Team:LZU-CHINA/Entrepreneurship

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Commercialization~
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Entrepreneurship

Commercializing our pancreatic cancer treatment~
Introduction Details Future Works
Introduction

Introduction

With the deepening of cancer research, pancreatic cancer has increasingly become a major concern in the international medical field. The United Nations (UN) and the World Health Organization (WHO) have announced that pancreatic cancer has become one of the biggest threats to global public health. Pancreatic cancer is a malignant tumor of the digestive tract. At present, there is no effective method for diagnosis and treatment. The traditional treatment methods for pancreatic cancer are chemotherapy and surgical cutting. When pancreatic cancer is found, most of them are advanced and the mortality rate is high. Newly diagnosed pancreatic cancer patients in the United States account for 2% of total cancer patients each year. According to estimates by the American Cancer Society (ACS), approximately 56,770 people will be diagnosed with pancreatic cancer in the United States in 2019.
Our team is committed to the application of a new type of cellular immunotherapy to further eliminate residual pancreatic cancer cells in the body, thereby improving the clinical treatment of pancreatic cancer. Our proposed treatment for pancreatic cancer ultimately needs to be applied to clinical treatment. In order to get more patients with pancreatic cancer, we begin to consider commercializing our results. At the beginning of the venture, we mainly started to study how to commercialize our clinical treatment products. At each step, we strictly abide by relevant technical regulations and national regulations such as GMP.

Progress

The team never touched the model of product commercialization and the company's operation. We visited Professor Zhang Dongyu of Lanzhou University of Finance and Economics, and exchanged discussions with him and listened to his suggestions. Professor Zhang told us that the initial stage of business needs to consider a long-term market plan. We look farther and realize that customer needs are a core point that needs to be considered at the beginning of the venture.
Subsequently, we used questionnaires to understand the thoughts of the three major stakeholders of cancer patients, clinical medical practitioners and investors in related fields. After receiving the questionnaire, we will integrate all the data, comprehensively and hierarchically, and analyze the relevant needs of different interest groups.
After completing all data processing, we have developed a preliminary statement of requirements based on customer needs and continuously improved and refined it in subsequent phases. So far, we have started to analyze the market and understand the situation of the corresponding competitors, and then build a value proposition covering all stakeholders.
At the same time, three model tools for building a business model: A.Jeroen Kraaijenbrink's strategic diagram (Strategie Schets, SS), Alex Osterwalder's Business Model Canvas (BMC), Ash Maurya's Lean Startup Canvas (Lean Startup Canvas) , LSC), we have a detailed understanding and comparison, we believe that our commercialization project needs to go to the direction of the startup, so we finally chose LSC as the most suitable business model display tool for us.
After initial completion of the above, we designed the core of our minimum viable product (MVP).
Finally, we exchanged our business plan with Professor Zhang again, and he expressed his views.
“The study of new therapies for pancreatic cancer is a very meaningful exercise. It is a good decision to consider the product after it has been FDA-approved and GMP-compliant. Students have applied epigenetics and biomedical therapy. A new type of treatment for pancreatic cancer has a positive effect on the clinical treatment of pancreatic cancer. They also noticed that the client's needs are the core and the development is based on synthetic biology and technology. The chemotherapy regimen is also different from the existing TIL, TCR-T and CAR-T therapies in the ACT field. They extract TIL cells, use genetic engineering to transform them, and apply the principles of protein pathways for treatment. The way the channel works is commendable, and I look forward to going further and further."
Details & Analyses

Demand statement

To develop a pancreatic cancer treatment method that can efficiently and accurately induce apoptosis of cancer cells, and the price can be widely accepted by the market and can be rapidly applied to clinical tests.

Value proposition

Through the preliminary research on relevant stakeholders, we have summarized and constructed the following values:
Innovative therapy
Clinical application is efficient and accurate
Meet market expectations
Therapeutic use can be extended

Market analysis

Most of the patients with pancreatic cancer that are currently being detected are already in advanced stage of cancer and cannot be cured by surgery and chemotherapy. Therefore, there is a great demand in the pancreatic cancer treatment market, and patients are in urgent need of new methods for treating pancreatic cancer. In 2010-2014, the global anti-cancer drug market compound growth rate was 6.5%, of which the emerging market growth rate led by China was 15.5%. The United States remains the largest market for anti-cancer drugs, accounting for nearly 40% of the market. The rapid growth of China's anti-cancer drug market in 2010-2014 increased from 43 billion yuan to 85 billion yuan, with a compound growth rate of 14.6%.
Solid tumors account for 90% of cancers, and the United States expects 1.6 million new solid tumor cases in 2019. In 2018, there are 3.8 million new cases of 18.1 million new solid tumors in the world, accounting for 1/5 of the world.
At present, the immune cell therapy led by CAR-T is in full swing in China, and the China Health and Wellness Committee is constantly updating the new policies and regulatory content in this field.
In March 2019, the Health and Health Commission issued a letter of opinion on the management of clinical research and transformation application management methods for somatic cell therapy. When somatic treatment is converted into an application project, it can be transferred to clinical applications.

Contrast with other innovative therapies in the ACT field

TIL is a highly differentiated, customized and targeted immunotherapy.
The engineered cells in our protocol will target cancer cells and subsequently be treated in conjunction with gene therapy using the principles of the protein pathway. There are two sets of induction and killing systems in the program, which kill cancer cells and have fewer side effects.

SWOT Analysis

Our team considers a variety of factors in SWOT analysis, including our strengths, weaknesses, opportunities and threats. S: Strengths, W: Weaknesses, O: Opportunities, T: Threats.

MVP

Our product is a complete set of clinical treatment processes, which need to be prepared lzu-pc. Lzu-pc is our new TIL therapy, pc is the abbreviation of protein circuits.
1. Collect tumor tissue samples from patients.
2. Extract the patient's TIL cells and add IL-2 to amplify lzu-pc.
3. After amplification, harvest and concentrate lzu-pc.
4. After the patient is ready, return TIL to the body and receive 6 courses of IL-2 intravenously.
5. Observe whether the treatment is effective.
We clearly understand the current deficiencies and decided to continually optimize our MVP in clinical testing through loop iterations, ie iteratively renew our MVP products through a cycle of design-build-test-learn.
Future Works
Through the current clinical phenotypic analysis, we can determine the high lethality of our treatment methods for pancreatic cancer, and there are already many investors such as Yuanhe starting point and sorghum fund who have become interested in our products.
At present, the Ministry of Science and Technology of China has issued a notice on “Some Policy Measures to Support SMEs in Accelerating Innovation and Development in the New Era”. From this, we understand that the new government policy supports science and technology innovation enterprises, and our products It happens to be an innovative treatment. We actively understood the details of the corresponding policies and decided to gradually establish a startup response policy to better carry out subsequent research.
Qiming Ventures has been very interested in knowing our products. They have signed a preliminary intention plan with us and decided to invest 1 million yuan to support our research.

Timeline after iGEM

Lean Venture Canvas (LSC)

Relevant laws and regulations

We are learning about FDA certification and other related content to ensure that we conduct subsequent research in compliance with relevant regulations to produce products that meet GMP quality standards.