Old Title vs New Title

1
Old Title vs New Title

• NIH Guidelines for Research Involving Recombinant
  DNA Molecules

• NIH Guidelines for Research Involving
  Recombinant or Synthetic Nucleic Acid Molecules
• Implement by 3/3/13

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Is chemical synthesis covered?

• synthesizer
• Not until in a

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III-F Registrations

• Nothing exempt in Boston
• BPHC adopts updated Guidelines unless
• Using nonhazardous plasmids (pBR) to clone gene
  of interest into host (nonpathogenic E.coli)
• Often the first step in creating a transgenic
  animal
• New exemptions for synthetic NA
• No origin of replication, no integration

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NIH Guidelines Definition of rNA

• Molecules constructed by joining nucleic acids
• can replicate in a living cell

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NIH Guidelines synthetic

• Nucleic acids that can base pr w naturally
  occurring nucleic acids

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NIH Definitions Continued

• Molecules resulting from replication of rNA or
  synthetic nucleic acids in past two slides

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Other Changes

• Fewer AAV serotypes need review
• Transfer of drug resistance traits
• Human Gene Transfer w nucleic acids

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Risk Assessment Synthetics

• of genome from each parent
• Fn/purpose of each sequence
• Assume same fn as original host?
• Synergism between sequences transgenes

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What Next? - XNA

• 6 sugars can form NA bbone
• Store retrieve genetic info
• Medical benefit? Slower breakdown in stomach
  bloodstream

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Real World Examples

• iGEM 2006
• Jay Keasling