Institute for Experimental Molecular Imaging, RWTH Aachen University Clinic, 52074, Aachen, Germany.
Institute for Biomedical Engineering, Faculty of Medicine, RWTH Aachen University, 52074, Aachen, Germany.
Drug Deliv Transl Res. 2020 Jun;10(3):721-725. doi: 10.1007/s13346-020-00740-5.
New nanomedicine formulations and novel applications of nanomedicinal drugs are reported on an almost daily basis. While academic progress and societal promise continue to shoot for the stars, industrial acceptance and clinical translation are being looked at increasingly critically. We here discuss five key challenges that need to be considered when aiming to promote the clinical translation of nanomedicines. We take the perspective of the end-stage users and consequently address the developmental path in a top-down manner. We start off by addressing central and more general issues related to practical and clinical feasibility, followed by more specific preclinical, clinical, and pharmaceutical aspects that nanomedicinal product development entails. We believe that being more aware of the end user's perspective already early on in the nanomedicine development path will help to better oversee the efforts and investments needed, and to take optimally informed decisions with regard to market opportunities, target disease indication, clinical trial design, therapeutic endpoints, preclinical models, and formulation specifications. Critical reflections on and careful route planning in nanomedicine translation will help to promote the success of nanomedicinal drugs. Graphical abstract.
新的纳米药物制剂和纳米药物的新应用几乎每天都有报道。虽然学术进展和社会承诺继续瞄准星空，但工业界的接受度和临床转化的关注度也越来越高。在这里，我们讨论了在推动纳米药物临床转化时需要考虑的五个关键挑战。我们从最终用户的角度出发，因此自上而下地解决发展路径问题。我们首先解决与实际和临床可行性相关的核心和更一般的问题，然后再解决更具体的临床前、临床和药物方面的问题，这些问题是纳米药物产品开发所必需的。我们相信，在纳米医学发展道路上尽早意识到终端用户的观点将有助于更好地监督所需的努力和投资，并就市场机会、目标疾病适应症、临床试验设计、治疗终点、临床前模型和配方规格做出最佳知情决策。对纳米医学转化的批判性思考和仔细的路线规划将有助于促进纳米药物的成功。
