Thorpe Abbey A, Bach Frances C, Tryfonidou Marianna A, Le Maitre Christine L, Mwale Fackson, Diwan Ashish D, Ito Keita
Biomolecular Sciences Research Centre Sheffield Hallam University Sheffield UK.
Department of Clinical Sciences of Companion Animals, Faculty of Veterinary Medicine Utrecht University Utrecht the Netherlands.
JOR Spine. 2018 Aug 2;1(3):e1027. doi: 10.1002/jsp2.1027. eCollection 2018 Sep.
Chronic back and neck pain is a prevalent disability, often caused by degeneration of the intervertebral disc. Because current treatments for this condition are less than satisfactory, a great deal of effort is being applied to develop new solutions, including regenerative strategies. However, the path from initial promising idea to clinical use is fraught with many hurdles to overcome. Many of the keys to success are not necessarily linked to science or innovation. Successful translation to clinic will also rely on planning and awareness of the hurdles. It will be essential to plan your entire path to clinic from the outset and to do this with a multidisciplinary team. Take advice early on regulatory aspects and focus on generating the proof required to satisfy regulatory approval. Scientific demonstration and societal benefits are important, but translation cannot occur without involving commercial parties, which are instrumental to support expensive clinical trials. This will only be possible when intellectual property can be protected sufficiently to support a business model. In this manner, commercial, societal, medical, and scientific partners can work together to ultimately improve patient health. Based on literature surveys and experiences of the co-authors, this opinion paper presents this pathway, highlights the most prominent issues and hopefully will aid in your own translational endeavors.
慢性颈肩痛是一种常见的致残性疾病，通常由椎间盘退变引起。由于目前针对这种疾病的治疗效果不尽人意，人们正在投入大量精力开发新的解决方案，包括再生策略。然而，从最初有前景的想法到临床应用的道路充满了许多需要克服的障碍。许多成功的关键不一定与科学或创新相关。成功转化到临床还将依赖于规划以及对障碍的认识。从一开始就规划好通往临床的整个路径，并与多学科团队一起进行规划至关重要。尽早咨询监管方面的建议，并专注于生成满足监管批准所需的证据。科学论证和社会效益很重要，但如果不涉及商业伙伴，转化就无法实现，商业伙伴对于支持昂贵的临床试验至关重要。只有当知识产权能够得到充分保护以支持商业模式时，这才有可能实现。通过这种方式，商业、社会、医学和科学伙伴可以共同努力，最终改善患者健康状况。基于文献调查和共同作者的经验，这篇观点文章介绍了这条路径，突出了最突出的问题，希望能对你自己的转化努力有所帮助。
