Texas Children's Hospital Center for Vaccine Development, Departments of Pediatrics and Molecular Virology and Microbiology, National School of Tropical Medicine, Baylor College of Medicine , Houston , TX , USA.
Department of Biology, Baylor University , Waco , TX , USA.
Hum Vaccin Immunother. 2019;15(10):2235-2242. doi: 10.1080/21645515.2019.1629254. Epub 2019 Jul 10.
Translational science for new biotechnologies (e.g. drugs, vaccines, devices, or diagnostics) depend on the development of a robust . This is driven by complex scientific, technical, logistical, financial and operational elements to determine the feasibility and probability of traversing the "valleys of death" leading to licensure. The potential results in terms of profitability and financial realization, called play a crucial role in establishing incentives for investment during and after development. With this review, our goal is to summarize the challenges in taking vaccines against neglected tropical diseases (NTDs) from development through licensure and provide a perspective that these vaccines can have measurable public health and economic profitability and market success. Understanding these processes and its challenges would open the opportunity to accelerate and advance these essential NTD vaccines through the last mile towards licensure and for the delivery to afflicted populations in low- and middle-income countries.
新生物技术（如药物、疫苗、器械或诊断试剂）的转化科学依赖于稳健的 的发展。这是由复杂的科学、技术、后勤、财务和运营要素驱动的，旨在确定穿越导致许可的“死亡之谷”的可行性和可能性。潜在的盈利和财务实现结果，称为 ，在开发期间和之后的投资激励中起着至关重要的作用。通过本次综述，我们的目标是总结将针对被忽视热带病（NTDs）的疫苗从开发到许可的过程中所面临的挑战，并提供一个观点，即这些疫苗可以具有可衡量的公共卫生和经济盈利性以及市场成功。了解这些过程及其挑战将为加速和推进这些重要的 NTD 疫苗通过最后一英里获得许可，并向中低收入国家的受影响人群提供疫苗提供机会。
