Abstract
In the past few years, there has been a substantial increase in research and initiatives towards human-relevant technologies in India, particularly the use and development of microphysiological systems models in India. However, this rise has also been accompanied by significant roadblocks in the availability of infrastructure, training and education programs, supply chain issues, and lack of funding. A recent meeting between technology developers in academia and industry had led to suggestions to address these limitations. To take forward these suggestions, a first-of-its-kind multi-stakeholder meeting was held between participants from the Indian government and regulatory bodies, policy-makers, pharma companies, and academia. Several recommendations were proposed by the government and regulatory bodies to address the current limitations to developing MPS technologies in India. We end with strategies to achieve the proposed recommendations and envision that these initiatives would commence in the coming few months. This would assist in achieving the proposed goal of developing India as a key player in the development and usage of human-relevant technologies.
Highlights
The last few decades have seen a global increase in the development of non-animal and human-relevant technologies, i.e., new approach methodologies (NAMs), which include in vitro and computational tests, and their respective regulatory implementation
There are certain roadblocks to achieving these goals. These were discussed at a recent meeting with academia and industry stakeholders involved in NAM development, including microphysiological systems (MPS) and computational models (Parvatam et al, 2021)
To combat the lack of awareness amongst students and researchers, certificate programs or curricula could be designed for various target audiences, including students, researchers, regulators, or personnel in contract research organizations (CROs) and micro, small & medium enterprises (MSMEs)
Summary
The last few decades have seen a global increase in the development of non-animal and human-relevant technologies, i.e., new approach methodologies (NAMs), which include in vitro and computational tests, and their respective regulatory implementation. These were discussed at a recent meeting with academia and industry stakeholders involved in NAM development, including MPS and computational models (Parvatam et al, 2021) These include lack of infrastructure, lack of a skilled pool of researchers trained in NAM methodologies, supply chain blocks, lack of awareness amongst academic and government bodies, bottlenecks in cell sourcing, and lack of communication between technology developers, regulatory bodies, and end-users. To address these issues, the Centre for Predictive Human Model Systems (CPHMS) at Atal Incubation Centre-Centre for Cellular and Molecular Biology (AIC-CCMB) organized a multi-stakeholder roundtable meeting between MPS technology developers (in academia and industry), regulators, policy-makers, and personnel from pharma companies (Tab. S11). Several recommendations were proposed by the members of the government, regulatory, and funding bodies during the meeting as discussed below
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