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 at 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
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Agenda

  • 3 Sep 2025
  • 4 Sep 2025
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8:30 AM

Registration and refreshments
注册签到 & 茶歇交流

9 AM

Chairperson’s opening remarks
主席开幕致辞

Speakers

Fiona Barry
Editor-in-Chief & Director of Outsourcing, GlobalData Healthcare 医疗健康部主席,Globaldata

9:15 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.

Moderator:

Fiona Barry, Editor in Chief & Director of Outsourcing, Globaldata Healthcare

Panelists:

Summer Xia, CEO & Founder, Trial-Data Medicine Li Zeng, CEO, Jing Medicine

Fiona Xing, Senior Director of Global Clinical Trial Supply, Brii Biosciences

 

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

 

  • 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潜在影响

 

主持嘉宾:

Fiona Barry, 医疗健康部主席,GlobalData

论坛嘉宾:

夏素琴,创始人,创达医药曾雳,创始人,和径医药

邢新苗, 供应链高级总监,腾盛博药

Speakers

Fiona Barry
Editor-in-Chief & Director of Outsourcing, GlobalData Healthcare 医疗健康部主席,Globaldata
Summer Xia 夏素琴
Founder & CEO, Trial Data Medicine 创始人,创达医药
Li Zeng 曾雳
CEO, Jing Medicine 创始人,和径医药
Fiona Xing 邢新苗
Brii Biosciences, Senior Director of Global Clinical Trial Supply

供应链高级总监, 腾盛博药

10 AM

Optimal Strategies for Chinese Innovative Biotechs to Maximize Pipeline Value for International Out- Licensing Opportunities 中国创新生物科技企业最大化管线国际授权价值的最优策略

  • Quickly generate initial efficacy signals - PROOF of CONCEPT - with globally recognized FDA/EMA
  • Secure expedited regulatory approval for Phase 1 and 2 clinical trials in
  • Achieve an efficient budget for clinical
  • 快速生成具有全球认可度(FDA/EMA 标准)的初步疗效信号 - 概念验证
  • 确保在欧洲获得加速的一期和二期临床试验监管审批
  • 实现临床试验预算的高效配置

Speakers

Dr. Claudia Hesselmann
PhD – Founder & CEO, ARENSIA Exploratory Medicine PhD,创始人兼 CEO, ARENSIA Exploratory Medicine

10:30 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
  • Common difficulties for China sponsors going
  • Managing cross-border clinical trials: logistics, communication, and cultural
  • Case studies of successful global-China
  • 与中国 CRO/CMO 合作——全球申办方必备指南
  • 中国出海常见难点
  • 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

Speakers

Paul Kong 孔亮
LaNova Medicines, VP of Clinical Operations

临床运营副总裁, 礼新医药

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
分会场 A:外包与临床运营

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

Speakers

Helena Shen 沈濬
Head of Expert Committee, DCT Academy 联合创始人,DCT学院

12 PM

Globalization of Phase 1 Clinical Trials to Maximize Program Delivery and ROI 一期临床试验全球化:最大化项目交付与投资回 报

  • Summary of market data and where Phase 1 studies are being performed.
  • What are investors looking for from Phase 1 clinical trial datasets?
  • What and where can Phase 1 studies be done to meet or exceed market demands?
  • Review relevant case studies given recent China Biotechs market success.

 

  • 市场数据总结及一期临床试验开展地区分析
  • 投资者对一期临床试验数据的关键需求
  • 满足或超越市场需求的一期临床试验方案及实施地点
  • 结合中国生物科技公司近期市场成功的相关案例研究

Speakers

Chris Hickey
MBA, Chief Business Development Officer, Nucleus Network MBA, 首席商务官员, Nucleus Network

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

  • AI integration across the drug development lifecycle
  • Building AI-driven drug discovery pipelines in China
  • Overcoming challenges in AI adoption
  • Success case study from Degron

 

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技术落地面临的挑战与应对
  • 达歌生物成功案例分享

Speakers

Siwei Li 李四维
Degron Therapeutics, Director, DMPK

药代动力学(DMPK)总监, 达歌生物医药

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 PM

The Clinical Trial Landscape for Small to Mid- Sized Biopharma in China 中小型生物制药企业在华临床试验发展路径

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

 

  • 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
  • 海南封关对中国医药企业的影响与机遇

 

 

Speakers

James Liu
Co-founder, Facan Bio 联合创始人, 发璨医药

2:30 PM

From Regional to Global: Best Practices for Progressing Your Drug Development 从区域到全球:推动药物研发的最佳实践

  • Understanding the current biotech landscape.
  • Top considerations for future development.
  • Engaging a global CRO.
  • 了解当前生物技术领域的发展态势
  • 未来发展的关键考量因素
  • 如何与全球 CRO 建立合作

Speakers

David Hsu
Executive Director, Clinical Trial Management, Medpace 执行总监,临床试验管理, Medpace

3 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

Speakers

Ellen Guan 关怡
RA Executive Director
药政事务执行总监, 思路迪医药

3:30 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 PM

Global Strategy Compass: The Great Navigation Era of Chinese Medical Devices 全球战略罗盘:中国器械的大航海时代

  • Case Studies on the Overseas Expansion of Chinese Medical Devices.
  • Exploring the Global Medical Device Market: Where to Set Sail First?
  • Practical Insights and Considerations for Multinational Clinical Trials.

 

  • 中国医疗器械出海案例分享
  • 全球医疗器械市场探索:出海第一站在哪?
  • 跨国临床试验实战与注意点

Speakers

Xiaoyu Deng 邓晓宇
MDCE, Founder

创始人,希毅医学

4:30 PM

PANEL DISCUSSION: The Future of Clinical Trials for China to Overseas: Trends and Predictions
专题讨论:中国临床试验海外机遇与展望

  • The impact of China’s biotech boom on global trials
  • How do the global policies and regulatory difference impact the decision of China biotech
  • The opportunities and challenges for clinical trials overseas and license out.

Moderator:

Xiaoyu Deng, Founder & CEO, MDCE

  • 中国生物科技热潮对全球试验的影响
  • 全球出海政策及监管差异对中国企业选择的决定影响
  • License-out 与海外临床试验的不同机遇与挑战

主持嘉宾:

邓晓宇,创始人,希毅医学

Speakers

Xiaoyu Deng 邓晓宇
MDCE, Founder

创始人,希毅医学
Cherry Zhang 张婧怡
Australia New South Wales Government Trade & Investment Office, Associate Director

商务官员, 澳大利亚新南威尔士州政府贸易与投资办事处
Chester Xiao 肖嘉
Director of China Life Science, IDA 中国区生命科学行业总监,爱尔兰投资发展局
Vikki Wang 王艳波
Head of China Center, U.S. Maryland China Center 主任,美国马里兰中国中心

5 PM

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

END OF DAY 1 AND NETWORKING DRINKS RECEPTION
第一天议程结束

8:30 AM

Registration and refreshments
注册签到与茶歇交流

9 AM

Chairperson’s opening remarks
主席开幕致辞

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

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

  • 去中心化临床试验 DCT 的发展历程
  • 国内外相关法规对 DCT 的指导要求
  • DCT 技术在临床研究中的具体应用和实践
  • 关于 DCT 发展趋势的展望和应对。

Speakers

Vincent Zang 臧文升
Innovent Bio, Sr. Director of Clinical Trial Operation

临床运营高级总监,信达生物

9:45 AM

China Clinical Trials: The emergence and transformation of China 中国临床试验:崛起与转型之路

  • Key trends in the evolving regulatory landscape leading to accelerated approval timelines, elevated quality standards and unlocking new opportunities for drug discovery.
  • Key trends driving market momentum leading to an increased market investment, innovation dynamics, and the rapid growth of China’s healthcare sector.
  • The future of clinical trials in China: China’s clinical trial landscape is evolving from a solid foundation into a global powerhouse for drug development and innovation.
  • 监管环境变革关键趋势:加速审批进程、提升质量标准,为药物研发开启新机遇
  • 市场动能核心驱动力:投资规模扩大、创新活力迸发,推动中国医疗健康产业快速增长
  • 中国临床试验未来展望:从坚实基础迈向全球药物研 发与创新的领军地位

Speakers

Jane Zhu
Operation Site Leader China, Eurofins Central Laboratory 中国区现场运营负责人, Eurofins Central Laboratory

10:15 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 AM

Use of RWE in Neurovascular Medical Device Example 真实世界证据在神经血管医疗器械应用示例

  • Clarifying the differences in using the terms RWE vs
  • Proving examples of RWE sources available: commercial, society, private.
  • Case study to explain a detailed implementation of RWE to support an expanded indication for a medical device
  • RWE(真实世界证据)与 RWD(真实世界数据)术语使用的区别
  • 现有 RWE 来源的实例:商业数据库、学会数据、私有数据源
  • 如何运用真实世界证据支持医疗器械适应症扩展的案例介绍

 

 

Speakers

Ted Chun
Owner, Chun Consulting 创始人,Chun Consulting

11:30 AM

AI-Driven New Paradigm for Healthcare AI 驱动的医疗健康新范式

  • Government & Regulation: From "Approver" to "Ecosystem Cultivator and Rule-Maker".
  • Pharmaceutical Companies: From "Drug Suppliers" to "Key Ecosystem Builders and Enablers".
  • Medical Institutions: From "Service Endpoints" to "Data-Driven Innovation Hubs".
  • Patient Population: From "Passive Recipients" to "Empowered Active Health Partners".
  • 政府与监管:从“审批者”到“生态培育者与规则制定者
  • 医药企业:从”药品供应商“到”生态系统的关键构建者与赋能者“
  • 医疗机构:从“服务终端”到“数据驱动的创新协同中心”
  • 患者群体:从”被动受众“到”自我赋能的主动健康伙 伴

Speakers

George Gu 顾文兵
Linscope Institute for Life and Health Innovation, Head of International Cooperation

国际合作部主任,领思生命健康创新研究院

12 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

1 PM

PANEL DISCUSSION: The Rise of Chinese Biotech: a competitive challenge for U.S. companies and investors
专题讨论 中国生物科技崛起:美国企业与投资者的竞争挑战

  • 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

Moderator:

Claire Qin, Chief Strategy Officer, Intelligen AI; BioPharma Investor

 

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

主持嘉宾:
秦祯,首席战略官,Intelligen AI

Speakers

Claire Chin 秦祯
Chief Strategy Officer, Intelligen AI
首席战略官,Intelligen AI
Megan Qin 秦飞
CMAC, Head of Medical Device Clinical Excellence Working Group

卓越临床联盟医疗器械工作组负责人,CMAC
Richard Sun 孙远
Department GM, BioBAY 招商部总经理,BioBAY
Ted Chun
Owner, Chun Consulting 创始人,Chun Consulting

1:30 PM

ROUNDTABLE SESSIONS
嘉宾主持圆桌讨论会

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1

What key aspects of inspection readiness should be considered right now?

Hosted By Claire Qin, Chief Strategy Officer, Intelligen AI; BioPharma Investor

ROUNDTABLE 2

Getting the best out of your sponsor – CRO partnership

Hosted by Megan Qin, Head of Medical Device Clinical Excellence Working Group, CMAC

ROUNDTABLE 3

Ensuring clinical quality assurance in supply chain management

Hosted By Daniel Gao, President, ISPE Supply Chain Committee

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:中国药企出海的机遇与挑战
主持嘉宾:秦祯,首席战略官,Intelligen AI

圆桌议题2:如何构建最优申办方-CRO合作伙伴关系
主持嘉宾:秦飞,卓越临床联盟医疗器械工作组负责人,CMAC

圆桌议题3:临床试验供应链质量管理保障机制
主持嘉宾:高晓伟,主席,ISPE供应链分会

Speakers

Claire Chin 秦祯
Chief Strategy Officer, Intelligen AI
首席战略官,Intelligen AI
Megan Qin 秦飞
CMAC, Head of Medical Device Clinical Excellence Working Group

卓越临床联盟医疗器械工作组负责人,CMAC
Daniel Gao 高晓伟
President, ISPE Supply Chain Committee
主席,ISPE中国制药供应链分委会

2:30 PM

Chairperson’s closing remarks and Prize Draw
大会总结致辞与抽奖环节

END OF CONFERENCE
会议日程结束

3 PM

BIOBAY Tour
BioBAY 园区参访之旅

Join us for an exclusive afternoon visit to Biobay, China's Biotechnology Megahub, a leading biomedical innovation zone in Suzhou. This is a unique opportunity for vendors and industry partners to meet local sponsors, network with clinical research experts, and explore the cutting-edge platforms Biobay offers.

  • Tour of Biobay Exhibition Hall
  • Visit to the Biobay Nucleic Acid Platform
  • Corporate Roundtable: Open discussion with sponsors and clinical experts

Spaces are limited. To reserve your place, please RSVP via Sales executive or contact Elyn Jiang at elyn.jiang@arena-international.com

 

诚邀您参加 BioBAY 独家下午参访活动,亲临苏州领先的生物医药创新产业集群——苏州生物医药产业园 (BioBAY)。本次活动为供应商及行业伙伴提供独特机会,与本土申办方会面交流、结识临床研究专家,并深度 探访 BioBAY 的前沿技术平台。

  • BioBAY 展示馆参观导览
  • 国家生物药技术创新中心核酸药物技术创新平台实地参访
  • 企业圆桌会:与申办方及临床专家开放式研讨

席位有限,请通过销售代表报名或联系  elyn.jiang@arena-international.com  预留席位

Speakers

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Paul Kong 孔亮
LaNova Medicines, VP of Clinical Operations

临床运营副总裁, 礼新医药

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.

 

Session Details:

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

2025-09-03, 10:30 AM

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Li Zeng 曾雳
CEO, Jing Medicine 创始人,和径医药

Dr. Li ZENG joined Jing Medicine as Chief Executive Officer in November 2021, bringing with him a wealth of R&D and business operation experience in the pharmaceutical industry with a career spanning over 18 years. He has held drug R&D, portfolio and project management positions of increasing responsibilities in multinational companies such as Novartis and Eli Lilly as well as in traditional local pharma and biotech firms such as Luoxin Pharmaceutical, 4B Technologies and Harbour Biomed.

Dr. Zeng received his bachelor’s degree in chemistry from Peking University and Ph.D. in Organic Chemistry from Stanford University. He conducted his postdoctoral research training in Chemical Biology at University of California, Berkeley.

曾雳博士于2021年11月加入和径医药担任首席执行官,拥有超过19年的新药研发和管理经验。曾博士先后在跨国药企诺华公司和礼来公司负责新药研发和项目管理,以及在罗欣药业、福贝生物和和铂医药等民营企业和生物技术公司负责战略规划和运营、新药产品线和项目管理。

曾博士分别在北京大学和斯坦福大学获得化学学士和有机化学博士学位,并在加州大学伯克利分校完成化学生物学的博士后训练。

Session Details:

Opening Keynote Panel
开幕主题论坛

2025-09-03, 9:15 AM

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Summer Xia 夏素琴
Founder & CEO, Trial Data Medicine 创始人,创达医药

Over 18 years of experience in clinical research and 9 years in digital CRO. Holds an MBA from The University of Hong Kong and is a pioneer in decentralized clinical trial (DCT) practices in China.​

Previously worked at world-renowned companies such as Roche, PPD, and Chiltern, leading multiple large-scale regional studies as the China lead, managing projects across nearly 150 research sites.​

Key Contributions: Co-author of *Real-World Research Guidelines 2018*; Co-author of Medical Code in the AI Era; Co-author of Blue Book on Remote & Intelligent Clinical Trials; Committee member of DIA (Drug Information Association), involved in oncology researcher training programs.​

18余年临床研究领域经验,9余年医疗数字化创业经历。香港大学工商管理学硕士,DCT中国临床研究实践的先行者。​

曾就职于罗氏、PPD、Chiltern等世界知名企业,参与多项大型regional study 任中国区负责人,负责近150家研究中心的项目管理工作。《真实世界研究指南2018 》执笔专家之一, 《AI时代医学密码》执笔专家之一,《远程智能临床试验蓝皮书》执笔专家之一,同时担任DIA组委会成员参与肿瘤研究者培训工作。

Session Details:

Opening Keynote Panel
开幕主题论坛

2025-09-03, 9:15 AM

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Helena Shen 沈濬
Head of Expert Committee, DCT Academy 联合创始人,DCT学院

Over 22 years of multinational corporation (MNC) experience in full lifecycle product development, real-world evidence, new product launch, pharmacovigilance, and GxP QMS compliance & auditing across oncology and specialty therapeutic areas.

Prior to DCTA and Trial Data, held positions at Roche China Medical Affairs and Eli Lilly Global R&D.

Master of Medicine in Hematology from Shanghai Jiao Tong University School of Medicine; practiced hematology at Hôtel-Dieu Hospital in Paris, France and Ruijin Hospital in Shanghai, China.

拥有超过22年跨国企业工作经验,负责全生命周期产品研发以及真实世界证据、新产品上市、药物安全警戒以及GxP质量管理体系合规与审计等多个方面,涉及多个肿瘤和特药治疗领域。

加入创达之前,先后在罗氏中国医学事务部、礼来全球研发担任多个职位。

毕业于上海交通大学医学院,获得血液学医学硕士学位,曾在法国巴黎Hotel Dieu Hospital和上海瑞金医院血液科就职参加临床工作。

Session Details:

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

2025-09-03, 11:30 AM

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

副总监,临床供应链运营, 武田研发中国及亚太中心

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。

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Siwei Li 李四维
Degron Therapeutics, Director, DMPK

药代动力学(DMPK)总监, 达歌生物医药

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.

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。

 

Session Details:

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

2025-09-03, 12:30 PM

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

供应链高级总监, 腾盛博药

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.

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。

 

Session Details:

Opening Keynote Panel
开幕主题论坛

2025-09-03, 9:15 AM

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Ellen Guan 关怡
RA Executive Director
药政事务执行总监, 思路迪医药

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。

 

 

Session Details:

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

2025-09-03, 3:00 PM

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James Liu
Co-founder, Facan Bio 联合创始人, 发璨医药

James Liu , Licensed Attorney,holding LL.M.s both from the University of Manchester and one of the top China’s university, as well as a Ph.D. in Management, with twenty years of dedicated experience in the biopharmaceutical and high-tech investment sectors. As a founding practitioner (Founder), I lead the formulation of corporate-wide strategy and development roadmaps, concentrating on core drivers for business growth: effectively integrating critical resources (particularly governmental relations and public policy resources), establishing deep public-private collaborative ecosystems, accurately discerning industry policy trends and driving their translation into execution to ensure corporate compliance and sustained competitive advancement. Leveraging comprehensive expertise spanning R&D, manufacturing, operations management, to investment and financing, I am committed to accelerating the industrialization of innovative achievements and steering organizations toward high-quality, sustainable growth.

刘 James,执业律师,拥有国内外著名高校生物化学本科、双法学硕士及管理学博士学位,于生物医药与高科技投资领域持续深耕二十年。 作为创业实践者(Founder),主导制定企业整体战略与发展路径,聚焦驱动业务增长的核心要素:高效整合关键资源(尤其是政府关系与公共政策资源)、构建深度政企协同生态、精准研判产业政策趋势并推动落地转化,确保企业合规经营与竞争力持续提升。 凭借覆盖研发、生产、管理至投融资的综合经验,致力于促进创新成果产业化,引领企业实现高质量的可持续增长。

 

Session Details:

The Clinical Trial Landscape for Small to Mid- Sized Biopharma in China 中小型生物制药企业在华临床试验发展路径

2025-09-03, 2:00 PM

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

临床供应链仓储物流运营亚太区总监,BMS

"Tessa Lai—Director, CSC Logistics APAC Warehouse & Distribution Operations Tessa has 15+ years’ experience in clinical supply including supply planning, manufacture, packaging, importation, logistic management and comparator sourcing. As the clinical supply Chain Logistic Asian Director, she manages all APAC clinical supply warehouses and logistic activities, oversees the clinical supply in China (mainland, Hong Kong, Taiwan), Japan, Korea, Australia, India and other Asian countries. Her team also manages APAC local comparator sourcing and related packaging and labelling."

"赖会明——CSC物流亚太区仓储与配送运营总监 赖会明在临床供应领域拥有超过15年的丰富经验,涵盖供应计划、生产、包装、进口、物流管理及对照药采购等全流程。 作为临床供应链物流亚洲区总监,她全面负责亚太地区所有临床供应仓库及物流运营管理,监管中国(大陆、香港、台湾)、日本、韩国、澳大利亚、印度及其他亚洲国家/地区的临床物资供应。其团队还主导亚太本土对照药采购及相关的包装标签业务。"

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Vincent Zang 臧文升
Innovent Bio, Sr. Director of Clinical Trial Operation

临床运营高级总监,信达生物

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.

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。

 

Session Details:

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

2025-09-04, 9:15 AM

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

卓越临床联盟医疗器械工作组负责人,CMAC

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.

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。

 

Session Details:

ROUNDTABLE SESSIONS
嘉宾主持圆桌讨论会

2025-09-04, 1:30 PM

Session Details:

PANEL DISCUSSION: The Rise of Chinese Biotech: a competitive challenge for U.S. companies and investors
专题讨论 中国生物科技崛起:美国企业与投资者的竞争挑战

2025-09-04, 1:00 PM

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Xiaoyu Deng 邓晓宇
MDCE, Founder

创始人,希毅医学

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.

Session Details:

Global Strategy Compass: The Great Navigation Era of Chinese Medical Devices 全球战略罗盘:中国器械的大航海时代

2025-09-03, 4:00 PM

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PANEL DISCUSSION: The Future of Clinical Trials for China to Overseas: Trends and Predictions
专题讨论:中国临床试验海外机遇与展望

2025-09-03, 4:30 PM

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Claire Qin 秦祯
Chief Strategy Officer, Investor, Intelligen AI 首席战略官,投资人,Intelligen AI
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George Gu 顾文兵
Linscope Institute for Life and Health Innovation, Head of International Cooperation

国际合作部主任,领思生命健康创新研究院

Head of International Cooperation, Linscope Institute for Life and Health Innovation. Over 20 years of leadership experience in multinational pharmaceutical and medical-device companies, spanning medical affairs, marketing, sales management, and strategy. Eight years as a principal consultant to global biopharma enterprises. Former oncologist at Zhongshan Hospital affiliated to Fudan University.

现任领思生命健康创新研究院 国际合作部主任。20余年跨国医药和器械公司管理,包括医学、市场、销售管理、战略等。8年跨国生物医药行业首席咨询顾问。原复旦大学附属中山医院肿瘤专业医师。

Session Details:

AI-Driven New Paradigm for Healthcare AI 驱动的医疗健康新范式

2025-09-04, 11:30 AM

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Fiona Barry
Editor-in-Chief & Director of Outsourcing, GlobalData Healthcare 医疗健康部主席,Globaldata

Fiona Barry is Editor-in-Chief & Director of Outsourcing at GlobalData, where she leads the PharmSource division in gathering news, data and analysis about contract manufacturing. She has covered the pharma industry for more than a decade, as a journalist and analyst.

Session Details:

Opening Keynote Panel
开幕主题论坛

2025-09-03, 9:15 AM

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Chairperson’s opening remarks
主席开幕致辞

2025-09-03, 9:00 AM

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Shelly Xie 谢晓琳
Associate Director, Clinical & QC Management, Eli Lilly 临床与注册管理供应链副总监,礼来

Shelly毕业于沈阳化工大学高分子化学专业,拥有超过15年在跨国制药企业(MNC)从事商业及临床供应链管理的经验。曾任职于科文斯、赛诺菲和安进等跨国药企,期间支持亚太研发中心的建立以及多个产品的中国上市、进口与本地化转产项目,并参与肿瘤、代谢、自身免疫等治疗领域的中美及亚太区域I~III期临床试验供应。Shelly于2023年加入礼来中国,现任临床及QC供应链负责人,持续推动中国同步研发策略,强化本地与全球供应流程衔接、注册用药保障及团队能力建设,并积极参与临床供应相关的外部生态系统建设

Shelly graduated from Shenyang University of Chemical Technology with a major in Polymer Chemistry. She has over 15 years of experiences in commercial and clinical supply chain management in multinational pharmaceutical companies (MNCs) including Covance, Sanofi and Amgen, during which she supported the establishment of Asia-Pacific R&D centers, as well as multiple projects involving the launch, import and localization switching of products in China. At the meanwhile, she has also participated in the supply for Phase I-III clinical trials in China, the United States and the Asia-Pacific region in therapeutic areas such as oncology, metabolism and autoimmune diseases.

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Chen Wang 王晨
Senior Expert, Beijing Daxing International Airport Area Cross-border Data Service Center 高级专家, 北京大兴临空区数据跨境服务中心
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Daniel Gao 高晓伟
President, ISPE Supply Chain Committee
主席,ISPE中国制药供应链分委会

Session Details:

ROUNDTABLE SESSIONS
嘉宾主持圆桌讨论会

2025-09-04, 1:30 PM

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Xiaomei Wang 王晓梅
Vice President, Clinical Operations, Keythera Bio-Pharmaceuticals
临床运营副总裁,凯复医药

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. 

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Yugang Ju 琚珏刚
Head of Clinical Operation, Insilico Medicine CBA-GP中国区联络人,临床运营负责人,高级总监,英矽智能
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Cherry Zhang 张婧怡
Australia New South Wales Government Trade & Investment Office, Associate Director

商务官员, 澳大利亚新南威尔士州政府贸易与投资办事处

Ms Cherry Zhang joined the Australia New South Wales government in Shanghai in 2012. She is dedicated to promoting bilateral trade and investment, maintaining government relations, and facilitating cooperation across multiple fields. She provides services to businesses interested in trading and investing in Sydney and New South Wales and assists New South Wales businesses in exploring opportunities in China, introducing new products and services to the Chinese and Australian markets.

张婧怡女士于2012年加入澳大利亚新南威尔士州政府上海办公室,致力于推进双边贸易投资,维系政府关系及多领域的合作。张女士为有意在悉尼和新南威尔士州进行贸易和投资的企业提供服务,并为希望在中国寻求商机的新南威尔士州企业提供帮助,将新的产品和服务引入中国市场和澳洲市场。

Session Details:

PANEL DISCUSSION: The Future of Clinical Trials for China to Overseas: Trends and Predictions
专题讨论:中国临床试验海外机遇与展望

2025-09-03, 4:30 PM

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Chester Xiao 肖嘉
Director of China Life Science, IDA 中国区生命科学行业总监,爱尔兰投资发展局

Mr. Chester Xiao is the Director of Life Sciences for IDA Ireland in China. IDA Ireland is the investment promotion agency of the Irish Government. Over the past 50 years, IDA Ireland has successfully established Ireland as one of the world's leading investment destinations and transformed Ireland into a 'knowledge economy'. Now IDA Ireland supports more than 1,800 client companies and operates internationally from its base in Ireland.

肖嘉先生目前担任爱尔兰投资发展局(IDA)的中国区生命科学行业总监。爱尔兰投资发展局是爱尔兰政府的投资促进机构。在过去的五十年里爱尔兰投资发展局成功将爱尔兰打造为全球领先的投资目的地之一,成功实现爱尔兰向“知识经济”的转型。爱尔兰投资发展局支持1800多家客户企业,以爱尔兰为基地开展面向国际市场的业务。

Session Details:

PANEL DISCUSSION: The Future of Clinical Trials for China to Overseas: Trends and Predictions
专题讨论:中国临床试验海外机遇与展望

2025-09-03, 4:30 PM

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Vikki Wang 王艳波
Head of China Center, U.S. Maryland China Center 主任,美国马里兰中国中心

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。

 

Session Details:

PANEL DISCUSSION: The Future of Clinical Trials for China to Overseas: Trends and Predictions
专题讨论:中国临床试验海外机遇与展望

2025-09-03, 4:30 PM

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Ted Chun
Owner, Chun Consulting 创始人,Chun Consulting

"With decades of experience in the healthcare industry and clinical research, Ted specializes in clinical operations, project management, data management, and innovative solutions. He also possesses a diverse management background across healthcare, life sciences, telecommunications, and aerospace. Currently he serves as regulatory and clinical consultant to three USA based medical device startup companies in Neurovascular, Cardiovascular and Orthopedic therapies and he was the leader of Stryker Neurovascular's global clinical operations team, overseeing pre and post-market clinical studies around the world (including China). He possesses a deep understanding of global device regulations and has successfully driven the launch of numerous innovative products. "

Session Details:

Use of RWE in Neurovascular Medical Device Example 真实世界证据在神经血管医疗器械应用示例

2025-09-04, 11:00 AM

Session Details:

PANEL DISCUSSION: The Rise of Chinese Biotech: a competitive challenge for U.S. companies and investors
专题讨论 中国生物科技崛起:美国企业与投资者的竞争挑战

2025-09-04, 1:00 PM

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Danni Liu 刘燕清
Shanhu Health, CEO

CEO,杉互健康
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Richard Sun 孙远
Department GM, BioBAY 招商部总经理,BioBAY

Session Details:

PANEL DISCUSSION: The Rise of Chinese Biotech: a competitive challenge for U.S. companies and investors
专题讨论 中国生物科技崛起:美国企业与投资者的竞争挑战

2025-09-04, 1:00 PM

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Dr. Claudia Hesselmann
PhD – Founder & CEO, ARENSIA Exploratory Medicine PhD,创始人兼 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:

Optimal Strategies for Chinese Innovative Biotechs to Maximize Pipeline Value for International Out- Licensing Opportunities 中国创新生物科技企业最大化管线国际授权价值的最优策略

2025-09-03, 10:00 AM

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Chris Hickey
MBA, Chief Business Development Officer, Nucleus Network MBA, 首席商务官员, Nucleus Network

Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. Having worked within all major biopharma markets including USA, Japan, China, EU and Australia has enabled him to become a trusted advisor to many customers and help them achieve their clinical drug development objectives. Chris’ deep knowledge of the global early phase drug development industry strengthens the tradition of success of Nucleus Network, our customers and partners in “Advancing Medicines, Improving Lives”.

Session Details:

Globalization of Phase 1 Clinical Trials to Maximize Program Delivery and ROI 一期临床试验全球化:最大化项目交付与投资回 报

2025-09-03, 12:00 PM

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Jane Zhu
Operation Site Leader China, Eurofins Central Laboratory 中国区现场运营负责人, Eurofins Central Laboratory

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China Clinical Trials: The emergence and transformation of China 中国临床试验:崛起与转型之路

2025-09-04, 9:45 AM

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Hedy Xiang
Adherence and Clinical Solutions Manager, APAC, Smurfit WestRock 亚太区依从性与临床解决方案经理, Smurfit WestRock

Hedy Xiang is a dynamic commercial business development with 15+ years of experience in life science, pharmaceutical packaging and clinical trial supply solutions. Since joining Smurfit WestRock in August 2023 as Adherence and Clinical Solutions Manager for APAC, she has been instrumental in expanding the company’s global capabilities across the Asia-Pacific region. Her focus includes patient-centric adherence & clinical trial packaging, child-resistant/senior-friendly (CR/SF) solutions, and innovative digital platforms for clinical trials.

Her expertise spans strategic business development, cross-functional collaboration, and end-to-end supply chain optimization for pharmaceutical and biotech industries.

Hedy holds a master’s degree from Shanghai Jiao Tong University and combines technical knowledge with commercial acumen to deliver tailored solutions that enhance medication adherence and clinical trial efficiency across not just APAC but Global markets.

项婧是生命科学和医药包装领域的资深专家,拥有超过15年的行业经验。自2023年8月加入 Smurfit WestRock 担任亚太地区的合规与临床解决方案经理以来,她在扩展公司在亚太地区的全球能力方面发挥了重要作用。她的工作重点包括以患者为中心的依从性以及临床试验包装、儿童安全/老年友好(CR/SF)解决方案,以及用于临床试验的创新数字平台。

她的专业领域涵盖战略业务发展、跨职能合作,以及针对制药和生物科技行业的端到端供应链优化。

项婧拥有上海交通大学的硕士学位,将技术知识与商业敏锐度结合,提供量身定制的解决方案,从而提高亚太市场到全球化的药物依从性和临床试验效率。

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David Hsu
Executive Director, Clinical Trial Management, Medpace 执行总监,临床试验管理, Medpace

Session Details:

From Regional to Global: Best Practices for Progressing Your Drug Development 从区域到全球:推动药物研发的最佳实践

2025-09-03, 2:30 PM

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OCT Advisory Board

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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.

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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.

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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.

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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.’

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