Team:Uppsala/PolicyPractices MicrobialDesigns
From 2014.igem.org
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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 (<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="# | + | 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 = '<br><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("tab5").innerHTML = '<br><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>'; |
Revision as of 14:54, 17 October 2014
Microbial Designs
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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.
Business idea
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.
Initially, our main goal is to develop a Lactobacillus strain, with the ability to treat people with the disease caused by the pathogen Yersinia enterocolitica. 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.
Regulations: Intellectual Property Rights and Clinical Trials
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.
If you want to learn more about Intellectual Property Rights and how we can make them compatible with the Registry, see the Intellectual Property Rights section.
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.
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.
If you want to learn more about the different aspects of clinical trials, please see the Clinical Trials and Regulations section.
The Market
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 Y. enterocolitica 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.
If you want to read more about our marketing strategy see the Marketing section.
Budget & Financing
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.
If you want to learn more details about the budget of Microbial Designs, see the Budget section.
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 Orphan Drug Act and funding through venture capitalists.
If you want to learn more about the different sources of funding and why this specific combination suits us best, see the Financing section.
Reflections
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 Reflections section.