Week 1 HW: Principles and Practices

1.First, describe a biological engineering application or tool you want to develop and why. As a pharmacy student, I have become increasingly interested in how drugs move from an initial idea to clinical use, and how many potential compounds fail long before they could reach patients. Drug development is an expensive and time consuming subject, and an ethically complex process, specifically in early stages. But many drugs are left behind as they fail to show strong enough effects or because the costs for further testing is too high.

This has led me to think whether there could be a more efficient way to evaluate the potential of these compounds before progressing into animal models. To address this challenge, I propose an engineered bacterial screening platform that could act as an early, low cost step in the process, especially for those drugs left behind that could be repurposed. This system could be used to report on the activation or inhibition of specific pathways, giving information on targets and if the drug should be continued to be studied before going to an animal model. It would act as an intermediate testing step making it cost effective and reducing the unnecessary animal testing.

This engineered bacterial screening could also be assembled as a living diagnostic tool for diseases that are difficult to detect using conventional methods or invasive procedures, especially when biomarkers are localized or non-specific. Engineered bacteria have already demonstrated potential as diagnostic tools because they can be programmed to detect biomarkers and respond with measurable outputs. And in this application, the engineered bacteria would work as a living biosensor, temporarily sensing for biomarkers and programs to give a clear response. Both applications would be limited to controlled clinical or research settings , allowing for the exploration through these innovative diagnostics while maintaining the commitment for patient safety.

2.Next, describe one or more governance/policy goals related to ensuring that this application or tool contributes to an “ethical” future, like ensuring non-malfeasance (preventing harm). Break big goals down into two or more specific sub-goals.

Ensure patient safety and non-malfeasance -Prevent uncontrolled bacterial replication, persistence, or dissemination -Ensure engineered bacteria can be safely eliminated after use

Enhance biosecurity -Ensure traceability and accountability in their handling and use -Prevent repurposing of the technology for harmful or unethical applications

Promote ethical and efficient drug development -Reduce unnecessary animal testing by strengthening early-stage screening -Improve early decision making on drug continuation or abandonment -Avoid discarding potentially beneficial drug candidates

Promote equity and accessibility -Develop cost-effective screening and diagnostic tools -Prevent socioeconomic or geographic disparities in access -Encourage drug repurposing for neglected or rare diseases

Maintain transparency and public trust -Clearly inform patients and research participants about the use of living biosensors -Communicate risks, benefits, and limitations transparently

3.Next, describe at least three different potential governance “actions” by considering the four aspects below (Purpose, Design, Assumptions, Risks of Failure & “Success”).

1. Ensure patient safety and non-malfeasance Mandatory biosafety and containment standards for all engineered bacteria.

-Actors: Researchers, biosafety committees, regulatory agencies

-Implementation: Kill-switches engineered in design. Validated containment protocols and approvals before use

-Failure: Mutations bypass containment → safety risk

With this action the purpose is to prevent uncontrolled bacterial survival or harmful interactions in human hosts. When talking about genetically modified organisms (GMOs), we already have a comprehensive set of laws for them. Taking this into account, for safety it would be required rigorous assessments and protocols for the authorizations for the idea to start being used.

2. Enhance biosecurity and prevent misuse Controlled access and traceability of engineered strains

-Actors: Governments, industry, research institutions

-Implementation: Centralized strain repositories Record-keeping of users and experiments

-Failure: Unauthorized use → biosecurity risk

The considerable attention to the control of the strains and the people using it through record keeping would help the prevention of engineered bacteria for unethical or harmful purposes. The idea of a data base is a tool, that already currently exists within EU Biosafety, that provides a unified repository of information on GMOs. We could work with them to create a specific repository for this engineering bacteria and keep records of the labs using them for drug development or as a screening tool.

3. Maintain transparency and public trust Public communication campaigns and stakeholder engagement Educate the public about risks, benefits, and uses of engineered bacteria

-Actors: Governments, healthcare institutions, researchers

-Implementation: Info campaigns, open reports

-Failure: Miscommunication → fear or backlash

There should be a full transparency of the techniques and the developments of the idea. Working with the government, communicating to the public about the project could be an easy way to reach the masses and prevent miscommunication or fear of it. Italian BCH AND EU Cartagena Protocol promote the public access of biosafety information already. following in steps, public engagement programs should be used to maintain trust.

4. Use of engineered bacteria as a mandatory pre-animal testing step

-Actor: Regulatory agencies, pharmacological industry

-Risk: Over-reliance on bacterial models Requiring bacterial biosensor validation before animal testing would ensure drugs engage intended pathways and reduce unnecessary animal experiments. Although this step would reduce the unnecessary use of animal models, we are assuming bacteria could be able to have the same mammalian pathways, which could give wrong results.

5. Promote equity and accessibility Subsidies and open-access initiatives for bacterial screening and diagnostics

-Actors: Governments, funders, industry, NGOs

-Implementation:

Low-cost bacterial screening platforms Partnerships to reach underserved regions

-Failure: Technology inaccessible in low-income regions

We could implement funding for low-cost bacterial screening platforms by working with public and private partnerships creating global health initiatives and open drug databases so the technology could be used globally.

Last, drawing upon this scoring, describe which governance option, or combination of options, you would prioritize, and why. Outline any trade-offs you considered as well as assumptions and uncertainties.

Upon the results of the scoring, the governance actions that should be prioritized are the mandatory biosafety Nand containment standards and have control access and traceability to the engineered bacteria strains. These two goals should be at highest priority as it would be the ones preventing incidents across patient and lab safety and protection. Engineered bacteria although it used for the screening and testing tool, the consequences of failing its containment and possibilities of mutations could be severe. Existing EU Legislation don Italian biosafety measures and frameworks give a sturdy foundation for these actions, making them both feasible steps, ensuring the safeguards in our project and validated containments protocols. Along with the need to maintain biosafety, is linked the controlled access to the engineered strains, which would be the best method to enhance the biosecurity and prevent any misuse. By maintaining repositories and detailed records of strains and ownerships and experimental uses, gives us the chance to rapidly respond to any incidents. Also, as it’s a regulatory access, the use for unethical purposes is discourage. This action builds on existing databases that share the same goals. As safety and security is assured, regulatory recognition for the engineered bacterial screening as mandatory step could be one that should give attention. This action promotes an ethical drug development by reducing unnecessary animal testing and improving early decisions. While it assumes for similar pathways and results to mammals, it reflects into the 3rs principles and offers a cost-effective way to rescue drugs that have been abandoned. There were a lot of trade offs considered when prioritizing these actions. As strong biosafety and security is needed, it becomes a new financial burden on researchers and overall, the industry. Overall, I think it’s always needed to prioritize the safety and security and ethical efficiency when it comes to creating and advancing engineered biology.

Reflecting on what you learned and did in class this week, outline any ethical concerns that arose, especially any that were new to you. Then propose any governance actions you think might be appropriate to address those issues. This should be included on your class page for this week.

Reflecting from this week’s work and class, I’ve realized that the importance for ethics is really needed, specially for synthetic biology. For the example of engineered bacteria, while the idea has beneficial purposes, the same properties that make them adaptable and programmable, also create concerns about misuse and unintended consequences. This made we more a ware of how closely this innovation is tied to responsibility and oversight overall.
Another ethical issues that caught mya attention is reducing animal testing and ensuring patient safety., although using engineered bacteria as a pre animal testing step would minimize the used of animal models, it introduces uncertainties in how well these systems could predict humans’ responses. The ideal of heavily simplified the models leads to further skewed decisions in developments that ultimately affects patients Public trust and transparency are also really important necessity. New technologies can face resistance and we as scientist should be able to include the people into understanding them and relieve those doubts and fear. Ethical concerns should always be address, creating appropriated governance actions that create a safe and controlled environment, with clear regulatory limits but also the transparency to the people. All of this combined creates a place where innovation is ensured, while maintaining safety and trust.

Bibliography

-European GMO Authorisation Database (EUGinius). (n.d.). GMO authorisation index. European GMO Initiative for a Unified Database System. Retrieved February 2026, from https://euginius.eu/euginius/pages/authorisation_index.jsf (euginius.eu)

-Cartagena Protocol on Biosafety – Biosafety Clearing-House (BCH). (n.d.). Cartagena Protocol on Biosafety. Secretariat of the Convention on Biological Diversity. Retrieved February 2026, from https://bch.cbd.int/en/ (pmc.ncbi.nlm.nih.gov)

-Pant, A., & Das, B. (2022). Microbiome-based therapeutics: Opportunity and challenges. Progress in Molecular Biology and Translational Science, 191(1), 229–262. https://doi.org/10.1016/bs.pmbts.2022.07.006 (review of microbiome-related therapeutic strategies) (PubMed)

-Zhou, Y. (2022). Engineered bacteria as drug delivery vehicles: Principles and prospects. Frontiers in Bioengineering and Biotechnology (review). Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC11611002/ (review of engineering bacteria for therapeutic delivery) (pmc.ncbi.nlm.nih.gov)

-Kulkarni, V. S., Alagarsamy, V., Solomon, V. R., Jose, P. A., & Murugesan, S. (2023). Drug repurposing: an effective tool in modern drug discovery. Russian Journal of Bioorganic Chemistry, 49, 157–166. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC9945820/ (overview of drug repurposing approaches) (pmc.ncbi.nlm.nih.gov)