Bench to Bedside Integrating Advances in Basic Science into Daily Clinical Practice

被引:5
作者
McGoldrick, Rory B. [1 ]
Hui, Kenneth [1 ]
Chang, James [1 ]
机构
[1] Stanford Univ, Med Ctr, Div Plast & Reconstruct Surg, Sect Plast Surg,VA Palo Alto Health Care Syst, Palo Alto, CA 94304 USA
关键词
Commercialization; Technology transfer process; Patenting; Marketing; Licensing; Company startup; Food and Drugs Administration; Clinical trials; EXIT;
D O I
10.1016/j.hcl.2014.04.004
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
This article focuses on the initial steps of commercial development of a patentable scientific discovery from an academic center through to marketing a clinical product. The basics of partnering with a technology transfer office (TTO) and the complex process of patenting are addressed, followed by a discussion on marketing and licensing the patent to a company in addition to starting a company. Finally, the authors address the basic principles of obtaining clearance from the Food and Drugs Administration, production in a good manufacturing practice (GMP) facility, and bringing the product to clinical trial.
引用
收藏
页码:305 / +
页数:14
相关论文
共 22 条
  • [1] Other ways of financing your company
    Aldag, Joern
    Kessel, Mark
    Ibrahim, Adrian
    Hill, Ray
    McCubbin, Paul
    [J]. NATURE BIOTECHNOLOGY, 2008, 26 (02) : 155 - 157
  • [2] Bioentrepreneurialism for the plastic surgeon
    Baker, Stephen
    Weinzweig, Jeffrey
    [J]. PLASTIC AND RECONSTRUCTIVE SURGERY, 2008, 122 (01) : 295 - 301
  • [3] Ben-Menachem G, 2006, NAT BIOTECHNOL, V24, P17
  • [4] Boezi K, 2006, NAT BIOTECHNOL, V24, P895
  • [5] Market Entry And Exit By Biotech And Device Companies Funded By Venture Capital
    Burns, Lawton R.
    Housman, Michael G.
    Robinson, Charles A.
    [J]. HEALTH AFFAIRS, 2009, 28 (01) : W76 - W86
  • [6] Campbell G., 2006, BIOPHARMACEUTICAL RE, V14, P1
  • [7] Building relationships with technology transfer officers
    Das, OP
    [J]. NATURE BIOTECHNOLOGY, 2005, 23 (07) : 781 - 783
  • [8] Elsbach KD, 2003, HARVARD BUS REV, V81, P117
  • [9] Ernst&Young, 2011, BORDERS GLOBAL BIOTE
  • [10] Gautam G, 2008, 2013 ASCI AAP JOINT