定于10月13-14日于上海浦東湯臣洲際大酒店由Deliver Life Sciences 主辦、大費城美中醫(yī)藥協(xié)會支持的亞太藥物研發(fā)領袖峰會2020，邀請 政府監(jiān)管機構、產(chǎn)業(yè)園區(qū)、行業(yè)協(xié)會、科研院校、臨床中心、中國創(chuàng)新型生物技術及制藥公司、特色原料藥及醫(yī)藥中間體研發(fā)企業(yè)、高端仿制藥研發(fā)企業(yè)、 新藥研發(fā)平臺、跨國制藥中國研發(fā)及創(chuàng)新中心、醫(yī)藥研發(fā)服務公司、臨床試驗研究機構、人工智能以及解決方案提供商、律所、投資以及咨詢機構等藥物研發(fā)領袖及高層代表共同探討并促進 ：

-- 匯聚中國制藥產(chǎn)業(yè) “源動力”:  我國制藥產(chǎn)業(yè)發(fā)展現(xiàn)狀與趨勢
-- 關鍵中間體的工藝開發(fā)、中試、商業(yè)化生產(chǎn)
-- 藥物分子砌塊的研發(fā)和工藝生產(chǎn)
-- 早期臨床用藥生產(chǎn)及原料藥及制劑藥學研究
-- 商業(yè)化制劑設計, 研發(fā)與中試放大, 技術及法規(guī)要求
-- 新藥創(chuàng)新中的原料藥工藝開發(fā)
-- 料藥工業(yè)生產(chǎn)中的雜質控制與系統(tǒng)研究
-- CMC的挑戰(zhàn)和策略, 處方工藝設計
-- QbD質量源于設計--創(chuàng)新設計與安全性考量
-- 基因毒性和元素雜質的控制策略和分析方法
-- 基于QbD理念的高端制劑仿制藥的研發(fā)策略
-- 仿制藥首仿策略，產(chǎn)品開發(fā)與一致性評價
-- 仿制藥BE臨床試驗開發(fā)策略及
-- 高端仿制藥研發(fā)與產(chǎn)業(yè)化的發(fā)展機遇
-- 制劑處方工藝開發(fā)與放大
-- 創(chuàng)新藥物研發(fā): 核酸干擾(RNAi)藥物: 抗病毒藥物: KRAS抑制劑: TGF-B抑制劑; MEK 抑制劑的開發(fā)
-- 創(chuàng)新藥物研發(fā): 加速小分子創(chuàng)新藥（小分子靶向抗腫瘤藥） 中國研發(fā)-- 契機與挑戰(zhàn)
-- 促進源于中國的創(chuàng)新-創(chuàng)新藥物研發(fā)與合作
-- 臨床開發(fā)策略，藥物警戒與上市后藥品不良反應監(jiān)測
-- 知識產(chǎn)權、專利與投融資機遇

同時為國內外專家高端交流，產(chǎn)業(yè)與資本對接搭建平臺。我們誠摯地邀請您出席本屆2020亞太藥物研發(fā)領袖峰會(‘APRDL 2020’)

特邀演講嘉賓：
謝沐風
上海市食品藥品檢驗所
【“基因毒性雜質和元素雜質控制策略與分析方法”圓桌討論】
謝沐風觀點：
1. 中國藥監(jiān)局要有獨立思考。不要被歐美藥監(jiān)局牽著鼻子走
2. 研發(fā)和控制過度就是過猶不及，現(xiàn)今我國的雜質理念已步入誤區(qū)
3. “水至清則無魚”的道理同樣適用于藥物研發(fā)和質控
【注射劑一致性評價&焦點問題論壇】
本人發(fā)言題目：我國注射劑目前存在問題和臨床療效與原研藥的差距
大綱：
1. 目前問題主要體現(xiàn)在注射用粉末劑型，其他液體類注射劑質量與原研藥無差距。
2. 強烈呼吁“切勿將注射劑一致性評價變成雜質研究的航空母艦”。
3. 注射用粉末劑型關鍵性藥學評價指標與目前質量現(xiàn)狀。
【口服固體制劑開發(fā)思路與策略論壇】
本人發(fā)言題目：對于口服固體制劑仿制藥研發(fā)美日差異、中國應各取所長
大綱
1. 知曉原研藥好在哪兒、才能把仿制藥仿到位。
2. 如何將BE試驗成功率提升至90%以上？
3.  BE試驗是金標準嗎？仿制藥的最高境界是什么？
謝沐風 介紹
1990年~1995年 沈陽藥科大學 日語藥學專業(yè)本科畢業(yè)
1995年~1998年 沈陽藥科大學 藥物分析專業(yè)碩士研究生畢業(yè)
1998年~至今 上海市食品藥品檢驗所工作 專業(yè)職稱：副主任藥師
主要從事化學藥品的仿制藥復核、藥典起草、進口藥品質量標準復核、現(xiàn)場考核和質量標準制訂等工作。 
2003年8月 ~ 2004年2月
赴日本國立醫(yī)藥品食品衛(wèi)生研究所（即國家藥品檢驗所）藥品部進修。
詳細了解了發(fā)達國家對于藥品的審評要點與技術要求；師從《日本藥品品質再評價工程（即仿制藥質量一致性評價）》“總設計師”系統(tǒng)學習了實施細節(jié)與技術應用，掌握了“如何采用多條特征溶出曲線評價口服固體制劑品質”方法與手段，深刻了解了溶出度試驗對于仿制藥的重大意義和舉足輕重的作用，以及發(fā)達國家如何提高和控制藥品內在品質的具體措施與手段。 
截止目前，發(fā)表了80多篇藥品品質評價方法的思路類文章，尤多篇溶出度和有關物質研究文章引起業(yè)內矚目。
2007年1月 曾擔任國家發(fā)改委價格司藥品價格處顧問。
2008年起~至今 擔任國家藥品監(jiān)督局高級培訓學院、全國醫(yī)藥技術市場協(xié)會等“化學藥品質量研究”授課教師。
2009年1月、在國內知名的藥學網(wǎng)站——丁香園創(chuàng)立“溶出度研究”專欄，登載了撰寫的10多萬字相關內容。
2009年~2012年 任國家食品藥品監(jiān)督管理局市場監(jiān)督辦公室專家顧問 負責指導“全國評價性抽驗工作”，并首次全面引入了“如何利用體外多條溶出曲線評價口服固體制劑內在品質”的作法，發(fā)現(xiàn)了部分國產(chǎn)上市品體外多條溶出曲線與原研品的顯著性差異，從而為臨床療效和毒副作用上的差距提供了佐證，為2012年初國家推出“仿制藥質量與療效一致性評價工作”奠定了基礎。
2010年 曾擔任國家藥品審評中心顧問，主持編譯了《日本橙皮書——多條溶出曲線數(shù)據(jù)庫》和《日本仿制藥生物等效性試驗系列指導原則》等。
2012年6月~2013年10月 擔任《國家仿制藥一致性評價項目》辦公室專家，參與起草了《如何測定原研制劑多條特征溶出曲線指導原則》、《如何進行仿制品與原研品多條溶出曲線比較指導原則》和具體品種比較法。
2013年12月 在國內知名藥學網(wǎng)站——丁香園創(chuàng)立“雜質研究與品質評價”專欄，登載了撰寫的10多萬字相關內容。截止目前，溶出度專欄和雜質專欄的內容已成為國內研發(fā)人員的《必讀手冊》。
擔任《中國醫(yī)藥工業(yè)雜志》、《藥品評價（醫(yī)院藥學版）雜志》編委
李敏 博士
副總裁, 分析領域首席科學家
浙江華海藥業(yè)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
總裁兼首席運營官, 聯(lián)合創(chuàng)始人
亞盛醫(yī)藥集團
Topic: 早期臨床用藥生產(chǎn)及原料藥及制劑藥學研究
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
吳振平 博士
資深副總裁, 藥學負責人
和記黃埔醫(yī)藥
Topic: 商業(yè)化制劑設計, 研發(fā)與中試放大, 技術及法規(guī)要求
Bio: 藥學研發(fā)專家, 具近30年藥學開發(fā)經(jīng)驗. 領導過多個項目的研發(fā)團隊, 將多個新藥候選藥物推進至臨床各個階段和市場, 包括舒尼替尼（Sutent）- 由輝瑞研發(fā)的新型具重磅炸彈潛力的抗癌藥物。吳振平博士于2008年起至今任職和記黃埔醫(yī)藥，負責組建藥學和生產(chǎn)部門. 公司已經(jīng)成功將十數(shù)個研發(fā)藥品推向臨床研究, 包括在中國和美國進行的研究. 多個項目已經(jīng)進入或完成三期臨床研究, 其中抗癌新藥呋喹替尼已經(jīng)上市. 
吳博士曾在位于加州的藥物研發(fā)公司Phenomix任藥學部高級總監(jiān). 在此之前, 他曾擔任輝瑞圣地亞哥全球研發(fā)中心（前稱為Agouron醫(yī)藥公司）藥物開發(fā)部總監(jiān), 更早之前在羅氏加州研發(fā)中心（Roche Palo Alto）任資深科學家. 吳博士于香港大學獲得博士學位并在加州大學爾灣分校取得了MBA學位. 他曾任中美生物技術和制藥協(xié)會理事長和會長 . 2003年, 他因舒尼替尼（Sutent）項目獲得輝瑞杰出員工獎. 他帶領的索凡替尼課題組榮獲2010年度和記黃埔醫(yī)藥優(yōu)秀團隊獎. 
張世英 博士
副總裁, 藥學負責人(CMC)
迪哲醫(yī)藥
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.
單波 博士
副總裁, 藥物開發(fā)與生產(chǎn) (CMC)
德琪醫(yī)藥
Topic: 原料藥工業(yè)生產(chǎn)中的雜質控制與系統(tǒng)研究  /  結合實際生產(chǎn)中的案例介紹了相應的分離解決策略 /  CMC的挑戰(zhàn)和策略, 處方工藝設計
Bio: 單波博士具有超過17年在歐美,中國的新藥和仿制藥研發(fā)和生產(chǎn)經(jīng)驗. 目前是德琪醫(yī)藥負責藥物早期研發(fā)和生產(chǎn)的副總裁. 單波博士曾經(jīng)帶領團隊完成共計1個國家一類新藥的申報上市,多個處于I-III期臨床試驗的一類新藥,以及一系列臨床前的項目開發(fā).單波博士帶領團隊完成了一個國家一類新藥生產(chǎn)基地從設計,土建,裝修,設備采購到工藝驗證和試生產(chǎn)的全過程,包括兩條API生產(chǎn)線,一條固體制劑生產(chǎn)線,并且于2018年通過了國家注冊現(xiàn)場和GMP動態(tài)核查.
單波博士曾先后擔任歌禮藥業(yè)副總裁,凱惠藥業(yè)（上海）有限公司常務副總經(jīng)理, 上海睿智化學研究有限公司執(zhí)行總監(jiān),GE Healthcare英國研發(fā)中心科學家等職務.單博士具有英國Aston大學藥物化學博士學位.
杜爭鳴 博士
高級副總裁, 藥學部首席總監(jiān)
百濟神州
Topic: 從新藥研發(fā)到商業(yè)化生產(chǎn) 
陳曦 博士
常務副總裁, 藥物開發(fā)與生產(chǎn) (CMC)
盛諾基醫(yī)藥
Topic: 新藥創(chuàng)新中的原料藥工藝開發(fā)
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.
佘勁 博士
副總裁, 藥物開發(fā)與生產(chǎn) (CMC)
華領醫(yī)藥
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: 從新藥研發(fā)到商業(yè)化生產(chǎn): CMC的挑戰(zhàn)與策略
馮濤 博士
副總裁, 藥物開發(fā)與生產(chǎn) (CMC)
來凱醫(yī)藥
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.
胡新輝 博士
高級副總裁, 藥物開發(fā)與生產(chǎn) (CMC)
云頂新耀
Topic: CMC的挑戰(zhàn)和策略, 處方工藝設計
Dr. Deepak Hegde 
資深副總裁, 藥物開發(fā)與生產(chǎn) (CMC) 
億騰景昂藥業(yè)
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
首席科學官
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
創(chuàng)始人兼首席執(zhí)行官
齊魯銳格 
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.
尹鶴群 博士
首席科學官 
復星醫(yī)藥
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.
邊鋒 博士
科學與創(chuàng)新高級總監(jiān)
輝瑞制藥
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 ( 云頂新耀 )
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
項目研發(fā)中心高級副總裁，負責工藝開發(fā)
凱萊英醫(yī)藥集團
Bio: 肖毅博士于2018年9月加入凱萊英醫(yī)藥集團擔任項目研發(fā)中心高級副總裁，負責工藝開發(fā)，導入提高研發(fā)水平和效率的新技術，以及工藝研發(fā)與上下游部門間的協(xié)調與整合。肖博士1991年獲日本名古屋大學博士學位（師從2001年諾貝爾獎得主野依良治教授）、后在美國科羅拉多州立大學L. Hegedus教授研究室進行博士后研究。肖毅博士曾任職于美國默沙東和施貴寶的工藝部門，有超過20年的制藥工藝的研發(fā)經(jīng)驗，并為施貴寶公司創(chuàng)建了催化劑研究實驗室，導入高通量篩選技術和以數(shù)據(jù)庫為基礎的工作流程。期間參與了數(shù)十個研發(fā)項目。已經(jīng)發(fā)表過50篇論文，贏得了包括綠色化學總統(tǒng)獎在內的多個國際大獎，在世界各地發(fā)表過40余次的學術講演，目前是2018年制藥化學反應與工藝會議的組委會成員之一，2019年美國有機反應與工藝的Gordon會議的工業(yè)界主席
李建昌 博士
首席執(zhí)行官
桑迪亞
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
首席技術官 
藥石科技
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.
部分確認的贊助商及展商包括:
樂威醫(yī)藥 ( Laviana ) ; 南京藥石科技股份有限公司 ( PharmaBlock ) ; 桑迪亞醫(yī)藥技術（上海）有限責任公司 ( Sundia ) ; 凱萊英醫(yī)藥集團  (  Asymchem Laboratories );
安捷倫科技(中國)有限公司 ( Agilent ); 保諾科技(北京)有限公司 ( BioDuro ); 上海泓博智源醫(yī)藥股份有限公司 ( Pharma Resources )   
南京明捷生物醫(yī)藥檢測有限公司 ( Milestone Pharma ) ; 杭州劑泰醫(yī)藥科技有限責任公司 ( METiS Pharmaceuticals ) ; 成都先導藥物開發(fā)有限公司 ( HitGen )
蘇州晶云藥物科技股份有限公司 ( Crystal Pharmatech ) ; 莊信萬豐醫(yī)藥服務煙臺有限公司 ( Johnson Matthey Pharmaceutical Services ) ; 蘇州諾衡( PRIMELONG )  etc.,

Preliminary Agenda and highlighting Part of the Plenary Keynote Speakers:
2020 Speakers Inviting/Confirming and Topic Proposals/ 2020部分擬邀請發(fā)言人及演講提案(草案)

Job Title/Affiliation 職稱及單位信息	Presentation Topic 演講題目
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 上海張江高科技園區(qū)開發(fā)股份有限公司	Shanghai Institute for Food and Drug Control 上海市食品藥品檢驗所
Tyligand Bioscience 泰勵生物科技	Abravit BioPharm
Huahai Pharmaceutical 華海藥業(yè)	Desano Pharmaceuticals 上海迪賽諾藥業(yè)
Hutchison China MediTech Limited 和黃藥業(yè)	Asieris Pharmaceuticals 亞虹醫(yī)藥
Zhejiang Hisun Pharmaceuticals 海正藥業(yè)	Shanghai SynCores Technologies, 上海科勝藥物研發(fā)有限公司
US Pharmacopeia 美國藥典委員會	Jiangsu Hansoh Pharmaceutical 江蘇豪森藥業(yè)
YSY Phamaceutical 裕松源藥業(yè)有限公司	Changzhou Sunlight Pharm 常州市陽光藥業(yè)集團公司
Basilea Pharmaceutica 巴塞利亞藥業(yè)	Shanghai Institute of Pharmaceutical Industry 上海醫(yī)藥工業(yè)研究院
Shanghai Pharmaceutical Group 上海醫(yī)藥集團	Shandong QiDu Pharmaceutical 山東齊都藥業(yè)
North East Pharm Research Institute 東北制藥集團研究院	Jiangsu Wuzhong Pharmaceutical 江蘇吳中醫(yī)藥集團有限公司
Shandong DISHA Pharmaceutical Company 迪沙藥業(yè)集團	Luoxin BioTechnology (Shanghai) 羅欣生物科技(上海)有限公司
Acebright Pharmaceuticals Group 創(chuàng)諾醫(yī)藥集團	Zhejiang Jingxin Pharmaceutical 浙江京新藥業(yè)股份有限公司
Antengene 德琪醫(yī)藥	BeiGene 百濟神州
Ascletis 歌禮醫(yī)藥	Hua Medicine 華領醫(yī)藥
Shenogen Pharma Group 北京盛諾基醫(yī)藥公司	YAO Pharma 重慶藥友制藥有限責任公司
BrightGene Bio-Medical Technology 博瑞生物醫(yī)藥（蘇州）股份有限公司	STA Pharmaceutical, a WuXi AppTec company 合全藥業(yè)
Jiangsu Tasly Diyi Pharmaceutical 天士力帝益藥業(yè)研發(fā)中心	Asymchem Laboratories 凱萊英醫(yī)藥
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 億騰景昂藥業(yè)	Jiuzhou Pharma 浙江九州藥業(yè)
HEC Pharma 東陽光藥物研究院	Chengdu Easton Biopharmaceuticals 成都苑東生物制藥股份有限公司
南京柏賢醫(yī)藥	National Shanghai Center for New Drug Safety Evaluation and Research, INNOSTAR 國家上海新藥安全評價研究中心
Novast Pharmaceuticals 南通聯(lián)亞藥業(yè)有限公司	Livzon Pharma Research Institute 麗珠集團研究院
Huahai Pharmaceutical 華海藥業(yè)	Shanghai Shilai Bio 上海時萊生物技術有限公司
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 人福普克藥業(yè)	Qilu Pharma   齊魯制藥
Qilu Pharma   齊魯制藥	Abravit BioPharm
Nanjing Sanhome Pharmaceutical 南京圣和藥業(yè)股份有限公司	Sichuan Kelun Pharmaceutical 科倫藥業(yè)
Hengrui Medicine 恒瑞醫(yī)藥	Grand Pharmaceutical 遠大醫(yī)藥
Yangtze River Pharmaceutical Group 揚子江藥業(yè)集團	Simcere Pharmaceutical 先聲藥業(yè)
Chenpon Pharma 上海臣邦醫(yī)藥科技有限公司	Jiangsu Nhwa Pharmaceutical 恩華藥業(yè)藥物研究院
Zhejiang Conba Pharmaceutical 浙江康恩貝制藥股份有限公司	Huahai Pharma 華海藥業(yè)
Shanghai Jingfeng Pharmaceutical 上海景峰制藥	ChiaTai TianQing 南京正大天晴
Hisun 海正藥業(yè)	CSPC Pharmaceutical 石藥集團
Qingfeng Pharmaceutical Group 青峰醫(yī)藥集團	Kunming Longjin Pharmaceutical 昆明龍津藥業(yè)股份有限公司
Shanghai CRMed Science 上海慈瑞醫(yī)藥科技股份有限公司	ZENJI Pharma 正濟藥業(yè)
Novel Technologies, Concepts and Case Studies in Drug Delivery and Formulation Design
Fudan University 復旦大學藥學院	China Pharmaceutical University 中國藥科大學
Roche 羅氏制藥	Chengdu Easton Biopharmaceuticals 正大天晴藥業(yè)
Suzhou Amerigen Pharmaceutical 蘇州愛美津制藥	National Shanghai Center for New Drug Safety Evaluation and Research, INNOSTAR 云頂新耀
Qilu Pharma 齊魯制藥	Livzon Pharma Research Institute 麗珠集團研究院
Qingfeng Pharmaceutical Group, Shanghai Qingrun Pharma 青峰醫(yī)藥集團, 上海青潤醫(yī)藥科技有限公司	Zhejiang Jingxin Pharmaceutical 京新藥業(yè)
Zhejiang Novus Pharmaceuticals l 浙江醫(yī)藥, 浙江創(chuàng)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 迪哲醫(yī)藥
Formulation Strategies for Solid Oral Dosage Form
Anbison Lab; BAHEAL Pharmaceutical Group 上海安必生制藥技術有限公司; 青島百洋制藥有限公司	Novast Laboratories   南通聯(lián)亞藥業(yè)有限公司
Zhejiang Huahai Pharmaceutical 浙江華海藥業(yè)	Abravit BioPharm
Cerecin Cerecin公司	Abbvie 艾伯維
Inhalation Formulation Technologies
OMNI Pharma 上海歐米尼醫(yī)藥科技有限公司	CF PharmaTech 蘇州長風藥業(yè)
PURITY, Chengdu Brilliant Pharmaceutical Group 四川普銳特藥業(yè)	ChiaTai TianQing 正大天晴藥業(yè)
Joincare 健康元藥業(yè)集團	Increase Innovative Medicine 北京盈科瑞創(chuàng)新藥物研究有限公司
Formulation Development, Rational Design & Development of Long-Acting Injectable Dosage Forms
Luye Pharmaceutical Group 綠葉制藥集團	Chengdu Easton Biopharmaceuticals 成都苑東生物制藥股份有限公司
Frontage Lab 方達醫(yī)藥	SAPA
Huiyu Pharma 四川匯宇制藥有限公司	Poly Pharmaceuticals 海南普利制藥股份有限公司
Beijing Tide Pharmaceutical 北京泰德制藥股份有限公司	Sichuan Kelun Pharmaceutical 四川科倫藥物研究院
Yangtze River Pharmaceutical Group 迪康藥業(yè)	Ferring Pharmaceutical 輝凌醫(yī)藥
Livzon Pharmaceutical Group 麗珠醫(yī)藥集團長效微球技術國家地方聯(lián)合工程研究中心	ChiaTai TianQing 南京正大天晴
GENERIC PEPTIDES Development for pharmaceutical Industry
SALUBRIS 深圳信立泰藥業(yè)股份有限公司	Chinese Peptide 中肽生化有限公司
Shenzhen Hanyu Pharmaceutical 深圳翰宇藥業(yè)股份有限公司	Hainan Zhonghe Pharmaceuticals 海南中和藥業(yè)股份有限公司
Novo Nordisk China Research Center 諾和諾德中國	Shanghai Institute for Food and Drug Control 上海市食品藥品檢驗所
Liposome Preparation and Evaluation
Shanghai Jiao Tong University 上海交通大學藥學院/杭州Highfield生物技術公司	Shanghai University of Traditional Chinese Medicine 上海中醫(yī)藥大學
Development of Traditional Chinese Medicine
Shanghai Hutchison Pharmaceuticals 上海和黃藥業(yè)有限公司	Yiling Pharmaceutical 以嶺醫(yī)藥
Shanghai University of Traditional Chinese Medicine 上海中醫(yī)藥大學	Tasly Pharma 天士力醫(yī)藥集團
Innovative Drug Discovery and Development -- RNAi therapeutics, Anti-Viral Combo,  KRAS inhibitors, MEK inhibitors, TGF-beta Receptor Inhibitors
Sirnaomics 圣諾制藥集團	Ascletis 歌禮醫(yī)藥
Suzhou Ribo Life Science 瑞博生物	Ark Biosciences 愛科百發(fā)生物醫(yī)藥公司
Innovent Biologics 信達生物	Zhimeng Biopharma 上海摯盟醫(yī)藥科技有限公司
Jacobio Pharmaceuticals 北京加科思新藥研發(fā)有限公司	Amgen 安進生物醫(yī)藥研發(fā)（上海）有限公司
KeChow Pharma 上海科州藥物研發(fā)有限公司	Ferring Pharmaceutical 勁方醫(yī)藥科技(上海)有限公司
Promoting China Innovation: Accelerating Small Molecule Drug Discovery and Development
Eccogene 誠益生物	IMPACT Therapeutics 英派藥業(yè)
Minghui Pharma 明慧醫(yī)藥	ENNOVA Bio 軼諾藥業(yè)
Fochon Pharmaceuticals 復創(chuàng)醫(yī)藥	TransThera Bio 藥捷安康
HEC Pharma 東陽光藥業(yè)	Autopharm 蘇州偶領生物
Yituo Pharma 奕拓醫(yī)藥	Betta Pharmaceuticals 貝達藥業(yè)
Laekna Therapeutics 來凱醫(yī)藥	Zelgen 澤璟制藥
CSPC 石藥集團	Ascentage Pharma 亞盛醫(yī)藥
Jacobio 北京加科思新藥研發(fā)有限公司	Ionova Bio 原力生命科學有限公司
Shanghai Pharma 上海醫(yī)藥集團	BeiGene 百濟神州
Zhongsheng Pharma 眾生藥業(yè)	XuanZhu Pharma 軒竹醫(yī)藥
Promoting China Innovation: Strengthening Pharma R&D Collaboration and Partnership in Asia & China
FOSUN Pharma 復星醫(yī)藥	Chipscreen Biosciences 深圳微芯生物
CSPC Shanghai Research Institute 石藥集團上海翊石醫(yī)藥技術有限公司	BeiGene  百濟神州
Innovent Biologics 信達生物	Phanes Therapeutics 凡恩世生物
Abbisko 和譽生物	Lynk Pharmaceuticals 凌科藥業(yè)
Hyperway Pharma 海博為藥業(yè)	Pharscin Pharma 華森制藥
Roche 羅氏制藥	Simcere 先聲藥業(yè)
Haiyan Pharmaceutical 上海海雁醫(yī)藥科技有限公司	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 綠葉制藥	Henlius 復宏漢霖
Tasly Pharmaceutical Group 天士力控股	Shineway Pharmaceutical Group 神威藥業(yè)集團
3S Bio 三生制藥	Yabao Pharmaceutical Group 亞寶藥業(yè)集團
OrbiMed Asia 奧博資本	Lilly Asia Ventures 禮來亞洲基金
Qiming Venture 啟明創(chuàng)投	WuXi Ventures 通和毓承
Drug Development Strategies and Safety Monitoring
Merck Research Laboratories 默沙東研發(fā) (中國) 有限公司	Eli Lilly China   禮來中國
IPSEN 法國益普生集團	Novartis 諾華中國
Zai Lab 再鼎醫(yī)藥	Innovent Bio 信達生物
CStone Pharmaceutical 基石藥業(yè)	Everest Medicines 云頂新耀
Genor BioPharm 嘉和生物	Hutchison MediPharma 和記黃埔
Elpiscience Biopharmaceuticals 科望醫(yī)藥	Clover Biopharmaceuticals 三葉草生物制藥
Harbour Biomed 和鉑醫(yī)藥	Zensun 澤生科技
Adlai Nortye Biopharma 阿諾醫(yī)藥	TenNor Therapeutics 丹諾醫(yī)藥
Qilu Pharmaceuticals 齊魯制藥	Denovo Biopharma 索元生物
I-Mab Biopharma 天境生物	Sihuan Pharmaceutical 四環(huán)醫(yī)藥
Luye Pharma 綠葉制藥	Xuanzhu Pharma 軒竹醫(yī)藥
NASH New Drug Development in China
Terns Pharmaceuticals 拓臻生物	Zhongsheng Pharmaceutical 眾生藥業(yè)
Sciwind Biosciences 先為達生物	Ascletis Pharma 歌禮制藥
CHIA TAI TIANQING 正大天晴	HighTide Therapeutics 深圳君圣泰生物技術有限公司
PegBio 派格生物	Shenzhen Chipscreen Bioscientces 微芯生物

 
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  
E kevin.tan@deliver-consulting.com