Decentralized & Hybrid - 2025 Archive

2025 ARCHIVES

SCOPE’s 14th Annual Decentralized & Hybrid stream brings together leaders in clinical innovation to discuss best practices and winning strategies for decentralized and hybrid trials. Industry leaders will share their insights on the state and future of decentralized and hybrid trials as well as innovative research strategies. Conversations will focus on novel DCT approaches, reducing site and patient burden with hybrid approaches, expanding trial access, and modernizing trial conduct. The stream includes two unique parts, each of which focuses on enabling trial modernization as clinical research needs evolve.

Part 1: Decentralized and Hybrid Trials

Part 2: DCTs and Clinical Innovation

Monday, February 3

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)

12:00 pm– 4:00 pm WORKSHOP 1: 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: Learn more and register here.

1:00 pm– 1:45 pm WORKSHOP 2: Exploring ClinEco—SCOPE’s Growing Online B2B Clinical Trial Community

PRESENTERS:
Marina Filshstinsky, MD, Executive Director, SCOPE Summit; Co-Founder, ClinEco
Micah Lieberman, Executive Director and Team Lead, SCOPE Summit; Co-Founder, ClinEco
Erik Yorke, Marketing Lead and Scientific Writer, ClinEco

Discover how you can stay connected and extend your SCOPE conference conversations year-round in this interactive workshop focused on ClinEco—the dynamic online B2B marketplace bringing together sponsors, CROs, site networks, and innovative solution providers to streamline partnering.

This workshop will help you understand how to take full advantage of ClinEco’s capabilities. Through real-world case studies, we'll demonstrate how ClinEco members streamlined their outsourcing processes, discovered new partners, and expanded their global reach. Whether you're a sponsor seeking new collaborations or a vendor looking to stand out, this session will provide actionable insights to boost your success.

Join us to experience the future of clinical trial networking and collaboration!

1:00 pm– 2:30 pm WORKSHOP 3: 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

Hannah Sieber, Co-Founder, CEO, Artyc

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 4: 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.
Brandy Porter, Assistant Director, Pharmaceuticals, Health, and Chemicals Center of Excellence & Expertise, U.S. Customs and Border Protection
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 5: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing

INSTRUCTORS:
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.

3:50 pm

Organizer's Welcome Remarks & 4th Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

3:58 pm

Chairperson's Introduction

Jenny Denney, Executive Vice President, Global Head Parexel FSP, Parexel

4:00 pm KEYNOTE PRESENTATION:

Fast-Forward to 2035: What Success Could Look like in Converging Clinical Research and Care—And How to Get There

Janice Chang, CEO, TransCelerate Biopharma, Inc.

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.

4:25 pm

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!

https://www.scopesummit.com/faq-how-to-succeed-at-scope

4:33 pm

Chairperson's Introduction

Fiona Geiger, Vice President, Operational Delivery, Operations, Endpoint Clinical, Inc.

4:35 pm INTERACTIVE KEYNOTE PANEL:

What Do Real Patients Actually Talk About?

PANEL MODERATOR:

T. Hephner, CRO, Inspire

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.

PANELISTS:

Emily McCormack, Social Media Director, New York Blood Center Enterprises

Fabian Sandoval, PhD, President & CEO, Emerson Clinical Research Institute

Quynh Tran, Director of Patient Activation, Cystic Fibrosis Foundation

5:05 pmSCOPE's 9th Annual Participant Engagement Awards Introduction (Sponsorship Opportunity Available)

5:10 pm

SCOPE's 9th Annual Participant Engagement Awards

PANEL MODERATORS:

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

Kelly McKee, Head of Innovative Patient Recruitment, Evinova, an AstraZeneca Company; Co-Creator of the SCOPE Participant Engagement Award

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

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

PANELISTS:

Tricia Barrett, CEO, Praxis

Brian Burkhardt, Co-Founder & Executive Director, Oliver Patch Project, Inc.

Michelle Everill, Vice President, Global Trial Optimization, Alnylam Pharmaceuticals

Gretchen Goller, Head, Enrollment Strategy, Oncology, Pfizer Inc.

Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative

Stacy Hurt, Chief Patient Officer, Patient Engagement, Parexel International

Kim Ribeiro, Chief Client Officer, Inside Edge Consulting Group

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

Tuesday, February 4

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.

8:25 amGrab Your Seat: Early-Bird Seat Raffle & Prize Giveaway! * (Sponsorship Opportunity Available)

*Must be present to win.

8:30 am

Welcome to SCOPE 2025—Who’s Here and Why, What’s New, Annual Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

8:40 am

Chairperson's Introduction

Jonathan Rowe, Principal & Head, R&D Quality Operations & Risk Management, ZS Associates, Inc.

8:42 am KEYNOTE PRESENTATION:

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”?

9:10 am THE CLINICAL TRIAL DATING GAME:

Beyond the Real-World Data, What Are Patients Saying?
Special LIVE Episode with Studio Audience–Patient Contestants will be Announced Onsite!

Brett Kleger, CEO, Inspire

The Bachelor: Kristopher Sarajian, Vice President, Marketing, Trialbee

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?

9:20 am KEYNOTE PANEL DISCUSSION:

How Patients Can—and Must—Disrupt Traditional Pharma Clinical Trials

PANEL MODERATOR:

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?

PANELISTS:

Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL

Heidi Bjornson-Pennell, Senior Program Manager, Science in Society and Lead, Rare As One Network, Chan Zuckerberg Initiative LLC

Nasha Fitter, Co-Founder & CEO, FOXG1 Research Foundation

Craig Martin, Founder, CEO, The Orphan Therapeutics Accelerator

Tracey U. Sikora, Vice President, Research & Clinical Programs, National Organization for Rare Disorders; Co-Founder, Every Cure

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: Decentralized and Hybrid Trials

11:00 am Chairperson's Remarks

Scott Dixon, Chief Commercial Officer, mdgroup

11:05 am

Accelerating Drug Development through Clinical Trial Delivery Innovation

Kim O'Day, Senior Director, Emerging Technology Operations, Clinical Trial Foundations, Eli Lilly & Co.

Participants will identify key learnings from the use of innovative research methods used to execute clinical trials in Patient Engagement and Decreased Patient/Investigator Burden. Attendees will hear specific examples of where innovative strategies were successful and understand future applications for clinical trial innovation.

11:30 am

Statistical Considerations for Effective Decentralized Clinical Trials

Charmaine Demanuele, PhD, Executive Director, AI/ML, Quantitative & Digital Sciences, Pfizer Research & Development

Decentralized Clinical Trials (DCTs) offer a patient-centered approach to engage with participants in the convenience of their homes or communities, utilizing digital health technologies (DHTs) and innovative data collection methods. DCTs provide patients with greater flexibility, reduce the need for frequent study visits, lower costs, facilitate recruitment of diverse patient populations, and potentially improve participant compliance. This presentation aims to highlight key statistical considerations involved in the design and implementation of DCTs, including selecting appropriate data types and DHTs for remote data collection, assessing data quality and completeness, determining relevant endpoints, estimating data heterogeneity, and handling missing data. We will also outline suggestions and valuable insights gained from previous DCT studies to effectively address these challenges

11:55 am

From Concept to Reality: Innovation and Use Cases in Trials with Decentralized Approaches

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, CEO, 4Biosolutions Consulting (Sci/Clin/Reg Affairs) & Co-Chair, EEE-SA, Clinical Trial Technology Modernization Network (CTTMN)

Anna H. Yang, PharmD, Clinical Innovation & Technology Leader, Genentech, Inc.

This presentation provides key information and explores innovations in DCTs, highlighting their impact on revolutionizing medical product development globally. We’ll examine technologies and trends supporting DCTs, including regional adaptations. Two trials will showcase real-world applications, logistical outcomes, challenges, and metrics impacting trial efficiency and data quality. Join us to discover how DCTs transform patient-centric clinical research and shape the future of healthcare innovation.

12:20 pm

ROI: Return on Innovation – a Model for Avoiding Distraction in a World of BSOs (Bright Shiny Objects)

Alex Simmonds, Global Drug Development Innovation Lead, R&D, Bristol Myers Squibb Co

Innovation in digital and data has yielded great benefits over human history but the term "creative destruction" does not just connote the displacement of incumbent ways of working, but also the folly of adopting too early. In this presentation, I will suggest a third option—a focus on solving the most pressing problems of the pharmaceutical development business, using the least possible amount of its capacity for change.

12:35 pm

Unsupervised Risk Detection in Decentralized Clinical Trials

Laura Trotta, Vice President, Research, Research Operations & Statistical Innovation, CluePoints SA

Unsupervised Risk Detection in DCTs

1:05 pm

Being Pragmatic About Pragmatic Trials

Drew Garty, CTO, Clinical Data Management, Veeva Systems

Gracy Crane, Senior Principal Scientist, Roche Products Ltd.

Chris Komelasky, CEO and Co-Founder, SiteBridge Research

Catherine Richards, PhD, MPH, President and COO, OM1

The growing interest around Pragmatic Clinical Trials (PCTs) is about more than assessing interventions within routine clinical settings. It also reflects an appetite for greater pragmatism in our clinical technologies and processes. What are the key differences between traditional clinical trials and pragmatic trials in real-world settings? Explore strategies for maximizing patient and site benefits, modernizing clinical data infrastructures, and moving Pragmatic Clinical Trials forward with industry experts.

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!

3:20 pm Chairperson's Remarks

Melissa Nezos, Executive Vice President, Clinical Operations, Firma Clinical Research

3:25 pm

Double Jeopardy! When Oncology DCTs Are Not the Answer, Are We Asking the Right Question?

Peter O'Neill, Vice President, Clinical Operations, TuHURA Biosciences

In the game show Jeopardy, contestants are given the answer first and must determine the right question. In the world of oncology clinical trials, decentralized clinical trials (DCTs) are often presented as the answer, but are we sure we’re asking the right questions? This session will explore the limitations of DCTs in oncology and delve into how emerging innovations like digital twins may provide the missing answers that DCTs cannot. By rethinking our approach, can we finally align the right questions with the right tools?

3:55 pm

Using Innovation and Hybrid Approaches in Oncology to Lessen Site and Patient Burden

Laurie Berry, PhD, Director, Strategic Solutions, Pfizer Inc.

Gretchen Goller, Head, Enrollment Strategy, Oncology, Pfizer Inc.

How can you improve the quality of your tools/toolbox for oncology patients? What tools are most used for oncology studies/what makes sense for oncology studies? How can we prepare for the future? The way in which we engage with today’s patients will not be the way in which we engage with tomorrow’s patient; how can we set ourselves up for success for that transition?

4:25 pm

Exploring eClinical Innovations: Enhancing the Patient Journey and Driving Clinical Trial Efficiency

Andres Escallon, Vice President, eCOA Solutions Strategy, Suvoda

Explore practical technology innovations that ease the clinical trial patient journey and advance health outcomes.

Learn what drives successful technology uptake among sponsors, sites, and patients.

Discover how patient feedback shapes technology solutions for a smoother trial experience.

Explore AI-driven eClinical technologies to enhance trial efficiency and simplify patient interactions, from Consent to reimbursement.

4:55 pm PANEL DISCUSSION:

Innovation and Hybrid Approaches for Oncology DCTs

PANEL MODERATOR:

Gretchen Goller, Head, Enrollment Strategy, Oncology, Pfizer Inc.

PANELISTS:

Peter O'Neill, Vice President, Clinical Operations, TuHURA Biosciences

Laurie Berry, PhD, Director, Strategic Solutions, Pfizer Inc.

Rochelle Williams-Belizaire, MPH, CPH, US Oncology Strategy Lead, Diversity in Clinical Trials, Boehringer-Ingelheim

5:25 pm

Setting the Tone for the Patient and Site Journey

Steve Rosenberg, CEO, uMotif

No one can dispute that the patient must be the center of clinical trials and sites the linchpin.

Patient advocacy groups have more influence on study design. The industry is investing in Chief Patient Officer roles. Site networks are consolidating. CROs are expanding and buying sites.

What’s missing, however, is a focus on enhancing the patient/site relationship.

This session explores the state of technology that supports the patient and site experience, successes/gaps, and concrete next steps.

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.

Wednesday, February 5

7:45 amRegistration Open

8:15 am

BREAKFAST PRESENTATION OPTION #1:Digital Innovation’s Role in Pediatric and Elderly Clinical Trials

Kyle Hogan, CEO, 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.

8:15 am

BREAKFAST PRESENTATION OPTION #2:Expanding the Patient Universe: Transforming Clinical Trials through Inclusive, Data-Driven Design

Christopher 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.

8:15 am

BREAKFAST PRESENTATION OPTION #3:

Scaling Success: How Sanofi and Trialbee Drive Patient-Centric Recruitment and Reduce Site Burden in Global Asthma Programs

Whitley Albright, Clinical Innovation and Operations Strategy Lead, Sanofi

Gaynor Anders, Chief Delivery Officer, Trialbee

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

8:50 am Chairperson's Remarks

Donna Mongiello, Senior Vice President, eCOA Strategy, Commercial, YPrime

8:55 am

Representation in Recruitment at Retail Pharmacy

Jim Carroll, Head, Real World Evidence & Clinical Trials, Walgreens

With the recent OIG report and latest FDA guidance on Diversity Action Plans, there is a heightened awareness around improving representation in clinical research. Walgreens will share recent case studies and success stories demonstrating the value of including a retail pharmacy-based approach in your recruitment plan.

9:15 am PANEL DISCUSSION:

Decentralized Clinical Trial Elements to Improve Participant Access and Representation

PANEL MODERATOR:

Marjorie Zettler, PhD, MPH, Consultant, Clinical Sciences, Conjugate Group

The potential for decentralized or hybrid clinical trials to mitigate disparities has received much attention, but are DCTs/hybrid trial populations actually more representative than those of traditional site-based trials? With increased emphasis on diversity in registrational clinical trials, can the use of DCT elements serve as one strategy to effect change? This panel discussion will explore opportunities and challenges in deploying DCT solutions to promote more representative clinical trials.

PANELISTS:

Aneta Woroniecka-Osio, MD, Decentralized Clinical Trial (DCT) Strategy Development Lead, Bayer

Brad Hightower, CEO, Hightower Clinical

Abigail Dirks, MS, Data Scientist, Center for the Study of Drug Development (CSDD), Tufts University

9:55 am

How Medable is Making the Design, Configuration and Launch of Studies Easier, More Efficient, and with Better Outcomes

Andrew Mackinnon, Senior Vice President & Executive General Manager, Customer Value, Medable, Inc.

Christina Fawcett, Dir Digital Engagement & Implementation, Global Clinical Ops & Dev, GSK

Medable Studio is a fully featured SaaS suite of study design, configuration, translation and launch tools that enables easy and efficient study builds. In this presentation Medable, with a partner from a key customer, will talk about design best practice, how Studio has enabled faster study launch, and the adherence and satisfaction outcomes that have been observed in live studies.

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 #1

11:20 am

Chairperson's Remarks

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, CEO, 4Biosolutions Consulting (Sci/Clin/Reg Affairs) & Co-Chair, EEE-SA, Clinical Trial Technology Modernization Network (CTTMN)

11:25 am

Through the Looking Glass of the Site Journey: Navigating Decentralized Clinical Trials

Deena E Bernstein, Vice President, Site Choice Account Development, TPS Global

Carlos E Orantes, CEO, Alcanza Clinical Research

We'll explore the clinical research site journey in decentralized clinical trials. We'll unpack the challenges behind DCT implementation through real-world examples and candid site feedback. This session will offer sponsors and tech vendors insight into the site journey and experience, highlighting opportunities to reduce site burden and optimize site and patient adoption of DCTs.

11:40 am

The Triple Lens and Dual Roles of Decentralized Trials: Insights from Patients, Providers, and Researchers

Faith Holmes, CMO, Medical Affairs, Elligo Health Research

We will approach the efficiencies and agility of decentralized trial models from the perspective of the patient/study participant, the medical provider/principal investigator, and the CRO/sponsor. Using a central core team as a single point of contact for contracts, budgets, regulatory, and managing the participant journey throughout the study with fit-for-purpose technology and processes.

12:10 pm PANEL DISCUSSION:

Decreasing Site Burden to Adopt DCT Methods

PANEL MODERATOR:

Jane Myles, Co-Lead, Priority Initiative 3B, DCT Playbook, Decentralized Trials & Research Alliance (DTRA)

Please join us for a panel discussion focused on the ongoing efforts to address site needs and reduce barriers to Decentralized Clinical Trial methods (DCT) adoption. Expert panelists and the audience will discuss relevant perspectives on how partnering with sites can help to enable fit-for-purpose clinical trials for the patient, sponsor, site, and ecosystem stakeholders.

PANELISTS:

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)

Sylvie Kruyner, Clinical Operations Manager & DCT Advisor, Bayer Pharmaceuticals

Caroline Redeker, Chief Strategy Officer, Advanced Clinical

Joe Dustin, Founder & Managing Partner, eClinical Consulting

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!

2:30 pm

SCOPE around the World, Faces from the Community

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute; Co-Founder, ClinEco

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

2:35 pm

Chairperson's Introduction

Brad Stefanovic, PhD, Head Clinical Innovation, Pro-ficiency, a Simulations Plus Company

2:37 pm KEYNOTE PRESENTATION:

Fostering Clinical Innovation in a Large Pharmaceutical Organization

James Gallagher, Senior Director, Innovative Health, 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.

3:00 pm KEYNOTE PRESENTATION:

Harnessing Tech & AI for Quality and Performance in Clinical Trial Operations

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.

3:20 pm

SCOPE Award Winners & Announcements

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

3:25 pmSponsored Presentation (Opportunity Available)

3:30 pm KEYNOTE PANEL DISCUSSION:

The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond

PANEL MODERATOR:

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.

PANELISTS:

James Gallagher, Senior Director, Innovative Health, Johnson & Johnson Innovative Medicine

Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.

Brian Martin, Chief AI Product Owner, BTS; Head of AI, R&D Information Research; Senior Research Fellow, AbbVie, Inc.

Demetris Zambas, Vice President & Global Head, Clinical Data Sciences, Pfizer Inc.

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.

Thursday, February 6

7:15 amRegistration Open

7:45 am

BREAKFAST PRESENTATION:What Sites Really Need to Deliver Successful Patient Engagement Strategies

Leslie Ives, Senior Director, Patient Recruitment, Patient Strategy and Insights, Parexel International

Brittany Harvey, Clinical Project Mgr, Clinical Operations, UCB Inc

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites

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: DCTs and Clinical Innovation

8:20 am

Chairperson's Remarks

Lamisa Parkar, Group Vice President, Business Planning and Development, Oracle

8:25 am

Incorporation of Decentralized Clinical Trial Components in Early Clinical Trial Planning

Jessica Marer, Director, Global Clinical Operations, Trial Optimization and Planning, Teva Pharmaceutical Industries Ltd.

Attendees will be presented a key element in the incorporation of decentralized components: the planning. Attendees will hear how developing a 3-step strategy (explore, evaluate, and implement) may drive successful implementation of decentralized components into clinical trials.

8:45 am PANEL DISCUSSION:

Recognizing, Classifying, and Mitigating Patient and Site Burden Induced by Digital Health Technologies in Clinical Trials

PANEL MODERATOR:

Krista Russell, Head Digital Health Solutions, Takeda Pharmaceuticals

Developing a strategy and implementation of modern Digital Health Technologies for collecting data in clinical trials presents vast opportunities for patients and discovery of data not previously available. However, new challenges are also introduced that present burden across the care continuum sponsor, clinical sites, and study participants. In this presentation, we pinpoint various root causes of DHT-induced burden and suggest strategies to ensuring an optimal experience for stakeholders involved.

PANELISTS:

Sophie Bartram, Fourth Year Undergraduate Student, Health Sciences Studies, Ohio State University

Andrea Paraboschi, PhD, Associate Director, Digital Solutions, Takeda

9:25 am

Simpler, Faster Trials Using Patient-Centric Solutions for Blood-Based Data Collection

Erwin Berthier, PhD, CTO, Tasso, Inc.

Clinical trial success hinges on well-coordinated data collection before, during, and after the trial occurs. Technologies that enable data collection at home can improve patient engagement and data density. In this presentation, we expand on learnings from the implementation of leading remote, patient centric blood testing solutions in clinical trials. We provide insight on key features and strategies that drive patient engagement, operational success, and high-quality data collection.

9:40 am

Transforming Recruitment: Harnessing Community Research Sites to Engage Rare CKD Populations

Jack Evans, Vice President, Site Operations, EmVenio Research

This presentation will explore the use of community-based research sites to recruit rare participants for Chronic Kidney Disease (CKD) studies, with a focus on those with the APOL-1 genotype. We will delve into the strategic selection of site locations and the critical role of community engagement in fostering trust and participation. By leveraging diverse site placements, we will demonstrate how we have effectively connected with underrepresented populations, expanding access to clinical trials and enhancing recruitment for precision medicine.

10:10 am PANEL DISCUSSION:

Access for All: How HCPs Are the Key to Changing Clinical Trial Participation

PANEL MODERATOR:

Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)

This panel will explore engaging healthcare professionals (HCPs) in clinical research, featuring HCPs and representatives from community care organizations (CCOs). Discussion will focus on HCPs' interest in participating, the roles they might perform, and the barriers to their involvement. Panelists will share insights on strategies to facilitate HCP participation in research, aiming to enhance collaboration and improve clinical trial recruitment and diversity.

PANELISTS:

Shelly Barnes, Global Clinical Innovations and Digital Lead, UCB

Joe O'Rourke, Head, Commercial Development, RWE Clinical Trials, Walgreens

Hassan Kadhim, Head of Clinical Operations and Development Business Capabilities, Vertex Pharmaceuticals

10:40 am

Decentralized Clinical Trials from the World-Saving Idea to the Inevitable Reality

Istvan Attila Kerekes, PharmD, Senior Clinical Project Manager, Global Medical Division, Global Clinical Operations, Gedeon Richter Plc

This presentation will give an overview and describe the planned and unexpected obstacles experienced during a Phase 2 exploratory clinical study that implemented a hybrid study design including telehealth visits, home visits, and electronic patient outcome measurements. The presentation would detail the reason for implementing such hybrid approach and show solutions for risk mitigation and actions taken to resolve arising issues during the study. Lessons learned from two other case studies will be also presented.

11:10 amNetworking Coffee Break

11:50 am

Chairperson's Remarks

Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative

11:55 am

Applying Social Determinants of Health (SDoH) in Clinical Study Planning and Execution

Daoying Hu, PhD, MBA, Director, Data Science and Digital Health, Johnson & Johnson Innovative Medicine

SDoH data can enhance our understanding of the barriers to participation in clinical trials and improve access for study participants. This presentation examines various types of SDoH data for site and patient strategies, and discusses how to effectively leverage these insights in clinical studies.

12:25 pm PANEL DISCUSSION:

Achieving Flexibility and Expanding Access While Preserving Data Quality

PANEL MODERATOR:

Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative

Is trial flexibility truly a threat to data quality? Concerns are often raised that offering flexible approaches to clinical trial design and conduct, such as collecting data in various settings and offering a flexible schedule of visits, will result in risks to data quality. This session will explore multi-partner perceptions around when and how data quality is maintained when flexible approaches are introduced and how flexibility can improve access to clinical trials.

PANELISTS:

Pamela Tenaerts, MD, MBA, CSO, Medable

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)

Wes Burian, Patient

1:25 pmTransition to Lunch

1:30 pm

LUNCHEON PRESENTATION: From Sync to Swim: Alimentiv’s Journey with Zelta ePRO

Wes Fishburne, Principal Product Manager, Zelta by Merative

Chris Walker, Director, Data Sciences, Alimentiv

Amid growing responsibilities and expanding clinical operations, data managers are increasingly challenged by the increasing number of eClinical solutions required to support a clinical trial. Join us to learn how the data managers at Alimentiv have leveraged Zelta’s ePRO module to streamline their eClinical data collection scheme to include patient-reported outcomes with the rest of their study data, achieving more control over their clinical trials and confidence in their outcomes. 

2:00 pmSCOPE Summit 2025 Adjourns