対象となる患者集団にアクセスできる治験実施施設への需要が高まり、新しいテクノロジーや複雑なプロトコルの急増により施設の業務負担がますます厳しくなっていることから、将来に向けて臨床試験を近代化するために、施設と連携する新たな方法が求められています。初開催の「施設エンゲージメント・イネーブルメント」会議では、施設の負担を軽減するための新たなアプローチと、治験依頼者と施設の両方の観点から長期的なパートナーシップを確立するためのフレームワークが提案されます。「共同戦略で試験の実施を改善」会議では、治験責任施設や機関との長期的な関係を構築・育成するための新しい戦略と、試験実施を最適化するソリューションを紹介します。「技術とコラボレーションによるスタートアップの合理化・業務負担の軽減」会議では、施設の負担を軽減し、施設向けのトレーニングを改善するための新しいテクノロジーやプロセスを検討するとともに、試験実施に伴う複雑さとコスト、治験依頼者から求められるものについて、施設の視点を提供します。
2月3日 月曜日
6:30 amGolf Check-In & Breakfast Buffet (Sponsorship Opportunities Available)
8:00 amSCOPE's 4th Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)
Connect with your peers and colleagues at SCOPE's 4th Annual Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.
*Limited space available. Separate registration and fee required for golf.
9:00 amRegistration Open
12:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)
PRE-CONFERENCE WORKSHOPS: IN-PERSON ONLY
会議前ワークショップ：対面のみ
12:00 pm- 4:00 pm 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: Collaborative Strategies to Improve Trial Execution
パート1：共同戦略で試験の実施を改善
PARTNERING TO ACCELERATE AND IMPROVE TRIAL DELIVERY
試験実施の迅速化と改善に向けた提携
Establishing Long-Term Partnerships for Study Success: AstraZeneca's Biopharmaceuticals Partners in Care Network and Site Engagement Model
Joshua Hershelman, Director, US Site Engagement, Site Management & Monitoring, AstraZeneca
As part of AstraZeneca’s vision to be sponsor of choice for sites and patients we are establishing our Biopharmaceuticals Partners in Care Network and Site Engagement Model. The goal of this collaboration is to co-create meaningful and efficient clinical trial experience to accelerate study delivery. The goal is to create long term partnerships coupled with collaborative scientific engagement. Now that the Biopharmaceuticals Site Engagement team is entering our sophomore season we have an exciting story to share and real world examples of how the team has supported study delivery in the US.
AZ (AstraZeneca) & MGB (Mass General Brigham): Innovative Partnership to Deliver Clinical Trials of the Future
Kelly McKee, Head of Innovative Patient Recruitment, Evinova; Co-Creator of the SCOPE Participant Engagement Award
Michele Teufel, Site Management & Monitoring Therapy Area Strategy & Portfolio Delivery, Development Operations, AstraZeneca
Join us for a panel discussion on the groundbreaking partnership between MGB, a premier Academic Medical Center, and AstraZeneca, including its digital health subsidiary, Evinova. This collaboration utilizes advanced technology for trial feasibility, AI-powered study design, and innovative recruitment strategies. Discover how integrating hospital-based multimodal datasets and operational workflows enhances trial efficiency and diversity. Gain insights into the future of clinical research.
Site Partnerships-Developing Site Relationships beyond Study-Level Engagement
Sven Knapinski, PhD, Director, Site Partnerships, Clinical Development, CSL Vifor
The aim of this newly created group in CSL is to build long-lasting relationship with the investigational sites and institutions that are key to our success beyond clinical trial participation. While Sponsors are competing for the sites with the best access to the needed patient population, many sites find themselves overloaded with trial requests. In addition to partnership-building efforts, the presentation highlights several initiatives the CSL Site Partnerships Team is launching to reduce site burden, expand the network, and improve feasibility outcomes, with direct positive impact on the delivery of CSLs trial portfolio.
Rethinking Recruitment: The Value of Site-Centric Enablement with Sponsor, Site & Vendor Alignment
Tate Stubbs, COO, Executive, HealthMatch
HealthMatch’s portfolio recruitment approach has provided significant advantages for site driven recruitment strategies, leveraging the efficiency of multi-study screening to maximise patient and site results. This presentation examines the next frontier of how sponsors can maximize recruitment outcomes through a collaborative recruitment strategy design with both sites and vendors, leading to better overall performance and more efficient sponsor investment.
Unlocking Cost and Time Savings: The Impact of Workflow Technology on Site Enablement
Catherine Gregor, Chief Clinical Trial Officer, Thought Leadership, Florence Healthcare
Discover the direct benefits of enabling research sites with cutting-edge workflow technology. Learn how leading pharma companies achieve significant cost and time savings by streamlining document exchange and participant enrollment. Through real-world case studies, we’ll explore how global implementation of advanced solutions enhances document management and enrollment tracking, leading to faster, more efficient trial timelines.
Reimagining Clinical Trial Collaboration with AI: Boosting Engagement & Efficiency for Sites & Sponsors
Sharmin Nasrullah, General Manager, Life Sciences and Clinical, Salesforce.com, Inc.
Discover how AI agents and collaboration tools embedded in the flow of work accelerate clinical trials for sites and sponsors. With Life Sciences Cloud, powered by Agentforce, study teams are guided through study start-up documentation, site feasibility and selection, and study conduct activities. Life Sciences Cloud connects study teams across sponsors, CROs and clinical sites, providing real-time assistance in the flow of work to enable faster trials.
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!
BUILDING TRUST AND COLLABORATION BETWEEN PATIENTS, HCPs, AND RESEARCH TEAMS
患者・HCP・研究チーム間の信頼とコラボレーションの構築
Enhancing Patient and HCP Engagement for Improved Accessibility, Enrollment, Retention, and Outcomes
Angela Bilkhu, Senior Global Patient Partnership Director, Sickle Cell Disease and aHUS, Roche
Effective patient and healthcare provider (HCP) engagement is crucial to the success of clinical trials, impacting accessibility, enrollment, retention, and ultimately, trial outcomes. This session will explore strategies for deepening our understanding of patient needs and HCP perspectives to create more inclusive and patient-centric trials. By examining case studies and discussing innovative approaches, participants will gain insights into how to improve communication, build trust, and foster collaboration between patients, HCPs, and research teams. Join this discussion to learn how to drive better engagement, enhance trial participation, and achieve more meaningful clinical outcomes.
Optimizing Our Focus on Site-Facing Training
Mette Flindt Heisterberg, PhD, Competency Development Specialist, Clinical Operations Office, Global Trial Portfolio, Novo Nordisk AS
In the past year, Novo Nordisk has meticulously optimized site-facing training, emphasizing user-centric learning journeys. By establishing a dedicated site learning unit and refining processes, we can deliver best-in-class learning experiences. Shifting our focus, we aim to explore optimal training delivery and foster flexible, engaging experiences for our site staff. We invite you to join us in exploring our challenges, solutions, and reflections, as we embark on this transformative journey.
Talk Title to be Announced2nd ANNUAL SITE INNOVATION AWARD
第2回年次 施設イノベーション賞
Celebrating Creativity in Site-Centric Approaches to Advance Clinical Trials for All Stakeholders
Please join us for SCOPE’s 2nd Annual Site Innovation Award, recognizing sites and partnerships pioneering new approaches to improve clinical trials. Our definition of innovation is inclusive of low-tech or high-tech solutions, or any site operations-related process improvements that effectively reduce site burden and improve a site’s ability to advance clinical research while providing patient-centered care.
Congratulations to the 2025 SIA Finalists:
- Active Intelligence -- Pre-Screening with AI: a No Cap Glow Up for Site Enrollment
- Cedar Health Research -- Expanding Clinical Trial Access To Diverse Communities Through the science of Artificial Intelligence and the Art of Community Engagement
- Velocity Clinical Research -- Velocity VISION: Improving Clinical Trial Accessibility for Participants
- WCG Site Network -- Customized Site Support
- West Clinical Research and Stitch -- Less Admin, More Enrolled Participants: Our New Communication Approach
Talk Title to be Announced
Smarter Studies, Better Outcomes: Automated Data Collection for Prospective Research and Registries
Catherine Richards, President and COO, OM1 Inc.
Traditional data collection methods in clinical research are plagued by inefficiencies, rigid designs, and limited diversity-resulting in costly delays and incomplete insights. This presentation will explore how AI-powered, tech-enabled solutions are transforming prospective studies and registries for sites and sponsors. Learn how flexible, adaptive study designs reduce site and patient burden, achieve unparalleled cost savings, and deliver more comprehensive real-world data to achieve better outcomes with unmatched efficiency.
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
IMPROVING SITE/SPONSOR COLLABORATION: PERSPECTIVES FROM BOTH SIDES
施設/治験依頼者のコラボレーションの改善：双方の視点
What Sites Really Want from Study Sponsors and CROs
Norman M. Goldfarb, Executive Director, Site Council
After over 40 years of clinical research, sponsors and CROs should have a good understanding of what sites want from the relationship. However, sites continue to be amazed by the apparent lack of understanding. Don't miss this opportunity to hear what leading sites really, really want from sponsors and CROs. You may be surprised.
What Sponsors Don't Seem to Understand about Site Costs
Norman M. Goldfarb, Executive Director, Site Council
Clinical research is complicated and is getting more complicated every day. Every complication carries a cost. Take a look behind the curtains to learn how leading sites devour money to meet the many sponsor, regulatory, and other priorities they face every day-and how sponsors and CROs can lighten the load.
Helping Sites Succeed: An Industry-Wide Approach to Reduce Tech Burden
Nick Whitney, Senior Director & Commercial Lead, Site Suite, IQVIA Technologies
Sponsors of clinical trials are keenly aware that to speed up study start-up and conduct, they need to help clinical research sites manage the array of technology they require them to use. This panel of site, sponsor, and technology leaders will discuss approaches they are deploying to reduce site tech overload, and what more needs to be done to make an impact on site efficiencies and study timelines.
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
TECHNOLOGY ADVANCEMENTS TO REDUCE SITE BURDEN
施設の負担を軽減する技術の進歩
Interoperability Will Slash the Technology Burden on Sites
Norman M. Goldfarb, Executive Director, Site Council
Technology proliferation is crushing clinical research sites under a landslide of passwords, training, patient support, "anomalies," and redundant data entry. But wait! There is a path through the wilderness-interoperability will save the day and perhaps sooner than we expect.
Real AI at Real Sites Today
Norman M. Goldfarb, Executive Director, Site Council
Artificial intelligence is the cure for every clinical research ailment -- anyway, that's the dream. The reality, as usual, is like everything else in clinical research: incremental steps forward. Learn how cutting-edge sites are already setting AI to work on practical solutions to pressing problems-and that's the reality.
Increasing Access to New Patients by Enabling Sites to Run Trials in their Own Communities through Site Network Support
Caroline Potts, General Manager, MRN Site and Patient Services, Medical Research Network
Nearly 80% of trials fail to meet initial enrollment targets and timelines, only 25% of global trial participants are people of color and approximately 30% of a trial budget is dedicated to recruitment.
Creating more equitable and efficient trials begins with engaging and empowering clinical research sites to run trials in their own communities.
By providing individualized support through advanced training and operational delivery capabilities, site networks can lower the risk of trials failing to recruit enough patients, ensure a representative sample of patients, create equitable access to participation, and retain patients for the duration of the trial.
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: Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden
パート2：技術とコラボレーションによるスタートアップの合理化・業務負担の軽減
DATA & TECHNOLOGY PLATFORMS: ACCELERATING SITE FEASIBILITY PROCESSES
データ・テクノロジーのプラットフォーム：施設の実現可能性プロセスを加速
8:20 amChairperson's Remarks (Sponsorship Opportunity Available)
Streamlined Clinical Trial Feasibility with Technology, Tools, and Process Excellence
John Yannone, Director, Feasibility Strategy, Innovative Health Engagement and Advocacy, Johnson and Johnson
How do we enable teams to navigate complex organizational dynamics, synthesize disparate data sets, and maximize trial efficiency all while balancing costs and speed? A suite of enabling tools and improved processes has shown the potential to drive fit-for-purpose protocols, efficient country strategy, and enhanced site selection while improving transparency and leveraging AI/ML + advanced analytics. This discussion will empower teams to discuss best practices in feasibility, specifically at large multinational pharmaceutical companies.
Optimizing Clinical Strategy with Innovative Technology in a Dynamic Organization
During a period of significant growth and change, Regeneron's Global Trial Optimization and Global Development Systems Teams implemented an innovative digital-first strategy to overcome challenges in trial feasibility, patient engagement, and site identification. Using an agile methodology and an Appreciative Inquiry model, the team identified workflow issues, designed a comprehensive solution, and delivered a flexible, scalable application. This approach improved data quality, standardized deliverables, and optimized resources, providing a foundation for future business needs. The project highlighted the importance of collaboration, communication, and a strong change management strategy for successful technology adoption.
Empowering Clinical Research Sites: Collaborative Strategies and Technological Innovations for Enhanced Trial Execution and Operational Efficiency
Ade Lawrence, MD, MSc, Founder/CEO, Bioluminux Clinical Research
This presentation will explore advanced strategies for site engagement and enablement, emphasizing the integration of collaborative approaches and cutting-edge technologies to optimize clinical trial execution. Drawing on extensive experience in clinical trials and pharmaceuticals, the discussion will highlight practical solutions to streamline start-up processes, reduce operational burdens, and foster stronger site-sponsor relationships, ultimately leading to more efficient and successful trials.
Are Questionnaire Licensing and Translation Hurdles Slowing Down Your Trials?
Are questionnaire licensing and translation hurdles slowing down your trials? Early and strategic engagement with your licensing, localization, and eCOA partners might be the solution you’re looking for. In this session, two seasoned experts in eCOA and localization will dive into key preparatory steps to make your study more feasible from both a licensing and localization standpoint-driving smoother regulatory approvals and helping you meet critical timelines. You’ll gain practical insights on successful early engagement, including essential questions to ask your providers, the value of connecting partners early, setting realistic expectations, and assessing content suitability-empowering you to streamline diverse global study start-ups.
The Value of Quest Lab Data in Clinical Trial Design and Recruitment
Steve Schlachter, Director Product Portfolio, Healthcare Analytics Solutions, Quest Diagnostics, Inc.
Learn the value of lab data in clinical trials and the power of Quest to help optimize site feasibility and selection, improve investigator selection, and optimize patient identificaiton and recruitment. Make more informed decisions with Quest and enhance the overall success of your trials.
Feasibility Process Update to Ensure Active Site Engagement: One Year Later
A year has passed since AstraZeneca implemented enhancements to our feasibility process, aimed at fostering active engagement from the initial interaction through to site selection. Over the past year, we've had the opportunity to test these improvements, gather insights, and refine our approach. In this session, we will share the valuable learnings from this journey, discuss the additional updates we've made, and outline our future plans to further optimize the process.
Building Meaningful Engagement: PCORI's Foundational Expectations for Partnerships in Research
Caroline Davis, MPP, Senior Program Associate, Public and Patient Engagement, PCORI Patient Centered Outcomes Research Institute
PCORI’s Foundational Expectations for Partnership in Research incorporates the last 10 years of evidence on engagement from PCORI awardees, staff, and the larger research field to update the guidance on engagement into one systematic framework. We consider these expectations to be the building blocks of meaningful and effective engagement. This session will review the various methodological approaches used to complete the update and present the guidance along with information on how to access this tool.
11:10 amNetworking Coffee Break
INTEGRATING CLINICAL RESEARCH INTO CLINICAL CARE
臨床研究を臨床ケアに統合
Taking Research to the People: Decentralized Trials, Leveraging Technology to Enable Community-Based Approaches
Amy Yarker, Senior Business Development Manager, Life Sciences Partnership & Growth, NIHR Clinical Research Network
This session will explore the transformative power of decentralized clinical trials, taking research beyond traditional hospital clinics to reach participants in social care settings and underserved communities. Discover how cutting-edge technology and innovating methods are breaking down barriers, improving accessibility, and generating valuable real-world evidence. From mobile research units to patients’ homes, learn how decentralized trials are bringing research directly to people.
Talk Title to be AnnouncedIntegrating Community Health Solutions: A Case Study
Shelly Barnes, Global Clinical Innovations and Digital Lead, UCB
Is it operationally feasible to develop a clinical research plan that incorporates community-based health entities or solutions? The FDA has indeed advocated for the inclusion of community health providers in clinical trials. However, challenges remain, particularly when major community solution providers face difficulties in establishing a favorable cost model. Also, is there substantial evidence indicating that investigators or community health providers are willing to participate in this new clinical trial execution model? This UCB case study aims to examine the advantages, disadvantages, and potential challenges of integrating community health solutions into clinical trials.
1:25 pmTransition to Lunch
LUNCHEON PRESENTATION: Rethinking Trial Design with Real-World Data
Kwame Marfo, Senior Director, Product Strategy, Clinical Development, Komodo Health
Discover how Komodo’s innovative no-code solution, MapView with MapAi, is reshaping the way clinical development teams understand and address the diverse healthcare journeys of patients from different racial and ethnic backgrounds. Komodo’s presentation will explore how streamlined data insights can uncover disparities, enhance trial inclusivity, and optimize patient representation, empowering teams to design more equitable and effective clinical trials.
2:00 pmSCOPE Summit 2025 Adjourns
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
アジェンダ・講演者・スポンサー更新
2025年 プログラム
◆
Sunday Golf, Kick-Off Keynote & Participant Engagement Award
月曜のゴルフ、キックオフ基調講演、参加者エンゲージメント賞
◆SCOPE’s Kickoff Reception
SCOPEによるキックオフレセプション
◆
Patient Voice in Trial Design and Protocol Development
試験デザインとプロトコル開発における患者の声
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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
◆
Enrollment Planning and Patient Recruitment
登録計画・被験者募集
◆
Patient Engagement and Retention through Communities and Technology
コミュニティ・技術による被験者エンゲージメントとリテンション
◆
Clinical Trial Forecasting, Budgeting and Contracting
臨床試験の予測・予算編成・契約
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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
◆
Modernizing Lab, Biomarker & Data Management Operations
ラボ・バイオマーカー・データ管理業務の近代化
◆
Biomarker & Biospecimen Technology & Innovation
バイオマーカー・バイオ試料の技術とイノベーション
◆
Data Technology for End-to-End Clinical Supply Management
E2Eの臨床サプライ管理向けデータ技術
◆
Clinical Supply Chain Strategies to Align Process, Products and Patients
臨床サプライチェーン戦略でプロセス・製品・被験者を連携
◆
Clinical Trial Venture, Innovation & Partnering *
臨床試験のベンチャー・イノベーション・提携 *
*Separate Registration Required
