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首页 > 商务会议 > 医疗医学会议 > 亚太药物研发领袖峰会2020 ( APRDL 2020 ) 更新时间:2020-09-18T14:14:49

亚太药物研发领袖峰会2020 ( APRDL 2020 )
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亚太药物研发领袖峰会2020 ( APRDL 2020 ) 已截止报名

会议时间: 2020-10-13 09:00至 2020-10-14 18:00结束

会议地点: 上海  上海锦江汤臣洲际大酒店  浦东新区张杨路777号 周边酒店预订

主办单位: 迪易咨询 Deliver Life Sciences

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        会议介绍

        会议内容 主办方介绍


        亚太药物研发领袖峰会2020 ( APRDL 2020 )

        亚太药物研发领袖峰会2020 ( APRDL 2020 ) 宣传图

        亚太药物研发领袖峰会2020 ( APRDL 2020 ) 

        本届峰会围绕着从新药研发到商业化生产的话题开展讨论 ( From R&D to Commercialization ) 

        从新药研发到商业化生产 | 10月13日-14日 上海浦东锦江汤臣洲际大酒店

        Deliver Life Sciences 主办、大费城美中医药协会 支持的亚太药物研发领袖峰会2020,邀请 政府监管机构、产业园区、行业协会、科研院校、临床中心、中国创新型生物技术及制药公司、特色原料药及医药中间体研发企业、高端仿制药研发企业、 新药研发平台、跨国制药中国研发及创新中心、医药研发服务公司、临床试验研究机构、人工智能以及解决方案提供商、律所、投资以及咨询机构等药物研发领袖及高层代表共同探讨并促进 :
        -- 汇聚中国制药产业 “源动力”:  我国制药产业发展现状与趋势
        -- 关键中间体的工艺开发、中试、商业化生产
        -- 药物分子砌块的研发和工艺生产
        -- 早期临床用药生产及原料药及制剂药学研究
        -- 商业化制剂设计, 研发与中试放大, 技术及法规要求
        -- 新药创新中的原料药工艺开发
        -- 料药工业生产中的杂质控制与系统研究
        -- CMC的挑战和策略, 处方工艺设计
        -- QbD质量源于设计--创新设计与安全性考量
        -- 基因毒性和元素杂质的控制策略和分析方法
        -- 基于QbD理念的高端制剂仿制药的研发策略
        -- 仿制药首仿策略,产品开发与一致性评价
        -- 仿制药BE临床试验开发策略及
        -- 高端仿制药研发与产业化的发展机遇
        -- 制剂处方工艺开发与放大
        -- 创新药物研发: 核酸干扰(RNAi)药物: 抗病毒药物: KRAS抑制剂: TGF-B抑制剂; MEK 抑制剂的开发
        -- 创新药物研发: 加速小分子创新药(小分子靶向抗肿瘤药) 中国研发-- 契机与挑战
        -- 促进源于中国的创新-创新药物研发与合作
        -- 临床开发策略,药物警戒与上市后药品不良反应监测
        -- 知识产权、专利与投融资机遇
        同时为国内外专家高端交流,产业与资本对接搭建平台。我们诚挚地邀请您出席本届2020亚太药物研发领袖峰会(‘APRDL 2020’)

        查看更多

        迪易咨询 Deliver Life Sciences 迪易咨询 Deliver Life Sciences

        Deliver Life Sciences is a specialty producer and organizer of the conference, workshop, public training together with the tailored consultative solutions to serve the growing biomedical industry in Asia. Through looking into the current trends of regulation, scientific findings and cutting-edge technology and working with the leading associations, regulatory agencies, industry and academia KOLs, we translate, formulate and promote our tailored offerings from the basic medicinal research, discovery to development till commercialization.

        会议日程 (最终日程以会议现场为准)


        2020 Speakers Inviting/Confirming and Topic Proposals/ 2020部分拟邀请发言人及演讲提案(草案)

        Job Title/Affiliation

        职称及单位信息

        Presentation Topic

        演讲题目

        Pharmaceutical Intermediates, QbD, API Research & Development -- Pharmaceutical R&D Trends in China
        * New modalities research opportunities and challenges
        * Drug formulation and relevant manufacturing process
        * Quality control of API, analytical development, excipients and packaging materials
        * Study of drug CQAs (Critical Quality Attributes) and relevant quality control
        * Drug stability study
        * QbD Overview in API Manufacturing
        * API Synthesis and Manufacturing
        * Achieve Stability, High Concentration and Excellent Manufacturing System

        Shanghai Zhangjiang Hi-Tech Park Development Co., Ltd

        上海张江高科技园区开发股份有限公司

        Shanghai Institute for Food and Drug Control

        上海市食品药品检验所

        Tyligand Bioscience

        泰励生物科技

        Abravit BioPharm

        Huahai Pharmaceutical

        华海药业

        Desano Pharmaceuticals

        上海迪赛诺药业

        Hutchison China MediTech Limited

        和黄药业

        Asieris Pharmaceuticals

        亚虹医药

        Zhejiang Hisun Pharmaceuticals

        海正药业

        Shanghai SynCores Technologies,

        上海科胜药物研发有限公司

        US Pharmacopeia

        美国药典委员会

        Jiangsu Hansoh Pharmaceutical

        江苏豪森药业

        YSY Phamaceutical

        裕松源药业有限公司

        Changzhou Sunlight Pharm

        常州市阳光药业集团公司

        Basilea Pharmaceutica

        巴塞利亚药业

        Shanghai Institute of Pharmaceutical Industry

        上海医药工业研究院

        Shanghai Pharmaceutical Group

        上海医药集团

        Shandong QiDu Pharmaceutical

        山东齐都药业

        North East Pharm Research Institute

        东北制药集团研究院

        Jiangsu Wuzhong Pharmaceutical

        江苏吴中医药集团有限公司

        Shandong DISHA Pharmaceutical Company

        迪沙药业集团

        Luoxin BioTechnology (Shanghai)

        罗欣生物科技(上海)有限公司

        Acebright Pharmaceuticals Group

        创诺医药集团

        Zhejiang Jingxin Pharmaceutical

        浙江京新药业股份有限公司

        Antengene

        德琪医药

        BeiGene
        百济神州

        Ascletis

        歌礼医药

        Hua Medicine

        华领医药

        Shenogen Pharma Group

        北京盛诺基医药公司

        YAO Pharma

        重庆药友制药有限责任公司

        BrightGene Bio-Medical Technology

        博瑞生物医药(苏州)股份有限公司

        STA Pharmaceutical, a WuXi AppTec company

        合全药业

        Jiangsu Tasly Diyi Pharmaceutical

        天士力帝益药业研发中心

        Asymchem Laboratories

        凯莱英医药

        Genotoxic Impurities in Pharmaceuticals
        * Overcoming challenges and barriers, sharing knowledge, strategies, best techniques and new methodologies in GTI predictions, analysis and control during the drug development process, overview and practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D)

        EOC Pharma

        亿腾景昂药业

        Jiuzhou Pharma

        浙江九州药业

        HEC Pharma

        东阳光药物研究院

        Chengdu Easton Biopharmaceuticals

        成都苑东生物制药股份有限公司

        南京柏贤医药

        National Shanghai Center for New Drug Safety Evaluation and Research, INNOSTAR

        国家上海新药安全评价研究中心

        Novast Pharmaceuticals

        南通联亚药业有限公司

        Livzon Pharma Research Institute

        丽珠集团研究院

        Huahai Pharmaceutical

        华海药业

        Shanghai Shilai Bio

        上海时莱生物技术有限公司

        Emerging Trends for the Generic Pharmaceutical Industry in China -- Generic Drugs and Quality Control
        * Best Practices & Strategies for Generic Drug Development
        * Modernization of Bioequivalence Standards for Generic Products
        * Application of Quantitative systems pharmacology (QSP)
        * Bioequivalence approaches for complex injectable API and formulations
        * Pharmaceutical Quality Assurance
        * Quality by Design (QbD) for generic drugs
        * Challenges of Manufacturing Generic Drugs
        * Patent Access& Intellectual property& FDA Regulations

        Epic Pharm

        人福普克药业

        Qilu Pharma  

        齐鲁制药

        Qilu Pharma  

        齐鲁制药

        Abravit BioPharm

        Nanjing Sanhome Pharmaceutical

        南京圣和药业股份有限公司

        Sichuan Kelun Pharmaceutical

        科伦药业

        Hengrui Medicine

        恒瑞医药

        Grand Pharmaceutical

        远大医药

        Yangtze River Pharmaceutical Group

        扬子江药业集团

        Simcere Pharmaceutical

        先声药业

        Chenpon Pharma

        上海臣邦医药科技有限公司

        Jiangsu Nhwa Pharmaceutical

        恩华药业药物研究院

        Zhejiang Conba Pharmaceutical

        浙江康恩贝制药股份有限公司

        Huahai Pharma

        华海药业

        Shanghai Jingfeng Pharmaceutical

        上海景峰制药

        ChiaTai TianQing

        南京正大天晴

        Hisun

        海正药业

        CSPC Pharmaceutical

        石药集团

        Qingfeng Pharmaceutical Group

        青峰医药集团

        Kunming Longjin Pharmaceutical

        昆明龙津药业股份有限公司

        Shanghai CRMed Science

        上海慈瑞医药科技股份有限公司

        ZENJI Pharma

        正济药业

        Novel Technologies, Concepts and Case Studies in Drug Delivery and Formulation Design

        Fudan University

        复旦大学药学院

        China Pharmaceutical University

        中国药科大学

        Roche

        罗氏制药

        Chengdu Easton Biopharmaceuticals

        正大天晴药业

        Suzhou Amerigen Pharmaceutical

        苏州爱美津制药

        National Shanghai Center for New Drug Safety Evaluation and Research, INNOSTAR

        云顶新耀

        Qilu Pharma

        齐鲁制药

        Livzon Pharma Research Institute

        丽珠集团研究院

        Qingfeng Pharmaceutical Group, Shanghai Qingrun Pharma

        青峰医药集团, 上海青润医药科技有限公司

        Zhejiang Jingxin Pharmaceutical

        京新药业

        Zhejiang Novus Pharmaceuticals l

        浙江医药, 浙江创新生物有限公司

        Nanjing Delova Biotech

        南京清普生物科技有限公司

        Genor Biopharmaceutical

        嘉和生物

        Dizal Pharma

        迪哲医药

        Formulation Strategies for Solid Oral Dosage Form  

        Anbison Lab; BAHEAL Pharmaceutical Group

        上海安必生制药技术有限公司; 青岛百洋制药有限公司

        Novast Laboratories  

        南通联亚药业有限公司

        Zhejiang Huahai Pharmaceutical

        浙江华海药业

        Abravit BioPharm

        Cerecin

        Cerecin公司

        Abbvie

        艾伯维

        Inhalation Formulation Technologies

        OMNI Pharma

        上海欧米尼医药科技有限公司

        CF PharmaTech

        苏州长风药业

        PURITY, Chengdu Brilliant Pharmaceutical Group

        四川普锐特药业

        ChiaTai TianQing

        正大天晴药业

        Joincare

        健康元药业集团

        Increase Innovative Medicine

        北京盈科瑞创新药物研究有限公司

        Formulation Development, Rational Design & Development of Long-Acting Injectable Dosage Forms

        Luye Pharmaceutical Group

        绿叶制药集团

        Chengdu Easton Biopharmaceuticals

        成都苑东生物制药股份有限公司

        Frontage Lab

        方达医药

        SAPA

        Huiyu Pharma

        四川汇宇制药有限公司

        Poly Pharmaceuticals

        海南普利制药股份有限公司

        Beijing Tide Pharmaceutical

        北京泰德制药股份有限公司

        Sichuan Kelun Pharmaceutical
        四川科伦药物研究院

        Yangtze River Pharmaceutical Group

        迪康药业

        Ferring Pharmaceutical

        辉凌医药

        Livzon Pharmaceutical Group

        丽珠医药集团长效微球技术国家地方联合工程研究中心

        ChiaTai TianQing

        南京正大天晴

        GENERIC PEPTIDES Development for pharmaceutical Industry

        SALUBRIS

        深圳信立泰药业股份有限公司

        Chinese Peptide

        中肽生化有限公司

        Shenzhen Hanyu Pharmaceutical

        深圳翰宇药业股份有限公司

        Hainan Zhonghe Pharmaceuticals

        海南中和药业股份有限公司

        Novo Nordisk China Research Center

        诺和诺德中国

        Shanghai Institute for Food and Drug Control

        上海市食品药品检验所

        Liposome Preparation and Evaluation

        Shanghai Jiao Tong University

        上海交通大学药学院/杭州Highfield生物技术公司

        Shanghai University of Traditional Chinese Medicine

        上海中医药大学

        Development of Traditional Chinese Medicine

        Shanghai Hutchison Pharmaceuticals

        上海和黄药业有限公司

        Yiling Pharmaceutical

        以岭医药

        Shanghai University of Traditional Chinese Medicine

        上海中医药大学

        Tasly Pharma

        天士力医药集团

        Innovative Drug Discovery and Development -- RNAi therapeutics, Anti-Viral Combo,  KRAS inhibitors, MEK inhibitors, TGF-beta Receptor Inhibitors

        Sirnaomics

        圣诺制药集团

        Ascletis

        歌礼医药

        Suzhou Ribo Life Science

        瑞博生物

        Ark Biosciences
        爱科百发生物医药公司

        Innovent Biologics

        信达生物

        Zhimeng Biopharma

        上海挚盟医药科技有限公司

        Jacobio Pharmaceuticals

        北京加科思新药研发有限公司

        Amgen
        安进生物医药研发(上海)有限公司

        KeChow Pharma

        上海科州药物研发有限公司

        Ferring Pharmaceutical

        劲方医药科技(上海)有限公司

        Promoting China Innovation: Accelerating Small Molecule Drug Discovery and Development

        Eccogene

        诚益生物

        IMPACT Therapeutics

        英派药业

        Minghui Pharma

        明慧医药

        ENNOVA Bio

        轶诺药业

        Fochon Pharmaceuticals

        复创医药

        TransThera Bio

        药捷安康

        HEC Pharma

        东阳光药业

        Autopharm

        苏州偶领生物

        Yituo Pharma

        奕拓医药

        Betta Pharmaceuticals

        贝达药业

        Laekna Therapeutics

        来凯医药

        Zelgen

        泽璟制药

        CSPC

        石药集团

        Ascentage Pharma

        亚盛医药

        Jacobio

        北京加科思新药研发有限公司

        Ionova Bio

        原力生命科学有限公司

        Shanghai Pharma

        上海医药集团

        BeiGene

        百济神州

        Zhongsheng Pharma

        众生药业

        XuanZhu Pharma

        轩竹医药

        Promoting China Innovation: Strengthening Pharma R&D Collaboration and Partnership in Asia & China

        FOSUN Pharma

        复星医药

        Chipscreen Biosciences

        深圳微芯生物

        CSPC Shanghai Research Institute

        石药集团上海翊石医药技术有限公司

        BeiGene
        百济神州

        Innovent Biologics

        信达生物

        Phanes Therapeutics

        凡恩世生物

        Abbisko

        和誉生物

        Lynk Pharmaceuticals
        凌科药业

        Hyperway Pharma

        海博为药业

        Pharscin Pharma

        华森制药

        Roche

        罗氏制药

        Simcere

        先声药业

        Haiyan Pharmaceutical

        上海海雁医药科技有限公司

        Haihe BioPharma

        海和生物

        Strengthening Pharma IP Patent and Patent Litigation Strategies relating to Pharma & Biologic; Funding and Investment Opportunities

        Luye Pharmaceutical Group

        绿叶制药

        Henlius

        复宏汉霖

        Tasly Pharmaceutical Group

        天士力控股

        Shineway Pharmaceutical Group

        神威药业集团

        3S Bio

        三生制药

        Yabao Pharmaceutical Group

        亚宝药业集团

        OrbiMed Asia

        奥博资本

        Lilly Asia Ventures

        礼来亚洲基金

        Qiming Venture

        启明创投

        WuXi Ventures

        通和毓承

        Drug Development Strategies and Safety Monitoring

        Merck Research Laboratories

        默沙东研发 (中国) 有限公司

        Eli Lilly China  

        礼来中国

        IPSEN

        法国益普生集团

        Novartis

        诺华中国

        Zai Lab

        再鼎医药

        Innovent Bio

        信达生物

        CStone Pharmaceutical

        基石药业

        Everest Medicines

        云顶新耀

        Genor BioPharm

        嘉和生物

        Hutchison MediPharma

        和记黄埔

        Elpiscience Biopharmaceuticals

        科望医药

        Clover Biopharmaceuticals

        三叶草生物制药

        Harbour Biomed

        和铂医药

        Zensun

        泽生科技

        Adlai Nortye Biopharma

        阿诺医药

        TenNor Therapeutics

        丹诺医药

        Qilu Pharmaceuticals

        齐鲁制药

        Denovo Biopharma

        索元生物

        I-Mab Biopharma

        天境生物

        Sihuan Pharmaceutical

        四环医药

        Luye Pharma

        绿叶制药

        Xuanzhu Pharma

        轩竹医药

        NASH New Drug Development in China

        Terns Pharmaceuticals

        拓臻生物

        Zhongsheng Pharmaceutical

        众生药业

        Sciwind Biosciences

        先为达生物

        Ascletis Pharma

        歌礼制药

        CHIA TAI TIANQING

        正大天晴

        HighTide Therapeutics

        深圳君圣泰生物技术有限公司

        PegBio

        派格生物

        Shenzhen Chipscreen Bioscientces

        微芯生物

        查看更多

        会议嘉宾 (最终出席嘉宾以会议现场为准)


        部分确认的赞助商及展商包括:
        安捷伦科技(中国)有限公司 ( Agilent );  南京明捷生物医药检测有限公司 ( Milestone Pharma ) ; 乐威医药 ( Laviana ) ; 南京药石科技股份有限公司 ( PharmaBlock ) ;
        桑迪亚医药技术(上海)有限责任公司 ( Sundia ) ; 凯莱英医药集团  (  Asymchem Laboratories );上海泓博智源医药股份有限公司 ( Pharma Resources )  
        保诺科技(北京)有限公司 ( BioDuro ); 杭州剂泰医药科技有限责任公司 ( METiS Pharmaceuticals ) ; 成都先导药物开发有限公司 ( HitGen )
        江苏欣诺科催化剂有限公司 ( SINOCOMPOUND ) ; 美国化学文摘社 ( CAS ) ; 庄信万丰医药服务烟台有限公司 ( Johnson Matthey Pharmaceutical Services ) ;
        海维科技(HAIWEI Technologies ); 上海博志研新药物技术有限公司 ( BociMed )  etc.,

        部分确认的发言嘉宾包括:
        早期临床用药生产及原料药及制剂药学研究
        郭明 博士总裁兼首席运营官联合创始人,亚盛医药集团
        吴振平 博士资深副总裁药学负责人,和记黄埔医药

        从新药研发到商业化生产 - CMC研究的策略与挑战质量研究的通盘考量: [ 杂质研究晶型研究;  粒径研究 ]
        From R&D to Commercialization: CMC Challenges and Strategies

        胡新辉 博士高级副总裁药物开发与生产 (CMC), 云顶新耀
        张世英 博士, 副总裁药学负责人(CMC), 迪哲医药
        单波 博士,  副总裁药物开发与生产 (CMC), 德琪医药
        杜争鸣 博士高级副总裁药学部首席总监百济神州
        陈曦 博士常务副总裁药物开发与生产 (CMC), 盛诺基医药
        佘劲 博士高级副总裁药物开发与生产 (CMC), 华领医药
        冯涛 博士副总裁药物开发与生产 (CMC) , 来凯医药
        马元辉 博士执行总监药物开发与生产 (CMC) ,  海和药物
        王志宣 博士. CMC项目运营总监,  赛诺菲研发

        * Continuous Manufacturing of Drugs -- Development to Commercialization
        Deepak Hegde 博士首席技术官, 亿腾景昂药业

        新药研发与质控专家 – 检验基因毒性杂质分析方法的开发技巧与验证策略
        Application of multi-stage mass spectrometry (MSn) in solving challenging problems in pharmaceutical industry: from rapid structure elucidation, drug degradation mechanism studies, to detection of genotoxic impurities
        李敏 博士,  副总裁分析领域首席科学家, 浙江华海药业有限公司
        陈洪 博士副总经理成都苑东生物制药股份有限公司
        谢沐风, 上海市食品药品检验所

        * CRO Spotlight Session:
        新药开发过程中关于CMC的挑战和策略时间成本及EHS
        章世杰 博士首席技术官,  药石科技
        肖毅博士项目研发中心高级副总裁负责工艺开发凯莱英医药集团
        李建昌 博士首席执行官桑迪亚

        * R&D Innovation in China: Innovative Medicines Discovery and Development:
        Kerry Blanchard 博士首席执行官云顶新耀
        鲁先平 博士董事长兼首席执行官深圳微芯生物
        Xiayang Qiu 博士创始人兼首席执行官齐鲁锐格
        包骏 博士总裁兼首席执行官英派药业
        郑彪 博士首席科学官, 劲方医药
        罗文 博士首席执行官兼首席科学官, 索元生物
        陆阳 博士总裁兼首席执行官, 圣诺制药
        尹鹤群 博士首席科学官齐鲁制药
        万昭奎 博士创始人兼首席执行官凌科药业
        边锋 博士资深总监, 辉瑞亚洲创新中心
        党群 博士首席执行官石药集团上海翊石医药技术有限公司
        李进 博士,创始人董事长兼首席执行官成都先导化学
        etc.,

        Here I highlight some speakers for your reference at the 2020 summit:
        李敏 博士
        副总裁分析领域首席科学家
        浙江华海药业有限公司
        Topic: Application of multi-stage mass spectrometry (MSn) in solving challenging problems in pharmaceutical industry: from rapid structure elucidation, drug degradation mechanism studies, to detection of genotoxic impurities
        Abstract: This presentation will cover two aspects of multi-stage mass spectrometry (MSn) application: the first one covers the utilization of LC-MSn in conjunction with mechanism-based stress studies for rapid elucidation of degradant structures and drug degradation mechanisms. The second aspect covers the application of MSn in the detection and quantification of genotoxic impurities. The particular challenges, such as sensitivity and specificity (e.g., sample matrix interference) at sub-ppm levels of these impurities, will be presented and discussed.
        Bio: Dr. Min Li received his PhD in Organic Chemistry from Johns Hopkins University in 1991. Following a postdoctoral research in medicinal chemistry, he had worked for several multinational pharmaceutical companies with increasing responsibilities, including Roche, Merck & Co., Inc. Schering-Plough, and Merck again. Over the years, he has led technical teams of senior-level scientists for various analytical and pharmaceutical manufacturing process investigations and troubleshooting, impurity peak identification, study of drug degradation chemistry, analytical development, and support for new drug filing. Since September 2014, he became Vice President for Analytical Operation at Huahai Pharmaceutical, a leading Chinese pharmaceutical company with operations in both China and US. He also established the Center of Excellence for Modern Analytical Technologies (CEMAT), a technical core group created for solving the most challenging technical problems from pharmaceutical R&D to scale-up and commercial production at the company.  Dr. Li is a leading expert in drug degradation chemistry and he published a single-authored book, “Organic Chemistry of Drug Degradation” (by Royal Society of Chemistry) in 2012; the Chinese translation of this book was published in September 2019. He is the first/communicating author of more than 50 publications in organic, medicinal, bioconjugate, and analytical chemistry (including mass spectrometry). He is currently a member of the expert committee (Chemical Medicines 5) at United States Pharmacopoeia (USP) and a board member of Sino-American Pharmaceutical Professional Association (SAPA).

        郭明 博士
        总裁兼首席运营官联合创始人
        亚盛医药集团
        Topic: 早期临床用药生产及原料药及制剂药学研究
        Bio: Dr. Guo has been working in the healthcare industry since 1991, including ABC Laboratories, Pfizer, Ascenta Therapeutics, and Ascentage Pharma.  At Pfizer (1995-2005) with various technical and management roles, Dr. Guo participated in many NCE drug R&D projects, several of which have successfully reached commercial stages. At Ascenta (2005-2009), Dr. Guo was the founding Vice President of Pharmaceutical Sciences & Manufacturing, and also General Manager of Ascenta (Shanghai) R&D Center which engaged in NCE drug R&D in China from 2005.  Dr. Guo played an important role in Ascenta’s >$600M global out-licensing deals (i.e., with Sanofi-Aventis in 2010 and with Debio in 2011).  Dr. Guo co-founded Ascentage Pharma in 2009, a globally positioned China innovative NCE drug R&D company, and currently serves as President & COO.  The company has quickly built up a pipeline of 8 clinical-stage NCE projects along with several IND-enabling and discovery stage projects, covering oncology and anti-aging / anti-viral therapeutic areas through its apoptosis/PPI platform.  During 2002-2005, Dr. Guo served as an Overseas Advisor for Beijing Zhongguangcun Biotech Park in China.  He has been an adjunct professor, a faculty and graduate student adviser for the IPEM program at Peking University during 2007-2018.  Dr. Guo served as an Independent Board Director at Porton Corporation (Chongqing, China) during 2012-2016, overseeing its successful IPO at Shengzhen Exchange, China, in 2014.  As a co-founder and the founding Chairman, Dr. Guo has served on Board of Directors of SABPA (www.sabpa.org).  Dr. Guo received his Ph.D. degree in Organic Chemistry at the University of California at San Diego; M.Sc. in Medicinal Chemistry at Institute of Materia Medica, Chinese Academy of Sciences; and B.S. in Chemistry at Peking Normal University

        马元辉 博士
        执行总监, CMC  
        海和药物
        Bio: Dr. Ma obtained his Ph.D. from Shanghai Jiao Tong University, and went on with organocatalyst research in NTU as a postdoctor. He has 10 more years of experience of drug R&D and management, focus on CMC. Dr. Ma joined HaiHe in mid of 2016, and set up CMC department. He oversees CMC development and DS/DP manufacturing for all HaiHe’s pipeline products
        Topic: 从新药研发到商业化生产 - CMC研究的策略与挑战质量研究的通盘考量
        -- CMC研究范畴(DS, DP, Quality
        -- 质量研究通盘考量的必要性和重要性
        -- 杂质研究
        -- 晶型研究
        -- 粒径研究
        -- 案例分享

        吴振平 博士
        资深副总裁药学负责人
        和记黄埔医药
        Topic: 商业化制剂设计研发与中试放大技术及法规要求
        Bio: 药学研发专家具近30年药学开发经验领导过多个项目的研发团队将多个新药候选药物推进至临床各个阶段和市场包括舒尼替尼(Sutent由辉瑞研发的新型具重磅炸弹潜力的抗癌药物。吴振平博士于2008年起至今任职和记黄埔医药,负责组建药学和生产部门公司已经成功将十数个研发药品推向临床研究包括在中国和美国进行的研究多个项目已经进入或完成三期临床研究其中抗癌新药呋喹替尼已经上市.
        吴博士曾在位于加州的药物研发公司Phenomix任药学部高级总监在此之前他曾担任辉瑞圣地亚哥全球研发中心(前称为Agouron医药公司)药物开发部总监更早之前在罗氏加州研发中心(Roche Palo Alto)任资深科学家吴博士于香港大学获得博士学位并在加州大学尔湾分校取得了MBA学位他曾任中美生物技术和制药协会理事长和会长 . 2003他因舒尼替尼(Sutent)项目获得辉瑞杰出员工奖他带领的索凡替尼课题组荣获2010年度和记黄埔医药优秀团队奖.

        张世英 博士
        副总裁药学负责人(CMC)
        迪哲医药
        Topic:  Considerations and Approaches to speed up CMC development to match the new clinical paradigms for Oncology studies
        Bio: 
        Shih-Ying joined Dizal at January 2019 as the CMC head for API and drug products development, Clinical manufacturing, and supply chain management. Before coming back to Shanghai, he has worked in Pharmaceutical Development in Bristol-Myers Squibb at New Brunswick New Jersey for 13 years. During the tenure in BMS, he has worked on more than 40 different new chemical entities including Brivanib and Cabozentinib in the oncology area, contributed more than 5 NDA dossiers preparation, especially as the author of the Module 3 QbD sections for Onglyza, which was approved as the first QbD-based NDA filings. Other approved NDAs that he has participated including Sprycel, Kombiglyza, Reyataz, and Daclatasvir. After coming back to Shanghai to join Hutchison MediPharma as the Executive Director of Formulation at 2015, he has contributed to Fruquintinib NDA approval in CFDA. He has also served as the CMC project lead to collaborate with AstraZeneca for the joint global development of Savolitib. In Hutchison he successfully finished two bio-equivalency studies to facilitate formulation changes during pivotal trials.

        单波 博士
        副总裁药物开发与生产 (CMC)
        德琪医药
        Topic: 原料药工业生产中的杂质控制与系统研究  /  结合实际生产中的案例介绍了相应的分离解决策略 /  CMC的挑战和策略处方工艺设计
        Bio: 单波博士具有超过17年在欧美,中国的新药和仿制药研发和生产经验. 目前是德琪医药负责药物早期研发和生产的副总裁. 单波博士曾经带领团队完成共计1个国家一类新药的申报上市,多个处于I-III期临床试验的一类新药,以及一系列临床前的项目开发.单波博士带领团队完成了一个国家一类新药生产基地从设计,土建,装修,设备采购到工艺验证和试生产的全过程,包括两条API生产线,一条固体制剂生产线,并且于2018年通过了国家注册现场和GMP动态核查.
        单波博士曾先后担任歌礼药业副总裁,凯惠药业(上海)有限公司常务副总经理, 上海睿智化学研究有限公司执行总监,GE Healthcare英国研发中心科学家等职务.单博士具有英国Aston大学药物化学博士学位.

        杜争鸣 博士
        高级副总裁药学部首席总监
        百济神州
        Topic: 从新药研发到商业化生产

        陈曦 博士
        常务副总裁药物开发与生产 (CMC)
        盛诺基医药
        Topic: 新药创新中的原料药工艺开发
        Bio: After Obtained his Ph.D. from Purdue University, Dr. Chen joined Department of Process R&D in Gilead Sciences Inc., and was responsible for process optimization, tech transfer and commercial manufacturing. He participated in many Gilead’s blockbuster projects, such as Viread, Emtriva, Hepsera, Truvada and Atripla. The combined sales of these products in 2012 exceeded 35 billion dollars.
        Starting from 2009, Dr. Chen held several executive positions for some pharmaceutical companies, including Process Director in WuXi AppTec Co., Ltd., Vice President of API division in Huahai Pharmaceutical Co., Ltd., Executive Vice President in Tibet Rhodiola Pharmaceutical Holding Co., President in Zhongke Biopharma Co., Ltd. Dr. Chen has 22 years pharmaceutical experiences in USA and China. His specialty is in areas of CMC and drug substance manufacturing. He has managed a wide range of projects, including API manufacturing, GMP appliances, formulation development, facility construction and supply chain management.

        佘劲 博士
        副总裁药物开发与生产 (CMC)
        华领医药
        Bio: Dr. Jin She is SVP of CMC at Hua Medicine (Shanghai) Ltd. Dr. She has over 15 years’ of experience in the biotechnology and pharmaceutical industry. Prior to Hua Medicine, he worked at MSD R&D Center (China) as Director of Process Chemistry, and Roche R&D Center (China) as Head of Process Research & Synthesis. Before returning back to China from the US, he worked at Inspire Pharmaceuticals Inc. as Sr. Research Scientist and team leader of Process Research. Dr. She has also been an Industrial Advisor for Engineering Master Program at East China Science & Technology University for the last 8 years. Dr. She Received his Ph.D. in organic chemistry from the University of North Carolina at Chapel Hill. He obtained his BS and MS degrees in chemistry from Beijing University.
        Topic: 从新药研发到商业化生产: CMC的挑战与策略

        冯涛 博士
        副总裁药物开发与生产 (CMC)
        来凯医药
        Bio: Dr. Feng is currently Vice President and head of CMC of Laekna Therapeutics. He oversees CMC development and manufacturing for all Laekna’s pipeline products. Dr. Feng has more than sixteen years’ experience in new drug research and development including preclinical development, early phase and late phase product development, clinical manufacturing and process validation towards commercialization. He has led the technical transfer, clinical manufacturing, and process validation of various products, including successful approval and commercial launch of Niraparib in China. Prior to Laekna, Dr. Feng has held various management roles in Zai Lab, WuXi Apptec, and Schering Plough in US. Dr. Feng received his PhD from Purdue University.

        胡新辉 博士
        高级副总裁药物开发与生产 (CMC)
        云顶新耀
        Bio: Dr. Steven Hu currently is the Senior Vice President of Everest Medicines, being responsible for CMC and supply chain. Before he was the Senior Director of CMC in Roche Pharm Research and Development (pRED) Shanghai, heading process research and synthesis, analytical, preformulation and formulation development to support Roche China portfolio. Before joining Roche, Steven was the Director of New Product Development (NPD) of GSK China R&D, overseeing the whole drug product development life cycle from formulation development and optimization, process development and scale-up to technology transfer to commercial manufacturing. Steven had worked in Merck (West Point, PA) and J&J (Spring House, PA) respectively in the United States before coming back China in 2010.

        Steven obtained his Ph.D. in Chemical Engineering from Brown University, USA, and then spent about two years at MIT as a Post-doctoral Research Fellow.
        Topic: CMC的挑战和策略处方工艺设计

        王志宣 博士
        CMC项目运营总监

        赛诺菲研发
        Bio: Dr. Zhixuan Wang is as project CMC operation management role in Integrated CMC New Product Program department at Sanofi China. She Holds Master degree from Peking University and Ph.D from Shenyang Pharmaceutical University. She started her career in drug product development in North China Pharmaceutical Group Corporation. In 2006 she joined in Chinese Academy of Sciences and working on transdermal drug delivery system research work. In 2007, she joined Novartis China as Senior Scientist in Chemical and Pharmaceutical Profiling, Novartis Institutes for Biomedical Research Co., Ltd, and followed GSK R&D China in 2011. Zhixuan has worked on a wide variety of Discovery & Development projects, her role includes compound developability assessment, physical form selection, formulation development, drug product manufacture and clinical supply, CTA/NDA submission and new product launch. She is also involved in Innovative drug delivery system research and development work. Dr. Wang has published ~ 30 papers and patents. Zhixuan has contributed chapters to “Liposome Technology” and “Novel technologies of microencapsulation and the application in DDS”.
        Topic: Innovative Drug/Compound Assessment, Formulation Development and Regulatory Requirement
        -- Attrition in Drug Discovery & Development
        -- NCE Assessment & Mitigation strategies
        -- Formulation Design & Development from early clinical to commercial
        -- Regulatory requirement & challenges


        Dr. Deepak Hegde
        首席技术官
        亿腾景昂药业
        Bio: Dr. Deepak Hegde completed his Doctorate in Biopharmaceutics and Pharmacokinetics from University of Mumbai in 1996. He also completed his Masters in Financial Management (M.F.M) from University of Mumbai in 2000.
        He is currently working with EOC Pharma as Chief Technology Officer. Responsible for development and manufacturing of new speciality anti cancer products for China. Prior to joining EOC, he was with GSK Shanghai, R & D China as Director, Global External Development & Supply, AsiaPacific, responsible for developing drug products for GSK global portfolio and for introduction of new products to China. Prior to this he worked with Wuxi AppTec as Vice President for Formulation Development. At WuXi Apptec, he was instrumental in setting up the Formulation Development Business as well as the formulation team, GMP facilities and systems which have since been approved by the EMA, USFDA and CFDA. While working with several multinational companies from US and Europe, he helped develop more than 150 NCEs. He established several enabling technologies like Microdozing, Nanonization, Spray Drying, and Holt Melt Extrusion (HME) etc. at WuXi AppTec which helped customers expedite the First in Man (FIM) studies in US, Europe, Australia, Korea & China. Prior to joining WuXi AppTec in Shanghai, he has worked at several positions across Rhone Poulenc, Sandoz (A Novartis Group Company) and USV Ltd, a premier Indian Generic Company.
        He has extensive experience in generic formulation development of solid and liquid oral and injectible formulations from a very early phase of development all the way to technical transfers to commercial manufacturing sites. At Sandoz, he worked on formulation development for the regulated markets like US and Europe and participated in technical transfers to commercial sites of Sandoz at Rolab in South Africa, and Novartis Bangladesh and Novartis Pakistan. Several generic products that he developed have since been registered and commercially launched in Europe, USA, South Africa and Asia.
        He is a life member of the Indian Pharmaceutical Association. He has two US patents, five PCT and US patent applications and several National and International publications to his credit.
        Topic: Continuous Manufacturing of Drugs -- Development to Commercialization

        Dr. Dhileep Krishnamurthy
        首席科学官
        浙江新和成股份有限公司
        Bio: Dr Dhileep Krishnamurthy is a senior pharmaceutical industry leader and have been advising and consulting in pharmaceutical research, development and technology platform for academia, industry and government across the world and in particular India, China and USA. Currently he is a CSO of NHU, China and working closely with government and Industry to enhance China and India collaboration in pharma industry.
        For past 25 years, Dr Krishnamurthy has worked in various multinational organization including BMS, Boehringer-Ingelheim, Dr Reddys, Piramal and NHU with increasing responsibility from Scientist to VP, Global Head R&D and CSO in USA, Germany, India and China. His strengths include, (a) building, mentoring, strengthening innovator and generic business using the 4 pilar model. (b) Cost reduction in API manufacturing using R&D, technologies, manufacturing excellence including US FDA approved plants, (c) Efficient R&D development for DMF filing using competitive advantaged routes by GCbD and QbD.
        He has obtained PhD in Chemistry from University of Utah, Salt Lake City and M.Sc from IIT, Bombay. He has more than 100 publications, patents and invited presentations to his credit. He has co-invented commercial process new drug Entacavir and Empagliflozin when he was working in BMS and BI. Recently, he has been named as Fellow of Royal Society of Chemistry and member of National 1000 talent program from PR of China. He also won the highest award for a foriegner “West lake friendship award” from Zhejiang Province, China. He served as one of the panel judges in “Presidential Green Chemistry Challenge Award” EPA, US Government and currently he is an editorial advisory board member in Green Chemistry a RSC Journal based in UK

        Topic: High Quality Active Pharmaceutical Ingredient Manufacturing in China & Future Development Trends

        Xiayang Qiu 博士
        创始人兼首席执行官
        齐鲁锐格
        Dr. Qiu is the CEO of Qilu Regor Therapeutics, an innovative drug discovery company he founded together with a team of accomplished scientists and executives from top global pharma companies. Located in Shanghai, Boston and San Diego, Regor leverages world-class expertise in Computer Accelerated Rational Discovery (CARD) and efficient R&D ecosystems to accelerate the delivery of novel therapeutic agents with high unmet medical needs for patients in China and around the world.
        Before returning to China in 2018, Dr. Qiu was Executive Director & Head of Structural & Molecular Sciences at Pfizer. He built and led a team of ~60 scientists with industry-leading expertise in structure-based drug design, computational sciences, and integrated molecular mode of action approaches. Prior to joining Pfizer in 2001, he was a member of GSK Global Target Evaluation Meeting and Novel Targets Committee. In 25 years in industry, he has contributed to 30 clinical candidates across diseases areas (inflammation & immunology, neurosciences, oncology, cardiovascular & metabolic, infectious & rare diseases) and therapeutic modalities (small molecule, ADC, biologics & vaccine). He discovered PCSK9 molecular mode of action that led to the industry-wide shift from seeking protease inhibitors to antibody therapies. He built the first cutting-edge cryo-EM lab in industry & New England, and delivered multiple clinical candidates using fragment-screening. He also served as President of New Drug Research for Qilu, one of the biggest pharmaceutical companies in China.
        Dr. Qiu graduated from Peking University, obtained PhD at Michigan State, and completed executive trainings at Harvard Business School. He was an NIH Fellow and HHMI Research Associate at University of Washington in Seattle. He has trained 15 postdocs, served on expert review panels for National Institute of Health and other US funding agencies, and has been a member of Faculty of 1000 since 2004. He has >6000 citations (h-index 39) from over 60 publications, including in top journals such as Nature and Science.

        Topic: Strategy and Technology Investment for Innovative Medicines

        -- Innovative medicines in China: progresses and gaps

        -- Lead identification technologies and structure-based drug design

        -- Computer-Accelerate Rational Discovery (CARD) and Artificial Intelligence

        党群 博士
        集团副总裁首席执行官,
        石药集团石药集团 上海翊石医药技术有限公司
        Bio: Max received his BS from Jilin University with honors and earned a CGP national scholarship sponsored by the Chinese government; he obtained his Ph.D. in organic chemistry from Purdue University in 1992, joined Gensia (later became Metabasis) as a medicinal chemist and worked until 2009 with his last position as director of medicinal chemistry. Max then joined Merck as a Senior Investigator in the External Basic Research department, and then from 2011 to 2013, he was Director of External Medicinal Chemistry, Asia Lead, based in Shanghai facilitating Merck-CRO operations; 2013-2016, he was a Principle Scientist in the exploratory chemistry department at the Kenilworth site. In 2016 he joined Eli Lilly as Asia Head, BD and External Innovation for diabetes and CV research and worked until March 2018 before joining Qilu Pharmaceutical as VP, Global Head of BD and External Innovation with responsibilities for all BD and external collaborations globally including in-license, out-license and setting strategies for drug discovery and external collaborations. In June 2019, Max joined CSPC as corporate VP, President of CSPC Shanghai Research Institute, CEO of InnovStone Therapeutics, responsible for small molecule new drug discovery efforts. Max has extensive experiences in business development globally and more than 25-years of experiences as a manager of drug discovery programs spanning from early (Target Selection and Validation, Lead Identification) to late (Lead Optimization and candidate selection) stages; led programs that advanced multiple compounds into human clinic trials (two completed Phase 2b POC studies); experiences in therapeutic areas including diabetes, dyslipidemia, hepatitis B and C, liver cancer, liver fibrosis, anemia, viral and bacterial infections; extensive knowledge of Structure-based Drug Design, Medicinal Chemistry, Drug Delivery, Prodrugs, Liver targeting Strategies, Combinatorial, Heterocyclic and Nucleoside Chemistry; more than five years of managing drug discovery programs executed at various CROs. His research activities have led to 91 publications and 60 patents.

        李进 博士
        创始人董事长兼首席执行官
        成都先导化学
        Dr. Li is the founder, Chairman and CEO of HitGen Inc., and also a Fellow of the Royal Society of Chemistry and a Guest Professor of Sichuan University, etc. Dr. Li has over 30 years biopharmaceutical experience (at Protherics, AstraZeneca, HitGen), with senior scientific and leadership roles in early stage research; as well as experience in initiating and leading major collaboration, research and outsourcing programmes. Dr. Li held Global Director positions of Compound Sciences and Computational Sciences at AstraZeneca, which included molecular design, synthesis and screening. Dr. Li has published more than 30 papers and 20 authorized patents.

        Since its foundation in 2012, HitGen has developed into one of the most influential companies in the field of novel drug discovery research centered on DNA Encoded Chemical Libraries (DELs). HitGen has established extensive international R&D collaboration and its own new drug pipelines. HitGen (688222.SH) became a listed company on the Science and Technology Innovation Board in Shanghai Stock Exchange on April 16, 2020.

        边锋 博士
        科学与创新高级总监
        辉瑞制药
        Bio: Dr. Feng Bian is a Senior Director and Asia Emerging Science Lead in Pfizer Asia Discovery Labs (ADL) of Pfizers Worldwide Research and Development. She is responsible for cultivating strong and in-depth scientific relationships with Asia Academic and Life Science Communities with a primary focus on southern China regions to access emerging sciences, promising compounds, and breakthrough technologies.
        Prior to ADL, Dr. Bian was a senior investigator in China Novartis Institutes for Biomedical Research and group head of liver pharmacology since 2014 in Shanghai. At Novartis, she was a project leader and managed liver disease pharmacology platform to deliver data packages for drug discovery projects. Before Novartis, she was a key scientist participated in setting up JnJ China research labs in 2012, and Associate Director of Biology to manage CROs and academic collaborations as well as internal R&D programs. Dr. Bian began her R&D career in Parke-Davis/Warner-Lambert in US as an in vivo pharmacologist in the Neuroscience Division, and later became a principle scientist in Pfizer
        s Neurodegeneration and Psychotherapeutics Unit, contributing to programs like Lyrica®, discovery programs for Alzheimers disease, bipolar depression and dermal fibrosis. Dr. Bian has 20 years of expertise in small molecule and biologics drug discovery and her work has enabled NMEs to reach first in human. Dr. Bian received her Doctorate degree in Biochemistry from The Ohio State University and her Bachelor of Science degree from Nankai University at Tianjin, China

        Dr. Kerry Blanchard
        Chief Executive Officer
        Everest Medicines ( 
        云顶新耀 )
        Dr. Blanchard’s career spans four decades in diverse leadership roles across North America and Asia. In February 2020 he was appointed as CEO of Everest Medicines after having served as Operating Partner at CBC Group, a healthcare private equity firm and one of the leading investors in Everest Medicines, since November 2019Prior to CBC Group, he was Chief Science Officer at Innovent Biologics, where he oversaw the NDA preparation and submission for the company’s PD1 antibody, sintilimab, which was approved in late 2018 and launched in China in 2019 and led the partnership efforts with Incyte to develop three small molecule oncology assets for Greater China. Previously, Dr. Blanchard was the Senior Vice President of Lilly China Drug Development and External Innovation, where he built and led the development and medical affairs teams, who designed and implemented clinical plans for assets across all therapeutic areas. He also built and executed the company external partnership drug development portfolio model in China. He positioned Lilly to capitalize on the positive changes in the Chinese regulatory environment to expand the China innovation ecosystem. He built multiple successful partnerships that delivered new medicines to the China market including Innovent Biologics (sintilimab) and Chi-Med (fruquintinib). At Eli Lilly and Company he also initiated the project and led the team who delivered abemaciclib, the best in class cdk4/6 inhibitor, to the clinic.
        His interests include discovering and developing medicines and the application of translational research principles to drug discovery. He was a co-founder and a member of the Board of Directors of the Asian Cancer Research Group, a not-for-profit company focused on the generation and dissemination of genetic and clinical data on cancers of importance in Asia. Dr. Blanchard received a BS degree in chemistry in 1977, a PhD in Biochemistry in 1982, and an MD in 1985 from Indiana University. He completed a residency in Internal Medicine and fellowships in Hematology and Medical Oncology at the Brigham and Womens Hospital, the Dana Farber Cancer Institute, and Harvard Medical School in 1990. Dr. Blanchard was a Damon Runyon Fellow and a Fellow of the American Cancer Society. Prior to coming to Eli Lilly and Company in 2000, he was a tenured Professor of Medicine and Biochemistry & Molecular Biology at Louisiana State University Health Sciences Center in Shreveport, LA. He has had multiple global roles in Lilly Research Laboratories including Senior Clinical Research Physician in Program Phase Oncology, Chief Scientific Officer Cancer Discovery, Executive Director of Cancer Discovery & Lilly Systems Biology-Singapore, Chief Operating Officer/Vice-President of Discovery Research and Vice-President of Integrative Biology, and Vice-President of Tailored Therapeutics. He was a member of the board for Lilly China and Zymeworks INC and is a member of the board for The Confucius Institute in Indianapolis; he is also a member of the scientific advisory board for CBmed GmbH in Graz, Austria.
        Topic: Development and Commercialization of Globally Innovative Medicines in China
        Bullet Points:
        -- The benefits and challenges of developing globally innovative medicines in China
        -- The benefits and challenges of having multiple global partners
        -- What the future will bring to the pharmaceutical industry in China


        尹鹤群 博士
        首席科学官
        齐鲁制药

        Bio: Hequn Yin is currently CSO of Qilu Pharma. Prior to joining Fosun, Hequn was a VP of Pfizer Oncology R&D in California, USA. Before Pfizer, he spent nearly 20 years with Novartis in New Jersey, USA where he held positions of increasing responsibility from a Sr scientist to an Executive Director. Hequn also worked at Hoffmann-La Roche in New Jersey during 1997-98.

        Hequn received a B.S. in chemistry from Peking (Beijing) University in 1985 and a M.S. from the Chinese Academy of Sciences in 1988. He earned a PhD degree in pharmacology from the University of Rochester, USA in 1995. Subsequently he conducted post-doctoral research in molecular biology & biochemistry at UC San Francisco, USA between 1995 and 1997. He also attend the eMBA program at Fairleigh Dickinson University in New Jersey.

        周敬业 博士
        首席执行官兼联合创始人
        诚益生物
        Bio: Dr. Zhou is Chief Executive Officer and co-founder of Eccogene. Prior to founding Eccogene, Dr. Zhou was the head of chemistry at Lilly China R&D Center, where he led project teams to achieve candidate selection milestones for diabetes and diabetic complications. Before joining Lilly in 2012, Dr. Zhou was investigator at GlaxoSmithKline working on drug discovery campaigns utilizing disruptive DEL technology. Dr. Zhou began his career at Tetraphase pharmaceutical, where he co-invented Eravacycline, an FDA approved drug for cIAI. He holds a Ph.D. in chemistry from Brandeis University and received a B.S. in life science from Fudan University.
        Topic: Challenges and Opportunities of NASH drug discovery
        -- Challenges of NASH drug discovery
        -- Opportunities of next wave NASH drug discovery
        -- Emerging NASH treatment strategy


        鲁先平 博士
        董事长兼首席执行官
        深圳微芯生物

        Bio: Dr. Xian-Ping Lu founded Shenzhen Chipscreen Biosciences, the leading drug discovery and development company in China focusing on innovative small molecular therapeutics, 19 years ago with a group of US-trained professionals. Previously he was Director of Research at Galderma R&D in Princeton until 2000, the year he became visiting professor at China’s State Key Laboratory for Biomembrane and Membrane Biotechnology in Tsinghua University. He also participated in founding Galderma Research Inc. and Maxia Pharmaceuticals in San Diego around 1994.

        Dr. Lu came to the US in 1989 for postgraduate fellowship study at the Department of Pharmacology, University of California in San Diego, followed by research at La Jolla Cancer Research Foundation (Burnham Institute). He obtained his Ph.D. in Molecular Biology and M.S. in Biochemistry from Peking Union Medical College, Chinese Academy of Medical Sciences, and his B.S. degree in Biochemistry from Sichuan University.

        With over 30 years of biomedical research and biotech/pharmaceutical experiences in various therapeutic areas, Dr. Lu is a skilled leader of diverse groups in global operating settings. He has published more than 100 peer-reviewed papers in prestigious journals including Nature, Science and The Lancet Oncology. He is the lead inventor of over 100 patented inventions in areas of small molecule therapeutics.
        Topic: Exploration of Epigenetic Modulation as a New Anti-cancer Treatment
        -- Relapse, metastasis and drug resistance still a great challenge facing in today’s therapeutic treatment
        -- Epigenetic aberrations in cancer development is a key process to target on the above-mentioned challenges
        -- Scientific effort to develop a novel epigenetic modulator as a new cancer treatment from blood cancer to solid tumors


        陆阳 博士
        总裁兼首席执行官
        圣诺制药
        Topic: Advancing siRNA Therapeutics for Enhancing Antitumor Activity of Immune Checkpoint Inhibitor
        Abstract: 
        Using a proprietary and optimized polypeptide nanoparticle-based delivery technology, we have developed the novel anti-fibrosis and anti-cancer therapeutics with siRNAs targeting both TGFβ1 and Cox-2 simultaneously (STP705), resulting in human fibroblasts apoptosis. STP705 was initially used for local treatments for skin hypertrophic scar and non-melanoma skin cancer. STP707 (a systemic formulation of STP705) was further advanced for treatment of liver fibrosis and cholangiocarcinoma, both of these indications have received Orphan drug designations by US FDA. Using a mouse syngeneic model of hepatocellular carcinoma, we tested a therapeutic potential of antitumor activity with a combination of STP707 and PD-L1 mAb. After multiple IV administrations twice a week, both single agent of STP707 and the combination treatments resulted in strong antitumor activity, more potent than those treated with Sorafenib and PD-L1 alone. Those antitumor activity were further supported by significant increase of CD8+ and CD4+ T cell infiltrations into the tumor tissue. I will discuss the unique advantage of our Polypeptide Nanoparticle (PNP) technology platform for safe and efficient siRNA delivery, and our strategy for advancing multiple clinical studies ongoing in both USA and China.

        万昭奎 博士
        创始人兼首席执行官
        凌科药业
        Bio: 万昭奎博士:波士顿大学博士、哈佛博士后;现任凌科药业董事长兼总经理。凌科药业主要聚焦肿瘤、免疫和炎症等疾病领域;公司成立两年多以来,已经开始建立了丰富的产品管线,并开启了国际合作的篇章,包括近期成功完成的一项海外技术授权(近2亿美金首付款和里程碑付款,加上两位数的销售提成)。万博士曾就职于强生亚太研发中心,领导该中心的化学及相关部门。就任强生之前,万博士曾在辉瑞/惠氏工作十二年,历任团队和项目负责人兼博士后导师。万博士至今涉足于多个疾病领域并为个临床和上市药物做出了显著贡献。万博士2008年入选为美国化学会工业界优秀青年科学家 (Young Industrial Investigators Award)2015年入选为英国皇家化学会皇家化学会会士 (Fellow of the Royal Society of Chemistry) 2017年入选为美国癌症协会癌症化学研究执行委员会委员。万博士至今已发表了近40多篇科技论文和140多个国际/国家专利。万博士为美中生物医学协会共同创始人、美中生物医药开发协会前理事;百华协会终身会员。

        罗文 博士
        首席执行官兼首席科学官
        索元生物  

        Bio: Dr. Wen Luo has over 20 years of experience in biomedical research and industry including more than 15 years of experience in applying genomic technology in drug discovery and development. Prior to founding Denovo Biopharma, Dr. Luo managed the genomic group and provided bioinformatic support to a broad range of research projects across a number of therapeutic areas including oncology, hematology, inflammation and metabolic diseases at Ligand Pharmaceuticals. He was also responsible for developing clinical biomarkers for drugs in various stages of clinical trials. Before joining Ligand, he was a senior scientist for bioinformatics at Incyte Genomics, where he managed one of the largest proteomic databases, LifePro. He was also involved in discovering novel human genes and splice variants, and was the co-inventor of patents covering hundreds of novel genes derived from these findings. Prior to Incyte Genomics, he was a research scientist at Sugen, which had been acquired by Pharmacia, where he worked on drug target identification and validation for a number of novel kinases discovered at Sugen. Dr. Luo was a Howard Hughes Medical Institute post-doc fellow at the University of California, San Francisco, and received his Ph.D. in Molecular Biology and Biochemistry from Indiana University School of Medicine. Dr. Luo received pre-med training at Peking University and medical training at Peking Union Medical College.
        TopicInnovative Approach to Develop First-in-class drugs Globally with Precision Medicine

        包骏 博士
        总裁兼首席执行官
        英派药业
        Bio: Dr. Jun Bao, President & CEO, with more than 20 years of comprehensive experience in the production and research, extensive experience in drug research and development, technology transfer, licensing and business development, venture investment, entrepreneurship and corporate finance. Before IMPACT Therapeutics, he was SVP & CBO at Shenogen Pharma. He also worked as Director of corporate development and financial planning in Onyx followed by Director of Worldwide BD & Head of China BD in GSK. Moreover, in Seattle, he worked at ICOS Corporation and Cell Therapeutics as a business development executive with progressive responsibilities. Dr. Bao has MBA degree from Univ. of Chicago, PhD degree from Univ. of Kansas and postdoc training at Johns Hopkins School of Medicine. He also served Director of Board of BayHelix.
        TopicSmall Molecule, Big Impact  Targeting Synthetic lethality for Anticancer Therapy

        谢沐风
        上海市食品药品检验所

        【“基因毒性杂质和元素杂质控制策略与分析方法”圆桌讨论】
        谢沐风观点:
        1. 中国药监局要有独立思考。不要被欧美药监局牵着鼻子走
        2. 研发和控制过度就是过犹不及,现今我国的杂质理念已步入误区
        3. “水至清则无鱼”的道理同样适用于药物研发和质控

        【注射剂一致性评价&焦点问题论坛】
        本人发言题目:我国注射剂目前存在问题和临床疗效与原研药的差距
        大纲:
        1. 目前问题主要体现在注射用粉末剂型,其他液体类注射剂质量与原研药无差距。
        2. 强烈呼吁“切勿将注射剂一致性评价变成杂质研究的航空母舰”。
        3. 注射用粉末剂型关键性药学评价指标与目前质量现状。

        【口服固体制剂开发思路与策略论坛】
        本人发言题目:对于口服固体制剂仿制药研发美日差异、中国应各取所长
        大纲
        1. 知晓原研药好在哪儿、才能把仿制药仿到位。
        2. 如何将BE试验成功率提升至90%以上?
        3.  BE试验是金标准吗?仿制药的最高境界是什么?

        Session Sponsor Speech:
        肖毅博士
        项目研发中心高级副总裁,负责工艺开发
        凯莱英医药集团
        Bio: 肖毅博士于20189月加入凯莱英医药集团担任项目研发中心高级副总裁,负责工艺开发,导入提高研发水平和效率的新技术,以及工艺研发与上下游部门间的协调与整合。肖博士1991年获日本名古屋大学博士学位(师从2001年诺贝尔奖得主野依良治教授)、后在美国科罗拉多州立大学L. Hegedus教授研究室进行博士后研究。肖毅博士曾任职于美国默沙东和施贵宝的工艺部门,有超过20年的制药工艺的研发经验,并为施贵宝公司创建了催化剂研究实验室,导入高通量筛选技术和以数据库为基础的工作流程。期间参与了数十个研发项目。已经发表过50篇论文,赢得了包括绿色化学总统奖在内的多个国际大奖,在世界各地发表过40余次的学术讲演,目前是2018年制药化学反应与工艺会议的组委会成员之一,2019年美国有机反应与工艺的Gordon会议的工业界主席

        李建昌 博士
        首席执行官
        桑迪亚
        Bio: Dr. Jim Li is chief executive officer of Sundia. In this role, Dr. Li is responsible for the oversight of all business divisions across the organization as well as formulating and driving key strategies for diversifying and growing the company. Dr. Li also leads the company’s executive committee, helping to drive Sundia’s overall global strategy.
        Dr. Li has led a distinguished career in the pharmaceutical industry, having spent over 18 years at various companies including Henkel, Wyeth, Pfizer and Wuxi Apptec in the area of process research and medicinal chemistry. During his career, he was involved in numerous drug discovery programs such as COPD, asthma, Rheumatoid/osteoarthritis, and diabetes. Dr. Li has co-authored more than 60 research articles and patents.
        Dr. Li received his Ph.D in Organic Chemistry from University of Central Lancashire UK followed by a postdoctoral fellow at the University of Chicago with Dr. Philip Eaton


        章世杰 博士
        首席技术官
        药石科技
        Bio: Dr. Shijie Zhang, currently serving as Chief Technology Officer at PharmaBlock, is leading initiative to extend the team’s competence in process development and manufacturing to support clients’ late phase and commercial programs. Dr. Shijie Zhang has 20 years of combined experience in medicinal chemistry, process chemistry, and API manufacturing. Before joining PharmaBlock, he led the CMC API team at Agios for the two FDA-approved therapies (Idhifa®, Tibsovo®), by managing and overseeing API development programs and manufacturing activities spanning from preclinical stage to commercial stage, and preparing API sections of regulatory filing documents, including IND, IMPD, NDA, and briefing documents.

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