SCOPEによる第8回年次「デジタルヘルス技術」ストリームでは、センサーやウェアラブルを使用した臨床試験のケーススタディを取り上げます。臨床試験にデジタルバイオマーカーやエンドポイントを導入するために必要な、今後のステップについても話し合います。検討されるトピックは、ウェアラブルのアナリティクスな妥当性と臨床評価、デジタルバイオマーカーのデータ統合、デジタル指標のE2Eの過程、DHTの採用と有用性の促進です。この会議は、専門家がDHTを紹介する機会を提供し、DHTの将来像に関する議論を後押しします。
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 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: Digital Biomarkers and End Point in Clinical Trials
パート1：臨床試験におけるデジタルバイオマーカーとエンドポイント
HARNESSING DIGITAL BIOMARKERS
デジタルバイオマーカーの活用
Chairperson's RemarksHarnessing Digital Biomarkers and Data Science: Paving the Way for Accelerated Drug Development in Parkinson’s Disease
Digital biomarkers have the potential to track Parkinson’s Disease (PD) progression with increased objectivity, sensitivity, and reduced variability compared to standard clinical scales. We discuss considerations in the development of PD progression digital biomarkers and present a machine learning-based framework for developing composite digital measures. We apply this framework to longitudinal PD study data and demonstrate the potential for digital biomarkers to enable smaller PoC trials and accelerated drug development.
Variability in Human Signal Device Readings: An Analysis of Contributing Factors and Experimental Design
Karthik Nakkeeran, Senior Data Scientist, Lingo, Abbott Labs
This study explores variability in human signal device readings due to factors such as sensor placement, tissue composition differences, calibration errors, and external interferences. By fitting subjects with devices from different manufacturers and collecting data over 14 days, the research analyzes significant differences in readings using parametric and non-parametric tests. The findings, illustrated with simulated data, highlight broader applicability of these methods in synthetic data-generation and drug-simulation studies.
eCOA BYOD: Exploring the Pros and Cons
Melissa Sesi, MBA, Associate Director, R&D Sourcing & Procurement, Merck & Co., Inc.
Electronic Clinical Outcome Assessments (eCOA) bring significant advancements in clinical trials, and the Bring Your Own Device (BYOD) approach has gained traction in the industry. It is crucial to understand the potential benefits and challenges associated with eCOA BYOD to have a comprehensive understanding of its implications in clinical research.
An Overview of Pi Health
Bobby Reddy, Co-Founder & COO, Pi Health
Pi Health is a health technology and clinical research organization that is committed to transforming global access to innovative medicines and clinical trials starting with Oncology.
Pi Health has a unique software platform that connects sites and sponsors around the world enabling breakthrough efficiencies and cost savings for clinical trials.
Pi Health's mission is to drive innovation and enable access to patients around the globe equalizing access and opportunities for the highest quality of care and research.
The Missing Link: How Smart Design Unlocks Real-World Healthcare Data
Tom Rhoads, CEO, Spencer Health Solutions LLC
Join us for "Collecting Longitudinal Patient Survey Data Via an In-Home Smart Medication Dispenser: Analysis of Panel Persistency, Response Rates, and Psychometric Properties." This session will showcase how intuitive smart medication dispensers improve patient adherence and engagement, facilitating the collection of reliable, real-world healthcare data. We’ll explore how these innovations drive higher response rates, improve panel persistency, and ensure quality data, ultimately supporting better healthcare outcomes and empowering payers and providers with actionable insights.
1:05 pmPresentation to be Announced
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!
DIGITAL BIOMARKERS IN ONCOLOGY STUDIES
オンコロジー研究におけるデジタルバイオマーカー
Chairperson's RemarksDigital Health Technology (DHT)-Derived Physical Activity and Performance in Cancer Cachexia
Carrie A. Northcott, PhD, Head of Digital Sciences, Biomeasures, Endpoints and Study Technologies (BEST), Pfizer
Cachexia is prevalent across cancer types and results in weight loss, muscle wasting, reduced physical activity (PA), and increased mortality. DHTs provide passive, unbiased, patient-focused, and quantitative measures of continuous PA/function. We will share evidence on the importance of PA to patients, and what a meaningful change is in cancer patients with cachexia. Moreover, we will discuss the use of the DHT-derived PA measures to assess function and support clinical trials.
LLS Sponsored Use of a Medical-Grade Wearable into the Beat AML Master Trial-The Oncology Journey
Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS
LLS/BAML began a sub-study to evaluate shortening the treatment cycle from 28 to 14 days in a Phase 2 trial for AML patients aged 60 and above. The study compares a 28-day schedule (Arm A) with a 14-day schedule (Arm B) of Venetoclax and Azacitidine, focusing on complete remission rates (CRs) and incorporating a wearable medical device. This FDA-cleared device collects physiological data continuously for up to two cycles and is complemented by Patient-Reported Outcomes (PRO) assessments and daily fatigue questionnaires. The study seeks to determine if wearable data aligns with patient-reported outcomes in oncology.
BUSINESS CONSIDERATIONS FOR DIGITAL BIOMARKER IMPLEMENTATION
デジタルバイオマーカー導入に関するビジネス上の考慮事項
Digital Health Solutions & Digital Accessibility
Stephen Framil, Corporate Global Head Accessibility, Office of Corporate Accessibility, Merck & Co., Inc.
With the increase in demand for personalized patient therapies through digital health-solution apps, digital accessibility design standards for patients with disabilities can be critical to drug dosage, adherence, verification, and information. With the Web Content Accessibility Guidelines (WCAG) design standards for Information & Communication Technologies (ICT)-inclusive of digital health solutions and software as a medical device-explore the why, the what, and the how for digital accessibility.
Building the Business Case for Adopting Digital Endpoints in Clinical Trials
Rachel Chasse, Associate Director, Digital Science Strategy, AbbVie
FDA recently qualified the first digital endpoint for clinical trials, and recent research has shown that digital endpoints can reduce the timelines and cost of clinical trials. However, to date, decision-makers have not had the clear value assessments, routine use cases, and efficient deployment strategies needed to confidently deploy digital endpoints at scale. In this session, collaborators from the Digital Medicine Society (DiMe)'s Building the Business Case for Digital Endpoints team will unveil new insights and project resources designed to shed light on the full return on investment of digital endpoints and to drive adoption in high-quality, fit-for-purpose digital measures as endpoints in clinical research.
Discussion points:
- Learn about DiMe’s value framework for including digital endpoints in clinical research, including when and how digital endpoints can show true value during medicinal product development
- Understand how to measure and evaluate the return on investment generated by digital endpoints
- Cultivate expertise towards making informed decisions and sustain investment in integrating digital endpoints into successful digital health strategies
Practical Innovations with AI and Automation
Sanjiv Waghmare, Chief Product Officer, Signant Health
The clinical research landscape is evolving rapidly, driven by demands for faster, more efficient trials. This presentation explores how automation and AI are transforming the clinical technology stack, and ultimately transforming clinical trial operations through enhanced efficiency without sacrificing data quality. Join us to discover how these technologies are shaping the future of clinical research and accelerating treatment development.
Talk Title to be Announced5:55 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
CASE STUDIES
ケーススタディ
Chairperson's RemarksAnalytical Validity and Clinical Evaluation of the Moticon Insole System for Assessing Gait in Parkinson’s Disease
This study explores the clinical potential of digital insoles for continuous, real-world gait assessment in Parkinson's disease (PD) patients. We evaluated 21 PD patients using digital insoles and a reference system during ON and OFF levodopa states. Results showed excellent reliability for key gait parameters and sensitivity to medication effects. The technology offers potential for more frequent, objective assessments in clinical and home environments, aiming to improve personalized care strategies, enhance disease monitoring, and optimize treatment in PD.
Internal Development to Phase 1 Clinical Validation of Bend Ease, a Novel Digital Measure of Morning Stiffness in Axial Spondyloarthritis
Morning joint stiffness presents a problem for clinical measurement: By the time a patient presents in a rheumatology clinic for assessment, morning stiffness has subsided and mobility appears more "normal." To address this measurement problem, our cross-functional team initiated Project Bend Ease, involving internal development and Phase 1 clinical validation of a smartphone app for self-measurement of spinal mobility at home in axial spondyloarthritis patients.
Ready, Set, Localize: Smarter Strategies for Global Trials
Jonathan Norman, Director Localisation Services, Linguistic Validation & eCOA SME, YPrime
In an industry striving to innovate with AI and other new technologies, achieving operational efficiencies are a pressing need for clinical trial leaders. This session explores practical strategies to accelerate globalization of clinical trials and expand patient diversity through proven tools and methodologies.
Key Takeaways:
Global Trial Efficiencies: How leveraging pre-built libraries and modernized localization processes can cut startup timelines while maintaining quality and compliance.
Diversity through Language: The role of comprehensive language and cultural adaptation in reaching underrepresented populations and improving trial outcomes.
Simplifying AI: AI-driven efficiencies in clinical trial localization that are possible today without the controversy surrounding the creation of target language content.
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
CASE STUDIES (CONT.)
ケーススタディ（つづき）
11:20 amChairperson's Remarks (Sponsorship Opportunity Available)
Accelerating Innovation in Sleep Measurement through Sibel’s Integrated Digital Health Platform
Shuai Steve Xu, Assistant Professor of Dermatology & Medical Director, Querrey Simpson Institute for Bioelectronics, Northwestern Memorial Hospital
Reliable and user-friendly sleep measurement is essential for assessing patients' quality of life in various clinical indications. Polysomnography (PSG), while offering detailed data, is impractical for many clinical trials, especially when longitudinal monitoring is needed. Wrist-based actigraphy provides a convenient alternative but often lacks accuracy. This presentation highlights the collaboration between AbbVie and Sibel Health to develop and validate innovative adhesive sensor technology, offering PSG-like accuracy without complexity. The discussion will cover the technology’s validation, clinical applications, and its potential to transform sleep measurement, enhancing precision and expanding measurable metrics for improved patient care and clinical development.
Validating a DHT for Late-Stage Clinical Trials
David Morra, Senior Director, Regulatory Digital Health, Merck & Co., Inc.
Discover the intricacies of validating a late-stage clinical trial's primary endpoint in this captivating talk. This talk will showcase a real-world use case, exploring the FDA feedback that led to a Complete Response Letter, and share their experience in negotiating with global pharmaceutical and medical device health authorities to develop and execute a successful validation plan.
From Data to Discovery: AI-Powered Trials in the Digital Health Era
Noble Shore, Vice President Technology Strategy & Product Adoption, Customer Success, Emmes
Explore how AI and real-world data (RWD) are transforming clinical trials. Learn how sponsors can accelerate startup with tools like Generative AI for protocol authoring and leverage RWD to ease site burdens and unify trial data. See how AI-enabled data platforms streamline processes, improve data quality, and provide real-time insights. Discover a roadmap to modernize trials, reduce timelines, and deliver results faster in the digital health era.
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: Digital Measurements Implementation at Scale
パート2：大規模なデジタル測定の実装
PARTNERSHIPS AND PATIENT-FRIENDLY APPROACHES
パートナーシップと患者に優しいアプローチ
8:20 amChairperson's Remarks (Sponsorship Opportunity Available)
The Future of Regulatory Acceptance of Digital Measures Is Happening Now
Martha Azer, PharmD, Associate Director, Regulatory Policy NA, Johnson & Johnson
Digital measures can enhance drug development by potentially unlocking new ways of measuring efficacy and safety for medicinal products. The regulatory pathways for digital measures in R&D are emerging along with regulatory guidance on evidence generation of digital endpoints. To ensure the successful use of digital measures in R&D, these need to be further shaped to accelerate implementation of digital measures in R&D in drug development and health authority acceptance.
Driving DHT Adoption and Utility through Advocacy and Multi-Organizational Collaboration
Kai Langel, CEO, DEEP Measures
Digitally derived measures of health can help unlock a whole new perspective into human health, but developing them is a complex effort needing involvement from multiple stakeholders. This session brings together the entire journey and illustrates the key pitfalls and solutions through real-world examples shared by leaders from key pharmaceutical and technology companies.
Generative AI Empowered Medical Writing
Sharon Chen, Founder and CEO, AlphaLife Sciences
Generative AI is projected to bring $60-$110 billion in annual value to the pharmaceutical industry by driving efficiency, innovation, and competitive advantage. In clinical development, GenAI optimizes workflows, reduces costs, and accelerates timelines. AlphaLife Sciences’ AuroraPrime platform harnesses this potential, providing end-to-end automation in medical writing to improve quality, compliance, and efficiency in creating essential regulatory documents.
Unlocking New Frontiers in Alzheimer’s Disease Research through Digital Measures
Sarah Valentine, Partnerships Lead, Life Sciences, Digital Medicine Society (DiMe)
Imagine a world where the relentless progression of Alzheimer's disease and related dementias (ADRD) could be detected earlier, monitored more precisely, and treated more effectively-all through the power of digital health technologies. In this session, we will share some of the exciting findings from a recent DiMe pre-competitive collaboration, involving experts from academia, industry, clinical practice, and patient advocacy groups, to support leaders engaging in ADRD research to harness the power of digital innovation to accelerate scientific progress and improve outcomes for patients and caregivers impacted by ADRD.
Magnol.AI-Engineering Large Wearable Sensor Data towards Digital Measures
Andrew D. Kaczorek, Data Engineer, Eli Lilly & Co.
While many industry players promote the ability to ingest wearable sensor data, what matters more than that is how to uncover data insights and turn these data into intelligence. Come hear about one of the industry's best examples of what a sensor cloud should (and can) do to ensure dBM research is done efficiently and rigorously.
11:10 amNetworking Coffee Break
ADVANCING DIGITAL HEALTH AND CLINICAL TRIALS CONVERGENCE
デジタルヘルスと臨床試験の融合を推進
Applying Social Determinants of Health (SDoH) in Clinical Planning and Site Strategy
Daoying Hu, PhD, MBA, Director, Data Science and Digital Health, Johnson & Johnson Innovative Medicine
SDoH data can enhance our understanding of the barriers to participation in clinical trials and improve access for study participants. This presentation examines various types of SDoH data for site and patient strategies, and discusses how to effectively leverage these insights in clinical studies.
Achieving Flexibility and Expanding Access While Preserving Data Quality
Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative
Is trial flexibility truly a threat to data quality? Concerns are often raised that offering flexible approaches to clinical trial design and conduct, such as collecting data in various settings and offering a flexible schedule of visits, will result in risks to data quality. This session will explore multi-partner perceptions around when and how data quality is maintained when flexible approaches are introduced and how flexibility can improve access to clinical trials.
1:25 pmTransition to Lunch
LUNCHEON PRESENTATION: From Sync to Swim: Alimentiv’s Journey with Zelta ePRO
Amid growing responsibilities and expanding clinical operations, data managers are increasingly challenged by the increasing number of eClinical solutions required to support a clinical trial. Join us to learn how the data managers at Alimentiv have leveraged Zelta’s ePRO module to streamline their eClinical data collection scheme to include patient-reported outcomes with the rest of their study data, achieving more control over their clinical trials and confidence in their outcomes.
2:00 pmSCOPE Summit 2025 Adjourns
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
アジェンダ・講演者・スポンサー更新
2025年 プログラム
◆
Sunday Golf, Kick-Off Keynote & Participant Engagement Award
月曜のゴルフ、キックオフ基調講演、参加者エンゲージメント賞
◆SCOPE’s Kickoff Reception
SCOPEによるキックオフレセプション
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Patient Voice in Trial Design and Protocol Development
試験デザインとプロトコル開発における患者の声
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Developing and Executing Effective Diversity Plans
効果的な多様性計画の策定と実行
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Enrollment Planning and Patient Recruitment
登録計画・被験者募集
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Patient Engagement and Retention through Communities and Technology
コミュニティ・技術による被験者エンゲージメントとリテンション
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Clinical Trial Forecasting, Budgeting and Contracting
臨床試験の予測・予算編成・契約
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Resource Management and Capacity Planning for Clinical Trials
臨床試験のリソース管理・キャパシティプランニング
◆
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
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Modernizing Lab, Biomarker & Data Management Operations
ラボ・バイオマーカー・データ管理業務の近代化
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Biomarker & Biospecimen Technology & Innovation
バイオマーカー・バイオ試料の技術とイノベーション
◆
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
