Feasibility & Study Start-Up

2025 ARCHIVES

Data-Informed Feasibility and Investigator Selection

Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

Identifying the right sites and implementing processes to streamline site activation, start-up, and operations is a complex and challenging endeavor. The convergence of evolving regulations, patient- and site-centric practices, DEI initiatives, real-world data, advanced analytics, and digital and decentralized models are reshaping traditional feasibility approaches. SCOPE’s 15th Annual Feasibility & Study Start-Up stream will address these challenges by exploring innovative strategies and methodologies. The Data-Informed Feasibility and Investigator Selection conference will focus on analytics-driven global site selection, incorporating patient- and site-centric approaches to planning and execution, and developing creative solutions into minimize site burden. Meanwhile, the Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden conference will provide insights into strategies that support sites through operational challenges, enhance DEI objectives, and leverage technologies and processes to optimize study deployment.

Part 1: Data-Informed Feasibility and Investigator Selection

Part 2: Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

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: Data-Informed Feasibility and Investigator Selection

11:00 am Chairperson's Remarks

Brook White, Vice President of Marketing/Commercial Operations, Marketing, CRIO

11:05 am

Mapping the Evolving Global Landscape of Investigative Site Models

Joan Chambers, Senior Consultant, Tufts Center for the Study of Drug Development

Over the past decade, clinical trial models have evolved with site staff embedded in clinical care, remote sites, retail pharmacies, urgent care, and mobile units. Many part-time sites have exited, while Site Management Organizations and Site Networks have scaled. Tufts CSDD presents new research mapping these changes, providing insights into the current global site landscape, emerging structural changes, and future site management strategies.

11:35 am

Opportunities for AI, RWD, and People to Power Trial Optimization

Desiree Abu-Odeh, PhD, MPH, Senior Scientist, Global Trial Optimization, Merck

Dana Wheeler, Associate Principal Scientist, Global Trial Optimization, Merck

Artificial intelligence (AI) and real-world data (RWD) pose exciting opportunities for streamlining and optimizing trial feasibility assessments. This presentation describes where AI and RWD fit together in trial feasibility work, need-to-know steps for clinical trial professionals using AI alongside RWD, and how we can use multiple methodologies to foster cross-functional collaboration to innovate and enhance trial feasibility.

12:05 pm

Using Advanced Methods to Improve Study Planning

Andrew Coates, Feasibility Director, AbbVie

Learn how Abbvie continues to advance predictive methods to inform study feasibility, geostrategy, and site selection during start-up to drive more accurate timelines and set organizational expectations. We continue to build trust, increase adoption, and overcome the change management curve with our clinical teams and governance.

12:35 pm

Streamlining Clinical Trials with AI-Powered Insights: An End-to-End Approach to Design, Planning, and Execution

Robert Buka, Senior Director, Product Management, Intelligent Trials, Medidata, a Dassault Systemes Co.

Kelly Hoang, Associate Director and Data Scientist at the AI Research Center for Excellence, Clinical Data Science, Gilead Sciences

When designing and planning trials, study teams often struggle with fragmented systems where data analytics are isolated, making it difficult to effectively apply insights to key decisions. Medidata is redefining study planning by delivering an integrated, end-to-end trial management ecosystem that leverages real-time data and AI to streamline decisions, from protocol optimization and feasibility assessments to live forecasting. This session will explore how a connected platform can minimize inefficiencies and empower smarter decision-making by study teams.

1:05 pm

Streamlining Site Feasibility: Unlocking Data for Faster Clinical Trials

Cristin MacDonald, PhD, Vice President, Client Delivery, WCG

Amy Froment, Senior Director & Head, Global Trial Optimization, Regeneron Pharmaceuticals

Nick Vaughan

Study start-up is a process commonly prone to delays due to the involvement of multiple stakeholders, systems, and decisions. One decision that can greatly impact the success of a study is determining which sites to partner with. Unfortunately, this process is broken. In this session, we’ll discuss a new approach to site feasibility, which unlocks data and insights for more precise sites matched to a study, reduces burden, and creates faster response times from potential sites.

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

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

3:25 pm

Expanding Horizons: Site Selection Strategies and Training for Diverse Enrollment Success

Marland May, Associate Director, Clinical Trial Diversity & Inclusion, AbbVie

Erin Reynolds, Associate Director, Data Science & Analytics, AbbVie

The main focus will be on the efforts to engage New to AbbVie investigators as well as New to Research site teams including the training opportunities available to support health care providers to enhance their research capabilities. New site performance indicators will be shared, highlighting the various factors that are taken into account when assessing adoption and progress: screening, enrollment, protocol compliance, and risk-based quality management signals. The presentation will also introduce the considerations behind site selection in relation to proactive Diversity Action Planning.

3:55 pm

Data Partnerships + AI to Maximize Study Optimization

Rohit Nambisan, Co-Founder & CEO, Lokavant

Clinical trials are growing more complex as biopharma shifts to rarer indications, with fewer participants per study and site, and increased challenges like data biases and unrepresentative datasets. AI and cross-industry data collaboration can address these issues by aggregating diverse data to predict outcomes, optimize strategies, and control timelines/budgets. Join us as we discuss how data partnerships and AI can optimize study performance and accelerate access to life-saving therapies for underserved patients.

4:25 pm

Putting Patients First: Redesigning Feasibility to Deliver Diversity in Clinical Trials

Vincent Spurr, Senior Manager, Solution Consulting, Citeline

Melissa Harris, Global Head, Patient Recruitment & Engagement, Fortrea

The 2025 FDA diversity guidance has brought the critical need for patient representation to the forefront of clinical research. This session will explore how reverse-engineering traditional feasibility processes can help sponsors prioritize patients from the very start, ensuring clinical trials reflect the diverse populations they aim to serve. Join Melissa Harris, Global Head of Patient Engagement and Recruitment at Fortrea and Vincent Spurr, Senior Manager, Solution Consulting at Citeline as they discuss how patient-first feasibility frameworks can accelerate enrollment, improve trial outcomes, and align with regulatory expectations. Through real-world examples, this session will demonstrate how data-driven strategies, innovative tools, and collaborative partnerships are reshaping feasibility planning with diversity and inclusion at the core.

4:55 pm PANEL DISCUSSION:

Integrating Diversity into Clinical Trial Feasibility & Site Engagement

PANEL MODERATOR:

Lauren Chazal MBA, Chief Business Development Officer, Headlands Research

As we shape the future of clinical trials, it’s critical to embed Diversity, Equity, and Inclusion (DEI) into the very fabric of feasibility studies. This panel will delve into the transformative power of technology, data-driven methodologies, and collaborative frameworks in revolutionizing site engagement. By examining successful case studies and sharing valuable insights, we aim to foster a discussion on making trials more efficient, patient-centered, and inclusive. Join us in driving innovation for sustained success in the clinical research landscape.

PANELISTS:

Gary Cobb, Head, Diversity & Inclusion in Clinical Trials, Boehringer Ingelheim Pharmaceuticals, Inc.

Asma Kasuba, Senior Director, R&D Data Science Global Development, Johnson and Johnson Innovative Medicine

Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Boots Alliance

5:25 pm

Streamlining Study Start-Up: Accelerating Site Activation & Reducing Tech Burden for Sites

Tom Johnson, Senior Director, Life Sciences & Health IT, Life Sciences Solutions, Exostar

We hear you. Sponsors are challenged with lengthy study start-up processes and ongoing monitoring, while the clinical trial sites are burdened with technology redundancy and sign-on silos obstacles. In this talk, we will give the sponsor's and site's perspective on the progress made to overcome these issues and share real examples of how sponsors and sites are collaborating and streamlining the user’s experience.

5:40 pm

Using Predictive Data to Transform Study Feasibility, Start-Up, and Enrollment

Debra Weinstein, Vice President - Internal Medicine, Science 37

Jeff Richardson, Senior Vice President, Patient Data & Recruitment Operations

Discover how Science 37 leverages predictive data to optimize participant identification, engagement, and enrollment across diverse regions—all as a single site. This session will provide an inside look at our innovative approach, featuring a real-world case study that highlights how we delivered results under tight timelines in a high-pressure environment.

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

Evan Frieder, Executive Director, Life Sciences, PointClickCare

8:55 am

Site Selection—Looking Beyond Historical Performance: Patients, Protocol, and Performance

Asma Kasuba, Senior Director, R&D Data Science Global Development, Johnson and Johnson Innovative Medicine

Site selection is the critical function of evaluating trial sites in specific geographical regions to ensure on-time and on-target enrollment completion. Relying solely on historical performance has been shown to be a weak predictor of a site’s future performance and of a trial’s overall timeline. To deliver robust predictions of site enrollment and site default status Johnson and Johnson Innovative Medicine has developed an advanced analytics pipeline to assist with site selection and planning. We present a framework for enrollment predictions and simulations in multi-center clinical trials while maintaining flexibility across trials in different therapeutic areas.

9:25 am

Towards an Automated Site Feasibility with Use of Ontologies

Thierry Escudier, Portfolio Lead, Pistoia Alliance

The Pistoia Alliance provides a unique pre-competitive collaborative platform for pharmaceutical members and R&D service providers. The Clinical Operations Ontology project aims to automate clinical trial processes by making data machine-readable through ontologies. Site feasibility is vital for aligning protocol requirements with site capabilities, ensuring study viability. Our proof of concept phase targets efficiency in trial planning by enhancing the manual site feasibility process. Leveraging linked data and standard methodologies, we aim to model clinical research designs effectively. By automating processes through ontologies and existing databases, we foresee to expedite decision-making and reduce redundant efforts.

9:55 am

Finding the Sweet Spot for Study Start-Up Collaboration

Ashley Davidson, Vice President, Product Lead, Advarra

Melissa Harris, Global Head, Patient Recruitment & Engagement, Fortrea

Hassan Kadhim, Head of Business Engagement, Clinical Operations & Clinical Dev, Vertex Pharmaceuticals Inc

In this session, we will uncover the often-overlooked needs of sites during study start-up, addressing the need for connectivity between study-specific and site operations technology. We'll explore how to achieve the perfect balance of site centricity, highlighting practical strategies to enhance site engagement and streamline processes, while ensuring critical visibility for sponsor teams. By understanding the diversity of site technologies and need for standardized feasibility and contract operations, we'll aim to create a startup landscape that works for every study stakeholder.

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

Nick Whitney, Senior Director & Commercial Lead, Site Suite, IQVIA Technologies

11:25 am PANEL DISCUSSION:

Balancing Innovation Options to Enable Adoption: Perspectives from Sponsors, CROs, and Sites

PANEL MODERATOR:

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

Change is hard—for everyone who is part of it. There are lots of innovative ways to operationalize trials—and yet they are rarely adopted at scale. How do we better balance the drive to innovate with the friction of adoption? What might we do better, together, to create better conditions for adoption? What can we use to progress, and what are the challenges that need attention?

PANELISTS:

Nicholas Focil, CEO, Fomat Medical Research

Christopher Herrick, Vice President, Research Technology, Mass General Brigham

Jean Kelly, Head of Clinical Operations, Rochester Clinical Research

Teri Wright, Director Clinical Lab Sciences & Devices Innovation, Clinical Trial Lab & Diagnostic Design, Eli Lilly and Company

11:55 am

Effective Strategies for Pharma to Engage Naive Sites in Clinical Research

Carrie Lewis, Executive Director, Clinical Program Optimization, Endo

Suzy Montanye, Site Relationship Manager, Endo

Terry Oehler, MD, Founder, Colorado Clinical Research

As an industry, it is essential to continuously bring on new sites and new physicians, ensuring they do not become a one-and-done site or Principal Investigator (PI). Therefore, Endo will share strategies to help Sponsors find effective ways to guide naive sites on where to start in clinical research and support them every step of the way, from pre-study visits to study closure.

12:25 pm

AI, Simulation, Avatars: Increase Content Velocity in Clinical Research Training

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

In this talk, I will discuss simulation as a means to mitigate deviations before they occur in your clinical program, the implementation of avatars for drafting of content and scalability of global programs, and AI-enabled agility to adjust content rapidly, based on the ever-changing needs of life science programs (protocol drafting, amendments, and deviation mitigation).

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: Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

8:20 am Chairperson's Remarks

Stacey Burghdoff, Executive Director, Strategic Alliance Management, ProPharma

8:25 am

Streamlined Clinical Trial Feasibility with Technology, Tools, and Process Excellence

John Yannone, Director, Feasibility Strategy, Innovative Health Engagement and Advocacy, Johnson and Johnson

How do we enable teams to navigate complex organizational dynamics, synthesize disparate data sets, and maximize trial efficiency all while balancing costs and speed? A suite of enabling tools and improved processes has shown the potential to drive fit-for-purpose protocols, efficient country strategy, and enhanced site selection while improving transparency and leveraging AI/ML + advanced analytics. This discussion will empower teams to discuss best practices in feasibility, specifically at large multinational pharmaceutical companies.

8:55 am

Optimizing Clinical Strategy with Innovative Technology in a Dynamic Organization

Amy McCormick, Associate Director, Global Trial Optimization, Regeneron

Anamika Sarkar, PhD, Intelligent Automation Lead, Global Development Solutions, Regeneron Pharmaceuticals, Inc.

Mark Springer, Director, Global Trial Optimization, Regeneron

During a period of significant growth and change, Regeneron's Global Trial Optimization and Global Development Systems Teams implemented an innovative digital-first strategy to overcome challenges in trial feasibility, patient engagement, and site identification. Using an agile methodology and an Appreciative Inquiry model, the team identified workflow issues, designed a comprehensive solution, and delivered a flexible, scalable application. This approach improved data quality, standardized deliverables, and optimized resources, providing a foundation for future business needs. The project highlighted the importance of collaboration, communication, and a strong change management strategy for successful technology adoption.

9:25 am

Are Questionnaire Licensing and Translation Hurdles Slowing Down Your Trials?

Jasmine Walker, Director, COA Partnership, Linguistic Validation, RWS Group

Jonathan Norman, Director, Localisation, Linguistic Validation & eCOA SME, Y-Prime

Are questionnaire licensing and translation hurdles slowing down your trials? Early and strategic engagement with your licensing, localization, and eCOA partners might be the solution you’re looking for. In this session, two seasoned experts in eCOA and localization will dive into key preparatory steps to make your study more feasible from both a licensing and localization standpoint—driving smoother regulatory approvals and helping you meet critical timelines. You’ll gain practical insights on successful early engagement, including essential questions to ask your providers, the value of connecting partners early, setting realistic expectations, and assessing content suitability—empowering you to streamline diverse global study start-ups.

9:55 am

The Value of Quest Lab Data in Clinical Trial Design and Recruitment

Steve Schlachter, Director Product Portfolio, Healthcare Analytics Solutions, Quest Diagnostics, Inc.

Learn the value of lab data in clinical trials and the power of Quest to help optimize site feasibility and selection, improve investigator selection, and optimize patient identificaiton and recruitment. Make more informed decisions with Quest and enhance the overall success of your trials.

10:10 am

Feasibility Process Update to Ensure Active Site Engagement: One Year Later

Katie Bonner, Director of Strategic Feasibility, AstraZeneca

Nadia Kallu, Strategic Feasibility Associate Director, AstraZeneca

A year has passed since AstraZeneca implemented enhancements to our feasibility process, aimed at fostering active engagement from the initial interaction through to site selection. Over the past year, we've had the opportunity to test these improvements, gather insights, and refine our approach. In this session, we will share the valuable learnings from this journey, discuss the additional updates we've made, and outline our future plans to further optimize the process.

10:40 am

CANCELLED: Building Meaningful Engagement: PCORI's Foundational Expectations for Partnerships in Research

Caroline Davis, MPP, Senior Program Associate, Public and Patient Engagement, PCORI Patient Centered Outcomes Research Institute

PCORI’s Foundational Expectations for Partnership in Research incorporates the last 10 years of evidence on engagement from PCORI awardees, staff, and the larger research field to update the guidance on engagement into one systematic framework. We consider these expectations to be the building blocks of meaningful and effective engagement. This session will review the various methodological approaches used to complete the update and present the guidance along with information on how to access this tool.

11:10 amNetworking Coffee Break

11:50 am Chairperson's Remarks

Joel Pinkham, Vice President Growth & Strategic Projects, Executive, HealthMatch

11:55 am

Taking Research to the People: Decentralized Trials, Leveraging Technology to Enable Community-Based Approaches

Amy Yarker, Senior Business Development Manager, Life Sciences Partnership & Growth, NIHR Clinical Research Network

This session will explore the transformative power of decentralized clinical trials, taking research beyond traditional hospital clinics to reach participants in social care settings and underserved communities. Discover how cutting-edge technology and innovating methods are breaking down barriers, improving accessibility, and generating valuable real-world evidence. From mobile research units to patients’ homes, learn how decentralized trials are bringing research directly to people.

12:25 pm

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 ismore critical than ever. This presentation introduces Patient Universe, a groundbreakingsolution designed to optimize trial feasibility while addressing health equity challenges. Attendees will learn how leveraging real-world health equity data can transform patientrecruitment strategies, create inclusive trial designs, and improve participant engagement.Through actionable insights and use cases, this session will demonstrate how advancedanalytics and innovative technologies can bridge gaps in representation, support diversity actionplanning and enhance trial outcomes.

12:55 pm

Integrating Community Health Solutions: A Case Study

Shelly Barnes, Global Clinical Innovations and Digital Lead, UCB

Is it operationally feasible to develop a clinical research plan that incorporates community-based health entities or solutions? The FDA has indeed advocated for the inclusion of community health providers in clinical trials. However, challenges remain, particularly when major community solution providers face difficulties in establishing a favorable cost model. Also, is there substantial evidence indicating that investigators or community health providers are willing to participate in this new clinical trial execution model? This UCB case study aims to examine the advantages, disadvantages, and potential challenges of integrating community health solutions into clinical trials.

1:25 pmTransition to Lunch

1:30 pm

LUNCHEON PRESENTATION: Rethinking Trial Design with Real-World Data

Kwame Marfo, Senior Director, Product Strategy, Clinical Development, Komodo Health

Discover how Komodo’s innovative no-code solution, MapView with MapAi, is reshaping the way clinical development teams understand and address the diverse healthcare journeys of patients from different racial and ethnic backgrounds. Komodo’s presentation will explore how streamlined data insights can uncover disparities, enhance trial inclusivity, and optimize patient representation, empowering teams to design more equitable and effective clinical trials.

2:00 pmSCOPE Summit 2025 Adjourns