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Agenda

  • 8 Sep 2026
  • 9 Sep 2026
Expand All

Streams

Stream one

Clinical Trial Supply

Stream two

Outsourcing & Clinical Operations

10:45 AM

The Next-Generation DCT Blueprint: AI-powered Network and Study Design Agility 下一代 DCT 蓝图:AI 驱动的网络洞察与试验设计动态适应性

  • Embedding agility into study decision models to intelligently support decentralized and hybrid trial models.
  • Creating connected DCT ecosystems to shorten study timelines and reduce overall operational burden.
  • Leveraging AI-driven insights to optimize end-to-end patient support and long-term adherence.
  • Intelligent Medication Management & Safety Monitoring with smart pillboxes to enable closed-loop medication adherence and safety surveillance.

 

  • 将动态适应嵌入研究决策模型,智能支持去中心化和混合型试验模式。
  • 打造互联的 DCT 生态系统,缩短研究周期并降低整体运营负担。
  • 利用 AI 驱动洞察,优化端到端患者支持和长期依从性。
  • 通过智能药盒实现智能用药管理与安全监测,形成闭环用药依从性和安全监测。

Speakers

Suqin Xia
Founder, DCT Academy

11:15 AM

Reserved for Nucleus Network

Nucleus Network专场

11:45 AM

PANEL DISCUSSION AI & DCT: Transforming Clinical Trial Delivery in China 圆桌讨论:AI +DCT:重塑中国临床试验交付

  • AI as Digital Workforce: Automating Clinical Operations and Intelligent Data Quality Control under ICH E6(R3)
  • From Pain Points to Solutions: DCT Application & Landing Practice

 

  • AI 作为数字化劳动力:在 ICH E6(R3) 框架下实现临床运营自动化与智能数据质量控制。
  • 从痛点到解决方案:DCT 应用与落地实践。

Moderator: Suqin Xia, Founder, DCT Academy

Speakers

Suqin Xia
Founder, DCT Academy

12:15 PM

PharMarketing – Technology Spotlight

PharMarketing – 技术聚焦

12:30 PM

Lunch and networking 午餐与交流

2 PM

How biotech companies can build operational excellence into trials from the outset 打造卓越的临床方案设计

  • Designing protocols with site and patient feasibility in mind to reduce complexity and accelerate recruitment.
  • Embedding operational planning early to improve timelines, budget predictability, and study execution.
  • Leveraging digital technologies, data, and AI to streamline trial management and reduce administrative burden.
  • Building collaborative partnerships with sites, CROs, and technology providers to drive efficient, high-quality trial delivery

 

  • 在方案设计阶段纳入中心和患者可行性考量,降低复杂度并加速招募。
  • 尽早嵌入运营规划,以改善时间线、预算可预测性和研究执行。
  • 利用数字技术、数据和 AI 简化试验管理并减少行政负担。
  • 与中心、CRO 和技术供应商建立协作伙伴关系,推动高效、高质量的试验交付。

Speakers

Dr. Ping Liu
CMO, 4B Technologies

2:30 PM

Reserved for Caidya 康缔亚专场

3 PM

From Scale to Strategy: How China’s Local Ecosystem Fuels Global Clinical Innovation 从规模到战略:中国本土生态如何推动全球临床创新

  • Leveraging China’s integrated research, healthcare, and technology networks to accelerate development
  • How scale, speed, and digital innovation are reshaping global clinical trial execution
  • Translating local operational excellence into global study success
  • Less on drug supply multinational sponsors can apply from China’s evolving clinical ecosystem

 

  • 借助中国一体化的科研、医疗和技术网络加速开发。
  • 规模、速度与数字化创新如何重塑全球临床试验执行。
  • 将本土运营卓越转化为全球研究成功。
  • 跨国申办方可从中国不断演进的临床生态中借鉴的经验。

3:30 PM

Afternoon refreshments and networking 下午茶歇及交流

4 PM

BOIN Design: Breaking Through Global Clinical Trial Bottlenecks to Accelerate Innovative Drug Development BOIN 设计:突破全球临床试验瓶颈,加速创新药物开发

Speakers

Xuewen Wang
Member of the Mathematical Pharmacology Committee, Chinese Pharmacological Society (CNPHARS)

4:30 PM

Reserved for Tigermed 泰格医药专场

8 AM

Registration and Morning Refreshment 注册与茶歇

8:25 AM

Chairperson’s Opening Remarks 主席开幕致辞

8:30 AM

OPENING KEYNOTE: China’s Biopharma Leap: From Fast-Follower to Global Innovator 开幕主题演讲:中国生物医药的跃升:从快速跟随到引领创新

China stands at an inflection point in global biopharma innovation. Having mastered the art of rapid development and commercialization as a fast-follower, the industry is now making a decisive strategic pivot towards becoming a true globald innovator. The rise of China-led international multi-center trials (MRCTs) and landmark global partnerships underscores a new reality: China is no longer just a vast market or a development executor, but a primary source of scientific insight and therapeutic value.

中国正处于全球生物医药创新的关键转折点。随着中国临床的蓬勃发展,现在已经逐渐引领全球创新。由中国主导的多中心临床试验(MRCT)以及具有里程碑意义的全球交易,正在展示着中国在临床试验中的角色转变——从全球申办方的执行中心,转变为科学前沿与医药创新的重要源头

  • From “Fast Follower” to Autonomous Innovation
  • Leveraging China’s Capabilities for Worldwide Development
  • From Local Assurance to Global Collaboration
  • Aligning Standards and Achieving Mutual Recognition
  • Building an Open, Collaborative Global Network
  • 快速跟随到自主创新
  • 借助中国能力推动全球开发
  • 从本土保障到全球协作
  • 标准统一与互认
  • 建立开放、协作的全球网络

Speakers

Sarah Nightingale
APAC Principal Consultant, GlobalData

9 AM

Reserved for ARENSIA

ARENSIA专场

9:30 AM

KEYNOTE PANEL: The Patient Enrollment Revolution: Global Lessons from China’s Clinical Trial Efficiency 主题圆桌:患者入组革命:中国临床试验效率带来的全球启示

Patient enrollment remains one of the most critical bottlenecks in global drug development, often delaying timelines, increasing costs, and limiting patient access to innovative therapies. Against this backdrop, China has emerged not merely as a region of vast patient numbers, but as a laboratory for systemic innovation in clinical trial execution.  患者入组仍是全球药物开发中最关键的瓶颈之一,常常导致时间线延误、成本上涨,而且还会限制患者获得创新疗法的机会。在这一背景下,中国利用其庞大的患者数量而,不断发展临床试验执行中的体系创新。

  • How China Building Beyond "Population Advantage"
  • How to Leverage AI and Digital Platforms in Patient Matching
  • The Power of Hospital Alliances and Regional Clinical Hubs
  • Aligning Patient Recruitment, Clinical Supply Strategy And Site Readiness To Reduce Delays
  • How to Adapt China’s Model for International Multi-Center Trials
  • 中国不仅是“人口优势”
  • 如何利用 AI 与数字平台进行患者匹配
  • 医院联盟与区域临床中心的发展
  • 患者招募、临床供应策略的动态调整
  • 如何将中国模式应用于MRCT

Speakers

Sarah Nightingale
APAC Principal Consultant, GlobalData
Jae-Young Ha
CBO, AriBio
Dr. Ping Liu
CMO, 4B Technologies

10 AM

Morning refreshments and networking 上午茶歇与交流

(Visit 3 booth at least)

(请至少参观3个展位)

10:45 AM

Clinical Supply Practices in MRCT MRCT 中的临床供应实践

  • Regulatory Compliance: Navigating strict NMPA oversight and IP-GMP rules for MRCT integration.
  • Sourcing Strategy: Utilizing local procurement and bonded zones to bypass customs delays.
  • Labeling Standards: Implementing mandatory Simplified Chinese text while maintaining blinding integrity.
  • Domestic Logistics: Managing secure cold-chain distribution networks across vast hospital networks.
  • Chain of Custody: Executing meticulous drug reconciliation leading to certified local destruction.

 

  • 法规合规:应对 NMPA 严格监管以及 MRCT 整合中的 IP-GMP 规则。
  • 采购策略:利用本地采购和保税区政策避免清关延误。
  • 标签标准:落实强制性简体中文文本要求,同时保持盲法完整性。
  • 国内物流:在广泛的医院网络中管理安全的冷链配送网络。
  • 监管链:执行细致的药品核对,直至获得认证的本地销毁

Speakers

Ning Mi
Clinical Supply Head, Dizal Pharma

11:15 AM

Reserved for Akesa

Akesa专场

11:45 AM

CASE STUDY 案例研究 Inner-Ear Gene Therapy — From Target to IND: How China’s Integrated CRO/CDMO Ecosystem Accelerates CGT Translation 内耳基因疗法 – 从靶点到 IND:中国CRO/CDMO 生态如何加速 CGT 转化

  • Proof of concept established: 2.5-year follow-up data for OTOF gene therapy demonstrate that inner-ear gene therapy is safe, effective, and delivers predictable therapeutic outcomes.
  • The target-to-IND pathway is mature: parallel workflows + a dense CRO/CDMO ecosystem + an integrated CRDMO model enable China to move from discovery to IND 50–70% faster than the global norm.
  • Supply chain readiness determines successful delivery: cold-chain logistics, potency testing, and end-to-end regulatory compliance systems (NMPA/QMS) are critical to the scaled delivery of cell and gene therapies (CGT).
  • Structural advantage: national strategic tailwinds + partners’ end-to-end delivery capabilities help Chinese companies such as Euhearing Therapeutics accelerate CGT implementation.

 

  • 概念验证已成立: OTOF 基因治疗 2.5 年随访数据证明内耳基因治疗安全、有效且疗效可预测。
  • 从靶点到 IND 已成熟: 并行化工作流 + 密集 CRO/CDMO 生态 + CRDMO 一体化,使中国「发现→IND」周期比全球快 50–70%。
  • 供应链就绪决定落地: 细胞与基因治疗(CGT)的冷链、效价与全程监管链(NMPA/QMS)是规模化交付的关键。
  • 结构性优势:国家战略红利 + 合作伙伴端到端交付,有助于以佑音医药等为代表的中国企业加速 CGT 落地。

Speakers

Martin Huang
Director of Clinical Operations, Shanghai Euhearing Therapeutics Co., Ltd

12:15 PM

Smurfit Westrock – Technology Spotlight

Smurfit Westrock – 技术聚焦

12:30 PM

Lunch and networking 午餐与交流

2 PM

Supply Chain Readiness for Cell and Gene Therapy Trials in China 中国CGT供应链实践

The rise of Cell and Gene Therapies presents a formidable supply chain challenge due to their nature as "living drugs." Success in China's CGT clinical trials thus hinges on mastering a complex, time-sensitive, and patient-centric logistical system to translate the immense potential of these therapies into reliable patient outcomes.
细胞与基因疗法的兴起为供应链带来了严峻挑战,因为其本质上属于“活体药物”。因此,中国 CGT 临床试验的成功取决于能否掌握复杂、时间敏感且以患者为中心的物流体系,将这些疗法的巨大潜力转化为可靠的患者结果。

  • What is the Unique CGT Challenge
  • Assessing China's Readiness in Cryogenic Logistics, GMP Facilities & Single-Use Technologies
  • Orchestrating the "Vein-to-Vein" Journey with Real-Time Tracking & Chain of Custody
  • Navigating NMPA Guidelines and Building QMS for Advanced Therapies
  • The Integrated Role of Specialized CDMOs, Logistics Providers & Clinical Sites

 

  • CGT 的独特挑战是什么
  • 评估中国在低温物流、GMP 设施和一次性技术方面的准备度
  • 通过实时追踪和监管链管理“从静脉到静脉”的全流程
  • 解读 NMPA 指南并为先进疗法建立 QMS
  • 专业 CDMO、物流供应商与临床中心的一体化角色

Speakers

Wenxue Gao
Director of Clinicla Research, No. 10 People's Hospital of Shanghai

2:30 PM

Reserved for Shanghai Shengsheng 上海生生专场

3 PM

Managing Complex Logistics for ADC and Bi-Specific Antibody Clinical Trials ADC 与双特异性抗体临床试验的复杂物流管理

Antibody-Drug Conjugates (ADCs) and Bi-Specific Antibodies (BsAbs) represent the cutting edge of targeted oncology therapeutics. The delicate balance of the ADC structure (linker, antibody, payload) and the intricate assembly of the BsAb (two distinct binding domains) impose unprecedented demands for coordination and control across every logistical step, from manufacturing to the patient's bedside.
抗体偶联药物(ADC)和双特异性抗体(BsAb)代表了靶向肿瘤治疗的前沿。ADC 结构(连接子、抗体、载荷)的精密平衡,以及 BsAb(两个不同结合结构域)的复杂组装,对从产线到病床的每一个物流环节都提出了前所未有的挑战。

  • Identifying Critical Vulnerabilities in ADC & BsAb Supply Chains
  • Strategies from Point-of-Manufacture to Global Distribution
  • How to Leverage IoT and Blockchain for End-to-End Traceability from Factory to Bedside
  • Dynamic Strategies for Dose Escalation & Biomarker-Driven Patient Stratification
  • Leveraging China's Mature Biologics Supply Chain Ecosystem
  • 识别 ADC 与 BsAb 供应链中的关键节点
  • 从生产端到全球配送的策略
  • 如何利用 IoT 与区块链实现从产线到病床的端到端可追溯性
  • 剂量递增与生物标志物驱动患者分层的动态策略
  • 借力中国成熟的生物制品供应链生态

Speakers

Rong chen
Chief Medical Officer, Doma Bio

3:30 PM

Afternoon refreshments and networking 下午茶歇及交流

4 PM

Comparator Sourcing: Navigating Global Supply for China Registration Trials 对照药采购:为中国注册临床试验驾驭全球供应

Securing the right comparator drug is often the most critical yet daunting hurdle in planning a registration trial in China. Unlike other supplies, a comparator is not merely a commodity; it is a regulatory benchmark, a clinical necessity, and a potential bottleneck that can derail timelines and compromise data integrity.

确保合适的对照药,往往是规划中国注册临床试验中最关键、也最具挑战性的环节。与其他物资不同,对照药并非普通商品;它既是法规基准,也是临床必需品,还可能成为影响时间线和数据完整性的瓶颈。

  • Why Compliance is Non-Negotiable
  • From Global Market to Local Solutions
  • Mastering the Logistics & Regulatory Journey
  • How to ensure Supply Continuity
  • What is the Evolving Landscape in the Future
  • 为什么合规不可妥协
  • 从全球市场到本地解决方案
  • 掌握物流与法规旅程
  • 如何确保供应连续性
  • 未来格局将如何演变

5 PM

PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials 圆桌讨论:保持领先:重塑临床试验的关键趋势

Clinical development is being reshaped by technology, new regulations, and a patient=centric focus. This panel will analyse key trends, from virtual trials to AI, separating hype from reality and providing a practical roadmap for leading the next generation of clinical research.

临床开发正在受到技术、新法规和以患者为中心理念的重塑。本圆桌将分析从虚拟试验到 AI 的关键趋势,区分炒作与现实,并为引领下一代临床研究提供实用路线图。

  • Practical Implementation of DCTs & Hybrid Models
  • Integrating RWE, AI, and Advanced Analytics
  • Evolving from Recruitment to True Engagement
  • Adapting SOPs, Vendor Partnerships, and Risk Management
  • Regional Variations in Adopting Next-Generation Trials

 

  • DCT 与混合模式的实践落地
  • 整合 RWE、AI 与高级分析
  • 从患者招募迈向真正的患者参与
  • 调整 SOP、供应商伙伴关系与风险管理
  • 下一代试验在不同区域的采用差异

Speakers

Sarah Nightingale
APAC Principal Consultant, GlobalData
Kamil Sitarz
Chief Operating Officer, Ryvu Therapeutics
Brian Sheridan
Vice President Global Adherence & Clinicals, Smurfit Westrock

5:45 PM

Chairperson’s closing remarks and Gala Dinner – Sponsorship Available 主席闭幕致辞 及 晚宴 – 可供赞助

Streams

Stream one

Clinical Trial Supply

Stream two

Outsourcing & Clinical Operations

9 AM

AI in Clinical Development: From Pilot to Production

  • Moving beyond proof-of-concept to enterprise-wide AI adoption
  • Demonstrating measurable impact across study design, recruitment, and trial execution
  • Overcoming data, integration, and governance challenges to scale successfully
  • Building the foundations for sustainable, AI-enabled clinical development

 

  • 从概念验证迈向企业级 AI 应用。
  • 在研究设计、招募和试验执行中展示可衡量影响。
  • 克服数据、集成和治理挑战,实现成功规模化。
  • 为可持续的 AI 赋能临床开发奠定基础。

9:30 AM

Bridging Global Standards and Local Scientific Excellence: Delivering Reliable Clinical Trial Testing in China 链接全球标准与本土科学:在中国交付可靠的临床试验检测

Speakers

Kevin JD Smith
SVP, Operations & Scientific Affairs, Eurofins

10 AM

From China to Europe: The Case for Poland and CEE as Your EU Hub for Early Clinical Development in Oncology 从中国到欧洲:选择波兰和中东欧作为肿瘤早期临床开发欧盟枢纽的理由

  • Why Poland/CEE delivers: A proven early oncology environment — dense investigator networks, treatment-naive patients, and fast site activation built for FIH-to-Phase-II programs
  • The regulatory pathway: What makes CEE data credible for FDA and EMA — and why country-level trial authorization in Europe is getting faster
  • The case in practice: What early oncology development anchored in Poland/CEE looks like — and the operational set-up decisions that determine whether it delivers for your global filing

 

  • 为什么波兰/中东欧可交付:成熟的早期肿瘤环境 - 密集的研究者网络、未接受治疗的患者群体,以及为 FIH 至 II 期项目打造的快速中心启动能力。
  • 法规路径:是什么让中东欧数据获得 FDA 和 EMA 认可 - 以及为什么欧洲国家层面的临床试验授权正在加速。
  • 实践案例:以波兰/中东欧为中心的早期肿瘤开发现状 - 哪些运营决策决定其能否服务全球申报。

Speakers

Kamil Sitarz
Chief Operating Officer, Ryvu Therapeutics

10:30 AM

Morning refreshments and networking 上午交流与茶歇

11:15 AM

Global Clinical Development Strategy: Enabling Chinese Innovators to Succeed Globally 全球临床开发战略:助力中国创新药走向全球

  • Selecting the right countries and sites to support global development goals
  • Using real-world data and feasibility insights to improve decision-making
  • Aligning site selection with recruitment, operational, and regulatory strategies
  • Creating scalable site networks for long-term global clinical development success

 

  • 选择合适的国家和中心,以支持全球开发目标。
  • 利用真实世界数据和可行性洞察改善决策。
  • 将中心选择与招募、运营和法规策略相结合。
  • 建立可扩展的中心网络,实现长期全球临床开发成功。

11:45 AM

Reserved for Emsere

Emsere专场

12:15 PM

PANEL DISCUSSION: Global Site Activation: Navigating Overseas Clinical Trial Applications 圆桌讨论:全球中心启动:海外临床试验申请的实务导航

  • Understanding country-specific site application and approval requirements
  • Reducing start-up timelines through effective planning and local partnerships
  • Common challenges and pitfalls when activating sites across multiple regions
  • Best practices for successful collaboration with investigators, sites, and regulators

 

  • 了解各国特定的中心申请与审批要求。
  • 通过有效规划和本地合作伙伴关系缩短启动时间。
  • 跨多个区域启动中心时常见的挑战和陷阱。
  • 与研究者、中心和监管方成功协作的最佳实践

Speakers

Julia Leng
Clinical Operation Director, Multitude Therapeutics
Kamil Sitarz
Chief Operating Officer, Ryvu Therapeutics

12:45 PM

Reserved for Event Sponsor 赞助商专场

1:15 PM

Lunch and networking

8 AM

Registration and refreshments 注册与茶歇

8:55 AM

Chairperson’s opening remarks主席开幕致辞

9 AM

Supply Chain Resilience by Design 供应链弹性供应能力的设计

  • Embedding resilience into supply chain strategy, operations, and quality systems
  • Leveraging digital technologies and data visibility to anticipate and mitigate disruptions
  • Strengthening supplier networks and risk management frameworks for long-term continuity
  • Balancing agility, compliance, and efficiency in an evolving global landscape

 

  • 供应链战略、运营和质量体系的风险管控。
  • 利用数字技术与数据可视化提前识别并缓解中断风险。
  • 强化供应商网络与风险管理框架,保障弹性供应能力。
  • 在不断演变的全球格局中平衡便利性、合规性和效率。

Speakers

Daniel Gao 高晓伟
President, ISPE Supply Chain Committee
主席,ISPE中国制药供应链分委会

9:30 AM

Reserved for Brocacef

Brocacef专场

10 AM

Panel Discussion: Dynamic Forecasting for Rapidly Enrolling Trials 圆桌讨论:快速入组试验的动态预测

  • Predicting enrollment trends to ensure uninterrupted clinical trial supply
  • Using data-driven forecasting to support agile decision-making
  • Managing uncertainty across global, multi-site studies
  • Best practices for responding to faster-than-expected recruitment and changing demand
  • 预测入组趋势,确保临床试验供应不中断。
  • 使用数据驱动的预测支持快速决策。
  • 管理全球多中心研究中的不确定性。
  • 应对超预期快速招募和需求变化的最佳实践。

Moderator: Daniel Gao, President, ISPE Supply Chain

Speakers

Daniel Gao 高晓伟
President, ISPE Supply Chain Committee
主席,ISPE中国制药供应链分委会

10:30 AM

Morning refreshments and networking 上午交流与茶歇

11:15 AM

Quality Management: Maintaining Quality Standards Across Complex Supply Networks 质量管理:在复杂供应网络中维持质量标准

Ensuring end-to-end quality standards is arguably the most significant operational challenge for sponsors and CDMOs alike. This complexity is heightened by the reality that a clinical supply network is a potential point of failure, risking not only product quality but the integrity of the entire trial.
确保端到端质量标准,可以说是申办方和 CDMO 面临的最重要运营挑战。由于临床供应网络中的任何环节都可能成为故障点,这一复杂性被进一步放大,不仅会影响产品质量,也会影响整个试验的完整性。

  • Rethinking the Role of the Quality Unit
  • Risk-Based Supplier Qualification and Lifecycle Management
  • Digital Platforms for End-to-End Quality Data Integrity
  • Managing Change in a Distributed Network
  • Building a Culture of Quality Across Organizational Boundaries

 

  • 重新定义质量部门
  • 基于风险的供应商资质认定与生命周期管理
  • 用于端到端质量数据完整性的数字平台
  • 分布式网络中的变更管理
  • 跨组织边界建立质量文化

Speakers

Johnny Ju 琚珏刚
Head of Clinical Operation, Insilico Medicine
英矽智能临床运营负责人

11:45 AM

Reserved for Event Sponsor 赞助商专场

12:15 PM

PANEL DISCUSSION: Turning Transit Troubles into Triumphs: Proven Strategies for Clinical Supply Success 圆桌讨论:化解运输难题,成就临床供应成功:经验证的策略

  • How to build a "Predict and Prevent" Supply Mindset
  • Dynamic Re-supply Models for a Dynamic Clinical Reality
  • A Step-by-Step Guide to Smoother Cross-Border Movements
  • Rapid Response Protocols and Effective Contingency Planning
  • Integrating Partners into a Single, Seamless Team

 

  • 如何建立“预测并预防”的供应思维。
  • 面向动态临床现实的动态补货模型。
  • 更顺畅跨境运输的分步指南。
  • 快速响应流程与有效的应急规划。
  • 将合作伙伴整合为一个无缝协作团队。

12:45 PM

Reserved for Event Sponsor 赞助商专场

1:15 PM

Lunch and networking

2:15 PM

PANEL DISCUSSION Vision for the Future: The Future Roadmap of China’s Pharmaceutical Innovation 圆桌讨论 未来愿景:中国医药创新的未来

China’s pharmaceutical innovation stands at a pivotal inflection point. After a decade of explosive growth, the industry is navigating a period of “capital winter,” intense policy-driven competition, and a strategic shift from the pursuit of quantity to the mandate of quality. However, this pressure is also a catalyst, forcing a clear-eyed re-evaluation of the path forward. Today, China is not just a vast clinical trial hub or a manufacturing powerhouse; it is defining its ambition to become a “world new drug creation center” by 2035.
中国医药创新正处在关键转折点。经历十年的爆发式增长后,行业经历了“资本寒冬”、政策驱动的激烈竞争,以及从追求数量转向强调质量的战略变化。在这种压力下,行业对未来发展有了更清醒的认识。现在,中国不再只是庞大的临床试验中心或制造强国;它正在定义到 2035 年成为“世界新药创制中心”的雄心。

  • The “Innovation Pivot”: From Fast-Follower to First-in-Class
  • The “Globalization 2.0” Playbook: From BD Transactions to Enduring Value
  • The “Dual Engine” of Policy: Regulatory Acceleration Meets Payment Reformation
  • Convergence and Concentration: Surviving the “Great Integration”
  • The Ultimate Alignment: Bridging the Pipeline to Unmet Clinical Need
  •  “创新转向”:从快速跟随到 First-in-Class
  •  “全球化 2.0”打法:从 BD 交易到持久价值
  •  政策“双引擎”:监管加速与支付改革并进
  • 融合与集中:在“大整合”中生存
  • 终极方案:将管线与未满足的临床需求相适配

Moderator: Sarah Nightingale, APAC Principal Consultant, GlobalData

Speakers

Sarah Nightingale
APAC Principal Consultant, GlobalData
Johnny Ju 琚珏刚
Head of Clinical Operation, Insilico Medicine
英矽智能临床运营负责人
Rong chen
Chief Medical Officer, Doma Bio

3 PM

Chairs Closing Remarks 闭幕致辞

END OF CONFERENCE 会议结束

Speakers

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Suqin Xia
Founder, DCT Academy

Session Details:

PANEL DISCUSSION AI & DCT: Transforming Clinical Trial Delivery in China 圆桌讨论:AI +DCT:重塑中国临床试验交付

2026-09-08, 11:45 AM

Session Details:

The Next-Generation DCT Blueprint: AI-powered Network and Study Design Agility 下一代 DCT 蓝图:AI 驱动的网络洞察与试验设计动态适应性

2026-09-08, 10:45 AM

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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:

Supply Chain Resilience by Design 供应链弹性供应能力的设计

2026-09-09, 9:00 AM

Session Details:

Panel Discussion: Dynamic Forecasting for Rapidly Enrolling Trials 圆桌讨论:快速入组试验的动态预测

2026-09-09, 10:00 AM

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Julia Leng
Clinical Operation Director, Multitude Therapeutics

Session Details:

PANEL DISCUSSION: Global Site Activation: Navigating Overseas Clinical Trial Applications 圆桌讨论:全球中心启动:海外临床试验申请的实务导航

2026-09-09, 12:15 PM

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Martin Huang
Director of Clinical Operations, Shanghai Euhearing Therapeutics Co., Ltd

Session Details:

CASE STUDY 案例研究 Inner-Ear Gene Therapy — From Target to IND: How China’s Integrated CRO/CDMO Ecosystem Accelerates CGT Translation 内耳基因疗法 – 从靶点到 IND:中国CRO/CDMO 生态如何加速 CGT 转化

2026-09-08, 11:45 AM

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Kamil Sitarz
Chief Operating Officer, Ryvu Therapeutics

Kamil Sitarz is Chief Operating Officer and Management Board Member at Ryvu Therapeutics, a European clinical-stage oncology company advancing a diversified pipeline of innovative therapies. He leads corporate strategy, enterprise governance, capital planning, and cross-functional clinical development execution across a diversified oncology portfolio.

He has been instrumental in transforming Ryvu into a multi-program clinical-stage organization, embedding disciplined portfolio governance and architecting development pathways designed to enhance execution predictability in complex, high-risk oncology settings. His leadership integrates clinical strategy with capital allocation discipline, ensuring alignment across scientific ambition, regulatory positioning, operational design, and financial planning to drive sustainable enterprise value.

 

Under his direction, Ryvu has built and scaled a robust clinical development organization capable of delivering international Phase I/II programs across challenging hematologic indications and multi-country site networks. He has also played a key role in establishing and governing strategic clinical collaborations with leading global oncology partners, strengthening Ryvu’s development footprint and reinforcing its credibility within the international biotech ecosystem.

 

With a PhD in Medical Genetics and an Executive MBA, Kamil combines scientific depth with enterprise-level strategic and operational leadership to advance innovation with rigor, accountability, and long-term growth orientation.

Session Details:

PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials 圆桌讨论:保持领先:重塑临床试验的关键趋势

2026-09-08, 5:00 PM

Session Details:

From China to Europe: The Case for Poland and CEE as Your EU Hub for Early Clinical Development in Oncology 从中国到欧洲:选择波兰和中东欧作为肿瘤早期临床开发欧盟枢纽的理由

2026-09-09, 10:00 AM

Session Details:

PANEL DISCUSSION: Global Site Activation: Navigating Overseas Clinical Trial Applications 圆桌讨论:全球中心启动:海外临床试验申请的实务导航

2026-09-09, 12:15 PM

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Johnny Ju 琚珏刚
Head of Clinical Operation, Insilico Medicine
英矽智能临床运营负责人

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.

Session Details:

Quality Management: Maintaining Quality Standards Across Complex Supply Networks 质量管理:在复杂供应网络中维持质量标准

2026-09-09, 11:15 AM

Session Details:

PANEL DISCUSSION Vision for the Future: The Future Roadmap of China’s Pharmaceutical Innovation 圆桌讨论 未来愿景:中国医药创新的未来

2026-09-09, 2:15 PM

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Rong chen
Chief Medical Officer, Doma Bio

Session Details:

Managing Complex Logistics for ADC and Bi-Specific Antibody Clinical Trials ADC 与双特异性抗体临床试验的复杂物流管理

2026-09-08, 3:00 PM

Session Details:

PANEL DISCUSSION Vision for the Future: The Future Roadmap of China’s Pharmaceutical Innovation 圆桌讨论 未来愿景:中国医药创新的未来

2026-09-09, 2:15 PM

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Xuewen Wang
Member of the Mathematical Pharmacology Committee, Chinese Pharmacological Society (CNPHARS)

Session Details:

BOIN Design: Breaking Through Global Clinical Trial Bottlenecks to Accelerate Innovative Drug Development BOIN 设计:突破全球临床试验瓶颈,加速创新药物开发

2026-09-08, 4:00 PM

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Ning Mi
Clinical Supply Head, Dizal Pharma

Session Details:

Clinical Supply Practices in MRCT MRCT 中的临床供应实践

2026-09-08, 10:45 AM

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Wenxue Gao
Director of Clinicla Research, No. 10 People's Hospital of Shanghai

Session Details:

Supply Chain Readiness for Cell and Gene Therapy Trials in China 中国CGT供应链实践

2026-09-08, 2:00 PM

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Dr. Ping Liu
CMO, 4B Technologies

Session Details:

How biotech companies can build operational excellence into trials from the outset 打造卓越的临床方案设计

2026-09-08, 2:00 PM

Session Details:

KEYNOTE PANEL: The Patient Enrollment Revolution: Global Lessons from China’s Clinical Trial Efficiency 主题圆桌:患者入组革命:中国临床试验效率带来的全球启示

2026-09-08, 9:30 AM

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Jae-Young Ha
CBO, AriBio

Session Details:

KEYNOTE PANEL: The Patient Enrollment Revolution: Global Lessons from China’s Clinical Trial Efficiency 主题圆桌:患者入组革命:中国临床试验效率带来的全球启示

2026-09-08, 9:30 AM

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Kevin JD Smith
SVP, Operations & Scientific Affairs, Eurofins

Session Details:

Bridging Global Standards and Local Scientific Excellence: Delivering Reliable Clinical Trial Testing in China 链接全球标准与本土科学:在中国交付可靠的临床试验检测

2026-09-09, 9:30 AM

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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.

 

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Sarah Nightingale
APAC Principal Consultant, GlobalData

Session Details:

OPENING KEYNOTE: China’s Biopharma Leap: From Fast-Follower to Global Innovator 开幕主题演讲:中国生物医药的跃升:从快速跟随到引领创新

2026-09-08, 8:30 AM

Session Details:

PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials 圆桌讨论:保持领先:重塑临床试验的关键趋势

2026-09-08, 5:00 PM

Session Details:

KEYNOTE PANEL: The Patient Enrollment Revolution: Global Lessons from China’s Clinical Trial Efficiency 主题圆桌:患者入组革命:中国临床试验效率带来的全球启示

2026-09-08, 9:30 AM

Session Details:

PANEL DISCUSSION Vision for the Future: The Future Roadmap of China’s Pharmaceutical Innovation 圆桌讨论 未来愿景:中国医药创新的未来

2026-09-09, 2:15 PM

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OCT Advisory Board

Select a member to learn more

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Dr Alison McMorn
Head of Clinical Strategy and Development, LifeArc

Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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Behtash Bahador
Senior Director, Community Engagement & Partnerships, Center for Information & Study on Clinical Research Participation (CISCRP)

Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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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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Aditya Kotta
VP Business Development, Novotech

Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

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Martin Rodriguez
Consumer Safety & Evidence Global Quality & Excellence Head, Opella

Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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Rosalie Filling
Vice President, Senior Global Head R&D Operations, Keenova

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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Edwin van Vulpen
Executive Director and Head of Clinical Business Development Euro-Asia
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