Team:IISER Kolkata/Entrepreneurship

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Overview

It is always desirable that a solution or research in the lab can actually be implemented into the real world. In the proposed implementation, we have formulated our idea into products by incorporating the needs of the stakeholders and to make it a good, safe and responsible solution. After developing an idea of how to implement our solution into the real-world, in this supporting entrepreneurship section we have tried to show that our idea can be realised in practicality, is scalable and can be produced to be used in the market. We have ideated how after this iGEM competition we can take forward this beautiful project idea to develop a product through an entrepreneurial approach.

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Objective of our startup

Our startup “naMOOste” is mainly focused on developing a cheap, easy to use, rapid, portable, storable test kit for Subclinical Bovine Mastitis disease to help in its early detection and also provide an antibiotic free cheap treatment to the infected cow to eradicate the threat of antibiotic resistance. It can also improve efficiency rate of the treatment, which can be distributed to small dairy farmers as well as large scale dairy companies.

Our vision is to become an emerging company in the pharmaceuticals industry in providing synthetic biology solutions to long standing problems of apt detection and treatment of disease. We aim to eradicate the problems of inaccessibility of veterinary services for the rural dairy farmers of our country and provide them with a handy solution to enable them to keep a regular check of the disease in their herd of cows.

Structure and Status of the Organization

To carry out all the work in a systematic and efficient manner, a proper structure is needed. Most of the team members are closely associated with the startup idea and they hold some key position at the organisation. But at the same time owing to the constraint of experience and technical knowledge to some extent we need experienced people in some key positions of our start-up.

To run our company successfully we need to have these four licenses -

(CompanyRegistration, DrugLicense, GST, FSSAI.)

Our start-up will be registered as a Private Limited Company, as this allows all our team-members to have shares in the company and it is not available for the general public to trade on stock market.

The documents required for registration and the procedure is following:-

Documents

Personal Documents
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  • DSC (Digital Signature Certificate) & DIN (Director Identification Number)
  • PAN (Permanent Account Number) Card
  • TAN (Tax Deduction and Collection Number)
  • Identity Proof (Aadhar Card etc.)
  • Passport Size Photo
  • DSC Form Download Format
  • Address Proof (Bank Statement Mobile Bill / Telephone)
Registered Company Office
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  • Rent Agreement
  • Property (Director/ Relative) - Registry Proof / House Tax
  • Receipts (Notarised) Latest Electricity Bill
  • NOC from the owner on the name of any director (Notarised)
Other Documents
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  • MOA (Memorandum of Association)
  • AOA (Article of Association)
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Market Analysis and Segmentation

India has the largest bovine population having more than 300 million bovines. India produced 198.4 million tonnes of milk in 2019-20 making it one of the largest dairy producers in the whole world. It has been registered that despite of COVID restrictions there will be a 5-6% growth i.e. Rs 1.5 lakh crore (USD 201.64 million) sectoral revenue generation in 2021-22, as per CRISIL [1]. Coupled with the exponential growth of the Indian veterinary healthcare market, having a revenue of approximately USD 1,083.13 million in 2020 and expected to reach USD 1,697.15 million by 2026 [2]. The prevalence of bovine mastitis ranges from 29.34 to 78.54% (Sharma and Rai, 1977; Ebrahimi et al., 2007; Sharma and Maiti, 2010) in dairy cows [3]. Based on these projections, it seems like a fairly conducive space to enter in this market with our product.

Currently available all the test-kits are either not sensitive enough or costly and require technical knowledge, lab facilities to be conducted. This brings scope for our detection kit to grab the attention of the users. While AMR (antimicrobial resistance) has received little attention in India (this has been possible due to the practice of access to antibiotics over-the-counter without proper prescription and direct marketing of drugs to the dairy farmers.) , few legal regulations passed in India. This is mainly due to the complex nature and lack of awareness of this phenomenon. Nevertheless, the Food Safety and Standards Authority of India (FSSAI) has recognized the legitimacy of these issues, and fixed ‘tolerance limits’ for veterinary drug residues, including antibiotics, in animal foods like milk, meat, eggs, etc.

Additionally, there are two options available currently for the treatment of bovine mastitis:

  1. Intramammary antibiotics, the classic mastitis tube and
  2. Systemic antibiotics given by the intramuscular or subcutaneous route.

The ease of application provided by our technique passes one of the key tests for an MVP proposed by Sergiy Andriyenko, that is, minimalism. Our product provides valuable utility to the novice, which would prove to be a huge addendum after the launch.

The animal health market can be segmented into five fragments (in order of preference):

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While the small-scale farmers own almost 60% of all the milk animals in the country.

The majority share in animal healthcare is not governed by them. Cattle aggregators (farmers who own more than 5 animals) only account for 5% of the milk producers in India.

Historically, veterinary clinics have emerged as the leading distribution channel for animal health care products in India and are expected to continue to be over the next few years. The segment led the overall market with a share of 33% in 2015. This could certainly be a preferred channel especially in the urban setting. For dairy animals, one of the most preferred channels continues to be pharmaceutical retailers, accounting for almost 51% of the share in livestock care. Also, while antibiotics still make up 50% of revenues for these major players, their new drug developments have begun taking AMR into consideration. This is in accordance with the increasing stringency of antibiotic regulation enforcement by ICMR’s Antimicrobial Resistance Surveillance and Research Network (AMRSN).

SWOT Analysis
Strengths
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  1. Scientifically sound project
  2. Tackling a world-wide problem
  3. Developed using inputs of people from all socio-economic and knowledge backgrounds
  4. Helps for massive scaling up of production from RISE organisation of Home Institute
  5. Exposure from after iGEM and attended startup summits
Weaknesses
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  1. Large scale clinical trials and approve of Ethical committee
  2. Comparatively higher prices for treatment
  3. Training of workers and transfer of technical knowledge
  4. After iGEM scalability as it is a student venture
Opportunities
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  1. Dairy industry is one of biggest industry in food sector
  2. Tackles the problem of antibiotic resistance which will be more prevalent in future
  3. iGEM exposure
  4. Emerging field of synthetic biology
Threats
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  1. Open source competition
  2. Usage of GMO is not welcomed by people and many countries as a whole
  3. Competition with veterinary pharma companies
  4. Underlying science is complicated so communicating it to investors
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Risk Analysis

In the case of a start-up there are various risks associated with it, so it is always important to analyze the risk properly to understand future prospects and performance of our project.[4] Here, 1 denotes highest risk and 5 denotes lowest risk.

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As we are making this venture as students it seems like we have a very high risk, but with proper guidance of incubators we can overcome this to excel in this field.

Product Validation

We have reached our target customer to understand their acceptance and wills regarding the usage of the product. From the survey conducted we can conclude that Small scale and large scale dairy farmers are really facing problems with usage of antibiotics and they are ready to use it, if it is proven well under all safety standards and prescribed by Veterinary doctors. So, regarding this we have talked with veterinary doctors and scientists, who also checked our theoretical model and found it to be preliminarily safe for usage. Still we have to check the efficiency of our method and have to go through large clinical trials to finally comment on this. We will be talking with the Animal Ethics Committee of our institute regarding this and get useful information stepping forward in this direction and also will be checking rules and regulations of the Government of India about the same. Our discussion regarding the ethics concerning our project is documented in the proposed implementation webpage. After clearing all the guidelines, preliminary products will be given in selected areas to milk-persons and dairy farms for the product feedback. Upon receiving that we will modify our products accordingly and after that launch in the market.

Business Model
  1. Value Proposition Canvas:
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    Value Proposition canvas
  3. Business Model Canvas
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    Business Model Canvas
Business Plan

To develop a successful business, financial strategy is very important and due to this we always need to have a proper plan moving ahead with incubators and partners. We have not completely developed the prototype till now. Still, we have done this by taking an arbitrary value to show the plan. When we will actually estimate the costs then the value will be substituted. All the calculation for the margin of Wholesaler and Pharmacist is calculated using standard profit margin by Pharmacy Council of India.

Suppose cost of production and packaging = Rs.20/-

Now, having 30% company margin make Minimum Selling of the product = Rs.26/-

MRP = Rs.60/-

MRP without GST = Rs.53.57/-

Price for Pharmacist = Rs.42.84/-

Price for Wholesaler = Rs.38.57/-

So, Money in Hand = Rs.(38.57-26)/- = Rs.12.57/-

Now for each product Rs.3/- will go to the salaries of the employee, Rs.2.57/- to the promotion, Rs.5/- to Research and development, Rs.2/- for additional costs.

Thus, once our setup is done this model will provide profits indicating successful running of the start-up if sales is well-managed.

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Business Plan Pie-Chart
Marketing and Sales Management

To run a business successfully, along with having a great product generating revenue is also equally important and for that we need to project our product’s benefits to the potential customers, that is where companies need Sales and Marketing Team. Marketing facilitates promoting and distributing of products and on the other hand Sales is involved over activities regarding selling products.

As our Business Model involves B2B, B2C and C2C, we have to plan our sales and marketing differently for different models.

For the B2B model our potential customers are Big Dairy Farms and products will be provided to them directly. Here, we will offer companies a deal. If they buy(depending upon the number of cows present in their dairy farm to test the disease on prescribed interval) numbers of test kits needed on a monthly basis, then the treatment will be provided to every subclinical bovine mastitis infected cows in that dairy industry.

For the B2C model our potential customers are stand alone milk-persons who are doing business in medium scale or small scales. Veterinary doctors, Pharmacist and Stockist possess key roles in this business model as through them our product will reach to the customers. We will involve Medical Representatives to popularize our test-kit and medicine among the Veterinary doctors, Pharmacist and Stockist. We will do

For the C2C model customers will circulate about our products to other potential customers.

Along with that we have developed mathematical models to optimize the number of tests required in a cow herd to check for all of the cows. This strategy will give us a competitive advantage as this will be provided to our customers and they can easily save their money using that model.

Scale Up Production (Academia to Industry)

Regarding this we have talked with RISE Organization of IISER Kolkata that is an incubation centre for students and professors of IISER Kolkata. We organized several rounds of discussions figuring out the problems and challenges we might face going to the production and tried to solve them with the help of experts from the organization.

Following the suggestions we have looked for our competitor’s market share, closely verified sensitivity and specificity of our biomarkers as well as the limit of detection from literature to make our test kit more effective. We have also theoretically developed the process of synthetising RNA-Hydrogel but due to lack of time lab synthesis was not possible.

We have talked with experts about Intellectual property rights and for patent application and taken their valuable advice regarding the same and are currently checking with pHNiNE firm Bangalore, if our detection kit and treatment method can be patented or not. We have received some positive feedback and talks are in progress. However, iGEM being an open-source registry of biological parts, this intellectual property is off-patent. To make our product patentable we can introduce new modifications in the gene circuit that was submitted to iGEM parts registry. For our treatment part, we have thought to manufacture GMOs from international companies following our proposed gene circuit and finally use this as medicine.[5]

Incubation of the StartUp
  1. Workshop on Functioning of Pharmaceutical Start-Up:
    On 10th-11th July we attended a workshop by Sandeep Kumar Soni, who has expertise in pharma startup setup. From this workshop we learnt about legal status and registration of a company, licensing and trademarking of our product market strategies, sales and management using what we developed our plans.
  2. Pharma Start-Up Webinar
  3. Bio-Entrepreneurship Awareness Programme:
    Centre for Cellular and Molecular Platforms (C-CAMP), which is an initiative under Department of Biotechnology - DBT, Ministry of Science and Technology, Government of India to propel life science innovation and entrepreneurship in India, organised an online ‘Entrepreneurship Awareness Programme’ on 28th July 2021. We attended the webinar and learned about the topics such as ‘What it takes to be a bio-entrepreneur’, ‘Converting an Idea into a Venture’, ‘Filing a Patent' etc.
  4. Bio Entrepreneurship Awareness Webinar
  5. EPIC Summer Boot Camp:
    iGEM Entrepreneurship Program Innovation Community (EPIC) organised a summer bootcamp on 26th August, 3rd September and 10th September for all participating teams. We learnt about The importance of interviewing our stakeholder, Developing our Business Model and finally Pitching our idea to investors in 3 subsequent days that helped us to shape our project better.
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    iGEM EPIC Summer Bootcamp Badge ™
  6. NBEC:
    We have also applied as a student venture in National Bio Entrepreneurship Camp, result of which is yet to be announced. It is one of the most renowned competitions for identifying and nurturing bio-entrepreneurs through cash-prizes, fundings mentorship along with its partners.
  7. E-Cell of IISER-K:
    We have officially collaborated with the Entrepreneurship Cell of IISER Kolkata to do our market research, review our business and marketing strategy and receive overall feedback on our project idea and pitching to investors.
    Meeting with E-Cell
Targets to reach

We have planned to develop our products maintaining all the guidelines in next 6-7 years and chalked out paths and target to achieve in next few years, which is provided below-

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Future Plan
Future expansion

For any product, after successful launching, it is important to keep up the sales but despite that upon reaching the maturity phase the sales declines. So, it is always important to explore different dimensions with the product and extend it. Our test-kit detects particular mi-RNA for the Bovine Mastitis disease and gives us the result of a cow being Bovine Mastitis positive or negative. There are several other diseases where mi-RNA acts as a biomarker and is upregulated upon the onset of the disease. It ranges from Breast Cancer, Ovarian Cancer, Cervical cancer to Cardio-vascular disease, Neuro disorder and bacterial infection.[6] So, using the same technique just by changing the complementary sequence of target mi-RNA we can make detection kits for many other diseases as well. We might need to pin down on which samples we are going to test the disease. We would like our company to extend and grow in this direction.

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Sales of a product with time
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