SCOPEによる第14回「分散型・ハイブリッド」ストリームでは、臨床イノベーションのリーダーが集まり、分散型試験・ハイブリッド試験のベストプラクティスや成功戦略について議論します。業界のリーダーが、分散型試験・ハイブリッド試験の現状と将来、革新的な研究戦略についての見識を共有します。新規のDCTアプローチ、ハイブリッドアプローチによる施設と患者の負担の軽減、試験へのアクセスの拡大、試験実施の近代化にフォーカスします。ストリームには2つの固有のパートが含まれ、臨床研究のニーズの進化に合わせて、試験の近代化を可能にすることに焦点を当てています。
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: Decentralized and Hybrid Trials
パート1：分散型試験・ハイブリッド試験
BUILDING THE FOUNDATION FOR DECENTRALIZED AND HYBRID TRIALS
分散型試験・ハイブリッド試験の基盤の構築
Accelerating Drug Development through Clinical Trial Delivery Innovation
Kim O'Day, Senior Director, Emerging Technology Operations, Clinical Trial Foundations, Eli Lilly & Co.
Participants will identify key learnings from the use of innovative research methods used to execute clinical trials in Patient Engagement and Decreased Patient/Investigator Burden. Attendees will hear specific examples of where innovative strategies were successful and understand future applications for clinical trial innovation.
Statistical Considerations for Effective Decentralized Clinical Trials
Charmaine Demanuele, PhD, Executive Director, Head, Quantitative Sciences for Digital Sciences & Translational Imaging, Pfizer Inc.
Decentralized Clinical Trials (DCTs) offer a patient-centered approach to engage with participants in the convenience of their homes or communities, utilizing digital health technologies (DHTs) and innovative data collection methods. DCTs provide patients with greater flexibility, reduce the need for frequent study visits, lower costs, facilitate recruitment of diverse patient populations, and potentially improve participant compliance. This presentation aims to highlight key statistical considerations involved in the design and implementation of DCTs, including selecting appropriate data types and DHTs for remote data collection, assessing data quality and completeness, determining relevant endpoints, estimating data heterogeneity, and handling missing data. We will also outline suggestions and valuable insights gained from previous DCT studies to effectively address these challenges
From Concept to Reality: Innovation and Use Cases in Trials with Decentralized Approaches
Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, CEO, 4Biosolutions Consulting (Sci/Clin/Reg Affairs) & Co-Chair, EEE-SA, Clinical Trial Technology Modernization Network (CTTMN)
This presentation provides key information and explores innovations in DCTs, highlighting their impact on revolutionizing medical product development globally. We’ll examine technologies and trends supporting DCTs, including regional adaptations. Two trials will showcase real-world applications, logistical outcomes, challenges, and metrics impacting trial efficiency and data quality. Join us to discover how DCTs transform patient-centric clinical research and shape the future of healthcare innovation.
Novel DCT Approaches for Public Health Emergency Preparedness: BARDA’s D-COHRe Program
Gina Conenello, PhD, Interdisciplinary Scientist, DRIVe & BARDA, US Department of Health & Human Services
The Biomedical Advanced Research and Development Authority (BARDA) within the ASPR at HHS has recently launched the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program. Strategic partnerships have been established with clinical research organizations that have access to healthcare sites to create an opportunity for clinical research directly where patients seek care and where medical products are utilized in real world environments. D-COHRe intends to address the challenges in DCTs in order to create a sustainable business model beyond BARDA support.
Being Pragmatic About Pragmatic Trials
The growing interest around Pragmatic Clinical Trials (PCTs) is about more than assessing interventions within routine clinical settings. It also reflects an appetite for greater pragmatism in our clinical technologies and processes. Hear from an executive panel of data management leaders discussing strategies for modernizing their clinical data infrastructures and the pragmatic enhancements they are pursuing around patient and site data strategies, rolling data locks, eCOA delivery, and more.
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!
DCTs IN ONCOLOGY
オンコロジーにおけるDCT
Double Jeopardy! When Oncology DCTs Are Not the Answer, Are We Asking the Right Question?
Peter O'Neill, Vice President, Clinical Operations, TuHURA Biosciences
In the game show Jeopardy, contestants are given the answer first and must determine the right question. In the world of oncology clinical trials, decentralized clinical trials (DCTs) are often presented as the answer, but are we sure we’re asking the right questions? This session will explore the limitations of DCTs in oncology and delve into how emerging innovations like digital twins may provide the missing answers that DCTs cannot. By rethinking our approach, can we finally align the right questions with the right tools?
Using Innovation and Hybrid Approaches in Oncology to Lessen Site and Patient Burden
Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.
How can you improve the quality of your tools/toolbox for oncology patients? What tools are most used for oncology studies/what makes sense for oncology studies? How can we prepare for the future? The way in which we engage with today’s patients will not be the way in which we engage with tomorrow’s patient; how can we set ourselves up for success for that transition?
Exploring eClinical Innovations: Enhancing the Patient Journey and Driving Clinical Trial Efficiency
Andres Escallon, Vice President, eCOA Solutions Strategy, Suvoda
Explore practical technology innovations that ease the clinical trial patient journey and advance health outcomes.
Learn what drives successful technology uptake among sponsors, sites, and patients.
Discover how patient feedback shapes technology solutions for a smoother trial experience.
Explore AI-driven eClinical technologies to enhance trial efficiency and simplify patient interactions, from Consent to reimbursement.
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
DCT ELEMENTS TO IMPROVE DIVERSITY
多様性を向上させる DCT 要素
Representation in Recruitment at Retail Pharmacy
Jim Carroll, Head, Real World Evidence & Clinical Trials, Walgreens
With the recent OIG report and latest FDA guidance on Diversity Action Plans, there is a heightened awareness around improving representation in clinical research. Walgreens will share recent case studies and success stories demonstrating the value of including a retail pharmacy-based approach in your recruitment plan.
Decentralized Clinical Trial Elements to Improve Participant Access and Representation
Marjorie Zettler, PhD, MPH, Consultant, Clinical Sciences, Conjugate Group
The potential for decentralized or hybrid clinical trials to mitigate disparities has received much attention, but are DCTs/hybrid trial populations actually more representative than those of traditional site-based trials? With increased emphasis on diversity in registrational clinical trials, can the use of DCT elements serve as one strategy to effect change? This panel discussion will explore opportunities and challenges in deploying DCT solutions to promote more representative clinical trials.
How Medable is Making the Design, Configuration and Launch of Studies Easier, More Efficient, and with Better Outcomes
Andrew Mackinnon, Senior Vice President & Executive General Manager, Customer Value, Medable, Inc.
Medable Studio is a fully featured SaaS suite of study design, configuration, translation and launch tools that enables easy and efficient study builds. In this presentation Medable, with a partner from a key customer, will talk about design best practice, how Studio has enabled faster study launch, and the adherence and satisfaction outcomes that have been observed in live studies.
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
SITE AS THE KEY STAKEHOLDER IN DCTs
DCTにおける主要ステークホルダーとしての施設
Decreasing Site Burden to Adopt DCT Methods
Please join us for a talk that will discuss ongoing efforts to address site needs and reduce barriers to Decentralized Clinical Trial methods (DCT) adoption. Topics may include "bring your own tech" strategies for sites, clarifying roles in DCT implementation at sites, and embedding site input on including DCT methods in trials.
The Triple Lens and Dual Roles of Decentralized Trials: Insights from Patients, Providers, and Researchers
Faith Holmes, CMO, Medical Affairs, Elligo Health Research
We will approach the efficiencies and agility of decentralized trial models from the perspective of the patient/study participant, the medical provider/principal investigator, and the CRO/sponsor. Using a central core team as a single point of contact for contracts, budgets, regulatory, and managing the participant journey throughout the study with fit-for-purpose technology and processes.
Decreasing Site Burden to Adopt DCT Methods
Jane Myles, Co-Lead, Priority Initiative 3B, DCT Playbook, Decentralized Trials & Research Alliance (DTRA)
Please join us for a panel discussion focused on the ongoing efforts to address site needs and reduce barriers to Decentralized Clinical Trial methods (DCT) adoption. Expert panelists and the audience will discuss relevant perspectives on how partnering with sites can help to enable fit-for-purpose clinical trials for the patient, sponsor, site, and ecosystem stakeholders.
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: DCTs and Clinical Innovation
パート2：DCT・臨床イノベーション
PLANNING AHEAD; INTEGRATING HEALTHCARE SETTINGS IN CLINICAL TRIALS
臨床試験における医療環境の統合
Chairperson's RemarksIncorporation of Decentralized Clinical Trial Components in Early Clinical Trial Planning
Jessica Marer, Director, Global Clinical Operations, Trial Optimization and Planning, Teva Pharmaceutical Industries Ltd.
Attendees will be presented a key element in the incorporation of decentralized components: the planning. Attendees will hear how developing a 3-step strategy (explore, evaluate, and implement) may drive successful implementation of decentralized components into clinical trials.
Recognizing, Classifying, and Mitigating Patient and Site Burden Induced by Digital Health Technologies in Clinical Trials
Krista Russell, Head Digital Health Solutions, Takeda Pharmaceuticals
Developing a strategy and implementation of modern Digital Health Technologies for collecting data in clinical trials presents vast opportunities for patients and discovery of data not previously available. However, new challenges are also introduced that present burden across the care continuum sponsor, clinical sites, and study participants. In this presentation, we pinpoint various root causes of DHT-induced burden and suggest strategies to ensuring an optimal experience for stakeholders involved.
Simpler, Faster Trials Using Patient-Centric Solutions for Blood-Based Data Collection
Transforming Recruitment: Harnessing Community Research Sites to Engage Rare CKD Populations
Jack Evans, Vice President, Site Operations, EmVenio Research
This presentation will explore the use of community-based research sites to recruit rare participants for Chronic Kidney Disease (CKD) studies, with a focus on those with the APOL-1 genotype. We will delve into the strategic selection of site locations and the critical role of community engagement in fostering trust and participation. By leveraging diverse site placements, we will demonstrate how we have effectively connected with underrepresented populations, expanding access to clinical trials and enhancing recruitment for precision medicine.
Access for All: How HCPs Are the Key to Changing Clinical Trial Participation
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
This panel will explore engaging healthcare professionals (HCPs) in clinical research, featuring HCPs and representatives from community care organizations (CCOs). Discussion will focus on HCPs' interest in participating, the roles they might perform, and the barriers to their involvement. Panelists will share insights on strategies to facilitate HCP participation in research, aiming to enhance collaboration and improve clinical trial recruitment and diversity.
Decentralized Clinical Trials from the World-Saving Idea to the Inevitable Reality
Istvan Attila Kerekes, PharmD, Senior Clinical Project Manager, Global Medical Division, Global Clinical Operations, Gedeon Richter Plc
This presentation will give an overview and describe the planned and unexpected obstacles experienced during a Phase 2 exploratory clinical study that implemented a hybrid study design including telehealth visits, home visits, and electronic patient outcome measurements. The presentation would detail the reason for implementing such hybrid approach and show solutions for risk mitigation and actions taken to resolve arising issues during the study.
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
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Sunday Golf, Kick-Off Keynote & Participant Engagement Award
月曜のゴルフ、キックオフ基調講演、参加者エンゲージメント賞
◆SCOPE’s Kickoff Reception
SCOPEによるキックオフレセプション
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Patient Voice in Trial Design and Protocol Development
試験デザインとプロトコル開発における患者の声
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Developing and Executing Effective Diversity Plans
効果的な多様性計画の策定と実行
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Enrollment Planning and Patient Recruitment
登録計画・被験者募集
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Patient Engagement and Retention through Communities and Technology
コミュニティ・技術による被験者エンゲージメントとリテンション
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Clinical Trial Forecasting, Budgeting and Contracting
臨床試験の予測・予算編成・契約
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Resource Management and Capacity Planning for Clinical Trials
臨床試験のリソース管理・キャパシティプランニング
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Mastering an Outsourcing Strategy
アウトソーシング戦略のマスター
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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
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Data Technology for End-to-End Clinical Supply Management
E2Eの臨床サプライ管理向けデータ技術
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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
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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
