Challenges in nonhuman primate research in the 21st century

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The 19th Covance Primate Symposium was held in Münster on May 23-24, 2012, with 70 participants from 43 organizations. This year's focus was on "Challenges in Nonhuman Primate Research in the 21st Century." The diverse attendance and engaging discussions highlighted the relevance of the topic. Expert speakers addressed four key areas: the development of biosimilars, optimizing nonhuman primate use in nonclinical safety assessments, trends in developmental and reproductive toxicology (DART), and the significance of nonhuman primate models in regulatory toxicology. The acceleration of biosimilar development has introduced uncertainties, prompting the need for evolving guidelines. As biopharmaceuticals gain prominence, optimizing the use of nonhuman primates is crucial, necessitating refined study designs and animal numbers while ensuring meaningful preclinical studies. Progress has been noted in this area. Recent guideline changes in DART and juvenile toxicity evaluations have influenced species selection and study designs within preclinical programs. With increasing regulations surrounding the use of nonhuman primates, it is vital to recognize their essential role in drug safety evaluations and medical development.