Team:Thessaly/Entrepreneurship
Overview
AMALTHEA is a prevention toolkit for the evaluation of gut microbiome and alleviation of gastrointestinal symptoms developed by our multidisciplinary team, iGEM Thessaly. AMALTHEA intends to combat the rising threat of diet-related non-communicable diseases by providing a toolkit for strengthening the gut microbiome's health, ensuring the health and well-being of citizens all over the world.
We've been thinking about the commercial aspects of our product since the beginning. As a result, we reached out to a variety of stakeholders as well as the pharmaceutical and probiotic industries aiming to design our proposal and learn how to integrate it into the market. Furthermore, we won first place in Falling Walls Lab Greece, one of Greece's most prestigious innovation and entrepreneurship competitions. Following that, we prepared a business plan outlining our efforts to secure funding for the continuation our initiative. Finally, taking into consideration industry viewpoints, a SWOT analysis and a timeline for the next 24 months were created.
Problem Identification
Diet-related non-communicable diseases (NCDs) are one of the most serious pandemics in today’s world (FAO,2019).
Even though the human development index in Western society is high and people have access to enough food, there is
an unprecedented rise in diet-related NCDs, as an increasing number of people tend to draw themselves into
nutritionally poor dietary patterns (IHME, 2021). Currently, one in three people worldwide is malnourished
while 1.9 billion adults are overweight and 462 million adults are underweight (Fluitman, 2017).
Unhealthy diets pose a great risk of morbidity and mortality, accounting for over 10.9 million deaths, or 22% of all deaths among adults in 2017, according to theInstitute for Health Metrics and Evaluation (IHME) (IHME,2021). As stated by the World Health Organisation (WHO), 77% of the burden of NCDs in Europe represent 70%-80% of European healthcare costs (WHO, 2020). Additionally, data from the Food and Agriculture Organization (FAO) indicates that in Europe, at least 21% of adults suffer from them, while in Greece 1 in 5 suffer from Irritable Bowel Syndrome (IBS). The aforementioned diseases as well as Colorectal Cancer, Ulcerative Colitis and Crohn's disease, are part of gastrointestinal (GI) disorders. These disorders consist of the most prominent categories of diet-related NCDs, while many of them are reflected on the metabolic capacity of the gut microbiome, the microbial community that resides in our gastrointestinal tract, thus making it an attractive target for further interventions.
In order to create a competitive and successful toolkit capable of being established in the market, it is of vital importance to consider the opinion of experts in the field as well as crucial stakeholders, that will shape our work according to their needs. Aiming to
identify these experts we developed a stakeholders analysis. By grouping and categorizing them
according to their scientific field and their participation, helps us approach each and everyone of
them.
While developing a product, it is necessary to plan and research its strategy by identifying the
customer’s potential needs and wishes. Through a market analysis process, we were able to gather
valuable information about the targeted market, environment of it and all internal and external
factors, which directly or indirectly influence our decisions related to marketing activities. Such
factors could include an organization's strengths, weaknesses and competencies (internal) or, on the
other hand, the governmental, technological, economical, social, and competitive forces (external).
Based on the geographic segmentation, functional GI disorders affect the entire world, causing a great economic loss for every country (Canavan, West and Card, 2014). The epidemiological data shows that, at a global scale, more than 40% of people have FGIDs, which affect the quality of life and health care use. Indicatively, populations from countries, such as Spain, France, Russia, Canada and the U.S.A., have the highest prevalence of GI disorders, thus rendering our toolkit more than necessary, as it provides a platform for their detection, evaluation and amelioration, all at once.
The increasing prevalence of acute GI diseases imposes a great burden socially and economically. The total financial burden of GI disorders are estimated to be near 140 billion dollars, in the US,while for heart disease 113 billion dollars, making it one of the most “expensive” diseases worldwide. More specifically, the healthcare cost of IBD only, was estimated between 14.6 billion and 31.6 billion USD (Peery et al., 2019).
GI patients also suffer from social stigma, while they often don’t readily discuss their disease. That means that the total cost of 140 billion USD could be significantly higher, as many patients are underdiagnosed and the total cost is estimated only by patients whose medical history is known (Sandler et al., 2002).
Investments concerning Gastrointestial Dieseases
GI diseases have been increasing in incidence prevalence and severity in recent years, contributing as the main factors to the growth of the gastrointestinal therapeutics market. The increasing burden of gastrointestinal disorders in the country is also making the market more lucrative (Sperber et al., 2021).
Market players have extensively employed competition sustainability strategies such as new product development and regional and distribution channel expansion to gain a higher share in the market. The rising incidence of gastrointestinal diseases and obesity worldwide, along with the presence of key market players, are the main reasons for the increased interest in research and development on the aforementioned topics in the last decade. The growth of gastrointestinal market is U.S is prominently high (Figure 5.)(Gastrointestinal Therapeutics Market | 2021 - 26 | Industry Share, Size, Growth - Mordor Intelligence, 2021)
Investments concerning Gut Microbiome Research
From this analysis, we infer that there is a tendency for investments in research of GI disorders. Targeting the rising field of microbiome research, could be the “missing link”, as recent data show that microbiome plays a critical role in overall human health, making it the root of the problem. It is responsible for more than 75 different medical conditions, including disorders that are not related to the gastrointestinal tract. During the last 5 years, in the US, more than 1 billion dollars have been invested on microbiome research (Market, 2021).
By 2025 the human microbiome market is projected to reach 894 million USD and by 2028, 1,598 million USD (Figure.6). The Compound Annual Growth Rate (CAGR), showing the rate of return (RoR) that would be required, is estimated to be at 21.3% from 2025 till 2028. Therefore, there are a lot of opportunities in the future, for funds that could potentially be invested in our project, as a small part of microbiome research (GLOBAL HUMAN MICROBIOME MARKET FORECAST 2018-2026).
Investments concerning Probiotic Supplements
Probiotics are one of the most common medical prescriptions, when a patient is diagnosed with gastrointestinal disorders. Consumption of a probiotic supplement improves and maintains the overall gastrointestinal health by reducing harmful bacteria, supporting the relief of allergies, bloating, gas and constipation. Probiotics replenish protective bacteria and help maintain digestive functions and immune health. Prebiotics are the second most prevalent product that patients consume, which are non-viable food component that confers a health benefit by modulating the gut microbiota (FAO, 2007).
Data from the 2012 National Health Interview Survey (NHIS) stated that 1.6% of U.S. adults (3.9 million) had used prebiotics or probiotics for a certain time period. The global probiotic ingredients market size, is estimated in 2019 is nearly USD 4,500 million and the CAGR is estimated to be at 6% over the years 2019-2027 (Market Study Report, LLC,2021). Notably, the dietary supplement segment is one of the fastest growing markets amongst end use in the probiotic ingredients market. Additionally,, a growing number of consumers are looking up to companies manufacturing dietary supplements with prebiotic ingredients.
Porter's five forces model Analysis
Regulatory Framework
AMALTHEA, is our synthetic biology solution to unlock the full potential of the gut microbiome and tackle diet-related non-communicable diseases. We have divided our project into a three-layered system. First, we detect shortages in the levels of SCFAs through the usage of the “AMALTHEA” bio-electronic capsule. Then, the data is digitized and transmitted to the smartphone application “e-AMALTHEA” where a multidisciplinary team of health experts evaluates the results. Finally, if dysbiosis is in fact detected, we ameliorate it with the live-biotherapeutic synbiotic supplement “CERAS”, which produces the appropriate amount of SCFAs directly in the gut.
Presenting AMALTHEA to the Falling Walls Lab Competition
One of our biggest accomplishments during our journey as an iGEM Team, is our participation in one of the most renowned innovation and entrepreneurship competitions in Europe, called Falling Walls Lab. Falling Walls Lab, is an international forum for the new generation of innovators, pioneers, creators and visionaries. Its goal is to connect young scientists and entrepreneurs to a world-class platform that helps them drive their innovations, develop their communication skills and build relationships with each other, building a global network and a sustainable community of innovators.
During the regional competition in Greece, we had the opportunity to present AMALTHEA and won the first place which will lead us to the final of the Falling Walls Lab that will take place in Berlin on November 7th, 2021.
The innovation and entrepreneurship competition took place for the first time in Greece under the
auspices of the Greek Ministry of Development and Investment. Through our participation, our
innovative idea was presented to stakeholders and experts from a broad spectrum of specialists, in
the grounds of business and market. After our presentation we received valuable feedback from the
judges while having the honour to come in contact with Michalis Dritzas, Head of Deputy Minister of
Development and Investments in Research, Technology & Innovation, of Greece. We discussed our
project's potential to enter the real business and market world as a company.
There are many companies that have created tests for the evaluation of gut microbial communities and
their correlation with food and dietary patterns. From the multitude of products, none of them evaluate
the gut microbiome in real-time, measuring concentrations of metabolites directly in the gut with high
sensitivity and providing a most accurate clinical picture. We created our detection system, a
cutting-edge technology, that provides non-invasively real time measurements and site-specific
quantification of biomarkers. Moreover, the interconnection of our digital application gives the
opportunity to the user to come in contact with a multidisciplinary team of experts evaluating results
and giving instant feedback thus bridging the gap between experts and patients, through digital health.
Lastly, our synbiotic supplement is a personalized product that safely colonizes the patient’s gut,
maximizing the production of SCFAs in a long-term way and promoting sustainability.
In contrast with other available toolkits that collect samples from stool or blood, we chose to target the gut directly. That is because stools let us quantify only 5% of metabolites, a number not representative of gut concentrations. Moreover, such a low percentage, increases the confidence of the final value from such toolkits.Launching a new toolkit that could overcome these obstacles, we aim to meet the market’s needs for more effective and appropriate prognosis and prevention of gastrointestinal diseases.
SWOT Analysis
Making a SWOT analysis could help us identify the weakness and threats regarding our products in order to keep them under control or to convert them into strengths or opportunities.
There’s a lot to do when you’re trying to get your business off the ground.To make sure that our
project unfolds as expected, we need to take good care of these foundations.
We created two separate timelines, one for our capsule and one for our synbiotic supplement, with the main actions that have to be taken for our business to grow.
Following the iGEM competition, we hope to continue transforming our project into end-products and even our own start-up. To have a better understanding of the legal environment in Greece and what we'll need to launch our own company, as well as the end-goals of Synthetic Biology initiatives. A second meeting with the Epsilon Health Board of Directors in the presence of our PIs has already been planned and scheduled to see and plan our next steps for a bigger collaboration. In addition, following discussions with our PIs, we've scheduled a meeting with Effimia Panagiotidou, a legal advisor with the University of Thessaly's Research Committee Technology Transfer Office, who will advise us further on what is required to move forward with an intellectual property application on AMALTHEA.
Figure 1: Poor diet causes more deaths than any other risk factor (IHME,2021).
Unhealthy diets pose a great risk of morbidity and mortality, accounting for over 10.9 million deaths, or 22% of all deaths among adults in 2017, according to theInstitute for Health Metrics and Evaluation (IHME) (IHME,2021). As stated by the World Health Organisation (WHO), 77% of the burden of NCDs in Europe represent 70%-80% of European healthcare costs (WHO, 2020). Additionally, data from the Food and Agriculture Organization (FAO) indicates that in Europe, at least 21% of adults suffer from them, while in Greece 1 in 5 suffer from Irritable Bowel Syndrome (IBS). The aforementioned diseases as well as Colorectal Cancer, Ulcerative Colitis and Crohn's disease, are part of gastrointestinal (GI) disorders. These disorders consist of the most prominent categories of diet-related NCDs, while many of them are reflected on the metabolic capacity of the gut microbiome, the microbial community that resides in our gastrointestinal tract, thus making it an attractive target for further interventions.
It is worth noting that up until this day, we lack a complete toolkit that enables the holistic and
sustainable approach for the detection, amelioration and evaluation of the gut microbiome’s health status.
Stakeholders Analysis
Figure 2: Interest/Power stakeholders analysis for our capsule AMALTHEA.
Figure 3: Interest/Power stakeholders analysis for our probiotic CERAS.
Market Analysis
Based on the geographic segmentation, functional GI disorders affect the entire world, causing a great economic loss for every country (Canavan, West and Card, 2014). The epidemiological data shows that, at a global scale, more than 40% of people have FGIDs, which affect the quality of life and health care use. Indicatively, populations from countries, such as Spain, France, Russia, Canada and the U.S.A., have the highest prevalence of GI disorders, thus rendering our toolkit more than necessary, as it provides a platform for their detection, evaluation and amelioration, all at once.
Figure 4: Global maps showing study countries color-coded for prevalence of having any functional GI disorders.
The increasing prevalence of acute GI diseases imposes a great burden socially and economically. The total financial burden of GI disorders are estimated to be near 140 billion dollars, in the US,while for heart disease 113 billion dollars, making it one of the most “expensive” diseases worldwide. More specifically, the healthcare cost of IBD only, was estimated between 14.6 billion and 31.6 billion USD (Peery et al., 2019).
GI patients also suffer from social stigma, while they often don’t readily discuss their disease. That means that the total cost of 140 billion USD could be significantly higher, as many patients are underdiagnosed and the total cost is estimated only by patients whose medical history is known (Sandler et al., 2002).
Figure 5: Annual healthcare cost in the U.S for several diseases.
Investments concerning Gastrointestial Dieseases
GI diseases have been increasing in incidence prevalence and severity in recent years, contributing as the main factors to the growth of the gastrointestinal therapeutics market. The increasing burden of gastrointestinal disorders in the country is also making the market more lucrative (Sperber et al., 2021).
Market players have extensively employed competition sustainability strategies such as new product development and regional and distribution channel expansion to gain a higher share in the market. The rising incidence of gastrointestinal diseases and obesity worldwide, along with the presence of key market players, are the main reasons for the increased interest in research and development on the aforementioned topics in the last decade. The growth of gastrointestinal market is U.S is prominently high (Figure 5.)(Gastrointestinal Therapeutics Market | 2021 - 26 | Industry Share, Size, Growth - Mordor Intelligence, 2021)
Figure 6: Gross R&D about GI disorders.
Investments concerning Gut Microbiome Research
From this analysis, we infer that there is a tendency for investments in research of GI disorders. Targeting the rising field of microbiome research, could be the “missing link”, as recent data show that microbiome plays a critical role in overall human health, making it the root of the problem. It is responsible for more than 75 different medical conditions, including disorders that are not related to the gastrointestinal tract. During the last 5 years, in the US, more than 1 billion dollars have been invested on microbiome research (Market, 2021).
Figure 7: Investment on Microbiome Research , in U.S.(Market, 2021)
By 2025 the human microbiome market is projected to reach 894 million USD and by 2028, 1,598 million USD (Figure.6). The Compound Annual Growth Rate (CAGR), showing the rate of return (RoR) that would be required, is estimated to be at 21.3% from 2025 till 2028. Therefore, there are a lot of opportunities in the future, for funds that could potentially be invested in our project, as a small part of microbiome research (GLOBAL HUMAN MICROBIOME MARKET FORECAST 2018-2026).
Investments concerning Probiotic Supplements
Probiotics are one of the most common medical prescriptions, when a patient is diagnosed with gastrointestinal disorders. Consumption of a probiotic supplement improves and maintains the overall gastrointestinal health by reducing harmful bacteria, supporting the relief of allergies, bloating, gas and constipation. Probiotics replenish protective bacteria and help maintain digestive functions and immune health. Prebiotics are the second most prevalent product that patients consume, which are non-viable food component that confers a health benefit by modulating the gut microbiota (FAO, 2007).
Data from the 2012 National Health Interview Survey (NHIS) stated that 1.6% of U.S. adults (3.9 million) had used prebiotics or probiotics for a certain time period. The global probiotic ingredients market size, is estimated in 2019 is nearly USD 4,500 million and the CAGR is estimated to be at 6% over the years 2019-2027 (Market Study Report, LLC,2021). Notably, the dietary supplement segment is one of the fastest growing markets amongst end use in the probiotic ingredients market. Additionally,, a growing number of consumers are looking up to companies manufacturing dietary supplements with prebiotic ingredients.
Figure 8: Probiotic Market in 2019-till now.(Global probiotic supplement market size to witness remunerative growth through 2026)
Porter's five forces model Analysis
Figure 9: Porter's five forces Analysis for the evaluation of the market
Regulatory Framework
Capsule
To bring a medical device to market for commercial use, strict evaluation is required. Our product should comply with the general requirements set out in
the EU Medical Device Regulation (MDR) and FDA's Device Regulation . The main
requirements are:
In order for any firm to manufacture, repackage, relabel and/or import medical devices sold in the U.S., should abide under the regulation guides of the FDA’s Center for Devices and Radiological Health (CDRH) (Overview for Device Regulation,FDA,2020).
Medical devices are classified into three different Classes: I, II, and III, which have increasing regulatory requirements from I to III (Classification Of Medical Devices And Their Routes To CE Marking, 2020). The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
Through our discussion with Dr. Koutsioulis Dimitrios, Chief Executive Officer at Enzyquest, we concluded on the classification of our proposed device, which falls under the Class IIa medical devices. These devices pose medium risk for the user's health and their main characteristic is that after administration/installation, they stay in the body for only between 60 minutes to 30 days. The regulations regarding Class IIa medical devices require manufacturers to fulfill certain additional requirements:
- General compliance with the MDR regulation,
- Establishment, documentation, implementation and maintenance of a system for risk management,
- Clinical evaluation (according to MDR),
- Establishment and updating of the device's technical documentation,
- Establishment of a post-market surveillance system,
- Establishment of a quality management system,
- Acquiring an EU Declaration of Conformity.
In order for any firm to manufacture, repackage, relabel and/or import medical devices sold in the U.S., should abide under the regulation guides of the FDA’s Center for Devices and Radiological Health (CDRH) (Overview for Device Regulation,FDA,2020).
Medical devices are classified into three different Classes: I, II, and III, which have increasing regulatory requirements from I to III (Classification Of Medical Devices And Their Routes To CE Marking, 2020). The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
- Establishment registration,
- Medical Device Listing,
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
- Investigational Device Exemption (IDE) for clinical studies,
- Quality System (QS) regulation,
- Labeling requirements, and
- Medical Device Reporting (MDR)
Through our discussion with Dr. Koutsioulis Dimitrios, Chief Executive Officer at Enzyquest, we concluded on the classification of our proposed device, which falls under the Class IIa medical devices. These devices pose medium risk for the user's health and their main characteristic is that after administration/installation, they stay in the body for only between 60 minutes to 30 days. The regulations regarding Class IIa medical devices require manufacturers to fulfill certain additional requirements:
- technical documentation: includes elements such as the device description and specification, information supplied to the user, and pre-clinical and clinical data
- periodic safety update report (PSUR): a summary of the results and conclusions from the analysis of post-market surveillance data, gathered according to the post-market surveillance plan
- a quality management system (QMS): a description of all the elements related to the manufacturer's quality of processes, procedures and devices
- information to be supplied with the device: manufacturers of Class IIa medical devices need to provide instructions of use with the device to ensure safe use of the devices
For more information regarding the user and physician guides visit our Implementation Page.
Probiotic
Before scaling probiotic production and incorporating it in sterilized yoghurt for commercial launch, strict evaluation is required. To-date, there is no EU-wide legal framework defining probiotic bacteria or the food category “probiotics”.
Our probiotic supplement contains live organisms and is intended to prevent GI diseases and
ameliorate their respective symptoms, therefore it is regulated. The U.S. Food and Drug
Administration’s Center for Biologics Evaluation and Research, requires an Investigational
New Drug application to pursue clinical studies in order to go in the production line. (Federal Food, Drug, and Cosmetic Act. , US Code title 21, 2007). This
application has to contain the following:
If a probiotic meets the definition of a dietary supplement, the manufacturer may place the probiotic product on the market without premarket approval and may market the product with claims concerning the effect that the product has on the structure or function of the body.
If a probiotic falls within the definition of a “drug” and is not Generally Recognized As Safe (GRAS) and Generally Recognized As Effective (GRAE), then the probiotic also falls within the definition of a “new drug” and, accordingly, is subject not only to rigid premarket clearance requirements but also to the testing requirements of the Investigational New Drug application, with regard to clinical studies. These requirements include the steps showcased in Figure 10.
- Formal notification of the FDA about the intent to conduct clinical studies
- Submission to the FDA of comprehensive test protocols
- Development of an investigation plan
- Institutional review board oversight
If a probiotic meets the definition of a dietary supplement, the manufacturer may place the probiotic product on the market without premarket approval and may market the product with claims concerning the effect that the product has on the structure or function of the body.
If a probiotic falls within the definition of a “drug” and is not Generally Recognized As Safe (GRAS) and Generally Recognized As Effective (GRAE), then the probiotic also falls within the definition of a “new drug” and, accordingly, is subject not only to rigid premarket clearance requirements but also to the testing requirements of the Investigational New Drug application, with regard to clinical studies. These requirements include the steps showcased in Figure 10.
Figure 10: Regulation for probiotic products (ISAPP-2019).
Our solution
Figure 11: AMALTHEA - a prevention toolkit for evaluating gut microbiome.
AMALTHEA, is our synthetic biology solution to unlock the full potential of the gut microbiome and tackle diet-related non-communicable diseases. We have divided our project into a three-layered system. First, we detect shortages in the levels of SCFAs through the usage of the “AMALTHEA” bio-electronic capsule. Then, the data is digitized and transmitted to the smartphone application “e-AMALTHEA” where a multidisciplinary team of health experts evaluates the results. Finally, if dysbiosis is in fact detected, we ameliorate it with the live-biotherapeutic synbiotic supplement “CERAS”, which produces the appropriate amount of SCFAs directly in the gut.
AMALTHEA aims to hold the rising threat of diet-related non-communicable diseases by
providing a prevention toolkit to strengthen the health of the gut microbiome, ensuring
health and well-beign of citizens all around the world.
Figure 12: AMALTHEA- Project Outline.
Presenting AMALTHEA to the Falling Walls Lab Competition
Figure 13:Presenting AMALTHEA at the Falling Walls Lab Greece Competition
One of our biggest accomplishments during our journey as an iGEM Team, is our participation in one of the most renowned innovation and entrepreneurship competitions in Europe, called Falling Walls Lab. Falling Walls Lab, is an international forum for the new generation of innovators, pioneers, creators and visionaries. Its goal is to connect young scientists and entrepreneurs to a world-class platform that helps them drive their innovations, develop their communication skills and build relationships with each other, building a global network and a sustainable community of innovators.
During the regional competition in Greece, we had the opportunity to present AMALTHEA and won the first place which will lead us to the final of the Falling Walls Lab that will take place in Berlin on November 7th, 2021.
Figure 14:Meeting Michalis Dritzas, Head of Deputy Minister of Development and Investments in Research
Figure 15:AMALTHEA-The first winner of Falling Walls Lab Greece with the judges.
Our Road to Berlin
After our victory in the Greek Final we will participate in the international final, in Berlin,
among all the other fellow winners, from across the globe. In the big final we will come in contact
with institution leaders, decision makers and representatives from Venture capitals, like Eudemian,
letting us build our network and interact with one of the key players in the field. The perspective of
Eudemian is “to support the world’s boldest, turn the impossible into inevitable.” (~Eudemian official
website)
Furthermore, during our preparation for the big final, a two-hour interactive group coaching session with INNOKI,
will take place. During coaching session, INNOKI will give advice on
how to effectively pitch our innovative idea on stage. INNOKI is one of the biggest innovation
consultancies based in Berlin and Göttingen. Additionally, receiving feedback on our pitch will help
us improve our proposal presentation.
Learning how to prepare our Entrepreneurship Plan
As an iGEM team , it is very important to implement our project to the real world. Since none of us had any business, marketing or entrepreneurship background, it was necessary for us to learn how we can develop our project idea into a real project. The first step to achieve that was to participate in the Summer Bootcamp organized by iGEM EPIC.
In this 3-week Summer Bootcamp we participated in a number of activities and interesting talks surrounding topics like business management , learning how to pitch and developing our own entrepreneurship plan.
Learning how to prepare our Entrepreneurship Plan
Figure 16: Certification of attending the Summer Bootcamp organized by iGEM EPIC.
As an iGEM team , it is very important to implement our project to the real world. Since none of us had any business, marketing or entrepreneurship background, it was necessary for us to learn how we can develop our project idea into a real project. The first step to achieve that was to participate in the Summer Bootcamp organized by iGEM EPIC.
In this 3-week Summer Bootcamp we participated in a number of activities and interesting talks surrounding topics like business management , learning how to pitch and developing our own entrepreneurship plan.
Figure 17:Material from the 3-week Summer Bootcamp organized by iGEM Epic.
Figure 18: The program from the 3-week SummerBoot Camp organized by iGEM Epic.
Competitors
In contrast with other available toolkits that collect samples from stool or blood, we chose to target the gut directly. That is because stools let us quantify only 5% of metabolites, a number not representative of gut concentrations. Moreover, such a low percentage, increases the confidence of the final value from such toolkits.Launching a new toolkit that could overcome these obstacles, we aim to meet the market’s needs for more effective and appropriate prognosis and prevention of gastrointestinal diseases.
Figure 19:Our competitors in the field of evaluating the capacities of gut (Nutricare Life~ Official site).
Business Plan
Value Proposition Canvas
The Value Proposition Canvas helped us summarize all the critical details about our products. Moreover, we have focused and made a detailed look at the relationship between customers segments and value proposition. We focused on features, functionality, and benefits that our product can offer to users, by meeting their requirements from the right part. We created a toolkit in order to provide a holistic approach to evaluate gut microbiome and improving its capacity, leading to prevention of gastrointestinal diseases.
Business Model Canvas
The Business Model Canvas (BMC) is a business tool that we used in order to visualize and easily define our business idea. All the fundamental elements of starting a business are represented within the distinct blocks. The blocks on the BMC are focused on the customer, route to production and market, value proposition and general aspects of business. Creating an accurate BMC helps us take into consideration every step we need to take.
The Value Proposition Canvas helped us summarize all the critical details about our products. Moreover, we have focused and made a detailed look at the relationship between customers segments and value proposition. We focused on features, functionality, and benefits that our product can offer to users, by meeting their requirements from the right part. We created a toolkit in order to provide a holistic approach to evaluate gut microbiome and improving its capacity, leading to prevention of gastrointestinal diseases.
Figure 20: Value Proposition Canvas for our toolkit, product-related section.
Figure 21: Value Proposition Canvas for our toolkit, customer profile.
Business Model Canvas
The Business Model Canvas (BMC) is a business tool that we used in order to visualize and easily define our business idea. All the fundamental elements of starting a business are represented within the distinct blocks. The blocks on the BMC are focused on the customer, route to production and market, value proposition and general aspects of business. Creating an accurate BMC helps us take into consideration every step we need to take.
Figure 22: Business Model Canvas for our toolkit
SWOT Analysis
Making a SWOT analysis could help us identify the weakness and threats regarding our products in order to keep them under control or to convert them into strengths or opportunities.
Figure 23: SWOT Analysis for our toolkit.
PEST analysis
Figure 24: PEST Analysis, for our toolkit.
B2B Perspective
The endpoint of Synthetic Biology is industrialisation. Although as a iGEM project we serve the
fundamental scientific discipline such as synthetic genomics, engineering and molecular biology, it
is also important to integrate it to the market. Thus, we aimed to build bridges with the industry and
relevant stakeholders, such as pharmaceutical and probiotic companies to properly access our place in
the market and strategize our next moves for introducing AMALTHEA to the industry sector.
Figure 25: Meeting with EnzyQuest and presenting our project.
Our first engagement with the entrepreneurial world was with CEO of Enzyquest,
Dimitris Koutsioulis, and his colleague Anna Makri. After we presented our
project idea, they instructed us to check the legislative condition in the EU,
brainstorm around the addition of our project under the spectrum of the point
of care products. Moreover, they strongly suggested a summary business plan,
something necessary for the evolution of our project and our ideas.
Figure 26: Meeting with Pfizer Hellas , presenting our project.
Pfizer Hellas honoured our efforts by funding this year's journey to the iGEM competition. Being a pharmaceutical
company, we believed that their expertise would help us, not only in shaping our project’s core but also give us
important feedback for product development under real-world settings. Karamanou Vasso, the company’s Head of
Corporate Social Responsibility affirmed that personalized prevention toolkits are a rising tendency in Western
Society, making our project easily competitive and effective in the healthcare industry. Overall, they were
optimistic of our project’s applicability and impact in everyday life.
Figure 27: Meeting with Novartis , presenting our project.
Novartis is one of the leading pharmaceutical companies in Greece. Being a sponsor of Falling Walls Lab Greece,
they congratulated us on our victory, noting the importance of cutting-edge technologies like AMALTHEA being
implemented in the Greek Society.
Figure 28: Meeting with Epsilon Health , presenting our project.
To effectively launch our probiotic supplement into the market, we reached out to Epsilon Health, one
of the key probiotic-producing companies in Greece. Nestora Vlachos, the company’s CEO instructed us
to evaluate current legislation on the development of engineered probiotic strains as well as ensuring
the strain’s safety for market release.
Figure 29: Meeting with Olympos , presenting our project.
As our goal is to implement CERAS to a well accepted and traditionally friendly food in Greek Society,
we met with TYRAS A.E., the biggest dairy industry in Greece. After we laid out our project idea, we
spoke with Athanasios Athanasoulas, Head of Research and Development. He briefly presented to us what
it takes financially to launch a probiotic dairy product and discussed the probability of CERAS being
produced and deployed.
Figure 30:Meeting with Superfood, presenting our project.
Superfood is a fellow probiotic producing company. Our team members got the chance to meet with
representatives of the company to discuss laboratory production, industry capabilities in the Greek
Area and several concerns over CERAS.
Funding
When starting your own company it is crucial to secure funding. In order to have a stable future in
the business world, we have to create a funding strategy to ensure a constant influx of funds. A
combination of funding strategies will help us create a comprehensive approach.
First and foremost, our project AMALTHEA is nominated for the cash prize of Falling Walls Lab Finale, as we are going to present our project to the global Finale in Berlin on the 7th of November, where the international Lab winners get to interact and network with the world’s movers and shakers of science, business, and policy-making.
Our first step into the industry would need to rely on funding from organizations and research centers. Microbiome research is a rising field of interest and recent data shows that microbiome plays a critical role in overall human health. More specifically, as stated by the Food & Agriculture Organization, the gut microbiome is the missing link to tackle diet-related NCDs (FAO report). In an era where research surrounding the microbiome is finally an attractive funding target, from global or local organizations, we opt to follow the necessary process to submit our scientific proposal to the Microbiome Foundation. One of the main projects of the Microbiome Foundation is to provide funding to medical research on the gut microbiota in connection with digestive and metabolic diseases and projects with strong nutritional components. For that reason we believe that we would be ideal candidates for application.
Following that, funding provided by the University (Research Committee of University of Thessaly) could help us start our own start-up. After creating the prototype and improving our final proposal, our start-up would be attractive to Angel Investors to support and carry the company through its difficult early stages.
First and foremost, our project AMALTHEA is nominated for the cash prize of Falling Walls Lab Finale, as we are going to present our project to the global Finale in Berlin on the 7th of November, where the international Lab winners get to interact and network with the world’s movers and shakers of science, business, and policy-making.
Our first step into the industry would need to rely on funding from organizations and research centers. Microbiome research is a rising field of interest and recent data shows that microbiome plays a critical role in overall human health. More specifically, as stated by the Food & Agriculture Organization, the gut microbiome is the missing link to tackle diet-related NCDs (FAO report). In an era where research surrounding the microbiome is finally an attractive funding target, from global or local organizations, we opt to follow the necessary process to submit our scientific proposal to the Microbiome Foundation. One of the main projects of the Microbiome Foundation is to provide funding to medical research on the gut microbiota in connection with digestive and metabolic diseases and projects with strong nutritional components. For that reason we believe that we would be ideal candidates for application.
Following that, funding provided by the University (Research Committee of University of Thessaly) could help us start our own start-up. After creating the prototype and improving our final proposal, our start-up would be attractive to Angel Investors to support and carry the company through its difficult early stages.
Figure 31: Fundraising strategy for our project.
Timeline
We created two separate timelines, one for our capsule and one for our synbiotic supplement, with the main actions that have to be taken for our business to grow.
Figure 32: Capsule’s timeline by using the Gantt chart.
Figure 33:Synbiotic supplement’s timeline by using the Gantt chart.
Future vision
Following the iGEM competition, we hope to continue transforming our project into end-products and even our own start-up. To have a better understanding of the legal environment in Greece and what we'll need to launch our own company, as well as the end-goals of Synthetic Biology initiatives. A second meeting with the Epsilon Health Board of Directors in the presence of our PIs has already been planned and scheduled to see and plan our next steps for a bigger collaboration. In addition, following discussions with our PIs, we've scheduled a meeting with Effimia Panagiotidou, a legal advisor with the University of Thessaly's Research Committee Technology Transfer Office, who will advise us further on what is required to move forward with an intellectual property application on AMALTHEA.
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