With a view to reaching out to newer horizons in scientific discovery, research and development (R&D) laboratories in India and global markets are increasingly adopting advanced technologies like high throughput screening, Ultra Performance Liquid Chromatography (UPLC) and mass spectrometry.
Technology has transformed the entire R&D process. While scientists are now adopting in-silica techniques in drug development and dosing, the computerization of systems in the labs have brought in a sea change in biology computation and bio informatics. It has also led to an increased focus on pharmaco-genomics and pharmaco-vigilance. The pharma industry is looking to exploit innovations in technology to harness the capability in predictive processes based on a more complete understanding of how the human body work, said a panel of experts from Indian Institute of Science.
Technologies like combatorial chemistry and robotic screening have given a boost to drug development. The new scientific tools have helped to simplify complicated data .
Tech developments spur R&D projects
In India, the Bengaluru - based Strand Life sciences has bagged a US patent protection for its method for predicting organ toxicity. The method is currently employed in the form of a rat-based Virtual Liver model by the pharmaceutical industry to predict and assess hepatotoxicity of novel drug compounds in pre-clinical studies and by the cosmetics industry in the form of a skin and hair model. The company also announced the release of the human version of the Virtual Liver model with an even more direct application in human drug and chemical safety studies. It is based on a model of normal liver physiology, which combined with targeted assays, provide mechanistic insights into how a drug compound or chemical impacts the liver. Work on the liver model began in 2007 and the rat-based model was ready for commercialization in 2011.
“An estimated 50 per cent of drug failures in the clinical trial stage are attributed to toxicity, out of which 60 per cent are attributed to liver injury. Using our rat model , the pharmaceutical and cosmetics industry is able to reduce the number of and cost associated with animal trials.
The new human model will now enable them to more accurately observe the impact of a compound on the human system, making drugs safer before they enter into clinical trials”, said Dr Vijay Chandru, founder and chairman, Strand Life Sciences.
Waters has launched a new programme to support scientific innovation in the fields of health and life science research, sports science, clinical research and environmental protection. Through its Centers of Innovation Program, the company is partnering with leading research scientists using UltraPerformance Liquid Chromatography (UPLC) and mass spectrometry to open new doors to scientific discovery.“With the Centers of Innovation Program, we are expanding our emphasis on collaborative relationships with some of the world’s foremost scientific experts which, quite frankly, has been a focus of ours for many years,” said Dr. Tim Riley, Vice President and Director, Waters Centers of Innovation Program.
Cos pitch for innovation-led research
Important developments are taking place in systems biology with several firms conducting cutting edge work in predictive biology be it in signalling pathway analysis, developing tools to analyse and integrate information such as next generation sequencing and imaging data, as well as developing virtual organ or disease models to facilitate drug discovery, said Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd.
In fact, in 2012, Biocon had opened its advanced R&D centre with an investment of Rs. 200 crore within the Biocon Park. It is undertaking all its in-house drug research activities focusing on chronic diseases like diabetes, cancer and auto immune.“Our objective is to pursue world class research on biologics that will address the unmet medical needs, said Shaw.
India’s pharma and biotech companies are pursuing innovation-led research to develop advanced yet affordable solutions for several debilitating diseases, that would help stimulate the best talent both in India and abroad. The companies are also looking to offer an intellectually stimulating environment combined with an enabling ecosystem to conduct path - breaking research for biopharmaceuticals, said scientists from Jawaharlal Nehru Centre for Advanced Scientific Research
India lures MNCs
The global R&D scenario in the pharmaceutical sector is encouraging, and the same holds true for India. Research on new drugs helps the pharma industry reinvent and upgrade itself to counter the emerging public health threats. India offers a formidable brain pool for R&D and more cost-effective research opportunities as compared to regulated markets and other ASEAN counterparts.
Now most pharma MNCs are heading to India to set up their R&D centres. This trend has been evident in the last few years with many foreign MNCs launching their R&D projects through acquisitions, collaborations or direct investments, said Dr Manu Chaudhary, Joint Managing Director, Venus Remedies Ltd and Director, Research, Venus Medicine Research Centre.
It is heartening to see more and more Indian companies are now focusing their strategies around R&D. India has offered some unique research products to the world, especially in the herbals segment. The country’s R&D expenditure has doubled since 2007. It was estimated to be around US $40 billion in 2012, she added.
According to Micro Labs, R&D is the backbone of India pharma and biotech industry for new drug development efforts and for the launch of novel generic versions and drug delivery devices. Although there is a huge scientific talent pool in India, R&D has not taken off in the country. Much of our research is based on technology transfer and patent expired drugs. It is estimated that at any given point of time, a pharma or biotech company allocates over 30 per cent of the total turnover on R&D. Mere scientific resources is not adequate, R&D needs considerable support from the government going by the presence of national labs in the country. Though there has been considerable effort in the research institute and industry collaboration and a plethora of grants coming forth from the CSIR, DST and DBT, there is a need for concrete government concessions to nurture innovation and encourage the culture of the patents.
The impact of economic slowdown
The impact of the global economic slowdown on research in the pharma sector has been quite less in comparison to other sectors. Pharma companies have built good cash reserves, which has helped them augment their research initiatives.
Nonetheless, we cannot completely ignore the impact of economic slowdown. Whether actual or perceived, it makes companies adopt a more return on investment (RoI)-driven approach, which can have a bearing on research. As a company focusing on R&D on new antibiotics to counter the threat of anti-microbial resistance (AMR), we have observed that the R&D pipeline of antibiotics is drying up the world over because big pharma companies are reluctant to spend on research on new antibiotics due to poor RoI, said Dr. Chaudhary.
Visible trends in R&D
R&D in the pharmaceutical sector is progressing at a fast pace. Indian pharma companies are constantly innovating and adopting international standards to stay relevant in the competitive global market. The trend in R&D is to find low-cost solutions to healthcare problems, which may even include using existing molecules.
At the same time, the emergence of contract research organizations (CROs) in India is a result of a wave of global pharma companies outsourcing R&D to Indian markets, which is in turn improving the atmosphere for research in the country. Investments in R&D have gone up appreciably. Though the government has provided many R&D-linked incentives and is promoting public-private partnership (PPP) in R&D, the regulatory framework is not supportive, noted Dr. Chaudhary.
Challenges in R&D
Pharmaceutical research is facing a complex mix of challenges. Regulatory procedures are becoming more complex day-by-day. The regulatory framework, including that of clinical trials, needs to be simplified. The other constraints are lack of financing opportunities for R&D and the delay in securing intellectual property rights (IPR), said Dr. Chaudhary.
Indian patent regime supportive of global innovation
The Indian patent system is very sound. It is a big attraction for foreign pharmaceutical companies. As per a recent report issued by the Indian Patent Office, about 77 per cent of the total patents granted during 2010-2013 in the pharmaceutical sector were awarded to foreign pharmaceutical companies. Even the World Health Organisation (WHO) has strongly endorsed India’s patent laws and no country has challenged them. The trend of filing patents has really picked up in India.
A strong legal framework and industrial-friendly policies have helped generate interest of foreign multinationals in the Indian pharmaceutical market and industry, as is evident by their volumes of investments. Many of them are now looking to set up their base in India. The large-scale mergers, acquisitions and alliances being effected by companies based in the US, Europe and Japan with their Indian counterparts show their eagerness to do business in India and reflect the supportive nature of India’s IPR regime for global innovations.