Translational Medicine Brings Health to Patients in better way
——interview with Dr. Juan Granada

    转化心血管医学在中国还处于萌芽阶段，转化医学的研究前景如何？为何它如此重要？

    转化医学研究的目的在于给人类临床试验（药物或器械）舞台引出一个新概念。在我们的领域内，新兴技术经常是在发展中，世界范围内的研究中心需要制定策略、引导并促进这个过程的发展。早期的观点和发明凭借着专业和综合的研究项目作为指导，目的是为了给患者介绍新的治疗方法，最终改善人类健康。中心必须能够对每个阶段的研究进展周期进行调节，从早期观点的提出到方案的执行。项目是需要专科医生帮助定义临床应用还是高级研究人员进行临床前研究，必须在研究期间每一步提供专业意见。特别是对于中国来说，技术发展的新潮流正脱颖而出，在贯穿整个研究周期、对先进的技术具有丰富的研究经验的多学科专家团队（包括介入学家、外科医生和病理学家）必须进行整合。一旦临床前研究完成，项目能够继续下一步即临床批准阶段，这个阶段需要专业核心实验室准备数据出示给管理机构。

    目前这个正在不断发展的领域有哪些机遇？

    支架研发仍然是介入转化实验室最活跃的研究内容。在我们中心，我们开发出新一代的体内分析工具以更好地了解支架置入后血管愈合的过程。利用外科和其他学科的观念，我们研究了减少介入治疗创伤的能力、改善器械的生物相容性、加速血管愈合。

    心血管成像技术的应用是另外一个发展领域。发展成像技术改善心脏介入的安全性和有效性非常重要。例如， X线和超声的应用，如 3-D左室重建可能改善心内膜细胞传送功能的作用。此外，高级血管内成像的研究可作为体内评估药物洗脱支架置入后血管愈合情况的工具。在这些不断发展的治疗方法中，进展最快的要数药物涂层球囊局部药物输送、左心耳封堵术和经皮瓣膜技术。

    请谈谈您为 TCT准备的有关临床前项目的内容。

    这次 TCT会议，我们整合了一些全面的“转化医学研究”内容，一个分会场将集中于介入创新、实验方法和转化策略，将有一整天的连续对话和小组讨论。另一分会场是由领域内顶级专家展现 2010年最新器械的概念。这将是突出最新概念的一个版块，可能对未来 5年市场有很强的影响。作为主日程的一部分， DES峰会将展示 DES和药物涂层球囊最新技术。此外，临床研究的综合培训将涵盖器械研发规定的重要法规内容，其形式类似于今年 CIT期间召开的临床研究峰会。

    CCheart:  Translational cardiovascular medicine is in its very early stage in China. What is the promise of translational research, and why is it so important?

    Dr. Juan Granada:  The goal of translational research is to bring an innovative concept—whether it is a drug or device—into the arena of human clinical trials. In our field, in which emerging technologies are always under development, research centers around the world need to develop the strategies and navigate and facilitate this process. Early ideas and inventions are guided through specialized and comprehensive research programs in order to introduce new therapies to patients and ultimately improve human health. Centers must be able to accommodate studies at every stage of the development cycle, from early concepts to protocol implementation. Whether a project requires physician specialists to help define a clinical application or highly qualified researchers to carry out a preclinical study, one must provide insight and expertise at every step in the research continuum. Especially true for China where a new wave of technology development is currently emerging, a multi-disciplinary team of specialists including interventionalists, surgeons, and pathologists having extensive research experience in advancing products through the regulatory cycle must be assembled. Once preclinical research is complete, projects can progress to the next level which is clinical validation, in which specialized core laboratory functions are needed to prepare data for presentation to regulatory agencies.

    CCheart:  What are some of the areas of opportunity in this growing field?

    Dr. Juan Granada:  Stent development remains the most active area of investigation in interventional translational laboratories. In our center, we are advancing a new generation of in vivo analytical tools to better understand the process of vascular healing after device implantation. Working with surgical and non-surgical concepts, our group is investigating the ability to reduce the invasiveness of the intervention, improve the biocompatibility of devices, and promote vascular healing.

    Applied Cardiovascular Imaging is another growing field. It is important to develop imaging concepts that improve the safety and efficacy of cardiac interventions. For example, X-ray-based and ultrasound-based applications, such as 3-D reconstruction of the left ventricle, may improve the efficacy of endomyocardial cell delivery. In addition, research in advanced endovascular imaging could potentially provide the tools for the in vivo evaluation of vascular healing occurring after drug-eluting stent implantation. Among all the therapies that are under development, local drug delivery via drug coated balloons, left atrial appendage occlusion and percutaneous valve technologies are the ones that are most rapidly evolving.  

    CCheart:  Please tell us about the preclinical program you are developing for TCT.

    Dr. Juan Granada:  We have assembled a very comprehensive “translational research” component at TCT. One session will focus on interventional innovation, experimental pathways, and translational strategies. It will be a single day of back-to-back talks and panel discussions. One session will be led by top leaders in the field to highlight the best new device concepts for 2010. This will be a great session highlighting fresh concepts that have the potential to strongly influence the market within the next 5 years. As part of the main program, the DES summit will present the most recent advances in DES and drug coated balloon technologies. In addition, the comprehensive training in clinical research will cover important regulatory aspects required for device development and will follow a format similar to what was presented at the last CIT this year.