Team:Vilnius-Lithuania-OG/Entrepreneurship

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Entrepreneurship

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Introduction

Since the earliest stages, we have decided to explore an entrepreneurial side of our project and not only present it in the Giant Jamboree but also try to prepare it for the the market. We put an effort into clearing a market demand for our system by consulting with our sponsors and other professionals while in the same time establishing a potential customer network. Also, to protect our idea for the future implementation, we have submitted a patent application covering our solution and prepared a short guide on what the future iGEM teams should take into account in order to protect their intellectual property. Lastly, we have covered important factors and indicators that will help to turn our project into business.

Market demand

Using enzymes for compound synthesis has great advantages over chemical synthesis, such as shorter synthesis routes, reduced waste and high product yields. Moreover, enzymes are biodegradable and thus are a better alternative considering ecological aspect.

Yet, each unique enzyme takes years to develop, while the industry demand for biocatalysts is growing at a rapid pace. Numerous amino acid combinations form enzymes, but only a handful of them can transform a given substrate into the required product.

For example, after pharmaceutical company fully develops a particular drug, it takes an average of two additional years to develop the enzyme(s) that can facilitate synthesis of such molecule. And even advanced screening technologies and protein evolution cannot fully satisfy these market needs.

The enzyme industry has experienced significant growth due to the global growing demand for cleaner and greener technology, according to 2017 BCC Research. Moreover, the global market for industrial enzymes is expected to grow from nearly $5.0 billion in 2016 to $6.3 billion in 2021. Provided there is an increasing demand for enzymes in global market, it is safe to say there is also an increasing demand for protein engineering solutions. Also, the global protein engineering market is expected to reach $3.09 billion by 2025, according to a 2017 report by Grand View Research.

Our solution

Our team is ready to take the first steps into the new era of enzyme engineering. We believe we can accelerate the creation of novel enzymes immensely by:

  • Using our CAT-Seq technology to immensely advance the pace of novel catalytic biomolecule by enabling the swift exploration of sequence-function space.
  • Applying the vast sequence-function data to our developed Reaction Generative Adversarial Networks in order to accurately predict novel enzyme activities.

We have achieved the proof of concept of our project, therefore we already have a strong starting point from which can seek further research and development improvement.

With our proposed solution we can specialize in two main areas:

1. Unique enzymatic product development for a particular company. For example, this may be a fully finished and optimized single or multiple enzyme solution. After the product development is finished, customer would receive full development process information and appropriate enzyme sequences.

2. Service-type business solution. Companies which require optimization of their currently used product synthesis route or fundamental enzyme or enzymatic pathway research would have the possibility to buy this type of service from us.

Startup Competition by Agency for Science, Innovation and Technology

In spring, Agency for Science, Innovation and Technology (MITA) in Lithuania has held a startup competition called “Searching For Innovators”. We have participated in this competition with our CAT-Seq and ReactionGAN systems. Of course, at spring our project was in design stages, yet the motivation and ideas we had on how we could solve the current problems of novel biological part creation has left the judges a huge impression.

For this reason, we have Won the “Searching for Innovators” competition! The prize was a year long support in the from of active Mentoring. MITA will now help us establish a business, consult us in the topics of business strategy, finance, marketing and other.

That said, a high-technology startup that we plan to become after the iGEM competition would most benefit from accelerating in the international startup accelerators in hubs that are focused around Life Sciences and Biotechnology, and that is what we plan to do after the iGEM!

Google support

In august, Startup Lithuania announced a collaboration with the Google Cloud for Startups Program. The goal of the program is to help early-stage startups to take advantage of the cloud and get resources to quickly launch their idea on google platforms.

This was a wonderful opportunity for us as we were already using google platform to train or Generative Adversarial Networks for novel protein generation. The problem was that the training was very resource intensive and we did not have enough finances run it for a long time.

So, as the partnership between Startup Lithuania and Google has begun, we have submitted an motivational and strategic application to Startup Lithuania.

Soon after, we have received the sponsorship and were extremely happy we can accelerate our research on generative adversarial networks for unique catalytic biomolecule creation.

Protection of the Intellectual Property (IP)

As we are planning to commercialize our solution after the iGEM, we have had to carefully consider on how to protect our work throughout the iGEM year, yet still provide ourselves and other teams the full open-source iGEM experience. For this reason, we have strategized to submit a patent application on CAT-Seq system just before the biological part submission date.

There are some things we also plan to keep as a trade secret (for everything that will be developed after iGEM). For example, it would be smart to keep the connection between our experimental CAT-Seq pipeline and computational Artificial Intelligence pipeline a trade secret. That is because it would be very hard to protect it as a patent. That’s because here would be virtually no way to determine who would be using it, if it would be published as a patent. In contrast, it could be kept as a trade secret for a long time.

Right before the part submission deadline we have successfully submitted a national patent application. Writing the application was extremely challenging for us, as it was the first time for everyone. For that reason we have consulted with the IP department of our sponsors Thermo Fisher Scientific, which have helped us immensely to prepare a solid application. We plan to expand our patent application to USA and to the rest of Europe shortly after the iGEM competition ends.

A short iGEM guide on protecting IP using patents

As we have spent a large amount of time considering and planning the best ways to carefully protect our IP, while still being an active, we thought that this collected knowledge would be useful for the future iGEM teams.

1. A patent is basically a right to prevent others from manufacturing, using or selling your invention. They are very important in biotechnology industry as it takes a long time and to develop a novel product or technology and, also, the cost of that development is extremely high. Thus, a patent prevents competitors from using the patented materials or methods for commercial reasons.

To be patentable your invention should be novel (it cannot be previously published), useful (have a known function) and non-obvious (e.g. obviously combining previously known elements to come to your invention would not work).

The invention can be machines, processes (e. g. therapeutic or diagnostic methods) or compositions of matter (e. g. artificial proteins or nucleic acids, transgenic organisms). However, you cannot patent a product of nature (naturally occurring genes, proteins or other materials), scientific processes or theorems.

2. The first thing you should consider is whether you really need a patent. That is because patents can be very expensive to write, submit, maintain and enforce it - up to hundreds thousand of dollars. Another aspect is that some technologies are not worth to be patented because as they can be “outgrown” quickly, become obsolete or could be used confidentially as a trade secret (for example, software).

However, a patent is a strong selling point for many investors, as they can later be used for licensing and collecting royalties by allowing other companies to use your invention.

We would strongly advise the future iGEM teams to contact their university IP Management Office. Most universities have established procedures and assistants to help you with filing a patent application and explore other opportunities for your invention commercialization.

Our university’s IP Office, together with our sponsors Thermo Fisher Scientific helped us a lot by defining the patent structure and clarifying specifications and claims of our invention.

3. If you have decided that you really do need a patent, you should then invest a lot of time in searching patents, scientific articles or conference abstracts that may have already described the thing you are trying to patent.
The patent process is expensive and you don’t want spend a lot of time and money for filing an application when there is a previous invention that could prevent your patent or make it extremely narrow.

Also, there always is a possibility that there was already a patent submitted that covers your patent, but did not receive commercial success. If this patent is expired, you can freely use the technology, but, on the other hand, there will be no ways to prevent others to do so as well.

By the way, it is worth to invest the time into the patent searches for a completely different reason as well - they can be a valuable source of knowledge on how to structure the claims and the main description. Patent “language” is a completely different style of writing and one can only start learning it - be reading more of them.

4. Generally speaking the patent is divided into three main parts: specifications, drawings and patent claims. The most important part of the patent is claims.They point out the aspects of your product or technology that you regard as your invention and define your exclusive rights to it. The rest of the patent is there to support to what is claimed. You will also need specifications (a full and complete description) of your invention which provides the proof of understanding of the claims, and drawings that illustrate certain aspects of the invention so the reader can follow the text more easily.
When filing a patent you want to describe every detail of your invention, as well as its alternative versions. However, you can have the most thorough description of your invention but it will not matter unless you have been granted the claims that cover that description. Also, it is important to note that you can rearrange the patent application, but you cannot add a new material without filling a new patent application.

5. After you submit your application it is all about waiting. It may take up to a few years for patent to get fully accepted. This time is meant for the experts analysis, and also competitor disputes.

Customer profile

The largest part of our products will be unique and precisely tailored. As our future company would facilitate a B2B model, the most important sales and marketing factor would be building strong relationships with each of our clients. Mainly they will be companies producing drugs and/or chemicals that require enzymatic solutions for their production pipeline, or enzyme producing companies that are looking for technological solutions and research services.

Potential clients:

1. Novozymes. A Danish biotechnology company that develops and manufactures enzymes and microorganisms for industrial use. The company holds an estimated 48% of the global enzyme market, making it the world’s largest producer of industrial enzymes.

2. BASF. A German chemical company that extensively produces chemicals , including plastic materials, pharmaceuticals and chemicals for agriculture. It is the largest chemical producer in the world.

3. DSM. A global science-based company active in health, nutrition and materials.

4. Johnson & Johnson: number one on the list of top pharmaceutical companies across a range of industries from medical devices to pharmaceutical and consumer goods.

5. Novartis. It is the Switzerland's largest pharmaceutical companies and specialises in the development of biological therapies.

6. Roche. A Swiss multinational healthcare company that is well known for its innovative range of diagnostic solutions and medicines.

Competition

In this day and age the amount of data generated is as important as having good algorithms that employ it. While our competitors might use the best screening assays now available, our invention will allow to move from thousands of mutants in a day to millions of mutants in an hour. A change of this scale matters - large amount of data will allow our AI to evolve into new horizons, including the swift generation of novel enzymatic reactions and multiple enzyme metabolic route optimization.

Risks

The greatest risk we face is a technical one. As our company will be built around cutting edge technology and innovation, every research and development milestone we may miss might be crucial. That said, we have a clear strategy on how we will mitigate this risk in a consistent way – goal oriented development. By focusing on the end goal rather then specific paths leading to it, we can be more flexible on how we will reach it. That means that we can make sure we reach milestones in time by changing the particular approach along the way, and also having multiple parallel approaches to each objective.

Marketing

We believe that presenting our system in the iGEM competition and delivering it to scientists all over the world as an open-source system will help us to make a first strong step and impression. Later, our plan is to build a company network by participating in startup competitions, trade shows and conferences such as JP Morgan or BIO international, which may be an excellent environment to meet potential business partners and customers.

Furthermore, we are planning to prepare educational videos for students, open-source computational tools for scientist and blog articles for general public on various life science topics.

SWOT analysis

1. Strengths
    1. We use and have patented a state of the art system CAT-Seq which allows to precisely screen billions of catalytic biomolecule variants and record their sequence to activity relationship. It is a completely new speed scale of data acquisition.
    2. Together with CAT-Seq system we are utilizing what we believe are the next generation neural networks - Generative Adversarial Networks. Yet, to be accurate they require an enormous amount of sequence to activity data for each sequence, which only the CAT-Seq can provide.
    3. Strong team consisting of people with years of experience in the fields of biotechnology and synthetic biology.
2. Weaknesses
      1. Not as experienced in business development and management as competitors might be.
      2. The research and development pipeline depends on cutting edge high-technology, which increases the difficulty of research and engineering.
      3. The growing pace may be slow at first, as large amounts of initial sequence to function data is required to be collected to reach a certain breaking point in enzyme engineering.
3. Opportunities
    1. Accelerating demand in the synthetic enzyme market.
    2. Collaboration with already established large enzyme engineering or pharmaceutical companies.
4. Threats
    1. Harsh competition in the catalytic biomolecule engineering and similar industries.
    2. Extremely long incubation times for life science startups and spin-offs.

Conclusions

Our research and development pipeline consisting of CAT-Seq for data acquisition and ReactionGAN for novel enzyme generation has a tremendous potential to disrupt the synthetic biology and enzyme engineering markets. We have taken the first steps by analyzing our business case. Moreover, we have submitted a patent application just before the iGEM competition in order to protect our intellectual property.

There’s is a great amount of toxic chemical catalysts used every day all over the planet, and there is only one reason for that - the lack of catalytic biomolecules for various reactions. For that reason, we believe that it is important for us to continue developing CAT-Seq and accelerate the production Novel, Synthetic and Environmentally friendly Enzymes.