苏州驾玉生物赞助Phacilitate Asia Leaders世界干细胞峰会

原文始发于微信公众号（药时代）：苏州驾玉生物赞助Phacilitate Asia Leaders世界干细胞峰会

October 15-16, 2019, World Stem Cell Summit took place at Kerry Hotel in Pudong, Shanghai as the inaugural conference in China organized and jointly hosted by Phacilitate Leaders Asia and the Regenerative Medicine Foundation(RMF), where international experts in cell and gene therapy are brought together in China for the first time.

2019年10月15日至16日，世界干细胞峰会在上海浦东嘉里大酒店举行，这是由Phacilitate Leaders Asia和再生医学基金会（RMF）首次在中国联合举办的会议，汇集了国际细胞和基因治疗方面的专家。

Experts from Asia, America, and Europe openly shared knowledge and experience, enthusiastically formed new connections, and developed partnerships towards commercialization opportunities. The event highlighted not only the immensity of the rapidly growing world-wide industry, but also the tangibility of achieving real benefits to human health with the successful collaboration of stakeholders involved in cutting-edge research and product development of cell and gene therapy.

来自亚洲、美国和欧洲的专家公开分享知识和经验，热情地交流并为商业化机会建立基础。此次活动不仅展现了细胞治疗在全球行业的快速发展巨大潜力，而且强调了参与细胞和基因疗法前沿研究和产品开发各方面利益相关者的合作的重要性，以为人类健康带来切实的利益。

Figure 1. Bernard Loeffk

A surprise speaker, retired US Military General Bernard Loeffke (Figure 1), gave a very spirited talk on medicine as the bridge to peace between China and the US. He reminded us of his personal involvement with forming the first US-China diplomatic relations and that such a relationship is even more critical now amidst a delicate global situation. He emphasized the need for continuing to build the bridge using the opportunities gained through collaborative efforts in medicine as an example.

令人惊讶的开场演讲者是退休的美军退伍将领贝尔纳德·洛夫克（Bernard Loeffke）。他就医学作为中美之间和平互助的桥梁，进行了热烈的演讲。他个人直接参与了美国国务卿基辛格当年建立美中外交关系的经历，强调在当今微妙的全球形势下，中美坦诚合作关系变得更加关键。他强调继续利用医学合作的机会来搭建中美友谊的新桥梁。

JADE Biomedical took great pride as being a sponsor for the event. Founder and CEO, Dr. Claudia Lin, spoke at the conference on practical guidance on GMP quality management for the variety of cell therapies showing translational promise in laboratories and hospitals world-wide, (Figure 2).

Figure 2.Dr.Claudia Lin

Dr. Lin pointed out not only the existing challenges, but also the current opportunities in cell and gene therapy in China. She emphasized that quality is a core competency of all medicinal therapies and required for the success of products. Her talk provided a practical solution for achieving such quality by applying her coined term,“SRSQ” – System Approach, Risk Control Strategy, Scientific Rationale, and Quality Control Excellence, a concept Dr. Lin developed from her vast experience with bio-therapeutics product quality management. Dr. Lin’s talk distinctly connects the global trends and requirements in cell therapy regulation and quality management that bridge to the industry’s reality and specific challenges in China. She also offered her practical suggestions to the global cell and gene therapy community on how to reduce the gap in GMP Compliance and Quality Standards while reaping the benefits of the China market.

苏州驾玉生物有幸赞助了此次峰会。创始人兼首席执行官Claudia Lin（林巧）博士在会议上发表了有关GMP质量管理对各种细胞疗法的实用指导的讲演，描绘了全世界从研发实验室到医院病房细胞治疗的转化前景。林博士的讲演对于目前中国细胞和基因治疗的挑战和机遇做了分析。她强调，治疗药物的质量是所有药物产业化成功的关键。她的演讲通过运用她发明的专有名词“ SRSQ”（系统管理，风险控制策略，科学原理和卓越质量控制）提供了一种实现这种高质量药物的实用解决方案。这是林博士从她在生物治疗产品方面的丰富经验中而得来的理念和实操经验，她将细胞疗法的法规和质量管理全球趋势和要求与中国现状联系起来，并对于该行业近期应如何在中国发展提出了她个人的分析和建议；她认为帮助中国细胞治疗行业缩小与世界先进国家在质量和合规方面的差距将同时受益国际同行和中国市场。

A common theme emerged amongst the presentations from academic and industry leaders presenting their translational research and commercialization work – the most critical bottleneck to realizing the tremendouspotential of the scientific revolutionis the complex challenge around manufacturing and quality control; cell therapies are medicines which are live and therefore more vulnerable and variable than other commercialized therapeutics, hence they require more sophisticated approaches to ensure manufacturing success in order to produce safe and efficacious therapies.

其他学术界和行业领袖们在介绍他们的转化研究和商业化工作的演讲中产生了一个共同的主题-要实现细胞和基因疗法的巨大医学健康潜力，最关键要解决的瓶颈是产品制造和质量控制。细胞疗法是活的药物，因此比其他商业化的药物疗法更脆弱和易变，因此，它们需要更复杂的方法来确保产品制造稳定成功，安全有效。

Along with Dr. Lin, some of the other conference speakers that brought this to light were:

▲Joshua Hare – “Multiple applications for stem cell therapies – cardiovascular disease and aging”

▲Kunihiko Suzuki – “CAR-T in the clinic,” “Focus on quality and patients: the key to drug development,” and “Automated and scalable manufacturing strategies for CAR-T and advanced therapies”

▲Jeanne Fontana – “Ethical and cultural intersections – keeping things on track” and “Research and clinical applications: accelerating regenerative medicine to improve health and deliver cures”

▲Jane Andrew – “Cell and gene therapy & bio-manufacturing – A SWOT analysis of CDMO market demand and future capacity,” “Successful investment requires careful navigation of multi-dimensional roadmaps,” and “Sino-US investment strategies for stability and growth”

▲Yu Zhang – “CAR-T therapy in solid tumors”

其他一些演讲者包括：

▲Joshua Hare –“干细胞疗法的多种应用–心血管疾病和衰老”

▲铃木邦彦（Kunihiko Suzuki）–“临床中的CAR-T”，“关注质量和患者：药物开发的关键”和“ CAR-T和先进疗法的自动化和可扩展的制造策略”

▲珍妮·芳塔娜（Jeanne Fontana）–“道德和文化交汇点-保持步调一致”和“研究与临床应用：加速再生医学以改善健康状况并提供治疗方法”

▲简·安德鲁（Jane Andrew）–“细胞和基因疗法与生物制造-CDMO市场需求和未来产能的SWOT分析”，“成功的投资需要对多维路线图进行仔细的导航”和“中美稳定与增长的投资策略” ”

▲张宇–“实体瘤的CAR-T治疗”

Figure3.JADE booth

JADE Biomedical also hosted a booth in the conference exhibit hall for both days (Figure 3). It attracted a large percentage of the attendees at the conference. Meaningful exchanges were made and dynamic interactions at the JADE booth truly reflected the nature of JADE as being a global company with a strong footing in China. Particularly lively exchanges at the booth led by JADE’s COO David Kapitula involved Chinese, US, European, and Japanese companies regarding business collaborations and friendship.

驾玉生物还在会议展厅举办了一个摊位。会议吸引了很大一部分与会者在JADE展位进行了有意义的交流和动态互动，真正反映了JADE作为在中国具有扎实立足点的跨国公司的本质。在由JADE首席运营官David Kapitula领导的展台上洋溢着特别活跃的涉及中、美、欧洲和日本公司之间的业务合作与友谊。

Figure4.JADE booth

JADE booth featured its new service: Rapid Quantitative Mycoplasma Analysis & Detection (1 day vs. 28 days) for the global cell therapy community (Figure 4). JADE’s division, JADE Bio – Pacific® Laboratories Shanghai-Suzhou, distinguishes itself with their internationally GMP Compliant Material and Product Safety Testing Services in China for global. The rapid safety method is a critical improvement for advanced cellular and gene therapies to the current available Chinese Compendium culture assay. The experts at JADE Bio-Pacific® Laboratories provide this analysis fully qualified for global submission comparable to the China, EU, and US Compendia requirements for cell therapies and biologic therapeutics.

JADE展位展示了其新服务：针对全球细胞疗法界的快速定量支原体分析和检测（1天vs.28天）。JADE的分部JADE Bio-Pacific® Laboratories上海-苏州以在全球范围内符合国际GMP标准的材料和产品安全测试服务而独树一帜。他们的快速安全性方法是对先进的细胞和基因疗法质量控制进行的重要改良方法，可用于比对目前中国药典培养法。JADE Bio-Pacific® Laboratories的专家提供的检测方法完全符合全球药物监管申报的要求，可与中国、欧盟和美国药典对细胞疗法和生物疗法的要求相提并论。

Figure 5.

Overall, this coming together of like-minded leaders in such an engaging, open, and collaborative environment, in the spirit of mutual understanding based on integrity and common goals, proved that there is no substitute for collective progress better than the sharing that took place at this summit.

总体而言，志趣相投的领导者们在这种互动，开放和协作的环境中本着诚信和共同目标的相互理解精神汇聚在一起，这证明，没有什么比集体共享更好地替代了集体进步在这次峰会上。

This was one of the few truly international conferences of its caliber to ever take place in China. With their 30 years of collective experience, Phacilitate’s conference production and RMF’s world-wide leading position in cell and gene therapy advancement was well represented in this high-quality event which fulfilled its purpose and succeeded at fostering our industry’s global cause.

这是有史以来为数不多的真正在中国举办的国际会议之一。凭借30年的世界级会议组织经验，Phacilitate和RMF在细胞和基因疗法发展方面的全球领先地位在这一高质量的活动中得到了很好的体现，该活动有效促进了中国细胞治疗行业与全球同行们的沟通合作。