SCOPE Summitの第15回年次「リアルワールドエビデンス（RWE）」ストリームでは、日常的なヘルスケアで生成されるデータの重要性が高まっており、臨床研究と観察研究の双方に変革をもたらしていることにフォーカスします。患者の電子記録、レジストリ、薬局データ、ソーシャルメディア、ウェアラブルセンサーは、登録研究でますます使用されています。臨床試験とリアルワールドデータ（RWD）研究の境界線が曖昧になり、臨床試験におけるRWDの役割が拡大するにつれ、革新的なデータ技術と、製薬企業とデータ保有組織との戦略的コラボレーションが不可欠になっています。AIはRWDを活用し、深いインサイトと効率的なプロセスを推進する上で重要な役割を果たします。このプログラムでは、コミュニティや大学の医療センター、臨床試験実施施設、バイオ製薬企業、患者グループなど、RWD研究分野における関係者を結びつけ、知識と経験の交換を促進することを目的としています。
2月3日 月曜日
6:30 amGolf Check-In & Breakfast Buffet (Sponsorship Opportunities Available)
8:00 amSCOPE's 4th Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)
Connect with your peers and colleagues at SCOPE's 4th Annual Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit theSCOPE Summit websitefor further details.
*Limited space available. Separate registration and fee required for golf.
9:00 amRegistration Open
12:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)
PRE-CONFERENCE WORKSHOPS: IN-PERSON ONLY
会議前ワークショップ：対面のみ
12:00 pm- 4:00 pm USER GROUP: Innovation Day with IQVIA Technologies: Hear the vision. See the products. Join the journey.
Clinical trial sponsors are invited to join digital product leaders and industry colleagues for an afternoon of discussions, demos, and networking. This interactive event has been carefully curated to help clinical trial professionals crack key challenges across the clinical trial lifecycle: from participant and site user journeys to data security and workflows. Pharmaceutical executives with various roles in clinical operations, innovation, technology, finance/budgeting, data analytics, strategic sourcing, trial managers, medical directors, or patient and site engagement will enjoy an industry panel, interactive roundtables, live demos with product experts, and more! Pre-registration is requested, and IQVIA reserves the right to decline requests that don’t fall within attendee guidelines above: For more details, please contact us.
1:00 pm- 1:45 pm WORKSHOP: Join and Explore ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace
Join this hands-on session with ClinEco, SCOPE’s B2B clinical trial community and marketplace featuring 850+ companies. ClinEco unites sponsors, CROs, service providers, and sites to streamline partnering, vendor research, innovation, and learning. At SCOPE 2024 we introduced the ClinEco Commons, a collaborative space where you can access, visit, and share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco Community. This year we launch our 'Ask a ClinEco Luminary' program where members can connect directly, and discreetly, with industry leaders and receive insights on a wide range of clinical trial topics. Join now at:clineco.io/register. Open to all SCOPE attendees.
1:00 pm- 2:30 pm WORKSHOP: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials
INSTRUCTORS:
Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)
Diana Steinbuesch, BioX Operations Portfolio Lead (Oncology), Roche
While developing leading and innovative therapies, we must not lose sight of the environmental impacts and greenhouse gas emissions. We can reduce the environmental impact of our studies by prioritizing remote visits and monitoring, by reducing kit wastage, and working together to find ‘greener’ solutions. This workshop will provide a brief overview of research and introductory strategies for reducing emissions as well as a 'Sustainability 101' to help anyone in our industry get started towards developing more environmentally responsible clinical trials. Open to all SCOPE attendees. Sustainable Healthcare Coalitionis a Partnering Organization at SCOPE.
1:00 pm- 2:30 pm WORKSHOP: Efficient Importation of Biological Materials into the U.S.
INSTRUCTORS:
Jessica Hammes, Branch Chief, Biological Threat Exclusion, Agriculture Safeguarding and Risk Management, Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
Jennifer Merriman, Senior Manager, Strategic Biospecimen & Vendor Logistics, Consent, Biospecimens, & Imaging, Global Development Operations, Bristol Myers Squibb Co.
(Additional speakers to be announced.)
U.S. Customs and Border Protection and partner government agencies regulate the importation of biological materials into the United States. The efficient importation of these items can be challenging, as Clinical Trial landscape is ever-evolving. The purpose of this workshop is to discuss current challenges, best practices, and possible solutions to navigate this landscape.
2:00 pm- 3:30 pm WORKSHOP: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing
INSTRUCTOR:
Dawn Anderson, Partner, Consulting, Deloitte LLP
Ming Shen, Managing Director, Deloitte Consulting LLP
This workshop will explore sponsor and site perspectives on current challenges and future opportunities in clinical trial financing. It will address complexities in managing trial finance including estimation, budgeting, forecasting, invoicing, payments, reconciliation and others in clinical trial management. The workshop aims to identify innovative solutions to enhance finance management in clinical trials, fostering more accurate projections. Through discussions and interactive sessions, it seeks to provide insights for future opportunities to improve clinical trial finance.
MONDAY AFTERNOON PLENARY SESSION:
月曜日午後のプレナリーセッション：
CONVERGING CLINICAL RESEARCH AND CARE, PATIENT PANEL & PARTICIPANT ENGAGEMENT AWARDS
臨床研究・臨床ケアの融合、患者パネル、参加者エンゲージメント賞
Fast-Forward to 2035: What Success Could Look like in Converging Clinical Research and Care-And How to Get There
Mark McClellan, MD, PhD, Director, Duke-Margolis Institute for Health Policy; Former Commissioner, FDA
On this stage in 2024, we spoke about our mission to converge clinical research and clinical care for the benefit of patients worldwide. We envision a world in which patients participate in research at the point of care as seamlessly as possible. And although we’ve set our vision, and organized the work we are undertaking accordingly, the real fruits of those efforts will not be seen in the short term. We will use this session to talk about where we hope we will be by 2035. What might we reasonably achieve? What does success look like? And what will it take to get there? This session is designed to help us all to raise our gaze beyond the near-term and find inspiration in the future possibilities.
Tips for Getting the Most out of SCOPE
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
Visit our FAQ page! We hope this page answers some of your questions related to SCOPE. It consolidates a lot of info for speakers, attendees, and vendors into one page. We look forward to seeing you at SCOPE on February 3-6, 2025, at the Rosen Shingle Creek in Orlando, Florida!
What Do Real Patients Actually Talk About?
Whether at an industry event, a focus group, or another venue, we’ve all heard “real” patients share stories of their conditions, treatment journeys, and lives. But how accurate is what you’ve heard? Are the patients who speak on the podium or in a focus group truly representative of the majority of patients, or do they represent just a small sample? Our panel of patient engagement experts from some of the country’s leading patient advocacy groups and other representative organizations will give the story of what it’s like for most patients to live with illness, including rare and chronic diseases. Join us and learn about the true challenges of disease burden, unmet needs, treatment progression, the challenges-and rewards-of clinical trials, and more.
5:05 pmSCOPE's 9th Annual Participant Engagement Awards Introduction (Sponsorship Opportunity Available)
SCOPE's 9th Annual Participant Engagement Awards
Kelly McKee, Head of Innovative Patient Recruitment, Evinova; Co-Creator of the SCOPE Participant Engagement Award
Now in its 9th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2025 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/participant-engagement-award
5:45 pmSCOPE's Kickoff Reception: A Luau to Remember!
Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, we're turning up the tropical vibes with a luau theme.
DRESS CODE: Hawaiian shirts are encouraged! Show off your brightest, boldest, most tropical attire (grass skirts optional!) Let's bring the aloha spirit to life as we kick off another amazing SCOPE conference experience. Join us to reconnect with your old friends, make some new ones, and soak up the Florida sunshine in style!
7:00 pmClose of Day
2月4日 火曜日
6:30 amSCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)
Join SCOPE’s Coordinators on Tuesday, February 4 for our 5K Rise and Shine Fun Run! Don’t forget to pack your sneakers.
All of us at Cambridge Healthtech Institute recognize the importance of integrating well-being and fitness into our work travel routines. We're excited to offer our support to faculty, sponsors, and attendees in fostering a culture of wellness. This is an easygoing, informal running (or walking) event. 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 Rosen Hotel’s front lobby near the birdcage at 6:30 am sharp!
RUN COORDINATORS:
Eileen Murphy, Conference Producer, Production, Cambridge Healthtech Institute
Steve Wimmer, Vice President of Partnerships, 1nHealth
7:30 amRegistration Open
7:30 amMorning Coffee (Sponsorship Opportunities Available)
Get Up and Go! Jumpstart your morning with a specialty made-to-order coffee and some delicious treats, courtesy of our sponsors.
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TUESDAY MORNING PLENARY SESSION:
火曜日午前のプレナリーセッション：
REDUCING CYCLE TIMES WITH “IN-HOUSE” CAPABILITIES, DATING GAME WITH PATIENTS & NEW PARADIGM OF PATIENT-LED TRIAL SPONSORS
「インハウス」機能によるサイクルタイムの短縮、患者とのデートゲーム、患者主導の治験依頼者における新たなパラダイム
*Must be present to win.
Exquisite Clinical Trial Delivery in an Ever-Changing World-Evolution and Opportunity for Sustained Performance
Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.
This talk focuses broadly on Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. More specifically, how has Merck decided to optimize clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams? What are key considerations for clinical trial planning, site selection, and protocol design? And, what and why did Merck keep many core capabilities “in-house”?
Beyond the Real-World Data, What Are Patients Saying?
Special LIVE Episode with Studio Audience-Patient Contestants will be Announced Onsite!
SCOPE’s Gameshow Host: Brett Kleger, a man whose dream it was to be a wedding singer or gameshow host
In today’s episode of “The Clinical Trial Dating Game” we have our pharma industry bachelor looking for a volunteer for his trial. He must question and choose from among three patients, who are hidden from view. He has access to all of their data, but there is more to this person than data, so how will he know which questions to ask? How will he avoid bias? How will he recruit on time? Knowing how important patient centricity is to the clinical research industry and with so much on the line, will our bachelor land a date? What could go wrong?
How Patients Can-and Must-Disrupt Traditional Pharma Clinical Trials
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Should biopharma companies be the only "sponsors" for clinical trials of new medicines? Does the current model limit opportunities for unmet needs in small populations or leveraging repurposed drugs? This panel will gather leaders demonstrating ways that patient-led non-profit organizations are challenging assumptions and taking a leadership position in medicine development. No longer can we think of patients as guests at pharma's table-is the next transformation in medicine development going to be entirely patient-led?
9:50 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall-Best of Show Voting Opens
Join us for the Grand Opening Networking Coffee break in our biggest SCOPE Exhibit Hall ever! Mingle with friends, forge new connections, and exchange ideas over your morning cup of joe. Visit exhibitors and learn about their latest and greatest innovations and products...voting opens for our Best of Show awards so don’t forget to vote.
Part 1: Accessing and Generating RWD
「インハウス」機能によるサイクルタイムの短縮、患者とのデートゲーム、患者主導の治験依頼者における新たなパラダイム
UNITING STAKEHOLDERS AND INTEGRATING EVIDENCE
ステークホルダーの団結とエビデンスの統合
Regulatory Initiatives to Enable Pragmatic Trials
Gracy Crane, PhD, International Regulatory Policy Lead for RWD, Roche Products Ltd.
This panel will delve into regulatory initiatives that have been launched in pragmatic trials, including demonstration projects announced by the new CDER center C3TI, the crowdsourcing effort by FDA, and recent efforts within the EU, including the position paper by EFPIA on pragmatic trials and the recent ACT-EU meeting. The panel will also discuss how to reduce hurdles that drug developers may encounter while designing pragmatic trials.
Data, Data Everywhere, and Not a Byte to Use
Robert DiCicco, Vice President, Portfolio Management, TransCelerate BioPharma, Inc.
The 21st Century Cures Act created opportunities to leverage electronic health data to improve clinical outcomes and support regulatory decision-making. Despite its passage over seven years ago, that promise has gone largely unfulfilled. In the pharma R&D environment, there has been limited ability to unlock the potential of that data in a scalable way. The good news? Recent advances in technology, along with cross-sector collaborations, present renewed opportunity to take another leap forward in accelerating clinical research.
Su Chen, MD, Clinical Science Principal, MITRE; Steering Committee Chair, CodeX HL7 FHIR Accelerator
Uncovering Causal Relationships from Real-World Data (RWD) for Better Patient Outcomes: Use Case Presentation
Kavita Lamror, Partner, RWE & Digital Transformation, Maxis Clinical Sciences
Geriatric patients with non-small cell lung cancer (NSCLC) and late-stage diabetes mellitus complications represent a highly complex and vulnerable population. Co-morbidities, co-medications, age-specific frailty, and the interplay between cancer progression and diabetic complications make optimizing treatment outcomes very challenging. Chemotherapy exacerbates these complications, increasing risks of adverse events, and impacting quality of life. Causal graphs, rooted in graph theory and causal inference principles, provide a framework to address these complexities by uncovering causal relationships in real-world data (RWD), enabling personalized treatment strategies. This framework allowed MaxisIT to disentangle the intricate interplay between NSCLC, diabetes complications, and chemotherapy outcomes, accounting for confounding factors like age, comorbidities, and baseline health status, to personalize treatment for better patient outcomes and clinical decision-making.
Operationalize Post-Trial Access: Opportunities for Longitudinal Data Collection and Registry Creation
Becky Thompson, Senior Director, Solutions Consulting - Real World Research, Real World Evidence & Market Access Solutions, Parexel
Traditional approaches to post-trial access often lead to inefficiencies and missed opportunities for data collection. In this session, we explore how to develop a post-trial access platform that not only ensures continued patient access to treatment but also facilitates long-term data collection and potential registry creation. We'll examine the benefits for patients, sites, and sponsors, and explore how this model can be leveraged for real-world evidence generation and long-term safety monitoring, using practical examples and insights from lessons learned.
1:35 pmSponsored Networking Luncheon
Take this opportunity to refresh and refuel and network, compliments of SCOPE sponsors! Take a well-deserved break outdoors in the sun, or indoors in the air conditioning.
2:35 pmNetworking Coffee & Dessert Break in the Exhibit Hall
SCOPE’s hall this year is bigger than ever; there’s no way to cover it all in just one break. So, after lunch, grab some dessert and a cup of coffee and visit all those booths that you just couldn’t make it to this morning. Stay to hear our Best of Show Winner announcement and congratulate the winner!
GLOBALIZATION, INNOVATION, DATA INTEGRATION
グローバル化、イノベーション、データ統合
Patients, Connection, Clinical Trials
Melinda M Rottas, Head of Optimization, Analytics & Recruitment Solutions, Clinical Development & Operations, Pfizer Inc.
The selfless act of volunteering for a clinical trial enables the delivery of medical breakthroughs. At Pfizer, we believe that the participant experience, and the ability for a person to remain connected to research over time, is a critical component of their journey. Learn more about Pfizer's seamless experience from initial information seeking through study closure and beyond.
Multi-Stakeholder Real-World Evidence (RWE) Partnerships and Collaborations: International Experiences and Examples
Kelly H. Zou, PhD, Head, Global Medical Analytics and Real-World Evidence, Viatris; Founder, AI4Purpose
Learning objectives for this talk are: 1) showcasing multi-stakeholder partnerships and collaborations to harness real-world data (RWD) and evidence (RWE), 2) illustrating both successes and barriers for such efforts across geographical regions/countries and business functions, and 3) sharing some best practices in health innovations during this era of big data, digital health, and artificial intelligence (AI).
EHR to EDC: Shared Astellas Experience
Thanh Tran, Director, Immuno-Oncology Primary Focus Lead, Data Management, Astellas
Electronic Health Records (EHR) to Electronic Data Capture (EDC): Astellas Data Management is happy to share their learned experiences collaborating with a middleware vendor and clinical site. This presentation will provide Astellas's purpose, start-up, conduct, and lessons learned with actual real-world outputs.
Integrated Evidence Teams-Top or Flop?
Dorothee B. Bartels, PhD, Associate Professor (Apl. Professor) for Public Health and Epidemiology, Medizinische Hochschule Hannover; Founder, HealthData-Advisors, Board BBraun US
Xin Ma, Senior Vice President, Head, Integrated Evidence Generation & Business Innovation, MA&PV, Bayer
Integrating evidence in clinical and observational research is a growing challenge, given the variety of sources and data requirements. This talk will offer case studies and solutions on how to integrate evidence from various sources.
Real-Time Point-of-Care Patient Identification
John D. Chelico, MD, System Vice President & Chief Medical Information Officer, CommonSpirit Health
This panel will explore innovative approaches to identifying patients at the point-of-care using real-time data. Experts will discuss the integration of healthcare systems, data analytics, and technology to improve patient identification, ensuring timely access to clinical trials and personalized treatment options. Attendees will gain insights into overcoming challenges in implementing these solutions
Talk Title to be Announced
5:55 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)
Wind down at the end of a busy session day with colleagues and old and new friends. Networking is always in full swing at this reception, so raise a glass with your favorite exhibitors and take a chance at winning one of our fabulous raffle prizes (must be present to win). Continue your networking over dinner at one of the Rosen Shingle Creek's fine dining or casual restaurants and eliminate the need to face Orlando traffic.
7:15 pmClose of Day
7:15 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)
The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.
Shuttles will run a continuous loop from 7:00pm-11:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.
2月5日 水曜日
7:45 amRegistration Open
BREAKFAST PRESENTATIONS
朝食プレゼンテーション
BREAKFAST PRESENTATION OPTION #1:Digital Innovation’s Role in Pediatric and Elderly Clinical Trials
Kyle Hogan, Chief Executive Officer, Datacubed Health
This presentation examines how targeted digital tools improve retention rates among pediatric and elderly participants. Our pediatric focus reveals how gamification can create meaningful connections and enhance the trial experience while engaging caregivers. For elderly participants, we examine the use of accessible interfaces and remote monitoring solutions to address age-specific challenges. Attendees will discover strategies for implementing these solutions within their research programs.
BREAKFAST PRESENTATION OPTION #2:Expanding the Patient Universe: Transforming Clinical Trials through Inclusive, Data-Driven DesignChristopher Riley, Director, Strategic Insights, Solutions, H1
In today’s complex clinical research landscape, achieving patient-centricity and inclusivity is more critical than ever. This presentation introduces Patient Universe, a groundbreaking solution designed to optimize trial feasibility while addressing health equity challenges. Attendees will learn how leveraging real-world health equity data can transform patient recruitment strategies, create inclusive trial designs, and improve participant engagement. Through actionable insights and use cases, this session will demonstrate how advanced analytics and innovative technologies can bridge gaps in representation, support diversity action planning and enhance trial outcomes.
BREAKFAST PRESENTATION OPTION #3:Scaling Success: How Sanofi and Trialbee Drive Patient-centric Recruitment and Reduce Site Burden in Global Asthma Programs
Join Whitley Albright (Sanofi) and Gaynor Anders (Trialbee) to discuss how to keep patients at the center of focus while reducing site burden in a complex global asthma program by: connecting patients to the right trials with targeted outreach and a highly efficient global process; pre-qualifying all patients with live medical secondary screening to reduce the volume sent to sites, improve trust, and increase referral-to-consent ratio; keeping disqualified patients ready to enroll with program-level rematching; centralizing activity in a Patient Recruitment Platform (PRP) to manage progress, evaluate site performance, and measure campaign ROI; building a collaborative, supportive, and meaningful relationship.
Learn how these organizations are scaling recruitment success globally while achieving diversity and inclusion goals, reducing site burden, and keeping patients at the center of care.
8:45 amTransition to Sessions
TOKENIZATION UPDATE
トークン化の最新情報
Chairperson's RemarksHow to Tokenize a Clinical Trial to Facilitate Follow-Up with RWD
Simon Dagenais, RWE Lead, Internal Medicine, Pfizer Inc.
This presentation will explore how tokenization can be applied to clinical trials to streamline patient follow-up using real-world data (RWD). By linking trial data with external healthcare sources while preserving privacy, tokenization enables long-term tracking of outcomes and more comprehensive insights. Practical case studies and strategies for implementation will highlight the benefits and challenges of this approach.
Challenges and Key Considerations while Conducting a Trial Tokenization Study across the US, EU, and UK
Emily Zacherle, Senior Director, Healthcare Data Strategy, Novo Nordisk, Inc.
This presentation will examine the challenges and key considerations of conducting a trial tokenization study across the US, EU, and UK. It will explore varying regulatory frameworks, data privacy concerns, and cross-border data-sharing complexities. Attendees will gain insights into strategies for navigating these obstacles, ensuring compliance, and successfully implementing tokenization in diverse healthcare environments.
Complexities and Solutions Used to Conduct a Global RWE Program in COVID-19 and Immunocompromised Indications
Sylvia M. Taylor, PhD, Executive Director, Head, Medical & Payer Evidence, Vaccines & Immune Therapies, AstraZeneca
Conducting a global real-world evidence (RWE) program in COVID-19 and immunocompromised populations presents unique challenges, including data collection across diverse healthcare systems, varying regulatory requirements, and patient variability. This presentation will explore the complexities encountered in these global studies and highlight innovative solutions used to overcome these barriers, ensuring robust data integration and meaningful outcomes in real-time clinical settings.
Rich Clinico-Molecular Real-World Data is Transforming and Accelerating Cancer Clinical ResearchRyan Kennedy, Senior Vice President & General Manager, Digital Trial Solutions, ConcertAI
Clinical trial and randomized clinical trials remain the accepted gold standard of clinical research. In oncology research it is today possible to extract clinical and clinic-genomic co-variates from real-world patient records and preserve patient anonymity. The process is proving to tangibly and quantitatively increase confidence in matching of the right patient to the right targeted therapeutic agents as part of clinical trial design. We will be providing distinctive evidence through cases studies of analyzing human derived Medical Records linked with NGS panels bearing both DNA and RNA sequencing data and Whole Slide Imaging to de-risk clinical development, accelerating pathways to high medical unmet need patient populations
10:25 amCoffee Break in the Exhibit Hall
SCOPE is ALL about networking-with clients, colleagues, sponsors and exhibitors. Take this chance to visit booths you haven't been to, build new relationships, and fuel up with coffee for the rest of the busy day ahead. Last chance to vote for the Best of Show award! Make your vote count!
10:45 amSpecial Book Signing
Fundamentals of Decentralized Clinical Trials
Editors: Isaac R. Rodriguez-Chavez & Anna Yang
Location: Gatlin Foyer, ClinEco Booth #4
ACTIONABLE SOLUTIONS: GLOBALIZATION, AI, AND MORE
実用的なソリューション：グローバル化、AIなど
Conducting Effective Global RWD Studies
Aaron W. Kamauu, MD, MS, MPH, CEO, Navidence LLC
This panel will explore the challenges and best practices in conducting global real-world data (RWD) studies. Experts will discuss strategies for managing diverse regulatory landscapes, integrating data across multiple sources and regions, ensuring data quality, and addressing patient variability. Attendees will gain insights into overcoming obstacles and maximizing the value of RWD in a global context.
Advancements in the Use of GenAI in Real-World Research
John Cai, MD, PhD, Executive Director, Real-World Data Analytics and Innovation, Merck
This panel will highlight the latest advancements in applying generative AI to real-world research. Industry leaders will discuss how GenAI is transforming data analysis, improving patient insights, and driving efficiencies in healthcare research. The session will cover key developments, ethical considerations, and future potential of AI technologies in real-world evidence generation. Topics will include:
- Combining RWE and AI for the end-to-end medical evidence generation
- Unlocking Clinical Textual Data for Real World Evidence Generation
- GenAI for rapid RWD analytics in clinical development
GenAI for Rapid Analytics in Clinical Development
Generating Evidence with Relevance, Reliability, and Traceability
An all-time high amount of data is being captured and analyzed, 90% of pharmaceutical companies have real-world evidence teams, yet “data quality” is the challenge most frequently cited in literature. Join Ria Westergaard, Director of Product Strategy for Evernorth Clinical Trial Solutions, as she leads an interactive panel discussion to review use cases that demonstrate ways to overcome challenges and implement best practices.
12:55 pmSponsored Networking Luncheon
Once again, join us for lunch, courtesy of our generous sponsors.
1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall-Best of Show Winner Announced
SCOPE's Networking Coffee and Dessert Break is the perfect time to pick up a sweet treat, courtesy of our sponsors, and fuel up for the afternoon with a cup of coffee or soft drink. Visit our Game Card Sponsors to fill your Game Card with stickers and get in a little more networking time before afternoon sessions!
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WEDNESDAY AFTERNOON PLENARY SESSION:
水曜日午後のプレナリーセッション：
FOSTERING INNOVATION IN PHARMA R&D, LEVERAGING DIGITAL TOOLS WITHOUT LOSING YOUR MIND & UNLEASHING GenAI FOR TRIALS
製薬R&Dにおけるイノベーションの促進、デジタルツールの活用、試験向けGenAIの活用
Fostering Clinical Innovation in a Large Pharmaceutical Organization
April Lewis, Head, Innovative Health, Global Development, Johnson & Johnson Innovative Medicine
This presentation explores strategies for fostering innovation within a large pharmaceutical organization by focusing on four key areas: developing a clear mandate and compelling vision to guide innovation efforts; designing and engineering an infrastructure that supports creativity and collaboration; building a high-performance, diverse team empowered to drive innovation; and seeking opportunities for true patient-centricity and sponsor-agnostic innovation. By aligning these elements, the organization can create a sustainable innovation ecosystem that prioritizes patient outcomes and drives transformative breakthroughs in healthcare.
How Can Sponsors Leverage Increasing TechnologyCapabilities with Quality
Angela DeLuca, Associate Vice President, Global Study Operations, Amgen
Sponsors can leverage increasing technology capabilities to enhance quality by integrating advanced data analytics, AI, and automation into their drug development and manufacturing processes. These technologies enable real-time monitoring, predictive analytics, and streamlined workflows, ensuring higher precision and consistency in product quality. Additionally, digital tools facilitate better compliance with regulatory standards and more efficient management of clinical trials, ultimately accelerating time-to-market while maintaining rigorous quality standards.
3:25 pmChairperson's Introduction (Sponsorship Opportunity Available)
The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond
Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Johnson & Johnson
Gen AI, a groundbreaking approach that seamlessly merges artificial intelligence into our daily lives, holds immense potential for transforming the pharmaceutical and healthcare industries. This paradigm shift not only demands a thorough understanding of the ethical implications, potential biases, and social consequences of AI systems- it also requires a steadfast focus on creating tangible value that benefits individuals and society at-large. By harnessing advanced AI technologies, Gen AI can pave the way for unparalleled breakthroughs, elevating patient care, enabling personalized medicine, streamlining processes, and revolutionizing the way we approach healthcare as a whole. Join the debate on the real value-based use cases and explore the endless possibilities that Gen AI brings to the table.
4:00 pmBooth Crawl & Refreshment Break in the Exhibit Hall (Sponsorships Available) Last Chance for Exhibit Viewing
We know you're tired, we know the Exhibit Hall is huge, and we know you still have some booths to visit, some connections to make, some networking to do. SCOPE's Networking Booth Crawl is the time to do it! Crawl if you must, but be sure to visit our sponsored booths for some food, drinks, and enough energy to finish SCOPE strong! Our final Networking Exhibit Hall break is the final time to see the exhibits you haven't seen and meet the people you haven't yet met. The break ends with another amazing raffle prize, so be sure to get your Game Cards in and the lucky winner (must be present to win) could be you!
5:00 pmClose of Day
5:00 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)
The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.
Shuttles will run a continuous loop from 5:00pm-9:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.
2月6日 木曜日
7:15 amRegistration Open
BREAKFAST PRESENTATION
朝食プレゼンテーション
BREAKFAST PRESENTATION:What sites really need to deliver successful patient engagement strategies
Sites have shared that delivering successful patient recruitment is arguably one of the most persistent challenges they face. Despite this being well-known, not enough of the right support is provided to them, causing more than half of sites to pay out of pocket for unreimbursed recruitment expenses, all while the one-size-fits-all recruitment materials provided to them collect dust. By rethinking how we support sites in their patient engagement activities, sponsors and CROs can shift the paradigm to make patient enrollment delays and declining retention rates outliers, instead of the norm. This breakfast session will discuss strategies to transform patient engagement by leveraging site experience, incorporating patient insights and motivations, as well as AI solutions, to improve patient retention and deliver better study outcomes.
8:15 amTransition to Sessions
Part 2: Leveraging RWD for Clinical Research
パート2：臨床研究におけるRWDの活用
RWD TO TRANSFORM CLINICAL TRIALS
RWDが臨床試験を変革
8:20 amChairperson's Remarks (Sponsorship Opportunity Available)
Challenges and Recent Developments in RWD-Augmented Study-Control Arms
Demissie Alemayehu, PhD, Vice President, Biostatistics, Pfizer Inc.
In trials where the control arm is limited, it is essential to augment, borrowing information from external data sources. Guidelines have been issued to inform such study designs; effective implementation requires minimizing bias associated with lack of homogeneity among participants. Available techniques often fail to meet regulatory requirements. We will review recent developments and alternative approaches to achieve homogeneity and reduce bias.
Historical Placebo Controls to Characterize Event Rates in Ongoing RCTs
Chris Schneiderman, MPH, Director, Global Epidemiology, AbbVie, Inc.
The ‘Adverse Events in Placebo controls of AbbVie Clinical Trials’ (AEPACT) database developed by AbbVie leverages placebo control or standard of care arms from historical RCTs to estimate background AE rates and provide evidence in decision-making for SAE unblinding in ongoing, unblinded trials. By utilizing MedDRA SMQs, estimates of SAEs can be generated, offering a range of expected emerging AEs in these trials. This approach allows for unique insights into the background event rates of AEs in ongoing trials.
Leveraging Real-World Data for Feasibility and Site Selection
Explore how to utilize real-world data to enhance protocol development and feasibility/site selection. The session will provide an in-depth look at tools to identify patient distribution across various providers, systems, and geographies, as well as assessing trial feasibility with precision to ensure viable study plans. Leveraging detailed insights into investigator and healthcare provider practices can inform and optimize clinical trial performance.
Talk Title to be AnnouncedUtilizing Pharmacy Data in Observational Pharmacoepidemiology Studies
Scott Chavers, PhD, Senior Director, Epidemiology, Real-World Evidence Clinical Trials, Walgreens Co.
Pharmacy data has been a relatively untapped resource to the RWE industry. This talk will overview how to use pharmacy data for post-marketing RWE research and the overall impact on the product lifecycle. By learning which insights are available and how they can be used, sponsors may uncover new uses for this important data.
Gathering RWE on Life-Saving Devices: A 5-Year Review
Barbara Fink, Associate Director, Clinical Affairs, Emergency Care, Philips
Public access defibrillation programs continue to be one of the most important factors when a patient has a sudden cardiac arrest. But how do you gather and analyze RWE on this type of device? We will share what we have learned over a 5-year period.
11:10 amNetworking Coffee Break
DIGITAL PROTOCOL: FROM DESIGN TO IMPLEMENTATION
デジタルプロトコル：デザインから実施まで
The Role of AI in Powering Digital Protocols
Protocols often live in documents, requiring sponsors to manually configure data across many systems, and leading to inaccuracies and extended timelines. Global standards groups are calling for protocols to be digitized, but how will sponsors adjust to new digital formats? In this talk, we’ll share published research on the use of AI/LLM agents to digitize protocols and how this approach can drive more efficient research for sponsors and sites.
Transforming the Clinical Trial Protocol-Moving from a Document-Centric to a Data-Centric World
Chris Decker, President & CEO, CDISC
Since the beginning, the industry has been writing and copying protocols in Word while manually transcribing protocol information to the plethora of downstream systems, which is time-consuming, error-prone, and questions quality. Over the last few years, the industry has been working on moving from a document-centric to a data-centric protocol, helping industry reduce cycle times and improve data reliability and quality for sponsors, third party providers, and regulators. This panel will bring together TransCelerate, CDISC, HL7, and ICH M11 to discuss the current state of the digital protocol and the opportunities to transform the clinical trial lifecycle.
Amy Cramer, Founder and Director, Vulcan; Data Acquisition, eSource, Johnson & Johnson Innovative Medicine
1:25 pmTransition to Lunch
LUNCHEON PRESENTATION: The Perfect Pairing: How RWD Elevates Every Stage of Your Clinical Trial
Steve Lesser, Vice President of Growth for Clinical Trial Solutions, Optum Life Sciences
There’s no substitute for real-world data to get to the most complete patient picture-before, during, and after a clinical trial. Understand your target population to inform evidence and diversity strategies, accelerate recruitment with EHR patient screening, and drive market success post-trial. Steve Lesser, Vice President, Clinical Trials, Optum Life Sciences, will discuss the ways real-world data acts as a key ingredient at the different stages of a clinical trial.
2:00 pmSCOPE Summit 2025 Adjourns
* 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。
アジェンダ・講演者・スポンサー更新
2025年 プログラム
◆
Sunday Golf, Kick-Off Keynote & Participant Engagement Award
月曜のゴルフ、キックオフ基調講演、参加者エンゲージメント賞
◆SCOPE’s Kickoff Reception
SCOPEによるキックオフレセプション
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Patient Voice in Trial Design and Protocol Development
試験デザインとプロトコル開発における患者の声
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Developing and Executing Effective Diversity Plans
効果的な多様性計画の策定と実行
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Enrollment Planning and Patient Recruitment
登録計画・被験者募集
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Patient Engagement and Retention through Communities and Technology
コミュニティ・技術による被験者エンゲージメントとリテンション
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Clinical Trial Forecasting, Budgeting and Contracting
臨床試験の予測・予算編成・契約
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Resource Management and Capacity Planning for Clinical Trials
臨床試験のリソース管理・キャパシティプランニング
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Mastering an Outsourcing Strategy
アウトソーシング戦略のマスター
◆
Relationship and Alliance Management in Outsourced Clinical Trials
臨床試験アウトソーシングにおける関係と提携管理
◆
Modernizing Lab, Biomarker & Data Management Operations
ラボ・バイオマーカー・データ管理業務の近代化
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Biomarker & Biospecimen Technology & Innovation
バイオマーカー・バイオ試料の技術とイノベーション
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Data Technology for End-to-End Clinical Supply Management
E2Eの臨床サプライ管理向けデータ技術
◆
Clinical Supply Chain Strategies to Align Process, Products and Patients
臨床サプライチェーン戦略でプロセス・製品・被験者を連携
◆
Clinical Trial Venture, Innovation & Partnering *
臨床試験のベンチャー・イノベーション・提携 *
*Separate Registration Required
