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从临床前到产品发布测试(第四部分)

Testing from Pre-Clinical to Product Launch (Part Four)
课程网址: http://videolectures.net/mitworld_tannenbaum_afeyan_bonventre_gri...  
主讲教师: Noubar Afeyan, Steven R. Tannenbaum, Joseph V. Bonventre, Linda G. Griffith, James Green
开课单位: 麻省理工学院
开课时间: 2013-06-04
课程语种: 英语
中文简介:
“对我来说,系统生物学是一种宗教,当基于目标的药物发现不起作用时,你就会转向它,”努巴·阿费扬大胆地说。他声称,在损失数十亿美元之后,制药行业和学术界开始看到通过测量生物网络的结果来测试药物的价值。他称之为系统药理学,即你在活的系统中测量同一有机体中的多个分析物,扰乱状态并对每个样本进行数千次测量。研究人员使用计算机图像来可视化不同网络中药物反应的差异和相似性,然后尝试将这些结果关联起来。统计结果。Joseph Bonventre说,由于无法在药物开发早期预测毒性,制药行业在2003年损失了惊人的80亿美元,大约是所有药物失效成本的三分之一。他说:“我们一般不能在毒性太晚之前发现毒性,因此关键的挑战是通过有用的生物标记物、改进的动物模型和高通量技术来开发更好的临床前研究;在临床方面,提出“安全港法”来收集肾脏和其他毒性数据。”“发展联盟以验证生物标志物,处理IP问题,并构建一个改进的从床边到工作台的信息流。”Linda Griffith的愿景是“在芯片上构建人体”。她并不是在谈论个体的基因组或健康历史,而是一个活生生的、三维互联的信息系统。在一个芯片上的诉讼。如果你干扰了它,你就会使它发展成一种疾病。”这样的装置可以使研究人员预测药物的负作用,甚至可以建立疾病模型。格里菲斯版本的肝组织,建立在硅支架上,可能被证明对药物毒性测试特别有用。在Biogen,James Green说:“任何新方法或技术的正当理由的圣杯在于,我们将大幅削减将新产品从工作台移到床边所需的时间。”他认为,“药物和范例比24年前复杂多了一个数量级。”他希望新技术“将我们带入基因组,将数据解释为模式”提供了一些希望。
课程简介: “To me, systems biology is the religion you switch to when target-based drug discovery doesn’t work,” Noubar Afeyan states boldly. He claims that after losing billions of dollars, the pharmaceutical industry and academia are beginning to see the value in testing drugs by measuring outcomes in biological networks. He calls this systems pharmacology, where you “measure in living systems multiple analytes in the same organism, perturbing the state and taking thousands of measurements per sample.” Researchers use computer images to visualize the differences and similarities in drug response across many networks, and then try to correlate these responses statistically. The inability to predict toxicity early in drug development cost the pharmaceutical industry an astonishing $8 billion in 2003, says Joseph Bonventre, approximately one-third the cost of all drug failures. “We generally can’t pick up toxicity until it’s too late,” he says, so key challenges are developing better preclinical studies with useful biomarkers, improved animal models, and high throughput techniques; and on the clinical side, coming up with a “safe harbor approach to amass kidney and other toxicity data,” developing consortia to validate biomarkers, dealing with IP issues and building “an improved bedside to bench flow of information.” Linda Griffith's vision is “building a human body on a chip.” She’s not talking about an individual’s genome or health history, but “a living, 3D interconnected set of tissues on a chip. If you perturb it, you make it develop a disease.” Such a device would enable researchers to predict negative drug interactions and even to build models of disease. Griffiths’ version of liver tissue, built on a silicon scaffold, may prove especially useful for drug toxicity tests. At Biogen, “the holy grail for any justification of a new approach or technology is that we’re going to chop a significant amount off the time it takes to move a new product from bench to bedside,” says James Green. He believes that “drugs and paradigms are orders of magnitude more complicated than 24 years ago.” He hopes that new techniques “that take us into the genome, interpreting data as patterns” offer some promise.
关 键 词: 生物学; 医学; 药理学
课程来源: 视频讲座网
最后编审: 2019-11-14:cwx
阅读次数: 27