In our project, integrated human practices are known as a nuclear part since human health is one of the greatest concerns of modern society. In order to solve practical social problems that need to be solved urgently, our team will focus on the efficacy of paclitaxel and antibody-coupled drugs in refractory cancers and aim to contribute to preclinical drug development.

Our product is a monoclonal antibody for the detection of PTX in combination with an ELISA for the quantitative detection of small molecule PTX levels, with the goal of effectively supporting clinical studies for the development of ADC anticancer drugs. Moreover, we hope this product can offer more treatment possibilities for hard-to-treat cancers.

Figure 1. the mindmap of our IHP

To assess public awareness of the use of paclitaxel (PTX) in the fight against cancer, we conducted an online survey. As of August 9th, a total of 506 individuals completed this survey. The majority of participants fell within the 18-40 age range, with positive feedback also received from individuals under 18 and those between 40-60 years old. In terms of gender demographics, an almost equal distribution was observed, with 51.78% being male and 48.22% female.

Figure 2. the respondents

Among the survey questions, we inquired about respondents' beliefs in the potential for cancer cures, and an encouraging 67.39% displayed a positive attitude. 87.55% of the survey respondents believe that active cooperation with treatment is essential because life is precious.

Figure 3. Question 'Do you think that cancer can be cured completely?'

Figure 4. Public's attitudes toward cancer

Furthermore, a significant 74.11% of these respondents reported that someone close to them had experienced cancer, indicating a high incidence rate. This indirectly reflects the significance of the subject we are researching.

Figure 5. Question 'Have you or someone close to you experienced cancer?'

62.28% of the respondents mentioned that they have never participated in activities related to acquiring knowledge about cancer prevention and treatment. This indicates a significant lack of basic knowledge among the general public. In our future activities, we will focus on this situation.

Figure 6. Prevalence of scientific knowledge on cancer prevention

We also included a question about paclitaxel to evaluate people's knowledge. Approximately 67.79% indicated they had never heard of it, highlighting the importance of our project in disseminating information to increase awareness of this valuable substance among more people.

Figure 7. Question 'Do you know anything about paclitaxel (PTX) against cancer?'

Interview with Dr. Zhang, a Doctoral Supervisor of Shanghai Ninth People’s Hospital

Since our team’s program is about Cancer medical aspects, we decided to interview an expert in cancer care. With questions about the feasibility of the ELISA method for the cancer treatment drug PTX, we found Zhang Yanjie, a cancer expert from Shanghai Ninth People's Hospital. We met and talked with Dr. Zhang offline at the Shanghai Ninth People's Hospital Pudong Science Park.

Figure 8. Interview with Dr. Zhang, a Doctoral Supervisor of Shanghai Ninth People’s Hospital

Dr.Zhang is the Chief Physician of the Department of Oncology of the Ninth People's Hospital, attached to Shanghai Jiao Tong University of Medicine. She has been engaged in the medical teaching and research work of gastrointestinal tumors for more than ten years, and specializes in the prevention and early diagnosis of gastrointestinal tumors, the precancerous diseases of the gastrointestinal tract and the comprehensive treatment of gastrointestinal tumors, as well as molecular targeting therapy.

Dr. Zhang introduced us to some specifics of PTX and its current clinical applications. PTX is the most widely used and applicable cancertargeted drug, serving as the cornerstone of cancer treatment. It is considered safe enough that there is basically no need to worry about patient safety. The dosage is measured on a patient-specific basis, and it will not be replaced in the foreseeable time. Also, there are different types of PTX currently in clinical terms.

After Dr. Zhang's introduction, we are very pleased to have a more detailed understanding of PTX. When evaluating PTX as a pharmaceutical, patients typically prioritize three key factors: efficacy, potential side effects, and cost. It's important to note that the drug's efficacy can vary from person to person. Therefore, comprehensive communication with the patient, including obtaining their informed consent, is a standard practice before administering the drug. While it is true that PTX may have side effects, medical advancements have significantly mitigated these effects in recent years. Furthermore, the cost of PTX has become notably affordable and generally acceptable. This is a remarkable transformation from the past when a single pill could cost thousands of dollars, to the present where three pills can be obtained for a few hundred dollars.

Our discussions further enlightened us about our project's goals and directions.

Through further discussions and exchanges, we gained more and clearer understanding of our products and the direction of our project. We learned that the market for PTX is currently saturated, so we do not plan to upgrade on raw materials. At the same time, there is no efficient and cheap reagent assay in preclinical trials, so we focus our attention on the development of reagent assay kits. Moreover, current cancer drugs can only target a few specific targets, and many new drugs cannot be marketed in a timely manner because clinical trials cannot be conducted on time and clinical trials take too long, so the products we develop can improve the efficiency of clinical trials, thereby improving drug production efficiency, giving more patients the opportunity to try new drugs, improving their chances of survival, and contributing to the development of anticancer drugs.

This interview not only enriched our project but also reaffirmed its significance and feasibility, which gave us a great deal of inspiration and allowed us to take many fewer detours.

Figure 9. Interview with Dr. Zhang, a Doctoral Supervisor of Shanghai Ninth People’s Hospital

Figure 10. Interview with Dr. Zhang, a Doctoral Supervisor of Shanghai Ninth People’s Hospital

With the question of how to translate our project into a product, we conducted an online interview with Dr. Wang Tao, an Antibody Drug R&D researcher at Shanghai Pharmaceuticals.

Figure 11. Our online interview with Dr. Wang

First, we asked about the prospects and trends of anti-cancer drugs currently on the market. Dr. Wang told us that cancer is a hot topic because of its high global mortality rate, so for cancer drugs, its research and development as well as production is an urgent issue. The whole market of anti-cancer drugs is very concerned and supported by both the state and various enterprises, and about 9% of the annual growth rate is invested in drugs. For both China and the whole world, the investment in research and development of anticancer drugs is huge. In 2022, the market size of antibody drugs reached more than 230 billion U.S. dollars. By forecast, it might reach around $250 billion this year. So this market is still very big and promising.

After learning about the market trend of anti-cancer drugs, Dr. Wang provided some insights and suggestions for our project in this research. He firstly affirmed our Elisa testing method, because its testing machine is cheaper and has some advantages in cost. Then he pointed out some shortcomings of our project, we should carefully consider the scope of the market for our product, because different antibodies are suitable for different cancer symptoms.

Subsequently, Dr. Wang conducted a comprehensive analysis of the merits of our project. From a technological perspective, Elisa has reached a high level of maturity. Furthermore, Elisa kits are exceptionally user-friendly, boasting notable sensitivity. Additionally, Elisa kits offer cost-effectiveness and scalability as they can be manufactured in large quantities. Moreover, they exhibit a broad range of applicability and can accommodate diverse sample testing requirements.

We asked Dr. Wang if there were any competitors in the market similar to our product. He told us that there were. Henan University of Science and Technology and Southern University of Science and Technology are both developing products similar to the Elisa kit. However, the former is less accurate and prone to problems. Although the product of Southern University of Science and Technology has high sensitivity, the cost is much higher compared with our product.

At last, we made hypotheses about Dr. Wang. If he were a buyer for drug research, would he be willing to use our product in clinical trials？ His answer was yes. But he also had four factors to consider. The first is the stability of the product, the second is the cost issue, the third is the production cycle of the product, and the last is the result of comparing the advantages with other competitors.

We have benefited and been inspired by this interview with Dr. Wang. We not only understand more about the market situation our products are in, but also the strengths and weaknesses of our products. We will also consider many of the ideas Dr. Wang put forward in our future research. In addition, we will also be more refined and make reasonable improvements to the deficiencies he raised.

In order to better understand the needs and forms regarding our markets and customers, and to further understand the principles of our pharmaceuticals, we went to the Suzhou Suncadia Biopharmaceuticals CO, LTD. We visited their pharmaceutical plant, learned about the pharmaceutical process, and learned about the production cycle of new drugs and the role that ELISA test kits play during this period.

We learned that it takes about ten years to make a new drug from the beginning of research and development to the market, during which time it has to go through three phases of clinical trials, during which it is necessary to test the level of the drug in the blood plasma. We also learned that anticancer drugs are currently the main market for pharmaceutical companies, so I think there is a big market for ELISA kits to detect PTX concen.

Figure 12. Field trip

1.During our visit to Shanghai Ninth People's Hospital, where we interviewed Dr. Zhang, we gained valuable insights into various cancer treatment avenues, methods, and major drugs in use. We also learned about the unfolding clinical trials necessary for drug market release. This interview played a pivotal role in shaping our initial product design. Additionally, our field trip to this hospital affiliated with Shanghai Jiaotong University provided essential knowledge about current cancer treatments and the prevalence of new cancer drugs, helping us refine our project focus.

2.After defining the topic we conducted another expert interview, in which we got a better understanding of what competitors our product has, where the market for our product is mainly concentrated and the commercial potential of our product. After this interview we started writing the BP and fine tuning our product design.

3.We went to a pharmaceutical factory in Suzhou for a field trip, which gave us a better understanding of the production and manufacturing process of cancer drugs, gave us a better knowledge of the principles of our products, and gave us a clearer idea of the market and audience of our products. Based on this field trip, we fine-tuned our business plan and finalized the promotion video idea.

During the iGEM human practice events, we had a clearer understanding of the current cancer treatments, anti-cancer drugs and the current situation of cancer. It also made us realize how our designed products can help the modern human society, and enhanced our knowledge and interpretation of our products.

We're also keen to outline a brief overview of our plans for the future deployment of our project

Our initiative is centered on amplifying the therapeutic potential of paclitaxel (PTX) and antibody-linked drugs for challenging cancer types. By pioneering a monoclonal antibody tailored for PTX detection and coupling it with an ELISA for precise quantification, we aim to bolster clinical research for ADC anticancer drug formulation. This innovation holds the promise of expanding the therapeutic arsenal against particularly resilient cancers, addressing a pressing healthcare concern.

In addition, we have considered about who will be our clients.

Our envisioned clients primarily encompasses medical research hubs, leading pharmaceutical entities, and specialized clinical laboratories deeply rooted in oncology research, especially those delving into refractory cancers. Moreover, stakeholders engaged in the R&D of ADC anticancer solutions stand to gain significantly from our offering.

So, how will our clients use our products in the future? Regarding this question, we foresee esteemed research institutions and pharmaceutical giants seamlessly integrating our specialized monoclonal antibody and the accompanying ELISA kit into their drug research and validation protocols. This integration would facilitate accurate PTX quantification, enriching the data pool for clinical investigations. Our innovation has the potential to set a new benchmark in the realm of preclinical research for stubborn cancer types.

To summarize, our real-world implementation strategy is underpinned by rigorous research, comprehensive surveys, and invaluable insights from industry experts, painting a holistic picture of the current oncology landscape and PTX's pivotal role. We're poised to forge strategic alliances with pharmaceutical leaders and research powerhouses, capitalizing on our collective knowledge and expertise. Additionally, we're committed to spearheading awareness campaigns and educational drives, underscoring the transformative potential of our product, and fostering its widespread acceptance within the medical fraternity.

We also invite you to visit our entrepreneurship part for a more comprehensive review of our project prospect.