Outsourcing in Clinical Trials China 2025 2025中国临床试验外包大会

The launch of Outsourcing and Clinical Trials China is your opportunity to engage with the forefront of clinical trial innovation in one of the fastest-growing markets for clinical research.
中国临床试验外包大会的启动，为您在全球增长最快的临床试验市场之一，提供了一个与临床研究创新前沿接轨的机遇。

3 - 4

September

2025
  • Renaissance Suzhou Hotel
  • Ticketed
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
close

Featured Speakers

Back

Tessa Lai 赖会明​

BMS, Director, Clinical Supply Chain Logistics Asia Pacific

百时美施贵宝, 临床供应链仓储物流运营亚太区总监

Next speaker
Back

Vincent Zang 臧文升​

Innovent Bio, Sr. Director of Clinical Trial Operation

信达生物制药-临床运营高级总监

臧文升在临床运营行业已深耕16年。曾就职于于ICON、强生、先声药业，2019年加入信达生物。承担过多项药物（小分子化药、单抗、双抗、多肽等）的临床开发的全阶段的工作，并已有多个产品成功获批上市。在新药临床开发方面积累了丰富的经验。

With 16 years of deep expertise in the clinical operations industry, Vincent Zang has previously worked at ICON, Johnson & Johnson, and Simcere Pharmaceutical. In 2019, he joined Innovent Biologics, where he has been involved in the full lifecycle clinical development of multiple drugs (including small molecule chemicals, monoclonal antibodies, bispecific antibodies, peptides, etc.), with several products successfully approved for market launch. He has accumulated extensive experience in novel drug clinical development.

Next speaker
Back

Paul Kong 孔亮​

LaNova Medicines, VP of Clinical Operations

礼新医药, 临床运营副总裁

礼新医药临床运营副总裁。曾在精鼎、方恩等CRO公司任职并负责方恩临床运营工作，此后在罗氏以及珐博进、华领、康宁杰瑞等Biotech企业担任临床运营部门负责人，负责多项国际国内研究，并助力多项1.1类新药成功获批。

Paul Kong, leads Clinical Operation team within LaNova since Apr, 2021. He has more than 10 years experiences in CRO, such as Parexel and FMD, and then taking the leading role from various biotechs and big pharm, Roche, FibroGen, Hua Medicine and Alphamab in clinical operation team; and he has major contributions for lots of first in class production registration.

 

Next speaker

    Why attend?

    Why attend? 为何参会？

    The launch of  Outsourcing and Clinical Trials China is your opportunity to engage with the forefront of clinical trial innovation in one of the fastest-growing markets for clinical research. Here’s why you should attend:

    “中国临床试验外包大会” 为您提供与全球增长最快的临床研究市场创新前沿接轨的机遇。以下是您不容错过的理由：

    Access Local Expertise: Gain insights into the unique challenges and opportunities within China’s clinical trials landscape, directly from local and international experts.

    获取本土洞见
    直击中国临床试验生态的独特挑战与机遇，聆听中外专家的第一手经验分享。

     

    Regulatory Updates: Stay ahead with the latest regulatory developments and compliance strategies essential for navigating China’s evolving healthcare environment.

    掌握法规动态
    获取中国快速演变的医疗监管政策最新进展，学习合规策略以规避风险。

    Industry Networking: Build meaningful connections with leading CROs, biopharmaceutical companies, and other stakeholders driving clinical trial success in China.

    拓展行业人脉
    与推动中国临床试验成功的CRO龙头企业、生物制药公司及行业决策者建立深度合作。

    Strategic Collaboration: Explore strategies to optimize outsourcing partnerships and discover tailored solutions for managing clinical trial operations in a complex, dynamic market.

    优化合作战略
    探索复杂动态市场中的外包合作模式，定制化临床运营解决方案。

     

    Emerging Trends: Delve into cutting-edge technologies and methodologies shaping the future of clinical trials in China, from digital tools to innovative supply chain solutions.

    前瞻未来趋势
    聚焦数字化工具与创新供应链等前沿技术，洞察中国临床试验的未来形态。

    Agenda

    • 3 Sep 2025
    • 4 Sep 2025
    Expand All

    END OF CONFERENCE

    8 AM

    Registration and refreshments
    注册签到 & 茶歇交流

    8:30 AM

    Chairperson’s opening remarks
    主席开幕致辞

    8:45 AM

    Opening Keynote Panel
    开幕主题论坛

    The Evolving Clinical Trial Landscape in China: Challenges & Opportunities

    China has emerged as a key player in global clinical research, driven by regulatory reforms, a vast patient population, and increasing investments in biotechnology. This panel discussion will provide a comprehensive overview of the current clinical trial landscape in China, examining the challenges, opportunities, and future outlook for sponsors, CROs, and global stakeholders.

    • Current State of Clinical Trials in China; Growth trends and recent developments in the Chinese clinical trial ecosystem, impact of regulatory reforms, including NMPA’s efforts to streamline approvals, China’s role in global multi-regional clinical trials (MRCTs)
    • Challenges Facing Clinical Trials in China; Navigating regulatory complexities, Intellectual property (IP) concerns and data protection in clinical research, Operational challenges: site selection, patient recruitment, and investigator training, Differences in trial execution compared to the U.S. and EU
    • Clinical Trial Supply Chain: Challenges and Best Practice; Strategies for reducing supply chain disruptions and ensuring compliance
    • Opportunities for Sponsors & CROs

    The Future of Clinical Trials in China; How China is positioning itself as a leader in global drug development. Potential impact of geopolitical factors on international collaboration

     

    中国临床试验格局的演变：挑战与机遇

    中国凭借监管改革、庞大的患者群体及对生物技术日益增长的投资，已成为全球临床研究的关键参与者。本论坛将全面剖析中国临床试验的现状，探讨申办方、CRO及全球利益相关方面临的挑战、机遇与未来前景。

    • 中国临床试验现状：中国临床试验生态系统的增长趋势与最新进展；监管改革的影响（包括NMPA审批流程优化举措）；中国在全球多区域临床试验（MRCT）中的角色
    • 中国临床试验面临的挑战：复杂监管环境的应对策略；知识产权保护与临床研究数据安全；实操难点：研究中心筛选、患者招募及研究者培训；中美欧临床试验执行的差异性分析
    • 临床试验供应链：挑战与最佳实践
    • 降低供应链中断风险与合规保障策略
    • 赞助商与CRO的机遇

    中国临床试验的未来图景：中国如何确立全球药物研发领导地位；地缘政治因素对国际合作的潜在影响

    9:30 AM

    Reserved for ARENSIA
    赞助商专场

    Speakers

    Dr. Claudia Hesselmann
    Founder & CEO, ARENSIA Exploratory Medicine

    10 AM

    Global Relationships: Enhancing Collaboration in Outsourcing
    全球合作：加强外包协作关系

    • Working with Chinese CROs and CMOs – what global sponsors should know
    • Managing cross-border clinical trials: logistics, communication, and cultural considerations
    • Case studies of successful global-China partnerships
    • 与全球CRO/CMO合作——中国企业必备指南
    • 跨国临床试验管理要点：物流协调、沟通机制与文化适配
    • 中外合作成功案例深度解析

    10:30 AM

    Reserved for Event Sponsor
    赞助商专场

    11 AM

    Morning refreshments and networking – Please visit 3 booths in this break
    上午茶歇与交流互动——请在此期间至少参观3个展位

    STREAM A: Outsourcing & Clinical Operations

    11:30 AM

    Clinical Operations: Optimizing Efficiency in China
    临床运营：提升中国区执行效能

    • Site selection strategies and patient recruitment challenges
    • Decentralized trials and remote monitoring in China
    • Risk management and quality control in outsourced trials

     

    • 研究中心筛选策略与患者招募挑战
    • 中国本土去中心化临床试验与远程监查实践
    • 外包试验中的风险管理与质量控制

    12 PM

    Reserved for event Sponsor
    赞助商专场

    12:30 PM

    Implementing Artificial Intelligence in Drug Discovery and Development in China
    人工智能（AI）在中国药物研发中的应用实践

    China is rapidly integrating artificial intelligence (AI) into drug discovery and clinical development, driven by advancements in machine learning, big data analytics, and government support for biotech innovation. This session will focus on the practical implementation of AI, from early-stage discovery to regulatory submission, and discuss how companies can successfully leverage AI while navigating China’s evolving regulatory landscape.

    • AI integration across the drug development lifecycle
    • Building AI-driven drug discovery pipelines in China
    • Regulatory and compliance consideration for AI implementation
    • Overcoming challenges in AI adoption

     

    中国正快速将人工智能（AI）整合到药物研发和临床开发中，这得益于机器学习、大数据分析的进步以及政府对生物技术创新的支持。本环节将聚焦AI从早期发现到监管申报的实际应用，并探讨企业如何在不断变化的中国监管环境中成功利用AI技术。

    • AI在药物研发全生命周期中的整合
    • 构建AI驱动的中国药物研发管线
    • AI应用的监管与合规考量
    • AI技术落地面临的挑战与应对

    1 PM

    Lunch and networking – Please visit 3 booths in this break
    午餐交流时间——请在此期间参观至少3个展位

    2:15 PM

    Panel Innovation in Technology: Transforming Clinical Trials

    • AI and big data in clinical trial design and execution
    • Digital platforms for patient recruitment and engagement
    • Dissecting the challenges surrounding PIPL and how to overcome them

    科技创新：重塑临床试验格局

    • 人工智能与大数据在临床试验设计与执行中的应用
    • 数字化平台赋能患者招募与参与
    • 解析《个人信息保护法》(PIPL)相关挑战及应对策略

    2:45 PM

    Reserved for Event Sponsor
    赞助商专场

    3:15 PM

    Navigating Licensing & Regulatory Frameworks in China
    中国许可与监管框架的应对策略

    • Updates on China’s National Medical Products Administration (NMPA) regulations
    • Recent reforms in drug and device approval processes
    • Best practices for obtaining IND and NDA approvals in China

     

    • 中国国家药品监督管理局（NMPA）法规更新
    • 药品和医疗器械审批流程的最新改革
    • 在中国获得IND（新药临床试验申请）和NDA（新药上市申请）批准的最佳实践

    3:45 PM

    Afternoon refreshments and networking – Please visit 3 booths in this break
    下午茶歇与交流时间——请在此期间参观至少3个展位

    4:30 PM

    Regulatory Harmonization: Bridging China and Global Markets
    监管协调：连接中国与全球市场

    • Aligning with FDA, EMA, and NMPA requirements
    • Strategies for multinational trials involving China
    • Understanding China’s role in global drug development

     

    • 满足FDA（美国食品药品监督管理局）、EMA（欧洲药品管理局）与NMPA（中国国家药品监督管理局）的协同要求
    • 中国参与跨国临床试验的策略部署
    • 解读中国在全球药物研发中的战略定位

    5 PM

    PANEL DISCUSSION: The Future of Outsourcing in China: Trends and Predictions
    专题讨论：中国临床试验外包的未来趋势与展望

    • AI-driven trial forecasting and automation
    • Evolving business models in clinical outsourcing
    • The impact of China’s biotech boom on global trials

     

    • 人工智能驱动的试验预测与自动化
    • 临床外包业务模式的创新演进
    • 中国生物科技热潮对全球试验的影响

    5:30 PM

    Chairperson’s closing remarks
    大会主席总结致辞

    8:30 AM

    Registration and refreshments
    注册签到与茶歇交流

    9:10 AM

    Chairperson’s opening remarks
    主席开幕致辞

    STREAM A: Outsourcing & Clinical Operations

    9:15 AM

    Patient Centricity in Clinical Trials: A New Era in China
    以患者为中心的临床试验：中国新时代

    As China’s clinical trial ecosystem evolves, there is a growing emphasis on patient-centric approaches to improve recruitment, retention, and overall trial outcomes. This session will explore strategies to enhance patient engagement, leverage digital health solutions, and address cultural and regulatory considerations for patient-centric clinical trials in China.

    • Understanding the Shift Toward Patient- Centric Trials in China
    • Enhancing Patient Recruitment and Retention
    • Digital Health and Remote Monitoring in Patient-Centric Trials

    Regulatory and Ethical Considerations

     

    随着中国临床试验生态系统的演进，聚焦患者需求的模式正显著提升受试者招募、留存及整体试验质量。本环节将探讨如何通过数字化健康解决方案增强患者参与度，并解析中国患者中心式试验中的文化适应性与监管要求。

    • 中国患者中心化临床试验转型趋势解读
    • 创新患者招募与留存策略
    • 数字医疗与远程监测技术在患者中心化试验中的应用
    • 特殊监管要求与伦理考量

    9:45 AM

    Reserved for Event Sponsor
    赞助商专场

    10:15 AM

    Vendor Selection Strategies: Building knowledge for optimal decision-making
    供应商优选策略：科学决策方法论

    • Understanding the vendor landscape, best practice and key considerations
    • Key considerations for vendor selection
    • Vendor evaluation and due diligence

     

    • 全面认知供应商生态：行业实践与核心评估维度
    • 供应商筛选关键指标矩阵
    • 供应商能力评估与尽职调查规范
    • 战略合作伙伴关系维护机制

    10:45 AM

    Morning refreshments and networking – Please visit 3 booths in this break
    上午茶歇与交流互动——请在此期间至少参观3个展位

    11:45 AM

    Reserved for Event Sponsor
    赞助商专场

    12:15 PM

    PANEL DISCUSSION
    专题讨论

    The Clinical Trial Landscape for Small to Mid- Sized Biopharma in China

    • New regulations and guidance around clinical trials in China: how will this impact you?
    • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company

    An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

     

    中小型生物制药企业在华临床试验发展路径

    • 中国临床试验新规解读：对中小型企业的实际影响
    • 动态变化的CRO/供应商生态应对策略
    • 临床试验技术创新应用评估：有效方案与现存瓶颈

    3:30 PM

    Speaker Hosted Roundtables
    嘉宾主持圆桌讨论会

    Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

    Roundtable session lasts for 30 minutes and rotate

    ROUNDTABLE 1: What key aspects of inspection readiness should be considered right now?
    ROUNDTABLE 2: Getting the best out of your sponsor – CRO partnership
    ROUNDTABLE 3: Ensuring clinical quality assurance in supply chain management

     

    互动式圆桌会议为您提供与同行深入交流的独特机会，共同探讨行业关键挑战的解决方案并分享最佳实践。每场讨论由行业专家主持，聚焦单一议题，通过高互动形式拓展人脉网络，汲取他人经验智慧。
    （每场圆桌讨论时长30分钟，参会者可轮换参与）

    圆桌议题1：当前核查准备工作的核心要素
    圆桌议题2：如何构建最优申办方-CRO合作伙伴关系
    圆桌议题3：临床试验供应链质量管理保障机制

    Chairperson’s closing remarks
    大会总结致辞与抽奖环节 参与即有机会赢取科技产品等丰厚奖品

    Join us for a chance to win one of our prizes, including Technology products

    会议圆满结束

    1 PM

    Lunch and networking – Please visit 3 booths in this break
    午餐交流时间——请在此期间参观至少3个展位

    2:15 PM

    PANEL The Rise of Chinese Biotech: a competitive challenge for U.S. companies and investors
    专题讨论

    China’s biotech industry has rapidly expanded, posing increasing competition to U.S. biotech firms in drug development, clinical trials, and global market entry. With strong government support, access to capital, and a growing pipeline of innovative therapies, Chinese biotech companies— backed by aggressive venture capital (VC) funding—are reshaping the industry. This session will analyse the competitive landscape, the challenges faced by U.S. biotech firms, and the future dynamics of global biotech innovation.

    • The Rise of China’s Biotech Industry: The Chinese government’s “Made in China 2025” strategy and its impact on biotech innovation
    • The role of China’s National Medical Products Administration (NMPA) in accelerating drug approvals
    • The Role of Venture Capital in China’s Biotech Boom; How Chinese VCs and state-backed funds are fueling biotech startups and the differences between U.S. and Chinese biotech           funding models
    • Competitive Pressure on U.S. Biotech Firms

    Regulatory & Geopolitical Challenges: The impact of U.S.-China trade tensions and export       controls on biotech collaboration

     

    中国生物科技崛起：美国企业与投资者的竞争挑战

    中国生物科技产业迅猛发展，在药物研发、临床试验及全球市场拓展方面对美国生物科技企业构成日益激烈的竞争。凭借政府强力支持、资本优势及创新疗法管线的持续扩充，在风险投资（VC）加持下的中国生物科技企业正在重塑行业格局。本环节将深入分析竞争态势、美国企业面临的挑战以及全球生物科技创新的未来走向。

    • 中国生物科技产业崛起："中国制造2025"战略对生物科技创新的推动效应
    • 监管加速作用：中国国家药品监督管理局（NMPA）在新药审批中的角色演进
    • 资本驱动力量：中美国际资本运作模式差异——中国风险投资与政府基金如何赋能生物科技初创企业
    • 美国企业的竞争压力：核心技术与市场份额的双重挑战
    • 监管与地缘政治因素：中美贸易摩擦及出口管制对生物科技合作的影响

    Speakers

    Select a speaker to learn more

    Back
    Tessa Lai 赖会明
    BMS, Director, Clinical Supply Chain Logistics Asia Pacific

    百时美施贵宝, 临床供应链仓储物流运营亚太区总监
    Next speaker
    Back
    Vincent Zang 臧文升
    Innovent Bio, Sr. Director of Clinical Trial Operation

    信达生物制药-临床运营高级总监

    臧文升在临床运营行业已深耕16年。曾就职于于ICON、强生、先声药业，2019年加入信达生物。承担过多项药物（小分子化药、单抗、双抗、多肽等）的临床开发的全阶段的工作，并已有多个产品成功获批上市。在新药临床开发方面积累了丰富的经验。

    With 16 years of deep expertise in the clinical operations industry, Vincent Zang has previously worked at ICON, Johnson & Johnson, and Simcere Pharmaceutical. In 2019, he joined Innovent Biologics, where he has been involved in the full lifecycle clinical development of multiple drugs (including small molecule chemicals, monoclonal antibodies, bispecific antibodies, peptides, etc.), with several products successfully approved for market launch. He has accumulated extensive experience in novel drug clinical development.

    Next speaker
    Back
    Limin Guan 管利民
    Takeda R&D China and APAC Region, Associate Director, Clinical Supply Chain Operation

    武田研发中国及亚太中心 , 副总监, 临床供应链运营

    Limin Guan has 17 years of experience in the pharmaceutical industry, beginning with technical roles in drug substance process development within a pilot plant setting. Over the past 10 years, he has honed his expertise in clinical supply chain management, starting his journey at Novartis. His professional background includes integrating global supply chain experience across the US, EU, APAC, and beyond, through roles at Novartis, Zailab, Beigene, and Takeda, with a particular focus on the Asia-Pacific region. Currently, Limin provides leadership and strategic direction for Clinical Supply Chain activities in China and the APAC region. His responsibilities include overseeing outsourced operations, serving as the Global Clinical Supply Chain representative to local functions, and advancing capabilities in project planning and execution.

    管利民在制药行业拥有17年的经验，最初从事药物原料工艺开发的技术工作，主要集中在中试车间领域。在过去的10年里，他在临床供应链管理方面积累了丰富的经验，并从诺华开始了这一领域的职业旅程。他的职业背景包括在诺华、再鼎、百济和武田公司等担任职务，整合了在美国、欧洲、亚太地区及其他地区的全球供应链经验，尤其专注于亚太区域。目前，他负责领导和制定中国及亚太地区临床供应链活动的战略方向。他的职责涵盖监督外包业务，作为武田全球临床供应链与当地职能部门之间的代表，并推动项目规划与执行能力的提升。

    Next speaker
    Back
    Megan Qin 秦飞
    CMAC, Head of Medical Device Clinical Excellence Working Group

    CMAC-卓越临床联盟医疗器械工作组负责人

    秦飞拥有超过15年的医疗行业经验，PMI认证项目管理专家，专注于临床研究领域项目管理，临床路径规划，临床运营及创新智能化解决方案。她曾就职于罗氏制药、巴德医疗（碧迪医疗）、BI(勃林格殷格翰)以及史赛克医疗等世界知名医疗企业，曾担任中国区临床事务负责人，积累了丰富的药物及医疗器械GCP的知识和实践经验，在创新医疗器械、优化临床数据的应用，实施项目管理风险管控等方面尤其热衷。现兼任中国残疾人康复协会-医疗器械临床试验质量管理专业委员会委员，DIA真实世界研究工作组成员。

    Megan Qin has over 15 years of experience in the healthcare industry and is a PMI-certified Project Management Professional specializing in clinical research project management, clinical pathway planning, clinical operations, and innovative intelligent solutions. She has held positions at world-renowned healthcare companies including Roche Medical, Bard Medical (BD), BI (Boehringer Ingelheim), and Stryker Neurovascular, where she served as the Head of Clinical Affairs for China, accumulating extensive knowledge and hands-on experience in GCP (Good Clinical Practice) for drugs and medical devices. She is particularly passionate about innovative medical devices, optimizing clinical data applications, and implementing project management risk controls.
    Currently, she also holds roles as Committee Member of Medical Device Clinical Trial Quality Management Committee-China Association of Rehabilitation of Disabled Persons and Working Group Member of DIA Real-World Evidence Research Group.

    Next speaker
    Back
    Siwei Li 李四维
    Degron Therapeutics, Director, DMPK

    达歌生物医药, 药代动力学总监

    李四维博士，达歌生物药代动力学总监。2008年毕业于南京大学生物技术专业本科，2014年获美国辛辛那提大学化学博士学位。随后在美国密西根大学药学院从事博士后研究，并获斯坦福大学数据科学职业认证。李博士拥有10余年的药物研发经验，曾先后担任AI制药公司AI药理总监、百济神州高级主任研究员及美国硅谷精准医学公司研究科学家。同时，他还是爱思唯尔《Food Chemistry》期刊的杰出审稿人。李博士的研究方向聚焦于小分子非临床药代动力学研究；模型引导的药物研发(MIDD): PKPD模型和AI模型在药物研发中开发和应用；生物分析技术开发与应用。他还在AI赋能蛋白质组学及代谢组学研究方向拥有多年实践经验。曾参与10余个新药研发项目，并主导参与多个中美IND申报相关的非临床药代动力学研究工作。迄今在国际知名期刊发表论文20余篇及申请专利1项。

    Dr. Siwei Li, Director of DMPK at Degron Therapeutics. Dr. Li earned his B.S. in Biotechnology from Nanjing University in 2008 and received his Ph.D. in Chemistry from the University of Cincinnati (USA) in 2014. Then he served as postdoctoral research fellow at the University of Michigan College of Pharmacy and also obtained a professional certificate in Data Science from Stanford University. With over 10 years of experience in drug discovery and development, Dr. Li has held key positions including Director of AI Pharmacology at an AI Drug Discovery biotech company, Senior Principal Investigator at BeiGene, and Research Scientist at a Silicon Valley precision medicine company. He is also recognized as an Elsevier Outstanding Reviewer for Food Chemistry journal. His research focuses on small molecule non-clinical pharmacokinetics, Model-Informed Drug Discovery (MIDD): PKPD and AI model development and application in drug discovery and development, Bioanalytical technology development and application, AI-driven proteomics and metabolomics research. Dr. Li has contributed to 10+ drug discovery programs and led/participated in non-clinical PK studies supporting multiple China-US IND filings. To date, he has published over 20 papers in internationally renowned journals and filed 1 patent application.

    Next speaker
    Back
    Fiona Xing 邢新苗
    Brii Biosciences, Senior Director of Global Clinical Trial Supply

    腾盛博药, 全球临床试验供应链高级总监

    邢新苗目前任职于腾盛博药医药技术（北京）有限公司，担任临床供应链负责人。她从2005年进入医药行业，先后任职于施维雅，艾尔建，拜耳研发中心，默克雪兰诺研发中心，主要从事中国以及全球临床试验供应链协调和管理工作。​

    邢新苗拥有山东大学微生物学专业硕士学位，并获得美国索菲亚大学MBA学位。 此外，邢新苗持有美国项目管理协会的专业项目管理和项目集管理认证。

    Fiona Xing is currently serving as the Head of Clinical Supply Chain at Brii Bioservices (Beijing) Co., Ltd. She entered the pharmaceutical industry in 2005 and worked at Servier, Allergan, Bayer R&D Center and Merck Serono R&D Center, mainly engaged in local and global clinical trial supply chain coordination and management. ​

    Fiona Xing holds a master‘s degree in microbiology from Shandong University and an MBA degree from Sofia University in the United States. In addition, Fiona Xing has obtained professional Project Management (PMP) and Program Management (PgMP) certification from the American Project Management Institute.

    Next speaker
    Back
    Angela Yu 于琳
    East China Pharm, Head of Vendor Management

    华东医药, 临床供应商负责人
    Next speaker
    Back
    Paul Kong 孔亮
    LaNova Medicines, VP of Clinical Operations

    礼新医药, 临床运营副总裁

    礼新医药临床运营副总裁。曾在精鼎、方恩等CRO公司任职并负责方恩临床运营工作，此后在罗氏以及珐博进、华领、康宁杰瑞等Biotech企业担任临床运营部门负责人，负责多项国际国内研究，并助力多项1.1类新药成功获批。

    Paul Kong, leads Clinical Operation team within LaNova since Apr, 2021. He has more than 10 years experiences in CRO, such as Parexel and FMD, and then taking the leading role from various biotechs and big pharm, Roche, FibroGen, Hua Medicine and Alphamab in clinical operation team; and he has major contributions for lots of first in class production registration.

     

    Next speaker
    Back
    Shen Xiao 肖申
    Alebund, Chief Scientific Officer

    礼邦制药, 首席科学官

    肖申博士现任礼邦制药首席科学官，负责公司新药的临床前开发和全球药物注册，并协同首席医学官推进公司新药的临床开发工作。之前曾任海森生物医药有限公司首席医学官，思路迪医药的首席战略官和首席医学官。肖申博士曾在美国食品药物监督管理局（FDA）担任药理,毒理的非临床高级审评员负责内分泌，代谢疾病新药的非临床审评，和临床高级审评员负责心、肾、血管疾病新药的临床审评。在近二十年的 FDA工作生涯中，负责审评了数百个新药开发（IND）的各个阶段，跨度从临床前期、临床各期、及上市后的药物疗效、安全跟踪、随访；做为临床评审员和/或综合评审小组负责人负责审批了十几个新药的上市工作。其间曾在 FDA 医疗器械审评中心（CDRH），负责多个相关医疗设备的审评、审批（IDE，510k，PMA）。​

    加入 FDA 之前，曾作为内科临床主治医生、博士研究助理和博士后有十多年的临床工作和实验室研究经验，包括各类普通内科疾病诊治、抗生素临床药代动力学的研究、细胞信号传导的研究等。其间除了曾获国家科技进步三等奖一项，全军科技进步二等奖一项外，还获得 FDA，美国生理协会（APS），国际肾脏病协会（ISN），日本透析和人工脏器协会的多项奖励。​

    Be responsible for the setting of company's R/D product pipelines, non-clinical and clinical product development, and global regulatory affairs. Previously, he served as the Chief Medical Officer at Hasten Biopharmaceutical Co, Ltd, and the Chief Medical Officer and Chief Strategy Officer at 3D Medicines Inc for taking the full responsibilities of company’s clinical product development and global regulatory affairs.  

    Before that, Dr. Xiao worked in the US FDA as a senior medical officer and was responsible for the clinical review of new drugs in the areas of Cardiovascular, renal, diabetes, obesity and some other endocrine and metabolic diseases. During his nearly 20-year career at the FDA, he reviewed several hundreds of Investigational New Drug (IND) applications across various stages, including preclinical, clinical phases, and post-marketing drug efficacy and safety tracking, and follow-up. As a clinical reviewer and/or multiple discipline team leader, he approved over a dozen of NDAs/BLAs. He also worked at the FDA’s Center for Devices and Radiological Health (CDRH), where he reviewed and approved multiple medical devices (IDE, 510K, PMA). 

    Prior to FDA, as an attending physician in Nephrology in China and research fellow in US, he had over a decade of clinical practice and laboratory research experience. His experience includes diagnosing and treating a variety of general internal medicine diseases, renal diseases, conducting the clinical pharmacokinetics studies for different antibiotics, and studying cell signaling pathways. During this time, he was awarded numerous honors including the China National Scientific and Technological Third Award,  and many other awards from the FDA, the American Physiological Society (APS), the International Society of Nephrology (ISN), and the Japanese Society for Dialysis Therapy and Artificial Organs (JSDAO). 

    Next speaker
    Back
    Xiaoyu Deng 邓晓宇
    MDCE, Founder

    希毅医学创始人

    邓晓宇先生拥有17年全球多区域医药研究开发经验，曾在多个国际领先的临床研究组织担任重要职务，包括 Labcorp、Syneos、Chiltern 和 Covance，并帮助多个亚太区企业在欧洲和美国开展医药产品临床研发工作。在新冠疫情期间，他成功领导了 Covance 亚太区的首个新冠临床研究。作为希毅医学的创始人，他带领公司帮助 80 多项生物医药项目在海外顺利落地。
    邓晓宇先生毕业于哈佛大学流行病与临床试验专业，同时他也是美国项目管理协会认证项目管理专家，注册药剂师。

    Xiaoyu Deng, has over 17 years of experience in global clinical research and development. Mr. Deng is a recognized expert in planning and executing clinical trials across diverse global regions. He has held key positions at leading international CROs, including Labcorp, Syneos, Chiltern, and Covance. During the COVID-19 pandemic, Mr. Deng successfully led the first COVID-19 study in the APAC region for Covance, demonstrating his ability to lead high-stakes research under tight timelines.
    As the founder of MDCE, Mr. Deng has guided the company to substantial success, generating over 20 billion RMB in profits for its clients and helping more than 80 Chinese medical devices and drug products successfully land overseas.
    Mr. Deng holds a Master’s degree in Public Health (Epidemiology) from Harvard University’s T.H. Chan School of Public Health. He is also a certified Project Management Professional (PMP), and a licensed pharmacist.

    Next speaker
    Back
    Dr. Claudia Hesselmann
    Founder & CEO, ARENSIA Exploratory Medicine

    Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

     

    Session Details:

    Reserved for ARENSIA
    赞助商专场

    2025-09-03, 9:30 AM

    View In Agenda
    Next speaker
    Back
    Jason Zhu
    Henlius, CEO

    复宏汉霖
    Next speaker
    Back
    Shawn Zhu
    Henlius, CTO

    复宏汉霖
    Next speaker
    Back
    Jarod Chen
    Lynk Pharmaceuticals, Co-Founder

    凌科药业, 联合创始人
    Next speaker
    Back
    Jing Li
    Henlius, CMO

    复宏汉霖
    Next speaker
    Back
    Robort Luo
    Mi-tuo Bio, Co-Founder

    米陀生物, 联合创始人
    Next speaker
    Back
    Huaihan Cai
    Overseaspharm, Co-Founder

    越洋医药, 联合创始人
    Next speaker

    OCT Advisory Board

    Select a member to learn more

    Back
    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

     

    Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

     

    Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

     

    Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

     

    Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

    Next
    Back
    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

    Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

    Next
    Back
    THOMAS M TREMBLAY
    Vice President Of Clinical Development, Trefoil Therapeutics, Inc

    Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

    Next
    Back
    Bao Dinh
    Global Development Business Operation, Takeda

    With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

    Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

    Next

    Plan Your Visit

    Renaissance Suzhou Hotel

    Book Your Stay

    Arena International Events Group “(Arena”) is aware of numerous third-party agencies which are contacting Arena’s customers and purporting to have access to hotel room bookings, events attendee lists and selling unsolicited services. It is unclear whether the agencies in question are in possession of such information, or whether they intend to scam unsuspecting customers. Whilst Arena International Events Group pursues such third-party companies for their potentially illicit activity, Arena encourages you to be cautious in engaging with such third-party agencies and Arena shall not accept any responsibility for any losses incurred by you should you choose to engage with third parties that have no affiliation to Arena International Events Group..

    Sponsors

    Select a sponsor to learn more

    Featured Sponsor

    Session Sponsor

    Exhibitor

    Co-Sponsor

    Why partner?

     

    Contact us to become a partner

    Partnership Opportunities

    We work with you to design a bespoke package to meet your business needs, where you could:

    • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
    • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
      Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
    • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

    Event reach

    • 250+ attendees each year
    • 80% attendees C-suite level

     

    Take a look at our current sponsors

    Media Centre

    Media Partners

    Enquiry

    Contact Us

    SPONSORSHIP ENQUIRIES

    Nicholas McCudden

    Head of OCT Events

    +61 280 978 126

    SPEAKER ENQUIRIES

    Maya Hudson

    Head of Production

    MARKETING ENQUIRIES

    Moona Popal

    Senior Marketing Manager

    DELEGATE ENQUIRIES

    Sunny Saikia

    VIP Delegate Manager

    Sponsorship Enquiries

    To enquire about sponsorship opportunities for the conference, please contact:

    Nicholas McCudden

    Head of OCT Events


    +61 280 978 126

    Speaker Enquiries

    To enquire about speaking opportunities for the conference, please contact:

    Maya Hudson

    Head of Production