Heelan Bridget Theresa
a VP (Tech) ; PAREXEL International ; The Quays , UK.
Hum Vaccin Immunother. 2014;10(11):3409-14. doi: 10.4161/21645515.2014.982999.
Cancer vaccines are aimed at stimulating an immune response to tumor tissue. There is a high level of clinical activity in this rapidly advancing field with over 1,400 trials registered on Clincaltrials.gov. The recent approval of Sipuleucel-T which is the first cancer vaccine approved in the US and EU has encouraged developers in this field. In contrast to more established approaches for treating cancer such as chemotherapy, regulatory guidelines have been developed relatively recently for cancer vaccines. These guidelines advise on general clinical requirements. As there is an increase in innovative strategies with novel products, a 2-way dialog with regulators is recommended on a case-by-case basis to justify the clinical development plan, taking into account specific quality issues related to the product(s) in development. It is important that the rationale, background and justification for the planned development is convincing when interacting with the regulatory authorities, to enable drug developers and regulators to reach agreement.
癌症疫苗旨在刺激机体对肿瘤组织产生免疫反应。在这个快速发展的领域中，临床研究活动十分活跃，在ClinicalTrials.gov上注册的试验超过1400项。近期，美国和欧盟批准的首款癌症疫苗西普尤单抗（Sipuleucel-T）鼓舞了该领域的研发人员。与化疗等更为成熟的癌症治疗方法不同，癌症疫苗的监管指南是相对较新制定的。这些指南就一般临床要求提供建议。随着创新策略和新产品的增加，建议根据具体情况与监管机构进行双向沟通，以论证临床开发计划的合理性，同时考虑到与在研产品相关的特定质量问题。与监管机构沟通时，计划开展的研发工作的基本原理、背景和理由必须令人信服，以便药物研发人员和监管机构达成共识。
