Team:Groningen/Template/MODULE/PP/FP/application

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APPLICATION SCENARIO
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We are now in the year 2028, the world population has increased to over 8 billion people, putting an ever increasing pressure on healthcare to maintain a good livelihood for all. After facing major problems regarding antibiotic resistance in the early ten’s, a different kind of product was developed and marketed that could regulate the use of antibiotics and prevented the development of any resistant strains. Due to a well-defined implementation strategy of this technology in society, and by creating specific safeguards in the product, the rise of resistant strains has been brought to a halt. This story outlines the history of LactoAid, explaining how this product came to be and why it is such a success in modern healthcare.
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It all started with the development of the concept by a group of students: to have a bandage that only produces antimicrobial compounds when needed, contrary to applying loads of antimicrobial compounds in advance (thus increasing the risk of developing resistant strains). A bandage that gradually releases antibiotics was one of the first ideas. Although this might prolong the use of a single bandage, thereby reducing the risk of infection, it still applied antibiotics in a preventive way. Also, electronic systems could be a carrier for this concept, but these were quickly discarded due to their limited applicability on the relatively small burn wounds, and given the high manufacturing costs involved. After this, it was argued that a perfect host to hold such a system would be a single-celled organism; a bacterium. Bacteria are small, easy to produce, and can be engineered to fulfil specific functions. However, the field of synthetic biology was just starting to emerge. Not much was known about the implications of messing around with the DNA of living organisms, resulting in societal hesitance to accept this new technology. To reduce the scope of the project, it was decided to take burn wounds as a case-study for such a concept. At a later stage in the product development, the bandage was also developed to fit other types of wounds.
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The initial arguments against the implementation of GMO bacteria in a healthcare environment were mainly related to ethical and societal issues. Questions like; do the bacteria go into the wound? What is the risk of the bacteria getting out of the bandage into the environment? Is there a safeguard in case the bacteria leak out of the bandage? What are the chances of the bacteria mutating into a harmful pathogen? And many more. After these issues were addressed in the design of the bandage, as well as in the genetic design of the organism itself, the further development of the product was initiated. First of all, investors and strategic partners needed to be found to allow the full-scale deployment of this bandage. These were particularly important with regard to the scale of this project and to acquire funding (see timeline). These partners and investors were found by contacting research institutes and global health organizations (WHO, Red Cross).
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The full programme – from the concept generation to the product launch – was organized as a joint venture. Many parties from different industries were involved, and these were led by the group of students that started the project. It must be noted the large pharmaceutical companies (Bayer, GlaxoSmithKline, Astrazeneca) were hesitant in the initial stage of product development, but contributed at a later stage when the demand for novel antibiotic moderators became crystal clear. A list of all parties involved in the final stage of the product development:
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All healthcare related organizations/companies
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<div class="item">Hospitals</div>
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<div class="item">Burn wound centres</div>
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<div class="item">WHO</div>
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<div class="item">Red Cross</div>
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<div class="item">Insurance companies</div>
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<div class="item">Big pharma (at a later stage)</div>
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Consumer-organizations
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<div class="item">First-aid kits including infection detection.</div>
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<div class="item">Bandages to be bought in pharmacies.</div>
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The final product development, as described in the timeline, started in 2015 by generating different designs and testing their techno-economic feasibility. By 2018 the primary research and development was finalized, and the functionality of the best 5 designs could be tested in the lab (e.g. animal experiments) in the preclinical stage. The clinical trials were held between 2020-2026, after which all documentation was submitted to the EMA and FDA for approval regarding safety, risk and quality of the bandage. In 2027, both the FDA and EMA granted their approval for the LactoAid.
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It was a difficult road to market, especially regarding regulatory and safety issues, but finally the worldwide demand of this type of bandage was sufficient to drive the final development and make it through trials. Nowadays, the bandage is used in hospitals all over the world to treat open wounds. A consortium of companies and research institutes has been tasked to oversee the production and regulate the use of this bandage. This consortium is led by the WHO. There is no problem anymore with multi-resistant strains, and wounds can easily be kept clean throughout a patient’s stay. There is even talk of a LactoAid 2.0 (now in trials) that is genetically tweaked to produce growth factors. These are substances that stimulate cell growth. The result will be a super bandage that has the ability to heal certain wounds even faster.
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The application of LactoAid is best explained through an exemplary patient that enters a regular hospital:
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<div class="item">1. A patient enters the hospital, is heavily burned all over his/her body with 2nd and 3rd degree burn wounds.</div>
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<div class="item">2. The wounds are cleaned and then left to rest for three days to assess the severity of the wounds.</div>
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<div class="item">3. During these three days, the wound is protected by LactoAid. </div>
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<div class="item">4. After three days the wounds are found to be severe, and a skin transplant is needed.</div>
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<div class="item">5. The wound is rinsed again, and the skin transplant takes place. This needs to be done in multiple sessions due to the heavy impact the operation has on the body. This leads to a lot of time in which the wounds need to be kept clean. Therefore, LactoAid is again applied to the wound in the time between the operations. </div>
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<div class="item">6. As a result; A) patients suffer less because there is no free air flow over the wounds, B) the wound is protected by the bandage from environmental pathogens, C) pathogens already in the wound are killed by the bandage, reducing the frequency of reducing the bandage, D) wounds are healed quicker, cutting costs.</div>
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<div class="item">7. After every use (3-4 days), the bandage is deactivated and all modified bacteria are killed. Two systems are used to ensure no modified bacteria survive: A) after 3-4 days all nutrients are gone, B) a kill switch is activated by releasing an inducing compound within the bandage.</div>
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References:
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<div class="item"><a href="http://www.emergogroup.com/resources/videos-ce-marking">Emergo Group</a></div>
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<div class="item"><a href="http://www.bayerpharma.com/en/research-and-development/processes/index.php">From molecules to medicine</a></div>
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<div class="item"><a href="http://ec.europa.eu/health/medical-devices/files/meddev/2_1_3_rev_3-12_2009_en.pdf">European Commission ‘Cosmetics & medical devices’</a></div>
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<div class="item"><a href="https://2014.igem.org/Team:Groningen:PP:Martini">Various interviews with people from the burn wound centre Groningen</a></div>
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Revision as of 09:09, 17 October 2014

APPLICATION SCENARIO
 
We are now in the year 2028, the world population has increased to over 8 billion people, putting an ever increasing pressure on healthcare to maintain a good livelihood for all. After facing major problems regarding antibiotic resistance in the early ten’s, a different kind of product was developed and marketed that could regulate the use of antibiotics and prevented the development of any resistant strains. Due to a well-defined implementation strategy of this technology in society, and by creating specific safeguards in the product, the rise of resistant strains has been brought to a halt. This story outlines the history of LactoAid, explaining how this product came to be and why it is such a success in modern healthcare.
 
It all started with the development of the concept by a group of students: to have a bandage that only produces antimicrobial compounds when needed, contrary to applying loads of antimicrobial compounds in advance (thus increasing the risk of developing resistant strains). A bandage that gradually releases antibiotics was one of the first ideas. Although this might prolong the use of a single bandage, thereby reducing the risk of infection, it still applied antibiotics in a preventive way. Also, electronic systems could be a carrier for this concept, but these were quickly discarded due to their limited applicability on the relatively small burn wounds, and given the high manufacturing costs involved. After this, it was argued that a perfect host to hold such a system would be a single-celled organism; a bacterium. Bacteria are small, easy to produce, and can be engineered to fulfil specific functions. However, the field of synthetic biology was just starting to emerge. Not much was known about the implications of messing around with the DNA of living organisms, resulting in societal hesitance to accept this new technology. To reduce the scope of the project, it was decided to take burn wounds as a case-study for such a concept. At a later stage in the product development, the bandage was also developed to fit other types of wounds.
 
The initial arguments against the implementation of GMO bacteria in a healthcare environment were mainly related to ethical and societal issues. Questions like; do the bacteria go into the wound? What is the risk of the bacteria getting out of the bandage into the environment? Is there a safeguard in case the bacteria leak out of the bandage? What are the chances of the bacteria mutating into a harmful pathogen? And many more. After these issues were addressed in the design of the bandage, as well as in the genetic design of the organism itself, the further development of the product was initiated. First of all, investors and strategic partners needed to be found to allow the full-scale deployment of this bandage. These were particularly important with regard to the scale of this project and to acquire funding (see timeline). These partners and investors were found by contacting research institutes and global health organizations (WHO, Red Cross).
 
The full programme – from the concept generation to the product launch – was organized as a joint venture. Many parties from different industries were involved, and these were led by the group of students that started the project. It must be noted the large pharmaceutical companies (Bayer, GlaxoSmithKline, Astrazeneca) were hesitant in the initial stage of product development, but contributed at a later stage when the demand for novel antibiotic moderators became crystal clear. A list of all parties involved in the final stage of the product development:
 
All healthcare related organizations/companies
 
Hospitals
Burn wound centres
WHO
Red Cross
Insurance companies
Big pharma (at a later stage)
 
 
Consumer-organizations
 
First-aid kits including infection detection.
Bandages to be bought in pharmacies.
 
 
The final product development, as described in the timeline, started in 2015 by generating different designs and testing their techno-economic feasibility. By 2018 the primary research and development was finalized, and the functionality of the best 5 designs could be tested in the lab (e.g. animal experiments) in the preclinical stage. The clinical trials were held between 2020-2026, after which all documentation was submitted to the EMA and FDA for approval regarding safety, risk and quality of the bandage. In 2027, both the FDA and EMA granted their approval for the LactoAid.
 
It was a difficult road to market, especially regarding regulatory and safety issues, but finally the worldwide demand of this type of bandage was sufficient to drive the final development and make it through trials. Nowadays, the bandage is used in hospitals all over the world to treat open wounds. A consortium of companies and research institutes has been tasked to oversee the production and regulate the use of this bandage. This consortium is led by the WHO. There is no problem anymore with multi-resistant strains, and wounds can easily be kept clean throughout a patient’s stay. There is even talk of a LactoAid 2.0 (now in trials) that is genetically tweaked to produce growth factors. These are substances that stimulate cell growth. The result will be a super bandage that has the ability to heal certain wounds even faster.
 
The application of LactoAid is best explained through an exemplary patient that enters a regular hospital:
 
1. A patient enters the hospital, is heavily burned all over his/her body with 2nd and 3rd degree burn wounds.
2. The wounds are cleaned and then left to rest for three days to assess the severity of the wounds.
3. During these three days, the wound is protected by LactoAid.
4. After three days the wounds are found to be severe, and a skin transplant is needed.
5. The wound is rinsed again, and the skin transplant takes place. This needs to be done in multiple sessions due to the heavy impact the operation has on the body. This leads to a lot of time in which the wounds need to be kept clean. Therefore, LactoAid is again applied to the wound in the time between the operations.
6. As a result; A) patients suffer less because there is no free air flow over the wounds, B) the wound is protected by the bandage from environmental pathogens, C) pathogens already in the wound are killed by the bandage, reducing the frequency of reducing the bandage, D) wounds are healed quicker, cutting costs.
7. After every use (3-4 days), the bandage is deactivated and all modified bacteria are killed. Two systems are used to ensure no modified bacteria survive: A) after 3-4 days all nutrients are gone, B) a kill switch is activated by releasing an inducing compound within the bandage.
 
 
References:
 
Emergo Group
From molecules to medicine
European Commission ‘Cosmetics & medical devices’
Various interviews with people from the burn wound centre Groningen
 
 
 
 
 

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