Please describe your proposed solution.

<u>Context.</u>

The DSCSA outlines requirements for enhanced drug distribution security, which include the steps to achieve interoperable, electronic tracing of products at the package level.

These requirements for enhanced drug distribution security go into effect on November 27, 2023.

The FDA sets forth enhanced drug distribution security requirements for trading partners, including adherence to standards established by FDA for the exchange of transaction information and transaction statements in a secure, interoperable, electronic manner and the verification of product at the package level.

<u> WHAT PRODUCTS DOES THIS SOLUTION ADDRESS?</u>

In general, a product is a prescription drug in a finished dosage form for administration to a patient without requiring substantial further manufacturing, such as capsules, tablets, and lyophilized products before reconstitution.

<u>WHAT TRANSACTIONS DOES THIS SOLUTION ADDRESS?</u>

In general, a transaction is defined as a transfer of product between persons in which a change of ownership occurs.

<u>THE SOLUTION.</u>

Create an interoperable system that could identify and trace prescription drugs without require a centralized system to hold the information.

An interoperable system means the ability to exchange transaction history, transaction information, and transaction statements accurately, efficiently, and consistently among trading partners; and for a subsequent purchaser’s system, process, or practice to successfully capture and maintain the transaction history, transaction information, and transaction statements, regardless of whether they are provided in a paper or electronic format.

The proposal consists of 3 stages:

1) System Architecture and Design.

I will create a MVP for a system for trading partners to exchange transaction information and transaction statements, which generally must include package level product identifiers for each package included in the transaction.with the following features:

• Processes in place to verify products at the package level.
• Processes in place to promptly respond with the transaction information and transaction statement for a product upon a request by the Secretary, in the event of a recall or for investigations of suspect or illegitimate product.
• Processes in place to facilitate the gathering of information needed to produce the transaction information for a product in the event of a request by the Secretary, on account of a recall or for suspect or illegitimate product.
• Iif the trading partner accepts saleable returns, have systems and processes in place to accept product and saleable returns if the trading partner can associate the saleable return product with the transaction information and transaction statement associated with that product.

In addition,this system must also utilize data standards that facilitate a uniform process or methodology for product tracing and ensure the protection of confidential commercial information and trade secrets to protect such information should not be limited to adhering to EPCIS, but should also include using individual system(s) and procedure(s), and business practices that ensure the confidentiality of such information.*

• This feature is not cover by this proposal, in the future I will explore solutions like midnight or encoins to protect sensible data.

2) Prototype Implementation.

This proposal aims to develop a ‘MVP’ representing a fully interoperable system for trading partners. Therefore, this proposal evaluates all architecture components in Cardano and applies a implementation in an experimental setting to ensure their implementation ability.

3) Testing: In order to evaluate the MVP , I will test using an example of the industry, at least simulation on the testnet. I did a little consultation on lidonation , I can see that 190 proposals have been approved in catalyst related to healthcare. I will contact some of them in order to participate and test the prototype.

After examining the results of the proposal, I'll spotlight important findings. Finally, I'll summarize the current limitations of the system and suggest recommendations for future steps.

Please define the positive impact your project will have on the wider Cardano community.

<u>In what way will the success of the project bring value to the Cardano Community? </u>

• Advancement in Drug Distribution Security: The proposed system contributes to enhancing drug distribution security, aligning with the requirements outlined by the DSCSA. This not only ensures compliance but also positions Cardano as a robust and secure platform for critical industries.

• Community Empowerment: By creating an interoperable system for trading partners without the need for a centralized repository, the proposal empowers the Cardano community involved in pharmaceutical supply chains.

• Validation of Cardano in Regulatory Compliance: Successful implementation of the solution would showcase Cardano's capability to adhere to and facilitate regulatory compliance.

<u>How I will measure this impact? </u>

System Performance Metrics:

• Measure the efficiency of the traceability system in handling prescription drug transactions.
• Address and resolve any performance issues identified during testing.

User Feedback and Adoption Rates:

• Gather feedback on user experience and satisfaction with the proposed system.
• Track adoption rates among trading partners and stakeholders in the pharmaceutical supply chain.
• Monitor and report any security concerns or vulnerabilities during testing.
• Highlight the steps taken to ensure compliance with regulatory requirements.

<u>How I will share the outputs and opportunities that result from your project?</u>

• Regularly communicate progress through Cardano community channels, such as townhall meetings, breakout rooms.

• Share detailed documentation, reports, and findings through a final whitepaper, articles, or technical documentation posted on the Cardano forum and Cardano Spot.

• Actively seek collaboration opportunities within the Cardano ecosystem, fostering a collaborative environment that can lead to further innovations and applications.

What is your capability to deliver your project with high levels of trust and accountability? How do you intend to validate if your approach is feasible?

I'm going to talk a little bit about who I am, I'm originally from Mexico, I'm in Cardano for a little more than two years, I got funding in project catalyst fund7 with the proposal called "Support small farmers in Latam".

I was able to successfully delivered and completet the proposal, also in project catalysat I have participated as a reviewer in fund 8, 9 and in the last fund as a level 1 reviewer with a total of 80 proposals reviewed last fund.

As a member of the Latam Cardano Community, I have participated in educational content with Universities in Mexico.

• I´m leading in Mexico the proposal funded in fund10 "Universities Onboarding to Cardano" from Latam Community.

• I participated in the Cardano summit in mexico 2022.

• Representing Cardano Latam Community in "Cardano Days" , Guadalajara , Mexico.

I participated in organizing two CIP-1694 workshops in Mexico, in the Pan-latam workshop in Uruguay and participating in the final workshop in Edinburgh.

• Co-authored the Latina American regional conclusions document
• (https://github.com/latamcardano/CIP1694Workshops.)

Regarding prototype development, for the fund 7 proposal I submitted, I had to make a prototype capable of mining tokens, transferring them and creating Cardano wallets.

What are the key milestones you need to achieve in order to complete your project successfully?

<u>Milestone 1: System Architecture and Design.</u>

Main activities.

• Design the structure for package-level product identifiers in transactions.
• Develop processes for verifying products at the package level.
• Establish procedures for promptly responding with transaction information and statements in case of a recall or investigations of suspect/illegitimate products.
• Create processes to facilitate gathering information for producing transaction details during a recall or for handling suspect/illegitimate products.
• Implement systems and processes for accepting product and saleable returns, associating them with the relevant transaction information and statements.

Acceptance Criteria.

• Design documentation for the structure of package-level product identifiers.
• Detailed processes for product verification at the package level.
• Procedures for prompt response to recall requests or investigations.
• Processes to facilitate information gathering during recalls or for suspect/illegitimate products.
• Systems and processes for accepting and associating product and saleable returns.

Outputs.

• Design description document for package-level product identifiers.
• Documented processes for product verification, recall response, and suspect/illegitimate product handling.
• Implemented systems for accepting and associating product and saleable returns.

Documentation accessible via google drive.

Timeline: March 2024- June 2024

Budget: 23,000 ADA

><u>Milestone 2: Prototype Implementation.</u>

This milestone involves the practical implementation of a Minimum Viable Product (MVP) to represent a fully interoperable system for trading partners in the pharmaceutical supply chain. The focus is on evaluating all architecture components in Cardano and applying the implementation in an experimental setting to ensure their functionality.

Main Activities.

• Develop the system on the Cardano blockchain.
• Implement blockchain components following the designed architecture.
• Conduct initial tests to assess system functionality.
• Address identified issues or bottlenecks during the testing phase.

Acceptance Criteria.

• Functional system deployed on the Cardano blockchain(testnet).
• Implemented blockchain components documented and accessible.
• Initial testing report detailing system functionality and identified issues.

Outputs.

• GitHub repository containing the codebase for the interoperable system.
• Documentation on Google Docs outlining the implementation details.
• Website showcasing the MVP, accessible for community review and auditing.

Timeline: June 2024- November 2024

Budget: 39,000 ADA

><u>Milestone 3: Testing</u>

The evaluation of the developed MVP through testing, utilizing an industry-specific example. The testing process will include simulations on the testnet to ensure the functionality and effectiveness of the interoperable system, collaboration with healthcare-related proposals from Catalyst will be initiated to involve real-world scenarios and gather valuable feedback.

Main Activities.

• Conduct testing of the MVP on the Cardano testnet.
• Simulate industry-specific scenarios to assess system responses.
• Collaborate with healthcare-related proposals from Catalyst for real-world testing.
• Gather feedback from participants and stakeholders involved in the testing.

Acceptance Criteria.

• Successful testing of the MVP on the Cardano testnet.
• Simulated scenarios demonstrating system resilience and effectiveness.
• Collaboration initiated with healthcare-related proposals for real-world testing.
• Comprehensive feedback collected from participants and stakeholders.

Outputs.

• Test results documentation on GitHub for community review.
• Report on simulated scenarios, accessible via a document on google drive.
• Collaborative documentation with healthcare-related proposals.
• Website showcasing participant feedback and testing outcomes.

Timeline: November 2024- February 2025

Budget: 17,000 ADA

><u>Final Milestone: Project Completion and Evaluation.</u>

This milestone marks the conclusion of the project, involving a thorough examination of the results and key findings. The final project completion report and video will be created to summarize the overall journey, outcomes, and limitations of the system.

Main Activities.

• Compile and analyze the results of the implemented MVP.
• Spotlight significant findings and achievements throughout the project.
• Summarize the current limitations and challenges faced by the system.
• Generate the final project completion report documenting the entire process.
• Develop a conclusive video presentation highlighting key aspects and outcomes.

Acceptance Criteria.

• Comprehensive analysis of MVP results.
• Highlighted achievements and key findings documented.
• Clear summary of current limitations and challenges.
• Final project completion report accessible on a google drive document.
• Conclusive video presentation providing an overview of the project.

Outputs.

• Detailed project completion report in a downloadable format, on a google drive document.
• Video presentation accessible on community platforms and social media.
• Updated documentation on GitHub, summarizing limitations and recommendations.
• Community engagement through the global townhall to present findings.

Timeline: February 2025- March 2025

Budget: 7,500 ADA

Who is in the project team and what are their roles?

Cristian Rojas velez . Twitter : @CrisRo0787- Project Manager , researcher, in charge of documentation and reporting, architecture design and prototype development.

I plan to commit a minimum of 20 hours per week on average to this project over the course of 12 months. I believe the proposed timeline is reasonable, and the clearly outlined milestones provide a structured framework for me to deliver the project satisfactorily.

Please provide a cost breakdown of the proposed work and resources.

System Architecture and Design.

• Architecture design (320 hours)= 17,000 ADA
• Documentation-Technical Writing= 6,000 ADA

Prototype Implementation.

• Cloud services : 3500 ADA
• Documentation-Technical Writing= 3,000 ADA
• Development labor ( 500 hours) = 32,500 ADA

Testing.

• Test Setup: 4,000 ADA
• Community Outreach: 8000 ADA
• User Training Materials: 2500 ADA
• Website: 2500 ADA

Project Completion and Evaluation.

• Video Production: 4500 ADA
• Documentation - Final Project Report: 3000 ADA

Reserve: (in case of unforeseen expenses or adjustments): 5000 ADA.

To calculate the ADA price to be taken for the budget and its monthly volatility, I used the following formulas:

ADA price = the average price over the last 365 days = 0.32 USD

Monthly volatility = The standard deviation of that same sample (0.3137) multiplied by the square root of 30 (5.477) = 0.17 = 17%.

Then the required ADA will be =(85000 ADA ) * 1.17 = 99,450 ADA

How does the cost of the project represent value for money for the Cardano ecosystem?

The project encompasses system architecture and design, prototype implementation, testing, and project completion. Each phase involves a substantial amount of work, which justifies the overall cost.

The budget includes development labor for 500 hours, reflecting the effort required to design and implement a system. The hourly rate appears reasonable. 32,500 ADA , the time to develop the prototype I estimate it in 5 months , dedicating 25 hours a week, it would be a total of 500 hours , which gives an hourly wage of 20 usd approximately.

The other important expense is the design of the architecture for which 4 months are destined, in this case 20 hours a week for a total of 320 hours, which gives a salary per hour of 17 usd approximately.

Allocating funds for community outreach, user training materials, and a dedicated website demonstrates a commitment to engaging and educating the Cardano community.