Difference between revisions of "Team:Aalto-Helsinki/Entrepreneurship"

Stage 1: Eureka Moment

Finland is known as the sauna nation and we Finns are very proud of our sauna culture. In fact, if you visit Finland, a must do is to take off all your clothes and go to a little room heated to almost 100 ℃, where you will sit, naked, with others for a while and sweat. Since sweating in sauna is a huge deal, from the beginning of our iGEM project, we always had some or the other idea for sweat analysis. During our literature search to understand different substances present in sweat, to our astonishment we found that many proteins are also secreted in sweat as part of our innate immune system. That is when we serendipitously came across this interesting peptide dermcidin [2] which had antimicrobial activity against a range of different microbes. Though initially we had a range of possible application ideas and different problems to solve, the problem that connected with our team members the most was acne. We believe this was every household problem affecting millions in all age groups across different countries. To develop our product to solve acne required us first to validate the market demand and also product potential.

Focus Group Survey

Before developing any product, it was important for us to understand the consumers and their needs. So we started off with focus group survey with 194 people from different age groups between 16-60 year old. Our primary questions were directed towards understanding the depth of acne as a problem in consumers' day to day lives. Below is the list of questions and data we received.

About acne presence and severity among focus groups:

Correlation between acne severity and mental wellbeing:

Product Potential and Customer Group Identification

After the extensive focus group survey to identify the depth of acne problem, it was quite evident that acne was indeed a serious problem among a range of different age groups. At least 60% of our responders have been diagnosed with acne at some point of their life and at least 45% of our responders have suffered from acne more than 1 year. Hence, we realised a need for “continuous” treatment for acne. Further to understand the relationship between different acne severity and mental well being, we carried out a correlation analysis. There was a clear effect of acne on mental state among the people who have been diagnosed despite its severity. We did not, however, ask what was bothering them and to what extend acne affected their well-being. Similarly, acne has negatively affected the social interaction of our respondents. We realised Acne vulgaris affects about 85% of young adults aged 12–25 years and hence form our primary customer group.

The most commonly used products for acne among our focus groups were Oral antibiotics, Birth control pills, Retinoidi (Roacctuan) / Retinoids, Ayurvedic medicine, Finacea 15% gel (acid. azelaic.), Over-the-counter topical medicines (e.g., benzyl peroxide, salicylic acid), Isotretinoin Actavis, Prescription topical medicines (antibiotic), Laser or light treatment and Natural treatments.

Of the 194 participants, 95 of them didn’t report any side effects from the acne treatments. However, remaining reported some kind of side effects while using acne product or undergoing treatments.

Market Research

After identification of focus groups and realising product potential, we went for a careful market research to identify how much current acne treatments cost and what are the current acne products in the market.
Current acne treatment costs The following cost ranges are based on approximated acne treatment expenses in the United States.

For over-the-counter daily regimens that can include a cleanser, a toner and a non-prescription medicated lotion, acne treatment costs $30-60 (about 25-50€) or more per month.

An acne dermatologist visit usually costs $100-200 (85-170€). For prescription antibiotics, topical creams and ointments- or for hormone therapy, from birth control pills to a more aggressive regimen- acne treatment typically costs $45-200 (40-170€) per month. In some contries, acne treatments, such as prescription drugs and topical creams, can be covered by health insurance plans. The treatment often requires 2-3 months to see improvement. Once acne clears, it must be continued to treat the skin to prevent breakouts.

Additionally, for physical (cosmetic) treatments such as aestheticians facials or chemical peels, acne treatment typically costs $75-200 (65-170€) per session, with one or more sessions required per month. Once acne is cleared up, some patients choose to undergo additional treatments for scarring. These can include microdermabrasion and dermabrasion, which can cost up to $2,000 (1700€) or more, depending on the number of sessions needed.

Light and laser therapies can be used for the treatment of acne. There is, however, insufficient evidence to recommend the routine use of these therapies. The treatment costs can range from $100-400 (85-340€) per treatment, and $600-1500 (500-1300€) in total. Most patients will be cleared with somewhere between 4-8 treatments (3 weeks to 2 months).
Current acne products

These medications have different mechanisms of action and properties: antibacterial, sebostatic (reducing sebum production), comedolytic (reducing comedone formation) and anti-inflammatory.

Acne medications are rarely reimbursed in general. Their availability as well as prices vary across different countries.

We had successfully assessed the market and the consumer problem. Now it was time for the product development.

Stage 2: Product Development Phase

Consumer preference and needs

We asked the 188 consumers about the product preference they had in terms of how they wanted to use the product. This was crucial to take into account our product design. 42% of them preferred it in the form of a cream. while 27% of them preferred it as a face mask.

Product Development Strategy

Our product PORIFI would be the first product in the market to use an Antimicrobial peptide for acne treatment. We decided on a project based on hydrogels.

Process Development Strategy

Producing an antimicrobial peptide using chemical synthesis on a mass scale is really expensive. A few grams of the chemically synthesized antimicrobial peptide costs around 1000 €.
For comparison
4 mg of Dermcidin ~1400 dollars (purified)
1-4 mg ~420 dollars (10 dollars crude)
0,1 mg we bought for 300 e

Its tough to beat the current products in the market this way. Hence, we decided to go for production of our peptide DCD-1L in E. coli as an economical alternative.

Another challenge was to produce an antimicrobial peptide in E. coli without killing the bacteria itself. So we designed a system of production with Smt3 fusion tags for the production.

Consumer Acceptability

Having designed the product and the process, it was important for us to see if the product was accepted by the consumers. Below is the results for product acceptability.

It was interesting for us to know that around 78 % people were ready to use a product from genetically modified bacteria. Further, if the product was identical to something naturally found it body, 82% people were ready to use. This was a positive nod for us to proceed ahead in the development of product in terms of formulation and prototype development, packaging and quality testing.

Stage 3: Creation of Product Using Synthetic Biology

Trust over Technology

Using our production strategy, we were able to scale up from 5 ml batch to 500 ml batch. For details on the design process for production and success with the small scale and large-scale production, please check out our laboratory page.

Prototype Development and Formulation

Prototyping comes into play when the Design of the product needs to be verified during Product Development because it demonstrates or proves the design. Our main motives for prototype design was to a. Show the new product to investors
b. Test an idea to see if it really works.
c. Test the design to see if it passes certain requirements.
d. Evaluate necessary improvements
e. Get customer feedback.

There are 2 categories of prototypes:
1. Looks Like; Basically that’s prototypes that look and feel complete but not essentially function.
2. Works Like. Prototypes that function properly but doesn't look anything similar to the final product.

Our prototype falls under the first category. Contact us to check out our product prototype at the Jamboree.

Development of Packaging

For an interesting in-depth step by step design process of our product prototype, Development of packaging and formulation please check the Applied design page

It's important to have a unique and attractive packaging for a cosmetic product to be liked by the consumers. Packaging look is the first impression. Here is our design of the eco-friendly wooden box design for packaging of our product.

Quality Testing
We did quality testing involved shelf life study and stability of our product. The Urlinski company, which designs and manufactures the equipment for production of cosmetics and medicines, pointed out that the problem with preservative-free biomaterial based product is contamination and it turned out to be a real problem, because some of our samples got contaminated in a room temperature. Our conclusion was that biobased product gets contaminated too easily especially if the product is held in a room temperature and handled with bare hands. So we started trying out different formulations for our product with an approved cosmetic preservative benzyl alcohol (3%) and carried out shelf life study. One another advantage of including benzyl alcohol into formulation was it also added fragrance to the product.

Stage 4: Production Scale-up Estimation

From the 500ml batch, we were able to produce around 30 mg of DCD-1L peptide. Our next step was to estimate the production cost for Semi- Medium Scale up process.

*Costs Inclusive of Time, space, Labor skill expertise, energy and instrumentation

# The above mentioned prices are calculated values and quoted to calculate approximate production cost. Subject to vary during real time conversion/ Scaleup process

100 mg of DCD-1L/ recovered from per kg of input = 4518 Euros. But approx. range will be 3500-4500 for 100 mg of DCD-1L. Hence we have brought down the cost of DCD-1L production 10 times lower using synthetic biology technique as compared to chemical synthesis. Costs will go down with larger batch sizes and continuous fermentation process.

However, our cost of the product needs to be estimated yet based on final packaging and formulations used.

Business Model

Funding

Most crucial part of our product development and entrepreneurship journey is funding. We have so far collected around 80,000 euros for the initial RnD and product design. But we would be applying for an initial seed funding round to carry out further activities in research and development and product improvement. We continuously seek to improve the product from interviews and consultation with different people from industry and consumers. We have currently pitched our product idea in front of experts from the Pharma and Bio Industry. But we are yet to have investors pitch round which would be done only after the seed funding rounds are over.

Regulatory Approval and Safety Testing

Big part of working with genetically modified organisms is safety and this is why there are several laws and regulations concerning them. If our product is considered to be a GMO, which without the cellulose binding module is not exactly certain since despite the production method the end product is basically similar to the natural Dermcidin, we also have to consider these as part of the launching plan. It is to be noted that since our product would most likely fall under cosmetics, the regulations is less strict than with the medical or agricultural fields and the time to get the actual product to the market should be significantly shorter. To confirm these assumptions, we would need significantly more of legal expertise and would therefore consult a very specialized lawyer before we apply for permission to use Dermcidin as a cosmetic product.

In general, there are international treaties on safety in biotechnology like NIH Guidelines (https://osp.od.nih.gov/biotechnology/nih-guidelines/), The Codex Alimentarius (http://www.fao.org/fao-who-codexalimentarius/en/), OECD’s Recombinant DNA Safety Considerations (https://www.oecd.org/sti/biotech/40986855.pdf, also known as the Blue Book), The Cartagena Protocol of Biosafety (https://bch.cbd.int/protocol) and WHO’s Biosafety Programme (http://www.who.int/topics/biosafety/en/). Based on these there are several EU directives and regulations, which have also been implemented into Finnish national legislation in the form of e.g. The Gene Technology Act (geenitekniikkalaki 377/1995) and lower level national regulations [2].

If we have understood correctly and there hasn’t been any recent changes, placing on the market of non-food and nonfeed GMO-products is in Finland done according to DIRECTIVE 2001/18/EC. First the notifier contacts the competent authority in Finland who contacts the European Commission. Then if the other member states won’t object, the application proceeds to the European Committee and can be approved with a qualified majority or move forward to the European Council and Parliament, but the execution decision will be made by the Committee. GTLK (Geenitekniikan lautakunta) is the national competent authority in issues related to the Act of Gene Technology and it coordinates the functions of the supervisory authorities.

Detailed Plan for Product Development, Company Establishment and Launch of Product

Here is our detailed timeline and strategy for product development and company establishment.