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亚太药物研发领袖峰会(APRDL 2020)通知
点击次数:39842 发布日期:2020-8-21  来源:本站 本站原创,转载请注明出处
特色原料药. 定制合成. CMC工艺策略. 新型制剂 研发领袖峰会2020

亚太药物研发领袖峰会2020 ( APRDL 2020) -- 从新药研发到商业化生产

特色原料药. 定制合成. CMC工艺策略. 新型制剂 研发领袖峰会2020
 
2020年10月13日-14日 | 上海浦东锦江汤臣洲际大酒店  ”
 
峰会网址: www.aprdl2020.com
 
定于10月13-14日于上海浦东汤臣洲际大酒店由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、中国创新型雷竞技下载不了技术及制药公司、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’)

特邀演讲嘉宾:
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?
谢沐风 介绍
1990年~1995年 沈阳药科大学 日语药学专业本科毕业
1995年~1998年 沈阳药科大学 药物分析专业硕士研究生毕业
1998年~至今 上海市食品药品检验所工作 专业职称:副主任药师
主要从事化学药品的仿制药复核、药典起草、进口药品质量标准复核、现场考核和质量标准制订等工作。 
2003年8月 ~ 2004年2月
赴日本国立医药品食品卫生研究所(即国家药品检验所)药品部进修。
详细了解了发达国家对于药品的审评要点与技术要求;师从《日本药品品质再评价工程(即仿制药质量一致性评价)》“总设计师”系统学习了实施细节与技术应用,掌握了“如何采用多条特征溶出曲线评价口服固体制剂品质”方法与手段,深刻了解了溶出度试验对于仿制药的重大意义和举足轻重的作用,以及发达国家如何提高和控制药品内在品质的具体措施与手段。 
截止目前,发表了80多篇药品品质评价方法的思路类文章,尤多篇溶出度和有关物质研究文章引起业内瞩目。
2007年1月 曾担任国家发改委价格司药品价格处顾问。
2008年起~至今 担任国家药品监督局高级培训学院、全国医药技术市场协会等“化学药品质量研究”授课教师。
2009年1月、在国内知名的药学网站——丁香园创立“溶出度研究”专栏,登载了撰写的10多万字相关内容。
2009年~2012年 任国家食品药品监督管理局市场监督办公室专家顾问 负责指导“全国评价性抽验工作”,并首次全面引入了“如何利用体外多条溶出曲线评价口服固体制剂内在品质”的作法,发现了部分国产上市品体外多条溶出曲线与原研品的显著性差异,从而为临床疗效和毒副作用上的差距提供了佐证,为2012年初国家推出“仿制药质量与疗效一致性评价工作”奠定了基础。
2010年 曾担任国家药品审评中心顾问,主持编译了《日本橙皮书——多条溶出曲线数据库》和《日本仿制药雷竞技下载不了等效性试验系列指导原则》等。
2012年6月~2013年10月 担任《国家仿制药一致性评价项目》办公室专家,参与起草了《如何测定原研制剂多条特征溶出曲线指导原则》、《如何进行仿制品与原研品多条溶出曲线比较指导原则》和具体品种比较法。
2013年12月 在国内知名药学网站——丁香园创立“杂质研究与品质评价”专栏,登载了撰写的10多万字相关内容。截止目前,溶出度专栏和杂质专栏的内容已成为国内研发人员的《必读手册》。
担任《中国医药工业杂志》、《药品评价(医院药学版)杂志》编委
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
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. 他曾任中美雷竞技下载不了技术和制药协会理事长和会长 . 2003年, 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
Topic: CMC的挑战和策略, 处方工艺设计

Dr. Deepak Hegde 
资深副总裁, 药物开发与生产 (CMC) 
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 Senior Vice President-CMC. 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 NCE’s. 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. 
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.
尹鹤群 博士
首席科学官 
复星医药

Hequn Yin is currently CSO of Fosun 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.
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 Pfizer’s 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 Alzheimer’s 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 2019. Prior 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 Women’s 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
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2018年9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.
部分确认的赞助商及展商包括:
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 );
安捷伦科技(中国)有限公司 ( Agilent ); 保诺科技(北京)有限公司 ( BioDuro ); 上海泓博智源医药股份有限公司 ( Pharma Resources )   
南京明捷雷竞技下载不了医药检测有限公司 ( Milestone Pharma ) ; 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 )
苏州晶云药物科技股份有限公司 ( Crystal Pharmatech ) ; 庄信万丰医药服务烟台有限公司 ( Johnson Matthey Pharmaceutical Services ) ; 苏州诺衡( PRIMELONG )  etc.,

Preliminary Agenda and highlighting Part of the Plenary Keynote Speakers:
 


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
泰励雷竞技下载不了科技
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)
罗欣雷竞技下载不了科技(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
博瑞雷竞技下载不了医药(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
成都苑东雷竞技下载不了制药股份有限公司
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
上海时莱雷竞技下载不了技术有限公司
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, 浙江创新雷竞技下载不了有限公司
Nanjing Delova Biotech
南京清普雷竞技下载不了科技有限公司
Genor Biopharmaceutical
嘉和雷竞技下载不了
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
成都苑东雷竞技下载不了制药股份有限公司
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雷竞技下载不了技术公司
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
瑞博雷竞技下载不了
Ark Biosciences
爱科百发雷竞技下载不了医药公司
Innovent Biologics
信达雷竞技下载不了
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
安进雷竞技下载不了医药研发(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
诚益雷竞技下载不了
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
苏州偶领雷竞技下载不了
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
深圳微芯雷竞技下载不了
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
信达雷竞技下载不了
Phanes Therapeutics
凡恩世雷竞技下载不了
Abbisko
和誉雷竞技下载不了
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
海和雷竞技下载不了
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
信达雷竞技下载不了
CStone Pharmaceutical
基石药业
Everest Medicines
云顶新耀
Genor BioPharm
嘉和雷竞技下载不了
Hutchison MediPharma
和记黄埔
Elpiscience Biopharmaceuticals
科望医药
Clover Biopharmaceuticals
三叶草雷竞技下载不了制药
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
索元雷竞技下载不了
I-Mab Biopharma
天境雷竞技下载不了
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
拓臻雷竞技下载不了
Zhongsheng Pharmaceutical
众生药业
Sciwind Biosciences
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Ascletis Pharma
歌礼制药
CHIA TAI TIANQING
正大天晴
HighTide Therapeutics
深圳君圣泰雷竞技下载不了技术有限公司
PegBio
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Shenzhen Chipscreen Bioscientces
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Contact us
Kevin Tan
Conference Producer and Project Director
Organizing Committee
Asian Pharma R&D Leaders Summit 2020
T +86 21 6157 7321 | M +86 136 4196 1545  
kevin.tan@deliver-consulting.com
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