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
时间：2020-10-13 09:00 至 2020-10-14 17:00
湖南忆融速配 会议时间： 2020-10-13 09:00至 2020-10-14 17:00结束
|药企（Pharma/Biotech） 团队票买三赠一||￥4800.0||2020-10-12 17:00|
|非药企（Service / Solution Providers） 团队票买三赠一||￥6800.0||2020-10-12 17:00|
湖南忆融速配 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宣传图
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、中国创新型生物技术及制药广发证券
-- 汇聚中国制药产业 “源动力”: 我国制药产业发展现状与趋势
-- 商业化制剂设计, 研发与中试放大, 技术及法规要求
-- CMC的挑战和策略, 处方工艺设计
-- 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
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.大费城美中医药协会
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
2003年8月 ~ 2004年2月
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。
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).
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 (). 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
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. 广发证券 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广发证券 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医药广发证券 ）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.
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.
副总裁, 药物开发与生产 (CMC)
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）有限广发证券 常务副总经理, 上海睿智化学研究有限广发证券 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.
常务副总裁, 药物开发与生产 (CMC)
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.
副总裁, 药物开发与生产 (CMC)
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
副总裁, 药物开发与生产 (CMC)
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.
高级副总裁, 药物开发与生产 (CMC)
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)
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
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
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.
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.
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
-- 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:
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，并为施贵宝广发证券 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
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
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