Affiliation:
1. Contraception Research Branch, Fertility and Infertility Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health Bethesda Maryland USA
Abstract
AbstractIntroductionThis manuscript presents non‐hormonal male contraceptive development in the context of mitigating risk to investigators and investors.ObjectiveThe manuscript uses examples to illustrate drug development principles to move a project from discovery to development. The content is intended for those with reproductive biology backgrounds without significant exposure to drug development—particularly early‐stage targeted drug development—and those with general interest in developing non‐hormonal methods of contraception.ConclusionThe goal of issues addressed in this manuscript is to facilitate the advancement of innovative male contraceptives into late‐stage clinical trials, while keeping in mind early recognition of program deficiencies and development of mitigation strategies, or reassignment of limited, valuable resources.