document.getElementById("tab1").innerHTML = '<br><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 or follow the link that is presented at the short description of the subsections below.</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 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.</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 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.<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("tab1").innerHTML = '<br><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 or follow the link that is presented at the short description of the subsections below.</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 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.</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 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.<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("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>';