Partnership
Improving health of the digestive system: Partnership with the Stockholm iGEM Team 2022
It all started with a message in the iGEM 2022 global Slack channel and lasted until the end of the iGEM season 2022: our partnership with the Stockholm iGEM Team 2022! The fundamental pillars of our partnership are based on the shared aim of improving patients' quality of life and reducing the suffering caused by gastrointestinal conditions: IBD and pernicious anemia respectively. We both aim to bring our project from bench to bedside and have a similar path to follow ahead of us. Our partnership focused on the human practices area of our projects by mainly addressing the following areas:
- Understanding the market approval and regulatory process of our respective countries to shape future preclinical and clinical testing
- Education and science communication on vital functions of the digestive system to raise awareness about the importance of this system
- Biweekly mentoring and troubleshooting sessions
Understanding market approval: European Medicines Agency(EMA) and Swissmedic
We each presented our projects to our respective agencies, EMA and Swissmedic and received clarifications regarding the market authorisation processes.
EMA
This text was kindly provided by iGEM team Stockholm.
The European Medicines Agency (EMA) is an agency which coordinates the assessment of new medicinal products in the European Union. The EMA has around 1000 employees, while each national drug agency usually has around 500 - 1000 employees. We got in touch with Lorenzo Montrasio, with whom we discussed the workings of the EMA and he was able to give us clear explanations. Lorenzo has experience working for the Italian medicines agency and has represented it at the EMA. For the EMA, the process starts with an application from a company, having gathered all relevant data and completed clinical trials. The data is compiled into a dossier and presented to the EMA, at the headquarters in Amsterdam. The dossier will be picked up and discussed among experts and national authorities. One national agency, with one expert, will be assigned to assess the dossier within their national agency. Regularly, experts from all EMA countries meet to discuss ongoing assessments and every national agency can provide feedback and questions about any open dossier. These questions are discussed and pertinent ones are sent to the applicant. These questions can be requests to generate new data, but in most cases they aim to clarify existing data. The company then has to reply to the requests by making the appropriate adjustments. The experts can also decide to send an inspection to the clinical trial site if they suspect fabrication of results. Finally, the EMA gives an opinion about whether the medicinal product should get market authorisation or not, and sends it to the European Commission for legislative approval. Once approved, the product can be sold in any EU nation. If the application is rejected, the company has the possibility to appeal the decision of the European Commission.
Swissmedic
Swissmedic is the authority responsible for authorising and supervising therapeutic products in Switzerland. Hence, we reached out to their contact office to understand the requirements of submitting a clinical trial permit, a prerequisite for market approval. Feedback on the application for a clinical trial permit concerning the use of genetically engineered bacteria revealed that Swissmedic works closely with other federal institutions. When research with genetically modified organisms (GMOs) is conducted, additional data evaluating the risks for the environment and humans is essential for application documents. Therefore, we contacted the federal office for the environment (FOEN). We talked to Dr. Andrea Bonini, a scientific collaborator of the federal coordination centre for biotechnology. We could present our project (using synthetic biology to develop a novel treatment option for inflammatory bowel disease (IBD) based on genetically modifying a probiotic bacterium) to him. Dr. Bonini kindly involved experts critical to addressing our questions. Dr. Ursula Jenal (FOEN) provided us with material to understand how to assess the risks related to the first-time application of genetically modified organisms for clinical purposes. The application for a clinical trial with genetically modified organisms that can be excreted in the environment requires extensive preclinical analysis. Swissmedic demands the submission of data on the handling and production of GMOs, environmental risk mitigation and their preclinical data. To summarise, an application for a clinical trial permit is submitted to Swissmedic, which discusses its approval with other federal institutions. Positive feedback leads to a five-year permit that is additionally monitored by the local cantonal authorities. Up to now, there is no approved GMO-based therapy in Switzerland.
Conclusion
In both cases, relevant information is scattered on multiple webpages and in numerous documents, which means that getting a clear picture can be challenging, especially for teams or companies starting out with their medical product. In the Swiss case, more focus is put on the clinical trials authorisation since it is an integral part of the drug approval process. For the EU, the clinical trials are performed at the national level, which means that the EMA’s market authorisation process is disconnected from the clinical trials.
Integration of the general public and promote education on the importance of the gastrointestinal tract
We have dedicated many virtual meeting sessions to discussing the best approaches and teaching methods to engage with the public effectively. We have brainstormed how to increase awareness about pernicious anaemia and IBD by highlighting the impaired functions in the respective condition of focus. We figured that vitamins and the gut microbiome could be intersected and coherently combined to show a glimpse into the many functions of the gut. Therefore, we have designed a poster to explain the concepts behind the importance of the gut microbiota combined with the uptake and functions of vitamins.
Mentoring and support
The chemistry between our teams was great from the beginning and therefore we felt like our meetings were the perfect place to discuss current challenges and successes. We regularly updated each other on how to effectively manage and organize our iGEM teams and compared our experiences on essential topics like fundraising and project design. We discussed our project's experiments and results which helped us understand our current limitations and gave new perspectives on how to improve and aim for the best project possible.
