9 December 2021
The September 2021 BioMed21 regulatory roundtable discussion in India focused on the way forward for the development of human biology-based technologies through sustained funding, training and education, and the in-country development of such technologies. The Centre for Predictive Human Model Systems, a collaboration between Humane Society International/India and the Atal Incubation Centre-Centre for Cellular and Molecular Biology, organized the event as a follow-up to the first scientist roundtable that was held by them in December 2020.
The roundtable brought together key regulators from the Central Drugs Standard Control Organization and the Indian Pharmacopoeia Commission, government bodies like the Indian Council of Medical Research-National Animal Resource Facility and the Committee for the Purpose of Control and Supervision on the Experiments of Animals, and public funding bodies like the Department of Biotechnology, and industry stakeholders to strategize the development and uptake of human biology-based methodologies.
In his remarks, Dr Vinay Nandicoori, Director, CSIR-CCMB, laid emphasis on the importance of stakeholder dialogue involving governments, regulatory bodies, and technology developers to promulgate development of these methodologies in India. The CEO of AIC-CCMB, Dr Madhusudhana Rao affirmed the impetus provided by such meetings to streamline the process of adoption of new model systems in regulatory mandates and drug development.
The keynote speaker at the roundtable – Dr Ramchandra Gudde, Director, National Animal Resource Facility for Biomedical Research (NARF-BR) – described the role of the Indian Council of Medical Research-Centre for Excellence in Human Pathway-Based Biomedicine and Risk Assessment (established by ICMR at NARF-BR in late 2018).
The sessions that followed were based on three key takeaways from the scientist roundtable – 1. in-country development of human-relevant technologies, 2. training and education of emerging human-relevant methods, and 3. promotion of sustained funding.
The need for focused efforts in India to catalyze development of advances like organoids, organ-on-a-chip, systems and computational models took centre stage in the first session. The establishment of Centres of Excellence and the involvement of industry stakeholders for expertise on scaling-up of technologies has been essential in filling the gap. Interactive databases of researchers, skills, infrastructure, and other resources are still needed to identify and understand the research community’s needs. Training in the use of new technologies and a commitment by regulatory bodies to keep up with emerging technologies are also going to be important to implementation strategies.
Capacity-building through training and education via online as well as university courses, the expansion of databases on animal use in research, and the initiation of bilateral programs for knowledge were also discussed in the second session.
The third session, facilitated by Dr Rakesh Mishra, Director, Tata Institute of Genetics and Society, featured industry stakeholders who agreed upon the dire need for joint funding and collaboration between academia and industry, for harmonization of methods across manufacturers and academia, and for expanded public awareness and involvement to drive increased government investments in animal-free human biology-based methodologies.
The roundtable concluded with a session on the formation of working committees for education & training, basic research, and translational research. Participants in the session led by Dr Madhusudhana Rao (CEO, AIC-CCMB), were in strong agreement that multi-stakeholder working groups could successfully formulate roadmaps to turn the recommendations of the roundtable into actionable outcomes. This was an optimistic finish that foretells a bright future for the advancement of human biology-based technologies in the years ahead.
The meeting was attended by participants from Atal Incubation Centre-CCMB (Hyderabad); Humane Society International/India; CSIR-CCMB (Hyderabad); ICMR-BARF-BR; Indian Pharmacopoeia Commission; Central Drugs Standard Control Organization; DBT-BIRAC; TIGS; ReaGene Biosciences Pvt. Ltd. (Hyderabad); Aurigene Lifesciences; Committee for the Purpose of Control and Supervision on the Experiments of Animals; Zydus Cadila; Biological E; SPPU (Pune).
Let us know your thoughts on the current challenges facing the development and use of human-relevant methodologies.