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定义创新和安全的挑战（一）
Defining the Challenges Surrounding Innovation and Safety (Part One) |
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| 课程网址: |
http://videolectures.net/mitworld_douglas_ryan_spiegel_tepper_fal...
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| 主讲教师: |
Ernst R. Berndt; John A. Fallon; Robert J. Spiegel; Robert Tepper; Frank L. Douglas; Una Ryan
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| 开课单位: |
奥斯丁生物创新研究所
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| 开课时间: |
2013-06-04
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| 课程语种: |
英语
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| 中文简介: |
最近对制药业的审查----默克公司的 vioxx 试验突出了这一问题----正在导致药物开发和销售发生一些重大变化。该小组对舆论和政策的方向有着深刻的关切。 una ryan 的公司已经煮出了具有成本效益的疫苗, 这些疫苗可能有助于预防和治疗常见疾病, 可以口服, 只需服用一次, 就能提供快速保护。瑞安说, 现在, 新规定可能需要在她的药物上市前进行更详细的检测, 潜在的临床试验将高达5亿美元。她说: "如果我们要经历荒谬而繁琐的监管周期, 我们将无法以低价出售." 罗伯特·施皮格尔想知道, 新的监管环境是否会继续允许制药商 "接受""如果运动" 对药品安全采取零容忍 ", 而且有一种疯狂的行为, 要摆脱有一定安全问题的药物," 那么整个行业的经济模式就处于危险之中 ", 他说。 罗伯特·特珀概述了新的 "后维克斯" 模式, "监管机构表示, 公司的工作是从实验室开始风险管理。一旦我们看到一些副作用, 我们就必须将其纳入我们的发展计划, 以便我们了解它的效果. "这意味着制定长期计划, 包括对每一个开始服用药物的病人进行后续研究和登记。泰珀说: "我的请求是" 在科学和可行性的基础上保持这种灵活的 … ", 约翰·法伦担心, 像他这样的健康计划将起到赶超的作用, 以建立电子医疗数据库和医生支持的工具来帮助监测大量人群中的药物反应。已经对医疗成本不满的雇主组织现在 "对医疗计划说 … 当维克斯遇到麻烦时, 你在哪里？" 恩斯特·伯恩特指出, 随着 fda 新标准涉及药物监控、it 和工程正在成为药物评价和监测进程的重要组成部分, "这不仅意味着数据库必须在全国范围内标准化, 而且在国际上也必须标准化。
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| 课程简介: |
Recent scrutiny of the pharmaceutical industry -- brought into sharp focus by Merck’s Vioxx trial -- is leading to some big changes in the development and marketing of drugs. This panel shares deep concerns about the direction of public opinion and policy. Una Ryan’s company has cooked up cost-effective vaccines that may help prevent and treat common diseases, and which can be administered orally, with a single dose, delivering quick protection. Now, new rules may demand more elaborate testing before her drugs come to market, says Ryan, with potential clinical trials running up to half a billion dollars. She says, “If we’re going to have to go through ridiculous and onerous regulatory cycles, we won’t be able to sell at low prices.” Robert Spiegel wonders if the new regulatory environment will continue to allow drug makers to “take chances early, and make investments taking large risks?” If the movement is “toward zero tolerance toward drug safety, and there’s a frenzy to get rid of drugs with some safety issue,” then the whole economic model of the industry is in peril, he says. Robert Tepper outlines the new, “post-Vioxx” pattern, “where regulators say the job of the company is to begin risk management from the lab. As soon as we see some side effect, we must build that into our development program so we understand how it plays out.” This means drawing up long-term plans involving follow-up studies and registries of every patient starting the drug. “My plea, says Tepper, is “to keep this flexible…based on science and feasibility.” John Fallon worries that health plans like his will be playing catch-up to build electronic medical databases and physician-supported tools to help monitor drug reactions in large populations. Employer groups, already unhappy with the costs of health care, are now “saying to health plans…where were you when Vioxx got into trouble?” Ernst Berndt notes that with new FDA standards involving drug surveillance, “IT and engineering are becoming an important part of the drug evaluation and monitoring process,” which will mean not only that databases must be standardized nationally, but internationally as well.
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| 关 键 词: |
药物; 药理学; 卫生保健
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| 课程来源: |
视频讲座网
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| 最后编审: |
2020-06-26：yumf
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| 阅读次数: |
96
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