Team:UCopenhagen/Entrepreneurship


Timeline

SUNDhub startup incubator

|| June 18th ||
The initial Workshop of SUND Hub’s Start-up incubator program was the “Bootcamp Session”, where Peter Birk from Accelerace and Anders Graabæk from Validate (two Start-up acceleration Organisations) introduced us to the Entrepreneurship path. In this workshop we were introduced to the “Five anchors of a good opportunity”, where we were invited 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.

Nadia Storm & Peter Løvschall, quarterly meeting at SUNDhub

|| July 9th ||
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.

Caroline Lærke Oldin, master student at Copenhagen Business School

|| June 9th & July 21st ||
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, Caroline was kind enough to help us twice.

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Biobusiness Summer School (BSS)

|| August 10th-14th ||
The BioBusiness Summer School was a full-time week event, where different field experts and start-up owners where teaching the participants the key concepts to create a BioStart-up. Topics varied from personal experiences of Danish Biotech entrepreneurs to legal requirements and considerations. Talks were insightful and uplifting, motivating us towards an entrepreneurial journey. Moreover, we had some two types of training from BCG, one for structuring and analysing problems, and another one for pitch perfectly our idea, that would be beneficial for getting investors but also conveying the purpose to our customers .

Christian Groendahl

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.

William Bullock

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.

Pernille Gojkovic

Pernille Gojkovic, patent attorney from Høiberg, explained us how essential is to have Freedom to Operate (FTO) as well as IPR (intellectual Property Rights) over an idea. She summarized the entire process in 4 steps, where the first is to check the 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.

one more to disucss!!

Horten Attorneys

Horten Attorneys explained us the legal challenges of starting a business, touching upon 4 topics:
  • • 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:
    --convertible loans, where after a certain period of time, the money owed can be converted to shares.
    --crowdfunding, in the form of donation/reward (where you don’t need to pay back the money), peer to peer lending (which is similar to a loan) or investment (with which you need an investment agreement).
    --grants, which are donations to the project usually by big funds.

  • • 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.

Hanne, environmental impact assessment

|| August 27th ||
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. You can read more about it on ----proposed implementation---

Symbion opening ceremony of CPH-labs

|| August 28th ||
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 one bench space to continue our research after finishing iGEM.

SundHub customer discovery workshop

|| September 15th ||
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.

Global Synthetic Biology Conference

|| September 29th - October 2nd||
We attended the Global Synthetic Biology Conference in the end of September, 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. We also discovered there were more potentially useful applications of our solution, notably:
"Non-invasive monitoring of inflammation biomarkers through sweat could provide important data about the microbiome's rhythmic contribution and help improve microbiome interventions against chronic inflammation." - John W. K. Oliver, VP of R&D, ZBiotics Company

Accelerace mentorship

|| October 13th||
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.

Business development





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. 1. It is intended to channel or store blood
  2. 2. It is intended to modify the biological or chemical composition of blood
  3. 3. It is intended to have contact with injured skin
  4. 4. It is intended to be used by penetration of body orifices
  5. 5. It is intended for surgically transient use
  6. 6. It is intended as an active medical device either for therapy or diagnosis (supplies energy)
  7. 7. It intended to incorporate a medicine
  8. 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. (Target group and customer journer write it?)

Next steps

Road-map


Next stepsin detail

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