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Entrepreneurship

1.overview

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▶We approached our activities with the perspective of actually managing the project.In order to develop newly created technology, the process of using that technology to give back to society and generate profit is indispensable.Approaching the project with this perspective was very important to the research process!

▶The goal of our project is to make antidepressants readily available at a lower cost. To do this, we aimed to eliminate the ability of E. coli that has accumulated antidepressants, to multiply, so that they can be put into a cookie directly. The cookies we aim to develop have the potential to control depression easily.

While developing the product, Japan-United also made careful preparations for the actual delivery of the developed product to society. The following three points were kept in mind.

  1. Identify the customer carefully and design a product that the customer would want to use.
  2. Develop a realistic solution while ensuring scalability and originality.
  3. Incorporate the opinions of all stakeholders involved in all phases of the project.

The first point was considered from the very beginning of the project, and we put our customer first in identifying potential customers and their absolute needs from literature review, interviews with actual customer groups, to the provision of a prototype.

As for the second point, while making the product design more scalable and creative, we also considered the impact (both negative and positive) of the developed solution and came up with a feasible and realistic entrepreneurial plan.

Finally, for the third point, by gathering input from many relevant stakeholders in all phases of the project, we were able to help design a professional product and realistic plan that was applicable in the real world.

2.Creation of a formal business plan

▶In delivering its products to society, Japan-United has produced formal materials designed to help people start their own businesses in the project. For more information, please see the following documents。

https://static.igem.wiki/teams/4955/wiki/entrepreneurship/marketing-plan.pdf

The business plan was developed with feedback from Mr. Kohei Matsuki, CEO of Hurray Holdings Inc.

3.Product commercialization

3-1 Determination of product form

▶We decided to use sweets to offer the saffron ingredients we produced. This is because our product is an antidepressant with minimal side effects and our goal was to provide a means of self-control for depression.

To learn more about the creation of our product, we spoke with Hayato Kano, CEO of RelieFood Co. Please see the page on Human Practice for more details. After this discussion, we decided to offer the product as a cookie.

We also searched for a patisserie that would cooperate with us in the creation of the product, as we knew it would be difficult to do so with only our team’s efforts. With the help of Hitsujigumi, we confirmed that cookies would be the easiest to produce.

3-2 Prototype Production

▶With the cooperation of Hitsujigumi, we produced a prototype of the product. For regulatory reasons, the saffron used in this prototype was a natural product provided by Akaito Saffron. The ingredients used in the prototype production were as follows, using the simplest recipe we could find, for the purpose of clearly evaluating the taste of saffron.

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3-3 Sampling Food

▶The prototype products were served to potential end-users, including depression patients (both cured and in remission) and their relatives, and feedback was obtained. We were able to gather a total of 14 people for this tasting event, with the help of Depression Support Group Asao.

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Feedback received after the tasting is listed below:

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Based on this feedback, we will continue to improve our products with the goal of developing more consumer-friendly products.

3-4 Mounting Process

▶Considering the results, we investigated the process by which our product would be implemented in society.

There are two possible ways to market saffron by showing its efficacy and function for depression: pharmaceuticals and health-promoting foods. Considering the concept of our product, we believe that a health-promoting food is more appropriate.

There are three types of health-promoting foods: food with nutrient function claims, food for specified health uses, and food with functional claims. We researched the characteristics of each and identified the most appropriate type for our product.

Food with nutrient function claims: Foods used to supplement specific nutrients. Food with nutrient function claims can be marketed as a food with nutrient function claims if the specific nutritional components specified by the government are within the upper and lower limit amounts, and if the function of nutritional components and warning labeling, etc., are indicated. Food with nutrient function claims is a self-certification system that does not require an application for individual approval.

Saffron is not included in the specific nutritional ingredients designated by the government and therefore this type is not suitable for our product.

Food for specified health use: Food containing ingredients with benefits for health, and is officially approved to claim its physiological effects on the human body. Each product must undergo a review of the effectiveness and safety of the food, and must obtain permission from the government for labeling.

Food with functional claims: Food with functional claims for which the business operator is responsible. Based on the rules set by the government, a business operator is required to notify the Commissioner of the Consumer Affairs Agency of scientific evidence and other information regarding the safety and functionality of a food product prior to its sale to enable the labeling of its functionality.

We have found that the labeling of disease risk reduction is not permitted in Food with Functional Labeling, and it is not possible to achieve our goal of products that enable self-control of depression, through this type.

The feedback obtained from these surveys and tasting sessions indicated that we need to aim to market the product as a Food for Specified Health Uses.

We have reviewed the process required for registration as a food for specified health use.

①We need to send an application for labeling permission and an application for review to the Consumer Affairs Agency.

②The Consumer Affairs Agency will consult with the Consumer Commission and obtain a report. The Consumer Affairs Agency also makes a request for evaluation to the Food Safety Commission and receives the results of the evaluation. The Consumer Affairs Agency also makes an opinion inquiry to the Ministry of Health, Labor and Welfare (MHLW) and obtains a response.

③ While the Consumer Affairs Agency performs these procedures, we request the National Institute of Biomedical Innovation, Nutrition and Health or a registered testing institute to analyze the product along with a sample of the product.

④ As a result of the analysis, we receive a test result report, which we send to the Consumer Affairs Agency.

⑤If the product is determined to be appropriate in these processes, the Consumer Affairs Agency will distribute a letter of approval.[9]

4.References