三十年弹指一挥间,2016年福医同学夏威夷聚会 4:茂宜岛

哈纳之路是茂宜岛的必游景点。一路上风光明媚,美不胜收。一路上有十几个景点。哈纳之路不危险但是却有点困难开车。全长是42英里,有500多个180度的转弯,还有50多座只能通行一部车子的小桥。所以开车的时候就是要小心慢行。因为不好开车,所以没有旅行社要带你去,只好自己租车前往。有点危险,但是刺激。

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Regulation of immunotherapeutic products for cancer and FDA’s role in product development and clinical evaluation

Abstract

Immunotherapeutics include drugs and biologics that render therapeutic benefit by harnessing the power of the immune system. The promise of immune-mediated therapies is target specificity with a consequent reduction in off-target side effects. Recent scientific advances have led to clinical trials of both active and passive immunotherapeutic products that have the potential to convert life-ending diseases into chronic but manageable conditions. Clinical trials investigating immunotherapeutics are ongoing with some trials at advanced stages of development. However, as with many products involving novel mechanisms of action, major regulatory and scientific issues arising with clinical use of immunotherapeutic products remain to be addressed. In this review, we address issues related to different immunotherapeutics and provide recommendations for the characterization and evaluation of these products during various stages of product and clinical development.

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CAR T-Cell Therapy: Engineering Patients’ Immune Cells to Treat Their Cancers

For years, the cornerstones of cancer treatment have been surgery, chemotherapy, and radiation therapy. Over the last decade, targeted therapies like imatinib (Gleevec®) and trastuzumab (Herceptin®)—drugs that target cancer cells by homing in on specific molecular changes seen primarily in those cells—have also emerged as standard treatments for a number of cancers.

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维基百科:生物治疗

"生物治疗一种新兴的自身免疫的新型治疗方法,又称生物反应修饰剂,目前多应用于癌症,主要思想是运用生物技术和制剂对病人体内吸取的免疫细胞进行体外改造和扩增后回输到病人体内,极大化增强生物自愈能力来抗病。也是一种个人化医疗趋势产物。"

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"生物治疗一种新兴的自身免疫的新型治疗方法,又称生物反应修饰剂,目前多应用于癌症,主要思想是运用生物技术和制剂对病人体内吸取的免疫细胞进行体外改造和扩增后回输到病人体内,极大化增强生物自愈能力来抗病。也是一种个人化医疗趋势产物。"

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