SCOPE Europe 2024 の基調講演
CHI主催の国際会議、7th Annual SCOPE Europe: Summit for Clinical Ops Executivesに参加し、未来の優れた臨床運営(Clinical Ops)へと足を踏み入れましょう！今回の会議は3日間、スペイン・バルセロナのInterContinental Barcelona（Fira Center）で開催され、業界分析や新たな事例研究、人脈構築の機会がワンセットで提供されます。計6件の会議（うち2件は新規）を通じて、参加者は臨床試験のイノベーション・立案・実行に関する最新動向について検討することができます。基調講演やパネルディスカッション、ブレイクアウトディスカッションを傍聴したり、展示ホールに出向いて参加企業50社による最先端技術の展示を観察したりすることができます。また、30ヶ国・250組織から参加した500名以上のシニアエグゼクティブと交流することもできます。大手の製薬企業やバイオテクノロジー企業から、国際・地域レベルのCROや治験向け技術プロバイダー、学術機関、患者支援団体に至るまで、SCOPE Europeでは臨床試験分野のリーダーが一堂に会します。欧州内外のデジタル/ハイブリッド臨床試験に焦点を合わせた、この重要なイベントを見逃さないようご注意ください。ご一緒に、未来の優れた臨床運営を作り上げましょう！
10月28日（月）
MONDAY AFTERNOON: USER GROUP & WORKSHOP
Arrive on Monday in beautiful Barcelona and start SCOPE Europe on Monday afternoon! Visit our Travel page.
14:30 - 19:00 Innovation Day with IQVIA Technologies at SCOPE Europe
CO-SPEAKERS: 
Kevin Landells, Vice President Patient Centered Technology Delivery, IQVIA Technologies 
Stefan Dürr, Senior Director, Client Delivery, IQVIA Technologies 
Petar Genov, Senior Director, Business Operations and Capabilities - Payments, IQVIA Technologies 
Tim Reily, Vice President, Clinical Data Analytics, IQVIA Technologies 
Alison Liddy, Senior Vice President, Patient and Site Centric Solutions, IQVIA
Clinical trial sponsors are invited to join IQVIA Technologies’ digital product leaders and industry representatives for an afternoon of discussions, demos, and networking. IQVIA will share our vision to transform clinical operations, demonstrate our technologies that improve the patient, site, and sponsor journeys, and ask for your input on our roadmap for future product development. Innovation Day is complimentary and will be of interest to pharmaceutical executives or sites with roles in clinical operations, innovation, technology, finance, budgeting, data analytics, patient or site engagement, or strategic sourcing. IQVIA reserves the right to decline registrations for those not in these categories.
17:30 - 19:00 The Path towards Sustainable Clinical Trials: How to Minimise Environmental Impact and Stay Ahead of Future Regulatory Requirements
INSTRUCTORS:
Fiona Adshead, Chair, Sustainable Healthcare Coalition
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Marisa Minetti, Patient Research Partner, Chiesi Group
Keith Moore, Programme Coordinator, Sustainable Healthcare Coalition
Developing frameworks to define and manage sustainability risks, and effective guidelines to reduce the carbon footprint of clinical trial operations is a collaborative effort. Beyond benefiting the environment, adopting sustainable practices is increasingly demanded by stakeholders and can significantly influence customer choices and talent acquisition. Perhaps more compelling are the growing regulatory pressures and expectations, including the Corporate Sustainability Reporting Directive (CSRD) and Task Force on Climate-related Financial Disclosures (TCFD) among others. This workshop will discuss the current hotspots of carbon emissions in clinical research, introduce a new clinical trial carbon footprint calculator for assessing current state, and suggest introductory reduction strategies. Whether you are in clinical trial design clin ops, procurement, innovation, sustainability, or resource management, this workshop is for you.
MONDAY EVENING IN BARCELONA
Join friends and colleagues for dinner at a spot near the conference hotel, which is in a great location.
Main Conference Tuesday and Wednesday, 29-30 October 2024. Join the morning run/walk at 07:00. Registration opens at 07:45 and the opening presentations start at 08:50.
10月29日（火）
07:00 SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps Join SCOPE Europe’s Coordinators for our Fun Walk/Run! All of us at Cambridge Healthtech Institute recognise the importance of integrating well-being and fitness into our work travel routines. This is an easygoing, informal running (or walking) event where we ascend the stairs of the iconic Magic Fountain. No time chips, running bibs, or energy bars-just a laid-back opportunity for a small group to start the day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk-the goal is to get up and get moving! Meet us in the front lobby at the InterContinental at 7 sharp!
07:45 - 09:00 Registration and Morning Coffee
08:50 - 10:50 Join Conference Sessions (6 Tracks)
10:53 Grand Opening Coffee Break in the Exhibit Hall
The SCOPE Europe Exhibit Hall is the best place to fuel up with a mid-morning coffee while visiting with our many exhibitors. Learn about what’s new in the industry, connect with colleagues and vendors, and make some new friends.
TUESDAY MORNING PLENARY SESSION:
REINVENTING CLINICAL DEVELOPMENT & CONVERGING RESEARCH WITH CLINICAL CARE
11:50 Chairperson’s Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
11:55 KEYNOTE PRESENTATION: Reinventing Clinical Development and Overcoming Unnecessary Complexity
Christoph Koenen, Head of Clinical Development & Operations, Pharma Research & Development, Bayer
This keynote presentation proposes a paradigm shift in clinical development, advocating for the adoption of a minimal viable product (MVP) approach focused solely on fulfilling regulatory requirements. By streamlining processes and resources to the essentials, this strategy promises significant cost reductions and time efficiencies while maintaining regulatory compliance. Through case studies and implementation strategies, attendees will gain insights into how embracing this innovative approach can revolutionize clinical development, paving the way for greater agility, adaptability, and patient-centricity in the industry.
12:20 ClinEco Commons and the Power of the Clinical Research Community
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
The Commons is a ClinEco and SCOPE resource. It is a go-to hub for resources, tools, news, regulatory updates, and more, designed to support professionals in the field of clinical research. 'The Commons' serves as a collaborative space where you can access, visit, share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco community. The Ask a ClinEco Luminary feature allows users to connect directly with research leaders to learn from colleagues.
12:30 KEYNOTE PANEL DISCUSSION: Converging Clinical Research with Clinical Care: A Multi-Stakeholder Panel on Tackling this Bold Vision
PANEL MODERATOR:
Paul Duffy, Head, Global Clinical Site Partnerships, MSD
This plenary panel will show how stakeholders across biopharma R&D have come together to develop pragmatic solutions that are foundational to enabling the future of drug development and integrating clinical research as part of the care continuum. This panel will feature biopharma industry leaders, Health Authorities, patient advocates, and other industry consortia candidly discussing why everyone must work together to drive innovation in the R&D ecosystem, shape the future of healthcare, and bridge the gap between clinical research and clinical care.
PANELISTS:
Maria Dutarte, Executive Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)
Maria Koutsopoulou, Senior Vice President, Head of Global Development Operations, Merck KGaA
Bari Kowal, Senior Vice President & Head, Development Operations & Portfolio Management, Global Development, Regeneron Pharmaceuticals, Inc.
12:55 SCOPE Europe 2023 Accelerator Project Update and Outcomes: Innovative Outsourcing Process for BiotechMicah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
Last year at SCOPE Europe we engaged with sponsor orgs in attendance on a project with ClinEco, our B2B clinical research marketplace and network, to help with scoping, selection, and onboarding of outsourcing partners for a trial. The goal was to challenge the norms of clinical trials outsourcing, improve vendor selection, and speed up the RFI process...and more. We learned a lot with our partner and some of those key learnings apply to us all.
13:00 KEYNOTE PANEL DISCUSSION: Quantifying the Collection of Non-Core and Extraneous Core Protocol Data and its Relationship with Clinical Trial Performance
Emily Botto, Senior Research Analyst, Tufts CSDDPaul Duffy, Head, Global Clinical Site Partnerships, MSD
Joachim Lovin, DCT Specialist, Novo Nordisk
13:25 Transition to Networking Luncheon in the Exhibit Hall
13:35 Join Your Peers for a Networking Luncheon in the Exhibit Hall
Take this opportunity to refresh and refuel with our Exhibit Hall lunch. Enjoy good food and even better conversation during our walk and talk luncheon.
14:35 - 17:00 Join Conference Sessions (6 Tracks)
16:57 Reception in the Exhibit Hall with Beer, Wine, and Tapas
Wind down at the end of a busy session day with colleagues, beer, wine, and tapas. Have a drink with your favorite exhibitor and take a chance at winning a fabulous raffle prize (must be present to win)!
10月30日（水）
08:15 Registration and Morning Coffee
08:45 - 10:15 Join Conference Sessions (6 Tracks)
10:17 Coffee Break in the Exhibit Hall and Special Book Signing
More coffee, more exhibitors, more networking, and some delicious snacks. What’s not to love?
WEDNESDAY MORNING PLENARY SESSION:
INTEGRATING DIGITAL HEALTH TECH IN TRIALS & IMPROVING STUDY DESIGN WITH PATIENTS
11:00 Organiser's Welcome Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI); Co-Founder, ClinEco
11:05 KEYNOTE PRESENTATION: From Documents to Data: Let’s Digitally Transform Our Clinical Trial Protocol
Frank Berger, MD, Expert Data & Analytics Solutions, Clinical Development & Operations, Boehringer Ingelheim
A massive, fundamental change is knocking on the door: the shift from a document-based to a data-based, machine-readable Clinical Trial Protocol. This talk shares some insights for exploring this new territory, including pitfalls and the need for a cross-functional approach.
11:20 KEYNOTE PANEL DISCUSSION: Integrating Digital Health Technologies in Clinical Trials: A New Era for eCOA and ePRO
PANEL MODERATOR:
Moe Alsumidaie, Chief Editor, Editorials, Clinical Trial Vanguard
This panel will delve into how emerging digital health technologies, including eCOA and ePRO, are transforming patient data collection in clinical trials. It will cover the evolution of digital endpoints, patient-centric approaches, and the integration of these technologies into clinical research frameworks. How are digital health technologies, especially eCOA and ePRO solutions, revolutionizing data collection in clinical trials? Have they led to more patient-centric trials? What are the challenges in integrating these technologies into existing clinical trial frameworks, and how have they been overcome? What considerations should be made when selecting technology partners? Looking towards the future, how do you see digital health technologies evolving, and what implications will this have on clinical research?
PANELISTS:
Jacqueline Bowman, Head of Policy, European Association for the Study of Obesity (EASO); Registered Expert, European Commission and European Medicines Agency (EMA)
Bernhard Glombitza, Head, Clinical Operations EMEA and APAC, Bayer
Kai Langel, Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Global Regulatory Affairs, Janssen R&D
11:45 KEYNOTE PANEL DISCUSSION: How to Build Meaningful Relationships and Shift to Patient-Led Conversations for Improved Study Design and Execution
PANEL MODERATOR:
Maria Dutarte, Executive Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)
Join us for a critical exploration into the transformative approach of integrating patient insights into clinical trial protocols. This panel will explore how strong relationships and patient-led conversations can improve study design and execution, significantly easing the burden on sites and patients. Learn from experts about common pitfalls and challenges in patient engagement, gaining actionable strategies towards more effective and empathetic trials.
PANELISTS:
Jose Aibar, President, Dravet Syndrome Foundation Spain
Jacqueline Cannon, Chief Executive, The Lewy Body Society
Roger Legtenberg, PhD, Co-Founder, Partners4Patients Foundation UG
12:10 Join Your Peers for a Networking Luncheon in the Exhibit Hall
Join us again for lunch in the Exhibit Hall. Last chance to visit with exhibitors you missed and to enter our final raffle!
13:10 - 14:30 Join Conference Sessions (6 Tracks)
WEDNESDAY AFTERNOON PLENARY SESSION:
NEW ERA OF RISK/QUALITY (R3) & LEVERAGING AI TO ACCELERATE TRIALS
14:35 Clinical Research News' Best of Show Award: Recognizing Exceptional Innovation in Technologies Used by Clinical Research Professionals
Allison Proffitt, Editorial Director, Bio-IT World and Clinical Research News
Sponsored by Clinical Research News & ClinEco
The 2024 Best of Show Awards offer exhibitors of the SCOPE Summit Europe an exclusive opportunity to distinguish and highlight their products, ranging from an innovative application, technology, tool, or solution. The SCOPE community is invited to identify exceptional innovation in technologies used by life science professionals, voting on the most impactful new products of the year.
14:40 FIRESIDE CHAT: Redefining Excellence: The Future of Clinical Trial Quality
Coleen Glessner, Executive Vice President, Quality, Ethics and Compliance, Emergent BioSolutions
Patricia Leuchten, Founder and CEO, Diligent Pharma
Shyard Wong, Head, Clinical Quality & Continuous Improvement, Sanofi
This keynote will explore milestones from the past that have shaped our present approach to clinical trial quality. Delving into the present, we scrutinize the existing paradigms and contemplate the ongoing transformations in our approach to ensuring trial quality. As technological advancements, regulatory shifts, and societal demands continue to reshape the landscape, we confront the imperative of redefining what excellence means in the realm of clinical research. How will emerging methodologies, such as decentralized trials and real-world evidence, redefine our benchmarks for success? What role will artificial intelligence, big data analytics, and patient-centricity play in shaping the future of clinical trial quality?
15:05 USE CASE: From Theory to Therapy: Accelerating Clinical Trials with AI
Jonathan Crowther, PhD, Head Predictive Analytics, PRD (OARS), Pfizer Inc.
This new story and real-world use case is an exploration of the future potential of GenAI in clinical trials, focusing on optimizing trial efficiency, reducing costs, and the broader business impact. Inspire the audience to think about the long-term benefits of integrating GenAI into their processes.
15:20 KEYNOTE PANEL DISCUSSION: Data to Decisions: GenAI's Role in Transforming Clinical Trials
PANEL MODERATOR:
Allison Proffitt, Editorial Director, Bio-IT World and Clinical Research News
Artificial intelligence, data analytics, automation, and technology have the power to connect stakeholders and applications and enhance protocol design, study feasibility, and patient identification and recruitment. The recent explosion of innovation with generative AI is delivering promising advances as we all know. However, this involves constructing a robust data infrastructure, harnessing cutting-edge technologies, adhering to privacy and data security regulations, and enforcing data governance principles.
PANELISTS:
Dorothee Bartels, PhD, Associate Professor (Apl. Professor) for Public Health and Epidemiology, Medizinische Hochschule HannoverJonathan Crowther, PhD, Head Predictive Analytics, PRD (OARS), Pfizer Inc.
Farrell Healion, Senior Director Emerging Technologies, Global Clinical Solutions, AstraZeneca
15:45 Close of Conference
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
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