Team:Virginia/ItS

Manifold

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Human Practices
“The potential for synthetic biology and biotechnology is vast; we all have an opportunity to create the future TOGETHER.” - Ryan Bethencourt
Human Practices
CHAPTER 5: IMPLEMENT THE SOLUTION
5A) Pitching to Stakeholders
With our proposed solution at hand, our team met with the University of Virginia Licensing and Ventures Group to ideate an implementation strategy that could uphold Manifold as being a sustainable, socially good, and ethical solution throughout its implementation in the chemical manufacturing industry. But before meeting with representative Marc Oettinger, we wanted to outline important values, uncovered through our journey through integrated human practices, that needed to be included in our implementation approach to benefit the end-user. This included two following conditions.

Condition 1: Manifold is an open-technology platform that is free to all chemical manufacturers as long as they accept our terms of service.(This condition was inspired by our conversation with stakeholders and Dr. Kester, where we discovered adopting biosynthesis is a costly process due to the infrastructure to purchase bioreactors. By making Manifold a open synthetic biology platform, this offloads a large amount of the costs associated with biosynthesis)

Condition 2: All savings made from Manifold must directly go in reducing the price that consumers pay for a chemical of interest. (This condition was inspired with our conversations with patients at the free clinic, where we recognized many patients suffer from drug inaccessibility due to either the drug costing so much or the drug being unavailable at their local pharmacy. By making sure that the savings go directly to the end-user, we can prevent situations where the cost of medications, like insulin, are inexpensively made through biosynthesis but are sold at unreasonably high prices.)

With these conditions, our team was ready to meet with Marc Oettinger to understand how we can implement Manifold into the real-world and ideate an implementation strategy through University of Virginia Licensing and Ventures Group.
Marc Oettinger

WHAT STEPS DO WE TAKE TO IMPLEMENT MANIFOLD INTO THE REAL WORLD?

Introduction: : Marc Oettinger is a licensing manager for the University of Virginia Licensing and Ventures Group. Oettinger joined this Licensing & Ventures Group in June 2017 as a Licensing Manager specialized in physical and engineering sciences. Working predominantly with technologies related to the engineering and applied science applications, including materials, biomedical, mechanical, and computer/software industries, Oettinger is responsible for evaluating the patentability and marketability of specific assets created from UVA research. As a liaison to the UVA School of Engineering and Applied Sciences, Marc works to help educate, protect, manage, market and monetize intellectual property arising from the UVA research portfolio. We met with Oettinger through a recommendation made with Dr. Kester, hoping to secure a collaboration with the University of Virginia Licensing and Ventures Group to ideate an implementation approach

Discussion: From our hours long conversation with Oettinger, our team carefully explained our entire project, remembering to recount every distinction that made Manifold new, useful and non-obvious as advised by Dr. Kester. This is where our PDE model and computer graphics of Manifold came in particularly useful, as we could visually communicate to Oettinger precisely what Manifold was and how it differed from current technology in biosynthesis. Once Oettinger understood our project, the conversation became extremely productive as we attempted to understand how the University of Virginia Licensing and Ventures Group could assist Team Virginia in implementing our solution to the real world. We learned that technology transfer firms like the University of Virginia Licensing and Ventures Group Group look to transfer technologies to other organizations as a potential source of revenue. As a result, they offer immense funding and legal resources that turn concepts like Manifold into real-world companies. But in return, these firms take anywhere from 30-60% of entire company. From our conversation with Oettinger, we learned that the previous 2019 Virginia iGEM accepted an offer from the University of Virginia Licensing and Ventures Group , where they their company Transform is currently worth millions of dollars and owns a space in a research park in Charlottesville. Because of this experience working with iGEM teams, we seriously wanted to collaborate with the University of Virginia Licensing and Ventures Group . But the biggest issue in our conversation was our conditions. With our group agreeing that we wanted our project to be an open-platform to all chemical manufacturing companies, Oettinger had trouble recognizing how their firm could benefit from our project. Ultimately, this led our team to not have a collaboration, because our team’s vision drastically differed from Oettinger’s firm vision. Without having the opportunity to discuss the implementation further, we ended up not agreeing on a collaboration nor ideating a implementation approach.

Reflection: From our conversation with licensing manager Marc Oettinger, our team learned so much about the process of turning a scientific concept into a real-world product. Although we learned that entrepreneurship had the ability to take our project to the next level, our direction for Manifold as an open, synthetic biology platform ultimately resulted in our team looking elsewhere for assistance. Questioning what our team could do next, we met Dr. Kozminski, our principle investigator, to troubleshoot this problem. This eventually led our team to meeting with Dr. Kester, as Dr. Kozminski was a close friend, where Dr. Kester could potentially connect us with stakeholders at the nanoSTAR Institute. Over the course of a month, we explained to Dr. Kester our vision for Manifold, stating “Manifold was an open synthetic biology platform that helped the end-user directly.” Although Dr. Kester appreciated our vision, he unfortunately disagreed with how planned to run our company. “You have a great project…But you can’t make a company out of Manifold if you don’t have profit. Otherwise, its just a concept that doesn’t help anyone,” Dr. Kester urged. Understanding Dr. Kester’s point, our team seriously contemplated the best strategy to implement Manifold in the world. On one hand, we could pursue the standard route like Transform and simply turn Manifold into a profit-seeking business. But on the other hand, our Team Values document and our conversations with patients reminded our team that we needed Manifold to help end-users first, and the best way to do this was by making Manifold an open platform. With a consensus on our hand, we reapproached Dr. Kester with our affirmed vision for Manifold, where Dr. Kester conceded that he couldn’t change our minds but still wanted to help. Setting up an appointment with stakeholders at the nanoSTAR Institute, our team had the grand opportunity to present Manifold to real stakeholders and to ideate an implementation approach.


nanoSTAR Institute

WHAT DOES A BIOREACTOR SETUP LOOK LIKE IN PRACTICE?

Introduction: The nanoSTAR Institute is a translational research group at the University of Virginia that takes nanoscale research and turns those concepts into commercialized products. As a result, the nanoSTAR Institute has collaborated with multi-billion dollar companies like Pfizer to implement their research in the industrial biosynthesis of medications. At the University of Virginia however, the nanoSTAR institute has been a leading pioneer in promoting entrepreneurship within science and engineering curriculums. Their mission at the University of Virginia is to teach students about the importance of translating basic research into a positive contribution to society. With both their research and philanthropic ideals aligning with our project, we not only agreed to meet with stakeholders at the nanoSTAR Institute, but we also wanted to understand how we could ideate an implementation approach for Manifold that met our above conditions.

Discussion: Near the beginning of our iGEM experience, our team presented a proposal to implement Manifold to the manufacturing of industrial liposomes by the nanoSTAR Institute. Although we were unfortunately declined from this proposal, we became excited by our second attempt at presenting our redesigned version of Manifold. From our meeting with the nanoSTAR Institute, Team Virginia had the amazing opportunity to meet some of the experts we interviewed during our journey through integrated human practices, like Dr. Kester and Dr. Carlson. Nevertheless, after pitching our project, presenting our PDE model and sharing the computer graphic images of Manifold, the stakeholders at the nanoSTAR Institute realized that our project had great potential in the chemical manufacturing industry. However, upon sharing our vision for Manifold of making it an open-platform synthetic biology platform, they began questioning how we could make Manifold into a real company if there wasn’t a reliable way to make income. But taking inspiration from the MITRE Corporation, a not-for-profit organization that translates their research into commercialize products, we knew that making our attempt at making Manifold an open-platform was possible. With this proof-of-concept, we rationalized our position, stating we didn’t want Manifold to become a profit-seeking company, but instead an open-platform that any company can adopt and improve upon. This pitch led our team and the nanoSTAR Institute to agree on a collaboration. We would continue to develop a working prototype of Manifold and see where this technology went, while the nanoSTAR Institute would provide legal guidance as we applied for a full patent. With the help of the nanoSTAR Institute, we not only developed meaningful relationships with these stakeholders, but further received invaluable guidance as we continued to engineer Manifold.

Reflection: With the help of the nanoSTAR Institute, we met throughout the start of the fall semester to ideate an implementation approach for Manifold. We agreed that the best way to ensure that our conditions were met (stakeholders follow our terms of service, while all savings go directly to the end-user) was through applying for a full patent. This would allow us to write up a terms-of-service agreement, that would allow us to control exactly how our technology would be implemented in the real-world. Using the provisional patent filed by the 2020 Virginia iGEM Team, we set out to file a full patent with the redesigned Manifold.


5B) The Patent Process
From the legal guidance of the nanoSTAR Institute, our team was referred to countless of lawyers to begin our new chapter for Manifold of becoming a legitimate company. As a result, our team had the incredible opportunity to learn so much about the legal aspects to synthetic biology and how a concept like Manifold could be implemented into the real-world. Eventually, we met with one patent lawyer stationed in Northern Virginia that could assist our team in filing for a full patent. While the team waited as the patent process continued, our conversations with stakeholders and patent lawyers revealed just how complicated the entire patenting process was. But more importantly, we began questioning what was our next steps as a team? With a proof a concept at hand, what did we need to do to turn Manifold into a industrial replacement to current chemical manufacturing practices? Using the documentation obtained from the 2020 Virginia iGEM Team’s conversations with Rahul Keshap, a lecturer in the University of Virginia Law School, and Nicki Hasting, the executive director of Cville Biohub, we learned that the best path forward may unfortunately be to pass our project onwards. With all the work dedicated to Manifold, our team realized that we needed a new team that could turn our proof-of-concept into a viable company. Although we had the experience and the knowledge to redesign Manifold, understand its proper role in society, and build a working proof-of-concept, we didn’t have the experience to take our project to market. We needed a new iGEM team that could turn our project into a product.
5C) Vision for Implementation
Although our team realized that the best path forward for Manifold was to pass it on to a different team, we wanted to document our vision for Manifold, such that the future team would responsibly implement Manifold following the values and lessons obtained through our journey of integrated human practices. Our team envisioned: Manifold is an open synthetic biology platform that introduces the environmentally friendly and sustainable process of biosynthesis to the chemical manufacturing industry. This modular and industry-wide standardized version of Manifold provides all chemical manufacturers the ability to openly modify our device to manufacture any chemical of interest. This will result in significantly reduced chemical waste and lower carbon emissions, while improving chemical manufacturing yields and purities. By adopting our solution, all the savings made from Manifold must go directly to the end-user. Furthermore, it is the job of the next iGEM Team to maintain our team values and uphold Manifold as being a sustainable, socially good and ethical solution. With this documentation of our vision for Manifold and the patent being made, this signified an end to our integrated human practices journey.






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