Team:Virginia/Human Practices
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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
INTRODUCTION
A Global Problem
Modern medicine, or medicine as we know it today, offers a robust approach to curing and preventing disease. For instance, insulin saves hundreds of millions of people each year from diabetes. Aspirin prevented heart disease and severe pain amongst billions of patients worldwide. The recent COVID-19 vaccine is defending billions from this years-long pandemic, where public health and preventive healthcare could not. Because of the world’s growing need for pharmaceuticals, companies like Johnson and Johnson and Pfizer require modern methods to synthesize these chemicals at sustainable rates. However, with little research towards new synthesis methods, pharmaceutical companies continue to use antiquated manufacturing practices that ultimately result in drug shortages.
Drug shortages have long been a problem throughout the pharmaceutical industry, even in developed countries like the United States. Although the Food and Drug Administration has proposed recommendations to limit their negative effects
In the textile industry, the chemical synthesis of synthetic fibers generates 35% of the primary plastic that cause water pollution, releases over 13 million tons of chemical waste into the environment and suffers from regular production backlogs.
Drug shortages have long been a problem throughout the pharmaceutical industry, even in developed countries like the United States. Although the Food and Drug Administration has proposed recommendations to limit their negative effects
[1]Center for Drug Evaluation and Research. (2021, May 10). Drug shortages. U.S. Food and Drug Administration. Retrieved October 17, 2021, from https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages.
, current manufacturing practices produce low yields and excess impurities, leading to routine drug shortages. In fact, 62% of all drug shortages were a result of quality-failures in the pharmaceutical manufacturing process, primarily during chemical synthesis and plant synthesis. [2]Commissioner, O. of the. (2019, October 24). To help reduce drug shortages, we need manufacturers to sell quality. U.S. Food and Drug Administration. Retrieved October 17, 2021, from https://www.fda.gov/news-events/fda-voices/help-reduce-drug-shortages-we-need-manufacturers-sell-quality-not-just-medicine.
In plant synthesis, growing periods of plants delay drug production and their chemical yields fluctuate across seasons. On the other hand, chemical synthesis involves extensive purification due to the likely synthesis of unwanted products. As a result of these drawbacks, pharmaceutical companies must grow more ingredients and run more reactions to meet the demands of modern medicine. But, the global effect is that patients pay significantly more for medications, an additional $230 million on top of other medical expenses, to maintain current pharmaceutical manufacturing practices. [3]Ventola C. L. (2011). The drug shortage crisis in the United States: causes, impact, and management strategies. P & T : a peer-reviewed journal for formulary management, 36(11), 740–757.
Introducing a new method to drug synthesis would drastically reduce manufacturing costs across the entire pharmaceutical industry, while ensuring all patients have access to life-saving medications ALWAYS.
In the textile industry, the chemical synthesis of synthetic fibers generates 35% of the primary plastic that cause water pollution, releases over 13 million tons of chemical waste into the environment and suffers from regular production backlogs.
[4]Linda Greer Susan Egan Keane, Greer, L., Linda Greer - Alum, Lehner, P., Keane, S. E., & Murray, S. (2017, June 16). Encourage textile manufacturers to reduce pollution. NRDC. Retrieved October 17, 2021, from https://www.nrdc.org/issues/encourage-textile-manufacturers-reduce-pollution#:~:text=Textile%20mills%20generate%20one%2Dfifth,by%20burning%20coal%20for%20energy.
In the chemical manufacturing industry, tons of carbon dioxide and volatile organic compounds are released annually into the atmosphere, contributing to global warming and air pollution.[5]OECD environmental outlook for the Chemicals Industry. (2001). Retrieved October 17, 2021, from https://www.oecd.org/env/ehs/2375538.pdf.
In the plastics manufacturing industry, 300 million tons of chemical waste accumulate each year in bodies of water, leading to environmental degradation. [6]Parker, L. (2021, May 3). Plastic pollution facts and information. Environment. Retrieved October 17, 2021, from https://www.nationalgeographic.com/environment/article/plastic-pollution.
Inefficient chemical manufacturing is not only an economic problem, but a global problem that impacts everyone. As a global community, we must replace current chemical manufacturing practices with a more sustainable practice, so that we lower manufacturing costs across entire industries, ensure patients have access to life-saving medications, and end global pollution.
Our Responsibility to the World
From our initial exploration into integrated human practices, the 2021 Virginia iGEM Team understood that current pharmaceutical manufacturing practices were not sustainable and that an immense responsibility for persevering patient lives rested in our team. As a result, we methodically approached integrated human practices with the goal of understanding diverse perspectives and empathizing with patients, such that we could ideate an effective synthetic biology solution that satisfied the problems facing the pharmaceutical industry. However, as we learned more and more about the field of synthetic biology, engaged with experts across foreign disciplines, and even requestioned our project’s purpose, we realized that our responsibility didn’t end with modern medicine. Integrated human practices shaped and pivoted our design, turning a project focused solely on helping the pharmaceutical industry and realizing its greater potential in helping the chemical manufacturing industry at large. Here, the 2021 Virginia iGEM Team is proud to introduce our project Manifold, a synthetic biology platform that introduces the chemical specificity and environmental sustainability of biosynthesis and combines it with the large-scale manufacturing capabilities of industrial manufacturing.
In our Integrated Human Practices wiki section, we wanted this page to be more than just a documentation of our integrated human practices experience. We wanted to tell a compelling story that showcased the power of integrated human practices. We wanted to share the human aspects (e.g., the thought processes, the decisions, the struggles, the experts, and the team) behind our project. But most importantly, we wanted to inspire future iGEM teams to pursue integrated human practices seriously, and encourage their discoveries to guide their teams towards a more sustainable solution. Here, we recount our human practices experience and share how integrated human practices changed the purpose, the design and the implementation approach of Manifold.
In our Integrated Human Practices wiki section, we wanted this page to be more than just a documentation of our integrated human practices experience. We wanted to tell a compelling story that showcased the power of integrated human practices. We wanted to share the human aspects (e.g., the thought processes, the decisions, the struggles, the experts, and the team) behind our project. But most importantly, we wanted to inspire future iGEM teams to pursue integrated human practices seriously, and encourage their discoveries to guide their teams towards a more sustainable solution. Here, we recount our human practices experience and share how integrated human practices changed the purpose, the design and the implementation approach of Manifold.
OUR PATH TO INTEGRATED HUMAN PRACTICES
Purpose of the I4A Framework
To direct our team towards philanthropy and answering societal needs, we created the I4A Framework to emphasize 4 of our team values, including societal impact, meaningful expert feedback, project transparency and a people-centered focus . These team values were slowly realized throughout each phase of integrated human practices, eventually merging these values with our engineering design cycle and implementation approach and compiling them into our “Team Values” document. By aligning our vision for Manifold according to these team values, the I4A Framework helped direct our team towards building a more sustainable solution through a methodical, 5-step plan.
The Making of the I4A Framework
From the conceptualization of Manifold, the 2021 Virginia iGEM Team recognized that the possibility our project shifted towards a profit-seeking motive was entirely real. Without empathizing with our end-users, chemical manufacturing companies, like in the pharmaceutical industry, could exploit our project to increase the current supply of chemicals, while continuing to fix their prices at unnaturally high rates. After discussing these consequences with pharmacologist Dr. Mark Kester, we unanimously agreed that answering societal needs must be our central purpose, which was further strengthened by our one-on-one conversations with patients and ethicists. As a result, we sought guidance from previous iGEM frameworks and those used across medicine. These included the societal impact from the RRI construct (Responsible Research and Innovation), meaningful expert feedback from the University of Calgary’s Human Centered Design Process, research transparency from the 2018 Ramnarain Ruia Autonomous College, and people-centered focus from the University of Florida’s College of Medicine’s curriculum. Ultimately, Team Virginia integrated these guiding principles into our engineering design cycle and integrated human practices framework called I4A.Throughout the creation of Manifold, this framework reminded Team Virginia that answering societal needs must always be our central purpose, while further encouraging philanthropy and exploration of Manifold’s impact. However, synthesizing this framework and recognizing these team values required integrated human practices and physically experiencing both the struggles and incredible journey of making a synthetic biology project. With all the context to guiding the 2021 Virginia iGEM Team, we recount below our story of how integrated human practices entirely changed the direction of Manifold.
The I4A Framework
As the first step to the I4A framework, “Identify the Problem” involves understanding the entire problem within the context of its underlying cause and its related impact on the end-user. This step requires extensive research into the current literature, interviewing experts from fields directly and indirectly involved with the problem, and empathizing with end-users. As a result, team members not only become experts that can ideate socially valuable solutions, but more importantly, they become collectively motivated towards solving the problem. Correctly identifying the problem is crucial to directing a team towards success.
“Imagine Solutions” is where creative ideas are born. As the second step to our framework, “Imagine Solutions” provides a launching pad where out-of-the-box thinking is highly encouraged. Investing time into exploring possible solutions ensures every diverse thought is heard and fairly evaluated by the team. Afterwards, these imagined solutions are reviewed by team members for its societal value, risk assessment and feasibility. Now, the remaining solutions are assessed according to team values until an agreed solution is chosen. By taking action before imagining solutions, teams commonly return to this stage only after physically realizing an error to their chosen solution. Thus, being meticulous when imagining solutions saves more time, effort and resources in the long term.
The third step “Gain Insight” involves asking for expert feedback. Here, the agreed solution is scrutinized not by team members, rather by experts directly and indirectly related to the solution. These could be ethicists involved with the moral judgment of implementing the solution, government representatives involved with legal aspects of the project, or scientists involved with the feasibility and creation of the project. “Gain Insight” shines light on problems and ideas that weren’t considered before, while contextualizing the project within a real-world context. Using this knowledge, team members should be engineering and testing their project throughout this phase. As always, team members must keep open ears for transformative insight that can pivot the project towards a new direction. Although “Gain Insight” serves as the third step, teams should actively seek expert feedback across all steps of the I4A framework and update these experts with the team’s successes, failures and direction.
As the fourth step to the I4A framework, “Implement the Solution” requires teams to act on both the team’s proposed solution and the recommendations of experts. Here, team members work collaboratively and transparently to implement their solution into society, while monitoring its effectiveness as it relates to team goals. The implementation approach must be responsible, socially good, and ethical.
As the final step to the I4A framework, “Adjust the Project” requires team members to reflect on their failures and successes. If the device does not satisfy the team’s goal, team members must reevaluate the solution through serious reflection, discussion and expert feedback. If the device accomplishes the team’s goal, team members can adjust the project, such that it incorporates the solution. Additionally, team members propose future extensions to the project, further ensuring that the loop between the team’s solution, the stakeholders’ needs and the end user's impact effectively closes.
CHAPTER 1: THE BEGINNING
Origin of Manifold
During the 2020 iGEM competition, the 2020 Virginia iGEM Team designed the first version of Manifold that sought to introduce large-scale biosynthesis to the pharmaceutical manufacturing industry. Their solution involved using zinc-finger fusions to position pathway enzymes at specific locations along DNA scaffolds found inside bacterial microcompartments. Thus, when one enzyme finishes catalyzing a reaction, its product is immediately transferred to the next enzyme along the DNA scaffold corresponding to the next reaction in the biosynthetic pathway. These reactions would further be sequestered in a protein shell, unaffecting normal cellular processes. In practice, the 2020 Virginia iGEM Team designed Manifold to hasten pharmaceutical manufacturing by reengineering and specifically optimizing their device to maximally produce the chemical of interest (resveratrol as the prototype and other pharmaceuticals in the future). However, the COVID-19 pandemic prevented the 2020 Virginia iGEM Team from in-person lab work, leaving their project as merely a concept. With their unfinished work, the 2020 Virginia iGEM Team never made Manifold a reality.
Our Synthetic Biology Project: Manifold
With the end of the 2020 iGEM Competition and their project Manifold, a new group of University of Virginia undergraduates formed our team—the 2021 Virginia iGEM Team. After listening to last year members and their heartbreaking stories, we felt inspired to finish their work on Manifold, consequentially applying as a Phase II team in the iGEM competition. However, as we began integrating human practices in the early days, explored new conversations and reflected on Manifold’s role in society, our vision for Manifold quickly shifted. We wanted to expand on last year’s work, change their design through expert feedback, understand Manifold’s proper role in the larger chemical manufacturing industry, emphasize implementation and regulation strategies, build a synthetic biology platform for a socially good purpose. After recognizing the power of integrated human practices, we reapplied as a Phase I Team, beginning a new story for Manifold. In late May of 2021, we officially began our iGEM experience and immediately began integrating human practices into our project Manifold.
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