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Overview

We aimed to introduce our project to the general public during our Integrated Human Practice activities and gain reflection from them. By doing so, we learned how to improve our project to better suit the present and future situation of COVID-19, including its mutations. According to the results, Integrated Human Practice is a key part of our project as we adjusted our product, ACE2 antibody. Although creativity is the key to our project, the feasibility and practicality of our product needs to be considered as well. As outlined in the tree-map below, multiple professionals and many citizens helped us with the design and development of our antibody product.

Meanwhile, we tried to expand our social impact to a greater extent. Questionnaires, surveys, and interviews all helped us better connect with the world and promote our ideas more efficiently. In addition, we hoped that people would be able to lessen their worries about the coronavirus as the antibody would be ready to fight any mutated strain at any time. Below is a summarization of the rationale of our Integrated Human Practice activities.

Biomedical Professional Interviews

Professor Han

Professor Han is currently a professor at the Wuhan Institute of Virology, specializing in research on the coronavirus. He holds a PhD in virology from the University of Lubeck, Germany and a masters in science from the Chinese Academy of Sciences. We hoped that by interviewing him we would be able to spot weaknesses and consider alternatives to our original plans. Under his guidance we hoped to develop a clear direction for our project.

July 3, 2021- First Interview with Dr. Han

We arranged a meeting with Professor Han to find out more about the mutated strains of the coronavirus and the characteristics of the current vaccines. Dr. Han clarified that it’s still unknown whether our present antibodies are still effective on mutated viruses. However, when developing vaccines, scientists already try to consider the fact that the virus will mutate. They do this by studying previous strains of the virus and then targeting the part that stays the same throughout mutations. For example, the UK mutation, B117, is effectively still neutralized by our present antibodies. As the virus changes abroad, we can study its evolution and create a vaccine before it completely mutates and infects people, which scientists did for the influenza virus.

Dr. Han also explained the techniques of vaccine development, including ELISA, which we can use to test the efficacy of various antibodies against strains of coronavirus. By attaching a protein to the bottom of a plate and adding human blood, if the blood binds to it, it has antibodies for the protein. Other than ELISA, Western Blot is a commonly used test that can test for antigen-antibody reactions. Using Western Blot, we could also try the effectiveness of our antibody against mutated coronaviruses.

Dr. Han then went on to talk about the current vaccines, which inject mRNA into our cells’ ribosomes which then produce the characteristic S spike protein. Our immune system then creates antibodies against these cells with S proteins, creating a learned response against future attacks. However, Dr. Han believes that the mRNA has a few defects, including its high cost of production and low thermostability. He thinks the ideal vaccine type would be a live virus that doesn’t cause other diseases, similar to the rabies vaccine.

Dr. Han believes that as man’s range of activity increases, we will inevitably encounter more wild animal viruses. The best way to avoid this is to take samples of viruses from animals worldwide and test whether they are threatening to human cells. This way, we can prepare for these viral diseases before another epidemic occurs.

July 4, 2021- Interview with Ms. Zeng

After learning more about vaccines from Dr. Han, we tried to improve the thermostability of the vaccine as it would enormously benefit third-world countries that do not have an efficient cold-chain transportation system. Thus, we interviewed Ms. Zeng, who works for Pfizer. We believe that she can give us some insights into the development of a vaccine.

We know that the current COVID-19 vaccine can only be transported in special vaccine refrigerators at temperatures of -20 to 80 °C, so we came up with several ways to enhance its stability. However, Pfizer already tried every method we could think of, and the resulting vaccines did not meet FDA standards. She also indicated that these standards apply to antibodies as well.

Therefore, our team decided to abandon the idea of improving the thermal stability of vaccines. Since one of our team members mentioned in our meeting that he had done experiments on developing an innovative antibody that fights COVID-19, we changed our research direction. According to this team member, the previous antibodies were all designed to target the Spike protein of the virus, but if the virus mutates, the antibody will soon become ineffective. The new antibody that he worked on, Antibody X, is different as it targets the ACE2 receptor in human bodies. He said that there are still steps of developing Antibody X yet to be finished, so we wondered if we could do things to help.

July 5, 2021 - Second Interview with Dr. Han

During our second interview with Dr. Han, we had a more precise direction for our project and were able to ask more targeted questions. After the interview with Ms. Zeng, we found out that several vital experiments of testing the efficacy of Antibody X on mutated strains of coronavirus are still missing, so we started working on them. We came up with some questions during our development of Antibody X, which blocks the ACE2 receptor from the coronavirus’ S protein: we wondered if blocking the ACE2 receptor would inhibit ACE2’s normal functions and cause side effects.

Thus, we had another interview with Dr. Han. He pointed out that the ACE2 receptor typically operates as an enzyme that generates proteins by cutting the angiotensin protein into smaller pieces. However, the part that does this is separate from the ACE2 receptor, meaning that although blocking the ACE2 receptor could affect its functions as an enzyme, it most likely won’t be completely inhibited. In addition, since coronavirus victims are already in a state of emergency, the limited side effects of blocking ACE2 receptors are negligible.

However, Dr. Han also told us that most companies have been targeting the spike protein and not the ACE2 receptor because the coronavirus has other methods of infecting our body other than the ACE2 receptor, such as our lymphocyte cells. But there is still value in creating an ACE2 antibody as it can be used as an immediate prevention measure. For example, if we made the antibody inhalable, medical workers who often contact the coronavirus could take it and prevent the virus from entering our lung cells. Its immediate effect and its ability to block all mutated strains are where it holds its advantage over vaccines.

Lastly, we inquired about how our body’s immune system would receive the new antibody. Dr. Han said that we could change the human body system to help it accept the new antibody. We can test the potential side effects using rats whose cells have been genetically modified to resemble human cells.

Business Professional Interviews

July 3- Site visit and interview with Ms. Zheng

On July 3rd, we conducted a site visit at Zoetis. While observing the operation of a real-world biomedical corporation, we interviewed the director of China's marketing and training department, Ms. Zheng. We asked her some marketing and promotion questions that we encountered while developing our product, Antibody X.

Ms. Zheng explained that the essential thing while promoting a product or a technology is finding an appropriate target market with great demand. For example, the government has demand for vaccines; biomedical companies, R & D companies, and research institutes are more interested in our technology; individuals focus more on our product's effects and side effects, etc. After interviewing with Ms.Zheng, we understood which groups we should target and how to find our positioning in the COVID-19 market. We also gained a better sense of market research and how to produce an effective business report.

July 6 – Interview with Mr. Guo

In order to brainstorm for selling our idea to the world, we arranged an interview with Mr. Guo, the former strategic consultant of Accenture Consulting. He is currently a successful entrepreneur who would give us suggestions on how to develop a product and promote it to the world.

During the interview with Mr. Guo, we understood how a new medical product is invented, developed, produced, and promoted to the general public. First of all, he stressed the uniqueness of COVID vaccine as the world struggled through the pandemic and strived for recovery. That is why the government opened a green channel for the vaccine's fundraising, production, and promotion. Currently, in China, everyone would be able to access the vaccine as long as they want to. However, citizens from the third world are still unable to evade the infection since protein antibodies require high-standard transportation and preservation.

July 7 – Interview with Mr. Wang

We interviewed the head of commercialization of Fosun Pharmaceuticals about the development cycle of antibodies and some suggestions on our business plan.

For an antibody, Mr. Wang told us that it usually takes about one year to discover an antibody that costs about $2 million; pilot and preclinical trials typically take approximately 1.5 to two years. Pilot trials cost about $15 million, and preclinical trials cost about $7 million. Clinical trials take about five years, which are conducted in three consecutive phases. Phase I clinical trials usually cost about $8 million; Phase II clinical trials typically cost about $40 million; Phase III clinical trials usually cost over $100 million. However, due to the unique nature of COVID-19, we can speed up the process by eliminating phase III clinical trials, which would shorten the human trial phase to less than two years.

Regarding the business plan, we asked how to make it more successful. Mr. Wang told us that we should start with addressing the market's pain points and focus on solving them. He also emphasized differentiating ourselves from other competing products. For instance, what are the advantages or disadvantages of our product compared to others?

Moreover, we asked how to accurately predict the customer segment of our product as we are not sure whether we should sell it only in China or promote it to the global market. Although the worldwide market is much larger, there will also be more problems to face, including political, economic, social issues. Mr. Wang solved the for us by using a simple business theory that we should always focus on the market's needs. Given the very strict preventive measure in China, he felt that the primary market for this product is abroad.

At the end of our interview, we asked Mr. Wang if he could give us some suggestions for developing our product, Antibody X. He said we need to focus on its effectiveness and safety. Although there is a clinical need for a universal antibody-like Antibody X, not all antibodies can effectively turn into functional medicines. Moreover, the side effects of targeting ACE2 receptors in human bodies need to be considered in advance.

Market Research

July 5-Interview with Ms. Zhu

After the interviews with Ms. Zheng and Mr. Guo, we realized the significance of market research. Frontline workers are the primary focus of our marketing plan, and we wanted to understand the true feelings of the people who were closely contacted with the coronavirus. This way, we could create a product that captures the needs of the market.

We interviewed the head nurse of Shanghai First People’s Hospital, Ms. Zhu, whose job is hugely impacted by the pandemic. We first introduced our project on Antibody X and asked her several questions. She said that even after vaccination, she is still scared while facing NCC patients every day. The vaccine does not guarantee 100% immunity, and due to the rapid mutations of the coronavirus, the probability of infection is relatively high. She also mentioned that the pressure, safety hazard, and tiredness increased exponentially due to the pandemic, and she would love to have an antibody that can guarantee her safety.

As for the antibody, she believes that it is important to minimize the side effects. For example, some patients or health care workers suffering from NCC pneumonia may reject the antibody because they do not want their condition to worsen after the injection. The first-angle perspective of Ms. Zhu truly helped us in the designing and development of our product.