BeiGene Pharmaceuticals (Guangzhou) Co. Ltd.

——志合者，不以山海为远会议主题 | 百舸争流·志在全球会议时间 | 2023年3月24-25日（周五、周六）会议地点 | 上海·万豪虹桥大酒店会议规模 | 400人主办单位 | 上海市生物医药行业协会、珐成浩鑫、中电二公司、佰傲谷BioValley协办单位 | Rockwell Automation、新加坡经济发展局（EDB)支持单位 | “科创中国”生物医药产业科技服务团、美国华人生物医药科技协会（CBA)扫码报名▽日程安排论坛一密钥在手，出海展虹霓2023/3/24  下午驭海出征，从知规明策到合规▼随着中国医药研发实力的不断增强，诸多中国企业积极布局创新药国际化。FDA新政对中国创新药企的影响一直是近几年的热门话题。国内医药行业经过近十年的积淀，已开始在全球崭露头角。随着国内差异化创新能力稳步提升，本土药企开始按照FDA的规则开展MRCT（Multi-Regional Clinical Trial，国际多中心临床试验 ），从“License-in”向“License-out”转型，或独立上市拥抱全球市场。产品国际化也成为药企寻求“第二发展曲线”的核心关注点。但正如大航海时代的冒险家一样，出海从来都不是一帆风顺，尤其是作为特殊的强监管行业，不同国家之间迥异的法律体系、监管部门、监管要求，快速变化的监管细则都会令初次走出国门的中国企业面临严峻考验。日程13:30-14:10药品海外成功申报的关键因素与案例分享孙立英  三泰技术  首席科学家、创始人14:10-14:50生物药BLA注册法规解读及申报策略 (拟）高杨  邦耀生物  高级合伙人、首席战略官14:50-15:30创新药美澳临床申报的策略及案例分享陈兆荣  祐和医药  首席执行官兼首席医学官/百奥赛图  副总裁15:30-16:00茶歇16:00-16:40东南亚生物医药监管概览及中国药企出海策略顾蕊  艾社康  国际合作总监16:40-17:20FDA申报的准备与注册经验分享 (拟)温弘  上海生物医药基金  合伙人嘉宾介绍*排名不分先后，出场先后为序▼孙立英三泰技术  首席科学家、创始人‍• 孙立英博士，是前：美国FDA，评审专家/资深流行病学家；美国国立卫生研究院(NIH/NCI),项目主任/统计学家；美国杜克大学(Duke)，前列腺信息中心，主任/教授；美国军医大学(USUHS)，创始分子生物学实验室,主任/教授；心血管外科医生。国务院《政府特殊津贴获得者》；获中国国家科学进步一等奖和二等奖，军队科学进步一等奖和二等奖；美国食品药品管理局长《2016-杰出团队贡献奖》等。• 研究领域：医学-药物-医疗器械领域的国际标准、大数据、人工智能；中外药品和医疗器械的临床实验设计、数理统计和注册；开发了药品在中-美-欧-加-澳申报的eCTD系统和个体肿瘤优化诊治的决策支持系统等。高 杨邦耀生物  高级合伙人、首席战略官‍高杨博士，曾是中国国家药品监督管理局药品审评中心的高级审评官，8年时间内审评过千份申报项目并执行过几十次现场检查，涵盖跨适应症领域的新药临床申请、新药上市申请、仿制药申请、上市后补充申请等技术审评工作，对监管科学和CDE、FDA、EMA及ICH的技术指南有着全面深刻的理解。在制药行业拥有近20年的管理和开发经验，尤其在药物开发策略、申报策略、质量体系建设和商业化战略方面有着全面、丰富的经验。曾任礼来公司的法规CMC和医疗器械负责人；苏州亚盛制药的法规事务总监；PAREXEL的首席药物研发和法规顾问。陈兆荣祐和医药  首席执行官兼首席医学官/百奥赛图  副总裁陈兆荣博士，深耕医药研发行业三十余载，在新药临床研发、新药审评、医药注册，医学事务和药物安全等领域有着丰厚经验。在加入祐和前曾在Citrine Medicine, JHL等几家Biotech公司担任CMO。在GSK曾担任副总裁兼卓越注册中心负责人、中国/香港区医学总监。在此之前，他历任Bayer-Schering Pharma、Sanofi高管职位。陈兆荣博士毕业于山东医科大学医疗系，并在澳大利亚阿德莱德皇家医院获得临床药理学博士学位。他曾获阿德雷得皇家医院Florey研究基金及NH&MRC研究基金。也曾在澳大利亚药品管理局（TGA）从事药物审评与审批工作。顾 蕊艾社康  国际合作总监‍顾蕊女士，负责艾社康的国际合作业务，致力于推动亚太国家在药品监管方面的合作，并支持中国创新药企业在东盟和其他国家的拓展。她是艾社康与新加坡经济发展局（EDB）合作项目的负责人，为有志于迈向东盟以及更广阔的国际市场的中国本土药企搭建信息渠道和知识平台。此外，顾蕊在管理咨询和企业可持续发展方面拥有丰富的经验，专注于战略制定、业务发展和团队建设。温 弘上海生物医药基金  合伙人温弘博士，拥有近30年药物研发尤其转化医学的丰富经验。曾任美国FDA资深科研和审评官员5年，负责法规制定，复杂药物综合审评，药物上市后调查等。加入FDA前，在美国医药工业 (诺华和惠氏) 工作11年，参与32个药物（临床阶段）的研发和申报，其中9个新药获批上市。曾任诺华临床阶段项目负责人及科学技术（产业化）委员会核心成员，并获得最高科学奖“Novartis Leading Scientist”。加入上海生物医药基金前，曾任丽珠医药集团首席科学家(CSO)，全面负责集团研发包括指导生物药布局。现任上中国药促会国际创新药物监管专委会委员，中国临床肿瘤学会转化医学专委会常务委员。美国普度大学药学博士学位。2023/3/25  上午自主造船，摆脱掣肘拓疆扩土▼近年来，随着国家“一带一路”建设的提出，中国药企也开始在海外投资建厂，其中有为了规避国际贸易壁垒、降低用工成本和物流成本的原因，同时还有药企积极利用“一带一路”契机，加大对海外市场的开拓的目的。这也成为中国自主创新药品牌“亮剑”世界舞台的重要里程碑。海外建厂是中国药企发展的一个方向，将为我国药企走出去带来很好的契机，推动中国创新药实现海外生产、海外销售的布局。但海外建厂并不是一件容易的事，中国药企去海外建厂，需要拥有足够的企业实力，不只是资本方面，更多的是现代企业管理能力，以及对当地文化和法律的适应能力；需要充分评估海外建厂的风险；更需要有适合和鼓励产业发展的产业园区和配套资源。日程9:00-9:30海外建厂的项目规划 Overseas Biologics Facility PM李树德  华润医药  首席制造官9:30-10:00生物制药工艺与工程的结合探讨黄煜  珐成浩鑫  副总经理10:00-10:30茶歇10:30-11:00Automation and Digitization in Biopharmaceutical Manufacturing黄玮  复宏汉霖  首席运营官、高级副总裁11:00-11:30工程项目全生命周期管理概述王世忠  康希诺 工程服务中心副总裁11:30-12:00国际工程公司生物制药设施的设计策略丁之洁  Wood China  副总裁嘉宾介绍*排名不分先后，出场先后为序▼李树德华润医药  首席制造官‍李树德先生，曾任深圳乐土生物副总裁、杭州天境生物副总裁、广州百济神州首席工程官、武汉喜康生物厂长、成都迪瑞药业副总经理，负责上述生物制药公司新厂的建设；上海百迈博制药公司副总经理，领导在上海建立全新的单克隆抗体药物GMP生产工厂；梅里亚公司（Merial）中国区的疫苗生产项目总监。李树德之前也曾在BI勃林格殷格翰、Roche罗氏，以及GSK葛兰素史克等跨国药企，担任相关的职务。他在生物制药新厂的建设与运营经验涵盖了不锈钢系统，以及模块化/一次性系统。黄 煜珐成浩鑫  副总经理‍黄煜先生，现任珐成制药系统工程（上海）有限公司副总经理，同时担任国家标准《洁净室及受控环境中细胞培养操作技术规范》的起草人，是国内知名生物制药领域装备设计专家。其从事生物制药及发酵工艺行业逾二十年，历任过生物制药企业和设备制造企业一线管理人员、工艺工程师、项目经理、工程部经理等。从生产、技术、质量、验证等多角度全方位理解生物制药配液工艺和工程流程，具备很强的实操经验，工艺设计能力和项目管理能力。其先后承担过重组人胰岛素、人用狂犬疫苗、抗体类药物等多个生物制药领域的代表性项目。黄 玮复宏汉霖  首席运营官、高级副总裁‍黄玮女士，在制药和生物技术行业拥有超过25年的高级管理和领导经验，包括工艺开发、技术转让、制造、工艺和设施设计、资本项目执行和质量体系实施。加入本集团前，曾于Center of Marine Biotechnology、Baxter(AMVAX)Inc.、New Brunswick Scientific Inc.、Fluor Corp.、Bechtel Corp.、Fluor Corp.、REG Life Science Inc.、Newa Technology Inc.任工艺工程总监、工艺开发与工程副总裁、首席工艺工程师等职务。黄女士于1990年7月获中国华东化工学院生物化学工程专业学士学位，于1993年8月获美国马里兰大学化学与生化工程专业硕士学位。王世忠康希诺 工程服务中心副总裁‍王世忠先生，现就职于疫苗研发和制造企业，负责工程建设项目，工厂设备设施运维和EHS等相关管理工作；曾就职于钢铁冶炼、芯片制造、汽车配件加工、磁粉冶炼加工、固体口服制剂、生物医药、疫苗等不同行业领域，积累了丰富的先进制造业设备、设施的维护管理经验，领导或参与了多项精益生产和卓越运营的改进项目，尤其是对新建医药厂房项目管理工作有浓厚的兴趣和深切的体会；机械制造与工艺设备专业，天津大学MBA硕士，高级工程师，PPP项目经理。丁之洁Wood China  副总裁‍丁之洁女士，正高级工程师、注册化工工程师，从事医药工业的设计及项目管理工作近35年，是国内著名的GMP和生物医药工程技术专家，熟悉FDA、欧盟EMA及中国GMP及其他各项相关的建设规范。担任中国医药设备工程协会副秘书长、上海临港新片区生命蓝湾专家顾问、全国专业标准化技术委员会委员、中国标准化协会理事、上海市室内环境净化行业协会院士专家服务中心专家。丁女士主持设计了国内产量最大、自动化程度最高的血液制品设计项目；现国内自动化程度最高的单抗设计项目；第一个符合欧盟GMP要求的细胞治疗设计项目、生物芯片国家工程研究中心项目（全国仅二个）；以及全国第一个组织工程国家工程研究中心项目。更多细分论坛介绍，敬请期待参会报名↓↓↓码上报名免费注册媒体合作/参会报名/赞助咨询/学术报告请联系IGAC2023组委会 Seven 18121311478（微信同号）【备注：IGAC2023，进入志合大会群聊】分享活动为扩大会议影响力，IGAC组委会特举办“达人榜”活动，第一轮已圆满结束。即日起开启第二轮“分享达人榜”，一起参与吧~分享本篇推文或任何一篇IGAC会议推文至朋友圈，好友集赞满额即可线下兑奖；分享多多、豪礼多多，详情请见海报内容~请第一轮活动达人，联系组委会Seven兑奖~点击下方“阅读原文”，进入大会官网获取更多会议信息~

PRESS RELEASE CHARM Therapeutics Strengthens Leadership Team with Key Appointments to Support Drug Discovery and Development Capability Enhanced leadership team brings strong AI and drug discovery expertise and experience, reinforcing CHARM Therapeutics’ existing R&D capabilities LONDON – 4 January 2023 -- CHARM Therapeutics (“CHARM”, “The Company”), a 3D deep-learning research Company discovering and developing transformational medicines, today announces the expansion of its leadership team with a series of key appointments to strengthen its drug discovery and development, as well as operational management capabilities. Effective immediately, CHARM has appointed Ross Pettit as Chief Operating Officer, Sarah Skerratt as Senior Vice President, Head of Drug Discovery, Daniel Rohle as Vice President, Head of Cancer Biology, Andrew Doré as Vice President, Head of Structural Sciences, with a focus on drug discovery and development and Sergey Bartunov as Director, AI. These appointments will support CHARM as it builds out of its research and development function to advance discoveries driven by its proprietary 3D deep-learning engine towards development. CHARM Therapeutics raised $50 million in a Series A financing round announced in 2022, led by F-Prime Capital and OrbiMed, with General Catalyst and Khosla Ventures. Gary D. Glick Ph.D., Executive Chair of CHARM Therapeutics, commented: “The exceptional people joining CHARM bring the perfect combination of skills, from immersion in AI, oncology and translational research to long experience in organizational leadership. With world-class 3D deep learning and structure-based drug design technology, the CHARM team is well positioned to execute on the pipeline.” Laksh Aithani, co-founder, Chief Executive Officer and Board Member of CHARM Therapeutics, added: “I’m really happy to welcome Ross, Sarah, Dan, Andy and Sergey to the CHARM family. Their expertise will coalesce to help us build out a robust R&D function. This enables us to start to translate the output of our proprietary 3D deep learning technology, which focuses on predicting the co-crystal structure of a protein-ligand complex, into moving targets towards development.” Strength of new discovery and development talent Ross Pettit joins as Chief Operating Officer. Ross has over 30 years of extensive drug development experience in the biopharmaceutical industry across clinical operations, program management, data management, regulatory affairs and medical affairs. He joins CHARM from H3 Biomedicine, where he worked as Deputy President, holding leadership responsibilities over all business operations and leading the exclusive out-license of H3 Biomedicine’s splicing modulator to Roivant Sciences. Ross previously served in senior roles at Beigene Pharmaceuticals, AMAG Pharmaceuticals and ARIAD Pharmaceuticals. He holds an MBA in Healthcare management. As Senior Vice President, Head of Drug Discovery, Sarah Skerratt brings expertise across multiple areas of drug discovery that include medicinal chemistry, pharmacology, pharmacokinetics, toxicology, and pharmaceutical sciences, with senior experience ranging from biotech to large pharma. Sarah joins CHARM from Merck Sharp & Dohme, where she worked as Head of Preclinical Sciences at the London site, responsible for building and leading a multidisciplinary preclinical team. She has also served in senior positions at Vertex and Convergence/Biogen and spent many years at Pfizer Inc (2004-2016), where she held numerous roles with a strong track record in drug development. Sarah is an organic chemist by training, conducting her Ph.D. at the University of Nottingham before undertaking postdoctoral studies at Stanford University as a visiting Fulbright Scholar. Daniel Rohle joins CHARM as Vice President, Head of Cancer Biology. Daniel Rohle has strong experience in oncology drug discovery and translational research culminating in publications in top tier journals, including Nature and Science. His most recent position before joining CHARM was as Vice President, Biology at Ridgeline Discovery, where he led the basic biology and assay development group for biotech companies that Ridgeline Discovery was helping to build. He previously worked at Hoffman La Roche as a member of the leadership team in the Molecular Targeted Therapeutics group, and at GSK as an investigator in the Tumor Signalling DPU. Daniel holds a PhD in Pharmacology from the Weill Cornell Graduate School of Medical Sciences, which he obtained whilst working at Memorial Sloan Kettering in a collaboration with Agios Pharmaceuticals. As Vice President, Head of Structural Sciences, Andrew Doré heads CHARM’s interdisciplinary structural sciences group and brings senior experience with global pharmaceutical companies. Previously, Andrew spent 12 years as Director and Head of Crystallography at Sosei Heptares UK, founding and establishing the now world-renowned Crystallography and structural biology department with resultant landmark publications in Nature, Science and Cell. Prior to this he completed his postdoctoral studies at the Institute of Cancer Research in London. Andrew obtained his DPhil in Protein Crystallography from the University of Cambridge. As Director of AI, Sergey Bartunov brings more than 10 years of expertise in artificial intelligence and machine learning more specifically in Bayesian machine learning and deep learning. Prior to joining CHARM, Sergey worked on cutting edge AI projects at Alphabet’s Deep Mind and was a senior member of the teaching staff at the National Research University Higher School of Economics in Moscow, Russia. He was also involved with a number of AI-driven start-ups. He holds an MSc PhD from Moscow State University. ENDS For further information, please contact: CHARM Therapeutics Laksh Aithani, Chief Executive Officer Phone +44 7933 185425 laksh@charmtx.com Consilium Strategic Communications Amber Fennell /Jessica Hodgson / Chris Gardner Phone: 44 (0)20 3709 5700 charm@consilium-comms.com About CHARM Therapeutics CHARM Therapeutics is a 3D deep-learning research Company discovering and developing transformational medicines. Founded on 3D deep learning inspired by the breakthroughs of co-founder David Baker, CHARM Therapeutics has developed a proprietary technology based on the first rapid, accurate protein/ligand co-folding algorithm. The Company’s goal is to use these insights to address challenging targets in cancer and other disease areas and discover and develop new drugs against these targets. CHARM Therapeutics is Chaired by Gary Glick, founder of IFM Therapeutics, Scorpion Therapeutics and Odyssey Therapeutics. Laksh Aithani, a former machine learning engineer at Exscientia and start-up founder, is co-founder and Chief Executive Officer. London-based CHARM Therapeutics has raised $50 million to date and is building an interdisciplinary and entrepreneurial team, combining leaders from the fields of AI and biotechnology. It supported by high quality international investors including Orbimed, F-Prime, General Catalyst, Khosla Ventures, Axial and Braavos. For more information, please visit: www.charmtx.com