患者中心の臨床試験は、治験薬が適切な患者に適切なタイミングで適切な場所に届けられるように、効率的で合理化されたサプライチェーンプロセスに依存しています。SCOPEによる第8回年次「臨床サプライ・ロジスティクス」ストリームでは、最新の臨床試験の複雑さを乗り越える上で、サプライチェーン管理が果たす極めて重要な役割にフォーカスしたケーススタディとベストプラクティスを紹介します。第6回年次「E2Eの臨床サプライ管理向けデータ技術」会議では、デジタル化が臨床試験のサプライチェーンエコシステム全体の関係をどのように変革しているかについて探ります。複数のデータソースからインサイトを統合することで、組織はデータの品質と量を向上させ、正確な予測、効率性の向上、大幅な時間とコストの節約につながります。第8回年次「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」会議では、被験者とバイオ試料の重要な役割にフォーカスし、常に革新と迅速かつ効果的な意思決定を求められているサプライチェーンロジスティクスの専門家が集まります。この会議では、サプライ計画の最適化、実用的インサイトの獲得、最先端ツールの実装、最終的に患者にとって最良の結果を保証するための戦略を探ります。
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 USER GROUP: Innovation Day with IQVIA Technologies: Hear the vision. See the products. Join the journey.
Clinical trial sponsors are invited to join digital product leaders and industry colleagues for an afternoon of discussions, demos, and networking. This interactive event has been carefully curated to help clinical trial professionals crack key challenges across the clinical trial lifecycle: from participant and site user journeys to data security and workflows. Pharmaceutical executives with various roles in clinical operations, innovation, technology, finance/budgeting, data analytics, strategic sourcing, trial managers, medical directors, or patient and site engagement will enjoy an industry panel, interactive roundtables, live demos with product experts, and more! Pre-registration is requested, and IQVIA reserves the right to decline requests that don’t fall within attendee guidelines above: For more details, please contact us.
1:00 pm- 1:45 pm WORKSHOP: Join and Explore ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace
Join this hands-on session with ClinEco, SCOPE’s B2B clinical trial community and marketplace featuring 850+ companies. ClinEco unites sponsors, CROs, service providers, and sites to streamline partnering, vendor research, innovation, and learning. At SCOPE 2024 we introduced the ClinEco Commons, a collaborative space where you can access, visit, and share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco Community. This year we launch our 'Ask a ClinEco Luminary' program where members can connect directly, and discreetly, with industry leaders and receive insights on a wide range of clinical trial topics. Join now at: clineco.io/register. Open to all SCOPE attendees.
1:00 pm- 2:30 pm WORKSHOP: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials
INSTRUCTORS:
Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)
Diana Steinbuesch, BioX Operations Portfolio Lead (Oncology), Roche
While developing leading and innovative therapies, we must not lose sight of the environmental impacts and greenhouse gas emissions. We can reduce the environmental impact of our studies by prioritizing remote visits and monitoring, by reducing kit wastage, and working together to find ‘greener’ solutions. This workshop will provide a brief overview of research and introductory strategies for reducing emissions as well as a 'Sustainability 101' to help anyone in our industry get started towards developing more environmentally responsible clinical trials. Open to all SCOPE attendees. Sustainable Healthcare 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.
2:00 pm- 3:30 pm WORKSHOP: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing
INSTRUCTOR:
Dawn Anderson, Partner, Consulting, Deloitte LLP
Ming Shen, Managing Director, Deloitte Consulting LLP
This workshop will explore sponsor and site perspectives on current challenges and future opportunities in clinical trial financing. It will address complexities in managing trial finance including estimation, budgeting, forecasting, invoicing, payments, reconciliation and others in clinical trial management. The workshop aims to identify innovative solutions to enhance finance management in clinical trials, fostering more accurate projections. Through discussions and interactive sessions, it seeks to provide insights for future opportunities to improve clinical trial finance.
MONDAY AFTERNOON PLENARY SESSION:
月曜日午後のプレナリーセッション：
CONVERGING CLINICAL RESEARCH AND CARE, PATIENT PANEL & PARTICIPANT ENGAGEMENT AWARDS
臨床研究・臨床ケアの融合、患者パネル、参加者エンゲージメント賞
Fast-Forward to 2035: What Success Could Look like in Converging Clinical Research and Care-And How to Get There
Mark McClellan, MD, PhD, Director, Duke-Margolis Institute for Health Policy; Former Commissioner, FDA
On this stage in 2024, we spoke about our mission to converge clinical research and clinical care for the benefit of patients worldwide. We envision a world in which patients participate in research at the point of care as seamlessly as possible. And although we’ve set our vision, and organized the work we are undertaking accordingly, the real fruits of those efforts will not be seen in the short term. We will use this session to talk about where we hope we will be by 2035. What might we reasonably achieve? What does success look like? And what will it take to get there? This session is designed to help us all to raise our gaze beyond the near-term and find inspiration in the future possibilities.
Tips for Getting the Most out of SCOPE
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
Visit our FAQ page! We hope this page answers some of your questions related to SCOPE. It consolidates a lot of info for speakers, attendees, and vendors into one page. We look forward to seeing you at SCOPE on February 3-6, 2025, at the Rosen Shingle Creek in Orlando, Florida!
What Do Real Patients Actually Talk About?
Whether at an industry event, a focus group, or another venue, we’ve all heard “real” patients share stories of their conditions, treatment journeys, and lives. But how accurate is what you’ve heard? Are the patients who speak on the podium or in a focus group truly representative of the majority of patients, or do they represent just a small sample? Our panel of patient engagement experts from some of the country’s leading patient advocacy groups and other representative organizations will give the story of what it’s like for most patients to live with illness, including rare and chronic diseases. Join us and learn about the true challenges of disease burden, unmet needs, treatment progression, the challenges-and rewards-of clinical trials, and more.
5:05 pmSCOPE's 9th Annual Participant Engagement Awards Introduction (Sponsorship Opportunity Available)
SCOPE's 9th Annual Participant Engagement Awards
Kelly McKee, Head of Innovative Patient Recruitment, Evinova; Co-Creator of the SCOPE Participant Engagement Award
Now in its 9th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2025 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/participant-engagement-award
5:45 pmSCOPE's Kickoff Reception: A Luau to Remember!
Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, we're turning up the tropical vibes with a luau theme.
DRESS CODE: Hawaiian shirts are encouraged! Show off your brightest, boldest, most tropical attire (grass skirts optional!) Let's bring the aloha spirit to life as we kick off another amazing SCOPE conference experience. Join us to reconnect with your old friends, make some new ones, and soak up the Florida sunshine in style!
7:00 pmClose of Day
2月4日 火曜日
6:30 amSCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)
Join SCOPE’s Coordinators on Tuesday, February 4 for our 5K Rise and Shine Fun Run! Don’t forget to pack your sneakers.
All of us at Cambridge Healthtech Institute recognize the importance of integrating well-being and fitness into our work travel routines. We're excited to offer our support to faculty, sponsors, and attendees in fostering a culture of wellness. This is an easygoing, informal running (or walking) event. No time chips, running bibs, or energy bars-just a laid-back opportunity for a small group to start the day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk-the goal is to get up and get moving! Meet us in the Rosen Hotel’s front lobby near the birdcage at 6:30 am sharp!
RUN COORDINATORS:
Eileen Murphy, Conference Producer, Production, Cambridge Healthtech Institute
Steve Wimmer, Vice President of Partnerships, 1nHealth
7:30 amRegistration Open
7:30 amMorning Coffee (Sponsorship Opportunities Available)
Get Up and Go! Jumpstart your morning with a specialty made-to-order coffee and some delicious treats, courtesy of our sponsors.
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TUESDAY MORNING PLENARY SESSION:
火曜日午前のプレナリーセッション：
REDUCING CYCLE TIMES WITH “IN-HOUSE” CAPABILITIES, DATING GAME WITH PATIENTS & NEW PARADIGM OF PATIENT-LED TRIAL SPONSORS
「インハウス」機能によるサイクルタイムの短縮、患者とのデートゲーム、患者主導の治験依頼者における新たなパラダイム
*Must be present to win.
Exquisite Clinical Trial Delivery in an Ever-Changing World-Evolution and Opportunity for Sustained Performance
Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.
This talk focuses broadly on Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. More specifically, how has Merck decided to optimize clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams? What are key considerations for clinical trial planning, site selection, and protocol design? And, what and why did Merck keep many core capabilities “in-house”?
Beyond the Real-World Data, What Are Patients Saying?
Special LIVE Episode with Studio Audience-Patient Contestants will be Announced Onsite!
SCOPE’s Gameshow Host: Brett Kleger, a man whose dream it was to be a wedding singer or gameshow host
In today’s episode of “The Clinical Trial Dating Game” we have our pharma industry bachelor looking for a volunteer for his trial. He must question and choose from among three patients, who are hidden from view. He has access to all of their data, but there is more to this person than data, so how will he know which questions to ask? How will he avoid bias? How will he recruit on time? Knowing how important patient centricity is to the clinical research industry and with so much on the line, will our bachelor land a date? What could go wrong?
How Patients Can-and Must-Disrupt Traditional Pharma Clinical Trials
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Should biopharma companies be the only "sponsors" for clinical trials of new medicines? Does the current model limit opportunities for unmet needs in small populations or leveraging repurposed drugs? This panel will gather leaders demonstrating ways that patient-led non-profit organizations are challenging assumptions and taking a leadership position in medicine development. No longer can we think of patients as guests at pharma's table-is the next transformation in medicine development going to be entirely patient-led?
9:50 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall-Best of Show Voting Opens
Join us for the Grand Opening Networking Coffee break in our biggest SCOPE Exhibit Hall ever! Mingle with friends, forge new connections, and exchange ideas over your morning cup of joe. Visit exhibitors and learn about their latest and greatest innovations and products...voting opens for our Best of Show awards so don’t forget to vote.
Part 1: Data Technology for End-to-End Clinical Supply Management
パート1：E2Eの臨床サプライ管理向けデータ技術
DEVELOPING, INTEGRATING, AND OPTIMIZING RELIABLE AND FLEXIBLE IRT/RTSM SYSTEMS
信頼性のあるフレキシブルなIRT/RTSMシステムの開発、統合、最適化
Unlocking IRT Potential for Maximum Leverage
Alminaz Noorani, Associate Director Clinical Systems, Ultragenyx Pharmaceutical, Inc.
Unlocking IRT Potential for Maximum Leverage explores the impact of Interactive Response Technology (IRT) in clinical trials. This talk focuses on how IRT can streamline the trial, enhance data accuracy, and improve patient management. Share insights into leveraging IRT systems for more efficient data collection, real-time monitoring, and adaptive trial designs, ultimately boosting trial efficacy and accelerating the path to critical therapeutic discoveries.
Connecting Teams and Promoting Collaboration around IRT
Dawn Sorenson, Director, IRT Center of Excellence, Innovation Management, CSP & O, Daiichi Sankyo, Inc.
This presentation aims to empower teams at any stage of their Interactive Response Technology (IRT) journey by sharing effective strategies for enhancing collaboration. Attendees will learn practical tips for establishing global IRT standards, fostering alignment among study teams, and optimizing partnerships with internal and external collaborators. By promoting a culture of connectivity, the session will equip participants with the tools needed to streamline communication and enhance overall project success.
Automating Invoice Reconciliation for Clinical Trial Material Distribution
Anamika Sarkar, PhD, Intelligent Automation Lead, Global Development Solutions, Regeneron Pharmaceuticals, Inc.
Kyle Skillins, Associate Director, Clinical Drug Supply & Logistics, Regeneron Pharmaceuticals, Inc.
The Clinical Drug Supply and Logistics group at Regeneron faced significant challenges in reconciling a high volume of vendor invoices (3000-5000 per year) for distribution of clinical supply materials, which required significant manual effort. Regeneron has developed automation of reconciliation tasks, integrated with Clinical Supply information stored in IRT (Interactive Response Technology) using RPA (Robotic Process Automation) and AI (Artificial Intelligence) to bring efficiency in clinical trial financial compliance.
Talk Title to be Announced
LUNCHEON PRESENTATION: Enhancing Clinical Supply and Logistics to Advance Patient-Centric Care and DEI in Clinical Trials
Samit Bhatt, Vice President, Clinical Trial Patient Solutions, Myonex, Inc.
Clinical trials are critical to advancing medical innovation and improving patient outcomes. Attendees will gain insights into optimizing supply chain and logistics to improve the patient experience, emphasizing patient-centric approaches that align with the goals of DEI.
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!
THE CRITICAL ROLE OF COLLABORATION AND COMMUNICATION IN CLINICAL SUPPLIES MANAGEMENT
臨床サプライ管理におけるコラボレーション＆コミュニケーションの重要な役割
3:20 pmChairperson's Remarks (Sponsorship Opportunity Available)
Partnering with Internal Stakeholders and Vendors
Luis Vargas, IRT Manager, Global Clinical Drug Supply, Genmab US, Inc.
In today's dynamic organizational landscape, the ability to effectively partner with internal stakeholders and vendors is paramount to achieving organizational success. This discussion delves into the critical aspects of forming and nurturing these strategic alliances, providing insights and strategies to enhance collaboration, communication, and mutual benefit.
From Insight to Excellence: Leveraging Deep Domain Knowledge, Operational Leadership, and Clinical Supplies Expertise for Strategic Trial Success
Stephanie Russell, Senior Director RTSM Solution Services, Professional Services, Medidata, a Dassault Systemes Co.
This session will explore how deep industry expertise and operational leadership can transform clinical trial design and execution, ensuring strategic success. By leveraging adaptive approaches and real world experiences, it highlights how expert-led teams collaborate with study teams to overcome challenges, optimize outcomes and maintain trial integrity.
Key Learnings:
The importance of aligning trial design to anticipate and address challenges proactively.
How experienced teams help sponsors avoid common pitfalls, such as randomization errors, to ensure trial success.
Insights into navigating complex scenarios like First-In-Human (FIH) trials with expert-driven risk management.
The role of operational excellence in maintaining data integrity and trial credibility.
To Outsource or Not to Outsource, That Is the Question
Lisamarie Georgen, Senior Director Clinical Supplies Operations, MacroGenics, Inc.
Should you outsource Clinical Supplies Management? Should you keep Clinical Supplies Management in-house? Come join this presentation as we dive into the debate of outsourcing Clinical Supplies Management and discuss the pros and cons of each scenario.
Clinical Sample Logistics Best Practices
PAIN POINTS PANEL: Peer-to-Peer Resolutions
Lisamarie Georgen, Senior Director Clinical Supplies Operations, MacroGenics, Inc.
Clinical Supplies serves as the crucial link between numerous stakeholders, both internal and external. As clinical trials become increasingly complex, the pressure to deliver rapidly and efficiently intensifies. Consequently, Clinical Supplies teams are expected to be highly flexible and responsive. This session will delve into strategies for enhancing collaboration between Clinical Supplies and key partners, including Clinical Operations/Clinical Program teams, CMC/Manufacturing Teams, Vendors/CMOs, CDMOs, and IRT/RTSM developers.
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
Part 2: Clinical Supply Chain Strategies to Align Process, Products and Patients
パート2：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
LEVERAGING DATA TO SUPPORT UNIQUE CLINICAL SUPPLY CHAINS
8:50 amChairperson's Remarks (Sponsorship Opportunity Available)
8:55 amSponsored Presentation (Opportunity Available)
Cell Therapy Patient Operations: Enhancing Customer Experience Through Data-Driven Support
Michael Mehler, Director, Cell Therapy Operations, AstraZeneca
In cell and gene therapy, the vein-to-vein process involves multiple teams and touchpoints, requiring seamless coordination and robust data collection and analysis to ensure efficiency and patient success. For CGT clinical supply chain logistics professionals, data-driven insights help identify bottlenecks, optimize workflows, and improve decision-making across the supply chain. Manufacturers must provide consistent support throughout the entire journey, from apheresis to infusion, to ensure therapies are delivered on time. By combining high-touch operational support with data-driven insights, manufacturers can create a positive patient experience while improving the efficiency and reliability of cell therapy delivery.
Mitigating Risk and Complexity in Cell & Gene Therapy Trials with IRT
Cara Woodruff, Director, Product Management, IT Design & Development, Clinical Technologies, IQVIA Technologies
Cell and Gene Therapies (CGT) promise critical and transformative benefits to patients. However, even with record funding and new launches in this sector, trial and patient journey complexities pose significant barriers to the success and sustainability of these treatments. CGT pioneers require supply chain partnerships that deliver experience in mitigating trial risk and complexity, along with a consultative approach to protocol execution. Let’s explore how to succeed by optimizing pre-trial and pre-screening activities and reducing trial cost and risk with your IRT solution.
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
BUILDING THE SUPPLY INFRASTRUCTURE FOR CELL AND GENE THERAPIES
細胞治療・遺伝子治療向け供給インフラの構築
11:20 amChairperson's Remarks (Sponsorship Opportunity Available)
Ensuring Precision and Safety: Vein-to-Vein Tracking in Cell and Gene Therapy
Christine M. Fernandez, Consultant, Cell & Gene Therapy
Tracking cell and gene therapy (CGT) products from vein-to-vein is crucial to ensure their safety, efficacy, and regulatory compliance. Proper storage conditions and specialized containers are used to preserve cell products, with real-time tracking during transit to ensure timely and safe delivery to clinical sites. Before infusion, product identity and patient match are verified to ensure accuracy. Advanced tracking technologies enhance accuracy and data integration, facilitating seamless information flow. This comprehensive vein-to-vein tracking process underscores the critical role of precision and reliability in the successful delivery of CGT products.
Innovative Strategies for a More Robust (Yet Adaptable, Accessible, and Cost-Effective) Global Advanced Therapies Supply Chain
Lee Buckler, Senior Vice President, Advanced Therapies, Blood Centers of America
Cell therapies require unique and complex starting material, production, and affordability supply chain challenges. This presentation will discuss innovative strategies being tested and employed to optimise the production and delivery of these therapies to patients in community settings-outside of large urban research centers-across the globe.
Scaling CGT: Cracking the Supply Chain Code
Lee Buckler, Senior Vice President, Advanced Therapies, Blood Centers of America
The cell and gene therapy (CGT) supply chain presents distinct challenges that require specialized strategies. As demand for CGT continues to grow, scaling production while ensuring product integrity and quality is paramount. Success depends on maintaining cell viability and functionality throughout the process. This panel will focus on practical solutions for overcoming scaling obstacles, preserving product integrity, and fostering collaboration among stakeholders-spanning from patient to manufacturing and back.
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
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
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
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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
