Considerations regarding nonhuman primate use in safety assessment of biopharmaceuticals.
Selection of a pharmacologically responsive species can represent a major challenge in designing nonclinical safety assessment programs for many biopharmaceuticals (eg, monoclonal antibodies (mAbs)). Frequently, the only relevant species for nonclinical testing of mAbs is the non-human primate (NHP). This situation, coupled with a rapidly increasing number of mAb drugs in development, has resulted in a significant increase in the number of NHPs used in nonclinical safety assessment. Apart from ethical considerations related to responsible animal use, there is a clear need for more efficient and innovative approaches to drug discovery and development; these factors drive the need to investigate alternative approaches and strategies for the safety assessment. This review summarizes important scientific and regulatory perspectives derived from presentations and audience discussions in an educational forum at the 2010 annual American College of Toxicology meeting regarding opportunities for employing alternative approaches to minimize NHP use in mAb drug development.
Eli Lilly and Co., Indianapolis, IN 46225, USA. buckleyla@lilly.com
Lorrene A
LA
Buckley
Kathryn
K
Chapman
Leigh Ann
LA
Burns-Naas
Marque D
MD
Todd
Pauline L
PL
Martin
Janice A
JA
Lansita
D032761:Animal Experimentation / Q000941:ethics; D023401:Animal Use Alternatives; D000818:Animals; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D001709:Biotechnology / Q000379:methods; D055808:Drug Discovery / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D004345:Drug Industry; D017408:Guidelines as Topic; D006801:Humans; D011323:Primates; D016730:Program Development; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods*
D000911:Antibodies, Monoclonal