A significant global unmet need for new contraceptive options for both women and men remains due to side effect profiles, medical concerns, and inconvenience of many currently available products. The pharmaceutical industry has largely abandoned early research and development for contraception and will not likely engage to bring new products to the market unless they have been significantly de-risked by showing promise in early phase clinical trials. This lack of interest by big pharma comes at a time when scientific and technological advances in biology and medicine are creating more opportunities than ever for the development of new and innovative drug products. Novel partnerships between the academic sector, small biotechnology companies, foundations, non-government organizations (NGOs), and the federal government could accelerate the development of new contraceptive products. We discuss the challenges and opportunities that we have encountered as an NGO with a mission to develop novel contraceptive products for low- and middle-income countries and how it differs from developing products for higher-income markets. We hope that our experiences and “lessons learned” will be of value to others as they proceed down the product development path, be it for female or male or for hormonal or nonhormonal contraceptives.

中文翻译：

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新的避孕革命：开发行业之外的创新产品†,‡。

由于副作用、医疗问题和许多当前可用产品的不便，全球对女性和男性的新避孕选择的重大需求仍未得到满足。制药行业基本上已经放弃了避孕的早期研发，并且不太可能将新产品推向市场，除非它们在早期临床试验中显示出前景，从而显着降低了风险。大型制药公司对此缺乏兴趣，正值生物学和医学的科技进步为新药和创新药物产品的开发创造比以往任何时候都多的机会。学术部门、小型生物技术公司、基金会、非政府组织 (NGO)、联邦政府可以加快新避孕产品的开发。我们讨论了我们作为一个以为低收入和中等收入国家开发新型避孕产品为使命的非政府组织所遇到的挑战和机遇，以及它与为高收入市场开发产品的区别。我们希望我们的经验和“吸取的教训”对其他人在产品开发过程中有所帮助，无论是女性或男性，还是激素或非激素避孕药。