Achieving FDA approval for novel new nanomaterials

Table 5

Eva M. Sevick, discussion leader

Johnny ChenAmos 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.