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CAR-T: Transforming Blood Cancer Therapy

Register Now 12pm - 3pm, November 22, 2019Location: University City Science Center, Delaware River Room, 3rd floor, Philadelphia CAR-T therapy development has achieved big success over the past years with the regulatory approval by FDA for blood cancer treatment. In this workshop, experts from industry will be assembled to discuss the development and implementation of this therapy. Their topics will cover several key aspects of CAR-T industry chain, from discovery, manufacture to commercialization.   Speaker 1: Allison Montalvo, Executive Director, Head of Project Management and Clinical Supply, Tmunity TherapeuticsTopic: CAR-T CMC management: how to streamline drug development, manufacturing and logistics (Tentative)Speaker 2: Fang Chen, Senior Research Investigator, Center for Cellular Immunotherapies (CCI), University of PennsylvaniaTopic: Engineered T Cell Therapies From a Drug Development ViewpointSpeaker 3: Teng Peng, Application Support Manager, ACROBiosystemsTopic: The [...]

2019 Advanced Course on Pharmaceutical R & D

Register Now Download Brochure SAPA-GP, partnering with Drexel, is offering our 3rd annual training course on the pharmaceutical R&D value stream. Delivered by industry executives and veterans, this one day course offers a birdview of key insights and steps of bringing an innovative drug from concept to commercialization. Participants from academic researchers, industry players, business investors, and service providers are welcome. Please visit us at https://sapa-gp.org and contact Yixuan Qiu ([email protected]) for additional information (this event includes breakfast, lunch, coffee breaks, and parking in Drexel).

US-China Biopharma Congress 2019 & SAPA-GP 17th Annual Conference

Innovate and Collaborate - Thriving in the Changing Dynamics of Global Life Sciences Register Now Download Program Date: Friday, May 31, 2019 8:30 am-5:00 pm EDT Location: Sheraton Valley Forge Hotel 480 North Gulph Road, King of Prussia, PA 19406 Sponsors [Early bird registration ends Apr 21th]The clock is ticking! Register now to save! As the flagship event of SAPA-GP, our annual conference is expected to attract >1000 attendees, including seasoned and young professionals from coast to coast, several municipal government delegation teams from China, over 20 CEOs or executives from most of the big pharma companies in China, and high-level executives from major pharma companies such as GSK, JNJ, Merck, BMS, and Teva etc. Agenda 5 Parallel Tracks: Science, Technology, Business, [...]

Immuno-Oncology 2.0, Philadelphia Pharmaceutical Symposium 2018

December 8th, 2018 Crowne Plaza, King of Prussia, PA [/fusion_separator] Register Now [/fusion_separator] December 8th, 2018 Crowne Plaza, 260 Mall Blvd Vichit, King of Prussia.   Continuing last year's theme, the 2018 Philadelphia Pharmaceutical Symposium is titled "Immuno-Oncology 2.0" and will focus on breakthrough in Immuno-Oncology therapy and emerging new platforms. Join the vibrant Immuno-Oncology R&D community and exchange ideas with experts from academia and industry. Register Now! Early-Bird Registration will end on Nov 9th.   Featured Speakers: Carl June, MD. Perelman School of Medicine, University of Pennsylvania Katrin Rupalla, PhD, MBA. Head of Oncology Development Global Regulatory Science, BMS Scot Ebbinghaus, MD. Vice President and Therapeutic Area Head, Oncology Clinical Research, Merck & Co. Michael Kalos, PhD. Vice President of Immuno-Oncology, Janssen R&D [...]

US-China Biopharma Congress 2018 & SAPA-GP 16th Annual Conference

Read More Register Now Reshaping Global Biopharma Ecosystem June 8, 2018 Sharaton Vally Forge Hotel 480 North Gulph Road King of Prussia, PA 19406 Agenda Making Greater Philadelphia a Vibrant Hub for Life Science Startup Ventures Money Meets Ideas: Liberty Bell Venture Forum Neuroscience Touchdowns: Scientific Advances to Tackle Neurological Diseases Drug Discovery Across US and China CEO Forum Job Fair & Career Development: Reinvent Yourself International Business Establishment and Operation in USA Leveraging Real World Evidence to Transform Drug Development Regulatory, Clinical & Safety Considerations for the Approval of Cell and Gene Therapy Products AI-Powered Drug Discovery Biologics CMC: Delivering the Excellence of Biophamaceutical Medicines to Patients Our guests include: High-level executives from multi-national pharmaceutical companies and top Chinese pharmaceutical companies Officials from [...]

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!