Our partnership with iGem Dresden

Our two teams came into contact early in the iGEM competition thanks to a former iGEM member who had been on the Goettingen team back in 2018, who’s younger sibling was on this year's TU Dresden iGEM team. We had our first meeting back in May to discuss our cloning strategies. Rather serendipitously one of the TU Dresden team members had come into contact with a representative from the Life Science Factory the month prior. The Life Science Factory (LSF) is a start-up incubator geared towards the Life Sciences conveniently located in Göttingen. We then organized a joint tour of the LSF with members from Team Göttingen and Team Dresden.

It was at this meeting that we got to once more discuss our respective projects and our experiences in interacting with sponsors and industry stakeholders. Additionally, Team Dresden visited Team Goettingen’s lab space and thereby received a more detailed description of their project. Furthermore, we both attended the Junior Jam hosted by iGEM Münster where we attended a seminar and discussion session on launching start-ups. We kept in touch over the final months of the competition and revisited our discussion on entrepreneurship. While neither of our teams were able to bring our projects to the point of patenting or launching a product, we both had substantial interaction with industry stakeholders. As a result, we decided to collaborate in producing a start-up guide for iGEM-teams that could highlight the key questions to ask oneself when starting out. This final guide also includes our team-specific takeaways from each point, from early conceptualization to potential implementation.

Risks → No success without risks

Founding a start-up brings risk with it. One could lose all the invested money when the start-up is not successful. This could occur because no one is interested in the product or also when other big companies influence the market so that the start-up has no chance of further releasing products. Additionally, when the start-up fails it is harder to get the old job back. Depending on how long ago your last job was, there are probably fewer opportunities to find such a job again.

Sacrifices

When one establishes a start-up he or she has to invest a lot of free time into the start-up, this includes the foundation, product development and marketing. Furthermore, one must solve every issue and is responsible for logistics, therefore spending less or no time in the laboratory.

Market viability → Thinking like a scientist vs. entrepreneur

The products invented need to be suitable for the market and must be simple for application. Some ideas may sound reasonable at first but after talking with some other experts or customers it becomes clear that some ideas will not work or are too complicated. Before designing a product, one should consider interacting with people from other areas to design a valuable product.

Costs & materials

One should consider, before founding a start-up, what materials and equipment one needs and if it is possible with the prospects one has. Furthermore, an overview of costs for the start-up should be calculated in advance.

All in all, a good starting point is to fill out a so-called Business Model Canvas. This is a sheet that asks for the most important points to consider when starting a business. You can find various forms online. These include, for example: Value proposition, customer segments or cost structure. However, we would like to give you a quick overview of the most important aspects. So take a look at the following Start up guide.

Identify the Problem

To found a start-up it is necessary to identify the problem and for whom you are solving it for. Here, the following steps can help to identify the problem. Firstly, an understanding of occurring symptoms typically helps you to find the problems they were caused by and are probably worth solving. Hereby, try to identify problems you faced during your day, why they exist and what can be done to solve them. It is necessary to clearly define the problem before thinking of any solutions, this helps to dissolve one's unconscious bias towards the solution.

Literature Review (Determine Novelty) and propose a product

Novelty plays a significant role for innovation but is not the crucial factor for success, some ideas are turned down because it's already done somewhere else and some ideas are unique but have no potential. In general, the novelty of a solution needs to be scaled to identify the level of newness to the market or industry. Solutions often include many ideas, some of them are known and others not. These solutions can be divided into 4 categories: new to the world, new to the industry or market, new to the company and new to the product.

To propose a product, one should first review literature to understand the problem and know solutions that had already been proposed. Furthermore, you should interact with customers to get their feedback on their experience with the problem, if the solution is what they are searching for and identify the target customer. Accordingly, you can create a solution based on the customer’s needs and thereby increase the chance to build something that people need and are willing to pay for.

What is Intellectual property and do I have it?

Intellectual property is described as something that is created in one’s mind, these include inventions, designs or literary and artistic works. Hence, one owns intellectual property for creations of his or her own and when one bought intellectual property rights from the creator or previous owner. In science ownership is related to three things: who did the work, where the work took place and who paid for it. Was the invention done in an independent lab and paid by an individual person, then the person owns it. Furthermore, intellectual property is not always related to one person, it can also have more than one owner or businesses and can be sold or transferred. Intellectual property protection is therefore important that it cannot be stolen or copied by others. Some of those protections are automatic while others must be applied for.

Identifying customers or customer needs

A product is designed for the needs of a customer, therefore the identification of the needs of these customers is a pivotal task in the start-up process. Only if there are really customers waiting for the solution to their problem, there is a market for new products and technologies. It is important to keep in mind from the very beginning what is expected from such a new innovation, so that it can be developed precisely with this in mind. Otherwise, there is a risk of developing something that does not satisfy the needs of the actual target group.

Find support (LSF and sponsors)

Without support, the best idea will fail. Therefore, from the very beginning, it is important to seek contact with potential sponsors and experts in the field.

Without financial resources, nothing can get off the ground. But finding funders can be difficult, as we in iGEM also had to learn. Therefore, it is best to follow these tips: inquire early, preferably contact companies that are active in a similar subject area, ask contacts from your own environment (they may be able to provide further contacts), do not be shy and do not get discouraged if many contacts refuse, do not only write by email, but if possible also call (this is often the way to get to the people in charge), provide all important information about the project.

Experts are important because they bring with them the necessary experience that one still lacks when starting up. They can potentially save the project a lot of time by providing valuable insider tips.

Prototyping and initial testing

In many cases a proof of concept or POC represents a large hurdle in early development but offers an immense benefit in its ability to reassure investors and build confidence in the end product. Moreover, the production of working prototypes is important to spotting weak points in the existing design and methods. However, a valid POC should consist in more than just an in vitro assay confirming a drug target but should ideally encompass all aspects of productions, including regulatory considerations. It is therefore not only about proving whether a proposed solution will work, but also how it can be approved, produced, and applied. While many of these aspects go beyond the scope of an iGEM project it is still useful to take them into consideration. However, effort should be focused on developing a proper prototype that allows for assessment of one's guiding hypothesis and can be used to produce preliminary data. Depending on the context of one’s project the details needed for a proof of concept may vary, for example a project set in a clinical context will require more rigorous testing and data collection compared to projects involving software and non-medical applications.

Scale up

When moving away from establishing your project and its scientific validity it comes time to shift your mindset away from that of a scientist. Preparing for a market transition requires resources that go far beyond your small scale lab setup. Firstly, it is important to consider whether your chosen methods and products are even viable at a consumer scale. This often serves as a choke point for many start-up ideas, moreover lab space is costly and hard to come by. Solutions to these setbacks are highly individual, some may opt to outsource production and R&D research while others may make in house accommodations or opt for hybrid scale up strategies. This represents a particularly turbulent time for many early start-ups, especially those beginning as university spin offs which could previously rely on a degree of university support for lab spaces and devices. A popular alternative is the use of Contract Research Organization (CRO), which often provide clinical trial services, thus allowing companies to avoid the time and resource expenditure in onboarding additional personnel. Again the best strategy often depends on the specific application.

Regulatory Approval

Regulatory considerations should be involved in the project planning from the beginning to optimize for success. This is a frequent blockade for GMO eager iGEM teams who may develop a project with sound science but its endpoint application is not permitted. Any synbio product, be it drug development, medical devices, or agricultural products require a strenuous regulatory approval process, often by the FDA (US) or EMA (Europe) and frequently both. Quality control is one aspect of this regulation, while most early-stage start-ups don't have a fully established quality control department, they should still practice proper documentation and adherence to industry standards. For biologics and drug research intended for human use and Investigational New Drug Application (IND) is needed which requires supporting animal studies following good laboratory practices (GLP). Such GLP or GMP lab work is typically outsourced. Many academic founders typically get bogged down in proving their science and disregard the regulatory hurdles along the way. A solid piece of advice is to lay out a regulatory roadmap already in the early stages of proposing a business model.

Product to Market

Market success is determined long before a product reaches the actual market. Early market research and customer identification should be an integral part of the early business plan. In general it is a good guideline to develop your final product around the market needs rather than the pure scientific merit. When approaching the market one needs a concrete marketing-plan, this is often overlooked by founders who often falsely believe that the science will speak for itself. Early market research is also essential for success at this stage. One should be able to answer these simple questions: what is the total market size, what will be the responsiveness to your product, what is the competition, how much room is there for growth?

Given the variability of focus areas within the broad spectrum of synbio bio research it is important to consider the specifics of your team's niche, i.e the impact of stakeholders and regulatory institutions to consider may vary greatly.

In the following, we briefly describe how we, the iGEM teams Dresden and Göttingen, address the aspects described above:

Sources

Cite Lean business canvas paper: Include figure 1:
https://reader.elsevier.com/reader/sd/pii/S0024630119303887?token=3CAFEBBBCDDD0CB25289C32A5DA244954506AFE418F389B79E945A3051F692714A66F3F18720774B6FFF6E412CB3CB5D&originRegion=eu-west-1&originCreation=20221004153341

Here is a very detailed text: https://www.ctsi.ucla.edu/researcher-resources/files/view/docs/EGBS4_Kolchinsky.pdf