Understanding translational medicine requires comprehensive knowledge of its procedures, markets, and related regulations and laws. In order to be well-prepared before making our business plan, we interviewed a biotechnology company, Xbiome, to learn from their story and better analyze the feasibility of launching our product, Engine of Starlight. The interview also gave us a clearer insight into the processes and rules of launching scientific projects. Regarding marketing, we designed a questionnaire and handed it out to parents of autistic children. The questionnaire helped us know how widely synthetic biology is accepted among parents of various backgrounds. In the meantime, we held regular meetings within the team where team members took turns to present related laws and regulations. This enabled us to design our entrepreneurship work more reasonably.

An interview with Xbiome

We understand that what drives science does not drive business, and when these two worlds collide, there is a need for intermediaries and translators to ensure a shared understanding and a successful path from research to commercialism. Therefore, we interviewed Xbiome, an AI-based microbiome drug development company in China that is dedicated to developing microbiome therapies such as fecal microbiota transplantation (FMT) to alleviate and treat diseases of different systems. The capabilities of Xbiome have driven it to be one of the 50 Smartest Companies, as named by the MIT Technology Review in 2020, and we were impressed by their achievements in facilitating the transition from lab work to commercialization.

During the interview, the company directors shared their ideas on the strengths and weaknesses that university students might face as they launch their projects. They further explained the application of synthetic biology in various fields and highlighted its potential in translational medicine. At the end of the interview, they encouraged us to keep working on the translation of the project and offered valuable rules on validating the feasibility of commercializing scientific research.

Interview with Xbiome

As an industry-leading AI-based microbiome drug development company in China, Xbiome is dedicated to the development of microbiome therapies such as fecal microbiota transplantation(FMT) and mini-FMT for the alleviation and treatment of intestinal disease and diseases of other systems. It innovatively combines AI with gut microbiome technology into its proprietary drug development platform, which ensures powerful data support, significantly speeds up and increases the success rate of drug development and facilitates the transition from laboratory exploration to commercialization.

The world-leading capabilities of Xbiome have driven it to be named one of the 50 Smartest Companies in the world by the MIT Technology Review in 2020, one of the 50 Most Innovative Companies in China by the Fast Company in 2018, and one of Shenzhen Top 20 Leading Biotechnology Companies.

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Q:
What are the advantages of entrepreneurial projects in universities? In Chinese market, if you want to commercialize such projects, what are the current difficulties?

A:

Advantages of university entrepreneurship projects include:

(1) introducing cutting-edge technology features;

(2) The input cost is relatively low, which can be quickly verified;

(3) Challenge traditional concepts and traditional industries;

(4) The family burden of entrepreneurs is small, and it is convenient for them to devote themselves wholeheartedly.

Difficulties:

(1) Unclear thinking about the industrial pattern and business scenarios

(2) Chasing after the hotspots

(3) Mismatch between team capabilities and the goals to be achieved

Q:
We notice that the market growth of synthetic biology is gradually accelerating, and CAGR will reach 28.8% in 2019-2024. According to the statistics of SynBioBeta, the financing of synthetic biology is growing explosively. In the first half of 2021, the financing amount reached 57.8 billion yuan, with a year-on-year growth of 198.87%, which has exceeded the financing amount of the whole year of 2020. How do you view the Chinese market?

A:
The current prosperity of synthetic biology in the world investment and financing market reflects that its previous technology accumulation has reached a critical point. In the Chinese market, synthetic biology is more likely to play a great role because the downstream industries of synthetic biology are relatively complete, and the scale effect brought by technological innovation is large.

Q:
The biological industry is of great value in the future. In many directions, what do you think of medicine, especially intestinal health?

A:
The combination of biotechnology and artificial intelligence will bring great changes to the existing industry. The appearance of intestinal microbial pharmaceutical field is a new direction in the reform of medicine. This can greatly inspire the innovation of medicine field and enjoy a broad space for growth.

Q:
In China, most university enterprise alliances, or scientific research transformation, are still in the primary stage. How can the government, universities and industry make efforts to promote the marketization?

A:

The key to optimizing and promoting the marketization of achievements is the joint participation of the three parties to create a reasonable system.

In this system, the industry needs to take the initiative to communicate its customer needs, and even the judgment of future product development trends, to relevant R&D institutions.

Colleges and universities need to provide all-round support for the outcome from the perspective of research and development. Provide a platform for communication between industry and researchers, and guide more entrepreneurs to share and communicate in the school.

The government focuses on social benefits, and can provide policy guidance and public platform in this process.

Q:
What do you think is the difference in the safety and quality supervision between synthetic biology products and conventional medicine?

A:
Their safety and quality supervision need to be improved through joint discussion between experts and regulators. It is also necessary to coordinate with relevant departments according to some major principles to reach a consensus. These policies are often temporary and will be dynamically adjusted with the deepening of cognition.

Q:
As for intestinal health, intestinal flora is actually one of the most important determinants, but there are still many controversies in scientific research and industry, especially for products such as intestinal probiotics. What do you think?

A:

Whether the experimental results can be reproduced, whether the results of animal experiments can be transferred to people, and whether the experimental results of a group of people in a certain region can be applied to other populations in other regions? These all need more discussion and verification.

Many companies promote their products but lack rigorous mechanism research and clinical trials. The current chaos in the probiotic market requires more discussion and reflection by regulators and practitioners.

Questionnaire on the acceptance of synthetic biology

As we continued with the business plan, we decided to hand out a questionnaire among parents of children with ASD to have a deeper understanding of their acceptance of synthetic biology products. We tried to reach parents from different social and economic backgrounds to make our products better targeted. Specifically, during community service, we contacted parents at Star of the Sea, a rehabilitation center for autistic children. We explained the aim of our questionnaire and asked for their support before sending it out. It was encouraging that most of the parents were supportive of our work.

Our questionnaire

PDF preview

Regular meetings

Since we had not participated in entrepreneurship activities ourselves, we made it a routine to take turns explaining related laws and regulations. This was an efficient way of educating every team member on the rules that we were supposed to follow. We also had open discussions on the possible aspects we could look at. Gradually, we were able to develop an overview statement containing clear and reasonable information about our product.

Our discussion on related regulations

Discussion with iGEM WHU-China

Before launching the project, we held an online meetup on implementation together with iGEM WHU-China, one of the iGEM teams that we partnered with. We first shared our business plans and offered suggestions for each other. After that, we discussed the possibilities of launching the product in the current market. Since laws on synthetic biological products remain to be further developed, we decided to focus more on the scientific aspect and go deeper into the validity, affordability, and safety of the projects. Meanwhile, biosafety concerns were also discussed, and related laws and regulations were studied as well to double-check that we were operating responsibly.

Online meetup with iGEM WHU-China on implementation

We developed our business plan with the following objectives:

✔ Making Engine of Starlight a practical solution for mitochondrial dysfunction among autistic children

✔ Favoring the entrance of our product into clinical development

✔ Relieving the financial burdens of families with autistic children

✔ Making supplement taking convenient for children with ASD, especially during the pandemic

Meanwhile, the distribution, logistics, pricing, practicality, marketing, and safety of the product are all important to us. Therefore, our business plan covers the following aspects of business growth:

Here is the revised version of our business plan. You can scroll with the cursor inside the frame to view it.

Product evaluation plan

Evaluating the project is a helpful way to determine if it meets the team's goals and objectives. It gives us a better insight into the impacts and identifies areas that still require improvement. Consequently, we plan to evaluate our project regularly after its entrance into clinical development and application. We figured that an evaluation plan would be useful as we step far in entrepreneurship. In order to select suitable sources for our evaluation, we looked at commonly applied strategies in data collection. After comparing the advantages and disadvantages of interviews, focus groups, surveys, case studies, and observation, we decided to develop a conjoint approach that involves follow-ups, questionnaires, and quality detection.

The outline of our evaluation plan

Since we aimed to launch our products to the broader market, we also developed a product expansion scheme. Referring to some literature, we chose to apply the Ansoff Matrix, a 2×2 matrix representing four different growth strategies where a company enters a new or an existing market, to our scheme. This enabled us to look at new and existing markets and analyze the risk of each relationship to formulate plans for growth better.

WeChat Official Account is a China-based marketing platform that acts as a complete brand hub to gather followers and send them targeted content. Many researchers or just anyone who participates in lab work in our country would browse through articles on WeChat official accounts for updates of new findings in their field. As we read official account articles, we came across advertisements for biotechnology start-ups established by university graduates. This inspired us to establish a company ourselves based on the existing platform of our lab.

Advertising is another important aspect of entrepreneurship, utilitarianly or not. We noticed that salespersons of biotechnology companies generally visit surrounding laboratories to introduce their products to researchers. However, this form of advertising cannot be easily achieved during the pandemic. Additionally, promoting products offline can be disturbing for researchers in some situations too. Therefore, we decided to develop an online start-up and present the details of our products on a virtual platform. Necessary parameters will also be included on the page for each product, and our salespersons will take turns answering questions from customers with the Real-Time Contact function of the website.

It should be noted that the online company is defined as “online” merely for the promotion and purchase platform. Experiments will still be conducted in the laboratory.

Online conference by Mr. Wenjie Zhang

In order to have a deeper understanding of the current market in our country, we attended an online conference hosted by Mr. Wenjie Zhang, director of Shanghai Fuhong Hanlin Biotechnology Co., Ltd, on September 29th. During the lecture, Mr. Zhang introduced the innovativeness, risks, objectives, ideal size, and development speed of biotech and biopharma start-ups. We were able to develop a plan for further adjustment after his lecture.

Screenshot of the online conference

Defining the objectives

As a participating team in the iGEM competition, we decided to build our company mainly for future teams. After several discussions, we agreed on producing commonly used Parts such as Promoters, Terminators, and RBS at reasonable prices. This way, teams purchasing our products would achieve their objectives more economically.

Our platform

The State Key Laboratory of Reproductive Medicine was established at Nanjing Medical University in 1997. Centering around the main research directions, the laboratory established an excellent platform for analyzing and tracking reproductive cell development morphology, a protein regulatory network analysis platform, a reproductive genome and genetics analysis platform, and a reproductive health environmental exposure and metabolism analysis platform. It has also allotted sufficient space for model animal breeding and gene editing. In the past few years, the laboratory built a cloud information platform with independent intellectual property rights and established a complete cohort implementation standard, operation specification, and a high-standard sample resource database.

The State Key Laboratory of Reproductive Medicine

Our laboratory was based on the platform, and during the iGEM competition, we used a Level 1 standard microbiological lab with an open bench and chemical fume hood. Although our work in the treatment of ASD is not strictly related to the direction of the lab, we were given the opportunity to utilize the equipment, reagents, and other experimental supplies. Additionally, we received our training with the help from administrators of the lab before entering the lab, which ensured the safety of our conduct.

We believe that we will be able to provide quality service for future iGEM teams with the available resources and hopefully make more contributions to the promotion and development of synthetic biology.

Business plan

Here is our business plan for the online biotechnology start-up. We plan to continue our work in its establishment after the competition and focus more on the long-term and short-term effects in the process.