How iGEM Guelph determined that BloomBiota is both responsible and good for the world

 

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Introduction

 

Vitamin B12, or Cobalamin, is an essential nutrient, and without adequate levels, vitamin deficiency can occur. Vitamin B12 deficiency can lead to pernicious anemia and other health issues, as vitamin B12 deficiency is far reaching and impacts many areas of human health including neurological problems, anemia and cardiovascular issues and fertility/pregnancy complications (Al-Awami et al., 2023; Ankar & Kumar, 2022; Stabler, 2013).

 

A crucial factor in vitamin B12 deficiency is the gastric intrinsic factor (Al-Awami et al., 2023). Without functional levels of the gastric intrinsic factor (GIF), vitamin B12 deficiency and related health issues occur as this protein is essential for the transportation of vitamin B12 to the intestines, where it will be absorbed into the bloodstream (Al-Awami et al., 2023; Ankar & Kumar, 2022; Pepper & Black, 2011; Stabler, 2013).

 

As aging happens, lower levels of GIF occur, which results in the elderly being more susceptible for vitamin B12 deficiency (Rémond et al., 2015). With low levels of GIF, even if someone were to take supplements, they would be unable to properly absorb the vitamin B12 and thus, the supplements would be ineffective in curing their deficiency. This makes the need for a way to increase GIF levels within the human body imperative, hence the creation of our team’s project BloomBiota - a probiotic containing the gastric intrinsic factor to help with vitamin B12 absorption.

 

With millions affected by this deficiency and its far reaching health impacts, it is imperative to explore and better understand stakeholder needs. On this page, we unveil the multifaceted initiative undertaken to bridge the gap between science innovation and its impact on humanity. Through a lens of ethical considerations, community engagement and outreach, we can achieve a well-rounded project that considers the real world implications of our project and those that are impacted by it.

   

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Stakeholder Analysis

 

Embarking on our entrepreneurial journey, we recognized the paramount importance of anchoring our project in foundational values. The foundational values our team identified were sustainability, low environmental impact, accessibility and quality.

 

Our business team undertook a compressive market analysis to discern the key stakeholders in our project’s sphere of influence. It became clear that our primary stakeholders encompassed individuals affected by vitamin B12 deficiency, healthcare workers, and experts in gut and nutrition health. With their input, we refined our project to ensure it addressed the specific needs and concerns of those impacted by this health issue.

 

These stakeholders were identified through a stakeholder brainstorm and encompass a diverse array of expertise and perspectives, each contributing a unique facet to our project’s development and implementation. Below we identify and rationalize which stakeholders we believe are fundamental to a probiotic project.

 

 

Project Managers  

Their proficiency in project coordination and risk assessment guides us in maintaining a well-structured and efficient workflow.

  Government Representatives  

Their insights into regulatory compliance and ethical considerations ensure that our project aligns with broader societal values and legal frameworks.

  Community Leaders  

Engaging with local community leaders allows us to understand public perceptions, address concerns, and garner support for our initiative.

  Industry Experts  

Their specialized knowledge provides invaluable insights into market trends, potential applications, and strategies for successful commercialization.

  Marketers  

Marketing professionals offer expertise in effectively communicating the value proposition of our project to target audiences and stakeholders.

  University and Academic Advisors  

Their academic guidance and access to resources contribute significantly to our research and development efforts.

  Food Production Specialists  

Their expertise in food safety, quality assurance, and regulatory requirements is pivotal, particularly for projects related to food and nutrition.

  Investors  

By providing financial support and strategic insights, investors play a crucial role in realizing the potential of our project.

  Healthcare Professionals  

Their perspectives on public health impact, patient considerations, and clinical relevance are integral to the success of health-related projects.

  Environmentalists and Ecosystem Experts  

These experts evaluate potential environmental impacts and offer recommendations for sustainable practices, aligning our project with ecological well-being.

   

The engagement of diverse stakeholders helps us consider the broader implications and applications of BloomBiota. By incorporating varied perspectives, we aim to create a project that is not only innovative but also ethically sound, socially responsible and environmentally conscious.

   

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Consumers

 

Our target market is segmented (as identified in our Entrepreneurship page) and as such, our main target customers are the aging population, and vegans/vegetarians, lower income individuals along with the general population. To get a sense of vitamin and probiotic usage within our local community, we shared a survey with the student and faculty population on campus. The survey included questions about gender, age, education background, home situation, income, probiotic and vitamin usage, and reasons for probiotic usage.

 

This engagement has been a crucial aspect of our stakeholder communication strategy. Notably, the data revealed some key trends that are highly pertinent to our project. With over 75% of respondents being female, and the majority falling in the 18-20 year age range, it highlights a specific demographic that we should aim to serve. Additionally, a significant portion of respondents were in their undergraduate years, with no previous post-secondary degree or diploma. Most were residing away from home or on campus, although the second most common response was that respondents lived at home. Their diverse income ranges, spanning from below 20,000 to over 100,000, underscore the broad socioeconomic spectrum within the student population. It is significant to note that a substantial 76% of respondents already incorporate vitamin or probiotic supplements into their routines, with multivitamins being the most common. Understanding these preferences and habits allows us to tailor our project to meet the needs of our targeted customers effectively.

   

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Pharamacies and Medical Clinics

 

During our Human Practices work, we engaged with various pharmacies to gain valuable insights into the intricacies of vitamin B12 and conditions and medications that interact with it, and potentially interfere with its absorption. Our focus was on understanding the potential drug interactions, particularly with commonly prescribed medications like Metformin and proton pump inhibitors. The pharmacies provided us with informative printouts detailing these drug interactions, reassuring us that individuals can still remain on these medications without adverse effects while taking vitamin B12 supplements. There were also studies that supported these findings, although other studies suggest that while on certain drugs vitamin B12 levels may decrease and lead to deficiency (Kim et al., 2014; Singla et al., 2019). Another pharmacy stated that there were no commonly prescribed antibiotics or medicines that interact with vitamin B12 in their practice, although this could be different in another practice. Additionally, it was emphasized that while pharmacies are capable of filling prescriptions for vitamin B12 shots, they do not have the capacity to administer them, as only nurses or doctors are capable of administering vitamin B12 shots in Ontario, although nurses will commonly vaccinate in clinics. As such, the lack of necessity for a medical professional that is capable of administering a vaccine since a probiotic can be bought over the counter, highlights a significant consideration for our project's implementation. Furthermore, it was noted that vitamin B12 shots were recommended for those 30 years and older, although it is rare for 30 year olds to need a vitamin B12 shot and it is more common for 50 year old and up patients to receive vitamin B12 shots. One pharmacy noted that out of their approximately 50 patients per day they’d have 12 patients pick up vitamin B12 supplements and the attached clinic said that they administer the vitamin B12 shot to approximately 4 or 5 patients per week.

 

This stakeholder interview provided us with crucial information and strengthened our understanding of the practical implications of our work in the context of real-world healthcare practices.

   

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Intellectual Property

 

During our meeting with David Hobson, a Manager at the Research Innovation Office on campus, we were imparted invaluable insights into the delicate balance between patents and trade secrets, a decision that significantly shapes the trajectory of innovation. Emphasizing the ability to potentially protect a project through patents, he guided us through the stringent criteria a patent must meet, shedding light on the intricate process of patent application and its subsequent timeline. David outlined the three critical criteria that any patent must meet: novelty, utility/usefulness and non-obviousness. He emphasized that the non-obvious criteria is often hard to meet in the field of genetics.

 

David's counsel also delved into the finer details of patent application, highlighting that patents are only valid for 20 years from the application date and that it typically takes around five years to secure one, thus leaving patent holders with only 15 years of protection. Moreover, David provided crucial insights into potential patent eligibility for our project. With a discerning eye, he guided us through the two types of patents we could potentially pursue: one concerning the composition of the plasmid, and another focused on the genetically engineered strain. Furthermore, David addressed the geographical scope of patents, emphasizing that they are specific to individual countries. This highlighted the need for a tailored approach, ensuring that we target countries where our project could have a significant impact. His recommendation to present and weigh the importance of patenting based on feedback illuminated the need for a thoughtful and strategic approach.

 

As we delved deeper into the realm of genetic engineering, David’s expertise illuminated the critical distinction between patents and trade secrets, particularly within the probiotic industry. He emphasized the need for secrecy during the early stages of project development and that while patents are a powerful tool, they may not offer the desired level of protection. For instance, most probiotic companies are sold as trade secrets rather than patented goods, as their ingredient list will say something to the effect of “made with a proprietary mixture of bacterial species”, so patent applications are published approximately 6 months after application and thus the science becomes publicly available. His comprehensive overview underscored the strategic considerations that underpin intellectual property decisions, equipping us with the knowledge to navigate this complex terrain.

 

Moreover, David’s pragmatic advice extended beyond the laboratory, touching on key aspects of market analysis, stakeholder engagement and venture capital investment. His emphasis on understanding customer needs and market validation resonated strongly, reinforcing the importance of aligning our project with real-world demands. Additionally, David’s comprehensive overview of venture capital investments shed light on the key considerations that guide investment decisions, emphasizing the value of a coachable, experienced team. He provided a deep dive into what investors truly value - high probability of substantial return, emphasizing the importance of projects that can potentially generate significant revenue, ranging from thousands to millions. He pointed out that investors seek ventures that are more likely to “cross the finish line” and make a substantial impact.

 

David also delved into the risk considerations that play a pivotal role in investment decisions. He contrasted the risk associated with early-stage drug development with that of ventures like food delivery apps, underscoring that ventures in the drug space require nearly bulletproof scientific evidence due to the higher levels of risk involved. His insights highlighted the importance of minimizing risk in our project's development, particularly if we aim to attract venture capital investment.

 

As we move forward, David’s invaluable counsel will undoubtedly serve as a guiding compass, informing our decisions and propelling our project towards impactful and sustainable outcomes.

   

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John F. Wood Centre for Business and Student Enterprise

 

During our stakeholder meeting with the Woods Centre, we were provided with invaluable insights into entrepreneurship programs tailored to our project. They offered expert advice on the initial steps, specifically to start with market research, and ultimately move onto stakeholder engagement, to validate the importance and “sales factor” of our project. Moreover, they introduced us to campus programs that align with our venture, including a comprehensive start program. The Woods Centre's attentive listening to our pitch underscored their dedication to supporting our entrepreneurial journey.

   

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Project Management

 

In our stakeholder meeting with Mike, an expert in Project Management with a background in food production and quality assurance, we delved into critical aspects of our project’s management and risk analysis. The conversation began with a comprehensive discussion on risk factors and how they play a pivotal role in project success.

 

Our stakeholder emphasized the need to identify both positive and negative risks, highlighting that positive risks enhance the project while negative risks have the potential to derail it. They stressed the importance of a well-structured risk register, providing a detailed record of identified risks, responses, and lessons learned for future reference. For more details about our developed risk analysis, read our Entrepreneurship page.

 

The discussion then transitioned into the realm of quality assurance in food production, a domain where our stakeholder's extensive expertise shone through. They elucidated the meticulous process of writing product requirements and determining the desired quality, underlining its critical role in ensuring a successful outcome. They emphasized the need for rigorous adherence to Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP) standards, especially when dealing with products that have a direct impact on health, such as our probiotic.

 

Furthermore, our stakeholder elucidated the significance of a certificate of analysis for each probiotic package, an essential component to guarantee the quality and safety of our product. This certification process ensures that the probiotic meets all specified requirements, including absence of side effects, compliance with federal and provincial regulations, and longevity of shelf life.

 

In addition to these invaluable insights, our stakeholder provided a framework for stakeholder analysis, distinguishing between internal and external stakeholders. They emphasized the importance of considering the interests and concerns of each group, from the team and PIs to potential end users like healthcare workers, the general population, and regulatory bodies.

 

Overall, this stakeholder interview provided us with a wealth of expertise and guidance in project management, especially within the context of food production and quality management.

   

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Experts

 

Our project has been greatly enriched by the invaluable support and guidance we received from several on-campus Professors and researchers - namely Dr. Allen-Vercoe, Dr. Ayesha Ali, and Dr. Shapiro and Dr. Seah. Dr. Allen-Vercoe’s expertise has played a pivotal role in shaping our project, offering not only insightful advice but also generously providing access to essential lab space and equipment. In tandem with Dr. Ali, who’s expertise has been imperative in the development of a computational model to show how our probiotic functions within the human body and to simulate the behavior of our probiotic in various bodily environments, a critical aspect of our project. For a more detailed exploration of this modeling work, we encourage you to read the Modeling page. Additionally, the invaluable contributions of our PIs, Dr. Seah and Dr. Shapiro, who boast extensive knowledge in genome editing and bacterial systems, have been integral in fine-tuning our approach. Their guidance serves as a cornerstone of our project's success and moreover as our internal stakeholders have provided crucial support.

   

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Conclusion

 

The stakeholder meetings conducted throughout our iGEM journey have been instrumental in shaping the trajectory of our project. Engaging with experts in various fields, from genetic engineering to project management and healthcare, provided us with invaluable insights and practical guidance. These interactions helped us identify potential risks, refine our project approach, and gain a deeper understanding of the real-world implications of our work.

   

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Project Reflection and Important Consideration

 

Upon reflecting on our project, BloomBiota, several critical considerations have emerged.

  Regulatory Compilance  

Our stakeholder meetings highlighted the importance of adhering to federal and provincial regulations, especially in the context of producing a product with direct health implications like our probiotic. Ensuring compliance with Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP) standards is paramount.

  Quality Assurance  

The need for a rigorous quality assurance process, including obtaining a certificate of analysis for each probiotic package, cannot be overstated. This ensures that our product meets specified requirements and adheres to safety standards.

  Risk Management  

Our discussions with project management experts emphasized the significance of thorough risk analysis. Identifying and mitigating potential risks, both positive and negative, is essential for project success.

  Drug Interactions  

The stakeholder meetings with pharmacies shed light on important drug interactions, particularly with medications like Metformin and proton pump inhibitors. Understanding these interactions will be crucial for the safe implementation of our project.

  Administration Consideration  

It is crucial to bear in mind that while pharmacies can fill prescriptions, they may not have the capacity to administer them. This logistical consideration will be pivotal in the implementation of our project.

  Stakeholder Engagement  

While we engaged with a diverse set of stakeholders, it is important to consider if there are any additional stakeholders we may have overlooked. For instance, professionals or organizations specializing in environmental impacts can help evaluate the potential ecological effects of our project. They can also provide guidance on sustainable practices to ensure that our probiotic production aligns with environmentally conscious principles. Also, engaging with experts from the city’s water program can provide crucial insights into water quality standards and potential implications of introducing a probiotic strain into water systems. Understanding any regulatory considerations or safety measures related to water quality is essential. As emphasized by our Intellectual property expert, having a well-defined marketing strategy is key to the success of any project. Engaging with marketing professionals or agencies can help develop effective communication strategies, target audience identification, and brand positioning for your probiotic product. Furthermore, connecting with local regulatory bodies and authorities can help ensure compliance with regional guidelines and standards. They can provide crucial information on permits, licensing, and any specific regulations that may apply to your project. These would be the next stakeholders that our team would reach out to.

   

In summary, our stakeholder meetings have been invaluable in refining our project approach and ensuring that we consider all pertinent factors for a successful implementation. By incorporating these important considerations, we are poised to navigate the complexities of genetic engineering and make a meaningful impact in the field of synthetic biology.

   

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References

 

Al-Awami, H. M., Raja, A., & Soos, M. P. (2023). Physiology, Gastric Intrinsic Factor. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK546655/

Ankar, A., & Kumar, A. (2022). Vitamin B12 Deficiency. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK441923/

Kim, A. H., Chung, I., Yoon, S. H., Yu, K. S., Lim, K. S., Cho, J. Y., Lee, H. Jang, I. J., & Chung, J. Y. (2014). Drug Metabolism and Disposition: the biological fate of chemicals, 42(7), 1174-1179. https://doi.org/10.1124/dmd.113.055616

Singla, R., Garg, A., Surana, V., Aggarwal, S., Gupta, G., & Singla, S. (2019). Vitamin B12 Deficiency is Endemic in Indian Population: A Perspective from North India. Indian Journal of Endocrinology and Metabolism, 23(2), 211-214. https://doi.org/10.4103/ijem.ijem_122_19Stabler, S. P. (2013). Vitamin B12 Deficiency. The New England Journal of Medicine, (368), 149-160. https://doi.org/10.1056/NEJMcp1113996

Pepper, M. R., & Black, M. M. (2011). B12 in fetal development. Seminars in Cell & Developmental Biology, 22(6), 619-623. https://doi.org/10.1016/j.semcdb.2011.05.005

Rémond, D., Shahar, D. R., Gille, D., Pinto, P., Kachal, J., Peyron, M.-A., Dos Santos, C. N., Walther, B., Bordoni, A., Dupont, D., Tomás-Cobos, L., & Vergères, G. (2015). Understanding the gastrointestinal tract of the elderly to develop dietary solutions that prevent malnutrition. Oncotarget, 6(16), 13858–13898. https://doi.org/10.18632%2Foncotarget.4030

 

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