In order to promote and accelerate the pace of research and development, the Department of Biotechnology (DBT) has embarked upon a number of novel schemes.
To give a push to the growth of the biotech sector in the country, by encouraging young entrepreneurs to take up research and development (R&D) activities, the Biotechnology Industry Research Assistance Council (BIRAC), set up by DBT, is soon planning to go beyond early stage funding to the next the level. The council is also scouting for partners from the private sector so as to attract more funding opportunities to those promising projects that have high commercialisation potential.
BIRAC has shown proactive interest in exploring the possibility of entering into a public private partnership (PPP) with interested parties to attract more resources and investment opportunities. Through this initiative the Council is eager to support and aid those start-up companies showing promising results from their early R&D work. To get a better idea on the nuances of this, the Council is keenly studying the technicalities from those countries like Finland, Sweden, France etc, who have adopted it.
According to Dr Renu Swarup, managing director, BIRAC considering the success rate in those countries, this model has a high scope for adaptability in a country like India, especially since India has a huge talent pool of untapped potential among the youth. Unfortunately, she added, it faces lot of challenges and roadblocks due to lack of investment opportunity which stems out from the lack of confidence among the investors in the industry.
The Council is currently having discussion with many private players and other stakeholders to get an understanding on this matter. It is understood that once the modalities for the same is finalised, the government will go forward with this initiative, which is expected to be in place by end of 2015.
BIRAC has recently launched research and development (R&D) incubation clusters in five centres across India. Through this clusters, the government plans to groom and foster young entrepreneurs and researchers with an ideal platform that will not only provide technical aid for generating ideas with commercialisation potential but also will encourage early stage funding as well.
The council hopes to encourage researchers to take technology closer to market through a start up, while stimulating the funding from the private sector to support enterprise formation. Dr Renu Swarup informed that considering the difficulty in getting investment from the private investors to aid young entrepreneurs with their start up initiatives it was high time for the government to come out with a way to join hands with the private sector.
She further pointed out that this strategy is fulfilled through a grant funding scheme called Biotechnology Ignition Grant (BIG) which is available to scientist entrepreneurs from research institutes, academia and start ups. As per the requirement, the applicant must be either an incubatee or have a registered company with a functional R&D laboratory to be eligible for this grant, as the scheme is designed to stimulate commercialisation of research discoveries by providing very early stage grants to help bridge the gap between discovery and invention.
Dr Swarup informed that the call for proposal will be announced twice every year, on January 1 and July 1 and as part of this scheme, successful BIG Innovators receive up to Rs.50 lakh for research projects with commercialisation potential with duration of up to 18 months. The first phase of which has already been flagged off. The BIG Scheme is currently managed through three BIG Partners across the country who works with the Ignition grantees (BIG Innovators) to provide mentoring, monitoring, networking and other business development related activities.
The five biotechnology ignition grant partners are IKP Knowledge Park, Hyderabad, Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru, Foundation for Innovation and Technology Transfer, New Delhi, KIIT Technology Business Incubator, Bhubaneswar and Venture Centre (Entrepreneurship Development Centre), Pune.
BIRAC, under its contract research and services scheme (CRSS), has invited proposals from the public or private universities and research institutions to take their proof of concept leads and technologies towards commercial scale.
Under this scheme, the department of biotechnology (DBT) provides support to academia in the form of grant-in-aid for taking proof of concept of their leads/technologies towards commercial scale with industry under a specific contract and fee structure. Exploratory research or fundamental discovery with no proof of concept will be discouraged.
The requirements of the academic groups for some specific services from the industry such as toxicology studies, gene sequencing towards translational work, studies using specific industrial equipment etc. forming a part of commercial scale development could also be supported under this scheme.
Academia has to be the primary applicant with one or more partners of which at least one of them has to be a company. Public or private universities and research institutions having a well established research support system for basic or applied research are eligible for this proposal which will close on March 17, 2014. The academic partner will be provided grant-in-aid for further translational work required at their site (if any) and for the contract research/service components to be outsourced to the collaborating companies.
Earlier, the CRS scheme was launched by BIRAC to extend support to academia in the form of grant-in aid for validation of the proof of concept (PoC) by an industrial partner.
It was launched in the backdrop of the fact that numerous lab scale research leads are being generated in the academic sector through funding from various agencies like DBT, CSIR, DST, DRDO etc., which have the potential for validation and translation into products. Currently the academia is capable of limited translational research, however, product development is generally not a part of their mandate. Moreover, they may not have the required infrastructure to take on product development and commercialization activity.
DBT, under its Small Business Innovation Research Initiative (SBIRI) scheme, has invited proposals from Indian biotech companies for funding of research and development in the field of biotechnology. Under this SBIRI scheme, the DBT will provide support for innovation research in biotech companies including start-ups, small and medium enterprises and other ‘for-profit’ private companies.
Under this flagship public-private partnership programme, the DBT will support early stage and proof-of-concept for innovations based on valid hypothesis, R&D aimed at affordable product development, lab-scale technology refinement, validation of a technology at pilot scale, platform technologies/prototype development etc.
The proposals can be submitted solely by a company incorporated under the Companies Act, 1956 or Limited Liability Partnership (LLP) incorporated under the Limited Liability Partnership Act, 2008 or Joint Ventures either in the form of Company/LLP. The proposals can be submitted by any of the above entities jointly with other private or public partners (universities or institutes).
At least 51 per cent of the shares of the company should be held by Indian citizens. Minimum half of the persons who have subscribed their names to the LLP document as its partners should be Indian citizens. The main industry applicant should have DSIR recognized in-house R&D unit or patent granted or acquired, which will be used for the proposed project. The companies who are in the process of obtaining DSIR recognition or intend to do so can also apply.
The DBT launched the SBIRI scheme to boost public-private-partnership effort in the country. The distinctive feature of SBIRI is that it supports the high-risk pre-proof-of-concept research and late stage development in small and medium companies led by innovators with science backgrounds which is unique in nature to support private industries and to get them involved in development of such products and processes which have high societal relevance. SBIRI has unique process for generating ideas by bringing users and producers of technology together, it has the direct focus on producing product and a sense of urgency for producing defined results that only private sector engagement can produce.
The scheme aims to strengthen those existing private industrial units whose product development is based on in-house innovative R&D; encourage other smaller businesses to increase their R&D capabilities and capacity; create opportunities for starting new technology-based or knowledge-based businesses by science entrepreneurs; stimulate technological innovation; use private industries as a source of innovation and thereby fulfil government objectives in fostering R&D; and increase private sector commercialisation derived from government funded R&D.
At the same time the Department of Health Research (DHR) in association with DBT, Department of Agricultural Research and Education (DARE) and the Department of Space (DoS) will soon embark on joint research in the field of zoonotic diseases, which are infectious diseases that affect both animals and humans.
The Union health ministry's initiative in this regard is significant as zoonotic diseases continue to be major public health problems in India. There are several programmes in place being implemented by the ministry of health and family welfare for control of the zoonotic diseases in humans and also by the ministry of agriculture for control of the diseases in animals respectively. However, there are still certain gaps in our knowledge about these diseases and also in how to control them.
Earlier, a meeting was held in this connection on October 14 last year which was chaired by the Dr VM Katoch, secretary, DHR and director general, Indian Council of Medical Research (ICMR). The aims of this meeting were to identify priority areas for joint research and constitute working groups. It was also decided in the meeting that the lead department of each working group would organize the meetings of the working groups and develop concept proposals.
One of the priority areas of joint venture was identified to be zoonotic diseases. DHR will be the lead department of the working group dealing with this. The programme will be managed by a secretariat located in the ICMR-DHR co-ordination division. For implementation of activities, the ICMR has been identified as the nodal agency on behalf of the DHR. The overall scientific goals and procedures would be monitored by the joint working group (JWG) consisting of members representing the DHR, DARE, DBT, DoS and invited experts.
Aiming to understand the epidemiology of Pre-term Birth (PTB), its genetic and environmental interactions, and changes in vaginal microbial landscape, DBT has embarked on a Pre-term Birth Programme, which is the first inter-institutional programme on maternal-infant health and spontaneous pre-term birth sciences in India.
The programme is funded by the department under the Grand Challenge Programme. The total cost of the project is Rs.48.85 crore for a period of five years.
The programme envisages a multidisciplinary research effort to predict & diagnose Pre-term Birth (PTB) by enhancing the knowledge of the underlying pathophysiological mechanisms. It is expected that the clinically relevant research outputs from the study will aid characterization of biological, clinical and epidemiological risk factors to achieve appropriate risk stratification of mothers who may deliver before term. These in turn would provide a basis for discovery of novel therapeutic agents and determine appropriate timing for their clinical application. Together, it would strengthen the commitment of the DBT to health equity, contributing significantly to reduction in infant and maternal mortality.
The DBT's initiative in this regard is significant as globally PTB is the single largest cause of neonatal deaths. In India’s 27 million birth cohort annually, born annually, 3.6 million are born pre-term, and over 300,000 of them die each year. India, contributes the highest number of PT birth and deaths worldwide, specifically 25 per cent of the overall global pre-term related deaths. Despite substantial efforts to introduce new therapies for prevention, the problem persists and contributes significantly to neonatal and infant mortality and morbidity. Pre-term birth has substantial long-term consequences for those affected, well in to late childhood and adult life.
The program highlights include development and evaluation of putative biomarkers, identification of simple microbiological tool based vaginal risk factors, modulation of vaginal microbiota for therapeutic purposes and evaluation of environmental modification chosen from SNP analysis. Some of the major public health concerns addressed by the programme are biological risks and processes of foetal growth and PTB, clinical consequences of PTB and intra uterine growth retardation.
With an aim to creating a pool of trained clinical researchers in the area of neuroscience, DBT has launched a fellowship programme called 'Initiative on Neuro-Clinical Research Education (INCRE).
The shortfall of clinical researchers is a crisis that will heavily impact the research scenario of neuroscience research. Recognizing this critical need for neuro-researchers, the department has dedicated its HRD efforts towards investing in young clinicians with an aptitude and interest in neuro-clinical research.
The main objective of this initiative on INCRE is to facilitate hypothesis-driven research designed to address important issues in neuroscience by clinicians. Towards this aim, the department has invited applications from the eligible candidates. There would be up to 11 fellowships initially for this financial year, of one year duration that may be extendable for another year on case to case basis, based on performance review. Each fellowship will consist of a consolidated stipend of Rs.75,000 per month and Rs.5 lakh for one year to support research at an institution of repute.
D.M./M.Ch or MD- Psychiatry and interested in pursuing neuroscience research along with clinical responsibility; and has completed residency within the past five years are eligible to participate in the programmme. However, those early in their clinical career will be given priority.
In order to support clinical research in medium and small pharma units in India, DBT has formed a collegium of teaching universities from across the country which will help, advise and train pharma companies in conducting clinical trials and research for the sake of patient safety.
Dr B Suresh, vice chancellor, JSS University, Mysore, who is a member of the collegium, said, "This initiative of DBT will help meet the challenge of small companies who cannot approach big Clinical Research Organisations (CRO) or competent institutions due to financial constraints."
The collegium has finally seen the light of the day as more than 50 teaching institutions applied to be a part of the project. After a series of interviews, discussions and inspections, these teaching based institutions which are a part of the collegium were short-listed based on their eligibility and ability to deliver research, training and conduct clinical trials.
This would be instrumental in helping the small companies get extensive and exhaustive support for developing new procedures and protocols for clinical trials at a low cost.
The current trend of industry driven drug discovery and development rather than science based drug discovery suffers on account of data reproducibility and fails to offer complete data to the scientific community, industry and regulatory authorities.
Aiming to enhance participation of women scientists in biotechnology research, DBT had invited research proposals exclusively from women scientists in the country under its ‘biotechnology career advancement and reorientation programme for women scientists’ (Bio-CARe) scheme.
The programme is targeted towards career development of employed/ unemployed women scientists. The scheme is open for all areas of life science/biology including agriculture, veterinary science and medicine. Age limit for this programme has been kept as 55 to ensure maximum impact. It would also be a good opportunity for women scientists who have had a career break to get into the mainstream of research.
The programme aims at providing support for research project grants to women scientists (employed & unemployed) for whom it is the first extramural research grant. Women scientists who have received any earlier grant from any government funding agency as principal investigator are not eligible for this programme. The purpose of the programme is to build capacities for women scientists employed full time in universities and small research laboratories or unemployed women scientist after a career break so as to help them undertake independent R&D projects.
Under its advanced technology scheme Biotechnology Industry Partnership Programme (BIPP), DBT invited fresh proposals from biotech companies for providing support on a cost-sharing basis targeted at development of novel and high risk futuristic technologies mainly for viability gap funding and enhancing existing R&D capacities of start-ups and SMEs in key areas of national importance and public good.
Major thrust of the programme is towards funding technologies which address a major national problem and/or involves high level of innovation. The proposals spanning across the spectrum of pre-proof-of-concept to validation of established technologies are considered for support in the form of grant and/or loan.
A single or consortia of Indian companies - small, medium or large having DSIR recognised in-house R&D units, alone or in collaboration with a partner from another company, university, institute or organisation can participate in the programme.
The key feature of the programme is that it supports large, medium, small scale companies as well as start-up companies on cost sharing basis. It would push for high risk, discovery linked innovation and accelerated technology development. It will also support evaluation and validation of biotech products, besides supporting indigenous discovery, innovation and technology to products that are of national relevance or public benefit. Support is also available for infrastructure or facility set up.