Team:IISER Bhopal/Implementation

iGEM 2020 || IISER_Bhopal Proposed Implementation Overview

Implementation Overview

The BIG PIE aims to create an alternative therapy for diabetes using a biological delivery system that can transform gut cells into beta islet-like cells. We are enclosing these modified bacteria in a capsule to create the final consumable product- iβeta that will deliver our bacterial drug in the most efficient way to the target cells. Our work on drug delivery aims at maximising the efficiency of our final drug with the help of the perfect capsule.

Our proposed implementation took our project from the lab to the final product for our patients - the Pill iβeta.

Our interactions with an expert made us realise that the first stage to take our project from proof of concept in the lab to a product is to convert it into an easily administered oral formulation like a capsule that is easily accessible, ingestible and convenient for patients. Our data showed that over 83% of the people who took our survey preferred tablets or capsules. Hence, it was the perfect choice for our drug.

Keeping all necessary aspects in mind, we have designed a pH-sensitive capsule with bacteria enclosed in mucopenetrative microspheres that are perfect to deliver our biological drug to its target site in the duodenum. The work done with our capsule iβeta has influenced our project in a major way and helped improve the efficiency to create a robust targetting system.

Find out the details of our drug delivery capsule design.

Our email correspondence with the Central Drug Standards Control Organisation and interaction with an Endocrinologist from AIIMS Jodhpur, India, helped us understand the ethical and technical concerns involved in our project, as well as the drug safety and regulations. As per the CDSCO guidelines, our probiotic can be qualified as a “new drug” and would need to undergo rigorous clinical trials before being approved as a safe drug in the market.

Hence, as part of our implementation, we have created a roadmap that we intend to follow to help our project go from Capsule stage to the Market. This requires rigorous scrutiny of our bacterial efficiency, safety and functionality which can only be ascertained through multiple rounds of carefully created clinical trials which will help evaluate all possible outcomes and make our Live Drug market-ready.

Find out the details of the Clinical trials we have designed.

Our capsule iβeta is a pharmaceutical product and our end-users are diabetes patients. Our target group mainly includes late-stage Type-2 Diabetes Patients and Type 1 Diabetes patients.

The capsule will serve as a replacement for insulin injections. Over 50% of the diabetics who took our survey were using at least 3 insulin injections every single day. As per literature reviews, beta cells in the guts of mice were able to maintain glucose levels in the blood for 10 to 12 days. Our capsule iβeta containing probiotics can create beta cells that will have a life span of at least 3 to 4 days while also prolonging the effect of the cells. Though we do not have accurate wet-lab data to support this claim, as per our understanding from previous literature reviews on an average, a diabetic will only be required to consume iβeta every 3 to 4 days.

We have completed a thorough analysis of the market (how we intend to reach and diversify our market), competitors, customer needs, requirements (the assistance we can give to the diabetes patients), patient demographics etc. These are just some of the various aspects we have clearly identified and explained in the entrepreneurship section of Implementation.

Our safety policies are extremely stringent which will not only ensure the safety of the patient but also that of the environment. We have rigorously tested for biosafety issues and tried to eliminate them in the design stages.

Click here to know more about the market, consumer understanding, safety aspects, challenges and other considerations that we’ve made.