The Oligonucleotide Safety Working Group (OSWG) was established at the inaugural Food and Drug Administration (FDA) and Drug

Information Association (DIA) Oligonucleotide-Based Therapeutics Conference in 2007, with a mission to facilitate the exchange of information between industry, academia, and regulatory authorities on the emerging new class of oligonucleotide-based therapeutics. The OSWG has created subcommittees on various aspects of oligonucleotide safety assessment, including genotoxicity, off-target effects, reproductive toxicology and carcinogenicity, exaggerated pharmacology, safety pharmacology, and immunomodulatory effects. The subcommittees have published multiple whitepapers intended to provide consensus scientific recommendations, in hopes of facilitating successful approval of oligonucleotide-based therapeutics.

OSWG – List of White Papers for OTS Website

Links to NAT articles added:

  • Alton EW, HA Boushey, H Garn, FH Green, M Hodges, RJ Martin, RD Murdoch, H Renz, SB Shrewsbury, R Seguin, G Johnson, JD Parry, J Tepper, P Renzi, J Cavagnaro and N Ferrari (2012). Clinical expert panel on monitoring potential lung toxicity of inhaled oligonucleotides: consensus points and recommendations Nucleic Acid Ther 22:246-254.
    https://www.liebertpub.com/doi/10.1089/nat.2012.0345
  • Berman CL, K Cannon, Y Cui, DJ Kornbrust, A Lagrutta, SZ Sun, J Tepper, G Waldron and HS Younis (2014). Recommendations for safety pharmacology evaluations of oligonucleotide-based therapeutics. Nucleic Acid Ther 24:291-301.
    https://www.liebertpub.com/doi/10.1089/nat.2013.0477
  • Cavagnaro J, C Berman, DJ Kornbrust, T White, S Campion and S Henry (2014). Considerations for assessment of reproductive and developmental toxicity of oligonucleotide-based therapeutics. Nucleic Acid Ther 24:313-325.
    https://www.liebertpub.com/doi/10.1089/nat.2014.0490
  • Henry SP, R Seguin, J Cavagnaro, C Berman, J Tepper and DJ Kornbrust (2016). Considerations for the characterization and interpretation of results related to alternative complement activation in monkeys associated with oligonucleotide-based therapeutics. Nucleic Acid Ther 26:210-215.
    https://www.liebertpub.com/doi/10.1089/nat.2015.0593
  • Berman CL, SA Barros, SM Galloway, P Kasper, FB Oleson, CC Priestley, KS Sweder, MJ Schlosser and Z Sobol (2016). OSWG recommendations for genotoxicity testing of novel oligonucleotide-based therapeutics Nucleic Acid Ther 26:73-85.
    https://www.liebertpub.com/doi/10.1089/nat.2015.0534
  • Marlowe JL, V Akopian, P Karmali, DJ Kornbrust, J Lockridge and S Semple (2017). Recommendations of the oligonucleotide safety working group’s formulated oligonucleotide subcommittee for the safety assessment of formulated oligonucleotide-based therapeutics. Nucleic Acid Ther 27:183-196
    https://www.liebertpub.com/doi/10.1089/nat.2017.0671
  • Capaldi DC, A Teasdale, S Henry, N Akhtar, C den Besten, S Gao-Sheridan, M Kretschmer, N Sharpe, B Andrews, B Burm and J Foy (2017) Impurities in oligonucleotide drug substances and drug products. Nucleic Acid Ther. 6: 309-322.
    https://www.liebertpub.com/doi/10.1089/nat.2017.0691
  • Muslehiddinoglu J, R Simler, ML Hill, C Mueller, JHA. Amery, L Dixon, A Watson, K Storch, C Gazziola, F Gielen, SA Lange, JD. Prail, and DP Nesta (2020) Technical Considerations for Use of Oligonucleotide Solution API, Nucleic Acid Ther. 30: 189-197
    https://www.liebertpub.com/doi/10.1089/nat.2020.0846
  • Capaldi DC, N Akhtar, T Atherton, D Benstead, A Charaf, T De Vijlder, C Heatherington, J Hoernschemeyer, H Jiang, U Riede, F Ring, R Peter, J Stolee, and R Wechselberger (2020) Strategies for Identity Testing of Therapeutic Oligonucleotide Drug Substances and Drug Products. Nucleic Acid Ther. 30: #5
    https://www.liebertpub.com/doi/10.1089/nat.2020.0878
  • Berman CL, Antonsson M, Batkai S, Bosgra S, Chopda GR, Driessen W, Foy J, Hassan C, Hu XS, Jang HG, Meena, Sanseverino M, Thum T, Wang Y, Wild M, Wu JT. OSWG Recommended Approaches to the Nonclinical Pharmacokinetic (ADME) Characterization of Therapeutic Oligonucleotides. Nucleic Acid Ther. 2023 Oct;33(5):287-305.
    https://www.liebertpub.com/doi/10.1089/nat.2023.0011