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New guidelines for reproductive & developmental toxicity testing of oligonucleotide drugs

-based therapeutics present unique challenges when it comes to testing their potential to cause reproductive and developmental harm. New consensus guidelines for toxicity testing that take into consideration the combined chemical and biological characteristics of these novel biopharmaceuticals are presented in Nucleic Acid Therapeutics, a peer-reviewed journal from , publishers. The article is available on the Nucleic Acid Therapeutics website.

Joy Cavagnaro, Access BIO (Boyce, VA), , Berman Consulting (Wayland, MA), , Preclinisight (Reno, NV), Tacey White, Exponent (Philadelphia, PA), Sarah Campion, Pfizer (Groton, CT), and Scott Henry, Isis Pharmaceuticals (Carlsbad, CA), coauthored the white paper that highlights key points to consider in the design of scientifically valid and predictive toxicity studies. The authors summarize the findings of the Reproductive Subcommittee of the (OSWG) in the article “Considerations for Assessment of Reproductive and Developmental Toxicity of Oligonucleotide-Based Therapeutics.”

“I highly commend this latest white paper from the OSWG to researchers and regulators alike involved in the development and implementation of oligonucleotide or antisense based interventions,” says Executive Editor Graham C. Parker, PhD, The Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Children’s Hospital of Michigan, Detroit, MI.


Considerations for Assessment of Reproductive and Developmental Toxicity of Oligonucleotide-Based Therapeutics. Cavagnaro Joy, Berman Cindy, Kornbrust Doug, White Tacey, Campion Sarah, and Henry Scott. Nucleic Acid Therapeutics. October 2014, 24(5): 313-325. doi:10.1089/nat.2014.0490.

Mary Ann Liebert, Inc./Genetic Engineering News