Beyond Earth’s Gravity: Navigating Legal Hurdles in Space-Based Drug Research and Development
DOI:
https://doi.org/10.13052/ijts2246-8765.2024.043Keywords:
Space exploration, International Space Station, ISS, microgravity research, space-based drug development, low Earth orbit, LEO, commercial space ventures, NewSpace, 3D cell cultures, protein crystallization, tissue engineering, gene expression, biofabrication, regenerative medicine, biomanufacturing, biotech research, cost-effective space access, funding opportunities, venture capital in biotech, collaborative partnerships, democratization of space, space law and governance, export control laws, intellectual property in space, FDA regulations, space station decommissioning, national jurisdiction in space, ownership of research results, jurisdictional complexities, contractual framework for space research, access to space-based facilities, transportation logistics, data integrity in space research, private commercial space stations, post-ISS opportunities, hybrid legal frameworks, public-private partnerships in space, international collaborationAbstract
For over 20 years, scientists aboard the International Space Station (the “ISS”) have been expanding the boundaries of scientific knowledge. Leveraging microgravity and other extreme conditions unique to space, these scientists have made significant discoveries in cellular behavior, tissue engineering, gene expression, organism growth patterns, and regenerative medicine. This article aims to introduce the pharmaceutical and biotechnology communities to the exciting possibilities and challenges of conducting research and development (“R&D”) in space.
The scientific advantages of space-based drug R&D are compelling. Experiments conducted aboard the ISS National Lab, along with ground-based studies, reveal unique features that cannot be replicated under normal gravity conditions. For instance, space-based drug research has shown that microgravity conditions enable more efficient 3D cell cultures, improved protein crystal growth, and open up new possibilities for 3D printing of biomaterials, cells, tissues, and organs.
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