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赛车手蓝图 - 从构想到现实

系列第一

博士理查德·麦克法兰(Richard McFarland)

Armi首席监管官|生物菜

我很高兴看到6月在Millyard Spring Summit会议上公开揭幕的原型组织铸造厂。看到Armi成员聚集在一起来产生Armi的外在和可见的表现真是令人满意。Biofabusa技术路线图 - 很少有路线图实现的壮举,尤其是新社区撰写的壮举。当将BioFab USA资助的技术项目纳入可扩展,模块化,自动化,封闭的制造线中时,将需要整个ARMI社区的持续参与来开发组织铸造厂。

一种s much as I will savor seeing the Tissue Foundry mature right above my eyes in the same building that housed a 19thCentury machine shop that was America’s advanced manufacturing for its time, I realize that simply having a novel technology (no matter how innovatively it is manufactured) is insufficient to allow a great scientific notional product to translate to a commercial product. When I arrived at the FDA/CBER’s Office of Therapeutics Research and Review in 2000 there was great excitement about the prospect of new medicines for the new millennium from monoclonal antibodies, recombinant proteins, and tissue engineered medical products (TEMPs). Now, a generation later, the monoclonals and recombinants are biotech mainstays in both clinical practice and industry bottom lines, yet TEMPs have not matured as an industry. This divergence in industry maturity is certainly due, in part, to the increased manufacturing complexity of TEMPs relative to the biotech products. BioFabUSA’s technical projects and Tissue Foundry are addressing this complexity with bold initiatives.

除制造业外,五个关键因素对于从学术成就到临床医生的一部分的好主意至关重要。这些因素不在工程,科学或医学课程中足够深入,可以在没有额外的培训或经验的情况下掌握它们。然而,它们至少与完全商业化有关的温度(或其他高级疗法)的科学和工程基础一样重要。这五个因素塑造了秋季峰会:

·r真实的临床目标

·一种可访问的资本

·C填充性监管策略

·expanding可用的劳动力

·r征收偿还环境

认识到这一现实,阿米|Biofabusa设计了我们的秋季峰会,以提供有关这些主题的内容丰富的谈判,并散布着令人发指的交互式小组会议,为该领域提供了肥沃的环境,以进一步发展。无论您从我们的异质社区和会员资格中有什么看法,您都会在研讨会中找到学习和教学的领域。在每次峰会之后的几天和几个月中,我们听到了这些事件发生的偶然遇到的人际关系和合作。通过这些会议,我们的社区得到了加强,并发展成为创新的行业。我期待于2019年10月16日至17日在曼彻斯特见到大家。

在接下来的几周中,我将深入研究赛车手蓝图,并使用专门针对每个组件的博客文章。