Achieving FDA approval for novel new nanomaterials Table 5 Eva M. Sevick, discussion leader Johnny Chen Amos Gaikwad Wah Chiu

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.

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?

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)

Follow-up Set up executive committee to formulate strategies for presentation to respective university/college administrators. Build nanotechnology into programmatic investments.