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Regulations

We investigated the current regulations surrounding the use of phage therapy in the United States. To begin our work, we met with FCB_UANL to share policy proposal resources. FCB_UANL was able to share a proposal format for us to use, while we worked to set up meetings with experts that would be beneficial to both of our groups. Following this, we searched for previous iGEM projects that included regulations in their work. Upon searching for this, we came across the 2017 iGEM Tec-Chihuahua team, who wrote regulations and presented them to their local government officials. We looked across their work and were able to pull some ideas from this.

Following our initial planning, we began to gather information to include in our proposal. This proposal was split into several different sections: Summary, Background, Solution, Cost of Sepsis, Upscaling, and Ethical Implications. The purpose of our summary section was to outline what our goals were for writing the document, while the background section gave more information on the reason that our project is important for treating sepsis. Our solution section contains information on our wet lab design, and the cost of sepsis section outlines why alternative treatments are necessary. The last section outlines ethical implications, which we considered to ensure that our product would be safe to use and evenly distributed in the population.

Download the file here.

We met with many different experts to discuss our regulations. Our first meeting was with OSU Law student Brooke Zentmeyer, who gave us and FCB_UANL a presentation on the FDA process for proposals and bills.

Zoom with Zentmeyer — Figure 1. Zoom Meeting With OSU Law Student Brooke Zentmeyer and FCB_UANL

In this meeting, Brooke discussed the barriers to phage therapy approvals and the potential paths we could take to work towards solving this issue. She discussed the negative feedback loop that currently prevents phage therapy from being approved in clinical settings and potential solutions to this.

Phage Therapy Barriers — Figure 2. Barriers that Prevent Phage Therapy Federal Approval. Adapted from Brooke's Presentation

Following this discussion, we determined that it would be best for us to continue our current document and to talk with more experts in the field for their insight.

Once we finished up the majority of our document, we decided to meet with Dr. Kevin Bosse from Nationwide Children’s Hospital to discuss our regulations. In this meeting, Dr. Bosse gave us a presentation on the general regulatory process for the different products that FDA regulates. He looked over our document and gave us helpful feedback, mentioning that we should elaborate on the need for alternative treatments and to be thorough with our data collection for a higher chance of product approval. Dr. Bosse noted that, from his experience, we are most likely currently in the “research and development” phase of our project from an FDA-approval standpoint. He made a flow chart to demonstrate the different steps that the FDA takes in product approvals to help us realize the other steps we would need to take to seek approval for our project in the future.

Drug Development Flow Chart — Figure 3. Steps to Receive FDA Drug Development Approval. Adapted from Dr. Bosse's Presentation

We then met with Professor Efthimios Parasidis, who we were connected with by Brooke. Professor Efthimios contributed to our project by advising us to get a patent for our work and by giving us feedback on our document. Professor Parasidis mentioned that we should include information about the ethics of clinical trials and that we should make sure we look into animal studies as a means for getting data for FDA approval for human subjects.

Following these meetings and iterative process, we were able to write a thorough document to outline where our project is in the process of FDA approval. This is a very important part of our project, as it bridges the gap for us to be able to use our project in the real-world. This aspect also contributes to the future goal of more approval for synthetic biology products as a whole. While phage therapy has been around for many years, its popularity has just started increasing in the United States. This document offers a summary of the current considerations for phage therapy and can serve researchers and other iGEM teams in the future as a resource for considering factors that may lead to more effective implementation of a phage project in the real-world.