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BIRAC’s goal is to support development by de-risking and accelerating product development

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Biotechnology Industry Research Assistance Council (BIRAC), established by the Department of Biotechnology, Government of India, is playing a catalysmic role in building an innovative ecosystem in India. To encourage research and development in biotech, pharma and diagnostics, BIRAC has launched several programmes and is encouraging academic institutions partner them in these programmes. Dr Shirshendu Mukherjee, Mission Director,  Programme Management Unit, under BIRAC shares more details with Usha Sharma

Give us an update on Biotechnology Industry Partnership Programme (BIPP)

The Biotechnology Industry Partnership Programme (BIPP) supports the development of appropriate technologies in the context of recognised national priorities and was launched on December 5, 2008. BIPP partners with industries (Small, Medium or Large) to support high risk, nationally and socially relevant transformational technology/ process development on a cost sharing basis for path-breaking research in frontier futuristic technology areas having major economic potential and making the Indian industry globally competitive. The uniqueness of this scheme is that it is for “Break through research” which enables product and process development and is patentable, with IP ownership rights resting with industry. The key feature of this programme is to provide support for product evaluation and validation for limited and large scale field trial for agriculture products and clinical trials (Phase I, II, III) for health care products.

Tell us about the key programmes designed for the pharma sector. What has been the success rate of these programmes?

The cabinet approved National Biopharma Mission (NBM) for implementation in May 2017, with a total cost $ 250 million, which is co-funded 50 per cent by the World Bank. NBM is an industry-academia collaborative mission of the Department of Biotechnology (DBT) for accelerating early development for biopharma and is being implemented by BIRAC. The Mission Programme is a pan-India programme with the main aim of making India a hub for design and development of novel, affordable and effective biopharma products and solutions. This programme intends to aid in enhancing India’s innovation research to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharma to a level that will be globally competitive over the next decade, and transform the health standards of India’s population through affordable product development, especially by focusing on development of vaccines, biologics and medical devices for combating public health concerns.

How do you promote academic research and encourage industry to be part of such projects?

Biotechnological research and development in India is largely carried out by academic institutions (universities/ research organisations) and to some extent by industry (mostly large companies). By virtue of their strong infrastructure and technical capability academic/research establishments are mandated to research on variety of problems of national importance and societal relevance. Also, unlike industry, research by academia is not governed by commercial gains alone thus allowing them to work on problems involving even high degree of risk. To encourage/ support academia to develop technology/product (up to  proof-of-concept stage) of societal/national importance and its subsequent validation by an industrial partner, BIRAC has launched Promoting Academic Research Conversion to Enterprise (PACE ).

The scheme has two components as below:

1. Academic Innovation Research (AIR): The objective of Academic Innovation Research (AIR) scheme is to promote development of proof-of-concept (PoC) for a process/product by academia with or without the involvement of industry

2. Contract Research Scheme (CRS): Contract Research Scheme (CRS) aims at validation of a process or prototype (developed by the academia) by the industrial partner.

Post 2011, there have been downturn in the Indian clinical trial sector, how is BIPP encouraging the industry to revive clinical trials?

BIPP scheme has been supporting very high risk, nationally and socially relevant futuristic technologies, more of translational research with no assured market. BIPP, through its III (a & b) category, provides product evaluation and validation through support for limited and large scale field trial for agriculture products and clinical trials (Phase I, II, III) for healthcare products.

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There is a dire need for innovative drugs pipelines in pharma sector, what support does BIRAC – DBT offer to the industry in fortifying and accelerating their research pipeline?

The programme named Innovate in India (I3) is an industry-academia collaborative mission of Department of Biotechnology (DBT) in collaboration with World Bank for accelerating discovery research to early development of biopharma products and to be implemented by Biotechnology Industry Research Assistance Council (BIRAC).The aim of the mission is to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharma to a level that will be globally competitive over the next decade, and transform the health standards of India’s population through affordable product development. The programme will specifically focus on the development of new vaccines, bio-therapeutics, diagnostics and medical devices to address the rising burden of diseases in the country.

Unlike IT, the pace of innovation in pharma and biotech is slow, how can BIRAC accelerate the innovation process?

To strengthening the ecosystem, BIRAC is deploying a multipronged strategy categorises into incremental and non-incremental approach to generate maximal impact in next five years. BIRAC’s overall goal is to support the development of specific products by de-risking and accelerating product development. Together with experts from around the world the most promising candidates through the pipeline would be selected based on scientific merit/technical feasibility, degree to which the priority health needs, stage of development (earlier projects may carry more risk but also greater promise) and alignment with the target product profiles. Through this detailed and rigorous assessment, the probability of the product being brought closer to the market within the programme  timelines would be substantial. This would not only aid in decreasing development timelines, but also impact the uptake time by public health agencies.

What measures are DBT- BIRAC taking up for Mission AMR? And how are innovators being encouraged to join this mission? How do you ascertain their Proof of Concept?

The National Action Plan endorsed by Government of India, the Department of Biotechnology, in partnership with BIRAC, has initiated a major Mission Program on Antimicrobial Resistance with the vision to develop indigenous and cost-effective therapies against AMR; categorisation of AMR specific pathogen priority list of India; establishment of bio-repository for AMR-specific pathogens; and development of rapid and cost-effective diagnostic kits to identify AMR-specific pathogens. The first call under this mission was launched with focus on nurturing collaborations between academia and industry partners to enhance their capabilities and competencies for developing new antibiotics and alternative therapeutics for AMR.

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Applications were received under this call and currently are being reviewed. DBT-BIRAC’s AMR mission calls will cover research addressing the identification of new bacterial targets and/or therapeutic compounds, re-evaluation of existing anti-microbial compounds, either alone or in combination with other drugs or immune-modulators. Investigation on novel enzyme(s)/targets/ mechanisms or alternative therapeutics to overcome known antimicrobial resistance mechanisms and restore susceptibility to conventional antibiotics and enhances immune pathogen elimination through therapeutic antibodies and phage therapy; and disrupts colonisation and bio-film development through anti-biofilm products. The department has also notified the National Centre for Microbial Resource (NCMR), National Centre of Cell Sciences, Pune (an autonomous institute of DBT) to function as a bio-repository for resistant microbes/ infective agents (bacteria and fungi) and to carry out collection, storage, maintenance, preservation and characterisation of these microbes across the country.

BIRAC has collaborated with Nesta, a UK-based innovation charity organisation, to create a pipeline of innovators for the Longitude Prize, in the area of antimicrobial resistance. The Longitude Prize is a £10 million prize fund that will reward a competitor who can develop a point–of–care diagnostic test which will help to conserve antibiotics for future generations and revolutionise the delivery of global healthcare.

Tell us more about Biotech Ignition Grant (BIG) scheme and its implementation progress?

BIG is the flagship programme of BIRAC, which provides the right admixture of fuel and support to young start-ups and entrepreneurial individuals. BIG is the largest early stage biotech funding programme in India. Funding grant of upto `5 million ($70,000 approx.) to best in class innovative ideas to build and refine idea to proof-of-concept. The call for proposal is announced twice a year, i.e. on 1st January and 1st July for about 45 days and is currently managed through six BIG Partners across the country who works with the Ignition grantees (BIG Innovators) to provide mentoring, monitoring, networking and other business development related activities to establish and validate proof of concept. Funding is given in the form of Grant- in-Aid limited up-to `50 lakhs.

In September 2014 during the Start-up Konnect event in California, Narendra Modi Prime Minister had launched the Bharat Innovation Fund. How has this helped biotech and pharma companies?

Bharat Innovation Fund, launched by the Prime Minister Narendra Modi in September 2014 during the Startup Konnect event in California, will support innovation and innovative start-ups in areas of healthcare and life-sciences, sustainability, and digital technologies.

The DBT and BIRAC pledged to participate and engage with the Bharat Fund, as part of their efforts under the Startup India initiative, to help commercialise technologies from its labs and facilities, while also mentoring start-ups in the healthcare, agri-tech, and other biotech-related areas. The DBT-BIRAC plan to invest `50 crore over the next three  years to support startups through this fund.

Through various schemes of BIRAC, start-up India has been promoted to take a step further to promote government initiatives like Start-up India and Make in India. BIRAC has set up a facilitation unit which will act as the first hub to address the queries of start –ups, entrepreneurs, researchers, academicians, incubation centres, SMEs etc. The policies, rules and regulations are dynamic and keeping pace with the fast changing ecosystem is next to impossible for small companies and young entrepreneurs. BIRAC, through its various programmes, is already facilitating research and innovation and to complete the 360o start-up facilitation, it has envisaged setting up the FIRST HUB.

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