Dr. San Kiang
Chief Technology Officer
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.
Dr. Shanming Kuang
Head of Center for Pharma Crystallization at Porton Shanghai
Senior Director of Solid Form Studies, Center for Pharma Crystallization, J-Star
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.
Dr. Alfred Lee
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.
Prof. Junbo Gong
Professor, School of Chemical Engineering and Technology
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.
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.
Dr. Shawn Yin
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.
Dr. Chandler Greenwell
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.
Dr. Jessica Bruhn
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。
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.
Dr. Harsh Shah
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.
Dr. Jian Wang
SVP, Center for Pharma Crystallization,
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.
Prof. Calvin Sun
Professor, Director of Graduate Studies, and Associate Department Head, Department of Pharmaceutics
University of Minnesota
Pharmaceutical Materials Science, Powder Technology, Solid-state Science, Crystal engineering
Dr. Christopher Burcham
Senior Engineering Research Advisor
Eli Lilly and Company
Pharmaceutical Process Development with an emphasis on Crystallization and particle formation process design; mechanistic modeling