SCOPEによる第16回年次「データ」ストリームは、臨床試験の進化する状況を掘り下げ、データ統合の重要性と従来型のサイロを打破するためのテクノロジーの革新的な活用を強調します。大規模なR&Dデータのガバナンス、健康における社会的決定要因の適用、臨床データ統合の最適化に焦点を当て、業界のリーダーを集めて、データドリブンの戦略が臨床試験の効率と多様性をどのように高めることができるかについて探ります。業界トップクラスの専門家が、この分野における課題と機会に関する見識を共有し、急速に変化する臨床研究の環境で成功するための実用的なソリューションを提供します。
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 the SCOPE Summit website for 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 Coalition is 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: 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: Clinical Data Strategy and Analytics
パート1：臨床データ戦略とアナリティクス
ECOSYSTEM OF DATA: BREAKING AWAY FROM SILOS
データのエコシステム：サイロからの脱却
Optimizing Clinical Data Integration: A Path to Efficiency
Narayanarao Pavuluri, Senior Director & Global Head, Clinical Database Services, Merck
Clinical research requires seamless integration of data for maximum efficiency and accuracy. Clinical Data Integration connects various sources and systems, minimizing errors and delays. It provides real-time access to patient information, enabling faster trial initiation and informed decision-making. This approach streamlines workflows, offers scalability, and reduces site burden, resulting in greater research productivity. Embracing Clinical Data Integration transforms clinical trials, enhancing efficiency and accelerating research outcomes.
Practical Governance Strategies for Large-Scale R&D Data & Analytics
Gian Prakash, Director, Data & Analytics, Information Research, AbbVie, Inc.
Effective governance is essential for unlocking the full potential of large-scale R&D data & analytics. This presentation presents practical strategies for establishing and implementing a robust governance framework to support data-driven innovation. By addressing key challenges such as data quality, access, security, and ownership, organizations can foster a data-centric culture and accelerate time-to-value from R&D initiatives. This presentation offers actionable insights and recommendations for R&D leaders seeking to scale data democratization.
Help Is Here: Interpreting the New ICH E6 R3 Data Governance Requirements
The upcoming ICH E6 R3 (GCP) guideline introduces a brand new section related to data governance in clinical trials. Given the critical nature of data in clinical research, proper governance is essential to maintain the reliability of the trial results, protect the participants’ rights and safety, and ensure compliance with regulatory requirements. ACRO and TransCelerate collaborated to deliver a data governance framework and diverse solutions to support the understanding and interpretation of these new requirements.
Clinical Data Democratization Through Data Products
Sophia Nuijens, Director, Data Product, Drug Development Operations & Real World Evidence, Bristol Myers Squibb Co
Pharma companies need to democratize data access for clinical within their organization and make it easier for end users (Business analysts, analysts, data scientists, IT etc.) to run data and analytics use cases faster to accelerate clinical trials, patient care and outcome. With the evolution of various data management techniques such as Data Mesh, it’s important to tactically learn how to strategize and create domain driven “Data products” and enable seamless data access for end users
Melissa Mooney, Director, eCOA Solution Engineering, IQVIA Technologies
eCOA implementation begins with a solution design strategy that efficiently collects, stores, and manages data in a way that will optimize clinical data review and analytics while ensuring endpoint protection. IQVIA expert Melissa Mooney will explore the positive impact eCOA solutions are making on clinical data strategies, specifically:
•How eCOAs are being used to ensure endpoint protection
•The importance of planning and defining clinical data strategies in parallel to eCOA setup/design
•eCOA design considerations that create efficiencies in data analytics and monitoring
Is It Too Risky to Deploy AI in Your Clinical Trial? Understanding the Real Costs of Leveraging AI
While the speed and efficiency that AI offers to development programs is so commonly hyped, the risks potentially introduced are usually minimized or completely dismissed. We will talk candidly about these risks and discuss how to responsibly deploy AI-enabled solutions, without compromising confidence in your clinical trial results.
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!
DATA COLLECTION AND REUSE
データの収集と再利用
Clinical Content Reuse (CCR) with Development Data Flow (DDF) for Study Optimization
Siddharth Shah, Executive Director, Product Management, Data Science and Digital Innovation, BeiGene
Leveraging industry thought leadership, accelerators (TransCelerate, CDISC etc.), and content from critical path clinical documents to achieve optimal trial productivity by focusing on a mindful roadmap that balances the need for process-people and product(s).
It’s Been a While-10 Years of Data Sharing and Reuse: Highs, Lows, and What’s Next
Medha Patel, Clinical Design Analytics Director, Amgen
This is an opportunity for attendees to ‘zoom out’ on the meaty topic of clinical data sharing and reuse. An opportunity to take our eyes off the day-to-day, quarter-to-quarter, even year-over-year efforts and instead appreciate the bigger picture. We’ve been working to share and reuse data for the benefit of science, safety, and-ultimately-patients, for 10 years. Time travel with us back to the early days, through some highs and lows, and the outlook for what’s next. We have seen that amazing things are possible when we collaborate: this is a chance to renew our ‘why’ and move forward with curiosity and courage.
Streamlining Secondary Analysis of Clinical Studies-Lessons Learned
Radhesh Nair, Director, Data Science and Analytics, Clinical Development, AbbVie
AbbVie clinical trial data is housed in multiple databases across a myriad of organizations. Locating and accessing clinical data was a time-consuming challenge. We created one source of truth for clinical study data with appropriate governance to create efficiencies within the AbbVie pipeline while supporting enhanced patient care through predictive analyses. This allowed researchers to search and identify the right set of clinical studies to run secondary analyses to test research hypotheses. Harmonizing the study data access process eliminated duplicative effort and helped manage enterprise risk through the governance process.
The Three Little Pigs' Tale: A Blueprint for Strategic Clinical Trial Feasibility
Barbara Argibay Gonzalez, Vice President & General Manager Data Division, Anju Software
Is your clinical trial built with straw, sticks, or bricks?
Access to data has made clinical feasibility more robust and efficient, but successful studies blend clinical intelligence with team knowledge and real-world experience. As trials target specific patient populations, granular historical data is crucial for precision. Join us to explore how combining clinical intelligence with operational insights can drive accurate enrollment models, prioritize sites, and provide dynamic, data-driven insights for success.
Catalyzing Clinical Study Data Collection
Paul Jacobs, Associate Director, Development Innovation, Regeneron Pharmaceuticals, Inc.
Progress in the field of clinical study data capture has been relatively slow, but recent boosts in interoperability, technology and opinion is enabling a rapid transformation driven by the integration of Electronic Health Records (EHR) with Electronic Data Capture (EDC) systems. We will discuss this journey and propose our thoughts for future direction, with the potential for further reinvention of data collection and the emergence of an entirely new paradigm.
Impact of PRO Type, Frequency and Modality on Patient and Site Burden: Insights from BMS/Tufts/ZS Research Study
Chelsea Gallagher, Sr Dir Drug Dev Innovation & Digital Health, Business Insights & Analytics, Bristol Myers Squibb Co
Join BMS, ZS, and Tufts CSDD to explore the impact of clinical outcome assessments on trial participation burden. We will explore the insights from our insights from our 2024 global study with patients and sites to highlight the nuances of clinical outcome assessments and its impact on perceived burden of participation, including significant differences in perceptions, the impact of digital vs. non-digital modalities, and how pharma can use data driven burden analytics to design better trials.
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
CLINICAL DATA IN ONCOLOGY TRIALS
オンコロジー試験における臨床データ
"Science, Sealed, Delivered": Bringing Efficiency to Complex Oncology Trials
In this session we will review Pfizer’s strategy for supporting accelerated oncology trials and Clinical Data Sciences’ role using innovative tools, technologies, and strategies. We will discuss the evolution of how the concept of “critical data” streamlines efficiency through clinical trial operations; the incorporation of automation in our daily data review process; and the development of customized study metrics and analytics to support milestone deliverables.
Technology and Data-Driven Solutions for Increasing Enrollment of Diverse Patients in Oncology Trials
Reed Few, Director, External Innovation, Data Science & Digital Health, Research and Development, Johnson & Johnson
Increasing the representativeness of clinical trials has been an ongoing goal, which has only increased following FDA draft guidance on Diversity Action Plans in 2024. To achieve diverse enrollment, we have implemented several data-driven strategies, including collaborating with external partners to leverage novel technologies. We will discuss these efforts and our learnings from using data and technology to drive representative clinical trial enrollment.
Key Considerations for Utilizing AI/ML Screening Algorithms to Identify Patients with Immunotherapy
Usama Javed, PharmD, Associate Principal Scientist, Regulatory Digital Health, Merck & Co.
This presentation explores the development of screening criteria for trial participants using AI/ML algorithms. The criteria are formulated collaboratively by clinical specialists in the relevant field, defining inclusion and exclusion based on biomarkers and other diagnostic tests.
Accelerating Study Build with Generative AI
Wayne Walker, Senior Vice President, Rave Platform Technology, Medidata, a Dassault Systemes Co.
The complexity of study builds poses challenges in terms of time, cost, and accuracy. Generative AI (GenAI) transforms study builds by automating processes like generating the schedule of events, EDC forms, eCOA questionnaires, edit checks, quality control scenarios, and synthetic test data. This session highlights real-world examples of GenAI reducing study build effort and timelines, and ensuring a high-quality study start.
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
DATA INTEROPERABILITY
データの相互運用性
Interoperability Being a Value for Product Companies Enables the Patient Value and Delivery Agility to Sponsor Organizations
Donald Thampy, Executive Director, Merck
Every product company in the industry is striving to develop solutions that facilitate successful processes and functions. If the product is the engine, data is the fuel. Data is always in motion. The motion makes the data transverse multiple products in the ecosystem, and data is the connector. It begins from the patient, goes all the way to sit in a chart that demonstrates value of the drug. To solve that data-motion challenge, we have numerous connectors to weave the magical movement of data. However, it's worth considering whether there's a more effective approach for the industry to achieve this. Should product companies adopt the value of interoperability? What does that mean? Will the adoption of this value have the potential to address the challenges associated with integrations, data movement, transitions, and ultimately, cost burden on patients? Come and engage in a conversation!
Modern Clinical Data Management: Data Enablement for Tiered Clinical Data Review
Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.
Clinical data management has evolved significantly with the advent of advanced technologies. This session explores the approach to data enablement of tiered clinical data review, a strategic approach to ensure data quality and integrity throughout the clinical development process. By leveraging modern data engineering and technologies, we can enable complex back-end checks, patient profiles, listings, and anomaly detection congruently in addition to Electronic Data Capture (EDC) point-of-entry checks. This tiered approach allows for efficient identification and resolution of data issues at various stages, ultimately contributing to clinical trials' success and development of innovative therapies.
Talk Title to be Announced
Unlocking the Potential of Generative AI in Clinical Trials
Are you ready to explore the potential of Generative AI in clinical trials? In this session, you’ll learn more about how you can leverage the power of Generative AI through a privacy-safe clean room. Through this secure environment, sponsors and CROs can bring their data together with WCG’s data for collaboration and analysis. Specifically, we’ll discuss how this technology enables faster trials with actionable and insights.
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 Technology Capabilities 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: Data Science, ML, and AI
パート2：データサイエンス・ML・AI
ARE WE THERE YET WITH ETHICAL CONSIDERATIONS?
倫理的配慮は？
Content Generation and Knowledge Extraction for Clinical Documents
Vaishali Goyal, MS, AI Lead, Development, AstraZeneca Pharmaceuticals
With over 240 global clinical trials, we are currently running multiple pilots across our R&D pipeline, testing a range of AI technologies to simplify our processes. Specifically, AstraZeneca is investing in the AI technology to expedite content generation and insight extraction of key clinical assets.
AI-Powered Protocols: Breaking the Design Cycle with Data-Driven Retrospectives
Laura Russell, Senior Vice President, Head of Data and AI Product Development, Advarra
The protocol design process is ripe for innovation to address persistent challenges, including inefficiencies in trial operations and high participant attrition. The next wave of advancements will look to leverage emerging AI technologies and unified data ecosystems to break the cycle of inefficiency by tackling foundational issues rather than focusing solely on surface-level friction points. This session will delve into how smarter protocol design can become a reality by applying these advancements to data-driven retrospectives for continuous improvement.
How AI Document Automation Can Support Our Clinical Trials for EU Submissions: EU-CTR Synopsis Case Study
Marie Kromplewski, RN, MSN, Associate Director, Clinical Capabilities Manager, Clinical Center of Excellence, Bristol Myers Squibb Co.
In this session, BMS shares the innovation of creating a BOT to support clinical trial submissions to the EU Clinical Trial Regulation (EU-CTR). EU-CTR Regulations now requires submissions to include a synopsis and recommend the synopsis be understandable to a layperson. A BOT was developed to create the synopsis from the protocol and with AI technology, it converts the language to the required laymans terms. This is time saving technology to produce a document to support EUCTR submissions.
Dynamic Trial Monitoring for Ongoing Clinical Trials
Tai Xie, Founder & CEO, CIMS Global
Effective trial monitoring is essential for participant safety, data integrity, and regulatory compliance, yet existing tools fall short in meeting these demands. Dynamic Trial Monitoring (DTM) offers a real-time, integrated approach to trial oversight, enhancing efficiency and decision-making. This presentation will highlight DTM's principles and case studies, showcasing its ability to predict enrollment trends, detect safety signals, and enable agile, high-quality trial management.
Using Predictive AI To Optimize Recruitment Content for Diverse Audiences
Data-driven insights are transforming clinical trial recruitment. This presentation explores how predictive AI streamlines content creation by analyzing pre-publication messaging and visuals against historical benchmarks, ensuring resonance with target audiences and eliminating the need for A/B testing. We’ll demonstrate how our proprietary platform leverages AI to predict content performance across demographics, leading to optimized messaging, increased efficiency and better recruitment outcomes.
Digital Health Technology Data Integrity: Mitigating Data Loss and Poor Data Quality to Ensure Actionable ROI
Dudley Tabakin, CEO, Founder, VivoSense
This presentation addresses the critical issue of data integrity in digital health technologies and wearable sensors, focusing on mitigating data loss, inconsistencies, and poor data quality. These issues can undermine decision-making, thereby reinforcing stereotypes that "we are not there yet" in utilizing wearable sensor derived data in clinical validation. Strategies such as robust error detection, sensor wear compliance, data validation, artifact detection, and improved system integration are explored to ensure reliable, high-quality data. By partnering with external end-to-end solutions, sponsors can maximize actionable insights, improve patient outcomes, and drive a higher ROI.
Evaluating Generative AI in Regulated Environments: A Statistical Rigorous Framework for Regulatory Compliance and Safety
The need for rigorous statistical evaluation of generative AI in clinical trial settings is paramount to ensure regulatory compliance and patient safety. This talk explores a framework for assessing whether AI-generated contents, produced by large language models like GPT-4, are non-inferior to human-generated contents across key dimensions such as accuracy, clarity, consistency, and reasoning. The insights gained from this evaluation will be crucial in shaping the future integration of generative AI in regulated environments, potentially transforming how we approach clinical trials and drug development.
Ethical Consideration for AI Applications in Clinical Trials
Dominic De Bellis, PhD, Executive Director, AI Strategy & Operations Lead; Global Clinical Trial Operations, Medical Writing & Disclosure, Merck & Co., Inc.
This panel will provide an introduction to the concept of AI ethics and its significance and application to the pharmaceutical industry. Industry experts will discuss the progression of AI in the pharmaceutical industry and its impact on various operations, including drug discovery, trial management, customer care, etc, as well as the ethical considerations in using AI for drug discovery. Considerations include biases in AI algorithms, patient privacy concerns, and quality control. Ethical issues around data handling, privacy, and security also must be taken into account. Finally, panelists will discuss the importance of AI systems in complying with local and international regulations and standards and provide actionable insights.
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
◆
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
◆
Developing and Executing Effective Diversity Plans
効果的な多様性計画の策定と実行
◆
Enrollment Planning and Patient Recruitment
登録計画・被験者募集
◆
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
◆
Clinical Trial Forecasting, Budgeting and Contracting
臨床試験の予測・予算編成・契約
◆
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
◆
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
◆
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
◆
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
