Data - 2025 Archive

2025 ARCHIVES

SCOPE’s 16th Annual Data stream delves into the evolving landscape of clinical trials, emphasizing the importance of data integration and the innovative use of technology to break down traditional silos. With a focus on large-scale R&D data governance, the application of social determinants of health, and the optimization of clinical data integration, this stream brings together industry leaders to explore how data-driven strategies can enhance clinical trial efficiency and diversity. Top industry experts will share insights on the challenges and opportunities in the field, providing actionable solutions to thrive in the rapidly changing environment of clinical research.

Part 1: Clinical Data Strategy and Analytics

Part 2: Data Science, ML, and AI

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: Clinical Data Strategy and Analytics

11:00 am Chairperson's Remarks

David Herron, CEO, Perceptive Inc

11:05 am

Optimizing Clinical Data Integration: A Path to Efficiency

Narayanarao Pavuluri, Senior Director & Global Head, Clinical Database Services, Merck

Clinical research requires seamless integration of data for maximum efficiency and accuracy. Clinical Data Integration connects various sources and systems, minimizing errors and delays. It provides real-time access to patient information, enabling faster trial initiation and informed decision-making. This approach streamlines workflows, offers scalability, and reduces site burden, resulting in greater research productivity. Embracing Clinical Data Integration transforms clinical trials, enhancing efficiency and accelerating research outcomes.

11:30 am

Practical Governance Strategies for Large-Scale R&D Data & Analytics

Gian Prakash, Director, Data & Analytics, Information Research, AbbVie, Inc.

Effective governance is essential for unlocking the full potential of large-scale R&D data & analytics. This presentation presents practical strategies for establishing and implementing a robust governance framework to support data-driven innovation. By addressing key challenges such as data quality, access, security, and ownership, organizations can foster a data-centric culture and accelerate time-to-value from R&D initiatives. This presentation offers actionable insights and recommendations for R&D leaders seeking to scale data democratization.

11:55 am

Help Is Here: Interpreting the New ICH E6 R3 Data Governance Requirements

Arlene Lee, Director, Product Management, Data Quality and Risk Management Solutions, Medidata

Tashan K. Mistree, MS, Senior Director Business Operations, GSK

The upcoming ICH E6 R3 (GCP) guideline introduces a brand new section related to data governance in clinical trials. Given the critical nature of data in clinical research, proper governance is essential to maintain the reliability of the trial results, protect the participants’ rights and safety, and ensure compliance with regulatory requirements. ACRO and TransCelerate collaborated to deliver a data governance framework and diverse solutions to support the understanding and interpretation of these new requirements.

12:20 pm

Clinical Data Democratization Through Data Products

Sophia Nuijens, Director, Data Product, Drug Development Operations & Real World Evidence, Bristol Myers Squibb Co

Karan Setpal, Business Technology Manager, ZS

Pharma companies need to democratize data access for clinical within their organization and make it easier for end users (Business analysts, analysts, data scientists, IT etc.) to run data and analytics use cases faster to accelerate clinical trials, patient care and outcome. With the evolution of various data management techniques such as Data Mesh, it’s important to tactically learn how to strategize and create domain driven “Data products” and enable seamless data access for end users

12:35 pm

Using eCOA Technology to Drive Endpoint Protection, Clinical Data Strategies, and Analytics

Melissa Mooney, Director, eCOA Solution Engineering, IQVIA Technologies

eCOA implementation begins with a solution design strategy that efficiently collects, stores, and manages data in a way that will optimize clinical data review and analytics while ensuring endpoint protection. IQVIA expert Melissa Mooney will explore the positive impact eCOA solutions are making on clinical data strategies, specifically:

•How eCOAs are being used to ensure endpoint protection

•The importance of planning and defining clinical data strategies in parallel to eCOA setup/design

•eCOA design considerations that create efficiencies in data analytics and monitoring

1:05 pm

Is It Too Risky to Deploy AI in Your Clinical Trial? Understanding the Real Costs of Leveraging AI

Todd Rudo, CMO & Executive Vice President, Clario

Jay Ferro, Executive Vice President, Chief Information & Technology Officer, Clario

While the speed and efficiency that AI offers to development programs is so commonly hyped, the risks potentially introduced are usually minimized or completely dismissed. We will talk candidly about these risks and discuss how to responsibly deploy AI-enabled solutions, without compromising confidence in your clinical trial results.

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

Greg Tullo, Chief Customer Officer, North America Professional Svcs, Viedoc

3:25 pm

Clinical Content Reuse (CCR) with Development Data Flow (DDF): Key Considerations for Success

Siddharth Shah, Executive Director, Product Management, Data Science and Digital Innovation, BeiGene

Oanh Stephan, PhD, Executive Director, Head, Global Medical Writing, BeiGene

Leveraging industry thought leadership, accelerators (TransCelerate, CDISC etc.), and content from critical path clinical documents to achieve optimal trial productivity and submission excellence by focusing on a mindful roadmap that balances the need for process-people and product(s).

3:45 pm

It’s Been a While—10 Years of Data Sharing and Reuse: Highs, Lows, and What’s Next

Medha Patel, Clinical Design Analytics Director, Amgen

This is an opportunity for attendees to ‘zoom out’ on the meaty topic of clinical data sharing and reuse. An opportunity to take our eyes off the day-to-day, quarter-to-quarter, even year-over-year efforts and instead appreciate the bigger picture. We’ve been working to share and reuse data for the benefit of science, safety, and—ultimately—patients, for 10 years. Time travel with us back to the early days, through some highs and lows, and the outlook for what’s next. We have seen that amazing things are possible when we collaborate: this is a chance to renew our ‘why’ and move forward with curiosity and courage.

4:05 pm

Streamlining Secondary Analysis of Clinical Studies—Lessons Learned

Radhesh Nair, Director, Data Science and Analytics, Clinical Development, AbbVie

AbbVie clinical trial data is housed in multiple databases across a myriad of organizations. Locating and accessing clinical data was a time-consuming challenge. We created one source of truth for clinical study data with appropriate governance to create efficiencies within the AbbVie pipeline while supporting enhanced patient care through predictive analyses. This allowed researchers to search and identify the right set of clinical studies to run secondary analyses to test research hypotheses. Harmonizing the study data access process eliminated duplicative effort and helped manage enterprise risk through the governance process.

4:25 pm

The Three Little Pigs' Tale: A Blueprint for Strategic Clinical Trial Feasibility

Barbara Argibay Gonzalez, Vice President & General Manager Data Division, Anju Software

Is your clinical trial built with straw, sticks, or bricks?

Access to data has made clinical feasibility more robust and efficient, but successful studies blend clinical intelligence with team knowledge and real-world experience. As trials target specific patient populations, granular historical data is crucial for precision. Join us to explore how combining clinical intelligence with operational insights can drive accurate enrollment models, prioritize sites, and provide dynamic, data-driven insights for success.

4:55 pm

Catalyzing Clinical Study Data Collection

Paul Jacobs, Associate Director, Development Innovation, Regeneron Pharmaceuticals, Inc.

Progress in the field of clinical study data capture has been relatively slow, but recent boosts in interoperability, technology and opinion is enabling a rapid transformation driven by the integration of Electronic Health Records (EHR) with Electronic Data Capture (EDC) systems. We will discuss this journey and propose our thoughts for future direction, with the potential for further reinvention of data collection and the emergence of an entirely new paradigm.

5:25 pm

Impact of PRO Type, Frequency and Modality on Patient and Site Burden: Insights from BMS/Tufts/ZS Research Study

Arnab Roy, Associate Principal, R&D , ZS

Chelsea Gallagher, Senior Director, Drug Development Innovation & Digital Health, Business Insights & Analytics, Bristol Myers Squibb Co.

Abigail Dirks, Data Scientist, Tufts Center for the Study of Drug Development

Join BMS, ZS, and Tufts CSDD to explore the impact of clinical outcome assessments on trial participation burden. We will explore the insights from our insights from our 2024 global study with patients and sites to highlight the nuances of clinical outcome assessments and its impact on perceived burden of participation, including significant differences in perceptions, the impact of digital vs. non-digital modalities, and how pharma can use data driven burden analytics to design better trials.

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

Ariel Bourla, MD, PhD, Senior Director, Data Science and Digital Health, Johnson & Johnson R&D

8:55 am

"Science, Sealed, Delivered": Bringing Efficiency to Complex Oncology Trials

John Manlay, Senior Director, Clinical Data Sciences, Pfizer

Muz Mirza, Senior Director, Senior Group Lead, Oncology, Pfizer

In this session we will review Pfizer’s strategy for supporting accelerated oncology trials and Clinical Data Sciences’ role using innovative tools, technologies, and strategies. We will discuss the evolution of how the concept of “critical data” streamlines efficiency through clinical trial operations; the incorporation of automation in our daily data review process; and the development of customized study metrics and analytics to support milestone deliverables.

9:15 am

Technology and Data-Driven Solutions for Increasing Enrollment of Diverse Patients in Oncology Trials

Ariel Bourla, MD, PhD, Senior Director, Data Science and Digital Health, Johnson & Johnson R&D

Reed Few, Director, External Innovation, Data Science & Digital Health, Research and Development, Johnson & Johnson

Increasing the representativeness of clinical trials has been an ongoing goal, which has only increased following FDA draft guidance on Diversity Action Plans in 2024. To achieve diverse enrollment, we have implemented several data-driven strategies, including collaborating with external partners to leverage novel technologies. We will discuss these efforts and our learnings from using data and technology to drive representative clinical trial enrollment.

9:35 am

Key Considerations for Utilizing AI/ML Screening Algorithms to Identify Patients with Immunotherapy

Usama Javed, PharmD, Associate Principal Scientist, Regulatory Digital Health, Merck & Co.

This presentation explores the development of screening criteria for trial participants using AI/ML algorithms. The criteria are formulated collaboratively by clinical specialists in the relevant field, defining inclusion and exclusion based on biomarkers and other diagnostic tests.

9:55 am

Accelerating Study Build with Generative AI

Wayne Walker, Senior Vice President, Rave Platform Technology, Medidata, a Dassault Systemes Co.

The complexity of study builds poses challenges in terms of time, cost, and accuracy. Generative AI (GenAI) transforms study builds by automating processes like generating the schedule of events, EDC forms, eCOA questionnaires, edit checks, quality control scenarios, and synthetic test data. This session highlights real-world examples of GenAI reducing study build effort and timelines, and ensuring a high-quality study start.

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

Chris Weiss, Vice President, Sales, OpenClinica

11:25 am

Interoperability Being a Value for Product Companies Enables the Patient Value and Delivery Agility to Sponsor Organizations

Donald Thampy, Executive Director, Merck

Every product company in the industry is striving to develop solutions that facilitate successful processes and functions. If the product is the engine, data is the fuel. Data is always in motion. The motion makes the data transverse multiple products in the ecosystem, and data is the connector. It begins from the patient, goes all the way to sit in a chart that demonstrates value of the drug. To solve that data-motion challenge, we have numerous connectors to weave the magical movement of data. However, it's worth considering whether there's a more effective approach for the industry to achieve this. Should product companies adopt the value of interoperability? What does that mean? Will the adoption of this value have the potential to address the challenges associated with integrations, data movement, transitions, and ultimately, cost burden on patients? Come and engage in a conversation!

11:50 am

Modern Clinical Data Management: Data Enablement for Tiered Clinical Data Review

Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.

Clinical data management has evolved significantly with the advent of advanced technologies. This session explores the approach to data enablement of tiered clinical data review, a strategic approach to ensure data quality and integrity throughout the clinical development process. By leveraging modern data engineering and technologies, we can enable complex back-end checks, patient profiles, listings, and anomaly detection congruently in addition to Electronic Data Capture (EDC) point-of-entry checks. This tiered approach allows for efficient identification and resolution of data issues at various stages, ultimately contributing to clinical trials' success and development of innovative therapies.

12:10 pm

R&D Cloud Ecosystem with Agentic AI: A Game Changer for Clinical Development

Shakthi Kumar, Chief Strategy and Business Officer, EDETEK Inc

Ever felt like R&D could use a turbo boost? The landscape is evolving rapidly with data-driven innovation and seamless collaboration. Imagine a tailor-made R&D cloud ecosystem, powered by cutting-edge agentic AI, transforming CDM and analytics. Learn how we ignite innovation and accelerate clinical development: - What makes this approach transformative? (Hint: Not just the cloud!) - How can Agentic AI redefine clinical workflows? (Spoiler: It's smarter than average AI!) - Use cases (A preview!)

12:25 pm

Unlocking the Potential of Generative AI in Clinical Trials

Paul Mancinelli, CTO, WCG

Silvio Galea, Chief Data & Analytics Officer, WCG

Are you ready to explore the potential of Generative AI in clinical trials? In this session, you’ll learn more about how you can leverage the power of Generative AI through a privacy-safe clean room. Through this secure environment, sponsors and CROs can bring their data together with WCG’s data for collaboration and analysis. Specifically, we’ll discuss how this technology enables faster trials with actionable and insights.

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: Data Science, ML, and AI

8:20 am Chairperson's Remarks

Vincent Spurr, Senior Manager, Solution Consulting, Citeline

8:25 am

Content Generation and Knowledge Extraction for Clinical Documents

Vaishali Goyal, MS, AI Lead, Development, AstraZeneca Pharmaceuticals

With over 240 global clinical trials, we are currently running multiple pilots across our R&D pipeline, testing a range of AI technologies to simplify our processes. Specifically, AstraZeneca is investing in the AI technology to expedite content generation and insight extraction of key clinical assets.

8:50 am

Protocols Powered by Insights: Breaking the Design Cycle with Data- Driven Retrospectives

Laura Russell, Senior Vice President, Head of Data and AI Product Development, Advarra

The protocol design process is ripe for innovation to address persistent challenges, including inefficiencies in trial operations and high participant attrition. The next wave of advancements will look to leverage emerging AI technologies and unified data ecosystems to break the cycle of inefficiency by tackling foundational issues rather than focusing solely on surface-level friction points. This session will delve into how smarter protocol design can become a reality by applying these advancements to data-driven retrospectives for continuous improvement.

9:05 am

How AI Document Automation Can Support Our Clinical Trials for EU Submissions: EU-CTR Synopsis Case Study

Marie Kromplewski, RN, MSN, Associate Director, Clinical Capabilities Manager, Clinical Center of Excellence, Bristol Myers Squibb Co.

In this session, BMS shares the innovation of creating a BOT to support clinical trial submissions to the EU Clinical Trial Regulation (EU-CTR). EU-CTR Regulations now requires submissions to include a synopsis and recommend the synopsis be understandable to a layperson. A BOT was developed to create the synopsis from the protocol and with AI technology, it converts the language to the required laymans terms. This is time saving technology to produce a document to support EUCTR submissions.

9:25 am

Dynamic Trial Monitoring for Ongoing Clinical Trials

Tai Xie, Founder & CEO, CIMS Global

Effective trial monitoring is essential for participant safety, data integrity, and regulatory compliance, yet existing tools fall short in meeting these demands. Dynamic Trial Monitoring (DTM) offers a real-time, integrated approach to trial oversight, enhancing efficiency and decision-making. This presentation will highlight DTM's principles and case studies, showcasing its ability to predict enrollment trends, detect safety signals, and enable agile, high-quality trial management.

9:40 am

Using Predictive AI To Optimize Recruitment Content for Diverse Audiences

Kianta Key, Group Senior Vice President Digital & Head of Identity Experience, Digital Healthcare, GCI Health

Matthew Graffeo, Exec VP & Global Head of Digital, Healthcare & Digital, GCI Health

Data-driven insights are transforming clinical trial recruitment. This presentation explores how predictive AI streamlines content creation by analyzing pre-publication messaging and visuals against historical benchmarks, ensuring resonance with target audiences and eliminating the need for A/B testing. We’ll demonstrate how our proprietary platform leverages AI to predict content performance across demographics, leading to optimized messaging, increased efficiency and better recruitment outcomes.

9:55 am

Digital Health Technology Data Integrity: Mitigating Data Loss and Poor Data Quality to Ensure Actionable ROI

Jen Blankenship, Senior Research Scientist, Clinical Research & Development, VivoSense

This presentation addresses the critical issue of data integrity in digital health technologies and wearable sensors, focusing on mitigating data loss, inconsistencies, and poor data quality. These issues can undermine decision-making, thereby reinforcing stereotypes that "we are not there yet" in utilizing wearable sensor derived data in clinical validation. Strategies such as robust error detection, sensor wear compliance, data validation, artifact detection, and improved system integration are explored to ensure reliable, high-quality data. By partnering with external end-to-end solutions, sponsors can maximize actionable insights, improve patient outcomes, and drive a higher ROI.

10:10 am

Evaluating Generative AI in Regulated Environments: A Statistical Rigorous Framework for Regulatory Compliance and Safety

Venky Iyer, Director, Data Strategy & Enablement, Pfizer Inc.

Sheraz Khan, PhD, Director, Operational AI & Data Sciences, Pfizer Inc.

The need for rigorous statistical evaluation of generative AI in clinical trial settings is paramount to ensure regulatory compliance and patient safety. This talk explores a framework for assessing whether AI-generated contents, produced by large language models like GPT-4, are non-inferior to human-generated contents across key dimensions such as accuracy, clarity, consistency, and reasoning. The insights gained from this evaluation will be crucial in shaping the future integration of generative AI in regulated environments, potentially transforming how we approach clinical trials and drug development.

10:40 am PANEL DISCUSSION:

Ethical Consideration for AI Applications in Clinical Trials

PANEL MODERATOR:

Dominic De Bellis, PhD, Executive Director, AI Strategy & Operations Lead; Global Clinical Trial Operations, Medical Writing & Disclosure, Merck & Co., Inc.

This panel will provide an introduction to the concept of AI ethics and its significance and application to the pharmaceutical industry. Industry experts will discuss the progression of AI in the pharmaceutical industry and its impact on various operations, including drug discovery, trial management, customer care, etc, as well as the ethical considerations in using AI for drug discovery. Considerations include biases in AI algorithms, patient privacy concerns, and quality control. Ethical issues around data handling, privacy, and security also must be taken into account. Finally, panelists will discuss the importance of AI systems in complying with local and international regulations and standards and provide actionable insights.

PANELISTS:

Sheraz Khan, PhD, Director, Operational AI & Data Sciences, Pfizer Inc.

Mark F. Ciaccio, PhD, Senior Biology Data Scientist, Platform Informatics & Knowledge Management, AbbVie, Inc.

Jonathan Shough, CIO, PAREXEL International

11:10 amNetworking Coffee Break

11:50 am

Chairperson's Remarks

Sina Djali, Head, Data Management and Central Monitoring, Immunology and Medical Affairs, Johnson & Johnson

11:55 am

The Role of AI in Powering Digital Protocols

Yugang Jia, PhD, MPH, Director, AI & Data Science, Verily

Lauren Sutton, Director, Product Management, Research Solutions, Verily

Protocols often live in documents, requiring sponsors to manually configure data across many systems, and leading to inaccuracies and extended timelines. Global standards groups are calling for protocols to be digitized, but how will sponsors adjust to new digital formats? In this talk, we’ll share published research on the use of AI/LLM agents to digitize protocols and how this approach can drive more efficient research for sponsors and sites.

12:25 pm PANEL DISCUSSION:

Transforming the Clinical Trial Protocol—Moving from a Document-Centric to a Data-Centric World

PANEL MODERATOR:

Chris Decker, President & CEO, CDISC

Since the beginning, the industry has been writing and copying protocols in Word while manually transcribing protocol information to the plethora of downstream systems, which is time-consuming, error-prone, and questions quality. Over the last few years, the industry has been working on moving from a document-centric to a data-centric protocol, helping industry reduce cycle times and improve data reliability and quality for sponsors, third party providers, and regulators. This panel will bring together TransCelerate, CDISC, HL7, and ICH M11 to discuss the current state of the digital protocol and the opportunities to transform the clinical trial lifecycle.

PANELISTS:

Amy Cramer, Founder and Director, Vulcan; Data Acquisition, eSource, Johnson & Johnson Innovative Medicine

Stacy Tegan, Program Director, TransCelerate Biopharma, Inc.

Mary Lynn Mercado, PhD, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis Pharmaceuticals

Donald Jennings, Senior Advisor of Systems, Tech@Lilly Clinical Design and Operations, Eli Lilly and Company

1:25 pmTransition to Lunch

1:30 pm

LUNCHEON PRESENTATION:

The Perfect Pairing: How RWD Elevates Every Stage of Your Clinical Trial

Steve Lesser, Vice President of Growth for Clinical Trial Solutions, Optum Life Sciences

There’s no substitute for real-world data to get to the most complete patient picture—before, during, and after a clinical trial. Understand your target population to inform evidence and diversity strategies, accelerate recruitment with EHR patient screening, and drive market success post-trial. Steve Lesser, Vice President, Clinical Trials, Optum Life Sciences, will discuss the ways real-world data acts as a key ingredient at the different stages of a clinical trial.

2:00 pmSCOPE Summit 2025 Adjourns