Ellen Guan has over 15 years of extensive experience in regulatory affairs, covering the entire life cycle of new biologics and chemical drugs. She joined 3DMedicines in 2016 and is currently the Head of Regulatory Affairs department. She led her team to complete the registration work for the global first subcutaneous PD-L1 antibody injection, Envefolimab, in China, as well as seveal IND and pivotal clinical trials in the United States and Japan. She is familiar with the regulations for marketing applications in the Asia-Pacific region and maintains the registration work for post-marketing amendment in China. Before joining 3DMedicines, she worked at BeiGene and was responsible for the global IND filings and approvals of several of BeiGene’s self-developed products.
关怡在药品注册领域拥有超过15年的丰富经验，涵盖生物制品及化学药品新药的全生命周期。2016年加入思路迪医药，目前是该公司药政事务负责人，主持并带领团队完成全球首个皮下注射PD-L1恩沃利单抗注射液的中国上市及美国和日本IND及关键临床的注册工作，熟悉亚太地区的上市申请法规，维护产品在中国上市后变更的注册工作。2016年之前曾就职百济神州，负责数个百济自主研发品种的全球IND申报及批准。
Eric Schnitzer holds a degree in Biochemistry and brings over 16 years of experience in drug development, with a strong focus on eClinical technology. His background spans product strategy, operations, and market expansion, having worked with some of the industry’s leading eClinical providers.Throughout his career, Eric has consistently championed the use of technology to improve trial efficiency and enhance outcomes for all involved. Now at CRScube, he is leading efforts to expand the company’s innovative platform across Europe and the US, helping to streamline clinical trials through unified digital solutions.
Kelly serves as the Sr Director of Data Management Solutions and Services at Vita Global Sciences, bringing nearly three decades of dedicated experience in clinical research – most of that time focused on the intricacies and impact of Data Management. Throughout her career, she has championed innovation, precision, and the highest standards of data quality to help shape meaningful advancements across the life sciences industry.One of the true cornerstones of her professional journey has been mentorship. She is deeply committed to developing future leaders in clinical research, taking pride in cultivating inclusive, high-performing teams that are equipped to tackle the challenges of tomorrow. As she says herself: “Helping others grow isn’t just part of my job – it’s part of my purpose.”Kelly has consistently led the development of scalable data strategies and aligned operational frameworks with clinical objectives to drive measurable outcomes. Whether collaborating across functions or steering complex projects, she strives to create environments where insights thrive and therapeutic breakthroughs become reality.
Sylvain has dedicated his 21-year long carrier on providing software for the pharmaceutical industry. He specialized in clinical trials 16 years ago, working at various eClinical technology vendors. His path has taken him to many conference and webinar stages, where he consistently strives to make the audience think differently about the topic of focus. Sylvain is passionate about implementing solutions that increase the efficiency of all involved in a clinical trial. He is now the Vice President of Strategy and Marketing at CRScube, where he embraces the company’s goal to make clinical trials accessible to everyone. He also dedicates a lot of his time to patient advocacy, increasing awareness about health conditions through his podcast On One Condition.
Alina is a seasoned expert in intelligent automation, with over a decade of experience at ABBYY, a global leader in Intelligent Document Processing. Responsible for identifying and implementing optimal solutions to address customer bottlenecks across Europe, Alina collaborates closely with clients and partners, to drive the adoption of AI technologies and accelerate process automation. Alina holds a Master’s degree in International Economics and is currently pursuing a Master’s in Data Science at University of London, with a focus on the trustworthiness of Generative AI.
Vikki Wang has been with the China office of Maryland Department of Commerce since 2009 and has accumulated many years of experiences in international trade and investment consulting, supporting for Maryland companies’ business interests in China as well as Chinese companies going to Maryland. Past clients span across industries such as medical health, biotech, manufacturing, logistics, agriculture and others.
王艳波女士自2009年加入马里兰州中国办公室至今，拥有多年国际贸易和投资咨询经验，为马里兰州企业在华业务及中国企业赴美投资提供支持，曾服务的客户涉及医疗健康、生物技术、制造业、物流、农业等多个行业。
琚珏刚先生，目前在英矽智能担任临床运营负责人，管理所有临床研究项目从策略到运营交付的各种事宜，并涵盖人员/预算/流程等各方面的管理。同时也是CBA-GP中国区联络人。在加入英矽智能之前，琚珏刚先生曾在原力生命担任全球临床运营负责人，在岸阔医药担任产品开发策略和临床开发负责人，以及在昆拓/艾昆玮担任临床战略规划负责人。在此之前，琚珏刚先生曾在阿斯利康、安进/昆泰、诺华/昆泰和法码康担任过多项职务，涉及从全球临床研究的管理到研究中心的运营管理工作。琚珏刚先生毕业于上海交通大学，拥有科学学士和硕士学位。
Johnny Ju, currently as the Head of clinical operations in Insilico, responsible for clinical study projects from strategy to operational delivery, also covering the management of people / budget / process / etc. Also he is the point of contact in China for CBA-GP. Before joining in Insilico, Johnny had been the Global Clinical Operations Head in Ionova, Head of Product Development Strategy and Clinical Development in OnQuality, and Head of Clinical Strategy Planning in KunTuo/Quintiles. Even before, Johnny had taken multiple roles from Global clinical study management to site level operational management in AstraZeneca, Amgen/Quintiles, Novartis/Quintiles and Pharmacons. Johnny was graduated from Shanghai Jiao Tong University, with Bachelor and Master Degrees of Science.
王晓梅，北京大学医学部流行病与卫生统计学硕士。拥有10年以上国际项目管理经验和10年+Biotech公司创新药研发工作经验。熟悉药物研发临床前研究、IND申报和临床开发等工作，包括临床开发计划、临床试验方案制定；数据管理、统计分析、药物安全管理等领域，领导完成了多个在中国、美国和澳大利亚开展的I/II期临床试验，参与多个化合物中、美、澳新药临床试验IND申请和pre-IND沟通交流工作以及临床前研究工作。现负责凯复医药全球临床运营和法规注册工作。
Mrs. Wang received her Master of Epidemiology and Health Statistics from Peking University Health Science Center. With over 10 years of Global project management experience in China CDC and Damien Foundation Belgium and more than 10 years of innovative drug research and development experience in Biotech companies. She has been involved in preclinical research and development, IND application, and clinical operations, including data management, statistical analysis, and drug safety management. Mrs. Wang has led the completion of multiple Phase I and Phase II clinical trials in China, Australia, and the United States, and participated in the IND applications and pre– IND preparations, as well as preclinical researches for a variety of new drugs in China, Australia, and the United States. Currently she is in charge of the global clinical operations and regulatory affairs of Keythera Bio-Pharmaceuticals.
