AI for Clinical Trials - 2025 Archive

2025 ARCHIVES

The Inaugural AI for Clinical Trials stream program explores the practical applications and strategic integration of AI and GenAI in clinical trials. Emphasizing a holistic approach, the program explores how AI and machine learning can drive efficiency, from patient identification to trial timeline optimization, while addressing the ethical considerations that come with these advancements. Through expert-led presentations and panel discussions, attendees will gain insights into overcoming the challenges of AI adoption and how to leverage these technologies to enhance clinical operations and achieve measurable outcomes. This conference is designed to help clinical research professionals navigate the complexities of AI, ensuring its effective and responsible implementation across the industry.

Part 1: Generative AI in Clinical Research

Part 2: AI for Trial Optimization

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: Generative AI in Clinical Research

11:00 am Chairperson's Remarks

Siddhartha Bhattacharya, Life Sciences AI Leader, PwC

11:05 am

Scalable AI-Powered Approaches

Jonathan Crowther, PhD, Head Predictive Analytics, PRD (OARS), Pfizer Inc.

Maca Fernandez, Disease Intelligence Analytics Lead, Pfizer Inc.

This talk explores scalable AI-powered approaches that enhance efficiency and innovation across various sectors. It examines cutting-edge technologies, methodologies, and frameworks that facilitate the seamless integration of AI solutions within existing infrastructures. Attendees will gain insights into overcoming challenges related to scalability, data management, and resource allocation, ultimately empowering organizations to harness AI's full potential for transformative impact.

11:35 am

Challenges in Reaching the Desired Altitude for GenAI Applications in Clinical Trials

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

The desire to scale the impact of GenAI in applications for clinical trials comes with lofty ambitions and significant anticipated impact. Reaching the altitude necessary to deliver that impact means navigating many different kinds of turbulence on the way to 30,000 feet. Let's talk about how to anticipate and potentially avoid some of those challenges - the pilot has illuminated the seatbelt sign, please buckle up.

12:05 pm

Implementing Gen AI in Clinical Research

Janie Hansen, Business Systems Transformation, Global Development Information Management, Daiichi Sankyo, Inc.

Successfully bringing Generative AI from concept to reality in clinical research requires a shift from traditional system implementation approaches. Common challenges, including limited understanding, concerns about job security, insufficient training, and unclear perceived benefits, often result in resistance to change. To drive successful adoption, these barriers must be addressed proactively—starting with a compelling business case, followed by effective change management strategies, and culminating in a focus on delivering measurable ROI.

12:35 pm

GenAI: Pioneering the Next Era of Clinical Content Generation

Daniel Tortora, Senior Director, Global Head of Authoring & Workflow Business Solutions, Pfizer R&D

Lew Klein, IT Clinical Lead, R&D IT, AstraZeneca

Camille Chicklis, AI Strategy & Delivery Lead, Deloitte Consulting AG

Discover the journey of biopharma executives as they integrate GenAI into clinical content generation, from initial stages to practical application. Gain insights into their starting points, challenges faced, lessons learned, and the benefits realized from utilizing this technology.

1:05 pm

Harnessing Generative AI for Clinical Development

Patrick Leung , CTO, Development, Faro Health, Inc.

Vivian DeWoskin, Chief Strategy Officer, Strategy, Faro Health, Inc.

Clinical development is complex and increasingly costly. Recent advances in generative AI promise to reduce the time and cost of clinical trials through automation and data-driven insights. However, challenges remain, and the cost of failure is high. In this presentation, Patrick Leung (CTO) and Vivian DeWoskin (CSO) of Faro Health Inc. will discuss how Faro leverages its expertise in clinical science and AI to create solutions that advance clinical development tools and technology.

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

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

3:25 pm

Project GAIA: Structured Content Authoring Using a Generative AI Assistant

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

Bryan Feldman, Senior Director, Business Technology for Clinical Development, Regulatory Affairs, and R&D QA, AbbVie

Rapid progress in genAI has enabled advanced structured content authoring of diverse clinical, regulatory, & safety documents. We created an enterprise-wide web application called Project GAIA to autogenerate whole documents such as the Clinical Study Report, Informed Consent Form, and Product Safety Update Report using an extensible content template. The GAIA application can create whole documents in minutes by synthesizing and adding each section according to the template including AI-generated text, tables, images, and diagrams.

3:45 pm

Transforming Regulatory Document Authoring: The Promise of Human-Led Generative AI

Rogier Landman, PhD, Associate Director, Digital Medicine Data Science, Pfizer Inc.

The presentation will explore how Generative AI is revolutionizing the entire spectrum of regulatory document authoring, from protocols to clinical study reports, promoting standardization, ensuring compliance, and maximizing efficiency. It will highlight the paradigm shift in how these critical regulatory documents are drafted, emphasizing the transformative impact of Gen AI on the pharmaceutical industry. While showcasing how Gen AI accelerates the process, the presentation will also stress the essential role of human oversight in maintaining accuracy and regulatory standards, advocating for a collaborative "human-led" Generative AI approach that delivers the best outcomes.

4:05 pm

Accelerate Clinical Content Generation and QC with GenAI and Knowledge Graphs

Jenny Wei, PhD, Senior Director, R&D Informatics and Technology, Kite Pharma

Clinical trial documents authoring and quality control is still riddled with inefficiency due to the time-consuming, expensive, and manual way of working. AI has the potential to transform this space. At SCOPE, we will share our experience in automating content generation (CSR, IB, ICF, protocol, etc.) and document review (through evidence lineage tracking) with integrated NLG, genAI, and knowledge graph technologies.

4:25 pm

Navigating AI for Clinical Trials: Simplifying the Path to Insights

Mike Stocks, CTO, Executive Leadership, Medrio

Nicole Latimer, CEO, Medrio, Inc.

Clinical trials are becoming increasingly complex, with more data points, forms, and rules to manage. As biomarkers emerge as key endpoints, the volume of data to clean, monitor, and analyze grows exponentially. These processes are not just time-consuming—they're costly and critical to a trial’s success. Continually, sponsors and CROs are faced with the challenge of how to balance the surge in data while maintaining speed, quality and compliance Join Medrio CTO, Mike Stocks, and CEO, Nicole Latimer, as they explore how Medrio is integrating AI into the clinical trial process to streamline and accelerate data management. Learn practical applications for balancing machine learning and automation with human oversight, enabling more efficient workflows and reducing the burden on study teams.

4:55 pm

Lessons Learned on Realizing GenAI/LLM Values for Clinical Document Automation

Lily Xu, PhD, Senior Principal Data Scientist, Data Science, Vertex Pharmaceuticals, Inc.

Clinical document drafting is manual, time-consuming, and process-heavy. To address this business problem, our cross-functional teams have developed an "Autodrafter" using GenAI/LLMs to streamline and innovate the clinical document drafting workflow. In our presentation, we will share lessons learned on the pilot design and measuring impact to demonstrate the quantifiable benefits of GenAI in clinical operations. We will also discuss the progress of scaling the GenAI pilot for broader business use. Join us to learn about the transformative potential of GenAI in clinical document drafting.

5:25 pm

Mythbusters: Uncovering the Real and Right Now with GenAI in Clinical Trials

Matt Becker, Advisory Life Sciences Industry Consultant, Life Science Industry R&D, SAS Institute, Inc.

There’s a lot of hype around generative AI in life sciences, but what’s the real application? How does your platform stack up to support this technology? Using data and AI as the foundation, and GxP guardrails as the navigating guide, both sponsors and CROs can advance drug development with cutting-edge technologies—but only if the myths are busted, and the real, applicable uses of GenAI are tapped into. Join this session to grasp a real, right now understanding of GenAI in clinical 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

Alyssa Farrell, Director, Global Health & Life Sciences Market Strategy, SAS Institute, Inc.

8:55 am

A Multi-Company Study Examining the Adoption and Use of AI

Maria Florez, Senior Consultant, Tufts CSDD

Mary Jo Lamberti, PhD, Director and Research Associate Professor, Tufts Center for the Study of Drug Development (CSDD)

This talk will review where sponsors and CROs are deploying AI (artificial intelligence) and ML (machine learning) in clinical development based on a collaborative industry study; examine pharma investment levels in use of AI/ML in clinical research; and gather insights on the challenges of implementing AI/ML.

9:25 am PANEL DISCUSSION:

Overcoming Challenges and Managing Costs in Industrializing Generative AI

PANEL MODERATOR:

Srivatsan Nagaraja, Founder, Vidya Seva

The adoption of Generative AI into clinical trials offers transformative potential, enhancing efficiency, accuracy, and innovation. However, scaling Generative AI involves addressing significant challenges and managing costs effectively. This session will delve into these issues, providing practical solutions and insights through expert discussions and practical case studies. Join us for this in-depth session to discover how to effectively industrialize Generative AI in clinical trials to drive innovation and efficiency in bringing new drugs to market.

PANELISTS:

Prasanna Rao, Chief Products and Innovation Officer, Saama

Kannan Natarajan, PhD, Head, Global Biometrics & Data Management, Pfizer Inc

9:55 am

AI in Clinical Trials—Case Studies & Lessons From Real Implementations, Featuring a Fireside Chat with Eli Lilly

Siddhartha Bhattacharya, Life Sciences AI Leader, PwC

Lora Todd, Vice President, Clinical Trial Foundations, Eli Lilly and Company

Mike Luker, VP, Data & Analytics Clinical Design & Delivery, Eli Lilly and Company

This session explores AI's transformative role in clinical trials, using a case study driven approach to highlight real-world use cases and lessons learned from successful implementations. It also features a Fireside Chat with Clinical AI leaders from Eli Lilly, sharing insights on how they are harnessing AI to create digital FTE capacity in clinical development. Additionally, the session will cover top AI use cases driving success in clinical trials, best practices for implementing AI in clinical operations, and key lessons learned and potential risks to navigate. Don't miss this unique opportunity to hear directly from industry leaders and gain insights into the future of clinical trials with AI.

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

Jack Arnold , Vice President, Marketing, Ledger Run

11:25 am

Gaining 70% Efficiencies by Using AI in Clinical Study Data Conformance

Daniel Bachalis, MS, MBA, Senior Director, Engineering & Operations, Drug Development IT, Data, and Analytics, Bristol Myers Squibb Co.

Pharma companies typically conduct exploratory analytics on legacy clinical studies (or trial data) to uncover insights that could inform current and future trial phases. Combining legacy studies is a process prone to friction—not only due to the sheer complexity of clinical data, but also because legacy studies come in disparate formats and can differ dramatically across therapeutic areas and study phases. With the use of AI, we developed a platform that has substantially reduced the time to conform, improved quality of data, and reduced the need for subject matter expertise.

11:45 am

CATALYST Trial Timeline Planning—Enhancing Predictions with Advanced Machine Learning and Large Language Models

Sheng Zhong, PhD, Director of Statistics, Data and Statistical Sciences, AbbVie, Inc.

Accurate prediction of trial enrollment timelines at the portfolio-planning stage is essential to strategic planning and the efficient allocation of resources for pharmaceutical sponsors. Traditional methods rely heavily on structured datasets and manual data curation, often resulting in suboptimal outcomes. This presentation introduces an enhanced approach that leverages advanced machine learning (ML) algorithms and large language models (LLMs) to accurately forecast trial enrollment timelines.

12:05 pm

Data -Driven Evaluation of Clinical Trial Inclusion and Exclusion Criteria to Optimize Study Design

Brandon Rufino, Computational Science Manager, Sanofi

Clinical trials are key to drug development and a costly component to our business. 55% of terminated clinical trials fail due to slow recruitment. We hypothesize that this is, in part, due to restrictive and perhaps poorly justified inclusion/exclusion criteria. To combat this issue, we developed simulation techniques to evaluate inclusion/exclusion criteria and propose a set of criteria such that we maximize the size of the potential patient population whilst retaining a high probability of success.

12:25 pm

Digitalization - Study Design, AI, Specimen Management, and Beyond

Viral Vyas, Dir IT, Global Clinical Dev, Bristol Myers Squibb Co

Mike Sullivan, Executive Director, Global Development Operations, Drug Development IT, Bristol Myers Squibb Co

Jolene Hill, Vice President, Solutions Consulting, Nurocor, Inc.

Bristol Myers Squibb and Nurocor will share the real world experience of executing a digitalization strategy for clinical development incorporating a digital protocol. Stories from the trenches will highlight the challenges and successes in executing a strategy and the results and benefits of a digital protocol and digital specimen management process. GenAI then unlocks the potential for automating other clinical operations processes like contracting.

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: AI for Trial Optimization

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