Covance Gene Therapies

基因疗法

基因疗法提供了一种潜在的治疗方法,尤其针对罕见遗传疾病的患者。 Whether you're developing a viral vector-based therapy, such as an adeno-associated virus (AAV) or lentivirus (lenti) product, or applying gene editing technologies such as CRISPR/cas9, you'll benefit from our Expert Teams' deep knowledge and experience.

Assess safety, establish proof of concept and feasibility to support IND/IMPD/CTA submissions, and rapidly transition to first-in-human trials

Conduct Phase I, II, and III trials to support BLA/MAA submissions and preparation for post-marketing studies

进行真实证据研究,履行上市后承诺,优化基因疗法的可用性

Preclinical Solutions

  • In vitro & in vivo pharmacology & toxicology (acute & chronic)

  • Bioanalysis/PK: biodistribution, persistence & shedding

  • Biomarker strategy, assay development & testing

  • Regulatory & strategic product development consulting

  • Clinical development preparation & planning

  • BioCMC Testing– safety, identity, strength & purity

  • Commercialization Strategy Development

Clinical Trial Solutions

  • Patient identification & recruitment

  • Protocol modeling & development

  • Project & logistics management and oversight

  • 针对不良事件的医学监测和专门培训

  • First in Human/dose range-finding/escalation studies

  • Proof of mechanism/proof of concept (PoM/PoC) trials

  • Lab testing: PK, Biomarkers, Central Labs, Genomics, Specialty Testing and BioCMC

  • Regulatory & strategic product development consulting

  • Long-term follow-up preparation and testing strategy development

批准后解决方案

  • 长期随访研究

  • Lab Testing

  • Disease and product registries

  • 健康经济学

  • Field reimbursement

  • Clinical education

  • Payer and customer relations

  • Differentiation studies

全新细胞与基因疗法手术间

对微观科学的宏观投资

细胞与基因疗法异常复杂,但其对药物研发市场和患者的生活正在产生巨大影响。详细了解我们在细胞与基因疗法方面的920万美元投资。

重新定义研究的可能性

转变我们的早期研发服务

我们在科学创新上投资超过7亿美元,以期推进您的非临床研究。凭借更大的实验室空间、最新的技术和数字化后勤办公室,我们提供的解决方案具有前所未有的创新性。

两位科学家在看电脑屏幕

让我们开始探讨合作吧

欲了解详情? 

联系我们