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("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>';