From the day it came into existence, the Biotechnology Industry Research Assistance Council (BIRAC), an institution set up by the Department of Biotechnology (DBT), Government of India, has been backing a number of biotech startups to undertake research and innovation, in turn, strengthening and empowering the biotech industry in the country BY Akanki Sharma
Necessity is the mother of invention and this is what drives every startup that comes up with an innovation to fulfill an underserved need, benefitting the society, and leading to the growth and betterment of an industry. Further, when it comes to biotechnology industry, Biotechnology Industry Research Assistance Council (BIRAC) nurtures and supports these startups by bridging the gap between the industry and academic institutions in order to give a boost to the sector. And, the support offered by BIRAC has led to many success stories.
According to Dr Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology, and Chairperson, BIRAC, it evaluates the proposal based on unmet need, affordability, societal relevance, novelty and feasibility while considering a project for funding and closely monitors/mentors it for its successful completion.
(See interview: Startups must make sure their idea has a market need).
Let’s look at the case of Dr Ranjana Srivastava, who came up with a startup named Nextec Life Sciences. With a passion for science and a personal commitment to help people suffering from a particular lack of accurate diagnosis across the world, she came up with this biotechnology company, which is based in Lucknow, Uttar Pradesh. Founded in 2012, Nextec Lifesciences focusses on development of diagnostic assays for infectious diseases, biomarkers and diagnostic/ screening assays for lifestyle-related and life-threatening diseases, biosensors, newer screening system solutions for novel antimicrobials, anticancer and more. It also provides consultancy to biotech and non-profits, outreach programmes for villages in healthcare education and screening camps for lifestyle and life-threatening diseases and invites NGOs to form alliances.
The inspiration for the company came after one of her family members was diagnosed with primary complex, a form of TB (an infection of lungs) which affects young children. Dr Srivastava recalls, “The boy was not gaining weight and looked pale. After an X-ray of the chest, the doctor suspected primary complex and told us that this infection usually resolves on its own as a child develops immunity over a six- to-10-weeks period but in some cases, it can progress and spread all over the lungs (called progressive tuberculosis). In case it crosses the brain, it could be fatal and thus a combination of drugs was strongly advised. Over the period of his treatment, I observed that he lost his appetite, leading to severe weight loss. His immunity lowered, with a running fear of side effects.” She further informs, “Even after the treatment, the point that kept bothering me was how could the infection be confirmed without showing the presence of infectious bacilli. That’s when I decided to develop a DNA-based diagnostic test for TB.”
Srivastava adds, “We used molecular techniques to identify a stretch of DNA from the genome of Mycobacterium
tuberculosis, which was specific to M. tuberculosis. The fragment was sequenced and patented in the US (1997, 1998) and India (2006) for its use in the diagnosis of TB. Incidentally, it was the first biological patent from India and a detection system was developed. Central Drug Research Institute (CDRI) then licensed the technology to a Mumbai-based company but this did not work out. So, I decided to start a biotech company and generate funds for developing a TB kit to enable rapid and accurate diagnosis of TB, leading to the birth of Nextec Lifesciences.”
Inspiration and motivation
Just like Srivastava, Telangana-based Tergene Biotech was co-founded by Sathyan Kuppusamy, whose father M Kuppusamy has 40 years of experience in the field of vaccines and biopharma products. “We started the company with a vision to develop life-saving vaccines against infectious diseases. There is a huge unmet medical need to cure and treat infectious diseases, for instance, pneumonia. We started working on a 15 valent pneumococcal conjugate vaccine, which should be affordable and at the same time provide a wider protection against prevalent pneumococcal serotypes,” informs Sathyan.
However, any new journey comes with its own challenges. While doing something new, one witnesses several ups and downs, but if the passion to achieve something is strong enough, inspiration and support come your way.
So, while on her way to being an entreprenuer, Srivastava was inspired by her husband Dr Brahm S Srivastava, a scientist and Co-partner at Nextec. He became her first guru to teach her molecular biology. Post marriage, she moved to a molecular biology lab in the University of Brussels, Belgium. Thereafter, Dr Nityanand, former Director, CSIR-CDRI and Dr S
Ramachandran, former Secretary, Department of Biotechnology, GoI became the role models in her journey.
“Dr Nityanand gave me a lab and the freedom to work even as a pool officer with all financial support. He made sure that we established gene cloning in CDRI. This was the best scientific challenge responsible for my success. Dr Ramachandran played a great role in my sustainance in recombinant DNA field which was totally new for India and required imported reagents. He personally made sure of the availability of all molecular reagents, restriction enzymes and DNA ligase to all users within the country and established powerful gene cloning technology,” she shares.
Apart from it, a Biotechnology Ignition Grant (BIG) from BIRAC, Department of Biotechnology, Government of India (2015-2017) for development of DNA-based diagnostic kit for early and accurate diagnosis of tuberculosis came as another accolade for her. Using DNA as diagnostic marker, the kit detects TB within 20 minutes. Then, this year in March, Srivastava was also conferred Biotech BIRAC-TiE Winer Award for Entrepreneurial Research 2019 by BIRAC, Department of Biotechnology, GoI.
For Sathyan, his role model was his father who has worked with various organisations, including Ministry of Health and Family Welfare and Indian Council of Medical Research (ICMR). “I draw my inspiration from all his accomplishments and his never-ending quest for research and development of novel vaccines and bio-therapeutics,” he apprises.
Founded in 2008, Tergene has developed platform technologies for novel vaccine candidates and the first product would be the pneumococcal vaccine which is currently in the clinical stage of development. The startup has also supported several biotech companies and research institutions by supplying them with carrier protein, mainly used in conjugate vaccines and cancer research.
Sathyan states, “The research work on pneumococcal vaccine started in the year 2010. In 2011, the Department of Biotechnology (DBT) through their BIPP scheme supported Tergene with a small grant for ‘proof-of-concept’ work. More than the funding support, it was the encouragement given to a start-up company like us at that point of time and it should be noted that even BIRAC was not in existence during that time. Since then, we have been constantly receiving funding from BIRAC for the pneumococcal vaccine project. Apart from funding, BIRAC appreciates and recognises the advancement in the field of work we do. For instance, in the year 2013, Tergene received BIRAC’s Innovator Award in recognition of the technology that has been developed for an indigeneous, Asia-specific pneumococcal conjugate vaccine. They have been handholding us in terms of providing advisory on the regulatory pathway and representing the industry’s concerns to the regulatory bodies and appraising the Government of India about the development of much-needed vaccines like the pneumonia vaccine. Most recently, we received a grant funding from BIRAC under the National Biopharma Mission supporting the clinical trials of our pneumo vaccine.”
He adds, “BIRAC’s support will be there for any product until it sees the light of commercialisation and reaches the common man. The projects are selected on the basis of technical merits and also keeping in mind the country’s requirements and unmet medical needs, which are their top most priority.”
Tergene’s pneumococcal vaccine has completed Phase I clinical trials in India. Phase-II clinical trial of the vaccine is under way and the results are expected in the next two to three months. The company also has plans for global trials, which will be decided in due course of time.
Practices and suggestions
Another startup, AlgalR NutraPharms, that came into existence in July 2014, was founded by Mohanraj Subramanian, who is also the CMD of the company. Based in Tamil Nadu, it provides high-pure algal DHA oil and algal DHA capsules in bulk.
DHA provides significant health benefits to humans, particularly in reducing cardiac diseases, stroke, high blood pressure, depression, arthritis, and brain development in children. In earlier days, fish-derived DHA was popular but had several disadvantages, including fishy odour, fishy taste and heavy metal contaminations. Hence, pure vegetarians do not prefer it. So, Subramanian felt the need of extracting DHA from microalgae, which is 100 per cent vegetarian and came up with these capsules.
He also informs that BIRAC has played a crucial role in his company’s growth. “It has first financially supported the new idea, which has a market potential. Based on the proof of concept, BIRAC again supported us and took us to the next level. Now, our company can secure many international orders and we can compete with many Chinese companies on quality, and with the US and European companies on price. The institution assigned us a single mentor Professor Guhan Jayaraman at the initial stage, who later became a collaborator of our project. His guidance and support were productive. Moreover, BIRAC’s practices and suggestions in the Technical Expert Committee meetings were all productive and shaped us appropriately.”
When the going was tough during his entrepreneurial days, his professors became the role models who inspired him to keep on working towards his goal. Sathyan even expresses a little disappointment by saying, “Many young brains with the real potential to bring changes in our economy could not reach the target, as they were tired of too many regulatory components and financial setbacks.” Apart from DHA oil and algal DHA capsules, Algalr provides vegan algal DHA powder –FF10, FF20, FF30, and EN 10 (human nutritions); Omega3-226 for animal feed (pet animals); Omega3-Pro for animal feed (Aquaculture); Omega3-lite for animal feed (poultry industries) and Spiromax-PS and Spiromax-DR (for growth and disease resistance in prawn culture), apart from Algal DHA oil and algal DHA capsules.
Fairness and transparency
Moving on to the story of Pandorum Technologies based in Bengaluru, co-founders Arun Chandru and Tuhin Bhowmick came up with their startup in 2011 to bio-engineer functional human tissues and organs suitable for clinical implantation with the support of DBT and Association of Biotechnology Led Enterprises (ABLE). The duo had won Rs 5 lakh at BEST 2010 organised by the DBT and ABLE at the Indian Institute of Science, which became another motivational factor for them to work for the betterment of the society. Describing the role of BIRAC in supporting the journey of Pandorum, Chandru says, “We are recipients of BIG, IGNITE and SBIRI grants and fellowships. BIRAC-supported biotech ecosystem in India has been crucial for deep-tech startups such as Pandorum to sprout and thrive. More importantly, we have been fortunate to be mentored by Dr Renu Swarup, Chairperson, BIRAC. Leaders from academia and industry- Dr G Padmanabhan (ex-Director, Indian Institute of Science, Adviser – BIRAC and Dr Kiran Mazumdar Shaw, CMD, Biocon, have been instrumental in shaping our vision.”
A company with distinct synergy of life science, engineering and clinical competencies, Pandorum Technologies works on design and manufacturing of functional human tissues — cornea and liver — for medical research and therapeutic applications. Elaborating on how BIRAC stands as a support during the journey of biotech startups, Anand Anandkumar, Co-founder and Chief Executive Officer, Bugworks Research, says that only a small number of unique scientific ideas get translated into a product, and even a lower number of the products become profitable. Thus, the act to fund novel scientific ideas is a high-risk venture and that too in a country that generally lacks a technical and business finesse to support innovative scientific ideas. “BIRAC has been a clear gamechanger concept and application. It has been a harbinger in the field of biotech and medicine. Multiple seed grants from BIRAC initiated Bugworks’ journey from early 2014. One of the unique aspects of BIRAC is that its grant selection process is fair and transparent. It should be the ‘go-to model’ that might be introduced into other government agencies that deal with science translation in areas such as engineering, physics, and chemistry.”
The massive unmet need in the world owing to lack of any new broad-spectrum antibiotics since the 1960s became the reason Anandkumar thought of coming up with Bugworks Research. He says, “Of the nearly million deaths per year globally, a significant portion comes from India. We realised that neither western pharma companies nor Indian generic companies would invest in a space like antibiotics (that is so complex both from a science and economics space), and therefore started this company to invent a brand new class of broad spectrum antibiotics for the globe, from India.”
His father, who treated TB patients for more than five decades and whom he saw struggling with drug-resistant cases, became the inspiration for him coming up with this company. Bugworks Research was granted $3-million by Boston-based CARB-X last year for developing next-generation antibiotics for drug resistance. Sharing details about the current status of this project, he notifies, “We have selected a preclinical candidate and are going through late stage preclinical work. The Good Laboratory Practice Toxical (GLP Tox) study is scheduled to be completed by Q4 of this year. If all goes well, we will enter clinical trials during the early part of 2020.” As more and more innovations take place and biotech industry keeps growing in India, it is hoped that BIRAC will keep standing firm and offer its support for a better future of the industry ahead.