epidemic region. Taiwan has so far been effective in planning and implementing border control policies, but passive prevention measures are not sufficient to ensure ASF will not enter Taiwan through informal or illegal channels.

If ASF invades Taiwan, the only option is to cull all potentially infected pigs (since there is no vaccine), which does not really prevent the epidemic. Therefore, we hope to institute an inspection system for ASF that will be rapid, safe, and convenient, to provide one more level of protection for the pigs in Taiwan. In this way, we can discover the epidemic quickly and prevent the spreading of the virus when ASF ultimately enters Taiwan.

The process of transportation of ASFV sample, the time required to obtain results by current methods, and the potential for careless mistakes of personnel, may all lead to the spreading of the virus. Hence, ASFAST seeks to control the epidemic effectively and efficiently as soon as ASF invades, and promotes national policy to set up a complete protection system which includes both quarantine and cloud management.



Loopholes in safety management for pork in Taiwan

In addition to border protection as a way of epidemic prevention, more importance needs to be given to a second line of defense. The following diagram shows how Taiwan pig and pork safety management is currently executed.


Once the pig is ready to sell to the market, the pig farmer should sign a health declaration to guarantee there is no unusual symptom on the pig, based on visual inspection. After submitting the health declaration, the next step is to check for drug residues, and then the pork will be sold to the slaughterhouse. As mentioned above, there is no direct inspection for disease in the current detection process.



ASFAST’s countermeasure to the safety management of pork

We hope to improve the detection system at the upstream end of the industry supply chain, and also add a new requirement (declaring the pigs ASF-free) to the inspection in the health declaration.

For a short–term goal, we started from the upstream of the industry chain, the pig farm. During the process of consultation, we got lots of practical feedback and suggestions from frontline workers. Therefore, we set the promotion of inclusion of disease inspection in the health declaration as our short-term goal.

As a mid-term goal, we hope to establish a regular detection system, divided into first-level and second-level, according to the requirements and urgency at a given time. Each level test will be tested by our personnel. The first-level tests will be conducted every ten days, with tests of all the pigsties in Taiwan carried out simultaneously. The second-level test is picking one county every month and randomly select 1000 pigs to be detected. Currently, Taiwan should carry out the second-level test, but if there is any case occurs, the first-level test will be carried out.

The combination of the ASF Periodic Inspection System & Establishment of a Health Declaration, we have called the “ASF safety system”.





How ASFAST could change society

In view of maintaining the credibility of inspections, we will not sell machines, but provide safety system service for ASF (and eventually other diseases).

A safety management unit requires third parties to provide credible inspection data. The use of cloud data allows the management unit to clearly understand the status of pigs in a particular pigsty in a timely manner. The safety system service we provide for ASF (and other diseases) can reduce current detection loopholes and provide a more professional approach to pig disease management.

Pigs infected with ASFV can enter any area in Taiwan. Thus the advantages of the ASF safety system service include the ability of our product to detect the infected pigs on-site immediately and let the government quickly control the epidemic, as well as develop a coping strategy to avoid the spreading of virus. Furthermore, it can ensure the safety of pork in the slaughterhouse and reduce virus spread as long by ensuring it does not leave the pigsty.




IHP Timeline


After observation and field research, we decided to start from upstream management.
Change business model from selling single product to provide service
We expressed the concept of our product, ASFAST, to General Manager Ou from CCU Innovation Incubation Center. After exchanging ideas, the GM suggested that we provide testing service rather than a single product.
We determined to change from selling product to provide service, so we proposed the ASF safety system (African swine health check system and food safety certificate).
Adjust CRISPR-Cas9 to CRISPR-Cas12a
Professor Tseng gave us insightful opinions on how CRISPR Cas9 could bind the DNA of the virus and the how CRISPR Cas9 shows a difference when connected to the viral DNA.
After examining CRISPR methods we found that CRISPR Cas9 can only cut double-stranded DNA but can’t cut single-stranded DNA, so we switched to CRISPR Cas12a.
Change our target audience
After proposing our idea to establish the ASF health check system, pig farmers stated they didn’t support the idea. Hence, our target audience turned to the government.
Target audience turned to the government.
Government's suggestions on complementary measures and how our product should be refined
Director Hsu mentioned that we must specifically state the difference between our products and the current rapid screening technology on the market and how it will enhance the accuracy of the products to be adopted by the central government. Besides, he also explained that if we want to implement the legislation, we can start from the Bureau of Animal and Plant Health Inspection and Quarantine, and also consider complementary measures to reduce the farmers’ opposition.
Stop applying for a provisional patent
After discussing with an expert in patents, Chen Wen Yin, we confirmed that we do not need technical disclosure.
Confirm the design of experiment first, then the device
Professor Chang said that we should confirm the blood volume, virus concentration and the light intensity of the fluorescence first, then determine the design of the device.
Food safety certificate should be integrated under the existing certificate
Premier Chiang suggested that we integrate our test under the existing certificate. And he introduced us to the former chairman of COA because he is also interested in our ASF health check system.
Participate in various governmental events
We participated in a food safety seminar for ASF in the community held by the Pharmacists Association, and the deputy director introduced us to the section chief of the slaughterhouse.
Change in experimental goal
“PCR has been chosen as the common test for ASFV due to its precision and stability.” Thus Dr. Teng thought that in the early period of developing ASFAST, we must first prove the core ingredients of ASFAST including precision, low concentration performance, and stability of detection of the virus.
Confirm timing of application for a patent
Professor Chen shared the details of applying for a patent and some practical suggestions with us. We will definitely apply in the future.
Enhance the effectiveness of education
We don’t want to conduct sloppy education. So before going to teach children, we asked Dr. Liang about the abilities and details required for teaching children in class.
Replace food safety certificate with health declaration
After proposing our idea of ASF health check system to the section manager, he suggested that we integrate the ASF test in the health declaration. And he also supported our action of upstream management.
In the promotion of policy, we will make an effort to integrate the ASF test as a required part of the health declaration. The health declaration must be submitted. Hence, if this policy is passed, we will not suggest a separate food safety certificate.
Food safety certificate becomes a fallback plan
We proposed our desire to establish the ASF health check system to the upstream pig companies. The chairman said that if we integrate the test under the existing certificate, it could enhance the willingness of consumers to purchase certified pork.
We face a dilemma for promoting policy due to OIE’s standard
Chairman Cheng indicated if the domestic epidemic prevention work is carried out in Taiwan, it will make OIE doubt whether Taiwan is concealing an epidemic or even list Taiwan as an infected country. So we are worried about implementing the security system. We decided to pursue implementation of the policy first in affected countries while exploring a workable solution for Taiwan.
While looking for solutions to the policy questions, we try to establish the same system in affected countries.
Establish cooperative enterprise
We discussed with the Yuan Long Agricultural Cooperative about our business model for exporting the product, and Yuan Long hopes that we have a more detailed plan on cost and marketing, and they are willing to keep in touch with us.
Confirm cooperating enterprise and settle on a basic concept for export.
Plan contact with first-line operators
For our device, we need the first-line operators to give us some advice, so we contacted Section Chief Chen, hoping that she will pick relevant personnel for us, and she suggested that the veterinarian of a large livestock farm is most suitable.
Interview at local market
The public shared their opinions on ASF with us. To our surprise, some of them mentioned items related to practical implementation of policy that we didn’t know. It made us go deep to understand policy in Taiwan again.




Expert Interviews

Overview

From the time we began to think about this topic to the production of products, we have had only one purpose. We hope to bring a small change to the world through our concepts and ideas.

However, in order to integrate our projects into society, we have constantly held interviews with experts, companies, government agencies, the public, and all vested interests. In addition to product production, social connections are a part of our focus. From finding problems to solving problems, we are making a difference in this world.

Mar 22
When we decided to develop an ASF rapid screening detector, we invited the general manager of the National Chung Cheng University Incubation Company, Ou Chin Shih, to talk with us.

We demonstrated the idea of our product to him and expressed our desire to make a contribution to Taiwan. After discussion, we determined to change our business model from selling a product to selling service, which can really protect the pig industry.

Mar 29
We had difficulty finding out how CRISPR Cas9 will bind the DNA of the virus and how CRISPR Cas9 shows a difference when connected to the viral DNA. Hence, we consulted Professor Tseng who is an expert in this field. He mentioned that by sticking the CRISPR Cas9 to a substrate, the sample solution can be washed away, and the virus DNA connected to the CRISPR Cas9 will remain on the substrate afterward.

Nevertheless, after executing these methods we found that CRISPR Cas9 can only cut double-stranded DNA and can't cut single-stranded DNA, so we decided to switch to CRISPR Cas12a.

Apr 07
Our team believed that we should contact pig farmers first because they are the source of the pork industry supply chain. So before conducting professional interviews, we interviewed some local pig farmers and asked their opinions about our product as well as views on ASF.

We found that pig farmers were generally not interested in our products during the discussion. They think that it would be more helpful to develop vaccines. If ASF infected pigs appear in Taiwan, their pigs will still die because of the spreading, so the owners don't want to buy it.

After visiting the pig farmers, we determined that the target audience (TA) of our products will not be pig farmers, but the government. So we will work with the government to market our service.


May 13
After deciding that the government is our TA, we first found the Director of Chiayi County Agriculture Department to share our thoughts and ask for advice. The director said that the product concept is good, and the rapid screening can achieve the effect of epidemic prevention and protect the overall economy of Taiwan. But we must specifically declare the difference between our products and the current rapid screening systems on the market and enhance the accuracy of the product if we want it to be adopted by the central government. He also explained that if a law is to be implemented, it would start from the Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ), and also would consider compensatory measures to reduce the farmers' opposition.

After the consultation, we will make efforts to enhance the accuracy of the product and start contacting the BAPHIQ.

Jun 02
As our project progressed, we began to think about applying for a patent to protect our product, so we consulted Professor Chen, who has extensive experience in this area.

Professor Chen suggested that if the technology does not need to be disclosed in advance, there is no need to apply for a provisional patent. It does not help and would cost a lot. As for applying for a patent, we must be careful not to overlap with the patent content of others, to avoid disputes and failure of the application.
After consulting with Professor Chen, we dismissed the idea of applying for a provisional patent. We intend to apply for a formal patent directly because we do not need early technical disclosure.

Jun 05
For the detection mechanism of experimental design, we wanted to use spectroscopes and fluorescence to detect the experimental results, but we did not know if this is suitable for our overall experimental design, so we consulted Professor Chang, who is an expert in optical detection.

At the beginning, we first shared the overall experimental design and asked about the spectrometer specifications for the use of fluorescence to detect the effect of Cas protein. Professor Chang said that the blood volume, virus concentration and the light intensity of the fluorescence are the key factors to design the instrument. Hence, we should establish the above three items before designing the instrument.

Jun 12
Before discussing with the central government, we visited the Former Premier, Mr. Chiang, Yi Hua. We asked him about the difficulties that the startup will face and the precautions we need to understand for the implementation of administrative orders or amendments and the establishment of a food safety certificate.

Premier Chiang explained the problems he had encountered in dealing with this aspect. In the first aspect of food safety certificate, Premier Chiang shared the current food-related certificates in Taiwan, which are very diverse, which has caused the public to become confused about the food certificates.

Hence, he suggested that we place our test under the existing certificate, which could be very helpful for the perception of the people and the integration of food safety certificates. Secondly, even though this is not his field of expertise, Premier Chiang is very interested in the implement of ASF health check system, and he referred us to relevant government units.

Our team will continue to seek to establish a regular health check system for ASF and start the conversation with the appropriate food safety label unit.

Jun 24
To promote our idea to one more place, we participated in a food safety seminar for ASF in the community, held by the Chiayi City Pharmacists Association on June 24th. The mayor of Chiayi City and many government units also attended the event.

After the symposium, we shared the idea of our product and the desire to establish a safety system with the deputy director of the Chiayi City Health Bureau and the head of the Food Management Section of the Health Bureau. They showed interest in our ideas, so we stayed to discuss policy details.

In the end, the deputy director introduced us to the person in charge of the slaughterhouse. Hence, we will have further interviews with the slaughterhouse.

Dr. CHANG (left) and Deputy Director General LIAO (third from left).
Jun 25
Intention

Animal Health Research Institute (AHRI) is a division of the Council of Agriculture in Taiwan, it covers all the research and operation of animal health tests, including ASFV tests and research. Considering the authority of AHRI for ASFV epidemic prevention, we decide to pay them a visit at Tamsui, Taiwan to present ASFAST and discuss our project.
Presenting

We started the meeting by expressing our intention to develop ASFAST, followed by introducing our project, focusing on the biological approach used and the safety details of the device we are trying to manufacture.

After that, we also presented our marketing strategy to sell ASFAST as a complete service of ASF detection rather than the device itself. Finally, we stressed the need for cooperation with the government.
Comment

After listening to our presentation, the director of the research department, TENG, Ming-Chung shared his opinions on the development of ASFAST. “PCR has been chosen as the common test for ASFV due to its precision and stability.”

He stated that in the early developing stage of ASFAST, we have to start by proving the core component of ASFAST is truly able to detect the virus accurately despite a low concentration of virus DNA. Besides that, he suggested we should compare ASFAST directly with PCR in every aspect, including precision, low concentration performance, stability, and other measures.

Although the new technology may not be accepted yet at the regulatory level, to allow our technology to replace PCR this is the direction we need to pursue. The Animal Health Research Institute welcomed us to discuss the project with them again after the technical aspects are complete.

Jun 28
We invited Associate Professor Chen from National Chiao Tung University to share his experience of promoting iGEM competition in Taiwan for a decade and talk about applying for a biotechnology patent.

First, Prof. Chen said that iGEM is more than a competition for him, it is more about education. From a group of students to a group of employees of startups, they need to possess certain skills and attitudes. We benefited a lot from his experience. After the symposium, we discussed and changed the way our team operates, using more scientific management methods to run our team.

Prof. Chen also shared the details that biotechnology needs to pay attention to when applying for a patent, and told us how he applied for patents for the iGEM team. This will be a big help for us when we apply for a patent in the future.

Jul 01
Before going to teach children, we showed our educational content to Dr. Liang through video and asked about clarity of the details and how to maintain the attention of children taking the classes.

Dr. Liang also shared lots of teaching experience with us so that we have more concepts for future teaching, to make the children interested in learning new things.

Jul 03
Since we wanted to set up a food safety certificate to prove that pigs were screened for ASF, we consulted Section Manager Hsu of the Chiayi Meat Market.

After sharing our thoughts, Section Manager Hsu mentioned that the pigs must be issued a health declaration by the owner before being sent to slaughter. If the proof of freedom from ASF can be placed in the health declaration, the effect will be better, and a disaster like the spread of the outbreak of the FMD disease can be avoided. Hence, we decided to try to make changes in the health declaration.

Jul 05
To understand the insights of downstream companies in the pig industry, we visited a meat processing plant. The chairman of the board believes that our products will be helpful to them. He said that prevention of the spread of the epidemic can reduce the number of culled pigs, so Taiwan will not risk having no pork processing.

In addition, we also asked whether pigs with certification are beneficial to them. To reach substantial sales benefits, the special assistant said that if the seal is highly credible, consumers are willing to choose such products, so he suggested that we merge our testing with other certificates, to build on the recognized influence of the certificate.

Jul 09
To confirm the feasibility of our health check system, we visited Chen, Pao Chi, the former chairman of the Council of Agriculture, who has extensive practical experience.

We expressed our desire to establish an ASF health check system in Taiwan to prevent the rapid outbreak of an ASF epidemic. Chairman Chen said straightforwardly that this is not feasible in Taiwan. If the test is carried out without an outbreak, the World Organization for Animal Health (OIE) will wonder whether we are concealing an epidemic.

For example, Taiwan does not have mad cow disease, but because it imported beef from the USA and Canada, it was rated as a controllable risk epidemic area by OIE. Hence, Taiwan's epidemic prevention focus can only be placed on border quarantine.

After the interview, we thought that this health check system may not be feasible in non-epidemic areas, based on the complicated social structure behind it. This makes it hard to establish a domestic epidemic prevention system for Taiwan and made us think further about how we could put our idea into practice.

Perhaps we can first implement our system in epidemic countries so that they can improve control of the epidemic. To help different regions in different countries with the same original intention, we will continue to explore solutions in Taiwan's policy implementation.

Jul 11
To gain knowledge of the export potential, we asked advice from Yuan Long Agricultural Cooperative, which is one of the largest agricultural production and marketing companies in Taiwan, with extensive experience in exporting.

After we shared with them the business model of the team and our situation, the general manager held a symposium for us on 7/11, at which we talked about the qualifications and processes that we would need to sell our products or service abroad. We learned that the overall process is to receive an order, assemble the goods, organize the customs clearance documents, send the goods to the terminal with the staff to take the export order to the customs, and then pass the customs clearance operation, and the export is released to the importer.

This symposium was very important to our team, providing practical basic knowledge for our team about the process of exporting. After the symposium, the general manager exchanged contact information with us and reached a consensus with us about a business model. If we have any questions, we can continue to keep in touch with him. Yuan Long Agricultural Cooperative has become our primary partner company.

General Manager Lee (middle)
Jul 12
We visited the section chief of Chiayi Agriculture Department to understand the scope of the work of government veterinarians and ask for suggestions. At the beginning, we shared our product idea and asked the veterinarian about the design of our device.

The section chief said that the veterinarians under the Agriculture Department only executed the orders of an official document issued by the BAPHIQ. Usually, they would send blood back to the Tamsui laboratory for testing. Hence, she suggested that we look for large pig farms and cooperate with veterinarians on those farms who may have more experience with disease screening and greater autonomy.