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Team:Uppsala/PolicyPractices MicrobialDesigns
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| - | document.getElementById("tab1").innerHTML = '< | + | document.getElementById("tab1").innerHTML = '<h2>Overview</h2><p>In this overview section, we present our most important findings based upon developing of Microbial Designs. To view the subsections of our research, refer to the tabs above.</p><h2>Business idea</h2><p>The goal of Microbial Designs is to develop genetically modified microorganisms that in different ways will be of benefit to humans all over the world. As experts in working and modifying microorganisms, we create value by developing strains with promising properties. These strains can then be further developed by companies with larger research budgets.<br><br>Initially, our main goal is to develop a Lactobacillus strain, with the ability to treat people with the disease caused by the pathogen <i>Yersinia enterocolitica</i>. The Lactobacillus strain will target the pathogen specifically, which will make it less likely that resistance to the produced antibiotic will develop. This strain will be sold to big medical companies as a promising technology for solving the problem with antibiotic resistance. These larger companies, that have larger budgets for the development of medicines, will then take responsibility for getting the medicine through further clinical studies. Our future goal is to establish a larger company, that develops strains of bacteria that specifically targets and neutralizes different pathogens, and in that way obviate the human need for antibiotics of today.</p><h2>Regulations: Intellectual Property Rights and Clinical Trials</h2><p>One of the areas of regulations that is especially important to Microbial Designs is the Intellectual Property Rights involved in getting a patent. The general criteria that must be met for a patent, novelty, industrial applicability and inventivity, seem to apply to the designer microorganisms. The open-source structure of the Registry of iGEM, however, makes successfully applying for a patent more challenging.<br><br>If you want to learn more about Intellectual Property Rights and how we can make them compatible with the Registry, see the <i>Intellectual Property Rights section</i>.<br><br>One area of regulations that is specific for the medical application of our designer microorganisms concerns clinical trials. To approve a product for clinical use, multiple stages of testing must be passed. As these clinical trials are expensive, take a long time and have a low success-rate, Microbial Designs will only focus on earlier stages or pre-clinical trials and will thereafter sell these products to larger companies.<br><br>Sweden is a country where its notoriously challenging to develop new pharmaceuticals. This is why our company would most likely aim to develop our products in the United States.<br><br>If you want to learn more about the different aspects of clinical trials, please see the <i>Clinical Trials and Regulations section</i>.</p><h2>The Market</h2><p>One of the core aspects of Microbial Designs Bactissile is that it may be an alternative treatment for pathogens that are antibiotic-resistant. The disease caused by <i>Y. enterocolitica</i> is rare and not always life-threatening. Developing the Bactissile might open ways to develop treatments for severe illnesses that are caused by antibiotic-resistant pathogens, however, and such technology could become very valuable in countries where antibiotics-resistance is wide-spread. The fact that antibiotics-resistance occurs relatively infrequently in Sweden makes for another reason to focus our activities on other parts of the world.<br><br>If you want to read more about our marketing strategy see the <i>Marketing section</i>.</p><h2>Budget & Financing</h2><p>In order to start Microbial Designs activities, we will need start-up capital. To estimate the amount of money that we will need to start developing our designer microorganisms, we have consulted a professor who himself has been involved in starting a small biotechnology company. Based on our discussions with him, we estimate that our budget consist of approximately twelve million Swedish crowns (approximately two million dollars). The corresponding cost per treatment should then be ten thousand Swedish crowns.<br><br>If you want to learn more details about the budget of Microbial Designs, see the <i>Budget section</i>.<br><br>To access this start-up capital, we will need to reach out for funding. Sources of funds for newly established businesses are venture capitalists, business angels and government programs. Microbial Designs business plan is mostly compatible with a combination of funding through the American <i>Orphan Drug Act</i> and funding through venture capitalists.<br><br>If you want to learn more about the different sources of funding and why this specific combination suits us best, see the <i>Financing section</i>.</p><h2>Reflections</h2><p>Microbial Designs is sure to meet challenges during its development. We have reflected upon the different challenges that became apparent in the different sections and how to tackle them. We have bundled these considerations in the <i>Reflections section</i>.</p>'; |
| - | document.getElementById("tab2").innerHTML = '<p> | + | document.getElementById("tab2").innerHTML = '<h2>Property Rights</h2><p>A big aspect in finding venture capitalists and other investors is to have your product patented. A patent works like a security for the investor. It ensures that no other company will copy the product and make money on it as well as ensuring that they cannot outcompete your product in the market. Without patents it is very hard to find any investors since they want a security that the investment will be profitable. This results in the company having an empty budget, if the owners do not have a big amount of money to start with.</p><h2>The fundamentals of patenting</h2><p>To understand the fundamentals of patenting we talked to Gerald Petterson, a patent attorney at Uppsala University. Petterson explained that to be able to patent your invention it has to fulfill three main requirements. To begin with, the product needs to be industrially applicable. In other words, there has to be a market for the product. For instance, our medicine is an alternative to antibiotics that will treat patients infected with <i>Yersinia enterocolitica</i>. At present, 500-800 people in Sweden are infected with <i>Y. enterocolitica</i> every year.<sup><a href="#reference1">[1]</a></sup> Since the problem with antibiotic resistance is rising, there is a growing market and demand for our medicine.<br><br>The second requirement to patent an invention is novelty. It cannot be an existing product anywhere in the world. Furthermore, it cannot be known to a professional in the subject how to make the product. This is because you cannot patent anything that is widely known already even though it has not been patented. Our product, for example, is the only treatment against <i>Y. enterocolitica</i> that consists of gene modified Lactobacillus. In addition, if the combination of genes that we have used is not known to any professional already, it is fully possible to patent it.<br><br>Lastly, the product has to have a certain level of invention. It is not possible to take an already existing product, improve it slightly and then sell it in the same market as your own product and compete with the real inventors. However, if you find a whole new application for the invention by improving it, it is possible to patent it. For example, the company “upjohn” that worked with creating new heart medicines discovered that the medicine also worked for treating hair loss. Thereby they discovered a new, not obvious area of use for the product which made it possible for them to patent it as a medicine against loss of hair.<sup><a href="#reference2">[2]</a></sup> In our case, we have made a product that has a combination of genes that have not been assembled before to use as a medicine against <i>Y. enterocolitica</i>.<br><br>Furthermore, it is good to keep in mind when patenting your product, in what country you want to patent it. Because there are not many customers in Sweden, the most profitable for our company is to get a patent in the United States since the market is bigger there.</p><h2>Patent and iGEM</h2><p>Within iGEM, successfully acquiring a patent becomes problematic, since the contest enforces an open source policy. This policy means that someone that has contributed to the BioBricks foundation will not assert any existing or future intellectual property rights against anyone for using the contributed parts. This makes the parts hard to patent since the open source policy is the complete opposite of the policy of patent.<br><br>There exists a possibility, however, to patent only the combinations of the genes that builds up the medicine that our company is selling and still contribute only the different genes one by one. Thus, the team would still contribute to the foundation and be able to patent the product itself and the technology behind it. Furthermore, this would only benefit the BioBrick foundation, as sending in all different combination of genes would make the database overflow and make it hard to search for different parts. Likewise it would be hard to use and adapt the parts in other projects. Therefore, only patenting the combination of genes with the parts assembled would be a good solution that would not interfere with the open source policy.<br><br>Another problem with getting a patent while participating in iGEM is that we will present all our results and research which interferes with the novelty requirement. This can be solved, however, by sending in a request for patent before presenting our research in the competition. Thereby our product will be protected.</p><h2>Summary</h2><p>When patenting your product there are three main criterias that the invention has to fulfill. Those criterias are: industrial application, novelty and level of invention. Our product fulfills these requirements and therefore we should be able to get a patent and thereby further evolve our company. Even though some of the iGEM policies of open source interfere with the principle of patent there are solutions that will satisfy both aspects. Only patenting the combination of genes and still sharing the basic parts to the BioBrick foundation is a solution to this issue.</p><ul class="reference"><li><a id="reference1">[1]</a>http://www.slv.se/upload/dokument/rapporter/bakterier_virus_mogel/2007_8_livsmedelsverket_riskprofil_yersinia.pdf</li><li><a id="reference2">[2]</a>http://www.belgraviacentre.com/blog/the-unusual-history-of-minoxidil/</li></ul>'; |
document.getElementById("tab3").innerHTML = '<h2>Clinical Trials & Regulations</h2><p>Before a medical product can be launched on the market, it has to undergo several tests and get approval from various national and international boards. With this in mind, we tried to incorporate these regulations in our business idea by consulting the Swedish filliate of the pharmaceutical company Roche, which deals almost exclusively with getting their medical products approved for usage in Sweden. The following text is the information, given by them, on how to get a product approved.</p><h2>Studies to be conducted</h2><p>The first step of getting a medical product approved is to thoroughly study its effects, both positive and negative. In the following list, we show the different studies that need to be carried out , listed in a chronological order.<br><br>Preclinical Studies: Made before the clinical studies and contains mostly animal testing, performed on as wide a range of animals as possible. Preclinical studies are made to make sure it is worth going forwards with clinical studies.<br><br>Clinical Trials: The expenditure of the clinical studies as well as the agencies that examine our product, are paid solely by the company itself. The success rates for clinical studies are extremely low. If the study is performed in Sweden, all phases and experiments need to be approved by a number of agencies (ethical board, pharmaceutical board, etc).<br><br>Phase 1: Performed on healthy people to calculate possible dosage and to see different effects. A small test group with about 10-20 people (the number of people used in this phase depends on the type of disease studied). Phase 1 usually gives swift results.<br><br>Phase 2: Performed on sick patients to see if there is actually any real positive effect. This involves around one hundred patients, and takes about two years.<br><br>Phase 3: A study on the medicine’s effect compared to a control-group, which can be another medicine or a “Placebo pill”. Usually a double-blind study (Neither the doctor nor the patient knows who receives the actual medicine and who got the control). This involves around one thousand patients over a 3 year monitoring period. It is the most expensive phase during the clinical trials. Companies need approval from government agencies to be allowed to continue into Phase 3 studies. Only a handful of medicines pass the Phase 3.<br><br>(Phase 4: Carried out at hospitals after the medicine has been approved in order to assure that nothing unexpected occurs. This involves around two thousand patients)<br><br>The costs for these studies amount to incredible sums, especially Phase 3. Since they are also highly time-consuming on top of their vast price tag, our small company would not be able to get the product past these clinical trials. Not being able to get past the trials means we would never be able to sell our product, which means we would need to find another way of getting our product onto the market. Therefore, we will have to get a company that can afford the trials to do them for us, probably by selling the idea to them in one of the earlier stages.</p><h2>Getting approved</h2><p>All the data from these trials are included in a “product resume” (spc-text) which is sent to a larger agency for approval, either the EMA in Europe or the FDA in USA. Approval from a region’s agency is necessary in order to get permission to sell the product in that particular region. The EMA take about a year to examine all the data. How to produce the product needs to be a part of the resume. Another text is also sent along with the resume for patients to be able to read up on the medicine.<br>During EMA’s examination there is usually a lot of communication between the agency and the company to make sure the resume looks the way they want it to. While some countries approve studies carried out in other regions (Sweden included), other countries approve only the studies performed in said country. The FDA sometimes approve medicines they consider promising and thus let them pass certain phases quicker. Compared to the EMA, the FDA have a greater history of approving biological medicines.<br>If the same medicine has the potential to be used in treating other diseases, the studies have to be redone from phase 2. The EMA and läkemedelsverket (Swedish medical agency), both look at “Side effect vs gain” and how sick patients get from said disease as factors when they make their decisions.<br><br>Getting anything associated with genetic manipulation approved in Europe is extremely difficult. Since the FDA generally approve biological medicines, USA would probably be a better first market for our medicine as it is far more likely to get approved there.</p><h2>Regulations specific to Sweden</h2><p>After being approved by the EMA, the medicines should also be approved by the Swedish agencies in order to enable sale and usage. This process is however both complicated and expensive, and the steps taken depend on the market of the medicine, which could be pharmacies or hospitals.<br><br>Medicines sold at pharmacies needs to be approved by the TLV (Swedish agency for teeth and medicine) and the first thing they will decide is, whether the medicine will be paid for by the government or the individual. If the government is being benefitted by the person, then it will bear all the expense for the treatment and the medication. However, if the person cannot give back to the society, he/she would have to bear their own expense for the medication. This means that if the target group for the medicine is young people, who in their future will be able to pay tax, the medicine will be categorised as free.<br><br>Medicines distributed at hospitals are also examined by the TLV but the final decision taken for the approval is later made at other instances. The TLV takes 60 days to examine a medicine during which they first examine a medicine’s cost versus efficiency. The pharmaceutical company have to tell them at what cost they are planning to sell the medicine. If they want to change the cost, they will have to send in another application for approval. Companies usually have to market to hospitals and doctors to increase the chances of getting it approved and used in Sweden.<br><br>Because of its many agencies and rules Sweden has a really complicated market to get into. It also means that other parts of the world would be better places for us to launch our product especially since in Sweden, even after getting your medicine through trials and getting all the approvals required, you still might not be allowed to sell it because of other swedish agencies.</p><h2>Summary</h2><p>The costs involved in conducting the preclinical and clinical studies are large. They take a long, long time to pass. Therefore, our company’s only option would be to sell the idea early. Even if we have passed the trials in Europe, Sweden in particular would be difficult, to get an approval because of their regulations and systems, as well as getting into their market. Biological medicines usually have tougher rules, but FDA have proved more likely to approve their studies. Therefore the United States would provide a more attractive and potentially better market for our product. The fact still remains though that our company, as well as all other smaller companies, will have to in someway sell the idea in an earlier stage because of long and expensive clinical trials.</p>'; | document.getElementById("tab3").innerHTML = '<h2>Clinical Trials & Regulations</h2><p>Before a medical product can be launched on the market, it has to undergo several tests and get approval from various national and international boards. With this in mind, we tried to incorporate these regulations in our business idea by consulting the Swedish filliate of the pharmaceutical company Roche, which deals almost exclusively with getting their medical products approved for usage in Sweden. The following text is the information, given by them, on how to get a product approved.</p><h2>Studies to be conducted</h2><p>The first step of getting a medical product approved is to thoroughly study its effects, both positive and negative. In the following list, we show the different studies that need to be carried out , listed in a chronological order.<br><br>Preclinical Studies: Made before the clinical studies and contains mostly animal testing, performed on as wide a range of animals as possible. Preclinical studies are made to make sure it is worth going forwards with clinical studies.<br><br>Clinical Trials: The expenditure of the clinical studies as well as the agencies that examine our product, are paid solely by the company itself. The success rates for clinical studies are extremely low. If the study is performed in Sweden, all phases and experiments need to be approved by a number of agencies (ethical board, pharmaceutical board, etc).<br><br>Phase 1: Performed on healthy people to calculate possible dosage and to see different effects. A small test group with about 10-20 people (the number of people used in this phase depends on the type of disease studied). Phase 1 usually gives swift results.<br><br>Phase 2: Performed on sick patients to see if there is actually any real positive effect. This involves around one hundred patients, and takes about two years.<br><br>Phase 3: A study on the medicine’s effect compared to a control-group, which can be another medicine or a “Placebo pill”. Usually a double-blind study (Neither the doctor nor the patient knows who receives the actual medicine and who got the control). This involves around one thousand patients over a 3 year monitoring period. It is the most expensive phase during the clinical trials. Companies need approval from government agencies to be allowed to continue into Phase 3 studies. Only a handful of medicines pass the Phase 3.<br><br>(Phase 4: Carried out at hospitals after the medicine has been approved in order to assure that nothing unexpected occurs. This involves around two thousand patients)<br><br>The costs for these studies amount to incredible sums, especially Phase 3. Since they are also highly time-consuming on top of their vast price tag, our small company would not be able to get the product past these clinical trials. Not being able to get past the trials means we would never be able to sell our product, which means we would need to find another way of getting our product onto the market. Therefore, we will have to get a company that can afford the trials to do them for us, probably by selling the idea to them in one of the earlier stages.</p><h2>Getting approved</h2><p>All the data from these trials are included in a “product resume” (spc-text) which is sent to a larger agency for approval, either the EMA in Europe or the FDA in USA. Approval from a region’s agency is necessary in order to get permission to sell the product in that particular region. The EMA take about a year to examine all the data. How to produce the product needs to be a part of the resume. Another text is also sent along with the resume for patients to be able to read up on the medicine.<br>During EMA’s examination there is usually a lot of communication between the agency and the company to make sure the resume looks the way they want it to. While some countries approve studies carried out in other regions (Sweden included), other countries approve only the studies performed in said country. The FDA sometimes approve medicines they consider promising and thus let them pass certain phases quicker. Compared to the EMA, the FDA have a greater history of approving biological medicines.<br>If the same medicine has the potential to be used in treating other diseases, the studies have to be redone from phase 2. The EMA and läkemedelsverket (Swedish medical agency), both look at “Side effect vs gain” and how sick patients get from said disease as factors when they make their decisions.<br><br>Getting anything associated with genetic manipulation approved in Europe is extremely difficult. Since the FDA generally approve biological medicines, USA would probably be a better first market for our medicine as it is far more likely to get approved there.</p><h2>Regulations specific to Sweden</h2><p>After being approved by the EMA, the medicines should also be approved by the Swedish agencies in order to enable sale and usage. This process is however both complicated and expensive, and the steps taken depend on the market of the medicine, which could be pharmacies or hospitals.<br><br>Medicines sold at pharmacies needs to be approved by the TLV (Swedish agency for teeth and medicine) and the first thing they will decide is, whether the medicine will be paid for by the government or the individual. If the government is being benefitted by the person, then it will bear all the expense for the treatment and the medication. However, if the person cannot give back to the society, he/she would have to bear their own expense for the medication. This means that if the target group for the medicine is young people, who in their future will be able to pay tax, the medicine will be categorised as free.<br><br>Medicines distributed at hospitals are also examined by the TLV but the final decision taken for the approval is later made at other instances. The TLV takes 60 days to examine a medicine during which they first examine a medicine’s cost versus efficiency. The pharmaceutical company have to tell them at what cost they are planning to sell the medicine. If they want to change the cost, they will have to send in another application for approval. Companies usually have to market to hospitals and doctors to increase the chances of getting it approved and used in Sweden.<br><br>Because of its many agencies and rules Sweden has a really complicated market to get into. It also means that other parts of the world would be better places for us to launch our product especially since in Sweden, even after getting your medicine through trials and getting all the approvals required, you still might not be allowed to sell it because of other swedish agencies.</p><h2>Summary</h2><p>The costs involved in conducting the preclinical and clinical studies are large. They take a long, long time to pass. Therefore, our company’s only option would be to sell the idea early. Even if we have passed the trials in Europe, Sweden in particular would be difficult, to get an approval because of their regulations and systems, as well as getting into their market. Biological medicines usually have tougher rules, but FDA have proved more likely to approve their studies. Therefore the United States would provide a more attractive and potentially better market for our product. The fact still remains though that our company, as well as all other smaller companies, will have to in someway sell the idea in an earlier stage because of long and expensive clinical trials.</p>'; | ||
| - | document.getElementById("tab4").innerHTML = '<h2>Product properties</h2><p>The unique characteristics of our probiotic compared to generic drugs is that our product eliminates the pathogen without using antibiotics. This is a major asset for the future marketing of our product since antibiotic resistance is a well known and severe problem, making treatment of diseases more problematic.<br><br>The product will be easy to distribute as it will be produced as a pill, making it compatible with established drugs in respect to shipping. Both probiotics and antibiotics derives from cultivations of microorganisms grown in large batches. However, in comparison to probiotic drugs, antibiotics need to be extracted and purified from such cultivations. Thus the production of probiotic will be easier and also hopefully cheaper in comparison to antibiotic production.</p><h2>Target customers and positioning strategy</h2><p>Initially, to establish our product, we intended to target the Swedish market simply because of the convenience of location. However, according to our laws and regulation research, it’s difficult to get approval from appropriate authorities for such a product. It was further concluded that a better choice of location for establishment is the United States of America, where it’s easier to get companies authorized.<br><br>Target customers are people infected by the pathogen (Yersinia enterocolitica). To reach our customers we would approach hospitals and pharmaceutical companies and promote our product. By highlighting the threat of antibiotic resistance we believe that our product will be sought. Thus we will be able to establish a market which will be of major importance for the future success of the product.<br><br>The widespread of Y.enterocolitica is relatively low and seem to be most frequent in northern Europe and as an example, the disease affects about 500 - 800 people per year in Sweden[1 | + | document.getElementById("tab4").innerHTML = '<h2>Product properties</h2><p>The unique characteristics of our probiotic compared to generic drugs is that our product eliminates the pathogen without using antibiotics. This is a major asset for the future marketing of our product since antibiotic resistance is a well known and severe problem, making treatment of diseases more problematic.<br><br>The product will be easy to distribute as it will be produced as a pill, making it compatible with established drugs in respect to shipping. Both probiotics and antibiotics derives from cultivations of microorganisms grown in large batches. However, in comparison to probiotic drugs, antibiotics need to be extracted and purified from such cultivations. Thus the production of probiotic will be easier and also hopefully cheaper in comparison to antibiotic production.</p><h2>Target customers and positioning strategy</h2><p>Initially, to establish our product, we intended to target the Swedish market simply because of the convenience of location. However, according to our laws and regulation research, it’s difficult to get approval from appropriate authorities for such a product. It was further concluded that a better choice of location for establishment is the United States of America, where it’s easier to get companies authorized.<br><br>Target customers are people infected by the pathogen (<i>Yersinia enterocolitica</i>). To reach our customers we would approach hospitals and pharmaceutical companies and promote our product. By highlighting the threat of antibiotic resistance we believe that our product will be sought. Thus we will be able to establish a market which will be of major importance for the future success of the product.<br><br>The widespread of <i>Y. enterocolitica</i> is relatively low and seem to be most frequent in northern Europe and as an example, the disease affects about 500 - 800 people per year in Sweden.<sup><a href="#reference3">[1]</a></sup><sup><a href="#reference4">[2]</a></sup> Further, most infections are uncomplicated with most cases resolving themselves without further need of treatment. Hence it’s likely that the profit will be low if selling our product in the northern Europe. However we believe that our product will function as a stepping stone in the future development of pathogen killing probiotics, which hopefully can reduce the usage of antibiotics. Hence we believe that the logical regions, for marketing our product, are those which have problems with antibiotic resistance. Regions such as the United States, the western and southern parts of Europe have been identified as having high occurrence of antibiotic resistance. Thus these regions will be our main target for marketing our product [4].</p><h2>Size of the total market</h2><p>As described previously, the market is not particularly large as the infection rate is low and only those with a compromised immune system, such as elderly people or infants, will be needing treatment. Thus making it difficult to advance our product on the relatively small market.<br><br>If antibiotic resistance emerges to a level where many bacteria will be resistant, people will be forced to step out of their comfort zones and hopefully embrace this new technology. If we can evolve our technology into targeting pathogens that poses a greater threat than <i>Y. enterocolitica</i> we believe the market will expand at a fast rate.</p><h2>Promotions strategy (Commercial)</h2><p>There are many different ways when it comes to advertising a new product. When attracting customers you want to make sure to capture their attention in a memorable way. Another important aspect is the ability to reach as many people as possible. Hence we decided to make an animated infomercial. The goal of the infomercial was to show a schematic description of our modified probiotic and how it attacks the pathogen in the intestinal region. We determined that this would be a convenient and easy way to both describe and promote our product.<br><br>A lot of focus would be aimed towards providing the commercial to the hospitals and pharmaceutical companies. It is also highly important to combine the commercial with lectures to be able to thoroughly educate about our product and its focus on preventing antibiotic resistance.</p><h2>Summary</h2><p>As mentioned earlier, the market for treating <i>Y. enterocolitica</i> does not look promising, due to its low pathogenicity. However, if we manage to develop the idea of targeting other pathogens, we can be sure it will expand into a larger and more advantageous market. If we can promote the probiotica properly, it stands a fair chance of competing against antibiotics and therefore preventing the increase of antibiotic resistance. In the long run, this will hopefully decrease the threat against future medical treatments, saving millions of lives.</p><ul class="reference"><li><a id="reference3">[1]</a>Wallén Norell , Annica et al. 2013-11-18. Infektion med <i>Y. enterocolitica</i>. www-dokument.http://www.socialstyrelsen.se/Lists/Artikelkatalog/Attachments/19253/2013-11-18.pdf (accessed: 2014-08-07)</li><li><a id="reference4">[2]</a>Brink, Erik. 2006-01-07.Yersinia vanligt i nordeuropeiskt griskött. www-dokument. http://ja.agriprim.com/nyheter/visaNyhet.asp?NyhetID=6001&highlight= (accessed:2014-08-07)</li><li>[3]Lavinsky, Dave. 2013-09-30. Marketing Plan Template: Exactly what to include. www-dokument.http://www.forbes.com/sites/davelavinsky/2013/09/30/marketing-plan-template-exactly-what-to-include/2/ (accessed: 2014-07-10)</li><li>[4]Farrar, Tabitha. 2014-07-25. Antibiotic Resistance is fast approaching. www-dokument. http://guardianlv.com/2014/07/antibiotics-resistance-is-fast-approaching/ (accessed: 2014-08-07)</li></ul>'; |
| - | document.getElementById("tab5").innerHTML = '<p> | + | document.getElementById("tab5").innerHTML = '<h2>Budget</h2><p>To be able to build a company, we must have an approximate idea of the costs that will be involved in developing new designer microorganisms. For budget planning, we have consulted Anders Virtanen, professor at the Department of Cell and Molecular Biology at Uppsala University, who himself has been involved in starting the company Bioimics. Bioimics is a biotechnology company, which mainly focuses on developing new antibacterial drugs using RNA. Although their activities do not include design and modification of bacteria, their equipment and expertise concerning our field in biotechnology will be similar to ours, and therefore we considered it as a valid source of information.<br><br>When estimating the costs that are involved in building a company, two types of costs should be distinguished. The first type consists of operating costs. These are costs that are made during the production of products. In our case, the product is a microbial design with a potential for killing pathogens and the costs involved mostly consist of disposable equipment and other materials (such as enzymes and chemicals) that are deplenished during research. The rest of the operating costs consists of wages for the employees and external services (such as sending samples for sequencing).<br><br><i>Here are some examples of operating costs for our company:</i><br></p><table id="partsT"><tr><td>Disposable material/equipment</td><td>600 (Tkr)*</td></tr><tr><td>Salaries(including insurances, taxes etc)</td><td>4500 (Tkr)*</td></tr><tr><td>External services</td><td>2000 (Tkr)*</td></tr></table><p>* Tkr = One thousand Swedish Crowns<br><br>The other type of costs that have to be considered, consist of the assets of a company. These can be viewed as the property of a company. In our case, this includes material assets, material properties, such as a research facility and the machines and equipment that are used for developing microbial designs. It also includes immaterial assets, immaterial properties such as patents, liquid assets and financial resources that are needed to run the company.</p><br><br><i>Here are a few examples of the assets needed for Microbial Designs:</i><br></p><table id="partsT"><tr><td>Equipment (machines etc)</td><td>5000 (Tkr)</td></tr><tr><td>Rent for facility</td><td>300 (Tkr)</td></tr></table><br><p>In total, the costs for the first year of Microbial Designs are estimated to be approximately twelve million Swedish crowns. Microbial Designs is mostly involved in the early development of strains, selling developed concepts in the early stages of clinical trials. To get a return on our estimated required investments, this would necessitate selling such a developed strain for multiple tens of millions of Swedish crowns.<br><br>To make such an investment appealing to a larger pharmaceutical company would require the strain to earn more money than was invested in it, that is, to split even. While it may not be necessary to split even completely in the first year, the strain’s revenues should be greater than its operating costs. In that way, the strain will make more money over time than it costs to produce it.<br><br>If we assume that the operation costs remain constant for the pharmaceutical company that has acquired the strain that was developed to target and kill <i>Y. enterocolitica</i>, a modest estimate of the yearly revenues that would be required for the strain to be profitable is nine million Swedish crowns per year. When taking into account the number of patients that are infected by <i>Y. enterocolitica</i> each year (500-800), this would mean that our price for every patient treated should be around ten thousand Swedish crowns per year.<br><br>This substantial sum of money might prove to be too high for a disease that can also be treated through antibiotics, at least for now. Furthermore, this price per patient treated does not take the steep rise of costs into account that occur during clinical trials. It is therefore questionable whether revenues of nine million Swedish crowns per year will suffice for Microbial Design’s client to profit on their investment.</p>'; |
| - | document.getElementById("tab6").innerHTML = '<p> | + | document.getElementById("tab6").innerHTML = '<h2>Financing</h2><p>One of the major challenges for starting a company is to get the start-up capital. To understand this and try to find good solutions we have held interviews with several successful entrepreneurs and made a summary of the possibilities to get funding for our first biotech startup.</p><h2>Different sources of capital</h2><p>There are several sources for a startup to get capital, each with their respective positives and negatives. We will discuss about venture capital, private capital and loans, stock market, crowd funding and funds.<br><br>Private capital is going in with your own money to support the startup. This was the most common method used by Ulf Landegren, a professor at Uppsala University that has started several companies. He told us that this is the preferred alternative since it gives you full control over the company. You will have decided what is prioritized and you do not risk it getting sold to other companies when you do not want to sell it. Although according to Vohora et al. (2003)<sup><a href="#reference7">[1]</a></sup> guidance from someone that knows business and industry is very important. You will also lose your money if the company does not break even.<br><br>Venture capital and business angels could be interesting since they do not only provide a source of capital but also experience. Venture capitalists are investors who try to make profit out of funding start-ups and then selling them off at a higher prize. Business angels are similar, but are more focused on helping your company develop. According to Landegren both venture capitalists and business angels have often taken their own loans and are therefore in need of a high return, sometimes as much as five times the invested sum. This might lead to harsh treatment of your idea where you will need to compensate and change it as they need to invest more and therefore will want more control over the company. No matter how much progress your company is doing it will also probably lead to selling of the company within ten years even if your company is doing good. This was the case with Ulfs first company which he started in USA. The company was going good and was sold off at a high profit after about 6 years.<br><br>Another alternative is the stock market, though this can often not be the single source of capital but is coupled with private capital and/or institutions. This is a tougher version of venture capitalists since they will require you to have better proof and a stronger business plan. It will give you more control of the company though, and you can choose how much you want to give away. Biogaia used this alternative together with their own capital. However, they had come further in their business and also had knowledge about industry and entrepreneurship. They do not recommend to use the stock market as a source unless you developed your company further and are good at business plans.<br><br>A new emerging source of startup capital is crowdfunding. Crowdfunding is a term for asking a lot of people to invest a small sum into your idea. Thier profit is often given via pre-orders, given credit and involvement in the process of the idea. Since the sums are often quite small you either need a cheap company to fund or a lot of people. As such, crowdfunding is suited for ideas that have a wide interest amongst the public, eg. everyday products. Making crowd funding work for medical startups can therefore be really tough, and requires you to tackle a disease which affects many and not to expect to get all of your capital via this source. Since quite a low percentage of the population worldwide gets infected with our pathogen, crowdfunding is not suitable for our project. Further on, hospitals are our main customer and will most likely not fund crowdfunding programs.<br><br>A backbone of all startups are funds. There are a large amount of possibilities but most of them do not provide enough capital to fund the entire process; they could even require you to have different sources of funding. However, by combining different funds you could come a long way. Some common Swedish funds are <i>Industrifonden</i>, governmental <i>Almi</i> and <i>Vinnova</i>. Some governments have programs to help you fund certain ideas that would not receive funding otherwise. One example of this is the Orphan Drug Act in the United States, which you can apply for if you are treating rare diseases. It provides support with both protection of your idea via enhanced patent protection and funding via clinical research subsidies. This is perfect for our idea, but would require us to put our focus on the market in the United States.<br><br>To get any of these funding options, presentation of the business idea is vital. Most startups fail to receive funding by not having a good business plan enough, and in particular not having a solid business idea.</p><h2>Summary</h2><p>Your first company should be founded by help of venture capitalist or business angels and funds. That way you will be able to get both the capital and the knowledge to make your company sustainable. Though you need to be ready to sell that company and the idea. If it works out well you will have enough money to pursue the next company with your own capital and therefore control it yourself.</p><ul class="reference"><li><a id="reference7">[1]</a> Lockett A., Vohora A., Wright M., Critical junctures in the development of university high-tech spinout companies, Elsevier 2003</li></ul>'; |
| - | document.getElementById("tab7").innerHTML = '<p> | + | document.getElementById("tab7").innerHTML = '<h2>Reflections</h2><p>A problem that we have run into during the development of our business idea concerns the profitability of our product. Diseases caused by <i>Y. enterocolitica</i> are generally mild and occur quite infrequently. This makes it unattractive for large medical companies to develop our designs further. This does not necessarily form a problem directly for Microbial Designs, however, because our design activities can initially be financed by public funding.<br><br>The public money flow, however, does not suffice for developing the design to a real-life medical treatment. To show that our designs can result in clinically valuable products, our first design needs to be further developed. In that way, the lack of profitability of our <i>Y. enterocolitica</i>-targeting bacteria results in a bottle-neck.<br><br>Microbial Designs seems to have walked in to a dead end that often traps academics, starting to work with an idea before performing a thorough market analysis. As is remarked in an article from Vohora et al. about spin-off development “universities have lots of well-developed technologies, but with little proof of concept, no proof of market, and no commercial management.” <sup><a href="#reference8">[1]</a></sup><br><br>To tackle this challenge, our strategical plan would be to redirect our efforts to a pathogen that poses a more imminent threat to human health. If these designs are then developed, it will be more attractive for established medical companies to work further with this specific design. If a design has been successfully developed by these companies that work further downstream in the development process, this will prove the promise of designing microbes for combating disease. Furthermore, it will add a brand new treatment to the inventory that is available for doctors that are fighting antibiotic-resistant diseases.</p><ul class="reference"><li><a id="reference8">[1]</a> Vohora A, Wright M, Lockett A. 2004. Critical junctures in the development of university high-tech spinout companies. Res Policy 33: 147-175.</li></ul>'; |
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Latest revision as of 20:59, 17 October 2014
Stephanie Herman
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