Introduction
Throughout our project, we always considered the possibility of expanding beyond the scope of iGEM and commercialize our technology in the case where a market need develops around our technology.
Hopefully, after talking with different experts in the field of cancer therapy, management, and entrepreneurship, we found a serious unmet medical need that we can address through the technology that we have developed during our iGEM
project.
In the era dominated by “one-size-fits-all drugs”, stratified treatment has been perceived as a synonym for personalized medicine. However, this is not true!
The niche that we are targeting with our project is personalized medicine, and within this market niche the main problems that we are going to tackle are:
- Reducing the overall timeline for GMP to 2-3 weeks. The overall time needed for good manufacturing practice (GMP), from the start of processing of the patient’s sample for mutation discovery to vaccine release for administration, is about 3 to 4 months (Sahin et al., 2018) .
- Providing a non-invasive and easy-to-use tool for doctors to evaluate treatment response on specific tumor cell types.
Market Analysis
Cancer is the second most common cause of death in the United States, according to American Cancer Society. The economic costs that are associated with only melanoma treatment is $3.3 billion annually in the U.S. alone
(Guy GP et al., 2015)
.
Every year 300,000 people are diagnosed with melanoma within Europe and the U.S.( Forsea, Ana-Mariaet al., 2012 and Siegel RL et
al., 2017) According to standard guidelines, each patient is recommended to take regular follow-up tests for relapse each 2-6 months, depending on
the patient’s condition.
Considering that amounts to a maximum of 6 tests annually per patient and the fact that each patient usually needs 10 years of follow-up, we can expect 12,000,000 tests per year that are necessary for melanoma follow-up. Considering
the regular follow-up costs, we can expect a total market of $3 billion in this market niche that we have targeted. (Alexandrescu, Doru Traian., 2009).
The therapeutic side of our project, on the other hand, has much narrower market but more monetary valuable.
According to Grand View Research Inc, trends indicates that U.S. market alone will have a total market size of over $12.4 billion by 2025 in melanoma therapeutics (Grand View Research
Inc., 2017) . Currently this market in mainly protected by patents, however it
indicates the potential market size for the therapeutic products in melanoma.
We combined the rest of the market analysis in the “Porter’s Five-force” section to further look at competition and market entry barriers
Strategic Analysis : Porter's 5-Forces
We analyse the competitive environment of cancer therapeutic industry, specifically personalized vaccine, using Porter’s Five-Forces.
This framework consists of 5 main elements (or forces) that will shape the competition within each industry. This could then explain how much a firm could expect to profit in a given industry and overall industry attractiveness.
Threat of New Entrants :
There are high initial investments and fixed costs that are necessary for an entrant to enter this industry. This is mainly because of the development costs of new treatments, having a strong patent, and finally passing clinical trials to get approval for new drugs selling. Time-wise, the process of developing new drugs and getting necessary approvals takes, for the most part, years to reach a point that can be offered to the market.
Threat of Substitutes :
This is the most critical force in this industry. In the field of personalized cancer therapeutics for melanoma, there are many other substitute therapies, namely targeted therapy, radiotherapy, and chemotherapy.
Moreover, within the immunotherapy field, there are a number of alternative drugs to personalized vaccine, including PD-1/ L1 checkpoint inhibitors(Mahoney et al., 2015)
.
The main promise of personalized cancer vaccines is that they can increase the 5-year survival rate in patients with advanced melanoma while keeping toxicity low. Thus, oncologists will tend to use these drugs in the case that
their effects were safety approved.
Moreover, what we are offering is not only a treatment, rather a combination of treatments with monitoring which enables oncologists to react faster and increase the chance of patients to survive.
Bargaining Power of Buyers :
In this industry, buyers, who are patients, mainly do not possess high bargaining power. Despite that, in almost all cases insurance companies ( the ones who would pay back the treatments costs) have high bargaining power, especially for new treatments that are not being used widely. This could impose a high threat towards our future profitability.
Bargaining Power of Suppliers:
Our suppliers will be big biotech companies with medical grade. They are big companies and will have some bargaining power at some extent. However, since there is still competition between those suppliers at some degree, the bargaining power of suppliers could be lower than what we can expect in the case of monopoly.
Industry Rivalry:
The degree of competition in the cancer therapeutic industry is really high (Grand View Research Inc., 2017). There are many big players in this field, which can squeeze out any new entrants. The competition is fierce, even between those big players. Although, patents made it possible for the firms in this industry to enjoy working in a tight appropriability regime, there are many anticancer drugs that are currently being produced and are provided by big companies, e.g. Novartis, Roche, Amgen, and Sanofi. This means that succeeding in this industry requires a lot of investment in the supporting activities on top of primary activities, including marketing, to be able to survive in this industry.
In conclusion, the threat of substitutes for our products is expected to be manageable regarding the superior treatment outcomes and lower costs that our technology could bring to this field. There is not a high threat of new entries into this market, which ensure protecting our market after entry, while also making it really hard for us to enter this market. The bargaining power of buyers could be substantial, especially in some countries with special insurance programs. In addition, the bargaining power of suppliers could hurt our profitability in future, which can reduce it by vertically integrating towards our supplier for few key products and reduce this force. Finally, the current rivalry in the industry makes it really hard to keep up on competing with the established incumbents and this is the point which requires a good investment in supporting activities alongside our primary activities.
Market Needs
During our researches in identifying customer needs, we talked with several well-known specialists in the field of cancer therapy, Economics and Policy, and Entrepreneurship, including Prof. Dr. Olivier Michelin, Prof.
Daniel Spicer, Prof. Kenneth Oye,Marco Rüedi, Hervé Lebret, and Prof. Roger Clerc.
After initial considerations, the first step for us was identifying who is exactly our customer. After a lot of discussion and interviews, we found out, as counterintuitive as it may sound, patients are not our
customers. Although they are the ones that finally will benefit from our solution, our main customers are doctors and hospitals. This is due to the fact that patients are not the ones who decide which therapeutic approaches to
follow.
After identifying our main customer segments, we continued our findings by investigating what the market needs are. We found out that there are three main unmet needs in this market niche; melanoma therapeutics and follow-up
treatment:
- Due to the special characteristics of neoepitopes, which vary from one patient to another, developing personalized vaccines in most cases is not feasible and economically viable. Current techniques for producing neo-peptides, e.g. solid-phase peptide synthesis techniques, are very expensive and time-consuming. Another important factor is that the overall time needed for good manufacturing practice (GMP), from the start of processing the patient’s sample for mutation discovery to vaccine release for administration, is about 3 to 4 months and usually costs a lot. Since each patient may need a completely different set of peptides to be vaccinated with, this makes it a huge barrier for others to be scalable in this market.
- Monitoring patient’s response to treatment is a critical part of treatment procedure in personalized vaccine. After our interviews with different specialists in the field of personalized vaccine therapy, including Prof. Olivier Michielin, we found out that this is an important barrier for development of effective therapeutic solution. Since personalized vaccine is exclusive to each patients, there is a substantial need for monitoring patient’s response to the treatment. We put our effort to develop a non-invasive and easy-to-use tool for doctors to evaluate treatment response on specific tumor cell types.
- After successful treatment, patients should regularly be tested for disease recurrence. This requires sensitive, reliable, and non-invasive follow-up tests for patients (Dummer, R., et al., 2015). This will ensure detecting relapse in early stages, which will result in increasing patient survival rates.
SWOT Analysis
Now, for having a better look at where we stand, we will take a look at our SWOT (strengths, weaknesses, opportunities and threats) analysis, which could help us identify the weaknesses and threats to keep them under control, or even better, to convert them into the strengths or opportunities.
Strengths :
- Possibility of having an intellectual property (IP) on the technology.
- Access to the world-renowned experts as our advisors.
- Having a diverse and specialized team in the field of engineering.
- Access to various funding programs that are exclusive to EPFL students and other funding and investment opportunities in personalized vaccines which are exclusive to companies in Switzerland.
Weakness:
- Not having a standard and reliable technology.
- Primarily students team, which needs to get back to studies after iGEM competition. Thus, working exclusively on this project might not be possible for us within the next year.
- Lack of some expertise in our team, especially electrical engineers and computer scientists.
- Not having medical students/doctors as our team members.
- Unlike big pharma and biotech companies, which have access to huge pool of money and good brands, we don’t have access to them.
- We do not have a strong brand as a company in the cancer therapy field, which makes our work much harder compared to big brands in this industry.
Opportunities :
- Switzerland is becoming one of the main hubs in precision medicine (BaselArea.swiss, 2017 and Swiss Medical Weekly, 2018 ),which could bring new investment opportunities to the companies in this field and also help them grow faster by developing the ecosystem.
- Increasing funding opportunities for the field of precision medicine in Switzerland( Swiss Personalized Health Network, 2018 ) .
- Rapid growth in Synthetic biology , can make it possible for us to further improve and extend our solution in near future(Breitling et al., 2015 and McDaniel et al., 2005).
Threats :
- Regulations for protecting patients data in Switzerland and also policies for good manufacturing practices (GMP) could threat our ability not to be able to fully utilize the potential in our technology.
- There are many other promising cancer therapies and diagnostic alternatives that can make our solution non unique( Mahoney et al., 2015, Vaidya et al., 2010, Vanneman et al., 2012 and Yee et al., 2015).
Unique Value Proposition
After talking to different specialists and experts in cancer therapy and medical sector, we modified our value proposition to the field of cancer therapeutics to address two of the most important unmet medical
needs. Thus, our unique value proposition for our target market is as following:
“Providing a complete solution to patients and doctors to utilize the full potential of personalized medicine by both providing fully personalized vaccines and a monitoring system to evaluate patients’ response to treatment
faster, more reliably, and easily”.
For doing so, we envisioned the development of a platform based on cell-free expression protein systems, which can be standardized and reducing the overall timeline for producing vaccine along with good manufacturing practice
(GMP) to 2-3 weeks. The overall time needed now for good manufacturing practice (GMP), from the start of processing the patient’s sample for mutation detection to vaccine production for administration, is about 3 to 4 months
(Sahin et al., 2014).
To complete our therapeutic solution, we developed a non-invasive, sensitive, and easy-to-use tool that enables doctors to evaluate treatment response by directly measuring the progression of the remission of tumor cells.
Current methods and tools for analysing treatment responses to peptide vaccine therapy, including measuring peptide-specific CTL precursors in peripheral blood mononuclear cells (PBMCs)((Komatsu
et al., 2014)), that depend on special methods such as flow cytometry, and do not give any insights if the actual tumor is progressing or repressing, rather it is an indicator of T-cell maturation.
Steps for Commercialization of Our Technology
As we are targeting the therapeutic industry (specifically cancer therapeutics) and since entering this industry needs an intellectual property along with necessary approvals, it was not feasible for us to search
for investors in this stage of our project. Rather, we focused on early stage funding programs that could help us fill the gap between our current stage (a proof-of-concept) and fundraising stage.
For this reason, we contacted “Vice Presidency of Innovation” at EPFL to explore possible opportunities for getting early funding programs. During the meeting with Hervé Lebret, manager of Innogrants at EPFL, we first discussed
the potential of our technology and our target market. Then, we inquired the possible funding opportunities that are relevant for our stage. He took us through the funding programs at EPFL and more generally in Switzerland and
gave us some advice on how to proceed in our fundraising strategy.
Moreover, he introduced us to Marco Rüedi, MD and Innosuisse Start-Up Coach, to get mentorship and insightful advice regarding our development and commercialization strategy. Innosuisse programs, designed for ambitious
researchers, students and faculty of Swiss universities and research institutes, is a fast track and hands on entrepreneurship training taught by entrepreneurs. In our meeting with Marco , we discussed what we have done in our
project and tried to align our offering to what the market needs are. We then discussed about funding strategies and how we can proceed with filing a patent for our technology. We then agreed to continue our mentorship
relationship after iGEM competition.
For further developing our technology, we are also in the process of applying for Catalyze4Life program. Catalyze4Life is the School of Life Sciences program, which tries to fill the fundraising gap that exists in applicable
technologies in the health-care industry. For doing so, we contacted Kostas Kaloulis, manager at Catalyze4Life, to start the process of writing the proposal for getting the support, which enables us to receive initial funding,
lab space, and necessary mentorship during our technology development and preclinical phase. The result of our application will be available after 29th of October, 2018.
Throughout our discussion with those people, we found out that the most critical aspect of commercializing our technology and getting funds, is to have an intellectual property. For this reason, we also contacted the Technology
Transfer Office (TTO) of EPFL to further investigate the potential of our technology for filing a patent. We had a meeting with Mauro Lattuada, Technology Transfer Manager at EPFL, to further discuss the process of filing a
patent for the case of our technology. We decided to keep some parts of our technology confidential and avoid revealing them during the Giant Jamboree, to be able to file a patent afterwards.
Furthermore, we are in the process of applying for the IMAGINE IF! acceleration program, where we can receive tailored mentoring and access to a professional network while competing for non-dilutive funding that will allow us
to take our venture to the next level. The application round of this program has just started and we will participate in the IMAGINE IF! Event, which will happen on October 23rd, 2018.
Now, we are eagerly awaiting the iGEM competition to start our adventure towards our new venture! It would be a great opportunity to understand how other teams have ventured into start-up businesses as well as we would receive
a great amount of feedback of our projet, as it is far from over for CAPOERIA!