初開催の「臨床試験向けAI」ストリームのプログラムでは、臨床試験におけるAIとGenAIの実用的なアプリケーションと戦略的統合について取り上げます。全体的なアプローチを強調するこのプログラムでは、AIと機械学習が患者の特定から試験のタイムラインの最適化まで、効率化を高める方法を探りながら、これらの進歩に伴う倫理的な考慮事項に対処します。専門家主導のプレゼンテーションやパネルディスカッションを通じて、出席者はAI導入の課題を克服し、これらのテクノロジーを活用して臨床業務を強化し、測定可能な成果を達成する方法についての見識を得ます。この会議は、臨床研究の専門家がAIの複雑さを乗り越え、業界全体で効果的かつ責任ある実装を確実に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: Generative AI in Clinical Research
パート1：臨床研究における生成AI
GenAI IN CLINICAL TRIALS: SEPARATING CHAFF FROM GRAINS
臨床試験におけるGenAI：選別
Scalable AI-Powered Approaches
This talk explores scalable AI-powered approaches that enhance efficiency and innovation across various sectors. It examines cutting-edge technologies, methodologies, and frameworks that facilitate the seamless integration of AI solutions within existing infrastructures. Attendees will gain insights into overcoming challenges related to scalability, data management, and resource allocation, ultimately empowering organizations to harness AI's full potential for transformative impact.
Challenges in Reaching the Desired Altitude for GenAI Applications in Clinical Trials
Brian Martin, Chief AI Product Owner, BTS; Head of AI, R&D Information Research; Senior Research Fellow, AbbVie, Inc.
The desire to scale the impact of GenAI in applications for clinical trials comes with lofty ambitions and significant anticipated impact. Reaching the altitude necessary to deliver that impact means navigating many different kinds of turbulence on the way to 30,000 feet. Let's talk about how to anticipate and potentially avoid some of those challenges - the pilot has illuminated the seatbelt sign, please buckle up.
A 30,000ft View of AI Applications in Clinical Trials
Samar Noor, Vice President, Head of Statistical Programming, Global Biometric Sciences, Bristol Myers Squibb Co.
This talk addresses the impact of generative AI in clinical trials, highlighting its ability to optimize trial designs, enhance patient recruitment, and improve data analysis. By utilizing AI-driven simulations, researchers can predict outcomes and streamline processes, ultimately increasing efficiency and accuracy in clinical research. The session will also explore the ethical considerations surrounding the integration of AI technologies in this critical field.
Implementing Gen AI in Clinical Research
Janie Hansen, Business Systems Transformation, Global Development Information Management, Daiichi Sankyo Inc
Successfully bringing Generative AI from concept to reality in clinical research requires a shift from traditional system implementation approaches. Common challenges, including limited understanding, concerns about job security, insufficient training, and unclear perceived benefits, often result in resistance to change. To drive successful adoption, these barriers must be addressed proactively-starting with a compelling business case, followed by effective change management strategies, and culminating in a focus on delivering measurable ROI.
GenAI: Pioneering the Next Era of Clinical Content GenerationDiscover the journey of biopharma executives as they integrate GenAI into clinical content generation, from initial stages to practical application. Gain insights into their starting points, challenges faced, lessons learned, and the benefits realized from utilizing this technology.
Harnessing Generative AI for Clinical Protocol Authoring
Clinical development is complex and increasingly costly. Recent advances in generative AI promise to reduce the time and cost of clinical trials through automation and data-driven insights. However, challenges remain, and the cost of failure is high. In this presentation, Patrick Leung (CTO) and Vivian DeWoskin (CSO) of Faro Health Inc. will discuss how Faro leverages its expertise in clinical science and AI to create solutions that advance clinical development tools and technology.
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!
CASE STUDIES OF AI-POWERED DOCUMENT AUTOMATION
AI 活用のドキュメント自動化のケーススタディ
Chairperson's RemarksProject GAIA: Structured Content Authoring Using a Generative AI Assistant
Mark F. Ciaccio, PhD, Senior Biology Data Scientist, Platform Informatics & Knowledge Management, AbbVie, Inc.
Bryan Feldman, Senior Director, Business Technology for Clinical Development, Regulatory Affairs, and R&D QA, AbbVie
Rapid progress in genAI has enabled advanced structured content authoring of diverse clinical, regulatory, & safety documents. We created an enterprise-wide web application called Project GAIA to autogenerate whole documents such as the Clinical Study Report, Informed Consent Form, and Product Safety Update Report using an extensible content template. The GAIA application can create whole documents in minutes by synthesizing and adding each section according to the template including AI-generated text, tables, images, and diagrams.
Transforming Regulatory Document Authoring: The Promise of Human-Led Generative AI
Rogier Landman, PhD, Associate Director, Digital Medicine Data Science, Pfizer Inc.
The presentation will explore how Generative AI is revolutionizing the entire spectrum of regulatory document authoring, from protocols to clinical study reports, promoting standardization, ensuring compliance, and maximizing efficiency. It will highlight the paradigm shift in how these critical regulatory documents are drafted, emphasizing the transformative impact of Gen AI on the pharmaceutical industry. While showcasing how Gen AI accelerates the process, the presentation will also stress the essential role of human oversight in maintaining accuracy and regulatory standards, advocating for a collaborative "human-led" Generative AI approach that delivers the best outcomes.
Accelerate Clinical Content Generation and QC with GenAI and Knowledge Graphs
Jenny Wei, PhD, Senior Director, R&D Informatics and Technology, Kite Pharma
Clinical trial documents authoring and quality control is still riddled with inefficiency due to the time-consuming, expensive, and manual way of working. AI has the potential to transform this space. At SCOPE, we will share our experience in automating content generation (CSR, IB, ICF, protocol, etc.) and document review (through evidence lineage tracking) with integrated NLG, genAI, and knowledge graph technologies.
Navigating AI for Clinical Trials: Simplifying the Path to Insights
Clinical trials are becoming increasingly complex, with more data points, forms, and rules to manage. As biomarkers emerge as key endpoints, the volume of data to clean, monitor, and analyze grows exponentially. These processes are not just time-consuming-they're costly and critical to a trial’s success. Continually, sponsors and CROs are faced with the challenge of how to balance the surge in data while maintaining speed, quality and compliance Join Medrio CTO, Mike Stocks, and CEO, Nicole Latimer, as they explore how Medrio is integrating AI into the clinical trial process to streamline and accelerate data management. Learn practical applications for balancing machine learning and automation with human oversight, enabling more efficient workflows and reducing the burden on study teams.
Lessons Learned on Realizing GenAI/LLM Values for Clinical Document Automation
Clinical document drafting is manual, time-consuming, and process-heavy. To address this business problem, our cross-functional teams have developed an "Autodrafter" using GenAI/LLMs to streamline and innovate the clinical document drafting workflow. In our presentation, we will share lessons learned on the pilot design and measuring impact to demonstrate the quantifiable benefits of GenAI in clinical operations. We will also discuss the progress of scaling the GenAI pilot for broader business use. Join us to learn about the transformative potential of GenAI in clinical document drafting.
Mythbusters: Uncovering the Real and Right Now with GenAI in Clinical Trials
Matt Becker, Advisory Life Sciences Industry Consultant, Life Science Industry R&D, SAS Institute, Inc.
There’s a lot of hype around generative AI in life sciences, but what’s the real application? How does your platform stack up to support this technology? Using data and AI as the foundation, and GxP guardrails as the navigating guide, both sponsors and CROs can advance drug development with cutting-edge technologies-but only if the myths are busted, and the real, applicable uses of GenAI are tapped into. Join this session to grasp a real, right now understanding of GenAI in clinical 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
IMPLEMENTING AI IN CLINICAL TRIALS: WHAT ARE THE KEY CONSIDERATIONS?
臨床試験にAIを導入：主要な考慮事項は？
A Multi-Company Study Examining the Adoption and Use of AI
Mary Jo Lamberti, PhD, Director and Research Associate Professor, Tufts Center for the Study of Drug Development (CSDD)
This talk will review where sponsors and CROs are deploying AI (artificial intelligence) and ML (machine learning) in clinical development based on a collaborative industry study; examine pharma investment levels in use of AI/ML in clinical research; and gather insights on the challenges of implementing AI/ML.
Overcoming Challenges and Managing Costs in Industrializing Generative AI
Srivatsan Nagaraja, Founder, Vidya Seva
The adoption of Generative AI into clinical trials offers transformative potential, enhancing efficiency, accuracy, and innovation. However, scaling Generative AI involves addressing significant challenges and managing costs effectively. This session will delve into these issues, providing practical solutions and insights through expert discussions and practical case studies. Join us for this in-depth session to discover how to effectively industrialize Generative AI in clinical trials to drive innovation and efficiency in bringing new drugs to market.
AI in Clinical Trials-Case Studies & Lessons From Real Implementations, Featuring a Fireside Chat with Eli Lilly
This session explores AI's transformative role in clinical trials, using a case study driven approach to highlight real-world use cases and lessons learned from successful implementations. It also features a Fireside Chat with Clinical AI leaders from Eli Lilly, sharing insights on how they are harnessing AI to create digital FTE capacity in clinical development. Additionally, the session will cover top AI use cases driving success in clinical trials, best practices for implementing AI in clinical operations, and key lessons learned and potential risks to navigate. Don't miss this unique opportunity to hear directly from industry leaders and gain insights into the future of clinical trials with AI.
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
AI TO IMPROVE TRIAL EFFICIANCY AND OPTIMIZE PROTOCOL DESIGN
試験の効率を改善し、プロトコルデザインを最適化するAI
Gaining 70% Efficiencies by Using AI in Clinical Study Data Conformance
Daniel Bachalis, MS, MBA, Senior Director, Engineering & Operations, Drug Development IT, Data, and Analytics, Bristol Myers Squibb Co.
Pharma companies typically conduct exploratory analytics on legacy clinical studies (or trial data) to uncover insights that could inform current and future trial phases. Combining legacy studies is a process prone to friction-not only due to the sheer complexity of clinical data, but also because legacy studies come in disparate formats and can differ dramatically across therapeutic areas and study phases. With the use of AI, we developed a platform that has substantially reduced the time to conform, improved quality of data, and reduced the need for subject matter expertise.
CATALYST Trial Timeline Planning-Enhancing Predictions with Advanced Machine Learning and Large Language Models
Sheng Zhong, PhD, Director of Statistics, Data and Statistical Sciences, AbbVie, Inc.
Accurate prediction of trial enrollment timelines at the portfolio-planning stage is essential to strategic planning and the efficient allocation of resources for pharmaceutical sponsors. Traditional methods rely heavily on structured datasets and manual data curation, often resulting in suboptimal outcomes. This presentation introduces an enhanced approach that leverages advanced machine learning (ML) algorithms and large language models (LLMs) to accurately forecast trial enrollment timelines.
Data Driven Evaluation of Clinical Trial Inclusion and Exclusion Criteria to Optimize Study Design
Brandon Rufino, Computational Science Manager, Sanofi
Clinical trials are key to drug development and a costly component to our business. 55% of terminated clinical trials fail due to slow recruitment. We hypothesize that this is, in part, due to restrictive and perhaps poorly justified inclusion/exclusion criteria. To combat this issue, we developed simulation techniques to evaluate inclusion/exclusion criteria and propose a set of criteria such that we maximize the size of the potential patient population whilst retaining a high probability of success.
The Use of Digitalization and AI in Automating a Specimen Management Process
Bristol Myers Squibb and Nurocor will share the real world experience of executing a digitalization strategy for clinical development incorporating a digital protocol. Stories from the trenches will highlight the challenges and successes in executing a strategy and the results and benefits of a digital protocol and digital specimen management process. GenAI then unlocks the potential for automating other clinical operations processes like contracting.
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: AI for Trial Optimization
パート2：試験の最適化向け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
