Difference between revisions of "Team:NCKU Tainan/Human Practices"
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| − | <p> Purpose: to learn more about dialysis and whether our p-Cresol device is suitable and can be put in the dialysis center , we met | + | <p> Purpose: to learn more about dialysis and whether our p-Cresol device is suitable and can be put in the dialysis center , we met Dean of Feng Dian United Dialysis Center, Dr. Chen Kuan-Wen and attending physician, Dr. Hsu Hsun-Chieh to learn more about CKD patients who are doing dialysis , Dr. Hsu said to have p-Cresol reader is a good idea but we need to consider the cost of the device and treatment since in small clinic of dialysis center , if it is expensive and inconvenient , they will not apply the method or device. When we went there , we were still proposing having probiotic to reduce p-Cresol ,he told us probiotic can not be included in the NHI because it is considered as “healthy supplement” but usually this “healthy food” will be recommended by Doctor.We were wondering whether uremic toxin is harmful for CKD patients are known by them but Dr. Hsu said usually patients don’t have uremic toxin awareness since they mostly are only following doctor’s suggestion. Currently, only 1/10 of patients understanding intestinal bacteria. By our talks , we can summarized : |
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Revision as of 16:22, 16 October 2019
Overview
Sometimes as scientists, we tend to forget the world outside the lab. Innovations succeed inside the laboratory doesn’t mean it can be applied to the real world. An important aspect we need to consider is how our technology can be applied in society. Thus, human practice became one of the major pillars of our project, to test our project against the challenges in the real world. We believe that only through working with both professionals and consumers can we ensure that our product is beneficial to all. Our approach to human practices involved working with both professionals and the general public to understand their opinions and tailoring our project to meeting their demands. Through our interactions, we get to explore different aspects of the project that we would otherwise ignore, including intellectual property, sustainability, laws, and regulations.
The world is changing daily, and with it, talents, skills and experience needs to be a part of that growth cycle too. With the growing controversy on GMOs and live therapeutics, we realized our iGEM project is at the heart of this discussion. The research and results on live therapeutics are few and far between, with it only being brought to attention these past few years. There are still so many challenges and obstacles live therapeutics have to face before it is widely accepted as a treatment method. We realized that no matter how much research we do, we ended with more questions unanswered than answered. Can we make it out onto the market, and survive in the harsh and competitive environment? How do we ensure our product’s viability in the market? What is the current stance of the world when it comes to live therapeutics? To ensure we are able to finalize the different aspects of our products, we decided to turn to different aspects of society, engaging with doctors, nurses, researchers, professionals involved in the legal and business side of drug and device development, patients, students and the general public.
Expert Visit
-Doctors Visit
-Dialysis Center
-Dry Labs Visit
Enterprise Visit
-Winston Pharmaceutical Supply Co.
-GeneFerm Biotechnology
-GenMont Biotech Inc.
-NARLabs
-Synbio Tech Inc.
Government Association
-TFDA
-IPO ( Intellectual Property Office )
Expert visit
This has been called "one of the best-known sentences in the English language",[7] containing "the most potent and consequential words in American history".[8] The passage came to represent a moral standard to which the United States should strive. This view was notably promoted by Lincoln, who considered the Declaration to be the foundation of his political philosophy and argued that it is a statement of principles through which the United States Constitution should be interpreted.[9]The Declaration of Independence inspired many similar documents in other countries, the first being the 1789 Declaration of United Belgian States issued during the Brabant Revolution in the Austrian Netherlands. It also served as the primary model for numerous declarations of independence in Europe and Latin America, as well as Africa (Liberia) and Oceania (New Zealand) during the first half of the 19th century.
Dr. Te-Hui Kuo 4/15
Attending Physician, Division of Nephrology, National Cheng Kung University Hospital
We met with Dr. Te-Hui Kuo to gain knowledge about Chronic Kidney Disease. He provided us with invaluable insight into the connection between p-Cresol and Chronic Kidney Disease. We met with him during the early stages of the project, and he advised us to keep expanding on the idea of using blood measurement for uremic toxins. He also warned us that the public, and even doctors don’t pay much attention to uremic toxins, which encouraged us to design activities to spread awareness, which you can find in our public engagement page.
Dr. Junne-Ming Sung 6/25
Director and Attending Physician, Division of Nephrology, National Cheng Kung University Hospital
We met with Dr. Junne-Ming Sung to talk more about the viability of our device in the market. He guided us to think about the future of our device, highlighting several questions we had never thought of. His valuable insight allowed us to begin shifting the trajectory of our device to have a more functional role in the market. Instead of just being able to prove our biotherapeutic works, our device now has the potential to become a cornerstone in the diagnosis of Chronic Kidney Disease.
Ms. Huang Li-Hui
Nurse, Chia Yi Chang Gung Memorial Hospital Dialysis Center
In an activity hosted by Taiwan Chronic Kidney Disease Foundation, we had the opportunity to meet Ms. Huang Li-Hui. As someone who interacts with CKD patients on a daily basis, she was able to give us more insight on a CKD patient’s needs and wants. She talked us through the treatments that CKD patients undergo, mentioning that dialysis was often used as a prevention method for CKD patients, and they need to undergo dialysis three times a week. While uremic toxins and uric protein checks are important for CKD patients, they do not do routine checks on it - and even if they do, they only do creatinine checks once a month. Another interesting tidbit is that patients tend to favor chewing candy rather than injections or capsules.
Ms. Guo Yu-Zhen 8/29
Chronic Kidney Disease Nurse Specialist, National Cheng Kung University Hospital
As a CKD Nurse Specialist, she periodically give lectures on how to handle CKD patients and background knowledge on the disease, and thus, knows the disease very well. She taught us quite a lot about the disease, especially about the treatments. While there is no current treatment that can fully cure the patients, she does admit that the patients will sometimes take Chinese Herbal medicine or even go for acupuncture to give themselves a peace of mind. When we mentioned our project, she mentioned a current drug currently insured by National Health Insurance (NHI) that could be our market competitor. In order to make it in the Taiwanese market, she advised us to consider our drug being insured by NHI, as the government has policies regarding CKD in Taiwan, and thus insured most CKD treatments.
Tainan Dialysis Center
Purpose: to learn more about dialysis and whether our p-Cresol device is suitable and can be put in the dialysis center , we met Dean of Feng Dian United Dialysis Center, Dr. Chen Kuan-Wen and attending physician, Dr. Hsu Hsun-Chieh to learn more about CKD patients who are doing dialysis , Dr. Hsu said to have p-Cresol reader is a good idea but we need to consider the cost of the device and treatment since in small clinic of dialysis center , if it is expensive and inconvenient , they will not apply the method or device. When we went there , we were still proposing having probiotic to reduce p-Cresol ,he told us probiotic can not be included in the NHI because it is considered as “healthy supplement” but usually this “healthy food” will be recommended by Doctor.We were wondering whether uremic toxin is harmful for CKD patients are known by them but Dr. Hsu said usually patients don’t have uremic toxin awareness since they mostly are only following doctor’s suggestion. Currently, only 1/10 of patients understanding intestinal bacteria. By our talks , we can summarized :
- CKD patients do dialysis 3 times a week and it takes 4 hours per treatment
- ESRD Patients in Taiwan are usually treated by 95% Hemodialysis , 4% Peritoneal dialysis and 1% Renal transplant
- Taiwan CKD patients do dialysis but small percentage of them do kidney transplant.
We also got permissionWe also got permission from doctor and one CKD patient who was dialysing that time to be interviewed , our questions were more about how they got CKD and do they know uremic toxins accumulation in CKD which can lead to CVD? Patient replied us he was developed from diabetes and he thought the diets for CKD are based on the patient’s condition itself , he doesn't really know about uremic toxin but he does know CKD can lead to cardiovascular disease.
Professor Yi-Je Juang
Professor, Department of Chemical Engineering, National Cheng Kung University
While we were testing PDMS chip, we encountered a problem. When we injected whole blood into blood separation chamber, the blood would flow into reaction chamber instantly, causing impureness of the plasma. We hope to stop this from happening so we went to Professor Juang to ask suggestion toward our microfluidic wafer. He suggested us to apply a passive valve on the channel between whole blood chamber and reaction chamber. The passive valve can stop the flow of the blood without incurring any additional operation, which improved the purity of the plasma we gained significantly.
Furthermore, He told us to retry on PDMS spinning test (the PDMS would burst during centrifuge at that time) since theoretically PDMS layers should strongly adhered together and it should be inseparable. Also, he suggested us to use double-sided tape in the combination of acrylic disc, which is proved to be effective. By having a fruitful meeting with him, we restored our faith in PDMS and improved our project by applying passive valve and double-sided tape in microfluidic disc.
Professor Chia-Yuan Chen
Associate Professor, Department of Mechanical Engineering, National Cheng Kung University
Purpose : we proposed our first idea about device to Professor Chia , we had microfluidic chip in mind but we did not know how to apply it to device. We discussed about what type of microfluidic chip will be suitable for blood separation, how the chip connect to other channel of the device,and whether our chip is reusable or not. He told us to try using PDMS chip because it’s affordable and we once proposed using acrylic as our chip’s type but Professor said using acrylic costs expensive and actually PDMS and acrylic performs the same. From this discussion , we then decided to use PDMS-based microfluidic chip and by the help of his laboratory , we successfully made a few version of PDMS chips (Hyperlink to “DRY” device/chip )
Professor Ruey-Jen Yang
Chair Professor, Department of Engineering Science, National Cheng Kung University
Purpose : to consult toward our fail version of microfluidic chip based on PDMS because the runner joint made of pdms ruptures during the centrifugation process, although the third version of the wafer is reinforced at the joint, we still hope to find an alternative before the third version of the wafer comes out. Professor Yang has done low-cost paper-based chip development and micro-flow channel design, hoping to get help and advice in this regard.
After asking and briefly describing what we wanted to do, professor suggested us to find his student who was doing a pdms-related study. It told us that the bond between pdms and pdms is weaker than the bond between pdms and glass and acrylic. It will be deformed even when using pump. It is recommended that we try to use pdms and acrylic binding to test whether the strength could have a higher performance. Problems are also parameters of the oxygen plasma during binding will also affect the effect of the binding (the pressure and time of the binding), Professor Yang suggested that we make the whole acrylic disc into a microfluidic disc, which will save some space and fixed process and introduced pHD Weng to us.By his suggestions , we went to pHD Weng and test acrylic materials for bonding in our third version of device.
PhD Chen-Hsun Weng
Chief of Industry-Academic Collaboration in Medical Device Innovation Center, Tainan
Purpose: to learn about acrylic-based microfluidic chip and how to use acrylic cutting machine, we also consulted about what type of microfluidic chip suit us the best. We were testing our device parts and found some troubles regarding the chip we used, our first version used pdms type of microfluidic chip but apparently when we test it into our centrifuge, it bursted out therefore we went to PhD Chen-Hsun Weng, he suggested us to use paper-based chip because it can have a reaction of blood separation, while he also said pdms is harder to be customized and inefficient. After our meeting, we tried to use the acrylic-based microfluidic.
Enterprise visit
This has been called "one of the best-known sentences in the English language",[7] containing "the most potent and consequential words in American history".[8] The passage came to represent a moral standard to which the United States should strive. This view was notably promoted by Lincoln, who considered the Declaration to be the foundation of his political philosophy and argued that it is a statement of principles through which the United States Constitution should be interpreted.[9]The Declaration of Independence inspired many similar documents in other countries, the first being the 1789 Declaration of United Belgian States issued during the Brabant Revolution in the Austrian Netherlands. It also served as the primary model for numerous declarations of independence in Europe and Latin America, as well as Africa (Liberia) and Oceania (New Zealand) during the first half of the 19th century.
Geneferm
GeneFerm Biotechnology is a leading fermentation company, focusing on fermented fungi, microbes and also probiotics.
We visited GeneFerm to learn more about the criteria we need to meet before our product can enter the market. At this stage, we were still considering whether to market our product as a drug or probiotic.
From our meeting with Miss Erin Wu and Mr Eugene Wu, we learned:
- Quality control of a living cell on a medication
- Food Industry Research and Development (FIRDI) help in inspection of the supplement
- Comparison between food and medication process and regulation
- The risks if we do not apply patent for our drug or medical device
They suggested us:
- determine the usage of product like the age group and delivering product
- account the law and regulations since Taiwan does not have proper gene-editing regulations especially toward the biotherapeutic drug
- Education toward GMO usage
By their suggestions , we conducted survey for our drug method delivery and classified approximate age of ESRD patients who will consume biotherapeutic drug (Data can be seen in our entrepreneurship part)
Genemont
GenMont Biotech Inc. is a leading probiotic company in Taiwan , we had our first enterprise visit with GenMont’s Miss Tsai, Wan-Hua, Miss Mei-Ling Wang, Miss Janette Chen, our purpose is to learn about how probiotic is made , quality management and law regulation in applying this product to the market we proposed our project to Genemont , but before that they presented about how their company works and how they usually manage to have new probiotic and their process to reach the market. By this visit , we received a lot of feedback and realized we got many bugs and homework to do ,helping to shape our views in many terms such as law & regulation , not only just we need to go through National Health Insurance or Taiwan Food and Drugs Administration but they suggested us to apply for European Union and American Law to have worldwide approval , they also mentioned about safety assay on how our engineered E.coli is and by their suggestions , we optimized our kill switch a plan and run a functional check to make sure that engineered E.coli is safe. They suggested to use Lactobacillus since it’s more common in probiotic world
Synbio Tech
Synbio Tech , a company focusing on probiotic powder and healthcare products. We got a chance to meet Mr Jin-Seng Lin , Miss I-Ju Chang and Miss Erica Chang from Synbio Tech.Our purpose is to have valuable insights in how we are going to market the product and manufacture process . It was an enlightenment meeting ,we received a lot of suggestions on how we should market our products :
- Establish the key points of the products
- Marketing Promotion since our products are different and have a specific target , they suggested us our drug marketing is also limited
Winston
We went to Winston Medical Supply Co. to learn about the drugs market and the steps needed to be taken for a drug to be in the market. We were able to meet with Wang Yu-Cheng, CEO of the company and also Yi-Ching Chen, Marketing Director.We received a lot of feedback toward our wet and entrepreneurship part. He agreed that CKD is a serious problem in Taiwan and uses up a lot of money to deal with the treatments, but they were concerned about how we are going to maintain the effectiveness of yadF gene knockout, but after we showed them how we did a functional test, they then suggested it needs to be optimized later when we already finished with the fermentation and packaging part in the future.
Moving on to the marketing part, we showed them our biotherapeutic drug flowchart that includes the few steps we need to take in order to make our biotherapeutic successful in the market. Wang CEO emphasized that we need to start from API (Active Pharmaceutical Ingredients), and it needs to be divided into 4 parts which are Regulation, API, Formulation and Preclinical. After that we then can develop our drug more precisely. Through their recommendations, we came up with new flowchart of our CreSolve living therapeutic drug:
College X
Founded by the government, NARLABs is one of the leading research center in Taiwan. We were really appreciated to be able to visit the lab and the consulted our business model with the Narlabs’ startup base, aim to help new startup to build better business model and also provide fundings to potential startups. During the visit, we talked about the overall project of OMG and also showed them the current business model we had.
The meeting was successful and we gained a lot from Narlabs, mostly from the business part:
- Currently laws in Taiwan on engineered bacteria are strict and some laws are still under discussion, we should pay more attention on the laws and make sure to follow them.
- Coating the sensing bacteria on PDMS chips may be a good idea, but we need to be extra careful about the bacteria because most bacteria have a certain condition to survive.
- When developing the business model, sometimes it is also important to consider user experiences into the whole model. For example, where can the sensing device best serve our patient and if the device is safe enough to let the patients run by themselves.
Government Association
This has been called "one of the best-known sentences in the English language",[7] containing "the most potent and consequential words in American history".[8] The passage came to represent a moral standard to which the United States should strive. This view was notably promoted by Lincoln, who considered the Declaration to be the foundation of his political philosophy and argued that it is a statement of principles through which the United States Constitution should be interpreted.[9]The Declaration of Independence inspired many similar documents in other countries, the first being the 1789 Declaration of United Belgian States issued during the Brabant Revolution in the Austrian Netherlands. It also served as the primary model for numerous declarations of independence in Europe and Latin America, as well as Africa (Liberia) and Oceania (New Zealand) during the first half of the 19th century.
IPO (Intellectual Property Office)
Due to a suggestion made by Geneferm, we visited the Intellectual Property Office. We wanted to consult the expert and commissioner about the procedure of the patent application. We also wanted to know if there will be more regulations and laws to ensure the uniqueness and specificity of our product after the living therapeutic drug is marketed. In addition, we also wanted to understand why there are so many bio-related restrictions.
The director of IPO Tainan Branch gave us a patent-related course. He taught us the query skills of our patent search mechanism. The expert also reminded us to pay attention to the relevant application procedures. From category, item, objects to cost, they all have clear explanations. Even the years, nationality, and method of application have different regulations, too. Due to its unique operations and novel ideas, the director recommended us to apply “invention” patent for our living therapeutic drug. As for our p-cresol reader, it’s suitable to apply “new type” patent because the device has new features and new testing projects after our team’s improvement.
TFDA
By phone call:
Through Genmont’s suggestion, we contacted Taiwan Foods & Drugs Administration to propose our project. They were very clear in the difference between a probiotic and drug. They said that because we wanted to say our product has pharmacological effects, we need to market CreSense as a drug instead of a probiotic.
