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大费城美中医药协会成功举办首届培训药物研发班

2017年10月21-22日,大费城美中医药协会(SAPA-GP)于Benjamin's Desk成功举办了首届药物研发全方位精品培训班。本次培训班是SAPA-GP本着服务社区、培养人才的宗旨,而进行的一次开拓性大胆尝试,受到了学员的一致好评:多位业界知名专家;三十余人小班教学;精心安排的授课内容涵盖了专利保护、临床前研究、临床试验、制剂学、生产工艺、数据管理报告、法规事务,以及市场运作与商业价值估值等方方面面;力求帮助学员建立制药全局观的同时,深化其对关注领域的进一步理解。   在课程主管李玉锋博士的简短介绍后,来自Duane Morris LLP律师事务所的Jason Luo博士向学员们讲解了知识产权的相关策略。Jason Luo博士着重讲解了Abbreviated New Drug Application(新药报审简表)如何平衡品牌药和非专利药来提供更多的价格合理的处方药。 NeoVita Biopharm Cobbs Creek Healthcare 创始人及CEO皇甫钧博士用简单易懂的简笔画展现了病人拿到处方药的过程,以及及药厂和保险公司在其中扮演的角色。葛兰素史克(GSK)学科带头人吴振华博士通过互动案例分析来让学员们现场评估两个药物靶点,将药物靶点的选择评估过程生动灵活地展示出来。学员们不但学到了药企中的一些基本工作流程,并且认识到每一个决定都需要考虑多方面因素并做到平衡。   课程主管李玉锋博士介绍课程内容及美中医药协会   Jason Luo博士向学员们讲解知识产权的相关策略   皇甫钧博士详解药品市场,销售以及商品评估     吴振华博士讲解药物靶点的选择评估   随后,GSK副总裁严立博士带领大家进入对临床试验的讨论。Fountain Medical Development (FMD ,方恩医药)CEO张丹博士分享了他规划临床试验的宝贵经验。张丹博士强调了“逆向思维”在保证CDP设计的高效性中 起到的关键作用,以实例阐述了CDP 中的Plan A和PlanB,讲述了Safty Handling在当前医药发展新形式下日益重要的地位,比较了中美政策下的CDP,并讲解了好的CDP Team的构成及要点。Hengrui Therapeutics CMO Sean Zhang首先概要介绍了临床实验的Phase 0 到Phase 4,然后进一步介绍了All-in-One Study的概念、适用范围和优劣比较。Timeline的概念也始终贯穿在张博士的演讲中,包括可能加速Drug Development Process的步骤以及各国/地区在审批时间上的差异及影响。方恩医药生物统计和数据管理总裁刘铁浦博士详细阐述了数据分析、管理和申报的相关内容。 Spark法规事务带头人 Jim Wang博士介绍比较了欧洲和美国在药物申报、审查、审批过程中的异同。   严立博士讲解临床试验   张丹博士分享规划临床试验的经验   张向阳博士介绍早期临床试验阶段   刘铁浦博士讲解数据分析、管理和申报相关内容   Jim Wang博士介绍比较了欧洲和美国在药物申报、审查、审批过程中的异同   学员与主讲人针对课题进行热烈讨论   课程进入第二天。GSK资深科学家Haifeng Cui博士向学员们介绍了临床前的药物研发全过程,并且通过筛选药物的实例与学员们讨论了对导化合物的优化过程。崔海峰博士围绕着drug discovery cycle,逐一向学员们展示了临床前药物研发的每一步的核心过程。崔博士就研发的第一步即找到可能的有效分子,崔博士介绍了五种发现策略(“me-too”,利用已有靶点, 高通量筛选,基于分子片段的药物研发FBDD,通过临床观察发现药物)及其优劣势。在发现可能有效的分子结构后,要基于其药理学作用和药物代谢动力学性质的考量和安全性的分析,对其进行优化。   Advaxis公司药事法规部门的执行董事杜新博士介绍了药物活性成分的工业生产及分析方法。杜博士在演讲中强调了GMP(Good manufacturing practices)的各大主要考量点和严守sop(standard operating procedure)对产品安全和质量控制的重要性,并结合其在FDA和公司的两方面多年工作经历,分享了在药事法规方面的经验。杜博士借着分析近期通过FDA认证的生物药Dupixent(dupilumanb)和小分子药物Alecensa(alectinib hydrochloride)的生产实例,让学员们对两种类型药物的工业生产有了更实际的概念和直观的认识。杜博士的讲解,让学员们对药物生产的理解不仅仅停留在实验室和理论阶段,更是从实际生产的角度了解了真实的研发过程。   Haifeng Cui博士向学员们介绍临床前的药物研发全过程   杜新博士介绍药物活性成分的工业生产及分析方法   接着,默沙东(Merck) 制剂专家Jingtao Zhang博士向大家介绍了药物剂型设计的基本原理以及剂型选择的决定因素,给药途径开发过程中需要考虑的五个关键因素。张博士通过几个多肽制剂、长效制剂、基于核酸的制剂、纳米制剂等实例向大家展示剂型设计理念在实践中的应用。 最后,来自辉瑞(Pfizer)的资深医务主管Xianchen Liu教授向学员们讲解了比较效果研究这一新兴领域的喜人进展。Liu博士从分析大家所熟识的RCT(randamized control trial)的缺点出发,讲授了Efficacy和Effectiveness的不同和研究量化后者的必要性和重要性,并进一步引入了 HTA(Health Technology Assessment),CER,Real World Data(RWD)和RWE的概念定义、目的作用、发展历史、研究方法、以及其与大数据的有机结合。   Jingtao Zhang博士向大家介绍了药物剂型设计的基本原理   Xianchen Liu教授向学员们讲解了比较效果研究这一新兴领域的喜人进展   为期两天的课程在课程主管苏永超博士的总结致辞中拉下帷幕。主办方SAPA-GP特此感谢Wistar Institute、Benjamin’s desk、Pennsylvania Drug Discovery Institute、ACROBiosystems、科伦药业及药明康德对本次活动的大力支持。   讲员及学员反馈: 杜新博士: 我和几个同学有简短的交流。能从两天的时间,对drug development 有一个比较全面的了解,是件很好的事,对他们也很有帮助。以后多开拓生源,让更多的人受益!   学员黎献桦: 对今天的课程印象深刻!以下是我认为尤其独到的地方。吴振华会长用case study带大家量化分析target validation,展示了R&D Lead的决策方式。方恩医药CEO张丹博士讲到了reverse strategy,从临床phase 3出发考虑如何设计phase 2然后phase 1;Creative thinking in CDP,如何在起始落后的情况下反超对手;Prepare Plan B,如何应对clinical trial中的突发状况。Jim Wang的演讲详细梳理了新药申请中多次与FDA交流的各个重点,对比了FDA和EMA的不同要求,是真正全球视角对Regulatory Affair的剖析——很犀利!Speaker们对于市场实例信手拈来,这是专注industry几十年的专家才有的技能!后辈们收获颇丰。感谢SAPA-GP费心组织这么精彩的活动!            

Advanced Courses on Pharmaceutical R&D

Advanced Course on Pharmaceutical R&D Organized by SAPA-GP, Wistar Institute, Benjamin’s Desk & University Science Center Component of “Philadelphia Pharmaceutical Symposium”   When:  Oct 21-22, 2017 Where: Benjamin’s Desk, 30 North 41st Street, Philadelphia, PA 19104 Register Now Download Brochure TimeSpeakerTopicSaturday, Oct 21, Day 18:00-8:45Parking, Registration and Morning Coffee8:45-8:55Yufeng Li,Clinical Development Manager, GSKOpening Remarks8:55-9:00Zhenhua Wu,President, SAPA-GPIntroduction of SAPA-GP9:00-9:45Jason Luo,Partner, Duane Morris LLPIntellectual Property, Patents and Licensing9:45-11:15Wei Huang,Chief Methodologist,Cobbs Creek HealthcareSales and Marketing, Potential projection, Commercial Valuation11:15-12:15Zhenhua Wu, Director, GSKPre-Clinical Drug DiscoveryTarget ID/validationIn vitro/in vivo Pharmacology Noon-1:30Lunch1:30-3:30Li Yan, VP, Head Unit Physician, GSK; Dan Zhang, Chairman and CEO, Fountain Medical Development Ltd; Tiepu Liu,President of Global Biometrics, FMD K&L;Sean Zhang, CMO, Hengrui TherapeuticsClinical InvestigationsDevelopment strategy, Setup, Conduct, Monitoring, Data management and Reporting3:45-4:45Jim Wang,   [...]

2017 Pharmaceutical Career Development Workshop

Jump-start Your Career! -- Amazing Careers in Biopharma Sun, Oct 1, 2017 HSC 401, Hammer Health Science Center, Columbia University Medical Center 701 West 168th Street, New York, NY, 10032 Co-organized by: Career China Club   |   CUMC-CSSA   |   Sino-American Pharmaceutical Professionals Association -- Greater Philadelphia (SAPA-GP)   Sponsored by: ACRO Biosystems Topics include:   What are the career opportunities beyond the R&D in pharmaceutical industry? Long-term Career Planning Starting Your First Job in US:  Culture, Communication, and Networking skills You Need! Work VISAs and Immigration:  Overcoming Current Challenges   Speakers/Panelists: Valentine A. Brown, JD, Partner, Duane Morris LLP David Cragin, PhD, Associate Director, Chemical Notification and Registration, Merck & Co. Patrick Gerogia, Associate Consultant, QuitilesIMS Fang Shen, PhD, Drug Discovery Program Lead, Janssen Xiaoli Wang, [...]

生命之谷 创新之源 南京江北新区生物医药谷费城推介会成功召开

撰文: 程婷 司梦婕   大费城美中药协 (SAPA-GP)于8月21日晚在Radisson Hotel(King of Prussia)和南京江北新区代表团举办了推荐会和晚餐交流活动。 推介会吸引了近40位来自强生(Johnson & Johnson)、 默沙东 (Merck & Co)、 葛兰素史克 (GSK)、 提瓦 (Teva)、 药明康德、 Frontage 和 Alliance Pharma 等知名医药企业的专业人士。             南京江北新区管委会陈潺嵋副主任首先致辞。 她向大家介绍了南京这个历史悠久又生机勃勃的城市并重点介绍了南京江北新区的发展规划。 其中, 在生物医药领域以南京生物医药谷为依托, 重点集聚生物制药, 医疗器械等领域的企业, 加快建造千亿级先进生物医药产业集群。 现如今, 生物医药谷已经聚集310家生物医药企业, 重点发展生物医药领域的药物研发及产业化、 医疗器械、 医疗诊断、 医疗及健康服务、 医药研发外包及技术服务(CRO)和生物技术等产业方向。                   随后, 大费城美中药协副主席沈放致辞, 精辟地总结了大费城美中药协(SAPA-GP)的三大优势: 最专业、 最活跃、 最创新。 大费城美中药协为社会各界提供了一个最全面最专业的发展交流平台, 欢迎大家前来合作洽谈。             南京生物医药谷发展部杨涛部长详细介绍了园区的投资发展环境。 作为功能全面的专业园区, 南京生物医药谷围绕生物医药产业链上的研发、 中试、 生产、 流通等环节, 针对研发创新型生物医药企业不同发展阶段需求, 提供功能各异的产业空间, 提供包括政务、 人才培训、 融资、 法律、 知识产权保护、 信息检索等全方位一站式平台服务。             在自由问答环节里, 南京江北新区代表团有针对性地回答了在座的来自医药和生物科技专业人士提出的问题。 南京生物医药谷交通便捷, 创业资金政策优惠, 欢迎海外的科技顶尖专家, 创新型企业家, 创新人才入驻园区, 旨在打造具有国际影响力和独特优势的产业科技人才高地。      

Representatives from the Department of Commerce of Hubei Province Visited SAPA-GP at Philadelphia and New York City

Representatives from the Department of Commerce of Hubei Province Visited SAPA-GP at Philadelphia on August 17th and at New York City on August 18th. Introductory meeting with SAPA-GP team and SAPA-GP partners (August 17th, Blue Bell, PA)   Welcome speech by Cynthia DiBartolo, Chairperson of Greater NY Chamber of Commerce, Business leader in the White House Business Council and Executive Task Force for Wall Street Journal   Remark by Dr. Jijun Xing, the Science and Technology Counselor from the consulate General of P.R.China in New York (August 18th, Columbia University Medical Center)   Keynote speech by Mr. Qingsong Yang, Deputy Director, the Department of Commerce of Hubei Province   The signing Ceremony between SAPA-GP and the Department of Commerce of Hubei Province   Representatives from the Department of Commerce [...]

2017 SAPA-GP Summer Picnic

Register Now   When: Sat, May 27, 2017. 11:00 AM – 5:30 PM EDT Where: 170 Chapman Road, Pavilion 3, Doylestown, PA 18901 Activities: Volleyball, Tug of war, Dodge ball, Corn hole, Music chair, Three leg race, Soccer, Walk or bike trail around lake; Vote for your favorite homemade dish (1st and 2nd place win gift card ); 50/50 raffle ticket to win cash.   You are all invited to the annual SAPA-GP Summer Picnic to kick off the summer. All SAPA-GP members and their families are welcome to join us for free to enjoy the summer fun,activities for the whole family including volleyball, soccer, tug of war, three leg race, corn hole,and much more. We will be serving various Chinese food, BBQ and soft [...]

SAPA-GP 2017 Mentorship Program Started

一元复始,万象更新。伴随着时钟嘀嗒的脚步声,崭新的一年即将到来。于此同时, SAPA-GP 2017 Mentorship Program项目也正式启动。这个项目是SAPA-GP为我们的会员精心打造的一个长期职业发展项目,所有入选学员将与一位按照学员的自身要求而量身打造的资深导师配对,进行一对一的教导,为期一年。 期间我们Mentorship Program的负责人将定期追踪,确保学员和导师的教与学的质量。 感谢广大会员们和志愿者们, 对SAPA-GP 2017 Mentorship Program的高度关注与积极参与! 在短短的为期15天的报名时间里,申请人数不断爆表,火爆异常。可以说, SAPA-GP 2017 Mentorship Program在帮助学员成长的同时, 也收获了满满的热情与关注。我们相信,在不久的未来,将会有更多的自信而暂新的新星出现在生物制药的领域里, 熠熠生辉。 鉴于报名参与此次SAPA-GP 2017 Mentorship Program的超高人气, 我们特地将入选学员名额从原定的6名扩增至9名。他们分别是: Nan Lin, Xue Liang, Fei Shen, Mengjie Si, Dan Tian, Lin Wang, Shuang Wu, Chenchao Gao, Jingyi Zhang。详情如下表: 学员 导师 姓名 学校或公司 姓名 公司 职称 Nan Lin University of Pennsylvania Yingke He GSK Portfolio Director Xue Liang MRL Cambridge ESC Sean Fu Luye Boston President Fei Shen Drexel University Fang Shen J&J Principal Scientist Mengjie Si Temple University Feng Li Merck Principal Scientist Dan Tian University of the Sciences Rena Zhang Merck Director, DMPK Lin Wang ANP Technologies, Inc. Zak Huang CSL Behring Head of Global Regulatory Affairs Shuang Wu Columbia University Jian Chen UPenn Director of Bioinformatics, Gene Therapy [...]

2016 Philadelphia Scientific Symposium on Infectious Disease

Philadelphia Pharmaceutical Symposium 2016 was successfully held Dan He, Di Wu, Qiangnan Zhang, Mengchu Li, Xin Liu, Xiaojiao Xue, Mengjie Si Photography: Jianting Shi, Aimin Tang, Songmao Zheng Philadelphia Pharmaceutical Symposium 2016 was successfully held at Radnor Valley Country Club on December 3rd. This year’s topic is “Battles Against Old Foes: New Frontiers In Fighting Infectious Diseases”. Over 200 attendees working in this field were attracted to this interesting event. Dr. Zhenhua Wu, President-Elect of SAPA-GP, opened the 2016 Philadelphia Pharmaceutical Symposium on Infectious Disease with welcome remarks. He first introduced SAPA and talked about three main missions of SAPA-GP. Meanwhile, he introduced the SAPA-GP core activities of scientific meetings and displayed the past conferences and big events hold by SAPA-GP. At last, President Wu [...]

SAPA-GP 2016 Career Development Workshop

SAPA-GP 2016 Career Development Workshop Was Successfully Held By: Liwen Wu, Jing Liu, Yunshu Fan, Jiao Zhang, Qiangnan Zhang, Linlin Zhao, Xiaoyan Wang, Mengjie Si, Xue Liang Photo By: Peipei Huangyang, Jingyi Zhang, Jennifer Yuan, Jianting Shi The SAPA-GP 2016 Career Development Workshop for Biomedical Students was held at University of Pennsylvania, Philadelphia, on Saturday, September 24th, 2016. Focused on “Planning Career Development – Your Future Begins Now”, the workshop attracted over 180 attendees from Pennsylvania, Delaware, New York, New Jersey and other states, providing comprehensive information on landing the first job and future career development.   Dr. Zhenhua Wu, President-in-elect of SAPA-GP, opened the 2016 Student Career Development Workshop with a welcome speech. He briefly introduced SAPA-GP and emphasized that the career development workshop [...]

SAPA-GP 2016 Annual Conference

SAPA-GP Successfully Held 2016 Annual Conference By: Xue Liang, Jianting Shi, Mengjie Si, Zhen Lu, Ziran Zhao, Rong Fan, Dan Tian Photo by: Hao Wu, Jingyi Zhang, Ellen Shi, Xue Liang   On June 17th and 18th, Sino-American Pharmaceutical Professionals Association - Greater Philadelphia (SAPA-GP) successfully hosted the 14th Annual Conference at the Conference Center of Sheraton Valley Forge Hotel, at King of Prussia. Focusing on “Global Partnership: Delivering Biopharma Innovations To Patients”, this conference attracted warm response and wide participation – over 500 students and pharmaceutical professionals from Pennsylvania, Delaware, New York, New Jersey and other states. Experts and leaders from Chinese and US biomedical and pharmaceutical industry discussed strategies to bring innovative drugs to patients, and addressed the urgent needs in biopharmaceutical industry. [...]