Session 6: Asian NAMs’ Landscape: Scientific and Regulatory Perspectives

The 6th session of Pro Anima’s Life Talks series examined the development and adoption of New Approach Methodologies (NAMs) across Asia, with particular attention to India’s scientific capabilities, emerging regulatory initiatives and remaining implementation challenges. The central message was that Asia has substantial scientific and technological capabilities in NAMs, but these capabilities are developing through different national pathways and are not yet consistently translated into validated, transferable and routinely used methods. India has a particularly promising combination of academic research, pharmaceutical and biotechnology industries, clinical infrastructure, engineering expertise and entrepreneurial activity. However, these assets need to be connected through coordinated national initiatives, shared infrastructure, targeted funding and clearer regulatory pathways.

Watch the replay of this session to discover recent developments, emerging opportunities, and the challenges that need to be addressed in Asia and more broadly to accelerate the development and adoption of human-relevant, non-animal approaches in the region.

Guest

Dr. Prajakta Dandekar Jain is the program coordinator of the M.Tech. Pharmaceutical Biotechnology programme at the Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology (ICT), Mumbai. She leads interdisciplinary research in 3D cell culture, organ-on-chip systems, biomaterials, and bioprinting to develop human-relevant platforms for drug discovery, disease modelling, toxicology, and regenerative medicine. She earned her Ph.D. (Tech.) from ICT Mumbai and subsequently conducted postdoctoral research in Germany as a European Respiratory Society-Marie Curie fellow. A pioneer in India’s Non-Animal Methodologies (NAMs) ecosystem, she has advanced the field through research, technology translation, skill development, and policy engagement. She is a Member of the Bureau of Indian Standards (BIS) and contributes to India’s NAMs roadmap and standardization efforts. As the founder of the 3D Cell Culture Workshops and Conferences, she actively bridges academia, industry, start-ups, clinicians, and regulators to accelerate development and adoption of NAMs within India.

Moderator

Dr Clive Roper is Director of Roper Toxicology Consulting Ltd and has more than 35 years of experience in toxicology, including two decades advancing innovative in vitro models, microphysiological systems and organ-on-chip technologies. Following a 25-year career at Charles River Laboratories, where he served as Director of In Vitro Toxicology, he established an independent consultancy supporting technology developers, contract research organisations, industry, investors and regulators. His work focuses on the development, validation and regulatory application of human-relevant testing approaches, with particular expertise in dermal absorption, dermal and respiratory toxicology, and growing interests in liver and kidney models. Clive serves on multiple scientific and governance boards and is an active contributor to international initiatives advancing the adoption of New Approach Methodologies in regulatory science