Immunify.life Clinical Development plan: Part #1

An overview of the 7 phase R&D implementation plan.

The team a Immunify.life have been on a four- year research and development program travelling the globe meeting government ministers, community leaders and healthcare workers to understand their challenges and to develop technology that can meet their complex needs, to deliver real change.

The 7 phase program comprises the following steps:

1. Completed: In country consultation and evaluation.
2. Completed: Mumbai Proof of Concept (POC).
3. Developed: Mumbai TB app to a customised COVID-19 app for field testing.
4. In Progress: Cameroon in field study Covid19 plus qualitative research.
5. In Progress: Kenya in field Study and tie into Commonwealth secretariat Plus qualitative research.
6. In Progress: Design of clinical study for publication.
7. In Planning: Full Country COVID19 driven multiple-disease pilot study.

Phase 1: In country fact finding consultation & evaluation.

Commencing in 2018 the first iteration of Immunify.life ( Hexcel Global) engaged with countries in Africa and Asia to understand the challenges in healthcare delivering and to inform the development and design of blockchain enabled systems. Countries visited included

Democratic Republic of the Congo (DRC).

Cameroon.

Sudan.

Tanzania.

Ethiopia.

Nepal.

Phase 2: Mumbai POC

Based on all the feedback and learnings the company was reformed (Immunify.life) and developed the first prototype of a simple to use medical record. We conducted a pilot in a 270 bed hospital in Mumbai

This is was a small-scale study of 3 doctors and 50 patients over a four -month period and involved training local physicians on the system and ensuring the data capture options were consistent with local practices. Data was collected using android tablets connected via wifi to the internet Goals were:

1. To demonstrate the system can be implemented successfully in a previously paper based environment.
2. Test the effectiveness of the token reward system to monitor and reward patients and doctors based on goals that are achieved.
3. Demonstrate the ability of the disease management module to collect accurate patient data using a cloud-based system.
4. Define areas for improvement.

Feedback obtained from doctors during the pilot, was very positive. The software was been described as intuitive and the workflow mimics local treatment practices. The use of drop-down boxes and radio buttons minimised the need for typing copious notes, reducing the burden on doctors and allowing them more time with the patient. The doctors also recognised that the software was easily customisable and able to reflect local medical diagnosis and treatment practises. The token reward system proved simple to use and was a very strong drive of doctor behaviour.

The advent of the COVID pandemic had a big impact on the focus of the company. Rebranding as Immunify.life with a clear prioritisation of delivering a system that can help emerging economies fight this disease.

Phase 3: Mumbai TB app re-purposed to a COVID19 field testing app

The re-purposed COVID19 app incorporates the following:

• Feedback from the Mumbai field evaluation.
• Customisable to local clinical practices, formulary and languages.
• Local drug formulary & clinical practices pre-populated.
• Multiple patient identification fields to verify ID. (national id card, phone number, passport etc)
• Captured drug batch number. (for authenticity validation)
• Simple to use and learn with drop down boxes and radio buttons for most fields.
• Automatically issued incentive wallet to patients and captured informed consent.

Part #2 Phase 4 -7 next…

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