Conner Calzone, Tiffany Pang

9/24/20

Develop Top 20 FAQs for your project.

 

• Identify the most important questions, building on the referee Qs/

• Why? What? How? How well? How exactly? At steady-state?

• Provide concise and precise responses to each question

 

 

What is the specificity and sensitivity of your device?

1. 1. We have not yet determined the specificity and sensitivity of this device, but we are planning to test increasing the sample size of the test line antibody selection experiment and using purified HbA and HbS, in order to maximize the specificity and sensitivity. 
   2. (follow up answer) However, our test strip utilizes a direct binding lateral flow mechanism (sandwich structure) that is more analytically sensitive with a range of 98.2-99.5% compared to the competitive binding structure, with a sensitivity of 90%.

 

What approvals are needed to market this device and how long would they typically take?

1. 1. Sierra Leone Pharmacy Board: 5-6 months of consistent contact with them, and sending them our concept papers to read.

 

Why don’t you think that something like (our venture) has not been brought to the field before?

1. 1. Other ventures implemented in LMICs were too time consuming and expensive, our venture is a point-of-care and an affordable solution that can deliver results in 15 minutes because of the optimized use of reagents and materials, and the fact that we do not need a constant supply of electricity.

 

What are the core innovation of the device?

1. 1. So, our core innovation of our device is that it’s affordable, simple to use and eliminates a dilution step. It reduces the hook effect which will cause a false negative when the results should be positive due to an oversaturation of the hemoglobin bound to the test strip. 

 

(follow up question): How does the E-junction work? (refer back to slides and show the diagram)

1. 1. Arm 1 is where the blood is distributed, arm 2 and arm 3 is the wash buffer+blue latex beads. As can be seen, the second wash step eliminates the extra hemoglobin, allowing the two checkpoints (sandwich structure): the conjugated bead and spotted antibody with the HbA analyte to produce the diagnosis.

 

Once the device is distributed to the hospital, how will the device be implemented?

1. 1. We will sell a bulk amount of the test strips to clients (hospitals and clinics) and the staff will undergo the requisite training to use it. It will be implemented into the SOP’s of the hospital, where the diagnosing will be directly administered during the labor routine, right when the baby is born.

 

What do you plan to do with the money earned from sales? (giving back to SCD-related services; penicillin therapy)

1. 1. So, from these sales we plan to give them back to SCD-related services such as penicillin therapy. It is recommended for all children younger than 5 with SCD to take prophylactic antibiotics daily. The earliest treatments possible have been proven to show the best benefits to reduce child mortality rates.
2. Are there any SCD devices implemented in Sierra Leone right now?
   1. There have been a couple of tests such as the dried blood spot (DBS) programs, which involve collecting samples from newborns in high-risk areas and sending them to centralized laboratories for isoelectric analysis. These programs were initiated in Angola and Uganda, but were time-consuming and expensive with costs estimated to be around $9 to $15 per test.

 

Are there any SCD devices implemented in Sierra Leone right now?

1. 1. There have been a couple of tests such as the dried blood spot (DBS) programs, which involve collecting samples from newborns in high-risk areas and sending them to centralized laboratories for isoelectric analysis. These programs were initiated in Angola and Uganda, but were time-consuming and expensive with costs estimated to be around $9 to $15 per test.

 

What expenses must we consider to execute our plan?

1. As shown in our income statement, expenses to consider include networking, communications, transportation, advertising, start-up, raw materials, packaging and shipping.

 

What makes a hospital our target?

1. We will implement our product anywhere where they want it. We have identified the top 80 or so hospitals by overlaying GIS data with a population density map, but we will look to target pop-up clinics as well.

 

How do you plan to fund your venture? And who’s going to pay?

1. We will be pursuing grants for our project and donations from those doing work in or want to do work in Sierra Leone. Donors like NGOs, WHI, WHO and UNICEF will pay the extent of our launch costs.

 

How will you validate the usability of your device? 

1. We hope to return to Sierra Leone in Summer 2021 to begin alpha testing to validate the usability and basic accuracy of the device. To conduct this testing, the team has collaborated with Dr. Cheedy Jaja who currently has IRB approval to run a study on two other SCD screening devices, including the Sickle SCAN® device. Through Dr. Jaja, the team aims to carry out 10-20 trials for the device. These tests require no additional recruitment of human subjects beyond Dr. Jaja’s current patients.

 

How are you running future clinical trials?

1. Future clinical trials will emphasize establishing a treatment program at hospitals with health care workers and a follow-up study.

 

What are the metrics of success for your venture?

1. In the short term, within 5 years from launch, we can save over 5,000 lives per year, and reduce the percentage of under-five deaths in Sierra Leone due to Sickle Cell Disease (SCD) from 4.2% to 0.2%. In a steady state, 5-10 years in the future, our team wants our project to be absorbed into the Sierra Leonean Ministry of Health and strictly control the intellectual operations of the project. 

 

What determines our selling price per unit? 

1. A price that makes the device affordable for donors while allowing profits to be invested into SCD treatment methods like penicillin prophylaxis supplements.

 

How do we plan to integrate our devices into the hospitals?

1. Our relationship manager will gauge interest, and if interested, we will have our training expert come to the hospital’s hematology labs for the staff training. This allows us to integrate the device into their SOPs, not be involved directly.

 

1. How will we help patients throughout diagnosing sickle cell?
   1. The success of this project will not only be labeled by the completion of the screening device, but by the strengthened attitudes of communities’ towards the idea of diagnosing SCD. We have recognized the indigenous knowledge, traditional beliefs, and practices, hence our device is being customized to be non-disruptive to the current Sierra Leonean lifestyle. Therefore, the educational curriculum is aimed to provide locals with information on where and how to receive treatment.

 

1. What has been our plan to cope with the COVID-19 situation?
   1. Currently, there is a small team of us working hybridly at our on-campus lab to run tests, while in the meantime, we will also continue writing proposals for grants and competitions. 
   2. Some pieces we have worked on are the NIH Tech accelerator, DEBUT, GHTC IEEE and BMES. We also have plans to submit an article to either Lab on the Chip or the Journal of Hematology.

 

1. Why is this research important? What’s so significant about what you are doing?
   1. Everyone with sickle cell disease should be able to live a fulfilling life, BUT this is definitely not the case around the world right now. As mentioned before, in sub-Saharan Africa about 50-90% of individuals with SCA will die before the age of 5. Therefore, we make it our goal to promote early awareness of the disease’s presence and diagnose all children of 5 years or younger to lower child mortality rates.

 

1. Who is our main target consumer?
   1. For all children under the age of 5 who have sickle cell disease, our SCA diagnostic device is capable of identifying whether you have healthy blood, sickle cell disease or sickle cell trait, so they can take the necessary steps to get treatment.