{"title":"纳米医学和基因疫苗创新的监管见解:安全评估、挑战和监管视角","authors":"Eliana B. Souto , Cristina Blanco-Llamero , Karolline Krambeck , Neelakanta Sarvashiva Kiran , Chandrashekar Yashaswini , Humzah Postwala , Patricia Severino , Ronny Priefer , Bhupendra Gopalbhai Prajapati , Rahul Maheshwari","doi":"10.1016/j.actbio.2024.04.010","DOIUrl":null,"url":null,"abstract":"<div><p>This analysis explores the principal regulatory concerns linked to nanomedicines and gene vaccines, including the complexities involved and the perspectives on how to navigate them. In the realm of nanomedicines, ensuring the safety of nanomaterials is paramount due to their unique characteristics and potential interactions with biological systems. Regulatory bodies are actively formulating guidelines and standards to assess the safety and risks associated with nanomedicine products, emphasizing the need for standardized characterization techniques to accurately gauge their safety and effectiveness. Regarding gene vaccines, regulatory frameworks must be tailored to address the distinct challenges posed by genetic interventions, necessitating special considerations in safety and efficacy evaluations, particularly concerning vector design, target specificity, and long-term patient monitoring. Ethical concerns such as patient autonomy, informed consent, and privacy also demand careful attention, alongside the intricate matter of intellectual property rights, which must be balanced against the imperative of ensuring widespread access to these life-saving treatments. Collaborative efforts among regulatory bodies, researchers, patent offices, and the private sector are essential to tackle these challenges effectively, with international cooperation being especially crucial given the global scope of nanomedicine and genetic vaccine development. Striking the right balance between safeguarding intellectual properties and promoting public health is vital for fostering innovation and ensuring equitable access to these ground-breaking technologies, underscoring the significance of addressing these regulatory hurdles to fully harness the potential benefits of nanomedicine and gene vaccines for enhancing healthcare outcomes on a global scale.</p></div><div><h3>Statement of significance</h3><p>Several biomaterials are being proposed for the development of nanovaccines, from polymeric micelles, PLGA-/PEI-/PLL-nanoparticles, solid lipid nananoparticles, cationic lipoplexes, liposomes, hybrid materials, dendrimers, carbon nanotubes, hydrogels, to quantum dots. Lipid nanoparticles (LNPs) have gained tremendous attention since the US Food and Drug Administration (FDA) approval of Pfizer and Moderna's COVID-19 vaccines, raising public awareness to the regulatory challenges associated with nanomedicines and genetic vaccines. This review provides insights into the current perspectives and potential strategies for addressing these issues, including clinical trials. By navigating these regulatory landscapes effectively, we can unlock the full potential of nanomedicine and genetic vaccines using a range of promising biomaterials towards improving healthcare outcomes worldwide.</p></div>","PeriodicalId":237,"journal":{"name":"Acta Biomaterialia","volume":null,"pages":null},"PeriodicalIF":9.4000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1742706124001831/pdfft?md5=09c8a9ff719694e7945f0c06618e1000&pid=1-s2.0-S1742706124001831-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives\",\"authors\":\"Eliana B. 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Regarding gene vaccines, regulatory frameworks must be tailored to address the distinct challenges posed by genetic interventions, necessitating special considerations in safety and efficacy evaluations, particularly concerning vector design, target specificity, and long-term patient monitoring. Ethical concerns such as patient autonomy, informed consent, and privacy also demand careful attention, alongside the intricate matter of intellectual property rights, which must be balanced against the imperative of ensuring widespread access to these life-saving treatments. Collaborative efforts among regulatory bodies, researchers, patent offices, and the private sector are essential to tackle these challenges effectively, with international cooperation being especially crucial given the global scope of nanomedicine and genetic vaccine development. Striking the right balance between safeguarding intellectual properties and promoting public health is vital for fostering innovation and ensuring equitable access to these ground-breaking technologies, underscoring the significance of addressing these regulatory hurdles to fully harness the potential benefits of nanomedicine and gene vaccines for enhancing healthcare outcomes on a global scale.</p></div><div><h3>Statement of significance</h3><p>Several biomaterials are being proposed for the development of nanovaccines, from polymeric micelles, PLGA-/PEI-/PLL-nanoparticles, solid lipid nananoparticles, cationic lipoplexes, liposomes, hybrid materials, dendrimers, carbon nanotubes, hydrogels, to quantum dots. Lipid nanoparticles (LNPs) have gained tremendous attention since the US Food and Drug Administration (FDA) approval of Pfizer and Moderna's COVID-19 vaccines, raising public awareness to the regulatory challenges associated with nanomedicines and genetic vaccines. 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引用次数: 0
摘要
本分析探讨了与纳米药物和基因疫苗相关的主要监管问题,包括所涉及的复杂性以及如何应对这些问题的观点。在纳米药物领域,由于纳米材料的独特性以及与生物系统的潜在相互作用,确保纳米材料的安全性至关重要。监管机构正在积极制定准则和标准,以评估与纳米医药产品相关的安全性和风险,并强调需要标准化的表征技术来准确衡量其安全性和有效性。关于基因疫苗,监管框架必须量身定制,以应对基因干预所带来的独特挑战,这就需要在安全性和有效性评估方面进行特别考虑,尤其是在载体设计、目标特异性和长期患者监测方面。患者自主权、知情同意权和隐私权等伦理问题也需要认真关注,此外还有错综复杂的知识产权问题,必须在确保广泛使用这些救命疗法的当务之急之间取得平衡。监管机构、研究人员、专利局和私营部门之间的合作对于有效应对这些挑战至关重要,鉴于纳米医学和基因疫苗开发的全球范围,国际合作尤为关键。在保护知识产权和促进公众健康之间取得适当平衡对于促进创新和确保公平获取这些突破性技术至关重要,这突出表明了解决这些监管障碍对于充分利用纳米医学和基因疫苗的潜在益处以提高全球医疗保健成果的重要性。目前有多种生物材料被提议用于开发纳米疫苗,包括聚合物胶束、PLGA-/PEI-/PLL-纳米颗粒、固体脂质纳米颗粒、阳离子脂质体、脂质体、混合材料、树枝状聚合物、碳纳米管、水凝胶和量子点。自美国食品和药物管理局(FDA)批准辉瑞和 Moderna 的 COVID-19 疫苗以来,脂质纳米粒子(LNPs)获得了极大的关注,提高了公众对纳米药物和基因疫苗相关监管挑战的认识。本综述深入探讨了解决这些问题(包括临床试验)的当前视角和潜在策略。通过有效驾驭这些监管环境,我们可以利用一系列前景广阔的生物材料释放纳米药物和基因疫苗的全部潜力,从而改善全球的医疗保健效果。
Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives
This analysis explores the principal regulatory concerns linked to nanomedicines and gene vaccines, including the complexities involved and the perspectives on how to navigate them. In the realm of nanomedicines, ensuring the safety of nanomaterials is paramount due to their unique characteristics and potential interactions with biological systems. Regulatory bodies are actively formulating guidelines and standards to assess the safety and risks associated with nanomedicine products, emphasizing the need for standardized characterization techniques to accurately gauge their safety and effectiveness. Regarding gene vaccines, regulatory frameworks must be tailored to address the distinct challenges posed by genetic interventions, necessitating special considerations in safety and efficacy evaluations, particularly concerning vector design, target specificity, and long-term patient monitoring. Ethical concerns such as patient autonomy, informed consent, and privacy also demand careful attention, alongside the intricate matter of intellectual property rights, which must be balanced against the imperative of ensuring widespread access to these life-saving treatments. Collaborative efforts among regulatory bodies, researchers, patent offices, and the private sector are essential to tackle these challenges effectively, with international cooperation being especially crucial given the global scope of nanomedicine and genetic vaccine development. Striking the right balance between safeguarding intellectual properties and promoting public health is vital for fostering innovation and ensuring equitable access to these ground-breaking technologies, underscoring the significance of addressing these regulatory hurdles to fully harness the potential benefits of nanomedicine and gene vaccines for enhancing healthcare outcomes on a global scale.
Statement of significance
Several biomaterials are being proposed for the development of nanovaccines, from polymeric micelles, PLGA-/PEI-/PLL-nanoparticles, solid lipid nananoparticles, cationic lipoplexes, liposomes, hybrid materials, dendrimers, carbon nanotubes, hydrogels, to quantum dots. Lipid nanoparticles (LNPs) have gained tremendous attention since the US Food and Drug Administration (FDA) approval of Pfizer and Moderna's COVID-19 vaccines, raising public awareness to the regulatory challenges associated with nanomedicines and genetic vaccines. This review provides insights into the current perspectives and potential strategies for addressing these issues, including clinical trials. By navigating these regulatory landscapes effectively, we can unlock the full potential of nanomedicine and genetic vaccines using a range of promising biomaterials towards improving healthcare outcomes worldwide.
期刊介绍:
Acta Biomaterialia is a monthly peer-reviewed scientific journal published by Elsevier. The journal was established in January 2005. The editor-in-chief is W.R. Wagner (University of Pittsburgh). The journal covers research in biomaterials science, including the interrelationship of biomaterial structure and function from macroscale to nanoscale. Topical coverage includes biomedical and biocompatible materials.