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: Partner Selection and Trial Design
パート1：パートナー選定と試験デザイン
POWER-PLAYS: STRATEGIC PARTNERSHIPS FOR SMALL BIOPHARMA SUCCESS
パワープレイ：小規模バイオファーマの成功に対する戦略的パートナーシップ
Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma
This presentation will dive into the critical factors that small biopharma companies must consider when selecting partners for clinical trials. Peter will share insights on making the right choices to enhance efficiency, reduce risks, and drive growth, drawing from his extensive experience in the life sciences sector. His leadership and operational expertise will be invaluable as we enter our next phase of growth.
Strategic Partnerships for Accelerating Biotech Startups: From Pre-Clinical to Clinical Success
Alex Pastuszak, MD, PhD, Co-Founder & CEO, Paterna Biosciences
Gain insight into advancing pre-clinical biotech startups to clinical-stage companies through strategic partnerships from an industry leader with firsthand experience in the successes and challenges of these processes. In the biotech landscape, these collaborations, along with thoughtful vendor selection, are crucial for a startup's success. Partnering with reliable, niche top-tier service providers (contract research organizations) and specialized vendors allows startups to leverage cutting-edge technologies and regulatory expertise, facilitating seamless transitions between development stages. Early engagement with trusted partners streamlines research, optimizes resources, mitigates risks, and establishes a strong foundation for accelerated clinical progress. These partnerships not only drive operational efficiency but also spark innovation, positioning biotech startups for long-term success in a very competitive market with rigorous regulatory requirements.
CRO Selection-Finding the Right Fit
Brandie M. Jonas, MS, Senior Director, Program Management, Geron Corporation
It can feel overwhelming for a small biotech or biopharma company to find the right CRO fit as there are so many options these days. I've developed and implemented a strategy and tool kit that will enable CRO evaluation and ultimately lead to selecting a CRO who is fit-for-purpose.
Optimizing CRO Partnerships for Small Biopharma Success
Melanie Goodwin, Director, Clinical Outsourcing, Immunocore
Choosing the right (CRO) is critical for the success of clinical operations, especially for small biopharma companies. This presentation outlines a strategic approach to CRO selection, beginning with a comprehensive set-up of requirements and a thorough landscape analysis. By narrowing down potential CROs, and rigorously questioning to ensure alignment with your company's goals, we reveal how to streamline the selection process. Discover how taking a methodical and tailored approach can lead to a partnership that meets your specific needs.
Small Yet Mighty: The Critical Role of Study Start-Up Tech for Small Biopharma
Ashley Davidson, Vice President, Product Lead, Advarra
In this session, we will explore why site-centric study startup technology is essential for small biopharma companies, highlighting the significant ROI and streamlined workflow it offers for sites and study teams alike. Additionally, we'll emphasize the importance of site centricity, showing how focusing on site needs and challenges can enhance trial success and patient experiences. We'll delve into specific projects to show how site-centric technology helps smaller organizations achieve efficient study start-ups, demonstrating why investing in this tech is crucial for staying competitive in today's fast-paced biopharma and biotechnology landscape.
FDA's Diversity Guidance & Small BioPharma: Total Quality Management Lesson for Representative Recruitment
Dan Brenner, CEO & Founder, Business Development, 1nHealth
Sponsors progressing assets through the clinical development cycle are seeking to cut through the industry buzz words and noise to properly comply with the FDA's guidance on diversity and representation in clinical trials. Most sponsors have a plan, some execute it, but even fewer achieve their diversity objectives. 1nHealth has successfully supported some of the most significant studies to date by supporting recruitment to diversity cohort targets.
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!
PRECISION PLANNING: MASTERING CLINICAL TRIALS FOR SMALL BIOPHARMA BREAKTHROUGHS
精密計画：小規模バイオファーマのブレークスルーに対する臨床試験のマスター
Adopting a Hybrid FSP Model in a Fast-Paced Clinical Trial Environment
Galderma has implemented a hybrid Functional Service Provider (FSP) model for select clinical trials, outsourcing specific functions while still maintaining control over data and processes. This hybrid approach blends sponsor, CRO, and vendor tools and technologies. It allows increased oversight of quality and compliance and leverages in-house expertise with an expanded pool of specialized talent through the FSP provider. This presentation will highlight the pros and cons of implementing a hybrid FSP model in a fast-paced clinical trial environment with tight timelines and lean in-house cross-functional teams.
Trial Planning for Small- & Mid-Sized Biotechs: Free of Legacy Systems and Processes-But Short on Time and Money
Suzanne Vyvoda, COO, Ensho Therapeutics
Each clinical trial is unique. However, something small- and mid-sized biopharma companies have in common is the need to plan and execute trials in a way that does not mimic the contracts, budgets, and processes of typical bigger pharma and CRO partners. The smaller players often have a small clinical team and they want a CRO that understands their needs and knows how they are different. These smaller companies have the freedom to innovate-what to outsource and when, what capabilities and functions to build and why, who to partner with and how to find them, etc., but with this freedom comes the burden of creating on the go.
Streamlining Trial Planning for Small Biotechs: Key Lessons to Maximize Impact on a Tight Budget
Jeffrey S. Yablon, Head Business Development & Strategic Operations, Ubuntu Research, Inc.
This presentation will provide practical strategies for clinical operations executives in small and mid-sized biotech companies to overcome common trial planning hurdles. Presenters will share valuable lessons learned, offering actionable insights into how small biotechs can leverage limited resources effectively. Topics include optimizing trial processes, driving clinical proof of concept, and navigating partnerships-while avoiding the inefficiencies of legacy systems. Attendees will leave with clear, implementable tactics to streamline operations, reduce costs, and accelerate trial success.
Managing Your Clinical Trial Effectively: Engaging Patients and Sites for Success
Explore how small biopharma companies can achieve clinical trial success using tools that effectively engage patients and sites. Using a case study of a fully remote study, we will discuss the unique challenges faced by small biopharma, such as limited resources and short timelines, and how an integrated eClinical solution can help overcome these obstacles. Join us to learn how to transform clinical trial processes and drive success.
Blueprints for Success: Trial Planning & Design Insights from a Small Biopharma Leader
Kevin Eisenfrats, Founder & CEO, Contraline, Inc.
Gain actionable insights into clinical trial planning and design from Kevin, CEO and co-founder of Contraline. With over $30M in funding and a groundbreaking product in reproductive health, Kevin will share key takeaways and lessons learned from leading a biotech startup through the journey from concept to clinical stage. This session is a must for clinical operations executives launching and running trials.
Protocol and Feasibility Simulations to Optimize Trial Planning
Leverage protocol simulations and strategic tech partnerships to enhance trial predictability and streamline planning.
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
MANAGING DATA INDEPENDENTLY
データを独立して管理
Securing Clinical Trial Data: Navigating Cyber Threats and Regulatory Challenge
Christopher Hart, Partner, Co-Chair, Privacy and Data Security Group, Foley Hoag LLP
As clinical trials become more data-dependent, the risk of cybersecurity threats grows, especially in a shifting legal landscape with increasing multi-jurisdictional complexities. For clinical operations executives, staying ahead of regulatory changes is crucial to ensure data security and compliance. Chris Hart, Partner at Foley Hoag LLP, will discuss how small biopharma can proactively address cybersecurity, build robust data infrastructure, and strategically select outsourcing partners to safeguard clinical trial data.
Navigating the Diverse Future of Trial Data: Real World Data & Devices
Gaelan Ritter, Executive Director, Innovation and Digital Health Analytics, Bristol Myers Squibb Co.
The evidence generation required for clinical development is evolving rapidly. Many trials include various data types and sources, labs, biomarkers, wearable devices, real world EHR, and others. It is critical to understand the opportunities and risks inherent with those new sources, and know how to utilize and manage them effectively. Gaelan will discuss the current and future state of these data types, how to think about strategic partnerships with vendors in these areas, and how to navigate the evidence planning required to drive value in the integrated data future.
9:55 amSponsored Presentation (Opportunity Available)
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
Chairperson's RemarksRequirements for Managing Clinical and Non-Clinical Data
Empowering Success in Small Pharma/Biotech: Leveraging People and Process for Optimal Results
Sheila Gwizdak, Vice President, Head of Consulting, Halloran Consulting Group
This session will provide insights on how best to align people with process, essential for fostering innovation and sustainable growth. Learn how to strategically integrate human capital with process optimization, a cornerstone for success in the small pharma sector. Leveraging real-world examples and best practices, learn how organizations can effectively harness the potential of their teams-promoting a culture of collaboration and continuous improvement. We will focus on process-driven strategies that streamline operations, enhance quality control, and expedite time-to-market, all while maintaining high standards of quality and regulatory compliance.
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
Part 2: Vendor Oversight & Resource Management
パート2：ベンダー監視・リソース管理
KEY STRATEGIES FOR SMALL & MIDSIZE BIOPHARMA SUCCESS FOR FUTURE PLANNING
製薬企業の買収をナビゲート：中小規模のバイオファーマを成功に導く主要戦略
8:20 amChairperson's Remarks (Sponsorship Opportunity Available)
Mastering Acquisitions: A Clinical Ops Guide to Successful Biopharma Transitions
Scott T. Megaffin, CEO, Adiso Therapeutics
oin a seasoned C-level leader as they outline the key steps clinical operations executives need to navigate when a small biopharma company is acquired. This session will cover how to evaluate and integrate acquisition opportunities, manage operational transitions, and ensure data continuity. Gain practical strategies for maintaining clinical trial integrity, optimizing resources, and leveraging acquisitions to strengthen your company’s market position and drive sustainable growth.
Weathering the Drama of Change in Biotech: A Clinical Operations Perspective
Valerie Reynaert, Vice President, Global Clinical Operations, Immunocore
Join us for an insightful session on navigating the turbulent waters of change in the biotech industry. From mergers and acquisitions to going public, dramatic portfolio shifts, and new co-development ventures, learn how to build robust strategies to manage these significant transitions. Gain practical insights and actionable strategies from clinical operations experts who have successfully steered their organizations through these challenges. Don’t miss this opportunity to equip yourself with the tools to thrive amidst the drama of change!
Faster Submissions, Smarter Workflows: Lessons from Sanofi’s AI-Powered Translation StrategyGeorges Tavares, Clinical Translation Services Global Manager, Sanofi
In this session, learn how Sanofi has transformed its translation processes using centralized management by expert project managers, automated workflows, and integration of TransPerfect’s GlobalLink platform with Veeva eTMF. You’ll gain insights into Sanofi’s pragmatic, phased approach, including leveraging automation and AI-powered workflows. The result is a dynamic digital ecosystem that captures feedback, drives continuous improvement, and achieves over 30% savings in time and resources. Join us to hear actionable strategies you can take back to your teams to accelerate timelines, enhance inspection-readiness, and cut costs.
DEMONSTRATING VALUE OF CLINICAL OPERATIONS TO THE C-SUITE
臨床業務の価値を経営陣に実証
Talk Title to be AnnouncedAdvocating for Clinical Operations before Clinical Development
11:10 amNetworking Coffee Break
TACKLING OPERATIONAL CHALLENGES IN OUTSOURCING FROM START TO FINISH: STRATEGIES FOR EFFECTIVE TRIAL EXECUTION
アウトソーシングにおける業務上の課題に最初から最後まで取り組む：効果的な試験実行の戦略
Chairperson's RemarksStrengthening Sponsor-Site Partnerships in Outsourced Trials
Liza Micioni, Senior Director, Head of Clinical Operations, Tris Pharma
In fully outsourced trials, sponsor-site relationships might seem less critical-but are they? For small biopharmas, especially new players, these relationships can be pivotal. Shouldn't the CRO handle this? Why should sites care? Discover why building strong sponsor-site connections still matters and how it can make a difference in your trial's success.
Creating and Leveraging an Outsourcing Strategy for Smaller Biotechs
Bridging the Gap: A Case Study in Hiring through Bridge Programs and the Impact on Clinical Operations Effectiveness
Carrie Lewis, Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
The pharmaceutical industry has faced a number of challenges related to hiring the right candidates with the right skills and retaining them since the COVID pandemic introduced a whole new way of working. How can pharma and biotech companies think outside the box and hire candidates interested in entering clinical research but may not have the industry experience? How do these companies then retain these employees and grow their careers? How can hiring, training, and growing employees be done in a way to minimize the impact to ongoing trials? This case study will explore how Endo utilized a bridge program to find employees that ultimately thrive in the workplace.
1:25 pmTransition to Lunch
1:30 pmLuncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
2:00 pmSCOPE Summit 2025 Adjourns
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
アジェンダ・講演者・スポンサー更新
2025年 プログラム
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Sunday Golf, Kick-Off Keynote & Participant Engagement Award
月曜のゴルフ、キックオフ基調講演、参加者エンゲージメント賞
◆SCOPE’s Kickoff Reception
SCOPEによるキックオフレセプション
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Patient Voice in Trial Design and Protocol Development
試験デザインとプロトコル開発における患者の声
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Developing and Executing Effective Diversity Plans
効果的な多様性計画の策定と実行
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Enrollment Planning and Patient Recruitment
登録計画・被験者募集
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Patient Engagement and Retention through Communities and Technology
コミュニティ・技術による被験者エンゲージメントとリテンション
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Clinical Trial Forecasting, Budgeting and Contracting
臨床試験の予測・予算編成・契約
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Resource Management and Capacity Planning for Clinical Trials
臨床試験のリソース管理・キャパシティプランニング
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Mastering an Outsourcing Strategy
アウトソーシング戦略のマスター
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Relationship and Alliance Management in Outsourced Clinical Trials
臨床試験アウトソーシングにおける関係と提携管理
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Modernizing Lab, Biomarker & Data Management Operations
ラボ・バイオマーカー・データ管理業務の近代化
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Biomarker & Biospecimen Technology & Innovation
バイオマーカー・バイオ試料の技術とイノベーション
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Data Technology for End-to-End Clinical Supply Management
E2Eの臨床サプライ管理向けデータ技術
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Clinical Supply Chain Strategies to Align Process, Products and Patients
臨床サプライチェーン戦略でプロセス・製品・被験者を連携
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Clinical Trial Venture, Innovation & Partnering *
臨床試験のベンチャー・イノベーション・提携 *
*Separate Registration Required
