The need to develop a framework for human-relevant research in India: Towards better disease models and drug discovery
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Ó Indian Academy of Sciences ( 01234567 89().,-volV)( 01234567 89().,-volV)
Perspectives The need to develop a framework for human-relevant research in India: Towards better disease models and drug discovery SURAT PARVATAM1* , SHAM BHARADWAJ1, VEGESNA RADHA2 and MADHUSUDHANA RAO3 1
Centre for Predictive Human Model Systems, Atal Incubation Centre-CCMB, Hyderabad 500 039, India
2
CSIR-Centre for Cellular and Molecular Biology, Hyderabad 500 007, India 3
Atal Incubation Centre-CCMB, Hyderabad 500 039, India
*Corresponding author (Email, [email protected]) MS received 30 April 2020; accepted 1 October 2020 The low translational efficiency of animal models to humans, and the development of new-age methodologies that are human-cell based, is fuelling a paradigm change across the globe. In this perspectives paper, we discuss the current state of research, funding, and regulation in these 21st century technologies, including organoids and organ-on-chip in India. Recently, a road-map was drawn by Indian Council for Medical Research (ICMR) regarding alternatives to animals in research in India and it also held a special session in January 2018 to discuss latest developments in new human-relevant model systems. We document the regulatory and research landscape in this field in India. We also discuss the challenges present in this field which include lack of training and skills to handle embryonic or induced pluripotent stem cell (iPSC) lines, funding limitations, lack of domestic production of reagents leading to elevated costs, and lack of infrastructure, such as microfabrication facilities. In the end, we provide recommendations to enable innovation and application of human-relevant methodologies to develop India as a key player in this arena globally. Keywords. Disease models; drug discovery; framework in India; human-relevant research; organoids; organon-chip; policy
1. Growing shift towards human-relevant research Animal models have played critical roles in understanding human biology, and this has been primarily driven by the fact that humans share a high degree of similarity with various animals (Bernhard 2000). For example, protein-coding regions of mouse and human genome are 85% similar. Also, it is easy to test the functionality of various genes in the model organisms by increasing, decreasing, or silencing the gene expression using various genetic tools. These advantages are the basis of regulations currently being followed to test all drugs in two animal models prior to clinical trials. However, it is increasingly emerging that the animal models cannot capture severity, and http://www.ias.ac.in/jbiosci
phenotype, of a human disease in its entirety (van der Worp et al. 2010). Also, the use of animal models to conduct such large scale therapeutic screening involves prolonged duration, high costs (Giacomotto and Laurent 2010), and trauma to animals. Animals do not naturally develop many of the human diseases and researchers need to artificially induce the disease before studying them. However, the induced
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