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Why Attend?

Why attend? 为何参会？

Navigate Local Challenges: Gain critical insights into the unique complexities of clinical trial supply chains in China, including import/export regulations, regional distribution, and local manufacturing.

破解本土化难题
深度解析中国临床试验供应链特有的复杂挑战，包括进出口监管政策、区域配送网络布局及本土化生产策略等核心议题。

Regulatory Expertise: Stay updated on China’s regulatory environment, ensuring compliance while minimizing delays and risks in your clinical trial supply processes.

掌握监管先机
实时获取中国药监动态，系统学习如何在确保合规前提下，规避供应链延误风险与质量隐患。

Build Strategic Partnerships: Connect with key stakeholders, including suppliers, logistics providers, and biopharmaceutical companies, to foster collaborations that drive efficiency and innovation.

缔造战略联盟
与供应链核心决策者直接对话：包括头部物流服务商、本土供应商及跨国药企供应链负责人，构建高效协同网络。

Discover Innovative Solutions: Explore cutting-edge tools, technologies, and strategies to optimize supply chain management, ensure product integrity, and reduce operational costs.

解锁创新方案
探索保障产品完整性的前沿技术：从智能温控物流系统到区块链追溯平台，获取降本增效的实战解决方案

Stay Ahead of Trends: Learn about emerging trends and future directions in clinical trial supply tailored specifically to the Chinese market.

洞见未来趋势
聚焦中国市场独有的发展趋势：从MAH制度下的供应链重构到临床急需药物特殊通道，把握政策红利窗口期

Whether you’re launching trials in China or looking to refine your supply chain operations, this conference provides the knowledge and connections you need to thrive in one of the most dynamic markets for clinical trials.

无论您是首次在中国开展临床试验，还是寻求优化现有供应链体系，本次大会都将为您提供在这个最具活力的临床试验市场中蓬勃发展所需的关键洞见与战略人脉。

Sponsors Include:

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Company Information

ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

Company Website

To learn more, please visit our website - http://www.arensia-em.com/

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Nucleus Network is Australia’s largest Phase 1 clinical research organisation and the only Phase 1 specialist globally with phase I facilities in the US and Australia. 

Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. Combined, our clinics offer over 200 beds. All three clinics are strategically co-located within leading medical, research and biotech precincts offering unique access to ancillary services including bioanalytical laboratories, MRI, lumbar punctures, chest X-rays, ophthalmology assessments and others. 

Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies. 

We have access to a population of over 10.5 million people across all 3 sites, and the ability to offer a multi-site solution in recruiting participants and patients to our clients. 

Together with our client partners, we are fulfilling our purpose of ‘Advancing medicine, improving lives.’

Company Website

To learn more, please visit our website - https://www.nucleusnetwork.com/au/

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Akesa is an end-to-end provider of clinical trial supplies and services. Headquartered in Melbourne, Australia, Akesa boasts global reach with deep expertise in the Asia-Pacific region. We work alongside sponsors, CROs, research institutions, clinical trial sites and CDMOs to project manage the sourcing of finished products, including comparators, combination therapies, and standard-of-care medications, from validated suppliers and directly from manufacturers.

Company Website

To learn more, please visit our website - http://akesapharma.com/

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We’re more than a supplier: we’re a partner that can deliver consistent quality and superior service, a partner that fuels innovation to foster real and sustainable results. A deep understanding of the healthcare industry, our customers’ needs, and patient needs is critical to ensure our range of packaging products and services deliver value through the entire product lifecycle. These insights and the experience of the Smurfit Westrock Adherence & Clinicals team enable us to work in tune with regulations and clients to provide a service solution underpinned by an innovative and unparalleled range of packaging solutions that, at their heart, are patient focused. These include Clinical Trial Packaging, specialty labels, literature & booklets, Adherence packaging, component kits and SMART Digital Adherence Technology along with Digital Display Labels. Talk to us.

www.smurfitwestrock.com

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We are a global operational consulting firm helping Life Science companies stay compliant and inspection-ready. We specialize in Data Privacy (GDPR and global regulations), GxP Quality, and Computer System Validation. With senior-level experts across the EU, UK, and beyond, we support over 90 clients worldwide through audits, legal representation, and compliance excellence.

Company Website

To learn more, please visit our website - www.pharmarketing.net

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Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

Company Website

To learn more, please visit our website - www.novotech-cro.com

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Innovative Trials is a leading global clinical trial patient recruitment company. With over 10 years’ experience, Innovative Trials deploys “boots-on-the-ground” patient recruitment experts in over 70 countries, addressing individual sites’ unique patient recruitment and retention challenges in local language. Innovative Trials has experience in 25 therapeutic areas and 90+ conditions.

Company Website

To learn more, please visit our website - https://innovativetrials.com/

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Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

Company Website

To learn more, please visit our website - www.euromed-pharma.com

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TecEx Medical is an Importer of Record (IOR) and customs compliance specialist in the international clinical trial sector. With a team of professionals dedicated to successful importation (or exportation) of clinical trial supplies, we work with Sponsors, CROs, CMOs and Vendors to manage the clinical trial lifecycle.

Company Website

To learn more, please visit our website - https://tecexmedical.com/

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“Abacus Medicine provides tailored comparator sourcing services to support the efficient running of clinical trials for biotechnology and innovative pharmaceutical companies.

As part of The Abacus Medicine Group, we have access to over 10,000 key brands across multiple European and US markets, and sophisticated market analysis tools which provides us with an unrivalled inventory and supplier network.

This allows us to deliver a wide range of tailored and hybrid sourcing services to our clients.”

Company Website

To learn more, please visit our website - www.abacusmedicine.com

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德高｜百年积淀 | 供应链管理方案服务商
deugro leverages 100+ years of expertise, spanning 70 offices in 40 countries.
Backboned by GxP compliant Suzhou depot, we empower integrated end to end supply chain management solutions, encompassing clinical trials and temperature controlled services.

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Brocacef operates throughout the entire pharmaceutical chain, lending us an unique position as a wholesaler in the Dutch pharmaceutical healthcare industry. With expertise in global logistics, sourcing and supply chain experience Brocacef is able to offer a variety of services for clinical trials.

Company Website

To learn more, please visit our website - www.brocacef.nl

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Emmes Group, a specialty, technology and AI enabled contract research organization (CRO), is advancing and modernizing clinical research to improve patient outcomes. Founded as Emmes more than 47 years ago, we became a trusted clinical research partner to the U.S. government. Today, Emmes Group is a global full-service CRO operating in 72 countries worldwide collaborating with government agencies, public-private partnerships, and biopharma innovators. Now wholly owned by New Mountain Capital, we are transforming the future of clinical research and bringing life-changing treatments closer to patients. Where human intelligence meets artificial intelligence. Learn more at www.theemmesgroup.com.

Company Website

To learn more, please visit our website - www.emmes.com

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CMAX临床研究成立于1993年，是澳大利亚领先的早期临床试验机构之一，总部位于阿德莱德生物医药核心区。 作为业内公认的高水平研究中心，CMAX专注于I期临床试验及首人体试验（FIH），在全球范围内为制药和生物技术企业提供专业、高效的一站式早期开发解决方案。依托800余项早期研究经验和世界一流的研究设施，CMAX以卓越的数据质量、快速的启动能力以及严格的国际合规标准著称。 以受试者安全为核心，CMAX致力于加速创新疗法从实验室走向临床，为全球医疗健康创新持续赋能。

Company Website

To learn more, please visit our website - https://www.cmax.com.au/

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The PPD clinical research business of Thermo Fisher Scientific enable customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, our capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services.

Company Website

To learn more, please visit our website - https://thermofisher.com/ppd

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迅捷税务集团（ VAT IT ）/维爱特（上海）商务咨询有限公司，是一家专业的跨境税所，已成为跨境增值税细分领域的全球领头羊退税服务供应商，目前在全球有30+个分支机构，覆盖主要经济体，100+个国家/地区的客户提供专业服务。

VAT IT的退税业务基于海外当地国家6号法案、欧盟8号法案、13号法案，通过向海外税局申请，可返还企业已缴纳的增值税，并提供客户海外税号注册合规报税等服务，此服务专业合规，有法案支。

VAT IT is a specialized cross‑border tax firm and a global market‑leading VAT refund service provider in the niche cross‑border VAT sector. With over 30 branch offices worldwide covering major economies, we deliver professional services to clients across 100+ countries and regions.

VAT IT `s VAT refund services are underpinned by local Country Directive‑6, EU Directive‑8 and EU Directive‑13. By submitting formal applications to overseas tax authorities, we help businesses recover already‑paid foreign VAT. We also offer overseas tax‑ID registration and compliant tax‑filing solutions. Fully professional and compliant, our services are backed by relevant legislative provisions.

Company Website

To learn more, please visit our website - https://www.vatit.com/

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LabConnect is the world’s most agile central laboratory solutions partner supporting clinical trials of all sizes and complexity. With modern operations and strategic alliances with world-leading laboratories, LabConnect is uniquely positioned to provide access to the latest innovation and automation. LabConnect is the trusted partner for biotechnology, pharmaceutical, and clinical research organizations.

 

Follow LabConnect on LinkedIn

Learn more at labconnect.com

Company Website

To learn more, please visit our website - http://www.labconnectllc.com/

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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

    Globalization of Phase 1 Clinical Trials to Maximize Program Delivery 早期临床试验（一期）全球化：实现项目交付效益最大化

    • Globalizing Early-Phase Development: Explores expanding opportunities for biopharmaceutical innovators to run Phase 1 trials internationally.
    • Strategic Regional Advantages: Showcases destinations like Australia that offer rapid regulatory pathways, cost efficiencies, and universally accepted data.
    • Operational Optimization: Uses case studies to highlight strategies for accelerating timelines, optimizing study designs, and reducing costs.
    • Commercial Success: Illustrates how multi-region early-phase data drives robust partnering, licensing, and subsequent clinical success.
    • 早期开发全球化： 探讨生物医药创新企业在国际上开展一期（Phase 1）临床试验的拓展机遇。
    • 区域战略优势： 展示澳大利亚等基地的独特优势，包括快速的监管审批通道、高性价比以及全球通用的临床数据。
    • 运营层面优化： 运用案例分析，重点阐述加速项目时间线、优化试验设计以及降低成本的有效策略。
    • 商业成功助力： 阐明多区域早期临床数据的融合如何强力推动商务合作、品种授权以及后续临床研究的成功。

    Speakers

    Yi (Amy) Ai
    Senior Director of Business Development, Nucleus Network

    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
    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
    Sisi Shen沈思思
    Head of Clinical Operations临床运营负责人, Haihe Biopharma上海海和药物

    12:15 PM

    Technology Spotlight技术聚焦 Interplay between Privacy laws and GCP Guidelines数据隐私法与 GCP 指导原则的相互作用

    Many countries across the globe have enacted privacy laws and now Healthcare Authorities and Ethics Committees mandate that Clinical Trial Applications contain appropriate data privacy language. The good news is that it is simple in the Life Science industry because Good Clinical Practices have always protected the Rights of the Patients since the Code of Nuremberg in 1949. Participants will understand how to do it right the first time, they will learn the key points of attention, so the clinical trial is not delayed.

    全球许多国家已颁布隐私法。目前，各国医疗卫生当局和伦理委员会均强制要求临床试验申请（CTA）中包含适当的数据隐私表述。值得庆幸的是，生命科学行业在此方面有深厚积累——自1949年《纽伦堡法典》问世以来，”临床试验规范“（GCP）就一直致力于保护患者权益。本演讲/课程将帮助参会者了解如何从源头实现合规的正确路径，并深度剖析关键风控点，以避免临床试验的延误。

     

    Speakers

    Bertrand Le Bourgeois
    President, PharMarketing GDPR Life Sciences

    12:30 PM

    Lunch and networking

    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. Jiahong Zhao赵家宏博士
    CMO 首席医学官, CGeneTech盛世泰科

    2:30 PM

    Beyond Scale: Building Global-Ready Clinical Development from China 跨越规模：立足中国，构建面向全球的临床开发能力

    As more Chinese biotech companies expand clinical development beyond China, the question is no longer whether to go global, but how to build globally ready development programs from the outset. Drawing on practical experience and industry observations, this presentation will explore the critical decisions sponsors face across development planning, regulatory strategy, study execution, and operational readiness. It will also share common challenges, lessons learned, and practical considerations to help organizations better prepare for clinical development across the US, Europe, and other international markets.

    随着越来越多中国创新药企业加速国际化布局，当前面临的关键问题已不再是是否走向全球，而是如何从研发早期建立符合全球要求的临床开发策略。本次分享将结合实践经验与行业观察，探讨企业在全球临床开发过程中面临的关键决策，包括开发规划、注册策略、研究执行及运营准备等内容，并分享常见挑战、实践经验和可借鉴的建议，帮助企业更好地规划美国、欧洲及其他国际市场的临床开发。

    Speakers

    Jie Li
    China General Manager, Caidya

    3 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

    • The 3+3 design is simple but has limited statistical performance, failing to meet modern Phase I R&D needs.
    • BOIN is a model-assisted design whose core centers on constructing optimal decision intervals around the target toxicity rate.
    • BOIN combines strong statistical performance with high clinical feasibility.
    • Compared to 3+3, BOIN allocates patients more rationally and improves MTD accuracy.
    • BOIN has evolved into a design family that extends to efficacy, combination therapies, late-onset toxicities, and OBD optimization.

     

    • 3+3 简单但统计性能有限，已难满足现代 I 期研发需求。
    • BOIN 是模型辅助设计，核心是围绕目标毒性率构建最优决策区间。
    • BOIN 兼具较强统计性能与较高临床可实施性。
    • 相比 3+3，BOIN 能更合理分配患者并提高 MTD 准确率。
    • BOIN 已发展为设计家族，可扩展到疗效、联合用药、迟发毒性和 OBD 优化等场景。

    Speakers

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

    3:30 PM

    Afternoon refreshments and networking

    下午茶歇及交流

    4 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 supplys 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。

    Speakers

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

    4:30 PM

    MRCT end-to-end MRCT研究的端到端考量

    This session outlines an end-to-end framework for Multi-Regional Clinical Trials (MRCTs). It covers critical regional epidemiology and regulatory planning, third-party operational models, the impact of inter-ethnicity differences on future labeling, and navigating health agency registration decisions.

    Plan

    • Clinical epidemiology in different regions
    • Regulatory requirements on protocol design and patient recruitment
    • Timeline and financial models

    Do

    • Operational models involving third parties

    Check

    • Influence of inter-ethnicity differences and response differences on future label statements

    Access

    • Agency‘s decision on registration

     

    Speakers

    Connie Chen
    CMO, Tigermed

    5:45 PM

    Chairperson’s closing remarks and Gala Dinner – Sponsorship Available 主席闭幕致辞 及 晚宴 （锦绣厅）

    8 AM

    Registration and Morning Refreshment 注册与茶歇

    8:25 AM

    Chairperson’s opening remarks 主席开幕致辞

    Speakers

    Sarah Nightingale
    APAC Principal Consultant, GlobalData

    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

     

    • 从“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

    WINNING GLOBAL OUT-LICENSING: STRATEGIES FOR INNOVATIVE CHINESE BIOTECHS赢在海外授权：中国创新药企的全球化策略

    Chinese biotech is moving faster than ever from innovation to global ambition — but the challenge now goes beyond developing a differentiated asset. It's proving that asset's value early, generating globally credible clinical data, and reaching the right international partners before momentum fades. Drawing on real-world case studies, this session examines how delays at proof-of-concept erode value, how regulatory and operational efficiency compress development timelines, and how Chinese biotechs can expand globally without slowing execution. Attendees will gain practical insight into how faster PoC, stronger patient access, efficient global trial deployment, and high-quality international data strengthen partnering discussions and make assets more attractive to global pharma.

    中国生物医药产业正以前所未有的速度从“本土创新”迈向“全球雄心”。然而，企业如今面临的挑战已不仅限于研发具有差异化的资产，更在于如何在早期证明资产价值、生成具备全球公信力的临床数据，并在市场热度消退前精准对接国际合作伙伴。本议程将结合真实世界案例研究，深入探讨概念验证（PoC）阶段的延迟如何侵蚀资产价值、如何通过提升监管与运营效率来压缩研发周期，以及中国药企如何在不牺牲执行速度的前提下实现全球化扩展。参会者将获得极具实用价值的行业洞察，明确如何通过加速PoC进程、强化患者招募、高效部署全球临床试验以及获取高质量国际数据，来增加商务谈判筹码，从而让管线资产对跨国药企（Global Pharma）更具吸引力。

    Speakers

    Dr Al Palaniappan
    Chief Scientific Officer APAC 亚太区首席科学官, ARENSIA

    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

    Moderator: Sarah Nightingale, APAC Principal Consultant, GlobalData

    Speakers

    Sarah Nightingale
    APAC Principal Consultant, GlobalData
    Jae-Young Ha
    Chief Business Officer, Aribio
    Dr. Jiahong Zhao赵家宏博士
    CMO 首席医学官, CGeneTech盛世泰科

    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

    APAC is Not One Market: Why Cross-Border Supply Needs Better Partnerships 亚太地区并非单一市场：跨境供应链为何需要更紧密的合作伙伴关系

    Forcing a single clinical supply model across APAC creates delays, costs, and regulatory risks. This presentation addresses regional complexities through flexible strategies and local collaboration.

    • Model Selection: Evaluating central, regional, and hybrid supply frameworks.
    • Streamlined Logistics: Bridging gaps between sourcing, compliance, and local distribution.
    • Risk Mitigation: Overcoming cross-border bottlenecks and critical documentation challenges.
    • Strategic Value: Balancing speed, cost, and long-term partner alignment over transactional relationships.

    在亚太地区强推单一的临床供应链模型会导致延误、高昂成本和合规风险。本演讲将通过灵活的战略与本地化合作，探讨并解决这些区域复杂性问题。

    • 模式选择：评估集中式、区域式以及混合式的供应链架构。
    • 高效物流：消除采购、合规与本地分销之间的断层。
    • 风险缓解：克服跨境瓶颈与关键文件审查带来的挑战。
    • 战略价值：权衡速度与成本，建立长期的伙伴协作，而非单纯的业务交易

    Speakers

    George Vlachos
    Co-Founder and Co-CEO, Akesa

    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

    TECHNOLOGY SPOTLIGHT 技术聚焦 – A Demonstration of Digital Display Labels in Clinical Trials Operations & Supply Chain 数字显示标签（DDL）在临床试验运营与供应链中的应用演示

    • Exploring the capability of Digital Display Labels (DDLs) and the benefits for Clinical Trial Supplies
    • A demonstration of the functionality of DDLs; just in time labelling, lot & expiry update, multiple page count.
    • Understanding the operational ability to securely & remotely update content & language.
    • Integrating across IMP profiles, vials, bottles, blisters
    • 探究数字显示标签（DDLs）的技术能力及其对临床试验供应带来的效益
    • 现场演示数字显示标签（DDLs）的功能：实时/即时标签贴签、批号与有效期更新、多页面内容切换
    • 深入了解其运营能力：如何安全地进行远程内容及语言更新
    • 实现全方位集成整合：涵盖试验用药品（IMP）构型、西林瓶、药瓶及铝箔水泡眼包装（泡罩包装）

    Speakers

    Brian Sheridan
    Vice President Global Adherence & Clinicals, Smurfit Westrock

    12:30 PM

    Lunch and networking

    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

    Challenges, Strategies and Partner Selection for Supply Chain Management in Multi-Regional Clinical Trials (MRCTs) 多区域临床试验（MRCTs）中供应链管理的挑战、策略与合作伙伴选择

    This presentation systematically addresses the core challenges and efficient execution strategies of supply chain management for MRCTs. It delivers practical management frameworks and partner selection methodologies for clinical operations and supply chain managers to improve trials’ overall execution quality and speed. 本演讲将系统性地阐述多区域临床试验（MRCTs）中供应链管理的核心挑战与高效执行策略。演讲将为临床运营与供应链经理提供实用的管理框架以及合作伙伴选择方法论，以全面提升临床试验的执行质量与速度。

    Speakers

    Susie Wang
    Director of Project Management Center, Shanghai Shengsheng

    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

    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。

    Moderator: Jae-Young Ha, CBO, AriBio

    Speakers

    Jae-Young Ha
    Chief Business Officer, Aribio
    Mengjie (Michael) Li
    Head of Quality, 3S Bio
    Yunfeng Wan
    Senior Director, Ascentage Pharma

    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

    Moderator:  Rachel Wang, Consultant, Deallus

    Speakers

    Kamil Sitarz
    Chief Operating Officer, Ryvu Therapeutics
    Brian Sheridan
    Vice President Global Adherence & Clinicals, Smurfit Westrock
    Rachel Wang
    Consultant, Deallus
    Mengjie (Michael) Li
    Head of Quality, 3S Bio

    5:45 PM

    Chairperson’s closing remarks and Gala Dinner – Sponsorship Available 主席闭幕致辞 及 晚宴 （锦绣厅）

    Streams

    Stream one

    Clinical Trial Supply

    Stream two

    Outsourcing & Clinical Operations

    9 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

    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

    China has evolved from a participant in global clinical trials to a major driver of scientific innovation and drug development. As sponsors increasingly rely on China-generated data for global regulatory submissions, success requires more than adherence to international quality standards. This session explores how reliable clinical trial testing is achieved by combining globally harmonized quality systems with local scientific, operational, and regulatory expertise. Using examples from Eurofins Central Laboratory's experience in China, including biomarker testing, method transfer, and HGRAC-aligned study execution, the session demonstrates how global standards and local excellence work together to deliver trusted, regulatory-ready data that accelerates clinical development worldwide.

    中国已从全球临床试验的参与者，转变为科学创新与新药研发的核心驱动力。随着申办方日益依赖在中国生成的数据来进行全球监管申报，项目的成功不仅要求遵循国际质量标准，还需要更深层次的布局。本议题将探讨如何通过将全球统一的质量体系与本土的科学、运营及监管专业知识有机结合，来保障临床试验检测的可靠性。结合欧陆中央实验室（Eurofins Central Laboratory）在中国的丰富实践经验（包括生物标志物检测、方法转移以及符合人类遗传资源管理办公室/HGRAC要求的试验执行），本议题将深度展示全球标准与本土卓越实力的完美融合，从而如何交付值得信赖、符合监管要求的临床数据，最终加速全球新药研发进程。

    Speakers

    Kevin JD Smith
    SVP, Operations & Scientific Affairs, Eurofins

    10 AM

    Navigating Clinical Operations in Biotech’s Survival Mode 生物医药寒冬之下：如何驾驭临床运营的“生存模式”

    • Building Cross-Functional Leadership: Developing "T-shaped" talent with end-to-end operational vision.
    • Proactive Risk Management: Systematically anticipating and mitigating clinical trial risks.
    • Strategic Partnership with CROs: Redefining sponsor-CRO collaboration beyond transactional outsourcing.
    • From Trial Data to Market Value: Making clinical quality the cornerstone of biotech IPO credibility.

     

    • 构建跨职能领导力： 培养具备端到端（全流程）运营视野的“T型”复合型人才。
    • 前瞻性风险管理： 系统性地预测并缓解临床试验过程中的潜在风险。
    • 与 CRO 的战略合作伙伴关系： 重新定义申办方与 CRO 的合作模式，摆脱单纯的“交易型外包“。
    • 从试验数据到市场价值： 让临床质量成为生物医药企业 IPO（上市）公信力的基石。

    Speakers

    Jing Chen
    VP, Clinical Operation & Compliance, TenNor 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。

    Speakers

    Julia Leng
    Clinical Operation Director, Multitude Therapeutics

    11:45 AM

    Think Global, Execute Local: A Smarter Equipment Strategy for Clinical Trials in China 全球化思考，本土化执行：更智慧的中国临床试验设备策略

    Expanding clinical trials into China requires more than a global strategy, it requires local execution. In this session, Emsere will share how a smarter equipment rental and management strategy can simplify clinical trial operations, reduce logistical complexity, and ensure equipment is available when and where it's needed. Learn how combining global standards with local expertise helps sponsors execute successful clinical trials in China. 将临床试验拓展至中国，不仅需要具备全球化的战略眼光，更需要扎实的本土化执行力。在本次专题中，Emsere 将分享如何通过更智慧的设备租赁与管理策略来简化临床试验运营、降低物流复杂度，并确保设备能够在所需的时间和地点精准交付。您将了解到，如何将全球统一标准与本土专业经验相结合，从而助力申办方在中国成功执行临床试验。

    Speakers

    Jonathan Raven
    Chief Commercial Officer, Emsere

    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

    Moderator:

    Julia Leng Multitude Therapeutics

    Speakers

    Julia Leng
    Clinical Operation Director, Multitude Therapeutics
    Kamil Sitarz
    Chief Operating Officer, Ryvu Therapeutics
    Colin Lin林剑
    Clinical Head临床负责人, Mindrank德睿智药

    12:45 PM

    Lunch and networking

    8 AM

    Registration and refreshments 注册签到与晨间茶歇

    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

    Navigating Comparator Sourcing Challenges in Clinical Trials 攻克临床试验中的对照药采购难题

    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.

    • Strategies to ensure unbroken supply continuity.
    • Risk mitigation plans for sourcing uncertainties.
    • Practical insights from global pharmaceutical business.

    在筹备中国注册临床试验的过程中，获取正确的对照药往往是最关键但也最棘手的难题。与其他临床供应品不同，对照药不仅仅是一种物资，它更是监管的基准、临床的必需品，也是一个极易导致项目延期并损害数据完整性的潜在瓶颈。

    • 保障供应链持续不中断的应对策略
    • 针对采购不确定性的风险缓解计划
    • 来自全球制药企业的实用洞察

    Speakers

    Dustin Hoffman
    Business Manager Strategic Sourcing, Brocacef

    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
    Dr. Levvy Lv 吕承博士
    SVP高级副总裁, TCG Labs-Soleil
    Zhang Feng张锋
    Clinical Trials Head临床运营负责人, Hua Medicine 华领医药

    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

    AI powered GLP-1 R&D: from early prediction to clinical supply AI赋能GLP-1小分子的早研及临床供应链

    AI is reshaping the entire lifecycle of GLP-1 drug development. This presentation will systematically examine the specific applications of AI technology across the entire R&D chain, covering early-stage molecular design, activity and toxicity prediction, clinical trial design optimization, and optimized scheduling within the clinical supply chain. Using a case study of MindRank's MAP platform, the session will analyze how AI-driven approaches improve R&D efficiency, reduce costs, and shorten timelines, ultimately advancing a candidate drug into Phase III clinical trials within 4.5 years.

    AI正在重塑GLP-1药物的研发全链条。本报告将系统阐述AI技术在药物研发全生命周期中的具体应用，涵盖早期分子设计、活性与毒性预测、临床试验设计优化，以及临床供应端的优化调度。报告将结合德睿智药MAP平台的实际案例，分析如何通过AI驱动的方案提升研发效率、降低成本并缩短周期，并在4.5年内将相关候选药物推进至三期临床试验。

    Speakers

    Colin Lin林剑
    Clinical Head临床负责人, Mindrank德睿智药

    12:15 PM

    Platform Strategies: Designing Flexible Supply Chains for Multi-Modality Trials 平台化策略：为多模态临床试验设计灵活的供应链

    A single biopharma portfolio today may encompass a diverse mix of modalities—small molecules, monoclonal antibodies, ADCs, cell therapies, and more—each with vastly different and often contradictory supply chain requirements. This new reality demands a fundamental shift towards platform-based supply chain strategies.

     

    • What Are We Actually Building?
    • Orchestrating Complexity with Data & AI
    • From Transactional Vendors to Strategic Capability Partners
    • Upskilling Teams for a Multi-Modality World

     

    如今，单一生物医药企业的研发管线可能涵盖多种不同的药物模态——小分子、单克隆抗体（单抗）、抗体偶联药物（ADCs）、细胞疗法等。这些药物对供应链的要求截然不同，甚至相互冲突。这一新现状要求供应链管理必须发生根本性转变，全面走向平台化策略。

    • 我们究竟在构建什么？
    • 利用数据与人工智能（AI）协调整合复杂流程
    • 从传统的交易型供应商转型为战略能力合作伙伴
    • 赋能团队升级，全面迎接多模态时代

    Speakers

    Zhang Feng
    Clinical Trials Head, Hua Medicine

    12:45 PM

    Lunch and networking

    2:15 PM

    From Trial back to Target: Innovative CNS Drug Development 神经系统源创新药开发 之 靶标发现与靶点验证

    Speakers

    Prof. Yun Wang 王云教授
    Principal Investigator首席研究员, Institute of Brain Science, Fudan University复旦大学脑科学研究院

    2:45 PM

    Forging a World-Class Hub of Biomedical Innovation 打造世界级生物医药创新高地

    • Development of the biomedical industry in SIP
    • Innovation ecosystem for biomedical industry in SIP
    • 苏州工业园区（SIP）生物医药产业的发展历程与现状
    • 苏州工业园区（SIP）生物医药产业的创新生态系统

    Speakers

    Mandy Tong佟梦帆
    Deputy Chief, Division 1 of Investment Promotion Board投资促进局一处副处长, SIPAC 苏州工业园区管委会

    3:15 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: Rachel Wang王维新, Consultant顾问, Deallus

    Speakers

    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
    Rachel Wang
    Consultant, Deallus

    3:45 PM

    Chairs Closing Remarks 闭幕致辞

    END OF CONFERENCE 会议结束

    Speakers

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    Sarah Nightingale
    APAC Principal Consultant, GlobalData

    Session Details:

    Chairperson’s opening remarks 主席开幕致辞

    2026-09-08, 8:25 AM

    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:

    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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    Suqin Xia
    Founder, DCT Academy

    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

    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

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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:

    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

    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

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    Julia Leng
    Clinical Operation Director, Multitude Therapeutics

    Session Details:

    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

    2026-09-09, 11:15 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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    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, 9:00 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, 3:15 PM

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    Rong chen
    Chief Medical Officer, Doma Bio

    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, 3:15 PM

    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

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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, 3:00 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. Jiahong Zhao赵家宏博士
    CMO 首席医学官, CGeneTech盛世泰科

    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:

    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

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    Jae-Young Ha
    Chief Business Officer, 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

    Session Details:

    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

    2026-09-08, 4:00 PM

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    Mengjie (Michael) Li
    Head of Quality, 3S Bio

    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:

    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

    2026-09-08, 4:00 PM

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    Zhang Feng张锋
    Clinical Trials Head临床运营负责人, Hua Medicine 华领医药

    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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    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. 

    Session Details:

    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

    2026-09-08, 4:00 PM

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    Jing Chen
    VP, Clinical Operation & Compliance, TenNor Therapeutics

    Session Details:

    Navigating Clinical Operations in Biotech’s Survival Mode 生物医药寒冬之下：如何驾驭临床运营的“生存模式”

    2026-09-09, 10:00 AM

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    Mandy Tong佟梦帆
    Deputy Chief, Division 1 of Investment Promotion Board投资促进局一处副处长, SIPAC 苏州工业园区管委会

    Session Details:

    Forging a World-Class Hub of Biomedical Innovation 打造世界级生物医药创新高地

    2026-09-09, 2:45 PM

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    Prof. Yun Wang 王云教授
    Principal Investigator首席研究员, Institute of Brain Science, Fudan University复旦大学脑科学研究院

    Session Details:

    From Trial back to Target: Innovative CNS Drug Development 神经系统源创新药开发 之 靶标发现与靶点验证

    2026-09-09, 2:15 PM

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    Colin Lin林剑
    Clinical Head临床负责人, Mindrank德睿智药

    Session Details:

    AI powered GLP-1 R&D: from early prediction to clinical supply AI赋能GLP-1小分子的早研及临床供应链

    2026-09-09, 11:45 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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    Yunfeng Wan
    Senior Director, Ascentage Pharma

    Session Details:

    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

    2026-09-08, 4:00 PM

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    Sisi Shen沈思思
    Head of Clinical Operations临床运营负责人, Haihe Biopharma上海海和药物

    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

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    Dr. Levvy Lv 吕承博士
    SVP高级副总裁, TCG Labs-Soleil

    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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    Rachel Wang
    Consultant, Deallus

    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:

    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, 3:15 PM

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    Dr Al Palaniappan
    Chief Scientific Officer APAC 亚太区首席科学官, ARENSIA

    Session Details:

    WINNING GLOBAL OUT-LICENSING: STRATEGIES FOR INNOVATIVE CHINESE BIOTECHS赢在海外授权：中国创新药企的全球化策略

    2026-09-08, 9:00 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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    Susie Wang
    Director of Project Management Center, Shanghai Shengsheng

    Session Details:

    Challenges, Strategies and Partner Selection for Supply Chain Management in Multi-Regional Clinical Trials (MRCTs) 多区域临床试验（MRCTs）中供应链管理的挑战、策略与合作伙伴选择

    2026-09-08, 2:30 PM

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    Dustin Hoffman
    Business Manager Strategic Sourcing, Brocacef

    Session Details:

    Navigating Comparator Sourcing Challenges in Clinical Trials 攻克临床试验中的对照药采购难题

    2026-09-09, 9:30 AM

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    Brian Sheridan
    Vice President Global Adherence & Clinicals, Smurfit Westrock

    Brian as Vice President Global Adherence & Clinicals leads a team focused on providing Adherence focused, patient centric and Child Resistant Senior Friendly (CR-SF) packaging & service solutions to the Pharmaceutical, Biotech & Clinical Trial industries. Working in companies such as Cardinal Health, Catalent and other businesses Brian has gained invaluable insights and a thorough understanding of the demanding requirements, operating systems & ethos of these markets. Brians global team focuses on best-in-class supply infrastructure with an expanded focus on digital platforms, these solutions encompass electronic measure and monitor packaging solutions together with Cere®Screen Digital Display Labels.

    Session Details:

    TECHNOLOGY SPOTLIGHT 技术聚焦 – A Demonstration of Digital Display Labels in Clinical Trials Operations & Supply Chain 数字显示标签（DDL）在临床试验运营与供应链中的应用演示

    2026-09-08, 12:15 PM

    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

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    Bertrand Le Bourgeois
    President, PharMarketing GDPR Life Sciences

    Session Details:

    Technology Spotlight技术聚焦 Interplay between Privacy laws and GCP Guidelines数据隐私法与 GCP 指导原则的相互作用

    2026-09-08, 12:15 PM

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    Jie Li
    China General Manager, Caidya

    Session Details:

    Beyond Scale: Building Global-Ready Clinical Development from China 跨越规模：立足中国，构建面向全球的临床开发能力

    2026-09-08, 2:30 PM

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    Yi (Amy) Ai
    Senior Director of Business Development, Nucleus Network

    Session Details:

    Globalization of Phase 1 Clinical Trials to Maximize Program Delivery 早期临床试验（一期）全球化：实现项目交付效益最大化

    2026-09-08, 11:15 AM

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    Connie Chen
    CMO, Tigermed

    Session Details:

    MRCT end-to-end MRCT研究的端到端考量

    2026-09-08, 4:30 PM

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    George Vlachos
    Co-Founder and Co-CEO, Akesa
    With a career spanning over 25 years, George Vlachos is renowned for his expertise and leadership in the pharmaceutical industry.
    As Co-Founder and Co-CEO of Akesa, George’s focus on global sourcing and procurement of comparator pharmaceutical products has been crucial in navigating the complex challenges of clinical trial management. His proactive approach and vast network enhance Akesa’s capabilities in securing essential pharmaceuticals, ensuring the highest standards of quality in clinical operations.
    George has a deep knowledge of the clinical trial supply chain and its associated complexities developed across his vast career working at industry giants including contract research organisation (CRO) PPD and IQVIA, and with global pharmaceutical company at Lilly. During his early career, George excelled in managing large scale clinical trials across APAC as Region PM and developing a clinical trial distribution depot and GMP facility in Australia. George’s leadership within the industry and vast network helps to position Akesa as a leader in pharmaceutical sourcing for clinical trials, supporting substantial advances in global health.

     

     

    Session Details:

    APAC is Not One Market: Why Cross-Border Supply Needs Better Partnerships 亚太地区并非单一市场：跨境供应链为何需要更紧密的合作伙伴关系

    2026-09-08, 11:15 AM

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    Jonathan Raven
    Chief Commercial Officer, Emsere

    Jon is a seasoned professional with over 20 years of experience and has demonstrated expertise in helping Pharma, Biotech and CROs solve complex and challenging development issues; ensuring clinical studies remain on their critical path to success. Throughout his tenured career, Jon has held pivotal roles at Pfizer and Avantor where he has made significant contributions to the development and launch of life saving and life changing medicines and he now brings that expertise to Emsere. As a speaker, Jon engages audiences with insightful discussions, drawing from his extensive experience and unique perspectives.

    Session Details:

    Think Global, Execute Local: A Smarter Equipment Strategy for Clinical Trials in China 全球化思考，本土化执行：更智慧的中国临床试验设备策略

    2026-09-09, 11:45 AM

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