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用于生物防御的抗病毒药物的发现与开发:一家小型生物技术公司的经验

Discovery and development of antiviral drugs for biodefense: experience of a small biotechnology company.

作者信息

Bolken Tove C, Hruby Dennis E

机构信息

SIGA Technologies, Inc., 4575 SW Research Way Suite 230, Corvallis, OR 97333, United States.

出版信息

Antiviral Res. 2008 Jan;77(1):1-5. doi: 10.1016/j.antiviral.2007.07.003. Epub 2007 Aug 15.

Abstract

The unmet need for effective antivirals against potential agents of bioterrorism and emerging infections is obvious; however, the challenges to develop such drugs are daunting. Even with the passage of Project BioShield and more recently the BARDA legislation, there is still not a clear market for these types of drugs and limited federal funding available to support expensive drug development studies. SIGA Technologies, Inc. is a small biotech company committed to developing novel products for the prevention and treatment of severe infectious diseases, with an emphasis on products for diseases that could result from bioterrorism. Through trials and error SIGA has developed an approach to this problem in order to establish the infrastructure necessary to successfully advance new antiviral drugs from the discovery stage on through to licensure. The approach that we have taken to drug development is biology driven and dependent on a dispersive development model utilizing essential collaborations with academic, federal, and private sector partners. This consortium approach requires success in acquiring grants and contracts as well as iterative communication with the government and regulatory agencies. However, it can work as evidenced by the rapid progress of our lead antiviral against smallpox, ST-246, and should serve as the template for development of new antivirals against important biological pathogens.

摘要

对于针对潜在生物恐怖主义制剂和新出现感染的有效抗病毒药物的需求尚未得到满足,这一点显而易见;然而,开发此类药物面临的挑战令人生畏。即使有了《生物盾牌计划》以及最近的生物医学高级研究与发展局(BARDA)立法的通过,这类药物仍没有明确的市场,且用于支持昂贵药物研发研究的联邦资金有限。SIGA科技公司是一家小型生物技术公司,致力于开发用于预防和治疗严重传染病的新型产品,重点是针对可能由生物恐怖主义引发的疾病的产品。通过反复试验,SIGA已针对这一问题开发出一种方法,以建立从发现阶段到获得许可成功推进新型抗病毒药物所需的基础设施。我们采用的药物开发方法以生物学为驱动,依赖于一种分散式开发模式,利用与学术、联邦和私营部门合作伙伴的必要合作。这种联合方法要求在获取资助和合同方面取得成功,并与政府和监管机构进行反复沟通。然而,我们针对天花的领先抗病毒药物ST - 246的快速进展证明了这种方法是可行的,并且应该成为开发针对重要生物病原体的新型抗病毒药物的模板。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/934a/7114183/39566f974224/gr1.jpg

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