被験者募集は、臨床研究における最大のボトルネックの1つです。登録目標を達成できないと、コストのかかる遅延が生じ、さらに重要なことに、新薬を必要とする患者の手に届けるまでの時間に影響を与えます。SCOPEの第16回年次「被験者募集・エンゲージメント」ストリームでは、グローバル試験に登録するための戦略、AI/MLとデータアナリティクスの活用による募集・リテンション・多様性の改善、事前に登録計画を改善するための戦術について詳しく説明します。「登録計画・被験者募集」会議では、グローバル試験に登録するためのベストプラクティス、募集を加速させるマルチチャネルアプローチ、患者集団の特定に対する新しいデータドリブンのプロセスを共有します。「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」会議では、多様な集団に関与する方法、支援団体と提携する機会、参加者のユーザーエクスペリエンスと潜在的な技術の負担を見失うことなく新しいテクノロジーを活用するためのベストプラクティスについて探ります。
2月3日 月曜日
6:30 amGolf Check-In & Breakfast Buffet (Sponsorship Opportunities Available)
8:00 amSCOPE's 4th Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)
Connect with your peers and colleagues at SCOPE's 4th Annual Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.
*Limited space available. Separate registration and fee required for golf.
9:00 amRegistration Open
12:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)
PRE-CONFERENCE WORKSHOPS: IN-PERSON ONLY
会議前ワークショップ：対面のみ
12:00 pm- 4:00 pm WORKSHOP: Innovation Day with IQVIA Technologies: Hear the vision. See the products. Join the journey.
INSTRUCTOR:
Ming Shen, Managing Director, Deloitte Consulting LLP
Clinical trial sponsors are invited to join digital product leaders and industry colleagues for an afternoon of discussions, demos, and networking. This interactive event has been carefully curated to help clinical trial professionals crack key challenges across the clinical trial lifecycle: from participant and site user journeys to data security and workflows. Pharmaceutical executives with various roles in clinical operations, innovation, technology, finance/budgeting, data analytics, strategic sourcing, trial managers, medical directors, or patient and site engagement will enjoy an industry panel, interactive roundtables, live demos with product experts, and more! Pre-registration is requested, and IQVIA reserves the right to decline requests that don’t fall within attendee guidelines above: For more details, please contact us.
1:00 pm- 1:45 pm WORKSHOP: Join and Explore ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace
Join this hands-on session with ClinEco, SCOPE’s B2B clinical trial community and marketplace featuring 850+ companies. ClinEco unites sponsors, CROs, service providers, and sites to streamline partnering, vendor research, innovation, and learning. At SCOPE 2024 we introduced the ClinEco Commons, a collaborative space where you can access, visit, and share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco Community. This year we launch our 'Ask a ClinEco Luminary' program where members can connect directly, and discreetly, with industry leaders and receive insights on a wide range of clinical trial topics. Join now at: clineco.io/register. Open to all SCOPE attendees.
1:00 pm- 2:30 pm WORKSHOP: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials
INSTRUCTORS:
Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)
Diana Steinbuesch, BioX Operations Portfolio Lead (Oncology), Roche
While developing leading and innovative therapies, we must not lose sight of the environmental impacts and greenhouse gas emissions. We can reduce the environmental impact of our studies by prioritizing remote visits and monitoring, by reducing kit wastage, and working together to find ‘greener’ solutions. This workshop will provide a brief overview of research and introductory strategies for reducing emissions as well as a 'Sustainability 101' to help anyone in our industry get started towards developing more environmentally responsible clinical trials. Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.
1:00 pm- 2:30 pm WORKSHOP: Efficient Importation of Biological Materials into the U.S.
INSTRUCTORS:
Jessica Hammes, Branch Chief, Biological Threat Exclusion, Agriculture Safeguarding and Risk Management, Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
Jennifer Merriman, Senior Manager, Strategic Biospecimen & Vendor Logistics, Consent, Biospecimens, & Imaging, Global Development Operations, Bristol Myers Squibb Co.
(Additional speakers to be announced.)
U.S. Customs and Border Protection and partner government agencies regulate the importation of biological materials into the United States. The efficient importation of these items can be challenging, as Clinical Trial landscape is ever-evolving. The purpose of this workshop is to discuss current challenges, best practices, and possible solutions to navigate this landscape.
1:00 pm- 2:30 pm WORKSHOP: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing
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 Fun Run! This is an informal event, and ALL abilities are welcome. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk-the goal is to get up and get moving! Details will be shared closer to the event...remember to pack your sneakers.
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: Enrollment Planning and Patient Recruitment
パート1：登録計画・被験者募集
PARTNERING TO ACCELERATE AND IMPROVE RECRUITMENT
募集の加速と改善に向けた提携
Early Patient Advocacy Group Engagement: Best Practices for Establishing Efficient Partnerships
Patricia Roselle, Global Head, Patient Stakeholder Engagement, Sanofi
Speed is often the determinant of whether patients will be able to inform the development program and/or clinical trial. Some industry partners hesitate to engage PAGs early in R&D, in part due to the perception of slowing study timelines and engagement cycles. The PALADIN Consortium shares Patient Advocacy Groups and Industry Partner insights on why collaboration is important and how to get partnerships up and running faster and more efficiently.
Innovative Partnerships: Enhancing SGM Inclusivity in Clinical Operations
Garo Kiledjian, Founder & CEO, SGM Alliance
Explore how SGM Alliance's strategic partnerships are transforming clinical operations. Learn how collaborations with industry leaders and advocacy groups are driving inclusive protocol development, improving data collection, and enhancing staff education. Discover actionable insights and successful case studies that highlight the impact of these alliances on advancing SGM participation in clinical research.
Patient, Community, Academia, and Industry Partnerships to Promote Clinical Trial Diversity
Edward J. Bentlyewski, Assistant Director, Clinical Research Nursing & Quality Assurance, Columbia University
Industry sponsors, patients, and communities all have an interest in diverse and equitable clinical trials. The Herbert Irving Comprehensive Cancer Center (HICCC) advances this with its Diversity, Equity, and Inclusion in Clinical Trials Symposium and training programs. These initiatives engage stakeholders, fostering collaboration and bridging gaps between sponsors, patients, and researchers. This presentation highlights how HICCC is driving more inclusive and representative clinical trials.
Talk Title to be Announced
Partnering with Sponsors and Investigators to Accelerate Patient Recruitment and Enhance Retention and Compliance
Mike Andino, Senior Director, Patient Recruitment & Retention, ICON
This session will explore site engagement methodologies, patient optionality and navigating the complex landscape between strategic alignment and operational practicality. This includes the importance of early engagement, the patient voice, diversity, site support and endpoint protection. We’ll also discuss how to balance scale, precision, and impact to deliver content and support to the right person, at the right time, with the right frequency through the most appropriate channels.
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!
PATIENT CENTRICITY AND PATIENT SATISFACTION IN RECRUITMENT
募集における患者中心主義と患者満足度
Talk Title to be AnnouncedCompetitive Enrollment: Has This Strategy Run Its Course?
Agency + Digital + Database: Perfecting Patient Recruitment in Clinical Trials
Tobias Kruse, Managing Director Europe, Trials24 GmbH
When it comes to patient recruitment many choose an either-or strategy. They invest in custom collateral or they leverage digital marketing. However, when both strategies are combined with a powerful patient database, magic happens!
Join Dr. Tobias Kruse from SubjectWell and discover how to combine agency, digital, and database strategies, what are the characteristics of a powerful patient database, and how to accelerate global and local clinical studies.
Empowering Patients: New Sampling Technologies and Processes to Improve Recruitment and Retention
Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS
We will discuss the current landscape regarding blood biomarker data collection, with a focus on enabling convenient, less painful, and patient-centric small-volume sampling methods, including bloodless techniques. This approach aims to reduce the burden on patients, healthcare systems, and clinical trials. The speakers and panelists will review relevant protocols, logistics, and regulatory acceptance of these innovative methods. By harmonizing the efforts of various stakeholders and creating data-rich environments that support ongoing research and innovation, we can advance towards true patient-centricity, making healthcare more efficient and compassionate for patients and providers alike.
Dmitri Mikhailov, PhD, Director & Global Head, Biomarker Coordination, Novartis Institutes for BioMedical Research, Inc.
What if Patients Chose You? Rethinking Recruitment and Retention with Empathy and InnovationSpeaker to be Announced, Syneos Health
What if clinical trial recruitment and retention were no longer about convincing patients to participate, but about creating an experience so seamless, supportive, and personalized that they stay engaged from start to finish? Join us as we explore how human-centered technology flips the script - meeting patients where they are in their journey and making every step feel personal, empowering, and aligned with their needs. Explore how unified tech solutions simplify outreach, foster communication, and build trust, ensuring that patients feel supported at every stage. Learn how this patient-first approach drives enrollment, improves engagement, and transforms the patient journey into a more compassionate and connected experience.
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 #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
INNOVATIVE APPROACHES TO ENHANCE AND OPTIMIZE RECRUITMENT EFFORTS
募集活動を強化および最適化する革新的アプローチ
Empowering Partnerships: Collaborating with Patients and Advocacy Groups to Accelerate Clinical Research
Joan Chambers, Senior Consultant, Tufts Center for the Study of Drug Development
Industry stakeholders recognize the importance of leveraging and cultivating meaningful non-profit partnerships to enhance patient advocacy and accelerate the start-up of clinical trials. This session will discuss and provide insight into how to operationalize these partnerships, focusing on the tactical approaches to accelerating the start-up of clinical trials early on, working together, and maintaining the partnerships.
Monique Adams, PhD, MS, Executive Director, Global Head Diversity & Inclusion in Clinical Trials, Sanofi
Patient Remuneration: Results from a Review across IRB Types and Potential Impact on DEI and Recruitment
Tricha Shivas, Chief of Staff & Strategy, Foundation for Sarcoidosis Research
Industry presentations on DEI and patient recruitment have tended to focus on access to research and not other identified areas that drive participation-such as patient remuneration and time commitment. This presentation compiles data across multiple IRB types (central, community, academic) to explore similarities and differences in patient remuneration approach and potential impact to recruitment and DEI initiatives.
Talk Title to be Announced10:25 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
Bridging Barriers in Patient Recruitment
Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Co.
Walgreens is uniquely positioned to leverage access to patients and trust of communities to address gaps in evidence and relevance resulting from underrepresented groups in clinical trials. Bringing clinical trials into the community and engaging people where they’re comfortable provides structure for sustained education, which builds community capacity of knowledge and skills about clinical trials processes. Explore Walgreens Patient Advisory Board and learnings from community engagement approaches.
Why patients ignore your trials - and listen to consumer brandsMark Evans, Managing Director, Faze
Faze, part of one of the world’s largest communications group Havas who work with global brands including Adidas, KFC and Coca Cola and their record label manage artists including Taylor Swift.
Demonstrating case studies from the field in how applying consumer brand approaches can accelerate clinical trial recruitment, connecting authentically with patients, engaging and supporting them through to randomization.
LUNCHEON PRESENTATION: 12:55 pmSponsored Networking Luncheon
Once again, join us for lunch, courtesy of our generous sponsors.
1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall-Best of Show Winner Announced
SCOPE's Networking Coffee and Dessert Break is the perfect time to pick up a sweet treat, courtesy of our sponsors, and fuel up for the afternoon with a cup of coffee or soft drink. Visit our Game Card Sponsors to fill your Game Card with stickers and get in a little more networking time before afternoon sessions!
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WEDNESDAY AFTERNOON PLENARY SESSION:
水曜日午後のプレナリーセッション：
FOSTERING INNOVATION IN PHARMA R&D, LEVERAGING DIGITAL TOOLS WITHOUT LOSING YOUR MIND & UNLEASHING GenAI FOR TRIALS
製薬R&Dにおけるイノベーションの促進、デジタルツールの活用、試験向けGenAIの活用
Fostering Clinical Innovation in a Large Pharmaceutical Organization
April Lewis, Head, Innovative Health, Global Development, Johnson & Johnson Innovative Medicine
This presentation explores strategies for fostering innovation within a large pharmaceutical organization by focusing on four key areas: developing a clear mandate and compelling vision to guide innovation efforts; designing and engineering an infrastructure that supports creativity and collaboration; building a high-performance, diverse team empowered to drive innovation; and seeking opportunities for true patient-centricity and sponsor-agnostic innovation. By aligning these elements, the organization can create a sustainable innovation ecosystem that prioritizes patient outcomes and drives transformative breakthroughs in healthcare.
How Can Sponsors Leverage Increasing Technology Capabilities with Quality
Angela DeLuca, Associate Vice President, Global Study Operations, Amgen
Sponsors can leverage increasing technology capabilities to enhance quality by integrating advanced data analytics, AI, and automation into their drug development and manufacturing processes. These technologies enable real-time monitoring, predictive analytics, and streamlined workflows, ensuring higher precision and consistency in product quality. Additionally, digital tools facilitate better compliance with regulatory standards and more efficient management of clinical trials, ultimately accelerating time-to-market while maintaining rigorous quality standards.
3:25 pmChairperson's Introduction (Sponsorship Opportunity Available)
The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond
Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Johnson & Johnson
Gen AI, a groundbreaking approach that seamlessly merges artificial intelligence into our daily lives, holds immense potential for transforming the pharmaceutical and healthcare industries. This paradigm shift not only demands a thorough understanding of the ethical implications, potential biases, and social consequences of AI systems- it also requires a steadfast focus on creating tangible value that benefits individuals and society at-large. By harnessing advanced AI technologies, Gen AI can pave the way for unparalleled breakthroughs, elevating patient care, enabling personalized medicine, streamlining processes, and revolutionizing the way we approach healthcare as a whole. Join the debate on the real value-based use cases and explore the endless possibilities that Gen AI brings to the table.
4:00 pmBooth Crawl & Refreshment Break in the Exhibit Hall (Sponsorships Available) Last Chance for Exhibit Viewing
We know you're tired, we know the Exhibit Hall is huge, and we know you still have some booths to visit, some connections to make, some networking to do. SCOPE's Networking Booth Crawl is the time to do it! Crawl if you must, but be sure to visit our sponsored booths for some food, drinks, and enough energy to finish SCOPE strong! Our final Networking Exhibit Hall break is the final time to see the exhibits you haven't seen and meet the people you haven't yet met. The break ends with another amazing raffle prize, so be sure to get your Game Cards in and the lucky winner (must be present to win) could be you!
5:00 pmClose of Day
5:00 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)
The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.
Shuttles will run a continuous loop from 5:00pm-9:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.
2月6日 木曜日
7:15 amRegistration Open
BREAKFAST PRESENTATION
朝食プレゼンテーション
7:45 amSponsored Presentation (Opportunity Available)
8:15 amTransition to Sessions
Part 2: Patient Engagement and Retention through Communities and Technology
パート2：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
TOOLS AND PROCESSES TO REACH ENROLLMENT TARGETS & RETAIN PATIENTS VIA TRUST & TRANSPARENCY
信頼・透明性によって登録目標を達成、患者のリテンションを行うツールとプロセス
Enhancing Diversity in Clinical Trials through External Partnerships
Kemi Williams, Senior Director, Patient Science, AstraZeneca
Concerted engagement is necessary to increase equity, diversity, and inclusion, and address barriers to clinical trial recruitment & participation. AstraZeneca is deeply committed to promoting trial diversity and has established a repeatable and scalable strategy for collaborating with cross-sector external partners to improve trial diversity. This session aims to provide valuable insights into the challenges and opportunities that exist in trial diversity partnerships and, through a case study review, showcase our experience with the partnerships.
We Connect with Communities As Partners: Digital and On-the-Ground Strategies for Patient Support and Trial Diversity
Explore how Takeda leverages digital platforms and on-the-ground efforts to enhance our outreach to under-represented communities and how this mechanism can help measure engagement and potential impact. The WeConnectPatients.com portal has been instrumental in connecting patients with clinical trial educational resources and research opportunities. Delve into the various ways we are utilizing this tool to foster stronger community ties, improve patient recruitment, and promote diversity in clinical trials. We will also discuss our combined approach of digital engagement and direct community involvement, ensuring we reach communities effectively.
What Are You Missing in Recruitment and Enrollment?
Alyssa Vincze, Principal & Director, R&D, Milliman IntelliScript
Current (pre-)screening methods are slow and expensive, but did you know that they also miss critical information? IntelliScript’s studies show that ineligible participants are randomizing into trials in shocking numbers. Irix can fill the information gap and speed up enrollment by retrieving and interpreting health data on trial participants in a matter of seconds. Collect a HIPAA authorization to access our proprietary, nationwide data and make better, faster eligibility decisions.
How to Overcome Trial Planning & Recruitment Challenges
Lindsay Stahl, VP, Global Head of Patient Engagement & Recruitment, Citeline
Chiesi Farmaceutici is a multinational pharmaceutical company focused on the development of advanced treatments for respiratory, special care and rare disease patients. In 2023, Chiesi identified a gap in the digital footprint of its clinical research, which affected its efficient, timely recruitment of patients and ability to build strong relationships with trial stakeholders. This prompted Chiesi to closely examine its internal processes/procedures and seek the support of Citeline. The collaboration encompassed both technical and tactical support to drive enrollment and, ultimately, to raise awareness of its clinical research. Through this collaboration, Chiesi learned many valuable lessons along the way, which it will incorporate in the roll-out of its pivotal US-based asthma study on a new environmentally friendly inhaler in 2025 - and elaborate on in this insights-filled session.
A New Way Forward-Applying GenAI to Solve the Clinical Trial Recruitment Conundrum at Scale
Recognize upstream opportunities to engage larger groups of patients, patient advocacy groups (PAGs), healthcare professionals (HCPs), and clinical trial referral networks to significantly reduce timelines and achieve enrollment targets. Gain practical insights into how co-pilot approaches can address stakeholder challenges in the patient recruitment journey while maintaining a human-centered approach. Additionally, watch a live demo and explore real-world examples showcasing how referring physicians and sites benefit from and utilize these innovative technologies.
A Paradigm Shift in Personalizing the Clinical Trial Experience for Patients and Their Care Partners
Jean Stimola-Sposaro, Director, Global Clinical Trial Industry Collaborations, Global Drug Development & Global Development Operations, Bristol Myers Squibb Co.
Enabling options for timely and ethical return and management of health data generated during clinical trials to increase equity, inclusion, and access. What solutions can be used now to reduce burdens to implementation, what barriers remain, and why. Measuring the value of study participant experiences, stakeholder decision-making, and overall trust in the research enterprises, securing incentives that matter most to study participants and their care providers.
The Top 5 Most-Requested Resources Patients Ask for to Support Their Continued Participation: Considerations toward Creating Equitable, Engaging Clinical Trial Participation Experiences
Rachel Melloul, MPH, Project Manager, CISCRP
Enrolling and retaining patients in clinical trials remains a significant challenge, particularly among underrepresented groups such as Hispanic, Latino, Black, and African American populations. Our research highlights actionable strategies that sites and staff can implement to improve participation and retention. Key resources identified include: offering study visits closer to patients' homes, providing flexible scheduling, reimbursing out-of-pocket expenses, delivering regular study updates, and compensating patients for their time. In this talk, we will delve into these resources in more detail, offering examples of how clinical sites can integrate these solutions to enhance participant support and retention, especially for those from underrepresented communities, toward providing the support that patients find most impactful in improving their ability to stay enrolled throughout the trial.
Multichannel and Multidisciplinary Approach to Accelerating Patient Recruitment in Rare Disease Clinical Trials
Chris Cirillo, Senior Director, Clinical Operations, Chemomab Therapeutics
We will share the challenges and approaches used to accelerate recruitment in a Phase 2 clinical trial in a rare disease. We utilized a combination of multiple intentional, strategic efforts including direct-to-patient outreach, partnership with patient advocacy organizations, and concierge service to identify patients to move through the enrollment funnel. Through relationship building with investigators and coordinators, these tools were complementary to established site resources. We will also share the return of investment and impact that these efforts had on clinical development.
11:10 amNetworking Coffee Break
TRANSFORMATIVE SAMPLING TECHNOLOGIES TO REDUCE PATIENT BURDEN AND REACH BROADER POPULATIONS
患者の負担を軽減し、幅広い集団に届けるための変革的サンプリング技術
Incorporating Patient-Centric Sampling into Multicenter Clinical Trials: Output from the PCSIG Workshop
Jas Bajwa, Manager, Biosample Operations, Roche
The Patient Centric Sampling Interest Group PCSIG) is a not-for-profit organization that brings together a variety of interested parties who wish to develop and promote the use of patient centric sampling technologies for blood, plasma, urine and other human matrices to better facilitate the advancement of human healthcare and well-being. With this in mind PCSIG held a workshop bringing together individuals with various expertise and backgrounds, with a common passion for making patient-centric sampling a reality in decentralized clinical trials, and a vision of creating a roadmap to guide the industry to overcome associated challenges. The meeting was a great success and a roadmap was developed end to end from conception to delivery and this presentation will explore the findings. If you want to implement or build in the area of patient-centric sampling within your organization then this presentation is not to be missed and will provide valuable insights and rapidly advance your progress and learn from the experiences of many.
Learnings and Performance of a 50,000 Patient-Activated Community, Centered around Vaccine Clinical Trial Participation
Manuri Gunawardena, CEO, Executive, HealthMatch
HealthMatch & Velocity Clinical Research created a 50,000 patient activated vaccine community in 2024, months in advance of any specific study launch. The community was educated, nurtured and insights gathered to ultimately shape recruitment strategy and outcomes across multiple vaccine studies at the end of 2024. The speakers will share learnings from the project including performance around randomizations and patient education and discuss how this methodology can be applied successfully to other therapeutic areas
The Microsampling Journey: Enable Flexible Laboratory Collections to Make Trials More Accessible to Patients
Teri Wright, Director Clinical Lab Sciences & Devices Innovation, Clinical Trial Lab & Diagnostic Design, Eli Lilly and Company
Flexible blood sampling faces a significant challenge: identifying collection sites near patients with flexible hours that participate in clinical trials. An innovative solution involves using microsampling devices, allowing patients to collect blood samples at their preferred location. However, access to validated assays remains an obstacle. Today I will share our journey to implement microsampling.
1:25 pmTransition to Lunch
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
