Kuhn P, Keating S M, Baxter G T, Thomas K, Kolatkar A, Sigman C C
The Scripps Research Institute, La Jolla, California, USA.
CCS Associates, San Jose, California, USA.
Clin Pharmacol Ther. 2017 Nov;102(5):777-785. doi: 10.1002/cpt.645. Epub 2017 Mar 22.
Planning and transfer of a new technology platform developed in an academic setting to a start-up company for medical diagnostic product development may appear daunting and costly in terms of complexity, time, and resources. In this review we outline the key steps taken and lessons learned when a technology platform developed in an academic setting was transferred to a start-up company for medical diagnostic product development in the interest of elucidating development toolkits for academic groups and small start-up companies starting on the path to commercialization and regulatory approval.
将在学术环境中开发的新技术平台转移到一家初创公司用于医疗诊断产品开发，在复杂性、时间和资源方面可能显得艰巨且成本高昂。在本综述中，我们概述了为了阐明面向开始走向商业化和监管批准道路的学术团体和小型初创公司的开发工具包，当一个在学术环境中开发的技术平台被转移到一家初创公司用于医疗诊断产品开发时所采取的关键步骤和吸取的经验教训。
