|
|
| Line 940: |
Line 940: |
| | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> | | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> |
| | <div class="ModalDescription"> | | <div class="ModalDescription"> |
| − | <h1>Form</h1> | + | |
| − | We had an interview with Doctor Yuan-Yen, Chang on March 20th at Chung-Shan Medical University. Doctor Chang is the professor of microbiology. His specialties are virology, Immunology, and biotechnology.
| + | <h1>Form</h1> |
| − | <h1>Purpose</h1>
| + | Our team had an interview with Ph.D. Chih-Ming Chen, who is the Senior Director of the Business Development of TaiGen Biotechnology. |
| − | As a professor of microbiology, doctor Chang knows well about the knowledge as well as the mechanism of respiratory disease. Through this interview, we would like to know more about the background knowledge of respiratory disease and the diagnosis of influenza. We drafted the questions below:
| + | <h1>Purpose</h1> |
| − | | + | Through the interview, we would like to know if it’s possible to develop a medicine with aptamers and understand the market of influenza medicine nowadays. We drafted the questions below: |
| − | <li>How to detect influenza in a lab?</li>
| + | <ul> |
| − | <li>What kind of sample does the professor recommend for influenza rapid test? </li>
| + | |
| − | <li>Do you recommend using the blood to detect the flu directly? </li>
| + | <li>What is the mechanism of your(TaiGen) new influenza medicine—TG1000? How does it function as a medicine and a vaccine at the same time? </li> |
| − | <li>Do you recommend using swabs to detect flu directly? </li>
| + | <li>In the industry of influenza medicine, what aspect do the biotechnology companies focus on? What is the present situation of the influenza market? Why does TaiGen choose influenza as the subject to develop? </li> |
| − | <li>What are the current methods of influenza detection? </li>
| + | <li>How do biotechnology companies estimate the potential and prospect of a newly developed product? What aspect should be noticed? </li> |
| − | <li>Do you have any suggestions for our fast screening products? </li>
| + | <li>Can aptamers be applied to medicine? </li> |
| − | </ul>
| + | </ul> |
| − | <h1>Process</h1>
| + | <h1>Process</h1> |
| − | | + | <ul> |
| − | <li>Generally, a bacterial culture is performed in a lab, and the whole process takes about 3 to 7 days. </li>
| + | <li>Mr. Chen said that the mechanism of their new medicine—TG-1000 is Cap-snatching. It inhibits the duplication of influenza viruses and has shown well result on animal tests. It resists Type A and B and avian influenza H7N9 infection. Moreover, the validity period of the medicine lasts for 72 hours, which is better than Tamiflu. There isn’t only one molecule of the virus in one cell, so medicines have to reach a certain concentration to have a function. The viral molecules will combine with the medicine through random collision. By measuring the medicine's inhibition constant (IC50) or so-called binding constant can let us know their affinity to viruses. </li> |
| − | <li>The general influenza samples have two forms, blood, and swab. The advantage of a blood sample is a lot amount at one time. The advantage of the swab is non-invasive. </li>
| + | <li>The influenza virus often infects lung cells, however, the concentration of the medicine in the blood doesn’t represent the same as in the lung. It is important to prove that the concentration in both places is proportional. Also, confirming that whether the medicine can exactly achieve the goal is very important. </li> |
| − | <li>Dr. Chang recommended swab as the sample of our influenza rapid test. Since taking a blood sample needs to penetrate patients’ skin with needles, it is more invasive than taking a swab sample and less accepted by patients. Besides, drawing blood can only be conducted by professionally trained people, it isn’t good for promoting simple use. What’s more, a blood sample is valid only when there is viruses in the blood, or so-called viremia. </li>
| + | <li>The product is design as an oral medicine for easier taking in. Different diseases have different consideration, for example, intravenous injection make medicine spread faster in body but oral medicine is more convenient for patients to take in. </li> |
| − | <li>Dr. Chang recommended that we design a kit that can test lots of pathogens and is user-friendly, which means everyone, even people who aren’t professionally trained, can use it. To know more about the technique he suggested we visit Adimmune Corporation. </li>
| + | <li>Besides providing community immunity, the advantage of their product is its slow metabolism rate. It keeps the effect even longer than a week, so it doesn’t need to be taken earlier before infection like a vaccine, and the effect is also much better than the vaccine. </li> |
| − | </ul>
| + | <li>The limitation of the medicine is that the safety range of the dosage is narrow. If a child showed resistance to some other flu medicine, doctors can’t increase the dosage for the concern of safety. Although TG100 hasn’t passed a human test, the result of an animal test showed that the dosage can be increased. </li> |
| − | <h1>Feedback</h1>
| + | <li>The reason why they choose to develop influenza medicine is that there are 3 to 5 million people affected by influenza annually, and Tamiflu, the flu medicine most commonly used, has many limitations needed to be improved. </li> |
| − | After the interview, we had a clearer idea of our product. We decided to take swabs as the sample of our device. Our device needs to be fast, accurate and easy-to-use. We can make our product as kits in the near future, and we can ask Adimmune Corporation for more details.
| + | <li>If technology advanced more in the future, it is possible to design an antibody by just knowing the structure of the protein of a virus. With gene sequencing, we are able to compare the similarity between different viruses similar and apply the same medicine to similar ones, which reduces the cost of the process to develop new medicines. </li> |
| | + | <li>As for applying aptamer to medicine, Mr. Chen agreed with our idea. He said medicine is not restricted to only a specific type. He emphasized that collecting data is very important. </li> |
| | + | </ul> |
| | + | <h1>Feedback</h1> |
| | + | Through this interview, we got a lot of information about developing medicine. Besides, we knew more about the defects of influenza medicine nowadays. The importance of developing better medicine for influenza is worth noticing. Mr. Chen gave us a positive answer to our concept of applying aptamer to treatment. We then came up with the idea of applying aptamers to preventive medicine. |
| | + | |
| | + | |
| | </div> | | </div> |
| | </div> | | </div> |
| Line 994: |
Line 1,000: |
| | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> | | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> |
| | <div class="ModalDescription"> | | <div class="ModalDescription"> |
| − | <h1>Form</h1>
| + | |
| − | We had an interview with Doctor Yuan-Yen, Chang on March 20th at Chung-Shan Medical University. Doctor Chang is the professor of microbiology. His specialties are virology, Immunology, and biotechnology.
| + | <h1>Form</h1> |
| − | <h1>Purpose</h1>
| + | Our team visited Adimmune Corporation's Biotechnological Company and had an interview with the managers, the senior researchers of R&D division, and the managers of the marketing division on August 8th. |
| − | As a professor of microbiology, doctor Chang knows well about the knowledge as well as the mechanism of respiratory disease. Through this interview, we would like to know more about the background knowledge of respiratory disease and the diagnosis of influenza. We drafted the questions below:
| + | <h1>Purpose</h1> |
| − | | + | We wanted to know what would a biotechnological company, the potential stakeholder of our project, think of our research. Besides, we also wanted to know the issue of marketing, commercializing, and possible further applications. We drafted the questions below and separated them into two parts: |
| − | <li>How to detect influenza in a lab?</li>
| + | <p><b> Influenza and Aptamer </b></p> |
| − | <li>What kind of sample does the professor recommend for influenza rapid test? </li>
| + | |
| − | <li>Do you recommend using the blood to detect the flu directly? </li>
| + | <ul> |
| − | <li>Do you recommend using swabs to detect flu directly? </li>
| + | <li>If we would like our rapid diagnostic test product to help the government predict epidemiological trends, will it make the product more valuable if it can distinguish subtypes? </li> |
| − | <li>What are the current methods of influenza detection? </li>
| + | <li>If our product could provide not only AB subtype but also information about the time and places infection occurred. Is it more helpful for predicting epidemiological trends? </li> |
| − | <li>Do you have any suggestions for our fast screening products? </li>
| + | <li>Is it possible to predict the trends of the disease spreading after an outbreak? </li> |
| − | </ul>
| + | <li>Does our product help increase the effectiveness of making vaccines? </li> |
| − | <h1>Process</h1>
| + | <li>At Asian Health Exhibition, we met TaiGen Biotechnology and we knew that they had produced a new drug called TG1000. They claimed that it has a long-term half-life, so it has a preventive effect on flu. Aptamers also have the property of inhibiting virus invasion. How can we apply the feature to make a therapeutic and preventive medicine? </li> |
| − | | + | <li>Is it feasible to apply aptamers to vaccines? </li> |
| − | <li>Generally, a bacterial culture is performed in a lab, and the whole process takes about 3 to 7 days. </li>
| + | <li>Is it feasible to apply aptamers to automated wafer technology? </li> |
| − | <li>The general influenza samples have two forms, blood, and swab. The advantage of a blood sample is a lot amount at one time. The advantage of the swab is non-invasive. </li>
| + | |
| − | <li>Dr. Chang recommended swab as the sample of our influenza rapid test. Since taking a blood sample needs to penetrate patients’ skin with needles, it is more invasive than taking a swab sample and less accepted by patients. Besides, drawing blood can only be conducted by professionally trained people, it isn’t good for promoting simple use. What’s more, a blood sample is valid only when there is viruses in the blood, or so-called viremia. </li>
| + | </ul> |
| − | <li>Dr. Chang recommended that we design a kit that can test lots of pathogens and is user-friendly, which means everyone, even people who aren’t professionally trained, can use it. To know more about the technique he suggested we visit Adimmune Corporation. </li>
| + | |
| − | </ul>
| + | |
| − | <h1>Feedback</h1>
| + | <p><b>Marketing and Commercializing </b></p> |
| − | After the interview, we had a clearer idea of our product. We decided to take swabs as the sample of our device. Our device needs to be fast, accurate and easy-to-use. We can make our product as kits in the near future, and we can ask Adimmune Corporation for more details.
| + | <ul> |
| | + | <li>What kinds of standards are required for a product to put on the market? How are these standards usually been set? </li> |
| | + | <li>Who will be the target groups of our product on the market? </li> |
| | + | <li>If we want to develop a rapid diagnostic test product with aptamers in the future, is it possible to be put on the market? </li> |
| | + | <li>Is it possible that our product replaces antibody type of rapid diagnostic tests in the future? </li> |
| | + | <li>How can we obtain market analysis data? How to judge the professionalism of data? </li> |
| | + | </ul> |
| | + | |
| | + | <h1>Process</h1> |
| | + | <p><b> Influenza and Aptamer </b></p> |
| | + | <ul> |
| | + | <li>If our purpose is to predict epidemiological trends, of course, distinguishing subtypes are useful. Providing more detailed information such as time and places are also helpful since the epidemic data of Taiwan is one of the resources WHO make subtypes prediction with. </li> |
| | + | <li>Because there is no specific treatment for type A and type B, it won't help much on disease spreading after the flu outbreak, but it is helpful for WHO to understand the world epidemiological trends, especially if it can distinguish subtypes. </li> |
| | + | <li>The idea of applying aptamers to therapeutic is good. Aptamers are macromolecules and can block the target protein from viral invasion. If we choose HA as our target, it is important to follow its evolvement because HA changes every year. </li> |
| | + | <li>As for the idea to apply aptamers to preventive medicine, peptide vaccines. A peptide vaccine is any peptide that serves to immunize an organism against a pathogen. They are often synthetic and mimic naturally occurring proteins from pathogens. The researchers said the immune response of human bodies is so complicated that the development of the vaccine would be difficult. Most of the vaccines were mostly been found accidentally. </li> |
| | + | <li>The idea of applying aptamer to automated wafer technology is very good, but we need a more detailed operating mechanism to know if it is feasible. We can imagine a scene and think of the design, such as applying automated wafer technology to a microrobot or an aerial camera. </li> |
| | + | <li>We have to provide data about the processing speed. Since the subtypes change quickly, it is vital that the process becomes faster. </li> |
| | + | <li>We can use “Hai” to perform blood cell coagulation experiments first, and we can get the results in a few hours. </li> |
| | + | <li>Start with influenza, in the future, we can apply it to other targets such as Enterovirus 71. </li> |
| | + | </ul> |
| | + | |
| | + | <p><b>Marketing and Commercializing </b></p> |
| | + | <ul> |
| | + | |
| | + | <li>It is necessary to confirm whether the quality of the raw materials produced is always consistent. The storage period and the storage environment need to be supported with data. Besides, it is necessary to test whether the data measured by different people on different days are equal. The specifications of each component should conform to the standard. It is vital to set QA and QC methods according to our products. </li> |
| | + | <li>Mainly doctors are our target groups, they care about accuracy and price. The key point is to choose a good target for this product. The advantages of our product over existing ones are price, stability, sensitivity. For the companies, it isn’t attractive if it only distinguishes A or B type, but it would be very attractive for distinguishing subtypes. The government may cooperate with companies if he wants them to report subtypes, and the market will become bigger. Subtypes of influenza change quickly, which means that the efficiency of producing rapid diagnostic test becomes so important that it can distinguish various subtypes. </li> |
| | + | <li>It isn’t difficult for our product to pass the regulations and for manufacture. It is possible for this technique to enter the market. </li> |
| | + | <li>If there are advantages in price and accuracy over the existing antibody type products, it is affirmative that our product replaces them someday. </li> |
| | + | <li>We can find some companies, teams or papers doing research about market analysis or buy the data from companies. Besides, we can ask foreign companies. </li> |
| | + | <li>It is vital that we pay attention to the regulatory issues when modifying a product, and to comply with government regulations while doing research and developing. </li> |
| | + | <li>We have to make a substantial comparison figure for products used nowadays. If the price of us is lower and easier to manufacture than antibodies-type rapid tests. The existing products will be replaced by aptamers-type ones in all aspects. |
| | + | <li>We can consider more innovative ideas for further application such as hand lotion. </li> |
| | + | </ul> |
| | + | |
| | + | |
| | + | <h1>Feedback</h1> |
| | + | During the interview, one of the assistant managers said, “For your project, we would like to cooperate with your team!” Another female manager said, “Aptamer can be applied to various viruses or tests, the market would be quite large.” Most importantly, most of them thought it is a great advantage that our project is able to deal with global public health issues. Through the interview, we came up with more application ideas and we confirmed that peptide vaccines could hardly be produced. Also, aptamers are able to be applied to many other targets. Moreover, we knew more about what issue we should pay attention to marketing and commercializing. Last but not least, biotechnology companies might be willing to cooperate with us, which is important for our future entrepreneurship. |
| | + | |
| | + | |
| | </div> | | </div> |
| | </div> | | </div> |
| Line 1,047: |
Line 1,091: |
| | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> | | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> |
| | <div class="ModalDescription"> | | <div class="ModalDescription"> |
| − | <h1>Form</h1>
| + | <h1>Form</h1> |
| − | We had an interview with Doctor Yuan-Yen, Chang on March 20th at Chung-Shan Medical University. Doctor Chang is the professor of microbiology. His specialties are virology, Immunology, and biotechnology.
| + | We visited “TRANS Conference”, which was the biggest conference in biotechnology in Asia. The topic of the conference is “Transforming Healthcare, Transcending Limit”. We had conversations with the entrepreneurs in this conference. |
| − | <h1>Purpose</h1>
| + | <h1>Purpose</h1> |
| − | As a professor of microbiology, doctor Chang knows well about the knowledge as well as the mechanism of respiratory disease. Through this interview, we would like to know more about the background knowledge of respiratory disease and the diagnosis of influenza. We drafted the questions below:
| + | We would like to know other newly developed biotechnology products. We wanted to learn from those products and found how we could modify our products. |
| − | | + | |
| − | <li>How to detect influenza in a lab?</li>
| + | <h1>Process</h1> |
| − | <li>What kind of sample does the professor recommend for influenza rapid test? </li>
| + | We recorded the process of our observation and listed out the features of some products below: |
| − | <li>Do you recommend using the blood to detect the flu directly? </li>
| + | <ul> |
| − | <li>Do you recommend using swabs to detect flu directly? </li>
| + | <li>eNano Health Limited--Kiss & Tell—1st ever Saliva-Based Glucose Monitor: The product takes saliva as a sample instead of blood to examine glucose.</li> |
| − | <li>What are the current methods of influenza detection? </li>
| + | <li>eNano Health Limited--Manage Health Risk Before Feeling Sick: The product let users know their eating conditions through convenient testing tools. If there is a risk of their health (such as a high-risk group of diabetes), the users can eat the food developed by the company “eNANO P4 Food”. Users can use the App to share data with physicians and track their physical condition at any time to achieve health management. </li> |
| − | <li>Do you have any suggestions for our fast screening products? </li>
| + | <li>Helios Bioelectronics Inc. --Disease detection platform: The probe is coated on an electronic wafer, and the sample is reacted with the wafer, and then an electronic sensor is used to know whether a disease is present or not. The sample can be nucleic acids, proteins or cells. Through real-time digital results, combined with big data analysis, it can assist clinical diagnosis to achieve precise medical goals. The probes are coated on the electronic wafer by using covalent bonds, and they are well designed and were highly specific. Because the cost of the wafer is high and the entire wafer can’t be full of probes, so a dot distribution is required. In addition, the wafer is currently not reusable. The product directly relies on the change of the electrical signal to know the result (coloring is more troublesome). </li> |
| − | </ul>
| + | <li>Papivax Biotech Inc.--HPV therapeutic vaccine: The HPV vaccine currently on the market is a preventive vaccine. However, the incubation period of HPV is long. If the abnormality is detected but not reach the level of becoming cancer, the patient will have to endure this unknown suffering for a long time (about 5~10 years). Therefore, the newly developed therapeutic vaccine, using prime-boost therapy, can break into the DNA fragment of HPV, activate T cells through cellular immunity, attack infected cells, and prevent infection from spreading. We asked the researchers of the company some questions about how to avoid DNA degradation. They said it is difficult to know and they have observed through the amount of virus in the course of treatment. Then we asked how to confirm that the DNA injected to human bodies won’t become another pathogen. They said these DNAs do not enter cells but only induce T cells.</li> |
| − | <h1>Process</h1>
| + | <li>La vida Tech—WaCare: The product plays a role in preventive medicine. It helps users connect with friends and relatives, hospitals and health education units by entering various indicators of a body to form a network of care. If there are any abnormalities, the users’ friends, relatives or physicians can immediately know the situations and remind them. As for online health consultation and remote medicine, if users have health-related concerns, they can get professional and correct information through consultation with dietitians, pharmacists, and doctors. </li> |
| − | | + | <li>Studio1labs—Smart Sheet: Through the sensing elements inside the sheets, the heartbeat, breathing, posture changes of a patient lying on it are detected. Chronic disease and the condition of a postoperative patient can also be tracked. </li> |
| − | <li>Generally, a bacterial culture is performed in a lab, and the whole process takes about 3 to 7 days. </li>
| + | <li>Guzip Biomarkers Corporation—Cervical cancer detection paper: By detecting the methylation of DNA on the uterine surface, the product can determine whether there is a potential risk of cervical cancer. </li> |
| − | <li>The general influenza samples have two forms, blood, and swab. The advantage of a blood sample is a lot amount at one time. The advantage of the swab is non-invasive. </li>
| + | |
| − | <li>Dr. Chang recommended swab as the sample of our influenza rapid test. Since taking a blood sample needs to penetrate patients’ skin with needles, it is more invasive than taking a swab sample and less accepted by patients. Besides, drawing blood can only be conducted by professionally trained people, it isn’t good for promoting simple use. What’s more, a blood sample is valid only when there is viruses in the blood, or so-called viremia. </li>
| + | </ul> |
| − | <li>Dr. Chang recommended that we design a kit that can test lots of pathogens and is user-friendly, which means everyone, even people who aren’t professionally trained, can use it. To know more about the technique he suggested we visit Adimmune Corporation. </li>
| + | |
| − | </ul>
| + | <h1>Feedback</h1> |
| − | <h1>Feedback</h1>
| + | We documented how these products and the conversations with the entrepreneurs inspired us: |
| − | After the interview, we had a clearer idea of our product. We decided to take swabs as the sample of our device. Our device needs to be fast, accurate and easy-to-use. We can make our product as kits in the near future, and we can ask Adimmune Corporation for more details.
| + | <ul> |
| | + | <li>eNano Health Limited--Kiss & Tell—1st ever Saliva-Based Glucose Monitor: We started to think of the possibilities of developing our product as using saliva as the sample. </li> |
| | + | <li>eNano Health Limited--Manage Health Risk Before Feeling Sick: The idea of this product is very interesting and could be a business model for a combination of atypical forced marketing kits. In addition, the idea of App management seems to be applicable to our influenza detecting product. </li> |
| | + | <li>Helios Bioelectronics Inc. --Disease detection platform: We discussed the possibility of applying aptamer to an air purifier, the researchers of the company thought it an interesting idea. We could apply an electronic wafer to our air purifier design. |
| | + | The principle is that when the target substance in the sample is attached to the probe (aptamer), it changes the electronic arrangement of the wafer and further changes the electrical signal. In order to make the wafer reusable, we then think about whether there is any way to get the attached object to fall off the probe. The probe is connected to the target by hydrogen bonding, and the probe and the wafer are connected by covalent bonds. There should be other methods. </li> |
| | + | <li>Papivax Biotech Inc.--HPV therapeutic vaccine: We came up with an idea of applying our product to a therapeutic vaccine. The company's products correspond to the concept of our therapeutic vaccine. The therapeutic vaccines of our works also include the part of injecting DNA (aptamer) into bodies, but the principle is different. Our concept is inhibiting viruses to infect cells by binding to the viruses. Their product injects DNA into human bodies. It helped us figure out the problem that whether aptamer will degrade in human bodies and whether it will become another risk of infection. After the interview, we started to study how to stabilize the DNA injected into human bodies and how to enhance the signal. </li> |
| | + | <li>La vida Tech—WaCare: We asked the possibility of introducing our product to their App. The results of our product can be determined by naked eyes and it doesn’t require special equipment. Small-scaled hospitals, clinics, and even kindergartens can use our product and get results directly. However, since the accuracy of influenza screening is not very high, there may be false-negative results. If our product integrates with the app, users can get diagnosed through the results of our product and symptoms. They can also get medical advice and information. We thought it a great opportunity to cooperate with the company and develop an App. |
| | + | It was a precious opportunity to know different products in the market. There were many inspiring ideas at this conference. We came up with more concepts that we can apply to aptamers after attending this conference. We not only inspected and studied from other newly developed products but we also confirmed some of our idea through the discussion with the entrepreneurs. </li> |
| | + | |
| | + | |
| | + | |
| | </div> | | </div> |
| | </div> | | </div> |
| Line 1,101: |
Line 1,155: |
| | <div class="ModalDescription"> | | <div class="ModalDescription"> |
| | <h1>Form</h1> | | <h1>Form</h1> |
| − | We had an interview with Doctor Yuan-Yen, Chang on March 20th at Chung-Shan Medical University. Doctor Chang is the professor of microbiology. His specialties are virology, Immunology, and biotechnology.
| + | We visited the Incubation Center at Chung Shan Medical University and had an interview with the legal consultant on August 25th. |
| − | <h1>Purpose</h1>
| + | <h1>Purpose</h1> |
| − | As a professor of microbiology, doctor Chang knows well about the knowledge as well as the mechanism of respiratory disease. Through this interview, we would like to know more about the background knowledge of respiratory disease and the diagnosis of influenza. We drafted the questions below:
| + | We would like to know what legal issue our project had to be noticed. Moreover, we wanted to know how we can apply for the patent right for our technique. We drafted the questions below: |
| − | | + | <ul> |
| − | <li>How to detect influenza in a lab?</li>
| + | <li>Is there any legal issue related to our product that we should be noticed?</li> |
| − | <li>What kind of sample does the professor recommend for influenza rapid test? </li>
| + | <li>Before conducting technology transfer, what should we notice? </li> |
| − | <li>Do you recommend using the blood to detect the flu directly? </li>
| + | <li>What kind of patent right is recommended for us to apply? </li> |
| − | <li>Do you recommend using swabs to detect flu directly? </li>
| + | </ul> |
| − | <li>What are the current methods of influenza detection? </li>
| + | <h1>Process</h1> |
| − | <li>Do you have any suggestions for our fast screening products? </li>
| + | <ul> |
| − | </ul>
| + | <li>All new developed medical equipment should get medical equipment licenses from the government. We had to notice that which grade our product was. Our product should meet the regulations of that grade. </li> |
| − | <h1>Process</h1>
| + | <li>We have to submit information about our product such as the instruction manual, materials, structure, function, use. Besides, we have to fill out an application form. The manufacturers had to submit a Medical Device License and Good Manufacturing Practice License. </li> |
| − | <ul>
| + | <li>After conducting technology transfer to manufactures, there might be serious problems to notice that sometimes the technicians of manufactures might not be able to understand the principle of the product so they can’t find out the best way to produce on a large scale. </li> |
| − | <li>Generally, a bacterial culture is performed in a lab, and the whole process takes about 3 to 7 days. </li>
| + | <li>Different companies would have different business strategies. Some companies focus on developing new products, some focus on producing, some focus on marketing. There are also some companies that run the whole process. </li> |
| − | <li>The general influenza samples have two forms, blood, and swab. The advantage of a blood sample is a lot amount at one time. The advantage of the swab is non-invasive. </li>
| + | <li>Because our product would be known to the public, it is better to apply the patent right first. It is often recommended that the researchers started to fill out the forms of the patent right and submit it first because the procedure will last for at least a year. </li> |
| − | <li>Dr. Chang recommended swab as the sample of our influenza rapid test. Since taking a blood sample needs to penetrate patients’ skin with needles, it is more invasive than taking a swab sample and less accepted by patients. Besides, drawing blood can only be conducted by professionally trained people, it isn’t good for promoting simple use. What’s more, a blood sample is valid only when there is viruses in the blood, or so-called viremia. </li>
| + | <li>There is another kind of patent right which the review procedure would be shorter than the general one. However, the protection of the patent right would only last for 10 years, which is much shorter than the general one. Besides, we have to record all the details of our product and technique. Otherwise, other people can imitate the product easily. </li> |
| − | <li>Dr. Chang recommended that we design a kit that can test lots of pathogens and is user-friendly, which means everyone, even people who aren’t professionally trained, can use it. To know more about the technique he suggested we visit Adimmune Corporation. </li>
| + | </ul> |
| − | </ul>
| + | <h1>Feedback</h1> |
| − | <h1>Feedback</h1>
| + | After this interview, we understood the issues that we will face during technology transfer and applying for patent rights. |
| − | After the interview, we had a clearer idea of our product. We decided to take swabs as the sample of our device. Our device needs to be fast, accurate and easy-to-use. We can make our product as kits in the near future, and we can ask Adimmune Corporation for more details.
| + | |
| | </div> | | </div> |
| | </div> | | </div> |
| Line 1,153: |
Line 1,207: |
| | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> | | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> |
| | <div class="ModalDescription"> | | <div class="ModalDescription"> |
| − | <h1>Form</h1>
| + | <h1>Form</h1> |
| − | We had an interview with Doctor Yuan-Yen, Chang on March 20th at Chung-Shan Medical University. Doctor Chang is the professor of microbiology. His specialties are virology, Immunology, and biotechnology.
| + | Our team had an interview with Ph.D. Victor Tang, who is the Senior Research Chemist of New Product Research & Development Department of Eternal Materials Company on August 27th. |
| − | <h1>Purpose</h1>
| + | <h1>Purpose</h1> |
| − | As a professor of microbiology, doctor Chang knows well about the knowledge as well as the mechanism of respiratory disease. Through this interview, we would like to know more about the background knowledge of respiratory disease and the diagnosis of influenza. We drafted the questions below:
| + | The researchers of the Vector virus and Rickettsia laboratory introduce us to the company whom they transferred their technology—External Material Company. We would like to know more about technology transfer, or so-called transfer of technology(TOT), so we drafted some questions below. |
| − | | + | <ul> |
| − | <li>How to detect influenza in a lab?</li>
| + | <li>What roles do technology transfer companies play while producing rapid diagnose test products? What is the characteristic of External Material Company?</li> |
| − | <li>What kind of sample does the professor recommend for influenza rapid test? </li>
| + | <li>How to distribute the profit of technology transfer? How to assign a different type of technology transfer (exclusive license or not)? </li> |
| − | <li>Do you recommend using the blood to detect the flu directly? </li>
| + | <li>How long does it take from receiving the technology and producing the final product? </li> |
| − | <li>Do you recommend using swabs to detect flu directly? </li>
| + | <li>We would like to introduce our research and the issue we have confronted and ask for recommends. </li> |
| − | <li>What are the current methods of influenza detection? </li>
| + | </ul> |
| − | <li>Do you have any suggestions for our fast screening products? </li>
| + | |
| − | </ul>
| + | <h1>Process</h1> |
| − | <h1>Process</h1>
| + | <ul> |
| − | | + | <li>External Material Company can meet the clients’ requirements, providing monoclonal antibodies in a specific way. The company is now developing antibodies for detecting vector viruses and infectious diseases. Using their product--Serotype-specific Dengue NS1 Antigen Rapid Test Strips, which is easy to use, can detect NS1 protein in whole blood. It gets correct and detailed information with only a little amount of sample, which helps the government and medical institutions to identify the virus and provide more information about dengue fever. The product can also distinguish four types of dengue fever, which can be used for data statistics and assists airport customs to know whether passengers are infected by dengue fever in a faster way. Traditional methods can’t distinguish the subtypes of dengue fever. The sample has to be sent to laboratories to analysis, which might take one day. The product shortens the processing time to only 30 minutes. </li> |
| − | <li>Generally, a bacterial culture is performed in a lab, and the whole process takes about 3 to 7 days. </li>
| + | <li>Because the technique was provided by the government, and the government doesn’t give an exclusive license, so what External Material Company gets was a non-exclusive license. It means that if other companies want to use this technique, they can also get it. </li> |
| − | <li>The general influenza samples have two forms, blood, and swab. The advantage of a blood sample is a lot amount at one time. The advantage of the swab is non-invasive. </li>
| + | <li>In fact, aside from the antibody, the key point of producing a rapid diagnostic test is the formulation of the buffer. How to avoid cross-reaction is very important. </li> |
| − | <li>Dr. Chang recommended swab as the sample of our influenza rapid test. Since taking a blood sample needs to penetrate patients’ skin with needles, it is more invasive than taking a swab sample and less accepted by patients. Besides, drawing blood can only be conducted by professionally trained people, it isn’t good for promoting simple use. What’s more, a blood sample is valid only when there is viruses in the blood, or so-called viremia. </li>
| + | <li>As for distributing the profits, the External Material Company paid money for the technique to the laboratory first. If the company gets the certification, they would give a reward. If they sell the product to other countries, they have to pay a proportion of money back to the laboratory. </li> |
| − | <li>Dr. Chang recommended that we design a kit that can test lots of pathogens and is user-friendly, which means everyone, even people who aren’t professionally trained, can use it. To know more about the technique he suggested we visit Adimmune Corporation. </li>
| + | <li>External Material Company could have accomplished the designation of the product in one year since they had made similar products before and applied the experiences to the Dengue fever test kit. Without related experiences and professionals, it may take at least 3 years. </li> |
| − | </ul>
| + | <li>The characteristic of External Material Company is they provide antibodies by themselves, which reduces cost and they don’t need to worry about the shortage of antibodies in the market. </li> |
| − | <h1>Feedback</h1>
| + | <li>About the issue of DNA sequencing that our team is confronting, Tang Ph.D. gave us some suggestions. The first is about how to make confirmation after DNA sequencing. Generally, antibodies and antigens can be amplified with ELISA, but the signal of the aptamer is very small which is closed to the background level. Tang Ph.D. suggests we use some simulation software such as Gene Duck, Auto Duck®, and Discovery Studio. We can put the aptamer sequences in these softwares and simulate if the aptamer can combine with the protein. Some laboratories thought that SELEX is hard to conduct so they simply use softwares to find our the aptamers they want and synthesis the sequence. </li> |
| − | After the interview, we had a clearer idea of our product. We decided to take swabs as the sample of our device. Our device needs to be fast, accurate and easy-to-use. We can make our product as kits in the near future, and we can ask Adimmune Corporation for more details.
| + | </ul> |
| | + | |
| | + | <h1>Feedback</h1> |
| | + | Through the interview, we knew more about TOT which is important for our entrepreneurship. Besides, we got to know that simulation softwares are useful for simulating whether aptamers are able to combine with the protein. We then tried to use the softwares to simulate our aptamer sequences. |
| | + | |
| | + | |
| | </div> | | </div> |
| | </div> | | </div> |
| Line 1,206: |
Line 1,265: |
| | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> | | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> |
| | <div class="ModalDescription"> | | <div class="ModalDescription"> |
| − | <h1>Form</h1>
| + | <h1>Form</h1> |
| − | We had an interview with Doctor Yuan-Yen, Chang on March 20th at Chung-Shan Medical University. Doctor Chang is the professor of microbiology. His specialties are virology, Immunology, and biotechnology.
| + | We visited the Doctor of the Laws Huei-Chih Niu, who specializes in Health Care Law and Bioethics and Legal Policy for Gene Technology on August 29th. |
| − | <h1>Purpose</h1>
| + | <h1>Purpose</h1> |
| − | As a professor of microbiology, doctor Chang knows well about the knowledge as well as the mechanism of respiratory disease. Through this interview, we would like to know more about the background knowledge of respiratory disease and the diagnosis of influenza. We drafted the questions below:
| + | We would like to explore the issues of the social justice and ethics of our product and the procedure while conducting our experiments. We drafted the question below: |
| − | | + | <ul> |
| − | <li>How to detect influenza in a lab?</li>
| + | <li>While conducting the experiment, what kind of legal or ethical issues should be noticed? |
| − | <li>What kind of sample does the professor recommend for influenza rapid test? </li>
| + | <li>What issues will we face if our rapid diagnostic test product gets into the market? |
| − | <li>Do you recommend using the blood to detect the flu directly? </li>
| + | <li>What kind of issues or challenges will we face if our therapeutic vaccine gets into the market? |
| − | <li>Do you recommend using swabs to detect flu directly? </li>
| + | <li>If our rapid diagnostic test product or therapeutic vaccine gets into the market, what laws should we notice? What ethical issues or challenges we have to confront? |
| − | <li>What are the current methods of influenza detection? </li>
| + | <li>What is the universal cognition of the public for the issues of genetic modification and gene processing? Is the acceptance level high? |
| − | <li>Do you have any suggestions for our fast screening products? </li>
| + | <li>For the government, is there any concern about public safety? |
| − | </ul>
| + | </ul> |
| − | <h1>Process</h1>
| + | |
| − | | + | <h1>Process</h1> |
| − | <li>Generally, a bacterial culture is performed in a lab, and the whole process takes about 3 to 7 days. </li>
| + | <ul> |
| − | <li>The general influenza samples have two forms, blood, and swab. The advantage of a blood sample is a lot amount at one time. The advantage of the swab is non-invasive. </li>
| + | <li>Institutional Review Board (IRB) is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. While IRB reviewing applications, the committee members will check if our experimental procedures comply with laboratory safety specifications. We had to take notice of laboratory safety specifications.</li> |
| − | <li>Dr. Chang recommended swab as the sample of our influenza rapid test. Since taking a blood sample needs to penetrate patients’ skin with needles, it is more invasive than taking a swab sample and less accepted by patients. Besides, drawing blood can only be conducted by professionally trained people, it isn’t good for promoting simple use. What’s more, a blood sample is valid only when there is viruses in the blood, or so-called viremia. </li>
| + | <li>Rapid diagnostic tests belong to the category of medical equipment. Before getting into the market, it has to pass IRB and the examination of the Taiwan Food and Drug Administration (TFDA). Before passing IRB, it is still at the testing phase. In the future, it will have to conduct clinical trials, documents of the experimental designation, procedure and the environment should be submitted to IRB. Moreover, there will be a Sociologist examining whether the clinical trial is ethical. </li> |
| − | <li>Dr. Chang recommended that we design a kit that can test lots of pathogens and is user-friendly, which means everyone, even people who aren’t professionally trained, can use it. To know more about the technique he suggested we visit Adimmune Corporation. </li>
| + | <li>The issue which our products would confront is whether our product could get into the market before the outbreak. Other issues are that the advantages of detecting subtypes would be useless if WHO predicted the wrong subtypes with the help of our product. </li> |
| − | </ul>
| + | <li>As for the therapeutic vaccine, it belongs to the category of medical equipment. It has to conduct clinical trials and pass the examination of TFDA. Besides, therapeutic vaccines belong to the third level of medical equipment. </li> |
| − | <h1>Feedback</h1>
| + | <li>Before our product getting into the market, there would be many issues about patents that we should take notice of, including the experimental procedure and technique. </li> |
| − | After the interview, we had a clearer idea of our product. We decided to take swabs as the sample of our device. Our device needs to be fast, accurate and easy-to-use. We can make our product as kits in the near future, and we can ask Adimmune Corporation for more details.
| + | <li>For rapid diagnostic tests, the ethical issues we should be noticed are that if the product is safe and effective and if the cost of production is too much. As for therapeutic vaccines, they have to conduct clinical trials and go through four phases. First is to make sure it is safe by testing the safe dosage. Second is to make sure it is effective by finding some patients to test it. Third is large-scale testing by finding 2000 to 3000 patients to test the effectiveness. Forth is long-term monitoring for 5 to 10 years. </li> |
| | + | <li>While conducting the clinical trials, we have to obey four principles, which are respect for autonomy, non-maleficence, beneficence, and justice. Moreover, issues such as products after genetic modification being exposed to the environment should be noticed. </li> |
| | + | <li>Most people know that genetically modified food won’t be harmful to the human body. Most of the misunderstandings are driven by the media. The government doesn’t request companies to mark that they are genetically modified food. </li> |
| | + | |
| | + | </ul> |
| | + | |
| | + | <h1>Feedback</h1> |
| | + | After the interview, we learned thoroughly about the ethical and legal issues while developing our product and while getting into the market. We found that our product could have great impact on the prediction of the influenza subtype next season, resulting in the fact that our product needs to take responsibility. Besides, we got to know more details about the Institution Review Board(IRB), including the principles of a clinical trial. Because our product is related to medical, we thought it is important to be aware of the patients’ rights, too. In the end, Prof. Niu encouraged us to explore more about clinical trials and the rules of IRB. |
| | + | |
| | + | |
| | </div> | | </div> |
| | </div> | | </div> |
| Line 1,259: |
Line 1,327: |
| | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> | | <img src="https://static.igem.org/mediawiki/2019/a/a6/T--CSMU_Taiwan--ihp1.png" alt=""> </div> |
| | <div class="ModalDescription"> | | <div class="ModalDescription"> |
| − | <h1>Form</h1>
| + | <h1>Form</h1> |
| − | We had an interview with Doctor Yuan-Yen, Chang on March 20th at Chung-Shan Medical University. Doctor Chang is the professor of microbiology. His specialties are virology, Immunology, and biotechnology.
| + | We visited Animal Health Research Institute Council of Agriculture, Executive Yuan on September 3rd and we had an interview with the researcher and the director of Epidemiology Division “Fan Lee” |
| − | <h1>Purpose</h1>
| + | <h1>Purpose</h1> |
| − | As a professor of microbiology, doctor Chang knows well about the knowledge as well as the mechanism of respiratory disease. Through this interview, we would like to know more about the background knowledge of respiratory disease and the diagnosis of influenza. We drafted the questions below:
| + | We would like to extend our application of aptamer to Avian Influenza. We wanted to understand how the government deals with the issue of Avian Influenza and the possibility of applying our product to poultries. We drafted the questions below: |
| − | | + | <ul> |
| − | <li>How to detect influenza in a lab?</li>
| + | <li>We had searched for some information and knew that the government will randomly inspect some chicken farms to find if they have poultries infected by Avian Influenza. How does the government inspect poultries? </li> |
| − | <li>What kind of sample does the professor recommend for influenza rapid test? </li>
| + | <li>Is the detecting method nowadays able to prevent the spread of Avian influenza effectively? </li> |
| − | <li>Do you recommend using the blood to detect the flu directly? </li>
| + | <li>Is it possible to replace the method used nowadays with rapid diagnostic tests? </li> |
| − | <li>Do you recommend using swabs to detect flu directly? </li>
| + | <li>Are rapid diagnostic tests useful for examining the chicken? </li> |
| − | <li>What are the current methods of influenza detection? </li>
| + | <li>Is there any flaw in the prevention work of Avian influenza? </li> |
| − | <li>Do you have any suggestions for our fast screening products? </li>
| + | <li>Is it useful to prevent the spread of Avian influenza by early detection? </li> |
| − | </ul>
| + | <li>What measures does the government use to know if migratory birds are infected by Avian influenza? </li> |
| − | <h1>Process</h1>
| + | <li>Is it possible to apply our product to the detection of if migratory birds are infected by Avian influenza? </li> |
| − | | + | </ul> |
| − | <li>Generally, a bacterial culture is performed in a lab, and the whole process takes about 3 to 7 days. </li>
| + | |
| − | <li>The general influenza samples have two forms, blood, and swab. The advantage of a blood sample is a lot amount at one time. The advantage of the swab is non-invasive. </li>
| + | |
| − | <li>Dr. Chang recommended swab as the sample of our influenza rapid test. Since taking a blood sample needs to penetrate patients’ skin with needles, it is more invasive than taking a swab sample and less accepted by patients. Besides, drawing blood can only be conducted by professionally trained people, it isn’t good for promoting simple use. What’s more, a blood sample is valid only when there is viruses in the blood, or so-called viremia. </li>
| + | <h1>Process</h1> |
| − | <li>Dr. Chang recommended that we design a kit that can test lots of pathogens and is user-friendly, which means everyone, even people who aren’t professionally trained, can use it. To know more about the technique he suggested we visit Adimmune Corporation. </li>
| + | <ul> |
| − | </ul>
| + | <li>The government usually inspects the poultry farms that are more willing to be inspected. There are many poultry farms that often refuse their random inspection, which might be a risk to the public. The research institute often checks the poultry farms by taking the sample of some poultries and take the sample to the laboratory to analyze them through RT-PCR.</li> |
| − | <h1>Feedback</h1>
| + | <li>There are many poultry farms that are not willing to be inspected. And for those farms agreed, not all of them would be inspected. The government visits some of the farms, collecting samples, and send them to the laboratory to analyze. The problem of preventing work is not the detecting methods but that many poultry farms are not included in the prevention works. </li> |
| − | After the interview, we had a clearer idea of our product. We decided to take swabs as the sample of our device. Our device needs to be fast, accurate and easy-to-use. We can make our product as kits in the near future, and we can ask Adimmune Corporation for more details.
| + | <li>RT-PCR is a precise way to examine if there is a virus of Avian influenza in samples. Using a rapid diagnostic test cannot get an accurate result. Besides, examining all of the poultries with rapid diagnostic tests is time-consuming and unnecessary. It is more efficient to examine with RT-PCR. </li> |
| | + | <li>Aside from the problem that many poultry farms are not involved in Avian influenza prevention work, the problem of self-inspection of Avian influenza worth noticing. The government set up compensation for the poultry farms affected by Avian influenza. However, many farmers are not willing to report to the government that their poultries are inflected by Avian influenza. If they do so, the government will cull all of the poultries and the compensation is not enough to cover their losses. This results in the problem that only little farmers would report to the government about epidemics. </li> |
| | + | <li>It might be useful if there is a method that can help the government early detect epidemics of Avian influenza. It is important that all the poultry farms are included in preventing works. It helps the government master the situation and make responses in advance. </li> |
| | + | <li>As for migratory birds, the method they use to detect Avian influenza is that some experts collect samples of migratory birds and send them to the research institute to analyze. Because the samples are only of little amount, they often analyze them through RT-PCR. If they find Avian influenza in the sample, they will give the information to the media and remind other farmers to be aware of it. |
| | + | <li>A rapid diagnostic test is not that useful for detecting Avian influenza in migratory birds because the sample is not much and they have to make sure that the result is correct. </li> |
| | + | </ul> |
| | + | |
| | + | <h1>Feedback</h1> |
| | + | Through the visit to Animal Health Research Institute Council of Agriculture, we found out the reality of the prevention works of Avian influenza carried out by the government. There are many difficulties hard to be solved. Although we found out that rapid diagnostic test is not useful for the preventing works of Avian influenza. We figured out a new concept to solve the currently existing issues. We tried to develop an air purifier that can detect Avian influenza placed in poultry farms. |
| | + | |
| | </div> | | </div> |
| | </div> | | </div> |
