Mr. Garrett Edmunds is a Licensing Manager for the FSU Office of Commercialization. The Entrepreneurship team engaged in a crucial discussion with Mr. Edmunds, delving into the intricate aspects of our market strategy once our probiotic demonstrates its effectiveness in oxidizing TMA (Trimethylamine). This conversation created a roadmap that lies ahead for our project.

The foresight gleaned from this meeting underscored the importance of long-term planning, emphasizing that our journey extends well into the future, spanning a horizon of 5 to 10 years. One pivotal realization was the impending need for securing a patent to protect our innovative probiotic solution. As we progress, our probiotic's unique attributes and capabilities will necessitate legal safeguards to preserve our intellectual property and maintain a competitive edge in the market.

Furthermore, the discussion with Mr. Edmunds shed light on the significance of forging partnerships with manufacturers and distributors. These alliances are poised to play a pivotal role in the commercialization and widespread distribution of our probiotic therapy. As our project matures, these conversations will evolve into actionable collaborations, enabling us to bring our innovative solution to the hands of those who need it most.

Dr. Justin Vining is a Pediatric Cardiologist for Wolfson Children's Hospital & Tallahassee Memorial Hospital . Dr. Vining acknowledged the importance of addressing TMAU, even though it affects a relatively small number of individuals. He emphasized that research in this area is vital because it addresses an unmet medical need and has the potential to significantly improve the quality of life for those affected by the condition.

Dr. Vining drew our attention to the intriguing relationship between TMAU and Trimethylamine-N-Oxide (TMAO). He explained that TMAO has been the subject of increasing study due to its potential correlation with various health outcomes, particularly cardiovascular health. High levels of circulating TMAO have been associated with an increased risk of cardiovascular events and overall mortality. However, he highlighted that the link between TMAO and cardiovascular disease remains complex and not fully consistent in all studies.

Dr. Vining also stressed the importance of simplicity in designing a TMAU therapeutic. He emphasized that the treatment should not pose challenges for patients, but rather be as user-friendly as possible. Simplifying the treatment regimen and ensuring ease of access can help mitigate any potential barriers and ensure that the therapy is accessible and effective for those who need it.

Mr. Ron Frazier is a Teaching Faculty II and Entrepreneur in Residence at the Jim Moran School of Entreprenuership. One of the most significant contributions Mr. Frazier made was providing a network of valuable contacts within the industry. These connections opened doors to potential collaborators, mentors, and partners who could further our mission. Through Ron's introductions, we gained access to a wealth of knowledge and resources, enabling us to expand our support network and tap into the collective wisdom of seasoned professionals.

Ron's feedback on our Business Model Canvas (BMC) and SWOT Analysis was instrumental in shaping our strategic approach. His keen eye for business strategy and market dynamics helped us refine our plans and optimize our path forward. Ron's input was instrumental in ensuring that our business strategy remained agile, adaptive, and well-informed.

Ron's encouragement to think outside the box and embrace creative solutions was invaluable, motivating us to explore uncharted territory and push the boundaries of what is possible. He also pitched the idea to expand the technology of E. esperance outside of TMAU and potentially look at other rare diseases that can be treated with this same technology.

Mr. Bill Lickson is the Director of the North Florida Innovation Labs. Mr. Lickson's wealth of industry experience and insights created a clear path forward, shedding light on the critical aspects of positioning and promoting our product (initially we considered developing an enzymatic pill). One of the most significant takeaways from the discussion was an understanding of the regulatory landscape in relation to the Federal Drug Administration (FDA). Mr. Lickson provided guidance on how to navigate the FDA's regulatory framework effectively. We realized that our enzymatic pill should INSTEAD be a probiotic

Understanding that our product could be categorized as a probiotic was a breakthrough, as it meant that we would be subject to fewer regulatory hurdles compared to therapeutics requiring prescription by a patient's physician. This insight was instrumental in shaping our market entry strategy and regulatory compliance efforts.

Mr. Lickson's insights extended to the realm of market dynamics and consumer perception. He shared invaluable advice on how to position our product effectively, emphasizing the importance of educating potential consumers about the benefits and safety of our product. His recommendations aligned with our mission to not only provide a therapeutic solution but also raise awareness about TMAU and the potential of probiotics to address it.

Mr. Bill Hollimon is a Patent Attorney for Hollimon P.A. Mr. Hollimon, a seasoned expert in intellectual property and patent law, our team gained profound insights into the critical aspect of patenting our innovative probiotic solution for Trimethylaminuria (TMAU). This discussion laid the groundwork for safeguarding our intellectual property and ensuring that our groundbreaking enzymatic pill, E. Esperance, would be protected through patents.

Mr. Hollimon said there is potential to secure multiple patents which leads the path to patenting not only the final probiotic product itself but also the intricate method of production and its method of use. This multi-faceted approach to patenting was a strategic move, ensuring comprehensive protection for our innovative solution.

Mr. Hollimon indicated the importance of maintaining the patent's novelty, utility, and non-obviousness. These principles are foundational in patent law and serve as key criteria for patent approval. Novelty ensures that our probiotic solution brings something genuinely new to the field, utility emphasizes its practical application and usefulness, while non-obviousness underscores the uniqueness and inventive step of our approach. His expertise reassured us that our intellectual property would be safeguarded, enabling us to retain control over our probiotic while paving the way for future advancements in TMAU treatment.

Ms. Brooke McDuffie is a Medical Science Liasion for Novartis. While Novartis primarily focuses on Cardiovascular and Oncology Therapeutics, Ms. McDuffie recognized the unique and innovative nature of our work, which falls under the broader category of "Innovative" Medicine that Novartis encompasses. One of the key takeaways from our conversation was the acknowledgment that what we are pursuing—a therapeutic solution for a rare disease like Trimethylaminuria (TMAU)—fits within the realm of innovation in medicine. This recognition was particularly encouraging as it reaffirmed the importance of our mission to address an unmet medical need.

Ms. McDuffie provided crucial information to complete after the Jamboree, particularly regarding research grant applications. Since it's a lengthy process, she advised to have a proof of concept to incorporate in submitting a Grant Proposal. Her guidance in this regard highlighted the importance of planning for the project's sustainability beyond the iGEM competition. This insight served as a reminder of the long-term commitment required to translate our project into a real-world solution.

Dr. John Casey serves as the Head of Business Development at Senda Biosciences. Dr. Casey delved into a comprehensive discussion of our Design & Build Model and our Implementation Analysis. His expertise illuminated various facets of our project's design and execution, offering constructive feedback and enhancing our project's overall robustness. One of the notable highlights of our conversation was Dr. Casey's mention of ZBiotics, a company that developed a "hangover" probiotic which expresses an enzyme to degrade Acetaldehyde after consuming Alcohol. This reference served as an inspirational touchstone for our Business Model, providing valuable insights into successful strategies and approaches within the biotechnology sector.

Dr. Casey shared insights into why Senda Biosciences retracted its TMAU therapeutic development efforts in 2020. This withdrawal stemmed from the challenge of obtaining Orphan Drug Designation, primarily due to the difficulty in justifying substantial investments required for FDA approval in the context of a relatively small customer base, comprising fewer than one million individuals.

Dr. Casey's insights shed light on the economic realities and regulatory hurdles associated with rare disease therapeutics. This discussion served as a valuable lesson in the delicate balance between innovation, patient needs, and financial viability. It reinforced our commitment to finding creative and efficient ways to bring E. Esperance to the TMAU patient community.

Dr. Robert Tomko serves as Associate Professor of FSU College of Medicine's Department of Biomedical Sciences. Dr. Tomko provided us with valuable tools and techniques to effectively interpret and navigate patent documents. This newfound knowledge empowered our team to conduct more thorough patent research, ensuring that we could build upon existing innovations while avoiding potential roadblocks. Additionally, Dr. Tomko took the time to delve into the mechanics of ZBiotics' "Hangover Probiotic", shedding light on how their product operates. This exploration not only expanded our knowledge base but also offered valuable insights into successful models within the industry, inspiring us in our quest to develop E. Esperance.

His endorsement of our approach as reasonable was a vote of confidence in our project's viability. Moreover, his suggestion to consider utilizing E. Coli Nissle 1917 as a key component of our probiotic solution was insightful since it is approved of use by the Food and Drug Administration (FDA). This can be used for future reiterations.

Dr. Terrence Crofts is an Assistant Professor of FSU College of Medicine's Department of Biomedical Sciences. Dr. Crofts' lab specializes in exploring the intricate biochemical and genetic dynamics that underlie the interactions between microbial communities and emerging contaminants like antibiotics and pharmaceuticals. During our discussion, we had the privilege of sharing our meticulously crafted Design Model with Dr. Crofts. As someone deeply immersed in the realm of microbial communities and genetic factors, his insights were immensely valuable. Dr. Crofts not only provided us with candid feedback on our model but also assumed the role of a simulated judge, offering us a unique perspective akin to that of an iGEM competition judge. This exercise enriched our project by helping us refine our approach, anticipate potential questions, and strengthen our overall presentation.

One of the key areas we explored with Dr. Crofts was the efficiency of expressing the TMM Enzyme within the Small Intestine, a pivotal aspect of our project. His insights into microbial interactions and genetic factors were instrumental in guiding us toward a more robust and effective expression strategy. By delving into this aspect, we aimed to ensure that our probiotic, E. Esperance, could reliably and efficiently oxidize Trimethylamine (TMA) into Trimethylamine N-Oxide within the Small Intestine, addressing the core challenge of TMAU.

Mr. Norman Wyckoff is an Entrepreneurship Librarian for FSU Strozier Library. Mr. Wyckoff's expertise in entrepreneurship and venture analysis allowed us to complete a meticulous analysis of our project, examining it from every angle. This deep dive into our project's intricacies was instrumental in refining our approach. Mr. Wyckoff also provided us with important information by analyzing Synlogic's patent, which was particularly relevant to our project. This analysis allowed us to gain insights into existing intellectual property within our project's domain and helped us shape our own patent strategy effectively. Understanding the patent landscape was crucial in ensuring that our innovation would be protected and that we could proceed with our entrepreneurial efforts confidently.

Mr. Norman Wyckoff provided us with market analysis resources related to the companies ZBiotics, Senda Biosciences, and Synlogic. This information allowed us to gain a deeper understanding of the competitive landscape and market dynamics within the field of probiotics and therapeutics. Mr. Wyckoff also offered us advice on how to craft our Entrepreneurship Report, which would be essential in showcasing the real-world potential of our project. Additionally, his counsel on expanding the venture beyond TMAU post-iGEM opened up exciting avenues for future growth and impact.

Dr. Darren Brooks is the Assistant Dean for Executive and Professional Programs, Assistant Department Chair, Senior Lecturer and MBA Program Director for the FSU College of Business. Dr. Brooks' assessment provided us with a reassuring perspective: our pathway appeared to be outside the scope of Synlogic's patent, which boded well for our intellectual property strategy. However, he also emphasized the potential legal challenges that could arise if our solution gained traction in the market. This served as a reminder of the importance of securing our own patents and protecting our unique approach.

We explored the dynamics of Supply & Demand, particularly in the context of a company that formulates a product and a manufacturer responsible for commercializing it to reach clients. Dr. Brooks' insights clarified the essential relationship between these entities and highlighted the need for a seamless transition from development to distribution. This knowledge would prove invaluable as we crafted our business model and identified potential partners. One of the key takeaways from our discussion was the need for E. esperance to expand its horizons beyond TMAU once the product gained traction in the market. Dr. Brooks suggested exploring other rare diseases with enzyme deficiencies that could benefit from the "Synthetic Biology Technique" we were employing. This strategic diversification could enable the company to maximize its impact and reach a broader patient population while maintaining a focus on addressing enzyme-related disorders.

Dr. Brooks' final insight emphasized the importance of accessibility for TMAU patients. He advised against pursuing a prescription-based approach, emphasizing the significance of making E. esperance as easily accessible as possible while ensuring safety. This approach aligned with our mission of providing a practical and patient-centric solution, removing unnecessary barriers for individuals seeking relief from TMAU.

Dr. Alma Littles serves as the Dean of the FSU College of Medicine. Dr. Littles highlighted that TMAU primarily falls within the purview of Family Medicine Physicians, given its nature as a chronic and often undiagnosed condition. However, she pointed out that many healthcare professionals, including family medicine physicians, may not have the necessary knowledge and awareness to diagnose TMAU due to its rarity. This knowledge gap within the medical community can result in delayed or missed diagnoses for TMAU patients.

Dr. Littles highlighted that TMAU primarily falls within the realm of Family Medicine Physicians, given its nature as a chronic and often undiagnosed condition. However, she pointed out that many healthcare professionals, including family medicine physicians, may not have the necessary knowledge and awareness to diagnose TMAU due to its rarity. This knowledge gap within the medical community can result in delayed or missed diagnoses for TMAU patients. She even acknowledged that she was unaware of this condition until we discussed with her.

Dr. Littles emphasized that having concrete data on its effectiveness is crucial. As a physician, she expressed that she would feel more comfortable referring a patient with TMAU to consider E. esperance if there is scientific evidence suggesting that the probiotic can effectively reduce Trimethylamine (TMA) concentration levels in the body. This highlights the importance of conducting clinical studies and generating empirical data to support the therapeutic claims of E. esperance.

Dr. Littles mentioned that healthcare providers typically have more confidence in FDA-approved therapies. While E. esperance aims to achieve FDA compliance, having clinical data that demonstrates its efficacy and safety is essential to gain the trust and acceptance of physicians. Such data not only benefits patients but also facilitates the adoption of the treatment within the medical community.

Mr. John Wilcox is Co-Founder and Chief Executive Officer (CEO) for Diatech Diabetes & Mr. Luis Blanco is Co-Founder and Chief Technology Officer (CTO) for Diatech Diabetes. They both gave us great insight on how a young start-up must grow to fulfill their customer base and the obstacles that come with it. Their feedback on our Entrepreneurship Plan emphasized the importance of a streamlined approach to reaching TMAU patients. One key recommendation was to leverage E-Commerce as the primary distribution channel for E. esperance. They pointed out that involving doctors in the process might create unnecessary hurdles for TMAU patients and delay access to the treatment. Instead, the primary focus should be on developing a solution that works effectively and is readily accessible to those who need it.

They outlined the roles of the key contributors in the process. These contributors include the team responsible for creating the solution (E. esperance), the supplier providing the necessary bacterial strains and materials, the production company responsible for manufacturing E. esperance, and a strategic partnership with an E-Commerce company for distribution. This collaborative approach ensures that each party plays a crucial role in bringing the treatment to the market efficiently, without overspending.

Given the rarity of TMAU, both stressed the importance of building trust with TMAU patients. They highlighted that the global customer base for TMAU is relatively small, which means profits will also depend on each patient. Therefore, establishing trust and credibility within this community is paramount. Patients need to have confidence in both the product's effectiveness and the company providing it, especially when dealing with a condition as rare and challenging as TMAU.

Dr. Robley Light is a Professor Emeritus for the FSU Department of Chemistry & Biochemistry. Dr. Light raised pivotal questions that are integral to our project's success. Firstly, he inquired about our choice of organism for the probiotic, emphasizing the importance of selecting one that can thrive without adverse side effects. This led us to continue using E. coli, given its genetic manipulability and the availability of tools for genetic engineering. Additionally, Dr. Light prompted us to carefully deliberate on the enzyme selection, assay development, and the need for plasmid isolation and sequencing, all crucial steps in our project's design. These inquiries underscored the meticulous planning and scientific rigor required for our undertaking.

Furthermore, Dr. Light's questions delved into the testing strategy, challenging us to consider whether animal models or human testing would be necessary. This raised concerns about regulatory and ethical aspects, particularly in the case of human testing, necessitating collaboration with clinical partners and the completion of human research forms. His insightful queries highlighted the complexities involved in addressing Trimethylaminuria, an uncommon condition, emphasizing the need for collaboration with clinical experts and rigorous scientific methodology to ensure the success of our project.

Mr. Jared Namm is a Corporate Law Attorney for The Berman Law Group. Our conversation with Mr. Namm further emphasized the critical role of Intellectual Property (IP) and the imperative to secure a patent for our solution. This recurring theme underscored the significance of protecting our unique approach as we moved forward with E. esperance.

We explored with Mr. Namm the timeline for a company operating in a niche market, like ours, to generate sufficient revenue for growth and expansion. This discussion provided us with a realistic perspective on the financial trajectory we could anticipate. It also highlighted the need for strategic financial planning and resource allocation to sustain our venture while maintaining a long-term vision.

Mr. Namm offered valuable insights into the dynamics of the biotechnology industry, particularly in relation to smaller companies. He astutely pointed out that, despite having a patent in place, it's not uncommon for larger pharmaceutical companies to express interest in acquiring smaller ventures like ours. This suggestion prompted us to consider the possibility of acquisition as a strategic move, potentially offering opportunities for collaboration with well-established players in the industry, such as Synlogic or Proctor & Gamble.

Dr. Joseph Frascella is the Chief Clinical Research Officer for FSU Office of Research & Tallahassee Memorial Hospital. Dr. Frascella provided a clear distinction between FDA compliance and FDA approval, emphasizing the importance of navigating the regulatory landscape effectively. He emphasized that while FDA approval is a lengthy and resource-intensive process typically reserved for therapeutic drugs, FDA compliance is achievable and a crucial milestone for a product like E. esperance, which falls under the category of probiotics.

One of the pivotal takeaways from our conversation was the importance of conducting clinical studies to gather empirical data showcasing the effectiveness of E. esperance in reducing TMA levels in TMAU patients. Dr. Frascella's guidance in this regard was invaluable, as he shared insights on structuring and executing a clinical study that would meet the scientific standards required for medical validation.

The discussion also highlighted the significance of clinical studies in gaining acceptance from medical professionals. By providing solid data demonstrating the positive impact of E. esperance on TMAU patients, we not only reinforce the product's efficacy but also open doors for physicians to consider it as a viable treatment option for their patients. Dr. Frascella connected the team with the FSU College of Medicine's Institute for Pediatric Rare Diseases (IPRD) which led to funding of the team's project for the next 6 months after the iGEM Jamboree to further develop our Proof of Concept.

The discussion with the Florida Rare Disease Advisory Council (FRDAC) provided valuable insights into what the committee plans to do in the future. The FRDAC is actively pursuing the development of a web portal that will serve as a centralized resource for individuals seeking information and services related to rare diseases. This portal could potentially be a valuable platform for raising awareness about Trimethylaminuria (TMAU) and its treatment options.

The availability of research grants totaling $500,000 for rare diseases is an encouraging opportunity for researchers and organizations like ours. This funding can support further investigations into TMAU and the development of innovative treatments. To have a specific medical condition, such as TMAU, classified as a disability, the conversation typically involves engaging with the Medicaid office. Medicaid representatives can provide more detailed information about the processes and benefits associated with disability classification.

We also learned that while federal regulations overseen by the FDA are important, state-specific regulations can also come into play. However, the consensus is that, in the context of pharmaceuticals and treatments, federal regulations generally take precedence. we also that the Florida Agency for Healthcare Administration (AHCA) has a committee focused on pharmaceuticals and their potential inclusion in Medicaid programs. Engaging with this committee could provide valuable insights and potentially open doors to considerations for Medicaid coverage of E. esperance.

Dr. James Martin is a Pediatrician for Professional Park Pediatrics and Tallahssee Memorial Hospital. He emphasized the importance of incorporating both quantitative and qualitative data into the clinical study design. Quantitative data would primarily involve measuring the decrease in Trimethylamine (TMA) concentrations in TMAU patients after using E. esperance. This objective and measurable data would serve as a critical indicator of the treatment's effectiveness.

Dr. Martin suggested the inclusion of qualitative data to provide a more comprehensive understanding of the treatment's impact. The qualitative aspect would involve gathering feedback from TMAU patients regarding their subjective experiences. Dr. Martin proposed the use of a simple questionnaire with just two questions: (1) "Do you notice a decrease in harsh odor smell?" and (2) "Do others notice a decrease in harsh odor smell?" These questions aim to capture the patients' perceptions of the treatment's efficacy and its impact on their daily lives.

He emphasized that physicians would be more inclined to consider E. esperance as a treatment option for TMAU patients if there is robust data supporting its effectiveness. This highlighted the need for a well-designed clinical study that can provide conclusive evidence of the treatment's benefits.

Dr. Martin acknowledged the rarity of TMAU but recommended aiming for at least 100 participants. While he initially suggested a sample size of 2000, he recognized the practical challenges of recruiting such a large number of participants given the condition's rarity. Nevertheless, he believed that obtaining data from a substantial group of TMAU patients would be sufficient to demonstrate the effectiveness of E. esperance.

Dr. John Oliver is the Vice President of Research and Development for ZBiotics. During our conversation with Dr. Oliver, we addressed a key concern regarding oxygen concentration in the small intestine, which was a critical factor in the enzymatic oxidation of TMA into TMAO. Dr. Oliver alleviated our concerns by explaining that there is, in fact, an ample supply of oxygen in the small intestine to facilitate the enzymatic reaction required for our solution. This reassurance was a pivotal moment in our project, as it provided the scientific validation needed to proceed confidently.

In addition to his expertise in the field, Dr. Oliver shared valuable insights gained from his experience as a founder of a small startup. His guidance proved invaluable for our entrepreneurship team as we discussed the future steps of outsourcing product production. Dr. Oliver emphasized the importance of cultivating positive relationships with partners and collaborators in the production process, emphasizing the collaborative nature of the biotechnology industry.

One particularly interesting aspect of our conversation with Dr. Oliver revolved around the delivery form of our product. We engaged in a thought-provoking discussion about the differences between using a probiotic pill versus a probiotic liquid vial. Dr. Oliver pointed out that pills often carry a somewhat negative connotation, as they are typically associated with medications. Drawing inspiration from the innovative approach taken by ZBiotics, we decided to implement his advice and adopt a similar strategy for E. esperance. This strategic decision aimed to present our product in a unique and positive light, differentiating it from traditional medications and aligning with our vision of providing an innovative and user-friendly solution for TMAU patients.

Dr. Pradeep Bhide is the Jim and Betty Ann Rodgers Eminent Scholar Chair of Developmental Neuroscience and the Director of the Center for Brain Repair at the Florida State University College of Medicine.. With the connection from Dr. Frascella, we were able to receive funding approval from the Committee of FSU College of Medicine's Institute for Pediatric Rare Diseases (IPRD), which included Dr. Bhide, Dr. Richard Nowakowski, Dr. Michelle Arbeitman, and Dr. Cynthia Vied. Their collective endorsement has empowered us to embark on an ambitious six-month journey after the iGEM Jamboree to advance our proof of concept. This support not only emphasizes the project's potential but also underscores the collaborative spirit of our academic community, enabling us to take confident strides towards realizing our goals. Dr. Bhide also provided Candid Feedback on our Entreprenuership Report.

Dr. Brent Edington is the Director of the FSU Office of Commercialization. With the connection from Dr. Frascella, our discussion with Dr. Edington was a comprehensive exploration of both Synlogic's patent and the broader landscape of patenting processes. It was revealed that the World Patent published by Synlogic is NOT ISSUED, suggesting that it may have been withdrawn from the United States Patent and Trademark Office (USPTO). As a result, their published patent application remains in the public domain, indicating that we are unable to patent any aspects listed within it, including claims potentially similar to our own. However, Dr. Edington provided assurance that we can confidently file our patent application without concerns of infringing upon Synlogic's, as E. esperance is not an exact match to the Synlogic patent application. This insight was pivotal in shaping our intellectual property strategy, ensuring the protection of our unique approach.