精密医療の台頭により、バイオマーカーを活用した臨床試験が劇的に増加し、バイオ試料の収集・管理向けの新しいプロセスとテクノロジーが求められています。SCOPEによる第9回年次「バイオマーカー・精密医療」ストリームでは、バイオ試料とバイオマーカー管理のリーダーが集まり、バイオマーカーを活用した臨床試験の複雑な業務上の要件を効果的に対処するためのベストプラクティスを共有します。「ラボ・バイオマーカー・データ管理業務の近代化」会議では、サンプルやデータの追跡、データ管理とデータ標準化、規制、プライバシー、同意、ガバナンスに関する考慮事項など、バイオマーカーを活用した試験向けのフレームワークやポリシーを導く戦略とソリューションについて検討します。「バイオマーカー・バイオ試料の技術とイノベーション」会議では、高品質なバイオ試料、ラボへのアクセス、診断サービスを提供するバイオサンプル試料の収集技術、患者中心の業務アプローチ、ITソリューションにおける最新の進歩にフォーカスします。
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 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 pmOPEN WORKSHOP: Join and Explore ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace (IN-PERSON ONLY)
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. To register for the workshop, please opt into this workshop by selecting the checkbox under ‘Conference Selection.' Open to all SCOPE attendees.
1:00 pmOPEN WORKSHOP: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trial (IN-PERSON ONLY)
INSTRUCTORS:
Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)
Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific
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. To register, please opt into this workshop by selecting the checkbox under ‘Conference Selection. Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.
1:00 pmOPEN WORKSHOP: Efficient Importation of Biological Materials into the U.S. (IN-PERSON ONLY)
SPEAKERS:
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.
-jpg_35ced57f-4e01-4468-86ac-250cb4049821.jpg)
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: Modernizing Lab, Biomarker & Data Management Operations
パート1：ラボ・バイオマーカー・データ管理業務の近代化
INDUSTRY COLLABORATION TO STANDARDIZE AND ACCELERATE CLINICAL RESEARCH
業界連携による臨床研究の標準化と加速
Chairperson's RemarksBiospecimen Industry Collaboration: Pioneering Best Practices to Standardize, Accelerate, and Transform Clinical Research
Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC
Specimen Management is a critical, yet often overlooked function within clinical trials. The overwhelming majority of industry discussion currently focuses on quality data management practices and how build automated data pipelines, yet there is almost no corollary discussion of quality specimen management practices that would not only facilitate building those pipelines, but would also reduce queries (thus cost), increase quality and speed, and improve reproducibility of research, leading to higher confidence in the use of AI. The Biospecimen Industry Collaboration was formed by a dozen biopharma companies who recognize this key gap, and are building a best practices framework to enable the industry and its partners to standardize where possible, paving the way for the next-generation of tools and technology to transform clinical trials.
Operationalizing Precision Medicine: Best Practice from Protocol Design through Study Start-Up
This presentation will review the output of a workshop attended by 10 major global biopharma companies discussing areas of opportunity for industry standardization from Protocol Design through Study Start-Up, to streamline clinical trial operations.
Operationalizing Precision Medicine: Best Practice from Site Activation through Study Closeout and Final Disposition of the Specimen
This presentation will review the output of a workshop attended by 10 major global biopharma companies discussing areas of opportunity for industry standardization during Study Conduct through Closeout, to streamline clinical trial operations.
Biospecimen Industry Collaboration Q&A
Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC
Don't know where your specimens are? Frustrated with the status quo? Come hear from specimen management, data management, and biobanking experts who participate in the Biospecimen Industry Collaboration about how the best practices they are developing can benefit you and your team!
Arkady Gusev, PhD, Head, Lab Excellence & Operations in Biomarker Development, Novartis Institutes for BioMedical Research, Inc.
From Site to Result: Real-Time Sample Intelligence Unlocked with GenAI
Tobias Guennel, Senior Vice President, Product & Chief Architect, Data Management & Systems Integration & Innovation, QuartzBio
With QuartzBio’s Biomarker Intelligence Platform, you can ask questions, get answers, and gain insights across the entire precision medicine data ecosystem. Powered by an ensemble of Precision Medicine Large Language Models (LLMs), QuartzBio’s platform supercharges efforts of operations, translational, and informatics teams, using AI-driven integration of biomarker, sample, and clinical data. This unified, scalable, and interoperable solution enables real-time sample intelligence from point of collection to data generation.
The Road Less Traveled: Bridging the Research Gap in Rural and Tribal Communities
Jonathan Ernst, Vice President, Business Development, PCM Trials
This session will explore the unique challenges of conducting clinical trials in rural and tribal communities, inspired by insights from the Montana Pathways to Health Equity initiative. We will discuss logistical hurdles, such as extreme weather and long travel distances, and highlight innovative community-based research strategies to overcome these barriers. This discussion aims to provide a deeper understanding of the importance of inclusivity in clinical research through real-world examples and forward-thinking strategies, particularly for underrepresented populations. Attendees will:
Understand the logistical and geographical challenges of conducting clinical trials in rural areas, illustrated through case studies.
Identify innovative solutions and strategies to overcome these challenges.
Recognize the importance of inclusivity in clinical research and the role of community-based research models in achieving it.
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!
OVERCOMING OPERATIONAL CHALLENGES OF SAMPLE MANAGEMENT
サンプル管理の業務上の課題を克服
3:20 pmChairperson's Remarks (Sponsorship Opportunity Available)
Optimizing Specimen Reconciliation to Improve Compliance and Data Integrity
Maria Gujral, Senior Director, Biospecimen & Imaging Management, Bristol Myers Squibb Co.
In clinical trials, accurate and timely biospecimen reconciliation is crucial for compliance and data integrity. This presentation explores strategies and best practices to enhance reconciliation processes, addressing common challenges like discrepancies, delays, and data inconsistencies. We will highlight innovative solutions, including automated tracking systems and real-time monitoring tools, to streamline these processes. Gain insights into robust protocols that improve compliance and enhance the quality and reliability of clinical trial data.
Creating Accountability through Dashboards and Trend Reporting of Sample Data
Roger Craveiro, Associate Director Specimen Lifecycle Management, Global Clinical Trial Operations, Merck Animal Health
This talk will demonstrate how compiled clinical sample data through dashboards and trend reporting can be leveraged to engage leadership teams and drive accountability. By providing a clear view of key performance indicators, dashboards empower leaders to understand organizational health, address trends, and make strategic decisions. We will showcase how specimen data from management databases can be transformed into actionable insights to enhance decision-making across the enterprise.
Specimen Lifecycle Management: Overcoming Challenges to Launch Biospecimen Management Technology
Nancy DeFusco, Director, Specimen Lifecycle Management, Merck Sharp & Dohme LLC
The new platform technology provides reporting, forecasting, and real-time dashboards to support sample assessments, which will enable proactive decision-making in our clinical trials. Leadership engagement and promotion was critical to the organization’s acceptance and adherence. Our workstreams, sites, clinical, data management, quality, and suppliers continue to assess end-user feedback to improve additional efficiencies to the overall sample management process. Our deployment efforts of this platform enhanced our Change Management Process to support uptake within the organization, improving customer service to our stakeholders in the existing system, while further enhancements are tested directly, related to the feedback provided.
Using Gen AI for Content Extraction from ICFs to Ensure Compliance for Individual Site and Country to Meet Sample Destruction Timelines
Anamika Sarkar, PhD, Intelligent Automation Lead, Global Development Solutions, Regeneron Pharmaceuticals, Inc.
Generative AI used to extract country and site-specific sample retention timelines from individual ICFs across sponsored clinical trials resulting in a user-friendly dashboard created to document differences in sample retention timelines and to ensure compliance with sample destruction for all subjects. Using a sample destruction countdown feature, end users can see upcoming sample expiration dates and ensure sample destruction approvals and actions are completed and documented appropriately.
FDA Regulation of LDTs: The Impact on Clinical Trials for Precision Medicine
Christine P. Bump, JD, MPH, Principal, Penn Avenue Law & Policy
In May 2024, the FDA issued a final rule amending the definition of in vitro diagnostic products (IVDs) to include laboratory developed tests (LDTs). This change subjects LDTs to the agency’s medical device regulations, including for investigational uses and clinical trials. Many tests for biomarkers and precision medicine are LDTs. This session will explain the new requirements for laboratories and the impact on clinical trials for precision medicine.
5:25 pmSponsored Presentation (Opportunity Available)
5:55 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)
Wind down at the end of a busy session day with colleagues and old and new friends. Networking is always in full swing at this reception, so raise a glass with your favorite exhibitors and take a chance at winning one of our fabulous raffle prizes (must be present to win). Continue your networking over dinner at one of the Rosen Shingle Creek's fine dining or casual restaurants and eliminate the need to face Orlando traffic.
7:15 pmClose of Day
7:15 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)
The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.
Shuttles will run a continuous loop from 7:00pm-11:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.
2月5日 水曜日
7:45 amRegistration Open
BREAKFAST PRESENTATIONS
朝食プレゼンテーション
BREAKFAST PRESENTATION OPTION #1:Digital Innovation’s Role in Pediatric and Elderly Clinical Trials
Kyle Hogan, Chief Executive Officer, Datacubed Health
This presentation examines how targeted digital tools improve retention rates among pediatric and elderly participants. Our pediatric focus reveals how gamification can create meaningful connections and enhance the trial experience while engaging caregivers. For elderly participants, we examine the use of accessible interfaces and remote monitoring solutions to address age-specific challenges. Attendees will discover strategies for implementing these solutions within their research programs.
BREAKFAST PRESENTATION OPTION #2:Expanding the Patient Universe: Transforming Clinical Trials through Inclusive, Data-Driven DesignChristopher Riley, Director, Strategic Insights, Solutions, H1
In today’s complex clinical research landscape, achieving patient-centricity and inclusivity is more critical than ever. This presentation introduces Patient Universe, a groundbreaking solution designed to optimize trial feasibility while addressing health equity challenges. Attendees will learn how leveraging real-world health equity data can transform patient recruitment strategies, create inclusive trial designs, and improve participant engagement. Through actionable insights and use cases, this session will demonstrate how advanced analytics and innovative technologies can bridge gaps in representation, support diversity action planning and enhance trial outcomes.
BREAKFAST PRESENTATION OPTION #3:Scaling Success: How Sanofi and Trialbee Drive Patient-centric Recruitment and Reduce Site Burden in Global Asthma Programs
Join Whitley Albright (Sanofi) and Gaynor Anders (Trialbee) to discuss how to keep patients at the center of focus while reducing site burden in a complex global asthma program by: connecting patients to the right trials with targeted outreach and a highly efficient global process; pre-qualifying all patients with live medical secondary screening to reduce the volume sent to sites, improve trust, and increase referral-to-consent ratio; keeping disqualified patients ready to enroll with program-level rematching; centralizing activity in a Patient Recruitment Platform (PRP) to manage progress, evaluate site performance, and measure campaign ROI; building a collaborative, supportive, and meaningful relationship.
Learn how these organizations are scaling recruitment success globally while achieving diversity and inclusion goals, reducing site burden, and keeping patients at the center of care.
8:45 amTransition to Sessions
PERSPECTIVES ON HOW TO OPTIMIZE BIOMARKER & BIOSPECIMEN OPERATIONS
バイオマーカー・バイオ試料の業務を最適化する方法に関する視点
8:50 amChairperson's Remarks (Sponsorship Opportunity Available)
The Other Side of the Protocol: Insights from a Clinical Research Site
Suzin Webb, Site Director, Velocity Clinical Research
In the era of precision medicine, we are witnessing a significant change in how clinical trials are designed and conducted. Advances in many areas including AI, laboratory testing, sample collection, digital health, and decentralized trials are truly transforming clinical research. Research sites will likely need to work creatively, take on new technologies, and adapt standard practices. Real world challenges and solutions will be discussed from the research site’s perspective.
Biospecimen Management Consortium: Driving Sample Excellence in Clinical Research
Amy Ripston, Executive Director, Biospecimen Management Consortium
The Biospecimen Management Consortium (BMC) was founded to drive sample excellence in clinical research-by setting standards and developing best practices, streamlining biospecimen operations and data, and shaping regulatory policy. This panel of founding members will discuss the goals and objectives of the consortium, progress on its initiatives, how industry can contribute, and its roadmap for the upcoming year.
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
LEVERAGING AI TO IMPROVE INFORMED CONSENT PROCESSES
AIを活用し、インフォームドコンセントのプロセスを改善
11:20 amChairperson's Remarks (Sponsorship Opportunity Available)
IC-Scope: Use of LLMs to Evaluate Local Consent Scope and Enable Additional Research Use of Clinical Data and Samples
Dmitri Mikhailov, PhD, Director & Global Head, Biomarker Coordination, Novartis Institutes for BioMedical Research, Inc.
Use of clinical data and sample in research may go beyond what is planned in trial protocols. To respect participants rights, additional research projects should be covered by informed consents used locally at sites. Understanding local consent changes can be a daunting task for a project team seeking to use trial data or samples. This talk describes how LLMs can be used to streamline evaluation of local consent scope changes.
Leveraging AI to Codify Informed Consent
Cristin Freeman, Head, Informed Consent Management, Bristol Myers Squibb Co.
Informed consent codification to determine permissions and restrictions to utilize biospecimens and data is a manual and time-consuming task, but essential to ensure compliance and uphold commitments to participants. To increase efficiency and speed, BMS has developed an innovative AI tool to assist in IC Codification. The tool can identify relevant IC documents, scan and assess restrictive language to inform sample storage for clinical trial samples, and provide outputs to inform expedited reviews.
The Role of Radiology Imaging Biomarkers in Clinical Trials12:55 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!
-jpg_3fef6f50-a8ff-4613-b844-9dd3fd020160.jpg)
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
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
BIOSPECIMEN SUPPLY-CHAIN LOGISTICS
バイオ試料サプライチェーンロジスティクス
8:20 amChairperson's Remarks (Sponsorship Opportunity Available)
Logistics Considerations in a Global Clinical & Biospecimen Supply Chain
Thomas J. McDonald, MS, Consultant-Clinical Trials, Biospecimen & Vendor Relationship Management
Data derived from our clinical trial samples is essential to primary, secondary, and exploratory endpoints. Injecting human biospecimens into the global supply chain, however, can be a harrowing proposition. Often with limited stability, temperature control considerations, and analysis being performed on a different continent, we will review strategies and approaches to demystify the logistics and ensure maximum efficiency in your global biospecimen supply chain.
Exploratory Biomarkers in Clinical Trials: Right Clinical Site, Right Lab, Right Data, Right Time, and Right Quality
Arkady Gusev, PhD, Head, Lab Excellence & Operations in Biomarker Development, Novartis Institutes for BioMedical Research, Inc.
Exploratory biomarkers enable clinical decision making and often paves the way for precision medicine approaches in drug development. This presentation will focus on systematic approaches to biomarker (soluble, cellular, and digital endpoints) implementation in clinical trials, de-risking and ensuring biomarker deliverables and impact. Planning and feasibility process, clinical site training, CRO selections, data flow considerations, quality, and compliance standards will be presented and discussed.
Accelerating Clinical Trials with Smart Variation ManagementAnkit Bajpai, Associate Principal, ZS
Changes in clinical trials due to regulatory updates, logistical hurdles, & site-specific issues, are inevitable, leading to delays & inefficiencies. Effective variation management requires tailored strategies like process automation, workflow standardization, and enhanced oversight to address these complexities. This discussion explores how these solutions help reduce variation timelines by nearly 50%, optimizing resources and ensuring efficient trial execution.
9:40 amSponsored Presentation (Opportunity Available)
Tissue and Blood Biospecimen Journey: Strategies to Avoid Logistical Uncertainty
Michael Tanen, Director, Head of Laboratory Operations and Logistics, Merck
A critical part of any complex, biomarker rich clinical trial is the ability to de-risk the logistical uncertainties related to biospecimens. From collection, processing, tracking, analysis, and storage the lifecycle of a biospecimen can be complex and filled with potential obstacles. All of which are at times assigned or outsourced to various clinical teams, sites, CROs, third party vendors, and biorepositories. To minimize such obstacles, we will discuss various strategies to plan, de-risk, track and set up for biospecimen success in these complex clinical trials.
Where Are My Samples? Deconvoluting Biospecimen Supply Chain Logistics
Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC
The rise of diagnostics and biomarker-based medicines shifts the conversation from "Where are my results?" to "Where are my specimens?" This is especially true of cell and gene therapies, in which the specimen is the drug. However, trial managers, clin pharm & biomarker operations leads, cell and gene manufacturing professionals, and data managers all know that this is not an easy question to answer. Come listen to a panel of experts, whose entire focus is understanding where your specimens are, all around the globe, demystify specimen logistics. This is your opportunity to get your questions answered!
11:10 amNetworking Coffee Break
Part 2: Biomarker & Biospecimen Technology & Innovation
パート2：バイオマーカー・バイオ試料の技術とイノベーション
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
Talk Title to be Announced2:00 pmSCOPE Summit 2025 Adjourns
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
アジェンダ・講演者・スポンサー更新
2025年 プログラム
◆
Sunday Golf, Kick-Off Keynote & Participant Engagement Award
月曜のゴルフ、キックオフ基調講演、参加者エンゲージメント賞
◆SCOPE’s Kickoff Reception
SCOPEによるキックオフレセプション
◆
Patient Voice in Trial Design and Protocol Development
試験デザインとプロトコル開発における患者の声
◆
Developing and Executing Effective Diversity Plans
効果的な多様性計画の策定と実行
◆
Enrollment Planning and Patient Recruitment
登録計画・被験者募集
◆
Patient Engagement and Retention through Communities and Technology
コミュニティ・技術による被験者エンゲージメントとリテンション
◆
Clinical Trial Forecasting, Budgeting and Contracting
臨床試験の予測・予算編成・契約
◆
Resource Management and Capacity Planning for Clinical Trials
臨床試験のリソース管理・キャパシティプランニング
◆
Mastering an Outsourcing Strategy
アウトソーシング戦略のマスター
◆
Relationship and Alliance Management in Outsourced Clinical Trials
臨床試験アウトソーシングにおける関係と提携管理
◆
Modernizing Lab, Biomarker & Data Management Operations
ラボ・バイオマーカー・データ管理業務の近代化
◆
Biomarker & Biospecimen Technology & Innovation
バイオマーカー・バイオ試料の技術とイノベーション
◆
Data Technology for End-to-End Clinical Supply Management
E2Eの臨床サプライ管理向けデータ技術
◆
Clinical Supply Chain Strategies to Align Process, Products and Patients
臨床サプライチェーン戦略でプロセス・製品・被験者を連携
◆
Clinical Trial Venture, Innovation & Partnering *
臨床試験のベンチャー・イノベーション・提携 *
*Separate Registration Required
