New guidelines for reproductive and developmental toxicity testing of oligonucleotide drugs
Oligonucleotide-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.
Joy Cavagnaro, Access BIO (Boyce, VA), Cindy Berman, Berman Consulting (Wayland, MA), Doug Kornbrust, 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 Oligonucleotide Safety Working Group (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.
Nucleic Acid Therapeutics is under the editorial leadership of Co-Editors-in-Chief Bruce A. Sullenger, PhD, Duke Translational Research Institute, Duke University Medical Center, Durham, NC, and C.A. Stein, MD, PhD, City of Hope National Medical Center, Duarte, CA; and Executive Editor Graham C. Parker, PhD.