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Ocular translational science: A review of development steps and paths
Advanced Drug Delivery Reviews ( IF 15.2 ) Pub Date : 2018-02-04 , DOI: 10.1016/j.addr.2018.01.012
Brenda K. Mann , Darren L. Stirland , Hee-Kyoung Lee , Barbara M. Wirostko

Developing successful drug delivery methods is challenging for any tissue, and the eye is no exception. Translating initial concepts into advanced technologies treating diseases in preclinical models and finally into functional and marketable products for humans can be particularly daunting. While referring to specific ophthalmic companies and products, this review considers key exchanges that lead to successful translation. By building on basic science discoveries in the academic setting, applied science can perform proof-of-concept work with simple, benchtop experiments. Eventually, simple models need to be translated to more robust ones where cells, tissues, and entire organisms are incorporated. Successful translation also includes performing due diligence of the intellectual property, understanding the market needs, undertaking clinical development, meeting regulatory requirements, and eventually scale up manufacturing. Different stages of the translation can occur in different environments, including moving from academia to industry, from one company to another, or between veterinary and human applications. The translation process may also rely on contract organizations to move through the complex landscape. While the path to a commercial, marketable product may not look the same each time, it is important to design a development plan with clear goals and milestones to keep on track.



中文翻译:

眼转化科学:发展步骤和途径的回顾

开发成功的药物输送方法对任何组织都具有挑战性,眼睛也不例外。将最初的概念转化为临床前模型中治疗疾病的先进技术,最后转化为人类实用且可销售的产品可能尤其令人生畏。在谈到特定的眼科公司和产品时,本评论考虑了导致成功翻译的关键交流。通过在学术环境中建立基础科学发现,应用科学可以通过简单的台式实验执行概念验证工作。最终,需要将简单的模型转换为包含细胞,组织和整个有机体的更强大的模型。成功的翻译还包括对知识产权进行尽职调查,了解市场需求,进行临床开发,符合法规要求并最终扩大制造规模。翻译的不同阶段可能发生在不同的环境中,包括从学术界转移到行业,从一家公司转移到另一家公司,或在兽医和人类应用程序之间转移。翻译过程还可能依赖合同组织来穿越复杂的环境。虽然每次都可能无法获得商品化的商品,但是设计一个明确的目标和里程碑以保持发展的开发计划很重要。翻译过程还可能依赖合同组织来穿越复杂的环境。虽然每次都可能无法获得商品化的商品,但是设计一个明确的目标和里程碑以保持发展的开发计划很重要。翻译过程还可能依赖合同组织来穿越复杂的环境。虽然每次都可能无法获得商品化的商品,但是设计一个明确的目标和里程碑以保持发展的开发计划很重要。

更新日期:2018-02-04
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