基調講演

10月17日（火）

OPENING KEYNOTE: CLIN OPS AS A GROWTH DRIVER & EU TRANSPARENCY REGS & GLOBAL DCT ADOPTION THROUGH COLLABORATION
オープニング基調講演：成長の原動力としての臨床業務、欧州の透明性規制、協業による世界の分散型臨床試験の導入

11:50 Organizer's Opening Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

11:55 KEYNOTE PRESENTATION: Clinical Ops as a Growth Driver

Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL Behring GmbH
Clinical Operations is the hardest job you'll ever love. It drives the growth of a clinical development portfolio that results in new therapeutic options for the patients who need them. This awesome responsibility may look "easy" from the outside, but starting and managing a clinical trial is like launching a new business into a saturated market each and every time. Let's talk about how inspiring you are!

12:20 KEYNOTE PRESENTATION: Returning Results to Patients-Not Just a Regulatory Requirement with a Grace Period
Kimbra Edwards, PhD, Senior Director, Health Communication Services, Center for Information and Study on Clinical Research Participation (CISCRP)
EU Regulation/2014/536 requires results from trials initiated after January 2022 to be shared publicly within a year of completion and yet some sponsors are not sharing results. Several EU countries have successfully turned up the heat on sponsors who haven't shared the findings of their clinical trials actively pushing negligent sponsors and investigators to publicly share the results of past trials, an enforcement practice that's picked up momentum. After attending this presentation, the audience will: recognize the importance of returning trial results, in plain language, to all trial participants; describe the ramifications of not submitting plain language results; and plan for a large-scale implementation plan for returning results.

12:35 INTERACTIVE PANEL: Navigating Global DCT Adoption-Driving Change through Collaboration

PANEL MODERATOR:
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Global clinical trial teams are increasingly interested in using decentralized trial (DCT) methods. DCT technology and services providers have created a large variety of solutions for trial teams to use. However, there is no curated ‘source of truth’ accessible for providers or trial teams to understand which solutions can be used in which countries. The DTRA Regulatory Conduct Map initiative team has been focused on addressing this gap as part of its initial priorities to support the adoption of DCTs globally. In this session, initiative team members will share their approach to solving this challenge and how to use the deliverable they’ve created. Panelists will also share case studies on the application of this tool, and how it’s helping drive understanding and adoption of DCTs globally.

PANELISTS:
Dylan Bechtle, Associate Director, Regulatory Policy and Intelligence, The Janssen Pharmaceutical Companies
Megan Heath, Vice President, Region Head, Clinical Studies Unit Europe, Sanofi

10月18日（水）

MORNING KEYNOTE: MOVING eCOA, ePRO, e-SOURCE, EDC, AND ANY OTHER "e" INTO REALITY IN A DIGITAL HEALTH WORLD
モーニング基調講演：デジタルヘルスの世界におけるeCOA、ePRO、e-SOURCE、EDC、その他のあらゆる“e”の現実への移行

11:00 Organizer's Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

11:05 INTERACTIVE PANEL: eCOA- and ePRO-Centricity in a Digital Health World

PANEL MODERATOR:
Lisa Henderson, Editorial Director, Applied Clinical Trials
As digital health technologies make strides in collecting objective data from patients remotely, how does ePRO and other eCOAs fit within a holistic, patient-centered approach to quality data collection in clinical trials? This panel will discuss the importance of and differences among digital endpoints, digital biomarkers, and eCOA/ePRO.

PANELISTS:
Estrella Garcia Alvarez, PhD, Director, Global Clinical Operations, R&D, Almirall SA
Scottie Kern, Executive Director, eCOA Consortium, Critical Path Institut
Bryan McDowell, Vice President, eCOA Clinical Science & Consulting, eCOA Science, Clario
Danielle Middleton, PhD, MBBChir, Associate Medical Director, Patient Safety Physician Digital & Devices, AstraZeneca

11:30 INTERACTIVE PANEL: From Concept to Reality-The eSource-to-EDC Revolution Gathers Pace

PANEL MODERATOR:
Mats Sundgren, PhD, Senior Industry Scientific Director, i-HD (European Institute for Innovation through Health Data)
The eSource data captured daily in hospitals’ EHRs is increasingly gaining traction within the clinical research community as the basis of a powerful opportunity to transform the way clinical trials are run. This session discusses the potential and the challenges of direct transfer of clinically-validated data from EHR-to-EDC: Is there now a common impetus for investment in data quality by sites and sponsors? Can advances in technology deliver flexible and scalable solutions for EHR-to-EDC data transfer?

PANELISTS:
Peter Casteleyn, Director, Clinical Data Collection Solutions-EHR, The Janssen Pharmaceutical Companies of Johnson and Johnson
Paul Jacobs, Associate Director, Development Innovation, Regeneron Pharmaceuticals
Joe Lengfellner, Senior Director, Clinical Research Informatics, Memorial Sloan Kettering Cancer Center

CLOSING KEYNOTE: CLINICAL RESEARCH NEWS, SCOPE BEST OF SHOW AWARDS 2023, TECH TO ENABLE PATIENT-CENTRIC TRIALS & BUILDING SUCCESSFUL OUTSOURCING PARTNERSHIPS
クロージング基調講演：臨床研究ニュース、SCOPE BEST OF SHOW AWARDS 2023、患者中心の臨床試験を可能にする技術、成功するアウトソーシングパートナーシップの構築

15:20 Clinical Research News' Best of Show Award: Recognizing Exceptional Innovation in Technologies Used by Clinical Research Professionals (Sponsored by Clinical Research News & ClinEco)
Allison Proffitt, Editorial Director, Bio-IT World
The 2023 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 most impactful new products of the year. Exhibitors are invited to enter your products via the online submission form below. Attendees are encouraged to explore the novel technologies and solutions firsthand in the exhibit hall and vote for the People's Choice Award once the conference has begun.

15:25 CASE STUDY: Patient-Centric Sampling Solutions in Action
Lewis Millen, Global Clinical Sciences & Operations Innovation Lead, UCB
Chiara Rospo, Bioanalytical Scientific Manager Development Science, Translational Biomarkers & Bioanalysis, UCB Pharma SA
Real case studies of implementation of a patient-centric sampling solution at UCB will be discussed, highlighting the complexity and the skills required to be successful. Tips on overcoming challenges will be shared.

15:35 INTERACTIVE PANEL: Patient-Centric Blood Sampling as an Enabler for Decentralised Clinical Trials

PANEL MODERATOR:
Neil Spooner, PhD, Co-Founder and Chair, Patient Centric Sampling Interest Group (PCSIG)
In order to fully realise the potential for enhancing patient recruitment and retention for DCTs, the impact of blood sample collection for the determination of pharmacokinetics, measurement of biomarkers, and clinical chemistry also needs to be considered. This interactive panel will introduce you to technologies and workflows that enable the collection of these samples in the patient's home, either by self-sampling or by a caregiver, thus increasing patient choice and engagement. By attending this session, you will learn: What PCS is; What the potential benefits are when incorporating patient-friendly blood sampling into DCTs; Practical considerations on how to implement into your DCTs.

PANELISTS:
Chiara Rospo, Bioanalytical Scientific Manager Development Science, Translational Biomarkers & Bioanalysis, UCB Pharma SA
John Corcoran, Director, Decentralized Trial Solutions, Q² Solutions
Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC
Lewis Millen, Global Clinical Sciences & Operations Innovation Lead, UCB
Silvia Alonso Rodriguez, AstraZeneca

16:00 PANEL DISCUSSION: Unlocking the Crucial Ingredients for a Successful Outsourcing Partnership: Time to Challenge the Status Quo and Focus on Value-Based Contracts

PANEL MODERATOR:
Luiz Barberini, Head, External Manufacturing Operations, Bayer SA
The pharma industry is facing ever-increasing challenges. Our trials are becoming more complex, requiring greater flexibility, and technology is changing at a fast pace. Now is the time to rethink our outsourcing models. Our dialogue needs to focus on outcomes and value generation rather than arguing over the small things which can stifle innovation. How confident are you with your current approach, and what are the risks and consequences of sticking with the status quo? Our esteemed panel of experts, with diverse backgrounds, will explore how true value can be unlocked from collaborative partners. Key topics include: 1) Creating the right partnership and alliance culture to ensure the best outcome for both the sponsor and vendor; 2) How have procurement functions adapted in defining and measuring value-based contracts?; and 3) Incentivizing and rewarding innovation, and collectively owning a change in strategy.

PANELISTS:
Jason Gubb, Co-Founder, ClinOpsClarity
Piet Theisohn, Vice President, Resource Management, Clinical Development & Operations, R&D Clinical Operations, Bayer AG-Pharma
Julia Vassiliadou, PhD, Vice President, Clinical Operations, F2G