CBA 抗击新型冠状病毒知识系列讲座-2

CBA 抗击新型冠状病毒知识系列讲座-2

CBA 抗击新型冠状病毒知识系列讲座-2 抗击新型冠状病毒创新药物的研发 

演讲嘉宾:Dr. Patrick Lu, Sirnaomics Inc.                                     Dr. Shoubai Chao, CanSino Biologics Inc.

点评嘉宾:Dr. Hang Lu                               

庚子伊始,正值中国传统佳节春节来临之际,一场突如其来的“2019 新型冠状病毒”疫情向 我们无情袭来,不断蔓延的疫情更是牵动了无数 CBA 成员和朋友们的心,许多我们熟知 CBA 的骨干企业及个人,已经直接或间接地投入到了这场没有硝烟的战斗中! 抗疫情,CBA 在行动!作为 CBA 抗疫行动的一部分,CBA Biomarker Study Group 和 CBA Clinical and Regulatory Affair Study group 决定联合举办抗击新型冠状病毒肺炎知识系列讲座(CBA Anti-COVID-19 Webinar Series);这个系列讲座将就大家关注的新型冠状病毒的科学知识,流行病防控战略和机制,抗病毒药物制备和临床试验,病毒检测方法和应用, 特殊时期 FDA 的药政法规,防控工作的中长期规划等一系列问题,邀请本地的专家、学者、政府官员、企业家、工程技术人员来分享他们的真知灼见,并回答大家的问题。这个讲座将对 CBA 及社会公众开放,听众可用 Zoom 来加入。本讲座由商图信息(BIOMAP)负责中国国内推广。 御风雪呼唤抱薪者,抗疫情更需你我他。欢迎大家积极参加,并把您的宝贵意见反馈给我们。让我们携起手来,风雨同舟,共克时艰,将点滴爱心汇成江河,呼唤春风化雨,散尽阴霾,共盼灿烂阳光的到来!  

  时间:  2 月 26 日 周三晚上 8:30-9:30(美东时间); 2月27日周四上午9:30-10:30 (中国时间)。

讲座形式:线上讲座(webinar)

Webinar 链接的详细信息如下:

Register in advance for this meeting is required: 请事前注册:
https://zoom.us/meeting/register/tZAkfuyhqj8rMVV-GvB1aKLE_WEUV3SFUA

After registering, you will receive a confirmation email containing information about joining the meeting. 注册后,你将收到确认的电子邮件,还会告诉你参会的具体信息。

讲座内容:

报告1:RNAi技术是开发治疗新冠肺炎创新药物的有效方法

报告人:陆阳 博士

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Patrick Lu, PhD, CEO and Chairman of Sirnaomics Inc., the 2nd President of CBA. Dr. Lu and his team have developed RNAi technology to fight against respiratory tract viruses during the outbreak of SARS, H1N1 and its further development can work towards Coronavirus.

报告2:预防新冠肺炎的疫苗研发和防疫的中长期规划

报告人:巢守柏 博士

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Shoubai Chao, PhD, COO of CanSino Biologics Inc., the 20th President of CBA. Dr. Chao and his team have been working on the recombinant Ebola vaccine that has been approved in China. Now he is focusing on the vaccine for SARS-CoV-2.

点评嘉宾:陆杭 博士

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Dr. Hang Lu is CBA VP of Science Project and the director of BioAssay at Emergent BioSolutions and has been working in vaccine development at Emergent BioSolutions and Merck for ~ 20 years.  He has contributed to the development of several traditional and new generation vaccines from the preclinical to post approval in USA.

请关注下一讲:关于Remdesivir的临床研究  (3月4日8:30 pm of Eastern Time)

CBA抗击新冠病毒系列讲座精彩继续(二)

3月4日美国东部时间晚8:30,CBA第三期线上公益讲座如期举行。此次讲座围绕大家广泛关注的一个新药瑞德西韦(Remdesivir)展开。众所周知,瑞德西韦是吉利德(Gilead)制药研发的一款药物,在前期主要用于埃博拉(Ebola)病毒和中东呼吸综合征(MERS)等疾病的临床研究,在今年的COVID-19疫情中被快速用于临床试验,因此得到了全球医疗及制药相关领域的关注。此次讲座邀请了三位嘉宾,分别是周叶斌博士,Angela Zeng博士和张丹博士。

周叶斌博士现为供职于AbbVie的免疫学专家,也在业余时间利用个人微信公众号平台从事生物医药的科普工作。周博士首先深入浅出地介绍了药物研发的一般过程,然后介绍了几款被认为可能可以治疗新冠病毒的药物,比如克力芝(Kaletra)、氯喹、瑞德西韦和PD-1,并分析了每个药物的优劣以及可能存在的问题。周博士也和参与的听众分享了他自己微信科普平台的信息,会后也会继续与感兴趣的同道深入讨论。

紧接着,复旦大学医学、理学博士,前约翰霍普金斯医学院肿瘤学教职员,现任亚盛医药临床研究医生的曾琪博士详细解析了目前全球范围内已开展或即将启动的瑞德西韦的临床研究。曾博士在简要回顾SARS-CoV-2基础结构的基础上,首先分析了瑞德西韦可能的作用机制;然后她进一步分析目前中国开展的两个三期随机对照临床试验(Phase-3)的录入和排除标准,试验的设计特点及试验终点的评估。在报告中,她分别谈到了轻中度与重度患者在用药后试验效果的的评判标准;最后她提出了对瑞德西韦临床试验中的一些可以改善的方面,比如从伦理学角度是否可以直接采用单臂设计?是否可以在试验中期进行分组交叉以及所涉及的中期数据分析、中期揭盲等问题,指出即将启动的适应性设计(Adaptive design)可以针对性地解决相关疑虑。曾琪博士还简略介绍了现行开展的COVID-19临床试验的适应证及涉及面,同时提出了自己对现状的思考供听众们讨论。

最后, CBA 第八任会长, 方恩医药发展有限公司董事长兼首席执行官张丹博士以瑞德西韦为例,为大家讲述药物注册法律法规方面的知识。作为一个跨中、港、台、韩国、日本、英国、美国等多领域的临床CRO的首席执行官,在2007年创建方恩医药之前,张丹博士还曾任世界最大CRO公司昆泰的副总经理等职,在新药研发的申报方面具有多年的丰富经验。张总结合自身的实践经验,精辟、简洁地为大家分析了瑞德西韦开展的5个临床研究的精准设计,同时呼吁国内的临床试验尽快募集病员,推进试验。从注册战略角度,张丹博士为大家分析了如何设计临床试验更加合理,指出在此次疫情爆发的情况下,可以利用政策方面的优势,比如“同情心使用原则”和“紧急使用授权原则”,尽快推动临床试验的开展并收集数据进行分析。他也同时提到“动物法则”在缺乏临床试验资料的紧急情况下的使用,为在线的听众们提供了非常实用的思考与建议。

讲座后,大家踊跃提问,气氛热烈。此次讲座,让公众对广泛关注的药物瑞德西韦从研发过程、临床试验和注册法规方面都有了更多认识。

3月11日第4期讲座录音

3月11日美国东部时间晚9点,美国华人生物医药科技协会(CBA)抗击新型冠状病毒知识系列线上讲座第四讲在听众们的一片期待中如期准时开始。这次讲座在CBA前会长李利博士的主持下,第一位演讲嘉宾是中国生物工程学会精准医学专委会联席主任杨宏钧博士,他也是CBA的老战士,多年来一直活跃于中美两国的生物医药事业的舞台上,对中美两国生物医药领域的创新创业、商务发展、交流合作及人才培养等诸多领域做出杰出贡献。杨博士的演讲以“A Comparison of Detection Methods of SARS-CoV-2 ”为题,详细比较了现行可用的几种检测方法在COVID-19疫情爆发中的应用。他首先带领听众简略回顾了SARS-CoV-2的基因结构及形态学特征,强调spike 蛋白的重要性,然后简略介绍了qRT-PCR、宏基因组新一代测序(mNGS)、胸部 CT、抗体免疫检测、CRISPR‘s Sherlock 系统及ddPCR共六种检测方法。接下来,杨博士为在线听众们一一解析了6种方法的优缺点,如RT-PCR的敏感度受探针和引物的设计,病人发病的时期,鼻、咽拭子采样、分离、标本的储存及运送过程,试剂的活性,操作人员的培训和熟练程度,实验室的整个管理等诸因素的影响都有很大的关系。他以一个1049例患者进行RT-PCR及胸部CT的比较,阐述了RT-PCR的假阴性问题,提出应将RT-PCR与CT相结合从而降低漏检率。在分析抗体免疫检测时,杨博士分析了不同抗体IgM及IgG产生的时间先后,结合自身经验总结胶体金试纸条的测试快捷、简单,可以在15分钟就得到结果,而且还不需要专职人员操作,适合大范围患者群体的初筛。而宏基因组新一代测序 (mNGS),在精准测序的基础上,与大数据相结合,把所有环境微生物中的相关基因组信息整合在一起,从而尽快找出疾病的起源,但是这一先进的技术过程较复杂,耗时相对较长,所以仅适用于高度疑似病例的确诊。在介绍CRISPR’s SHERLOCK 系统时,杨博士详细介绍了CRISPR是近年基因编辑技术发展的新亮点,而SHERLOCK系统是哈佛大学张锋院士应用CRISPR检测病毒的最新方法。该方法曾在检测寨卡病毒时取得空前的成功。这次,张锋院士又把该方法应用于新冠病毒的检测。针对RNA及dsDNA病原的不同特征,杨博士借助形象的示意图,简明、清晰地介绍了这个检测系统的原理,并且高度评价这个检测方法的高度灵敏性,甚至可以检测到低至10-18M的样本量,同时兼具高度的特异性,尤其是该方法还突破了现有核酸检测指南的规定,以最具新冠病毒特征的Spike蛋白的RNA片段为检测目标。遗憾的是这一创新的检测手段尚未经过临床验证,也未获得FDA批准,我们只能期待不久的将来可以应用于这类应急

这次讲座的第二位嘉宾是北美华人临床化学家协会候任会长王永强博士。王博士曾担任研发经理、CAP认证实验室临床实验室主任等。他以“Viral Sample Management and Biological Safety”为题,分析指出COVID-19临床样本的社区采样很关键,而且采样后应保存于4摄氏度容器,并需要在采样后4小时内送检,否则容易发生RNA降解。王博士也再次强调医护人员应加强自我保护。在讲到临床实验室的检测时,王博士介绍了FDA通过的EUA中的体外诊断(IVD)及CLIA认证的LDT即实验室自行开发的技术;他详细为听众们介绍了CLIA(临床实验室改善修改条例)的法规标准及强化的领域(如实验人员资质要求,质控标准及执行标准等);同时,王博士也详尽介绍了在欧洲应用非常广泛的ISO15189标准,同时这也是在160多个国家共用的国际性的标准;这个系统在保证通用原则不变的情况下,也给各个单独的实验室提供了一定的灵活性。最后,王博士重点强调了CAP(美国病理学家学院)的系统及认证,指出如果同时具备CAP及ISO5189认证,那就表明此实验室已经进入全球顶端1%的范围,由此可见此两种认证的高标准。

在两位主讲者的讲座之后,另外两位嘉宾也加入了讨论。李游博士现任Thrive公司法规部主任,他曾供职于FDA并负责体外诊断、医疗器械等的审核。讨论中,李博士指出紧急使用法规(EUA)比平时的审评需要更少的数据,目前采用的指南,仅需敏感性、临床样本认证,纳入/排除标准等。他也客观分析了现在美国的新冠病毒检测受到一定条件限制,多数实验室仅有二级生物安全级别,但是只有达到生物安全级别三级以上的实验室才能进行检测,而全美仅有100多家满足条件的实验室。CBA的郭雁副会长有着生物技术研究和开发20多年的经验,她作为讨论嘉宾也指出,这次中国的科学家在很短时间内提供了病毒序列,是值得我们感谢的地方。她也补充说CRISPR技术的主要创始人张锋教授证实此技术可以直接检测RNA,不同于平时所用的方法,因此极具发展前景。

一个半小时的讲座,内容丰富、实例详尽。在最后,几位嘉宾也与线上听众互动答疑,充分讨论。听众们的参与热情很高,也非常期待后续讲座的更多精彩内容,在最后的两次讲座中,CBA结合听众的兴趣,特地安排了紧急状态下的药政法规的特殊授权及处理的专题,是广大医药界人士所关心的话题;同时,CBA还专门邀请了四位前会长们,结合他们自身创建的已经上市的医药公司的经验,共同探讨“防疫”与“复工”的双重挑战,周三晚9点,CBA与您继续相约。

CBA抗击新型冠状病毒知识系列讲座-1

CBA抗击新型冠状病毒知识系列讲座-1

CBA抗击新型冠状病毒知识系列讲座-1

新型冠状病毒解读和流行病防控战略演讲

嘉宾:Dr. Zhiming Zheng, NCI/NIH和Dr. Helen Schiltz, NIAID/NIH 

庚子伊始,正值中国传统佳节春节来临之际,一场突如其来的“2019新型冠状病毒”疫情向我们无情袭来,不断蔓延的疫情更是牵动了无数CBA成员和朋友们的心,许多我们熟知CBA的骨干企业及个人,已经直接或间接地投入到了这场没有硝烟的战斗中! 抗疫情,CBA在行动!作为CBA抗疫行动的一部分,CBA Biomarker Study Group 和CBA Clinical and Regulatory Affair Study group 决定联合举办抗击新型冠状病毒知识系列讲座(CBA Anti-Coronavirus Webinar Series)。这个系列讲座将就大家关注的新型冠状病毒的科学知识,流行病防控战略和机制,抗病毒药物制备和临床试验,病毒检测方法和应用,特殊时期FDA的药政法规等一系列问题,邀请本地的专家、学者、政府官员、企业家、工程技术人员来分享他们的真知灼见,并回答大家的问题。这个讲座将对CBA及社会公众开放,听众可用Zoom来加入。

御风雪呼唤抱薪者,抗疫情更需你我他。欢迎大家积极参加,并把您的宝贵意见反馈给我们。让我们携起手来,风雨同舟,共克时艰,将点滴爱心汇成江河,呼唤春风化雨,共盼新的一年春光明媚的到来! 

时间:2月19日 美东时间晚上8:30开始

研讨会形式:线上会议Webinar

Time: Feb 19, 2020 08:30 PM Eastern Time (US and Canada) Beijing time: Feb. 20, 9:30 AM

注意事项: 中国国内参会者经验用PC接入Join Zoom Meeting https://zoom.us/j/470329093

Meeting ID: 470 329 093(Participants from China are encouraged to use PC voice and review shared screen)One tap mobile+16699006833,,470329093# US (San Jose)+19294362866,,470329093# US (New York) Find your local number: https://zoom.us/u/aoTc33reQ  

报告人简介: 郑志明 博士

郑志明研究员现任美国国立卫生研究院国家癌症研究所肿瘤病毒RNA生物学实验室主任、资深研究员,是国际知名肿瘤病毒学专家。 郑志明研究员的主要研究领域包括病毒RNA转录后加工、肿瘤病毒如HPV和卡波氏肉瘤病毒(KSHV)的肿瘤发生学等,先后在国际知名学术期刊,如PNAS、Mol. Cell、PLoS Pathogens等发表论文140余篇。郑志明研究员曾于1987年在中国首次分离肠道病毒71型(EV71)和鉴定了一种新的痘病毒,并证实EV71为手足口病的主要病原体之一。郑志明研究员于1987年获得中国科学技术学会青年科学家奖,90年代发现了乳头瘤病毒RNA剪辑的调节因子,并于2009年获得美国国立卫生研究院创新研究奖,2010年获美国国立卫生研究院最具价值奖,2014年入选美国微生物科学院院士。 

Helen Schiltz 博士

Helen Schiltz的中文姓名是符海青。符博士1983年毕业于华南师范大学生物系,1986年获取中山大学植物生理学硕士学位,1995年获取美国路易斯安娜州立大学生物化学博士,主攻分子生物学及微生物学。在路州大学读书期间,曾经在Dr. Norimoto Murai教授的实验室参与多项植物转基因基因表达和和植株的筛选工作,其中就有烟草蛋白转基因,水稻抗除草剂转基因及大豆蛋白改良等研究。 符博士具有20多年的生物诊断及精准医学技术开发,新药研发,项目管理,产业化等工作经验。符博士现任美国国家健康研究院 (NIH)国家过敏和传染病研究所(NIAID)微生物学和传染病部(DMID)属下的生物防御,生物研究资源和转化研究办公室担任项目主管官员。自2004年以来,她帮助建立了1.4亿美元的集中生物防御试剂资源中心(BEI Resources)。通过BEI计划,符博士主持NIAID在传染病研究中试剂和分析标准化的建立,管理多项疫苗和新药开发项目的临床前免疫检测工作的实施和FDA申到,参与管理美国国家生物防卫重点项目(包括炭疽,天花病,各种细菌病毒)的诊断,疫苗及新药研发。之后,她于2005年成为新成立的药物研发部的主要项目官员,并担任代理部门主管。符博士前后参与和主持了20项生物防御和突发性(爆发性)微生物传染病的抗病毒和抗生素新药研发NIH的国家重点项目,管理超过7亿美元的政府投资科研资金及项目。

Dr. Guoping Zhao has accepted to be a CBA Scientific Advisor

Dr. Guoping Zhao has accepted to be a CBA Scientific Advisor

Dr. Guoping Zhao has accepted to be a CBA Scientific Advisor

Dear CBA members, supporters and friends,

We have a very exciting news to share with you all!

Dr. Guoping Zhao (赵国屏), a member of Chinese Academy of Sciences, has accepted the invitation to join our organization as a CBA Scientific Advisor. Dr. Guoping Zhao is a molecular microbiologist in Shanghai Institute of Plant Physiology and Ecology (SIPPE), Shanghai Institutes for Biological Sciences (SIBS), Chinese Academy of Sciences. Dr. Zhao was Born in Shanghai and received his bachelors in microbiology from Fudan University in 1982 and his doctorate in biochemistry from Purdue University in 1990. He is currently the Executive Director of the China National Human Genome Center at Shanghai, a Director of Shanghai Biochips, a Director of the Chinese Society for Microbiology and Biotechnology, and the Vice Chairman of the Shanghai Society for Microbiology. In 2005 he was elected to the Chinese Academy of Sciences.

Dr. Zhao studies the correlation between microbial metabolic regulation and the structure and function of enzymes as well as the reaction mechanism to develop the microbial and protein biotechnology engineering. Dr. Zhao is a leading scientist in the area of microbial genome and functional genomics research, where among other things he completed the whole genome sequencing and annotation for leptospira interrogans, identified a number of key metabolic pathways and gene functions, which led to new ideas for studying pathogenic mechanisms. Dr. Zhao led the molecular epidemiology of SARS and SARS coronavirus evolution research and built a solid foundation for understanding the animal origins of viruses and the genome variation rules when they are spread from animal to human.

CBA is very honored to have Dr. Zhao join us at the 20th Annual Conference of CBA (2015, China). Dr. Zhao’s thought-provoking lecture attributes tremendously to the success of this 20th anniversary event of CBA.

Since its founding 20 years ago, CBA has been serving as a bridge between US and China in the field of bio-med research with the goal of bringing new pharmaceutical agents to commercial development and healthcare market. Among many US-based professional societies and associations, CBA stands out as one of the most active, vibrant and engaging organizations. Dr. Guoping Zhao’s wealth of scientific knowledge and experience in both US and Chinese scientific communities will be a great asset to CBA’s future growth and our continued involvement in scientific research and biopharmaceutical development in both countries.

Again, we are very honored and excited to have Dr. Guoping Zhao as a valuable addition to the CBA team. We look forward to working with Dr. Zhao to take CBA to a higher level.

Sincerely,

CBA Leadership Team

CBA 2019 Fall Symposium Ended with Great Success

CBA 2019 Fall Symposium Ended with Great Success

CBA 2019 Fall Symposium Ended with Great Success
The long-awaited CBA 2019 Fall Symposium just closed its 1 day event with great success at Johns Hopkins Montgomery County campus on the past Saturday, Nov. 23th, 2019. Hosted by CBA (Chinese Biopharmaceutical Association), this symposium has attracted over 200 attendees to this intensive and very informative event. Speakers invited by CBA came from areas crossing Maryland to Boston, from industry and government representatives, and also patient advocate. Hot topics in biopharmaceutical area were covered and heated discussions were raised between speakers and audience.

This symposium started with the introduction by current CBA president Dr. Chuanhua Julia Xing; she briefly introduced the 24 years history of CBA development and showed different active functional groups as well as very vivid records of their enthusiastic events through the year. Talks in the whole day followed the theme of “The Next Horizon of Precision Medicine, Biomarker Discovery and Biopharma Innovation”, which the Symposium held. The first distinguished speaker is scientist Guangliang Wang, who served as the 1st author and one of the key contributors in 2019 Nobel Prize in Physiology or Medicine. He brought the audience back to the time when he and the Nobel Prize Winner Laureate Dr. Gregg L. Semenza worked very hard to clone HIF-1 (Hypoxia inducible factor-1) and purify the protein. Even it occurred back to over 20 years ago; the vivid description by Dr. Guangliang Wang still provided each audience a very clear picture of their persistence in science. Dr. Wang also talked about how Clinical applications of HIF-1 have robustly developed in recent years in various areas such as anemia resulted from renal disease, cardiac ischemia, pulmonary hypotension and stroke. It was also applied to wound healing and inflammation.

Warren Li, the Director of Oncology Translational Medicine in AstraZeneca gave a talk about “Considerations of Tumor Mutational Burden and other Predicative Biomarkers in Immune-oncology Late Clinical Development” right after the HIF-1 story. He shifted the gear from hypoxia to immuno-oncology field. By addressing how biomarker-driven patient selection remains challenging for immunol checkpoint inhibitors, Dr. Li gave the example of published data of checkmate 227 in NSCLC (Non-Small Cell Lung Cancer), then concluded that TMB (Tumor Mutation Burden) as immuno-oncology predictive biomarkers is a clear proof of concept in NSCLC and some other solid tumor indications, with blood TMB has advantages over tumor TMB but still some potential pending issues. Dr. You Li, the Director of Regulatory Affairs in Thrive Earlier Detection Corp., focused on “Liquid Biopsy in Cancer Diagnostics: Promises and Challenges”, he introduced the concept of “liquid biopsy” and described the current landscape, then rose the question “why cancer liquid biopsy is much more difficult than non-cancer disease”. He shared with audiences the challenges we are facing in the liquid biopsy area and consideration from regulatory authority perspective. Right after this topic, Dr. Zhiyong Xie, the Director of Statistical Learning from Pfizer Inc, who flew to this symposium from Boston, gave a talk on “Deep learning in Digital Biomarker Development”. By reviewing the development of digital biomarker, Dr. Xie highlighted how machine learning will give better diagnosis, quantification and prediction in diseases. With the advanced digital technique applied in medicine, we can foresee more and more goals will be achieved in the near future. The morning section ended by the past president Frank Li by announcing the found of new CBA Clinical and Regulatory Affairs study group (CCRA), he introduced the key members and the work plan for year of 2020.

The afternoon session started with a talk given by the State Senator Susan Lee, which explained the knowledge-based economy strategy of Maryland state, then emphasized on improving commercialization – taking innovation to market. At the end of her talk, she emphasized the policy of Maryland to support bioscience – biotech credit. Aligned with this, Marc Elrich, Montgomery County Executive, further explained the Welcoming and protective place for immigrants in the county, and the natural, geographic and social environment to attract Bio & IT and merge of Bio/IT etc. Lynn Stein Benzion – Director of Business Expansion and Retention and Life Science Lead, showed the detailed local assets in the biomedical field, then shared several success stories of collaborations and technique transfers between government agencies and companies. Local governmental representatives showed very broad interest and warm welcomes to everyone working hard in biopharmaceutical field.

Without a break, Founder and CTO from Pacific Biosciences, Dr. Stephen Turner gave a very passionate talk about how he started his first company. By sharing his own first-hand experiences; Stephen gave the audience a suggestion on how to raise funding for start-ups. Right after his speech, Dr. Wei Cheng, the Investment Director from Beijing Legend Star Investment Management Co, described the story from the other types of funds. As an expert in investment, Wei shared her thoughts about Venture Capital. This whole session provided huge amount of highly needed information for all starters from small biotech companies. The symposium directly went into the third session which first focused on “Differential Biomarker and Treatment strategies for PD-1 pathway blockade-based immunotherapies in China”. This topic was presented by Dr. Sheng Yao, the SVP from Shanghai Junshi /TopAlliance Biosciences. He reviewed the robust development history of this fast growing company and shared their clinical experience and differential strategies for their core product. Dr. Qingsong Zhu, the Chief Operating Officer from Insilico Medicine, talked about “Application of deep learning in biomarker and drug discovery”; then Dr. Wenming Xiao, the Senior Scientific Reviewer from FDA Division of Molecular Genetics and Pathology, gave a speech on “Towards best practice in cancer mutation detection with WGS and WES”. From a regulatory authority standpoint, Dr. Xiao highlighted balance between the profit and the risk, also emphasized a reasonable assurance of safety and effectiveness. The last session was presented by Yiou Wang, a patient advocate of rare disease. Ms. Wang talked about her experience in China about the role of patients and their organizations in rare disease policymaking. She clearly described the short-term goals as “awareness, accessibility, affordability,” and the long-term goals as “institutionalization, innovation, inclusion” for the “The illness challenge foundation”.

This whole day symposium went smoothly and marked as a remarkable success. Chinese biopharmaceutical association, one of the largest Chinese American professional associations in the US (www.cba-usa.org), was founded in 1995. It is an independent, non-political, not-for-profit professional organization, accumulated more than 8000 membership with > 80% having Ph.D degree. The well organized executive team has demonstrated its strong team effort and commitment to the society. Volunteers started preparation for this symposium and worked very hard through months. This Symposium set up the platform for all audience with different background and attracted some of the most influential organizations/companies, thoughtful leaders, scientists, physicians, regulators, investors, and executives from the public and private sectors from both China and the US. With holding this successful event, CBA once again proved its critical role in North America biopharmaceutical area and its high reputation in Asian American community. We believe the whole organization will continue serving the community and bridging the US-China biopharmaceuticals.