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Published byMyrtle Bishop Modified over 9 years ago
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Achieving FDA approval for novel new nanomaterials Table 5 Eva M. Sevick, discussion leader Johnny Chen Amos Gaikwad Wah Chiu
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FDA movement forward We need fate, safety, and toxicity data – infrastructure needed to obtain these data. Diagnostics easier to get through rather than therapeutics owing to microdosaging – infrastructure for investigator-initiated clinical trials needs to be in place. Best to design nano-agent to clear from the body. Intracellular uptake may not be good for non-metabolized nanomaterials.
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Comments Stem cell tracking/diagnosis – can nanotechnology be used to identify cancer stem cells in cancer patients? In preclinical models for study of anti-cancer stem cell therapy? Can nanotechnology provide the exquisite sensitivity for detection both clinically and preclinically? How can nanotechnology play role in personalized medicine?
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Selfish wishes Seed money for collaborative research projects – <5 page proposals. Houston should set up collaborative facilities for nanoresearch and nanomedicine. –Cell culture, small animal, primate, early consulting for trial design. Mini-course in nanomedicine translation (bridging engineering and medicine)
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Follow-up Set up executive committee to formulate strategies for presentation to respective university/college administrators. Build nanotechnology into programmatic investments.
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