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Nanotechnology: Regulatory Challenges

Nanotechnology: Regulatory Challenges. Presented By: Phillip M. Buckler Vice President of Regulatory Affairs and Quality Kereos, Inc. St. Louis, MO. Presented at the FDA Nanotechnology Open Meeting October 10, 2006 Bethesda, MD. Definition of Nanotechnologies. Size ≤ 100nm

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Nanotechnology: Regulatory Challenges

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  1. Nanotechnology:Regulatory Challenges Presented By: Phillip M. Buckler Vice President of Regulatory Affairs and Quality Kereos, Inc. St. Louis, MO Presented at the FDA Nanotechnology Open Meeting October 10, 2006 Bethesda, MD

  2. Definition of Nanotechnologies • Size • ≤ 100nm • Differential performance • Components organized on a nanometer-scale have significantly better/different performance than on a larger-scale FDA Nanotechnology Public Meeting October 10, 2006

  3. Diversity of Nanotechnologies • MEMS/NEMS • Nanocrystals • API milling • Quantum Dots (CdSe) • Nanotubes/Buckyballs (Cx) • Nanowires • Nanoparticles (metal, protein, etc.) • Nanodroplets (micelles, PFC emulsions, etc.) FDA Nanotechnology Public Meeting October 10, 2006

  4. Nanotech Safety Framework • Non-nanotech composition • Safety, distribution of constituents in bulk • Existing drug/device guidance • Nano-structure impact • Novel activity/reactivity • Biodistribution • Bioavailability FDA Nanotechnology Public Meeting October 10, 2006

  5. ca. 250 nm Example: Kereos LTEs • Ligand-Targeted Emulsions • “Oil-in-water” emulsions • Specific • Ligand “targets” the disease • Delivers payload to specific area • MRI: paramagnetic ion chelate • Therapeutic: paclitaxel • 10-100 ligands • ≈100,000 payload molecules TargetingLigand Lipid PFC Gd-chelate FDA Nanotechnology Public Meeting October 10, 2006

  6. Example: Kereos LTEs • Kereos “oil-in-water” emulsions • Specific • Ligand “targets” the disease • Delivers payload to specific area • MRI: paramagnetic ion chelate • Therapeutic: paclitaxel • 10-100 ligands • ≈100,000 payload molecules TargetingLigand Lipid Drug PFC FDA Nanotechnology Public Meeting October 10, 2006

  7. Example: Kereos LTEs • Non-nanotech composition • Safety, distribution of constituents in bulk • Liquid perfluorocarbon • Well-understood human safety as parenteral at higher doses • Paclitaxel • Extensive human safety experience, etc. as parenteral at higher doses • Gadolinium chelate • Several approved agents at much higher doses • Targeting ligand • NCE, small molecule RGD peptidomimetic FDA Nanotechnology Public Meeting October 10, 2006

  8. Example: Kereos LTEs • Non-nanotech composition • Existing drug/device guidance • Liposome guidance • Imaging guidance (3) (MRI agent) • Other guidance (therapeutic) • Non-clinical • Combination products FDA Nanotechnology Public Meeting October 10, 2006

  9. Example: Kereos LTEs • Nano-structure impact • Novel activity/reactivity • Biodistribution • Impact of targeting on PFOB and “payload” distribution • Differential clearance of Gd-chelate or paclitaxel vs. non-LTE • Bioavailability FDA Nanotechnology Public Meeting October 10, 2006

  10. Conclusions • Nanotechnology – broad umbrella • More useful as a word than as a classification • Argues against one-size-fits-all approach • Safety considerations should be based on • Non-nanotech composition • Safety/toxicity of components • Appropriate existing drug/device guidance • Changes due to nanostructure FDA Nanotechnology Public Meeting October 10, 2006

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