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肿瘤药物的科学严谨性:药理学、转化医学及临床视角

Scientific diligence for oncology drugs: a pharmacology, translational medicine and clinical perspective.

作者信息

Parasrampuria Dolly A, Bandekar Rajesh, Puchalski Thomas A

机构信息

Licensing Evaluation, Quantitative Sciences, Janssen R&D, 1400 McKean Road, Spring House, PA 19477, USA.

Licensing Evaluation, Quantitative Sciences, Janssen R&D, 1400 McKean Road, Spring House, PA 19477, USA.

出版信息

Drug Discov Today. 2020 Oct;25(10):1855-1864. doi: 10.1016/j.drudis.2020.07.014. Epub 2020 Jul 18.

DOI:10.1016/j.drudis.2020.07.014
PMID:32693162
Abstract

Increasingly, new drug development by major pharmaceutical companies relies on in-licensing of innovative therapies. Often there are limited data accompanying these novel entities. By focusing on scientific principles and generating key preclinical and clinical data, discovery companies can improve their valuations. From the lens of a large pharmaceutical company, we highlight key scientific aspects that are assessed to mitigate risk in valuations and deal terms. Our focus is on clinical development aspects for oncology drugs by stage of development. However, these lessons apply equally to other therapeutic areas.

摘要

大型制药公司的新药开发越来越依赖于创新疗法的引进授权。通常,这些新实体所附带的数据有限。通过专注于科学原理并生成关键的临床前和临床数据,研发公司可以提高自身估值。从大型制药公司的角度出发,我们强调在评估估值和交易条款时会考量的关键科学方面,以降低风险。我们重点关注肿瘤药物在不同开发阶段的临床开发方面。不过,这些经验教训同样适用于其他治疗领域。

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