重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)
重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

药物结晶技术是原料药(DS)与成品药(DP)之间的桥梁,通过此项技术,可以确保小分子药物具有一致且稳健的安全性和有效性。为了充分利用现有技术并开发出更先进的技术来解决新药开发项目遇到的瓶颈问题,博腾股份子公司J-Star 的药物结晶中心(CfPC)将于2021年10月14日至15日(美国时间)联合晶泰科技、BlazeMetrics和Technobis举办第二届全球药物结晶高峰论坛

Crystallization technologies are bridges between drug substances (DS) and drug products (DP) enabling consistent and robust safety and efficacy profiles for small molecule-based medicines. In effort to fully utilize existing tools and develop better methodologies for solving bottleneck problems in new drug development programs, The Center for Pharma Crystallization (CfPC) at J-Star, a subsidiary of Porton is pleased to announce the program of 2nd Pharmaceutical Crystallization Summit to be held on October 14- 15, 2021, jointly with our partners XtalPi, BlazeMetrics, and Technobis.

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本届药物结晶峰会将汇聚利兹大学,MIT、明尼苏达大学、辉瑞、默克、BMS、礼来的顶尖行业专家和学术专家共同探讨原料药结晶的研发和生产,主要涉及领域包括:

The annual Summit gathers leading industrial and academic experts such as University of Leeds, MIT, University of Minnesota, Pfizer, Merck, BMS, Eli Lilly and etc. to discuss their works related to DS crystallization R&D and manufacturing focuses on:

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

赋能技术联盟(ETC)确认的潜在发展领域

Areas of opportunity identified by Enabling Technologies Consortium (ETC)

    ●  晶体结构预测 Crystal structure prediction

    ●  晶体形态预测 Crystal shape prediction

    ●  溶解度评估 Solubility assessment

    ●  纯化 Purification

    ●  分析技术 Analytical technologies

美国国家学院(NASEM)确认的潜在创新领域

Areas of potential innovation identified by National Academies of Sciences, Engineering, and Medicine (NASEM)

   ●  协同加工原料药 Co-processed APIs

   ●  工艺强化 Process intensification

   ●  添加剂生产 Additive manufacturing

   ●  先进工艺控制与自动化 Advanced process control & automation

   ●  模块化系统 Modular systems

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本届论坛采用线上与线下相结合的方式,共有12个主题报告和3个专题讨论。会议将由制药行业专家(SME)主持和参与,涵盖以下专题:

●  更智能的固态研究和预配方研究

●  基于物理属性的结晶工艺研发

●  粒子工程和原料药-成品药协同加工

●  小组专题讨论

This year’s summit will be proceeding as a hybrid (live and virtual) event in 2 days with 12 keynote presentations and 3 topical panel discussions, moderated by SMEs from the pharma industry, covering the following topical sessions:

● Smarter Solid Form and Pre-formulation Studies 

● Physical Property Based Crystallization Process Development

● Particle Engineering and DS-DP Co-Processing

● Topical Panel Discussions

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Thursday, October 14, 2021 (US EDT) 

10月14日20:00至15日5:00(北京时间)

08:00 – 08:10(US EDT) 

20:00 – 20:10(北京时间)

Greetings and opening speech by Chairman, Dr. San Kiang, J-Star /Porton

 大会主席江山 博士(博腾/J-Star)致欢迎词和开幕词

08:10 – 12:00(US EDT)

20:10 – 24:00(北京时间,10月14日)

论坛1:更智能的固态和处方前制剂研究

Session 1: Smarter Solid Form & Pre-formulation Studies

08:10 – 08:15(US EDT)

20:10 – 20:15(北京时间)

Introduction by Moderator, Dr. Shanming Kuang, J-Star/Porton

论坛1主持人  匡善明 博士(博腾/J-Star)介绍论坛安排

08:15 – 09:05(US EDT)

20:15 – 21:05(北京时间)

Development of a Green and Sustainable Manufacturing Process for Gefapixant Citrate (MK-7264):A Solid-State Chemistry Perspective 从固态化学角度出发,开发一项绿色可持续的Gefapixant枸橼酸(MK-7264)生产工艺

Dr. Alfred Lee, Merck Research Laboratories

09:05 – 09:55(US EDT)

21:05 – 21:55(北京时间)

What Solid Form Should I Choose?

如何选择固体形态?

Dr. Ann Newman, Seventh Street Development Group

09:55 – 10:15(US EDT)

 21:55 – 22:15(北京时间)

  Coffee/Tea Break 茶歇

10:15 – 11:05(US EDT)

22:15 – 23:05(北京时间)

Understanding and Controlling the API Form/Powder Property Risks in Drug Substance and Product Processes 了解和控制原料药和成品药工艺期间的原料药晶型/散剂风险

Dr. Shawn Yin, Bristol-Myers Squibb

11:05 – 11:55(US EDT)

23:05 – 23:55(北京时间)

Absolute Structure Determination of API Molecules by MicroED Analysis of Co-Crystals Formed Based on COSMO-RS Prediction 基于COSMO-RS预测的共晶MicroED分析测定原料药分子的绝对结构

Dr. Chandler Greenwell (XtalPi), Dr. Harsh Shah (CfPC/J-Star/Porton) and Dr. Jessica Bruhn (NIS)

11:55 – 12:00(US EDT)

23:55 – 24:00(北京时间)

Closing Remarks by session moderator

论坛主持人致闭幕词

12:00 -13:00  Lunch (Sponsored by XtalPi)

午餐(晶泰赞助),仅限线下会议参与人员

13:00 – 16:45(US EDT)

01:00 – 04:45(北京时间,10月15日)

论坛2:粒子工程和原料药-成品药协同加工

Session 2: Particle Engineering & DS-DP Co-Processing

13:00 – 13:05(US EDT)

01:00 – 01:05(北京时间)

Physical Property Based Crystallization Process Development 基于物理属性的结晶工艺研发

Introduction by Moderator, Dr. San Kiang, J-Star /Porton

主持人 江山 博士(博腾/J-Star)

13:05 – 13:55(US EDT)

01:05 – 01:55(北京时间)

Examples of Particle Engineering to Improve Patient Outcomes and Product Manufacturing 粒子工程改善患者预后和产品生产的示例

Dr. Christopher Burcham, Eli Lilly and Company

13:55 – 14:45(US EDT)

01:55 – 02:45(北京时间)

Crystal habit modifications and spherical crystallization design in solution

溶液中晶习改性和球晶造粒技术

天津大学龚俊波教授

14:45 – 15:05(US EDT)

02:45 – 03:05(北京时间)

Coffee/Tea Break茶歇

15:05 – 15:55(US EDT)

03:05 – 03:55(北京时间)

Challenges and Opportunities in Optimizing Mechanical Properties of Drugs by Incorporating Excipients 加入辅料优化药物力学性能面临的挑战和机遇

Prof. Calvin Changquan Sun, University of Minnesota

15:55 – 16:45(US EDT)

03:55 – 04:45(北京时间)

Bridging the Gap between Drug Substance and Drug Product Productions via Co-Processing 通过协同加工弥合原料药生产与成品药生产之间的差距

Dr. Jian Wang, CfPC/J-Star/Porton

16:45 – 16:50(US EDT)

04:45 – 04:50(北京时间)

Closing Remarks by session moderator

论坛主持人致闭幕词

Social Hour & Summit Dinner 社交时间 & J-STAR/博腾晚宴

18:00 – 19:00  Open Bar 

(indoor & outdoor, sponsored by Technobis)

19:00 – 21:00  Dinner 

(European style four courses, sponsored by J-Star/Porton)

社交和晚宴,仅限线下会议参与人员

所有议程安排以论坛官网最终通知为准

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)
重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. San Kiang

Chief Technology Officer

Porton Pharmatech/J-Star

San Kiang(江山)博士是原料药&制剂连续生产工艺、粒子工程、制剂复合材料、原料药&制剂协同工艺以及工艺放大领域的专家,在罗格斯大学化学工程系任研究教授,研究方向为药物相关的连续生产和材料科学,擅长药物开发流程优化,致力于原料药到制剂的无缝衔接。他从业BMS三十五年,拥有丰富的原料药及制剂研发和技术转移经验,擅长结晶工艺、粒子工程、反应工程、连续工艺(制剂与原料药)、复合药物材料(PCM)以及协同工艺。San Kiang博士参与过11个最终投入商业生产的NDA项目;参与过QbD的项目申报,工作内容包括了风险评估和工艺流程建模,以及强调工艺设计的基础方法;全面了解cGMP、先进研发技术、战略资源开发、工厂设施以及在原料药到制剂过程中存在的问题。他是制药工程和工艺在线分析技术(PAT)应用领域的先驱,公认的结晶工艺和粒子工程专家;与FDA、全球高校、研究中心和技术社团有着广泛的联系。

Dr. San Kiang is a SME in continuous processing API, continuous processing DP, particle engineering, pharmaceutical composite material, co-processing and pharmaceutical process scale up in both API and DP. He is also a Research Professor at Rutgers University Department of Chemical Engineering. San does research projects on continuous manufacturing and material science related to pharmaceuticals. While he championed workflow in pharmaceutics development that eliminates DS/DP boundary, he also gained 35 years of pharmaceutical development and technology transfer experience in Bristol-Myers Squibb covering both Active Pharmaceutical Ingredient (API) and Drug Product (DP) areas. His expertise lies in crystallization, particle engineering, reaction engineering, continuous processing (both DP and API), pharmaceutical composite material (PCM) and co-processing. PCM is a relatively new technology in which API and excipients are combined under controlled conditions to produce a composite material with unique properties that can be used to address some common issues in formulation development, such as content uniformity, stability, powder flow, taste, drug release profile, bioavailability, and material handling containment requirements.
Moreover, San is a PhD chemical engineer with experience in directing multi-disciplinary teams in the scale-up of pharmaceutical, chemical and biochemical processes from development to manufacturing. He participated in 11 NDA projects that were eventually commercialized and achieved success in QbD filing with the inclusion of risk assessment and process modeling to emphasize fundamental approach to process design. Focused on problem-solving through mechanistic understanding, San is a results and execution oriented manager. He has comprehensive knowledge of cGMP, advanced development techniques, strategic sourcing, plant facilities and issues at the API-DP interface. He is a recognized pioneer in pharmaceutical engineering and the application of PAT as well as an expert in crystallization and particle engineering issues. He holds an extensive network with FDA, universities, research centers and technology consortia.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Shanming Kuang

Head of Center for Pharma Crystallization at Porton Shanghai

Senior Director of Solid Form Studies, Center for Pharma Crystallization, J-Star

匡博士拥有香港中文大学物理化学博士学位;在普渡大学完成博士后研究后的20余年间,他先后在BMS、罗氏、GSK、苏州晶云任职;负责管理固态化学小组,专注于药物晶型筛选与选择,以及结晶工艺开发和处方前制剂开发研究。他带领的团队在评估候选药物可开发性方面发挥着不可或缺的作用,可将固态性质问题的影响降至最低。匡博士评估过300多个小分子候选药物,同时发布论文和申请专利多达50余件。 

Dr. Shanming Kuang obtained his PhD in physical chemistry from the Chinese University of Hong Kong. After a postdoc at Purdue University, Dr. Kuang spent approximately 20 years in the pharma industry with BMS, Roche, GSK, Crystal Pharmatech and J-Star Research Inc.  His tenure included managing solid state chemistry groups focusing on solid form screening and selection, crystallization process development, and pre-formulation.  His teams were integral in understanding drug candidate developability and ensuring projects were minimally impacted by solid state property issues. Shanming has extensive experience in developability assessment for more than 300 small molecule drug candidates and has published more than 50 peered reviewed papers and patent applications.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Alfred Lee

Principal Scientist

Merck Research Laboratories

Alfred Y. Lee博士现任职于默克(美国)分析研究及发展部,担任该部门的首席科学家。在此之前,他还曾任职于GSK。Lee 博士的科学研究主要涉及晶体工程、结晶工艺开发、材料表征、晶体多晶型和固体物理化学等领域。同时,他还撰写了23篇科学出版物,拥有6项专利发明,并共同编辑《工业结晶手册》第 3 版。

Alfred Y. Lee is a Principal Scientist in the Department of Analytical Research & Development at Merck & Co., Inc. (USA). Prior to his current position, Dr. Lee was a Principal Scientist at GlaxoSmithKline PLC. Dr. Lee’s scientific interests are in the area of crystal engineering, crystallization process development, materials characterization, crystal polymorphism, and the physical chemistry of solids. He has authored 23 scientific publications, an inventor on 6 patents and is a co-editor on the 3rd edition of the Handbook of Industrial Crystallization.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Prof. Junbo Gong

Professor, School of Chemical Engineering and Technology

Tianjin University

龚俊波,自2004年起任职于天津大学化工学院化学工程系全职教授。分别于1995年和2001年获得天津大学工学学士和化学工程博士学位。2001-2004年在天津泰达经济技术开发区,2006-2008年在密歇根大学药学院完成博士后培养。2008年加入天津大学,任工业结晶技术国家工程研究中心(NERCICT)和化工系副主任。于 2016 年成为 NERCICT 执行董事。

龚教授的研究方向涉及晶体形核与生长模型的多个领域,包括晶体工程、晶体形状工程、粒子工程、PAT技术、球形结晶和连续结晶。主持国家自然科学基金、国家863计划、国家水污染控制与治理重大科技计划等学术机构和行业共同资助的科研项目100余项,以及精细化工企业( 例如,药物、维生素和农用化学品等)和无机盐。获得国家科技进步奖(2015年,二等奖),天津市科技进步奖(2014年,2016年,2019年,一等奖),中国专利优秀奖(2017年, 2020)、天津市专利金奖(2016、2017)、侯德邦化学科技青年奖(2015)。在Angewandte Chemie、Crystal Growth & Design、CrystEngComm、AICHE Journal、Chemical Engineering Science、Industrial and Engineering Chemistry Research等知名期刊发表同行评审论文330余篇,授权中国专利79项,授权国际专利4项。

Junbo Gong is a full professor with tenure in School of Chemical Engineering and Technology at Tianjin University since 2014. He received B. Eng. and Ph.D. in Chemical Engineering from Tianjin University in 1995 and 2001, respectively. Then he got his postdoctoral trainings from Tianjin Teda Economic and Technological Development Zone in 2001-2004 and School of Pharmacy at University of Michigan in 2006-2008. Since 2008, he joins in Tianjin University and was appointed as vice directors of both National Engineering Research Center for Industrial Crystallization Technology (NERCICT) and Department of Chemical Engineering. He becomes executive director of NERCICT in 2016.

Prof. Gong research interests involve with many areas of crystal nucleation and growth, including crystal engineering, crystal shape engineering, particle engineering, PAT technology, spherical crystallization, and continuous crystallization. He has held more than 100 research projects funded by both academic institution and industries, including National Natural Science Foundation of China, National 863 Program and National Major Science and Technology Program for Water Pollution Control and Treatment, as well as industrial companies of fine chemicals (e.g., pharmaceuticals, vitamins, and agrochemicals, etc.) and inorganic salts. He received over 20 academic awards and honors such as National Award for Science and Technology Progress (2015, 2nd prize), Scientific and Technological Progress Award of Tianjin (2014, 2016, 2019, 1st prize), Chinese Patent Award of Excellence (2017, 2020), Tianjin Patent Gold Medal (2016, 2017), and Hou Debang chemical science and technology youth award (2015). He has published more than 330 peer-reviewed papers in well-known journals such as Angewandte Chemie, Crystal Growth & Design, CrystEngComm, AICHE Journal, Chemical Engineering Science, and Industrial and Engineering Chemistry Research, and 79 authorized Chinese patents and 4 authorized international patents.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Ann Newman

Solid-State and Pharmaceutical Consultant

Seventh Street Development Group

Ann Newman 博士拥有超过 30 年的大型制药和CXO研究经验。她为制药公司提供有关固态问题的咨询、培训和在线服务。在康涅狄格大学获得化学博士学位。之后十年一直在BMS任职,她对各种制药系统进行了表征研究,涵盖了从后期药物发现到上市和制造的原料药和产品放大。随后,她成为 SSCI, Inc. 材料科学副总裁,负责监督 API 和药品样品的表征、结晶和多晶型筛选、盐和共晶选择、定量分析、无定形项目以及制药行业的问题解决。作为 Aptuit 的研发副总裁,她在全球六个地点发起了一项全公司范围的研发计划,涵盖 API、临床前(毒理学、安全性、药代动力学)、制剂、固体、分析、临床包装和监管等领域。同时,她在普渡大学担任工业和物理药学的兼职教员,是60 多篇出版物、100 次技术演示和 50 次网络研讨会的作者/合作者。

Dr. Ann Newman is currently a pharmaceutical consultant at Seventh Street Development Group with over 30 years of large pharma and contract research experience. She provides consulting, training, and webcasts on solid-state issues for pharmaceutical companies. Ann received her PhD in Chemistry from the University of Connecticut. For ten years, she performed characterization studies on a wide range of pharmaceutical systems at Bristol-Myers Squibb, covering drug substance and product scale-up from late drug discovery to launch and manufacturing. She then became VP of Materials Science at SSCI, Inc. overseeing characterization of API and drug product samples, crystallization and polymorph screens, salt and cocrystal selections, quantitative assays, amorphous projects, and problem solving for the pharmaceutical industry. As VP of R&D at Aptuit, she instituted a companywide R&D initiative over six global sites and covering areas such as API, preclinical (toxicology, safety, pharmacokinetics), formulation, solids, analytical, clinical packaging, and regulatory.  She holds an adjunct faculty position in Industrial and Physical Pharmacy at Purdue University and is author/collaborator on over 60 publications, 100 technical presentations, and 50 webinars.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Shawn Yin

Research Fellow

Bristol-Myers Squibb

Shawn (Xiaotian) Yin 博士在加拿大Waterloo大学获得固体化学博士学位。随后,他在Cornell大学材料科学与工程系完成了博士后学习。目前,Yin博士任职于BMS,担任科学总监。他的研究方向包括药物多晶型研究、药物产品中的 API 形式、药物物质的物理表征、药物科学中的粉末 X 射线衍射应用、用于药物递送的无定形和纳米材料。

Yin博士本人或同他人一起发表了超过 30 篇科学出版物,拥有 10 项专利。与此同时,他还是药物粉末X射线衍射研讨会的科学组织委员会成员,被国际衍射数据中心授予院士称号,是国内外科学会议和研讨会的常驻特邀讲师。

Dr. Shawn (Xiaotian) Yin received his Ph. D. in Solid-State Chemistry from University of Waterloo, Canada. He then completed his Post Doctoral fellowship at Department of Materials Sciences and Engineering, Cornell University. Currently, Dr. Yin is a scientific director at Bristol-Myers Squibb. His research interests include pharmaceutical polymorphic form studies, API form in drug product, physical characterizations of pharmaceutical substances, powder X-ray diffraction applications in pharmaceutical sciences, amorphous and nanomaterials for drug delivery.

Dr. Yin has (co)-authored over 30 scientific publications and 10 patents. He serves as a scientific organization committee member for the Pharmaceutical Powder X-ray Diffraction Symposium. He was awarded the title Fellow by International Centre for Diffraction Data. Dr. Yin is also a frequent invited lecturer at international and domestic scientific conferences and workshops.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Chandler Greenwell

Applications Scientist

XtalPi Inc.

Chandler Greenwell 博士是晶泰科技的应用科学家。他在计算机化学方面拥有丰富的专业知识,作为研发和商业开发活动中的纽带,他所负责的固态服务领域可以为美国以及欧盟的制药和农用化学药客户提供多种服务。他还同时负责协调公司与工业合作伙伴之间的固态研发合作。

在犹他州奥格登的韦伯州立大学获得化学和应用数学双学士学位。获得学士学位后,在犹他州盐湖城Allergan (now Teva)的研发稳定性实验室工作了一年。并在加州大学河滨分校的 Beran 小组完成了计算化学博士学位,在那里开发了数学模型来改进有机分子和分子晶体的计算。

Chandler Greenwell is an Applications Scientist at XtalPi, Inc. His expertise in computational chemistry allows him to act as an interface between research and business development activities. He serves as a liaison for solid state services offered by XtalPi to all the pharmaceutical and agrichemical clients in the US and EU territory. He is also responsible for coordinating solid-state R&D collaborations between XtalPi and industrial partners.

He received dual undergraduate degrees in chemistry and applied mathematics from Weber State University in Ogden, Utah. After his Bachelor’s, he worked for a year in the R&D stability laboratory at Allergan (now Teva) in Salt Lake City, Utah. He completed his PhD in computational chemistry in the Beran group at UC-Riverside where he developed mathematical models to improve calculations on small organic molecules and molecular crystals.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Jessica Bruhn

Principal Scientist

NanoImaging Services

专业领域是 X 射线晶体学(Scripps研究所)和单粒子 CryoEM(Salk研究所)应用于蛋白质和大分子复合物的结构和功能分析。于 2019 年加入了纳米成像服务 (NIS),这是一家领先的 CryoEM 和 TEM 服务提供商,在那里,除了其他项目,一直带头进行微晶电子衍射 (MicroED) 开发工作。

MicroED是一种新型的结构测定方法,能够测定比单晶x射线衍射(~0.2-2μm)小数量级的晶体的结构。这种方法对从事制药小分子领域的研究人员尤其有吸引力,因为在许多情况下,MicroED可以完全消除结晶筛选和优化。这大大减少了结构测定所需的时间和材料,并扩展了可以通过晶体学进行结构表征的化合物/晶型的类型。

My formal training is in X-ray crystallography (Scripps Research Institute) and single-particle CryoEM (Salk Institute) applied to the structural and functional analysis of proteins and macromolecular complexes. I joined NanoImaging Services (NIS), a leading provider of CryoEM and TEM services, in 2019 where, amongst other projects, I have been spearheading our microcrystal electron diffraction (MicroED) development efforts.

MicroED is a novel structure determination method capable of determining structures from crystals orders of magnitude smaller than those required for single-crystal X-ray diffraction (~0.2-2μm). This method is especially attractive for those working in the pharmaceutical small molecule space as crystallization screening and optimization can be completely eliminated in many cases when MicroED is employed. This greatly reduces the time and material required for structure determination, as well as expands the types of compounds/polymorphs that can be structurally characterized by crystallography.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Harsh Shah

Senior Scientist 

J-Star 

Harsh Shah博士在 J-Star担任高级研究院,领导药物发现和药物产品开发方面的“fit-to-purpose”研究项目。他专注于通过搜索的新化学实体的物理化学稳定性固体形式,有助于推进开发和使用先进的分析和计算技术的优化高效的流程和处方前研究。他之前的工作经历包括在长岛大学 Lachman 药物分析研究所,美国FDA、BMS、Triclinic Labs、Vertex Pharmaceuticals 和 Amneal Pharmaceuticals。Shah博士获得的国内外奖项包括 InSc 的“2020 卓越研究奖”、长岛大学“2020优秀博士生奖”和 AAPS年会 “2019 学术研究奖——第二名” 。他在期刊上发表了 17 篇研究论文,在国内外会议上发表了 20 多篇文章。Shah 博士是 AAPS Open、Asian Journal of Pharmaceutics 和 International Journal of Science and Pharma Innovations 的编委以及各种专业协会的活跃成员,包括 AAPS、Rho-Chi、IPSE 和 ACS。

Harsh Shah is working as a senior scientist at J-Star  Inc. (Cranbury, NJ), where he leads “fit-to-purpose” research projects in drug discovery and drug product development. He is focused on helping to advance by searching physicochemically stable solid forms of new chemical entities, develop and optimizing efficient processes and preformulation studies using advanced analytical and computational techniques. His prior experience includes working at Lachman Institute for Pharmaceutical analysis at Long Island University, collaborative projects with the United States Food & Drug Administration (FDA), Bristol Myers Squibb, Triclinic Labs, Vertex Pharmaceuticals and Amneal Pharmaceuticals. Dr. Shah is a recipient of nationally and internationally recognized awards which include “Research Excellence Award – 2020” by InSc, “PhD Outstanding Student Award – 2020” at Long Island University, and “Academic Research Award – 2019 – 2nd place” at AAPS NERDG annual conference. He has published 17 research papers in Peer-Reviewed Journals and more than 20 abstracts in National & International Conferences. Dr. Shah is an editorial board member for AAPS Open, Asian Journal of Pharmaceutics and International Journal of Science and Pharma Innovations. He is an active member in various professional societies including AAPS, Rho-Chi, IPSE, and ACS.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Jian Wang

SVP, Center for Pharma Crystallization,

J-Star/Porton

王建博士于1994年在匹兹堡大学取得化学工程博士学位,师从Donna Blackmond教授和Irving Winder教授。曾在默克任职十余年,擅长利用以科学与技术为基础的策略来指导原料药结晶和反应工程。王博士于2005-2010期间在Mettler Toledo AutoChem担任顾问, 期间直接推动了PAT在工艺研发中的应用。2011-2013年,她在苏州晶云药物担任结晶工艺开发副总裁,帮助多元化的客户解决极具挑战的结晶工艺问题。2014年初,王博士在J-STAR成立结晶团队(现名为药物结晶中心, CfPC)。作为J-STAR CfPC的副总裁,她一直致力于为CfPC培养一支由行业专家组成的综合团队,从而为全球药物开发项目提供技术严谨、协同、与高效的服务。

Dr. Jian Wang is an expert in API crystallization, with comprehensive knowledge of the science and technologies required to meet the needs of small molecule drug development. She has over 30 years of R&D experience in API crystallization and reaction engineering, and has been providing R&D services since 2005 to pharmaceutical clients around the globe.

Dr. Wang received her Ph.D. degree in Chemical Engineering in 1994, from the University of Pittsburg with Prof. Donna Blackmond and Prof. Irving Winder. She published 20 peer-reviewed articles and 6 patents (5 related to API crystallization) before getting into technical services.

During her 11-year tenure at Merck since 1994, Jian became an expert in API process R&D and a champion in implementing science-based and technology-enabled approaches. She promoted the application of PAT tools in process R&D serving as a consultant at Mettler Toledo AutoChem during 2005-2010. In 2011-2013, Jian took the responsibility as VP of Crystallization Development at Crystal Pharmatech, helping a diverse client base in solving API crystallization problems. To better assist new drug development programs, Jian started up a state-of-the-art crystallization center at J-Star  in the beginning of 2014 complementing its strong API Process Research. She now leads the Center for Pharma Crystallization at J-STAR as Senior Vice President, addressing a wide range of challenges associated with API isolation from early to late developmental stages. Working closely with drug formulation experts, Jian also has been driving the establishment of drug formulation services at J-Star that are well integrated with API crystallization R&D.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Prof. Calvin Sun

Professor, Director of Graduate Studies, and Associate Department Head, Department of Pharmaceutics

University of Minnesota

专业领域:药物材料科学、粉体技术、固态科学、晶体工程

Pharmaceutical Materials Science, Powder Technology, Solid-state Science, Crystal engineering

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Christopher Burcham

Senior Engineering Research Advisor

Eli Lilly and Company

制药工艺开发,重点是结晶和颗粒形成工艺设计;机械建模

Pharmaceutical Process Development with an emphasis on Crystallization and particle formation process design; mechanistic modeling

 
重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Friday, October 15, 2021 (US EDT) 

10月15日20:00至16日5:00(北京时间)

08:10 – 16:50(US EDT)

20:10 – 24:00(北京时间,10月15日)

论坛3:基于物理属性的结晶工艺研发

Session 3: Physical Property Based Crystallization Process Development

08:10 – 08:15(US EDT)

20:10 – 20:15(北京时间)

Particle Engineering and DS-DP Co-Processing

粒子工程和原料药-成品药协同加工

Introduction by Moderator, Dr. Yuriy Abramov, XtalPi

主持人 Dr. Yuriy Abramov (晶泰科技)

08:15 – 09:05(US EDT)

20:15 – 21:05(北京时间)

The Importance of Understanding and Characterising the Physical & Chemical Properties of APIs in the Digital Design of Drug Products 了解并表征原料药理化性质对于成品药数字化设计的重要性

Prof. Kevin Roberts, University of Leeds

09:05 – 09:55(US EDT)

21:05 – 21:55(北京时间)

Continuous Crystallization and Purification:The Role of Impurity Incorporation Mechanism in Non-Equilibrium Processes 连续结晶和纯化:掺入杂质在非平衡状态下发挥的作用

Prof. Allan Myerson, Massachusetts Institute of Technology

09:55 – 10:15(US EDT)

21:55 – 22:15(北京时间)

Coffee/Tea Break茶歇

10:15 – 11:05(US EDT)

22:15 – 23:05(北京时间)

Co-Crystals Platform to Improve Physical Properties of Early Intermediates during API Manufacturing Process 改善原料药生产工艺期间早期中间体物理性质的共晶平台

Dr. Samir Kulkarni, Pfizer

11:05 – 11:55(US EDT)

23:05 – 23:55(北京时间)

Correlation of Solubility with the Metastable Limit 溶解度与介稳极限的相关性

Prof. Ken Morris, Long Island University

11:55 – 12:00(US EDT)

23:55 – 24:00(北京时间)

Closing Remarks by session moderator

论坛主持人致闭幕词

12:00 -13:00  Lunch (Sponsored by BlazeMetrics)

午餐(BlazeMetric赞助),仅限线下会议参与人员

13:00 – 15:00(US EDT)

01:00 – 03:00(北京时间,10月16日)

论坛4:小组专题讨论

Session 4: Topical Panel Discussions 

13:00 – 13:10(US EDT)

01:00 – 01:10(北京时间)

Introduction by Chairman, Dr. San Kiang, J-Star/Porton

主席介绍,Dr. San Kiang,J-Star/Porton

13:10 – 13:45(US EDT)

01:10 – 01:45(北京时间)

Potentials and Technologies to Increase Success Rate of Polymorph Screening 提高晶型筛选成功率的潜力和技术

Dr. Alfred Lee, Merck Research Laboratories

13:45 – 14:20(US EDT)

01:45 – 02:20(北京时间)

Overcoming Industrial Challenges in Implementation of Crystallization Technologies 克服实施结晶技术面临的工业问题

Dr. Kevin Girard, Pfizer

14:20 – 14:55(US EDT)

02:20 – 02:55(北京时间)

Realizing Regulatory Challenges in Applying Crystallization Technologies 克服应用结晶技术面临的监管问题

Dr. Christopher Burcham, Eli Lilly and Company

14:45 – 15:00(US EDT)

02:55 – 03:00(北京时间)

Closing Remarks by Chairman, Dr. San Kiang, J-Star /Porton (end of webcasting)

博腾/J-Star San Kiang 博士作为大会主席致闭幕词(网络直播结束)

参观J-STAR研发中心

以下安排仅限线下会议参与人员

15:00 – 15:15

Coffee/Tea Break 茶歇

15:15 – 15:45

Bus Ride to CfPC Labs at J-Star   

统一乘车前往J-STAR研发中心

15:45 – 17:00

 CfPC Lab Tours (breaking up in groups) 

 分组参观研发实验室

17:00 

结束愉快之旅

所有议程安排以论坛官网最终通知为准

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Alfred Lee

Principal Scientist

Merck Research Laboratories

Alfred Y. Lee博士现任职于默克(美国)分析研究及发展部,担任该部门的首席科学家。在此之前,他还曾任职于GSK。Lee 博士的科学研究主要涉及晶体工程、结晶工艺开发、材料表征、晶体多晶型和固体物理化学等领域。同时,他还撰写了23篇科学出版物,拥有6项专利发明,并共同编辑《工业结晶手册》第 3 版。

Alfred Y. Lee is a Principal Scientist in the Department of Analytical Research & Development at Merck & Co., Inc. (USA). Prior to his current position, Dr. Lee was a Principal Scientist at GlaxoSmithKline PLC. Dr. Lee’s scientific interests are in the area of crystal engineering, crystallization process development, materials characterization, crystal polymorphism, and the physical chemistry of solids. He has authored 23 scientific publications, an inventor on 6 patents and is a co-editor on the 3rd edition of the Handbook of Industrial Crystallization.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. San Kiang

Chief Technology Officer

Porton Pharmatech/J-Star 

San Kiang(江山)博士是原料药&制剂连续生产工艺、粒子工程、制剂复合材料、原料药&制剂协同工艺以及工艺放大领域的专家,在罗格斯大学化学工程系任研究教授。研究方向为药物相关的连续生产和材料科学,擅长药物开发流程优化,致力于原料药到制剂的无缝衔接。他从业BMS三十五年,拥有丰富的原料药及制剂研发和技术转移经验,擅长结晶工艺、粒子工程、反应工程、连续工艺(制剂与原料药)、复合药物材料(PCM)以及协同工艺。San Kiang博士参与过11个最终投入商业生产的NDA项目;参与过QbD的项目申报,工作内容包括了风险评估和工艺流程建模,以及强调工艺设计的基础方法;全面了解cGMP、先进研发技术、战略资源开发、工厂设施以及在原料药到制剂过程中存在的问题。他是制药工程和工艺在线分析技术(PAT)应用领域的先驱,公认的结晶工艺和粒子工程专家;与FDA、全球高校、研究中心和技术社团有着广泛的联系。

Currently Chief Technology Officer at Porton Pharmatech/J-Star , Inc. San Kiang is an SME in continuous processing API, continuous processing DP, particle engineering, pharmaceutical composite material, co-processing and pharmaceutical process scale up in both API and DP. He is also a Research Professor at Rutgers University Department of Chemical Engineering. San does research projects on continuous manufacturing and material science related to pharmaceuticals. While he championed workflow in pharmaceutics development that eliminates DS/DP boundary, he also gained 35 years of pharmaceutical development and technology transfer experience in Bristol-Myers Squibb covering both Active Pharmaceutical Ingredient (API) and Drug Product (DP) areas. His expertise lies in crystallization, particle engineering, reaction engineering, continuous processing (both DP and API), pharmaceutical composite material (PCM) and co-processing. PCM is a relatively new technology in which API and excipients are combined under controlled conditions to produce a composite material with unique properties that can be used to address some common issues in formulation development, such as content uniformity, stability, powder flow, taste, drug release profile, bioavailability, and material handling containment requirements.

Moreover, San is a PhD chemical engineer with experience in directing multi-disciplinary teams in the scale-up of pharmaceutical, chemical and biochemical processes from development to manufacturing. He participated in 11 NDA projects that were eventually commercialized and achieved success in QbD filing with the inclusion of risk assessment and process modeling to emphasize fundamental approach to process design. Focused on problem-solving through mechanistic understanding, San is a results and execution oriented manager. He has comprehensive knowledge of cGMP, advanced development techniques, strategic sourcing, plant facilities and issues at the API-DP interface. He is a recognized pioneer in pharmaceutical engineering and the application of PAT as well as an expert in crystallization and particle engineering issues. He holds an extensive network with FDA, universities, research centers and technology consortia.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Yuriy A.Abramov

VP of Scientific Affairs

XtalPi Inc.

现任晶泰科技科学事务副总裁,Dr. Yuriy A.Abramov在辉瑞供职超18年,拥有计算科学领域的丰富经验,是卓越的新药研发等多领域的知名计算化学家。在制药行业的计算科学领域拥有广泛的科学与技术专业知识。曾为多个小分子药物设计项目在靶点鉴定、先导化合物发现、先导化合物优化、临床试验化合物选择和药物研发方面提供计算支持。也曾为目前已上市的多个药物NDA申请项目提供计算化学支持。

Dr. Yuriy Abramov is a computational scientist with over 18 years industrial experience at Pfizer Inc. He has scientific and technical expertise in the broad area of Computational Science in Drug Discovery and Development. Currently he holds a position of VP of scientific affairs at XtalPi Inc.

Dr. Abramov also holds a position of an Adjunct Professor at Eshelman School of Pharmacy, University of North Carolina, Chapel Hill. He is also a Professor of Practice at School of Pharmacy at University of Connecticut, Storrs, CT.

Dr. Abramov is an editor of the book “Computational Pharmaceutical Solid State Chemistry”, an author of 80 publications in peer-reviewed journals and book chapters.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Christopher Burcham

Senior Engineering Research Advisor

Eli Lilly and Company

制药工艺开发,重点是结晶和颗粒形成工艺设计;机械建模 

Pharmaceutical Process Development with an emphasis on Crystallization and particle formation process design; mechanistic modeling.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Kevin Girard

Associate Research Fellow

Pfizer

研究领域:API和制剂的结晶领域,以及制药行业中连续加工新兴技术的商业化应用,特别是连续结晶,分离,干燥。

Area of Research Interest: I am generally interested in crystallization, all things at the API/Drug Product interface, and the emerging utilization and commercialization of continuous processing in the pharmaceutical industry, especially Continuous Crystallization, Isolation, and Drying.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Dr. Samir Kulkarni

Principal Scientist

Pfizer

研究领域:共结晶、工艺优化和放大、结晶、材料特性、杂质排除。

Area of Research Interest: co-crystallization, process optimization and scaleup, crystallization, material property, impurity rejections.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Prof. Kenneth Morris

University Professor, Director of the Lachman Institute for Pharmaceutical Analysis

Long Island University

暂缺

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Prof. Allan Myerson

Professor of the Practice

Massachusetts Institute of Technology

结晶、制药生产 Crystallization, pharmaceutical manufacturing.

重磅嘉宾介绍 | 2021全球药物结晶高峰论坛 (Bilingual)

Prof. Kevin J Roberts

Brotherton Professor of Chemical Engineering

University of Leeds

现为英国利兹大学化学工程系Brotherton教授,也是EPSRC复合颗粒产品及工艺博士培训中心的负责人。他的研究工作包括基础研究和应用研究,后者与制药行业、特种化学品行业、精细化工行业和营养品行业有着合作。Roberts教授至今发表论文450余篇,共指导90余位研究生进行研究工作。

Kevin Roberts is currently Brotherton Professor of Chemical Engineering at the University of Leeds in the UK where he is also Director of the EPSRC’s Centre for Doctoral Training in Complex Particulate Products and Processes.

His research work encompasses both fundamental and applied research, with the latter in collaboration with the pharmaceuticals, specialities, fine chemicals, and nutritional products sectors. He has published more than 450 papers and has led, mentored and developed the research work of more than 90 post-graduate research students.

 

 

END

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