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Fostering innovation in medical diagnostics

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Donning several hats with ease, Dr Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology, Chairperson of BIRAC and a scientist in an exclusive conversation with Prathiba Raju spoke about how BIRAC’s guidance has created a great impact in improving R&D and indigenous start-up culture in the arena of medical diagnostics. She also speaks about the vibrant start-up ecosystem created and its strong industry academia linkage

Since its inception, how has BIRAC been supporting the biotechnology industry, diagnostics and pharma in particular?
The main purpose with which Biotechnology Industry Research Assistance Council (BIRAC) was set up seven years back was to support the biotechnology industry, as it shows in the name. Our focus was to try and see how we can support the startups and create a strong and vibrant innovation ecosystem. The main areas which we focus on our partnerships with the industry is primarily connecting the academia with the industry. There was a missing link, our first and foremost action was to connect it and make it into a platform. Our second major focus was to build capacities and of course, the third and most important is how do we make our Indian industry globally competitive. Now with BIRAC, the researchers get the support right from incubating their idea, development of the diagnostic tool and learning how to get through the regulatory processes. From paper to product in each stage, BIRAC helps them to bring all the stakeholders of innovation in one platform. So, BIRAC has successfully been able to work through all these and also look at bringing in strategic partnership – both national and international.

Can you elaborate on BIRAC’s work in the diagnostic sector?
Nearly 60 per cent of our support is in the biopharma sector and within that also, more than 50 per cent of it goes to medical devices and diagnostics sector. Firstly, the medical diagnostics segment obviously has a shorter gestation period and the complexity of the regulations – not in terms of the actual policies, but in terms of the time it takes, is less. It’s not as capital intensive as the vaccine development area. When we look at it from the BIRAC perspective, we promote a lot of inter-disciplinary research and we have been approached by a lot of biomedical engineering groups, engineering groups and IITs. Medical devices is a sector where we have actually seen a lot of engineering students, the competitive groups working with the biologists and taking forward many innovative projects in anti-microbial resistance, cancer and vector-borne disease. BIRAC’s assessment in terms of what is required in the market has helped such young engineers. So, we have really been able to support a lot of them. In 2017, the Department of Biotechnology (DBT) got the government’s approval to start the biopharma mission. Under this mission, we look at the product development vertical in which medical devices segment plays a significant role. We have supported more than 1000 startups through direct funding and via incubation support. We have nearly 500 other beneficiaries who come in through academic institutes, smaller companies, SMEs, etc. If you look at the products, about 50 per cent of them are in the market and nearly 75 per cent of them are in the area of medical devices and biopharma.

In medical diagnostics, there is a lot of R&D which needs to be done but we don’t concentrate much on it. After BIRAC and lot of push from the IIT students, how has it turned the phase?
DBT’s primary goal is to fund the research to academic institutes. We do support a lot of research in medical diagnostic BIRAC came forward to create the fund to be able to help the startups and the industry. So, a lot of academic research is moving out now from the laboratories to the startups and to the industry. Today, a lot of new diagnostic devices are coming out– be it for infectious diseases or for screening of various cancers. It is not just because of funding , but connecting the academia, industry and the startups as well. Also, incubation centres play an important role. For instance, IKP Knowledge Park, which runs medtech and biotech incubator IKP-EDEN, research park at IIT Kanpur are all focussing on medical device prototyping, validation, and research and development. They facilitate a lot of translation of the research, help startups to understand what those gaps are and take it forward.

BIRAC also has a number of collaborations with UK-based NESTA, Wellcome Trust to name a few. Can you tell us more on this?
The underlined philosophy of BIRAC is that we carry out all our activities through well-defined and well-identified strategic partnerships that we take on– be it national or international. Our models of partnership are different but the whole principle behind the partnership is partners that we choose add strength to whatever we are doing within our activities– be it connecting with larger networks, where our startups can get access to larger market, investors or co-funding partners where they bring in their funds and help us to look at co-funding opportunities. In terms of larger partnerships viz country-to-country, there would be larger network of researchers, startups, mentors who would engage with themselves. Our partnership with Wellcome trust-the DBT-WT Indian Alliances is an excellent initiative to promote capacities in biomedical research. Our largest co-funding partnership is with the Gates Foundation. We have the project management unit which is funded by them and the WellcomeTrust and DBT is the main government partner in that which is responsible for running a large number of Grand Challenges India programme. Apart from it, we have the Grand Challenges Exploration. Recently, we did one on the Idea Challenge, Data Challenge and Reinvent the Toilet programme – the main focus of these programmes was on maternal and child health. Another programme on AMR was a four-country challenge – Brazil, South Africa, Africa and India. Currently, we are also developing a partnership with Grand Challenges Canada.

How is the partnership with Canada different from Brazil, Africa and South Africa?
Grand Challenges Canada is a funding body, which encourages innovative market place. It looks at innovations which come from across the world. DBT has an MoU with them and with this partnership, we are enabling our innovators to compete in Grand Challenge Canada — a global innovations platform.

The biotechnology sector is growing exponentially. The target is to reach $100 billion by 2025. Where does India stand in this and how is BIRAC going to accelerate this?
We had put out an action plan in 2016 when the government brought out the Start Up India Action Plan and this number of $100 billion by 2025 was in our 2015 strategy that was announced in December. Our main target is to scale up the number of startups. Thus, we had then said that we will have 2000 startups by 2020. While we directly support 1000, but the ecosystem itself has a large number in it (around 1700-1800), we do say that anything that happens within the biotech sector, somewhere the enabling factor has come from DBT and BIRAC. We have created incubation facilities, mentor groups and more importantly, we have brought investors on the front who can recognise and appreciate the biotech innovations. According to a report, we were somewhere around $45 billion at the bioeconomy as a whole. Going by those numbers, $100 billion seems a doable figure by 2025, and we will have a large number of initiatives that we have proposed — like facilitating new product development, building capacities and more importantly, focussing on building the infrastructure, and a lot is happening for biopharma through the National Biopharma Mission.

Elaborate on the National Biopharma Mission?
The National Biopharma Mission specifically focusses on the development of new vaccines, bio-therapeutics, diagnostics and medical devices to address the rising burden of diseases in the country. They are into new product development, creating the shared infrastructure facilities and building capacities. Each vertical has its own different challenges. The main objective in product vertical is to identify priorities and decide the importance in terms of disease burden and develop indigenous product. Next task is to quickly get the product to the market, easing the regulatory policies and also, ensuring the product made are not just globally competitive, but also cost-effective and affordable for our own national needs is the target of the mission. For example we are looking into the factors in the new vaccine development viz dengue, pneumococcal vaccine, influenza. We are now trying to see how we can facilitate the TB vaccines

How will BIRAC compliment the medical diagnostics in future?
As for medical devices, we are looking at testing facilities, validation and prototyping of any of the medical devices. So, there are a large number of requirements, which come in through the lead assessment and we are supporting them. Our focus is to create a conducive environment for research, bring in suitable infrastructure facilities so the medical diagnostics field comes out with indigenous and innovative products.

How do you see the future of startups in India?
The startup culture is here to stay. Our policies that we are putting in for enabling the startup ecosystem will only grow. It will only compliment and identify what is missing and add value to that by bringing new policies. Our challenge today is looking at the scalability and sustainability of the ecosystem, and we are trying to address that currently. Each of these components – the Launching Entrepreneurial Driven Affordable Products (LEAP) fund, which provides capital assistance to startups with new and meritorious ideas, innovations and technologies, Accelerating Entrepreneurs or ACE fund which is to foster R&D and innovation in biotechnology domains, including areas such as healthcare, pharma, medical devices, agriculture, sanitation, product commercialisation unit, the bilateral co-operations that we have built for connecting ecosystems — these are all enablers in that direction. We also need to understand that there are huge challenges in the sustainability of these start ups. The biggest challenge is that a start up has to make sure that whatever idea they are taking forward, there is a market need for that particular idea.

Many a times, there is no proper need assessment. BIRAC and government plays an important role in that. When we get into investing in them at their ignition grant stage, we do a thorough diligence to see whether their idea has a market potential. If there is no market potential, they don’t get funded. The reasons is that it is a highly-competitive funding process but it’s also to ensure that those who get funded have a correct path that they follow. So, they need to be connected with technical and business mentors to take it forward. Even after selecting an idea which has got a market potential, it can still fail because it’s all about science. Entrepreneurs’ journey is complex and with biotechnology, it becomes more complex. More than 20 per cent of our start-ups have good success stories. The startup ecosystem will glow and we will continue to strengthen it.

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