Team:UCopenhagen/Entrepreneurship

Timeline

Business development

Next steps

Introduction

CIDosis team members joined the SUND Hub Incubator Program early on in the iGEM journey. Through this endeavor, we were inspired to meet people who could guide us through each stage of a MedTech start-up. In this section, we will take a walk through how the entrepreneurship journey began at the CIDosis office and our interactions with business experts. Our main takeaways from the meetings were:

• Learning how to pitch to investors and convey our message to other stakeholders

• Legal, organizational, structural, and financial requirements for creating a MedTech start-up

• Understanding how to analyze the competitor and customer landscape

• Regulatory requirements for market entry of a medical device

Timeline

Start-up Bootcamp: Essentials

|| June 18th || SUNDHub Start-up Incubator: Workshop 1, Peter Birk & Anders Graabæk

SUND Hub is an innovation environment for students, part of the Faculty of Health and Medical Sciences (SUND in Danish). This Hub helps students pursue their ideas or help initiating startups while building skills in entrepreneurship and innovation. The SUNDHub Start-up Incubator is a program aiming to kickstart stablished ideas in the Start-up world.

The Bootcamp Session was primary lead by Peter Birk from Accelerace and Anders Graabæk from Validate, two Start-up acceleration Organisations. In this workshop we were introduced to the the Entrepreneurship path, with elements such as the “Five anchors of a good opportunity”. This concept invited us to think if our solution was creating significant value for a compelling medical need or problem; if it was a good fit and timing and with a differentiation and sustainable advantage over other solutions; and lastly, whether it would have a profit and return potential. We were also advised to “Love the problem, and not the solution”, to allow for innovative ideas upgrading our solution, avoiding staying static in one solution that does not fit the needs of the patient. Moreover, we did several exercises to learn how to frame our goal in order to articulate it better when presenting it to people outside of the project, through the NABC model (Need, Approach, Benefits and Competition). We felt inspired by this articulation of our purpose and decided to also create a Golden circle where we showed first the WHY, then the HOW and in the end the WHAT or our solution.

Meeting with Start-up experts from SUNDHub

|| July 9th || Nadia Storm & Peter Løvschall

As a part of the SUND Hub Start-up incubator program, we had to present our projects to Nadia Storm and Peter Løvschall, in order to get the perfect guidance on how to start diving into the entrepreneurial part of the project. In this meeting, we realized how important is to know the audience background before you pitch your idea, and the need of always summarising the entire project in the first lines, and then explain each part more thoroughly. We also received feedback on what other information we needed to be more credible when pitching, such as experts backing up assumptions we drawn from papers, or patient stories that would make the problem more tangible.

Strategies for medical devices

|| June 9th & July 21st || Caroline Lærke Oldin, Student Assistant at Ambu, specialised in medical devices

We had thought a bit about how CIDosis would fit into a competitive consumer market. However, none of us had any expertise in business management, let alone how one would go about getting a GMO medical product approved for market. Luckily, we were able to have two meetings with Caroline, Business Master student working in medical devices. She gave us some inspiration of different kind of analysis we could make for our product, but most importantly, she was the first person that recommended us to launch our product to just one or two target diseases. She explained that even though we wanted to create our product for several diseases, we would get an easier approval if we started with the most important or the one we could create the most impact to, and the continue with the rest.

Biobusiness Summer School by Synapse x BCG

|| August 10th-14th ||

The BioBusiness Summer School was a full-time week event organised by Synapse (Student Organisation aiming to bridge the gap between academia and industry) and BCG (Boston Consulting Group). In this event, different field experts and start-up owners where teaching the participants the key concepts and considerations to create a BioStart-up, motivating us towards the entrepreneurial journey. Moreover, we had two training sessions with BCG, for structuring and analysing problems, and for properly pitch an idea in a structured way.

How to be a successful Bioentrepreneur

Christian Groendahl, CEO, SNIPR Biome

Christian Groendahl, founder of SNIPR Biome, told us about the importance of developing a “T” and not an “I” personal profile, where we have spread arms towards more knowledge, and not deep expertise, and not just the deep expertise. He introduced us to the IPO concept (Initial Public Offering), that we would have to consider if some day we decided to take a start-up to the public stock markets. He incited us to first do due diligence of our idea, and if after that, the idea works and it is still a great idea, we shouldn’t let anyone make us doubt about it or renounce.

BioBusiness Vocabulary

William Bullock, Consultant, NNIT

William Bullock, Consultant from NNIT, introduced us to an alphabet of business terminology. Our key take-aways from this talk were the difference between Material Transfer Agreement (MTA) and Licensing Agreement (LA), where the latter is just the idea and the former is also the material goods involved in it.

Why businesses need IPR

Pernille Gojkovic, Patent Attorney, Høiberg

Pernille explained us how essential is to have Freedom to Operate (FTO) as well as Intellectual Property Rights (IPR) over an idea. She summarized the entire process in 4 steps:

•Check patent requirements (it should be statutory, novel, useful and non-obvious). In this step, Pernille made a really good job making us conscious of the importance of the “novel” part. The idea should have never been disclosed before, which is why she remarked several times during the presentation that scientists trying to guess the future applications of their discoveries in the discussion parts of the papers, are their own enemies in case they want to get a patent on their discovery.
•Secure the investment: once we have gotten an IPR license, as this is usually what investors require for large investments.
•Obtain the FTO: as sometimes you might fall inside a bigger patent that prevents you from exploiting yours. Therefore, you then need to obtain a license from them, with a monetary cost.
•Commercialising your product.

Legal challenges when starting a business

Horten Attorneys

Two attorneys from Horten explained us 4 of the most important legal aspects to take into account when creating a business:

• Company form: they introduced the audience to the different types of legal company forms, their protection for the owner, and their economical liability, which made us consider the option of creating a Private limited company (ApS in Denmark), where we would need a minimum of 40.000DKK, but it would grant us economic protection.
• Shareholder agreement: this agreement is the one that states how the company is managed. It is the contract between the owner/s and the company, where the responsibilities of each are explained. they introduced us to the Tag alone or Drag alone clauses, that can be stated in the Shareholder agreement. These are different clauses that can be used strategically to bound the second party to buy or sell more shares. Other clauses that can be included is for example the Deadlock situation, that appoints a 3rd professional party to make a decision if there is a 50/50 situation.
• Funding: There are 3 options often used:
• Workforce: There are differences in the protection rights of each type of title, and therefore, the funders do not have any protection right status, the employees do have protection rights (contracts, insurance, holidays,...) and consultants don’t have protection rights, and are usually autonomous.

How to make an Environmental Impact Assessment (EIA)

|| August 27th || Hanne Dalsgaard, MSc Environmental Engineering, DTU

Making sure that our environmental impact is as low as possible is not only important for ethical reasons, but also important for getting a CE approval. In order to know more about the subject of making an environmental impact analysis, we had along meeting with Hanne Dalsgaard Nicolaisen. She shared her knowledge on how to do a EIA and the key points to consider. You can read more about it on proposed implementation

Planning for lab space after iGEM

|| August 28th || Symbion opening ceremony of CPH-labs

The team was invited to the Symbion Lab Opening Ceremony. Symbion is a coworking start-up space, that recently constructed a laboratory to be used by some of the start-ups. We got offered free lab space during idem and also one bench space to continue our research after finishing iGEM.

Deep customer discovery

|| September 15th || SUNDHub Start-up Incubator: Workshop 2, Customer discovery

We followed a presentation on exploring our customers - how they are, how they think and feel, how they behave. Special attention was paid to qualitative methods – in-depth interview, behavior observation, play. Such approach was especially recommended to early startups. After the presentation, we engaged in a series of exercises – empathy map, five whys, stakeholder analysis, the qualitative interview, open-ended business-model questionnaire.

While discussing our customer insight with Anna, one of the SUND Hub leaders, she reminded us of the importance of healthcare decision-makers and pharmacies for our business model. She suggested that we focus a little bit more on these, as we had already gathered significant amount of knowledge about users (patients and doctors) who might not be customers, however. Together, we identified a couple of domain experts to reach out to in order to strengthen our business model.

Practising our elevator pitch

|| September 29th - October 2nd|| Global Synthetic Biology Conference

We attended the Global Synthetic Biology Conference, where we talked to a variety of people representing various companies and occupations, ranging from academics to investors. Based on our discussions, we understood that early stage investors emphasized interpersonal skills, the importance of functioning team, passion, ability to take suggestions from others.

We were encouraged by generally positive feedback for our project, and we also discovered there were more potentially useful applications of our solution. For instance, John from ZBiotics proposed us a potential future partnership if we managed developing our product.

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Ensuring future mentorship

|| October 13th|| Accelerace mentorship

During the last sprint of our project, we were contacted by Accelerace, that offered mentorship to continue our project after the competition and help us realize how to make the science start-up together with NovoNordisk fonden.

Overview of the entrepreneurial process

|| October 21st|| SUNDHub Start-up Incubator: Workshop 3, From idea to Business

During this workshop, we engaged with different experts that SUNDHub had brought for the Start-ups to ask the different considerations. As we thought we needed some extensive help in areas such as patents and regulations, we decided to plan bigger meetings with two f them: AWA Patent Attorneys and Rømer Consulting, for IP and regulatory advise, respectively.

Future IP steps

|| October 22nd|| Rasmus Kvist & Helene Robertsen, Patent attorneys, AWA

Date of filing (DoF)- PVS (denmark), PCT (international), EPO (europe)--> legal institutions where you file them. Novelty search and drafting 3 months before DoF. Usually done as well by professionals. Patent bureau--> analyse the competitor's pipeline/portfolio 6 months after: search report (SR)+ WO (written opinion)--> tell you if you can file a patent or not depending on the information available. It is uaually god that the scope of protection is wide, so the WO usually has some info that you cannot touch. DoP (date of priority)--> before you can file other applications claiming priority to the initial one. EPO or PCT--> they will have the same standard Publication: after 18 months --> publicly available 2 years after the DoF scope of protection decided. Patent application (PA): you have to write about what is claimed * just write the bare minimum. 30 months after the application, the pct dies and you can go to the other authorities (those are the costly). By then you choud have already sell product of have bigger funding. We need to find the novelty part. We have one year before the DoP to provide as much data as we can to prove that it works the way we claim. .

Diving into the regulatory landscape

|| October 23rd|| Claus Rømer, CEO, Rømer Consulting

It is a medical device, not an in-vitro diagnostic, just diagnostic medical device. Medical device regulation if we don’t do it before may this year. Probably similar to approve in US or europe At a glance it will be the same but unsure on the details MDR-C1-C2 enters into force 26 may 2021 Article two medical device definition -very clear our patch is a medical device in this definition. Our app is also a medical advice – if it shows a bar graphs then it acts on the data for the patient and thus is a medical advice as well. THis is for Europe only (us more tricky in clarification aspects –in us if it is similar to another device then it will make it easier. We need public available databases and find a similar device. ) In EU we have clasification rules –different authroisation pathways. ANNEX VIII rules. (both for invasive and non invasive devies) Not an active device – but the software will be an active device. (it analyzes the raw data--> it wouldn’t be a medical devce if it would just make easy calculations) Yeast is not animal Need to know their definition of nano – maybe we should not use it for our description of or nanofilm Initial conlcusion – none of the special rules apply. The app will be subject to rule 11. Medical device IIa app and patch is a class I (chapter III) -rule 1 2 and 3 does not apply. Seperating the patch and the app it will be much easier to present the the patch on th emarket because it is only calss 1, however the patch is class 2a so It needs more quality check. Technical documentation and ISO regulation (quality management) in case we decide to go towards class IIa (app) Set of requirements that are mandatory to prove: The notified body will check it. They are in the harmonized standards; it is not a law. They are still not done for this new regulation—> difficult. We need a risk management system. ISO14971: additional guidelines or risk management system. We always need a quality management and a risk management system. The only difference between I or II, is that the notified body appears in the class II. The availability of notified body is quite limited at the moment--> takes more time and more money. That is why it would be better if we can justify that it is a class I. --> we asses it internally and then we can put the product on the market. We would need a lower detail in the documentation. We should approve them in different parts, as we can already put it in the market, proves that people buy it, and attract more investors, it drives up your value. Software medical device software ie63204 1-2 years to develop, and around 5-10 million DKK. Reality 5 years without experts. Class 2 device needs to notify a notified body – they review your quality management system. We will need clinical trials for the patch. We need to demonstrate that it is safe from the lab perspective beforehand, like it doesn’t produce rushes, that the nanomaterial goes in one way and not both. Demonstrate usability: know how to use and read the patch. 10 to 50 subjects Usually takes 3-6 months to prepare and to obtain results (other3-6). Approval by ethics cometee, and health authorities (3 months and 3 months more to prepare the application). Then you can test on human beings. Whole clinical aspect 3-5 million DKK. Before being ready to apply, everything of the lab should be tested. 12 months from proof of concept to prepare the technical documentation. We need a CE mark. Before that we need to have the clinical data. After the CE--> market. We should avoid using this word from the regulatory perspective (as we do not fall inside the definition of a nanomaterial) We can create one easy product and then come back with new generations of the patch, with the nanomaterial, the app,….

Business development

With the help of several experts with business background, we chose to start our Business Development Process by Creating a NABC model of our solution. This helped us framing the situation in a more specific manner.

The NABC Model served as an inspiration for creating our own Golden Circle, which defines our purpose in a more specific and organised way.

Moreover, during the first session of the SUNDHub Start-up Incubator, we were introduced to the Lean Canvas. This is a version of a typical Business Model Canvas, that has been optimized for Start-ups, in order to faster discover if the proposed Business model is viable. It allows for a faster and more agile transformation and iteration in order to find a working model. Here you can find the last iteration we did of our canvas, on the 15th of October.

Regulatory measures

There is a lot of regulatory measures one would need to take in order to get a product like ours to market. The first thing is to get a CE marking proving that we conform with health, safety and environmental protection standards in the EEA (European Economic Area). The first step towards getting a CE marking for medical devices is figuring out what risk class it belongs to. There are four different risk classes for medical devices, the fourth encompassing high risk devices such as pacemakers, and the first encompassing low risk devices such as reusable surgical instruments. It is possible to determine what classification a device belongs to by a process of elimination.

As a baseline a non-invasive medical device belongs to class 1, unless:

1. It is intended to channel or store blood
2. It is intended to modify the biological or chemical composition of blood
3. It is intended to have contact with injured skin
4. It is intended to be used by penetration of body orifices
5. It is intended for surgically transient use
6. It is intended as an active medical device either for therapy or diagnosis (supplies energy)
7. It intended to incorporate a medicine
8. It is a device containing non-viable animal tissues, cells, or other substances, or microbial or recombinant tissues, cells, or other substances

Clause number 8 clearly describes our medical device. Medical devices fitting the description of this clause belongs to class 3 unless the device contains only “tissues, cells or substances of animal origin that have been rendered non-viable" or “the device is intended by the manufacturer to come into contact with intact skin only” ( http://www.legislation.govt.nz/regulation/public/2003/0325/latest/DLM224296.html).If either of these subclauses applies, the device is classified as class 1. Our device contains viable cells, but since it is it only intended to be used on the skin it belongs to class 1. With that out of the way, we can evaluate the possibility of getting a CE marking for our product. Part of getting a CE marking is showing by means of clinical trial the efficacy of the product. Obviously, this is not a possibility for us. There is however some tasks that are possible for us to do in order to gauge the likelihood of getting a CE approval.

Competitors analysis

Sweat tests

There is currently not a direct competitor that would offer a point-of-care solution for monitoring inflammation through sweat.

Blood tests

Pro: Done with doctor supervision (not reliant on patients knowing anything). Most precise test we have Cons: Invasive, not point-of-care, price???, not feasible to do as frequent as patch

Salivary tests

Pros: marketed Cons: not point-of-care, less precision (tests not performed at the level of cytokines), more invasive than a sweat patch, passive drooling is less appealing than natural sweating

Stool tests

Pros: marketed, point-of-care, fast Cons: less precision (tests not performed at the level of cytokines), more invasive than a sweat patch, not appealing, only for localized inflammation

Next steps

We decided to build a Quarterly Roadmap that would express the goals already reached and the ones that are yet to be accomplished.

Q1/2021:
- Transition from an iGEM project into a start-up

• Registration as a Private Limited Company (ApS). ✅
• Sign Shareholder Agreement.
• Expansion of skillsets on the team- App development and scientific confirmation.
• Identify challenges and deadlines with experts regarding applications and approvals.

Q1/2021:
- Securing Idea

• Establishing strategic partnership- experienced in GMO or MedTech
• Finding a sponsor/investor/funding
• Application for Intellectual Property (IPR and FTO)

Q3-Q4/2021
- Strengthening scientific context

• Prospective study on cytokines in human sweat: through CRO (Contract Research Organisation)
• Optimize patch design and yeast implementation

Q1-Q2/2022
- Preparation for clinical trials

• Consult experts about authorisation and human resources needed for Clinical Trials
• Applying for clinical trials: Developing the Clinical Research Manuscript
• Finding a production partner
• Getting more investors

Q3/2022 - Q1/2024
- Develop clinical trials

• Clinical trial operations management
• Prepare preliminary market approval
• Figuring out details about productions
• Finding strategic partners and investors

Q2-Q3/2024
- Preparation for Market Entry

• Application for Market approval
• Finding a marketing partner
• Start planning Sales force and Marketing strategy
• Scale-up of manufacturing production