AI in Clinical Research

2026 ARCHIVES

The 2nd Annual AI in Clinical Research 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: Agentic AI in Clinical Research

Part 2: AI for Trial Optimization

Monday, February 2

7:00 amGolf Check-In & Breakfast Buffet*

8:00 am– 3:30 pm MaxisAI: INSPIRE Agentic AI Summit

12:00 pm– 4:00 pm IQVIA Technologies Innovation Day

1:00 pm– 3:30 pm Using Data and AI to Accelerate Trials: WCG User Group and Product Roadmap Discussion

1:00 pm– 3:30 pm Enhancing the Efficiency of Pipeline Delivery: Disruptive Scenarios and Strategic Responses

2:00 pm– 3:30 pm OPEN WORKSHOP: Modernizing Informed Consent: AI, Automation, and Ethics in Global Clinical Trials

For more details on Pre-Conference Events, please visit: Workshops/User Groups

9:00 amRegistration Open

9:00 amSCOPE's 5th Annual Masters of Clinical Research Golf Tournament* SOLD OUT (Sponsorship Opportunities Still Available)

Network on the greens at SCOPE's 5th Annual Golf Tournament! Visit the SCOPE Summit website for player and sponsorship opportunities.

1:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)*

1:00 pm– 3:45 pm SCOPE'S Pickleball Networking Session: Paddles & Partnerships

Kick off the SCOPE 2026 conference with food, fun, and pickleball! Whether you're a pickleball pro or have never picked up a paddle, this event is perfect for everyone. Limited spots available. Register Here

2:00 pmClose of the Masters of Clinical Research Golf Tournament

*Limited spots available. Separate registration and fee apply.

3:45 pmGrab Your Seat: Early-Bird Seat Golden Ticket Raffle & Prize Giveaway! *

*Must be present to win.

3:50 pm

Organizer's Welcome Remarks & 5th Annual Masters of Clinical Research Golf Tournament Awards and Jacket Signing

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

3:58 pm Chairperson's Introduction

Rob Goodwin, COO, Parexel

4:00 pm FIRESIDE CHAT:

Hope: The Double-Edged Sword of Patient Experience

Lindsay Guentzel, Multimedia Journalist & Patient Advocate

Jane Myles, Vice President, Programs and Initiatives, Decentralized Trials & Research Alliance (DTRA); Vice Chair, The Myositis Association (TMA) Board of Directors

Brad Watts, CAR T Recipient and Patient Advocate, Emily Whitehead Foundation

In this fireside chat, two CAR T trial participants and a patient advocate/clinical research professional unpack the journey: find the trial, fight the insurer, cross state lines, then live the trial reality, along with your family. Careful research, long consent forms, and great care teams can still miss key things that matter. For clinical researchers, we share a clear look at what we ask—and what patients still can’t see.

4:25 pm

Tips for Getting the Most out of SCOPE

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

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 2-5, 2026, at the Rosen Shingle Creek in Orlando, Florida! https://www.scopesummit.com/faq-how-to-succeed-at-scope

4:33 pm Chairperson’s Introduction: Developing Site Relationships beyond Study-Level Engagement

Elisa Cascade, Chief Growth Officer, Head of Americas, TrialScreen

4:35 pm

SCOPE's 3rd Annual Site Innovation Awards

Wouter Daniels, Clinical Trial Patient & Site Engagement Lead, Boehringer Ingelheim Pharma GmbH & Co KG

Angela DeLuca, Associate Vice President, Global Study Operations, Amgen

Irfan Khan, CEO, Circuit Clinical

Mara Kramer, Feasibility Transversal Projects Lead, Global Clinical Early Operational Strategy, Sanofi

Sean Soth, Senior Vice President, Strategy and Global Business Partnerships, SCRS

Amanda Wright, Co-Founder & Senior Vice President, Healthcare Alliance, Javara

We are excited to announce our 3rd Annual Site Innovation Award, recognizing sites and partnerships pioneering new approaches to improve clinical trials. This is an opportunity to highlight your successes and be recognized by your peers for your dedication to advance clinical research. By sharing your actionable solutions, you will inform the broader Clinical Operations Community at SCOPE. Our definition of innovation is inclusive of low-tech or high-tech solutions, or any site operations-related process improvements that effectively reduce site burden and improve a site’s ability to advance clinical research while providing patient-centered care. The Site Innovation Awards program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/site-innovation-award

5:05 pm SCOPE's 10th Annual Participant Engagement Awards Introduction: Industry Mandate and Collaboration for Expanding Access to Clinical Trials

Mike Martin, Drug Development Practice Area Lead, R&D Consulting, ZS Associates

5:10 pm KEYNOTE INTERACTIVE PANEL:

SCOPE's 10th Annual Participant Engagement Awards

PANEL MODERATORS:

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

Kelly McKee, Vice President, Strategy & Transformation, Science 37; Co-Creator of the SCOPE Participant Engagement Award

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC; Co-Creator of the SCOPE Participant Engagement Award

Now in its 10th 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 2026 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:

Beth Brooks, Head of Patient Insights & Behavioral Sciences, Patient Informed Development & Health Value Translation, Sanofi

Mark Evans, Managing Director, Patient Recruitment Expert

Jameka Hill, Senior Director, Clinical Trial Health Equity, Moderna, Inc.

Neha Shah Londono, Director, Clinical Trial Diversity and Community Engagement Lead, Pfizer Inc.

Samantha Rogers, Director, Patient Engagement & Patient-Centered Innovation, Raven (RA Ventures)

Brad Watts, CAR T Recipient and Patient Advocate, Emily Whitehead Foundation

5:40 pmSCOPE's Winter Games Opening Reception (Sponsorship Opportunities Available)

Break out your coolest Winter Games—inspired look—no snow required! Think country flag t-shirts, Olympic colors, or your favorite team gear. While we may be in sunny Florida, let’s ignite the spirit of unity, energy, and excitement—as we toast to teamwork and triumph!

7:00 pmClose of Day

Tuesday, February 3

6:00 amSunrise Yoga: In Gratitude for Clinical Research Participants

Join us at sunrise for a restorative yoga session celebrating the invaluable contributions of clinical research participants. Led by a trained instructor, this all-levels practice will focus on mindful movement, breath, and grounding—no experience necessary. Yoga mats and towels will be provided by the hotel; just wear comfortable clothing. During this yoga session, CISCRP asks participants to join us in showing gratitude for the individuals who have participated in clinical research. Each ticket includes a complimentary breakfast and a branded CISCRP yoga towel. Proceeds from this event help support CISCRP's mission. Yoga begins at 6:30 am.

Registration Link: https://www.ciscrp.org/sunrise-yoga

6:30 amSCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)

Lace up and join SCOPE’s Coordinators for the Fun Run on Tuesday, February 3! Sprint, jog, walk, or talk-your-way-through—ALL abilities are welcome. This informal event is all about getting moving together. New meet-up location for 2026! Meet outside at the back of the Gatlin Terrace by the paved path. We will do three loops around the property, do as few or as many as you have time for, but we will start promptly at 6:30 am! Meet us in the Rosen Hotel’s Gatlin Terrace at 6:30 am sharp!

7:30 amRegistration Open

7:30 amMorning Coffee (Sponsorship Opportunities Available)

Fuel your morning with made-to-order coffee and sweet bites, courtesy of our sponsors.

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

Don’t miss your chance to win! Arrive early, grab your seat, and take part in SCOPE’s Early Bird Seat Raffle & Prize Giveaway. Exciting prizes are up for grabs—must be present to win!

8:30 am

Welcome to SCOPE 2026—Welcome to the Clinical Trials Factory

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

8:38 am Chairperson's Plenary Keynote Introduction: Patient Engagement as a Guiding Principle in Research

Lisa Moneymaker, Chief Strategy Officer, Medidata

8:40 am

KEYNOTE FIRESIDE CHAT: Aligning Purpose, Innovation, and Operational Excellence in Clinical Development

Eliav Barr, Head, Global Clinical Development and CMO, Global Clinical Development, Merck & Co.

Pharma’s mission to deliver life-changing therapies depends on its ability to innovate while staying grounded in execution. This keynote will highlight how companies are aligning purpose with investment in new clinical models and technologies. The conversation will focus on where big pharma is directing innovation strategy—and how operational alignment ensures impact for patients and the healthcare system.

Interviewed By:

Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

9:05 am

SCOPE’s Stretch Break & Annual T-Shirt Toss

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

Take a quick pause to stretch, recharge, and enjoy a little SCOPE tradition—our Annual T-Shirt Toss! Watch for the t-shirt slingshot sending giveaways into the audience as we add some fun to your day.

9:15 am KEYNOTE PANEL DISCUSSION:

From Years to Months: Is Radical Acceleration in Clinical Research Possible?

PANEL MODERATOR:

Jeremy Goldberg, Operating Partner, Healthcare, Arsenal Capital Partners

Clinical development timelines remain one of the biggest barriers between breakthrough innovation and patients in need. Incremental process tweaks won’t cut it—what’s required is a step-change in how trials are designed, executed, and financed. This keynote will push beyond theory into bold, actionable strategies for compressing timelines, rethinking operational models, and deploying capital where it can have the greatest impact. Leaders will examine how smarter investment, data integration, and operational transformation can turn years into months—and what will truly move the needle for the future of clinical research.

PANELISTS:

Sandeep Burugupalli, Head, Data Science & Biopharmaceuticals R&D, AstraZeneca

Shawne Moran, Head, In-Country Study Operations-Americas, EMD Serono/Merck KGaA Darmstadt, Germany

Jared Saul, MD, CMO, Commercial Healthcare and Life Sciences, Amazon Web Services

9:45 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall —Best of Show Voting Opens

Step into SCOPE’s one-of-a-kind exhibit hall! With 300+ leading clinical trial technology and service companies, it’s the place to discover new partners and reconnect with familiar ones. Cast your vote for SCOPE’s Best of Show, recharge with coffee, snap a photo, and don’t forget your comfy shoes—you’ll have miles to explore!

Part 1: Agentic AI in Clinical Research

11:00 am Chairperson's Remarks

Krishna Cheriath, Vice President, Digital & AI, Biopharma Services, Thermo Fisher Scientific, Inc.

11:05 am PANEL DISCUSSION:

Fit-for-Purpose AI Applications in Clinical Trials

PANEL MODERATOR:

Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

This panel will explore practical AI applications in clinical trials, linking each use case to measurable outcomes like time savings and ROI. Featuring an esteemed group of industry experts, the talk will combine case studies with an open discussion on implementation and impact.

PANELISTS:

Henry Wei, MD, Executive Director, Development Innovation, Regeneron

Amy Chowansky, Senior Director, AI Strategy Lead, Pfizer Inc.

Nareen Katta, Head of Data Science & Analytics, AbbVie, Inc.

11:35 am

Clinical Control Tower—A View on Melding AI Predictive Features with Operational Overview

Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen

The Clinical Control Tower integrates operational oversight with AI-driven predictive insights to enhance trial management. This talk will explore how predictive features can be combined with real-time operational data to anticipate risks, optimize site performance, and support decision-making, offering a practical perspective on leveraging AI while maintaining a comprehensive view of trial operations.

11:55 am

From Automation to Autonomy: How Agentic AI is Transforming Clinical Trials

Prasanna Rao, Chief Products and Innovation Officer, Executive, Saama

As clinical trials grow in complexity, the need for intelligent, adaptive systems has never been greater. Traditional automation focuses on task execution, but Agentic AI represents the next evolution with systems that not only perform tasks but can also plan, reason, and make autonomous decisions based on real-time data.

In this session, we will explore how Agentic AI is accelerating the shift from reactive to proactive data management, and next steps in this evolution including exploring reasoning models such as DeepSeek. We’ll share our perspective on how this paradigm shift is enabling us to build more infrastructure that is adaptive, cost effective and truly scalable. Join us to explore how Agentic AI is setting the stage for a more efficient, insight-driven future of clinical trials, and where AI in clinical development is heading next.

12:20 pm

Building a Unified Clinical Intelligence Ecosystem Using Graph (Magellan)

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

Ankit Singh, MS, Senior AI Scientist, IR – Global Therapeutic Platforms, AbbVie, Inc.

Project Magellan is an initiative by AbbVie's BTS-IR Global Therapeutics Platform organization with potential to become a foundational capability in supporting a variety of AI-centric use cases in research and development by digitizing clinical documents and creating an integrated graph-based environment. Built on modern graph technology and leveraging the Integrated Data Platform, Magellan uses Agents to extract and integrate clinical documents that enable extensive data exploration through a visual explorer, a conversational chat, and the ability to connect systems via an API layer.

12:45 pm

Beyond Automation: Agentic AI and the Future of Clinical Trial Design and Execution

Krishna Cheriath, Vice President, Digital & AI, Biopharma Services, Thermo Fisher Scientific, Inc.

We are entering the era of agentic AI—systems capable not just of analysis, but autonomous reasoning and adaptive decision-making. This session examines how agentic AI can reshape trial design, site selection, patient recruitment, and monitoring. It explores real-world pilots and governance frameworks that ensure safety, transparency, and human oversight, while unlocking efficiency and innovation.

1:10 pmSponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break.

2:10 pmNetworking Coffee & Dessert Break in the Exhibit Hall

Keep the conversations going in the Exhibit Hall with coffee and dessert, courtesy of SCOPE sponsors. Network with colleagues, explore new products and services, and don’t forget—Best of Show Award voting is still open, so be sure to cast your vote!

2:15 pmSpecial Book Launch & Signing

Barnett's Good Clinical Practice: A Question & Answer Guide 2026/2027
Editor-In-Chief: Donna Dorozinsky, RN, MSN, CCRC
Location: Booth #129 (Free copies for the first 30 visitors!)

3:00 pm Chairperson's Remarks

Denis Pesacreta, Manager, Pharma & Life Sciences R&D Analytics, PwC US

3:05 pm

The Data & AI Imperative: Transforming Clinical Operations for the Next Decade

Mike Sullivan, Executive Director, Global Development Operations Business Insights & Technology, Bristol Myers Squibb

Clinical operations are facing a critical inflection point. The need for faster, more cost-effective trials, improved patient & site experience, and near-real-time actionable insights is driving the industry towards innovative solutions. Advances in artificial intelligence are opening the door to a fundamentally new approach—one in which intelligence is embedded across trial design, execution, and oversight. This presentation offers a forward-looking perspective on how data, automation, and human judgment may converge over the next decade to reshape how clinical research operates, learns, and scales.

3:30 pm PANEL DISCUSSION:

AI in Clinical Development: Shaping the Regulatory Environment to Enable Transformative Innovation

PANEL MODERATOR:

Kevin Bugin, PhD, Head, Regulatory Policy and Intelligence, Amgen

This session will explore how emerging AI applications in clinical development—from operational optimization to patient identification—are challenging and advancing current regulatory paradigms. Presenters will share real-world use cases, such as Amgen’s ATOMIC initiative, and examine evolving regulator perspectives (including EMA and FDA) and regulatory considerations. Attendees will gain insights into strategic considerations for external engagement, regulatory policy implications, and the kinds of frameworks needed to responsibly scale AI-enabled innovation in drug development.

PANELISTS:

Anindita Saha, Associate Director, Data Science and Artificial Intelligence Policy, FDA CDER

Tala Fakhouri, Vice President, Regulatory Consulting, AI & Digital Policy, Real-World Research, Parexel

3:55 pm

Designing with Foresight: Turning Operational Data into Protocol Performance

Ian Bailey, Managing Director, AI & Data Science, Advarra

Jamie Bendrick-Peart, Senior Director, Innovation & Strategic Projects, SMM Oncology, Novartis Pharmaceuticals Corp

What if we could validate study assumptions before the first site is activated? This discussion dives into how combining AI with operational datasets enables sponsors to evaluate design hypotheses, identify amendment risks early, and optimize trial execution. Hear from industry leaders on how data-driven insights are reshaping protocol development and improving decision-making across the clinical lifecycle.

4:20 pm

AI as the Catalyst: Re-Imagining Clinical Trial Delivery

Rob Goodwin, COO, Parexel

AI is increasing trial predictability and speed but cannot deliver transformative value if applied to legacy processes, roles, and incentives. The future of clinical research requires purpose-driven processes, integrated data and redefined roles.

4:45 pm PANEL DISCUSSION:

Agentic AI: Driving Business Value Through Implementation, Change Management While Navigating Compliance & IP Challenges

PANEL MODERATOR:

Hassan Kadhim, Senior Director, DTE Business Engagement for Clinical Operations and Medical Writing, Vertex Pharmaceuticals

Agentic AI introduces significant privacy and legal concerns. Legal teams are wary of using proprietary data to train third-party AI tools. Business functions are eager to adopt AI solutions rapidly to realize their benefits. Data science teams must balance customer demands with regulatory and compliance requirements.

PANELISTS:

Angela DeLuca, Associate Vice President, Global Study Operations, Amgen

Nagaraja "Sri" Srivatsan, CEO, Endpoint Clinical, Inc.

Angela Radcliffe, Founder, Intelligence Applied AI

5:10 pm

From Insights to Outcomes: A Practical AI Playbook for Trial Teams

Suzanne Caruso, General Manager, Clinical & Regulatory & SI, Citeline

AI’s real value in clinical research isn’t automation alone — it’s connection. By linking decisions across the trial lifecycle, AI helps teams move faster, reduce friction, and focus on patients. This session cuts through the hype to show how AI supports trial teams in practice: shaping protocols that won’t stall, validating cohort feasibility, informing country and site mix, and activating recruitment when eligibility appears. We’ll outline the principles that make AI trustworthy — data quality, context, and interpretability — and where human checkpoints remain essential. The takeaway is a pragmatic view of AI as connective tissue across the workflow, improving efficiency and decision-making without losing sight of the people at the center of research.

5:22 pm

Who's Training on Your Trial? Where Your Data Goes When You Use AI

Storm Stillman, CEO, Curebase

Every time your team pastes trial data into ChatGPT, where does it actually go?

This session breaks down the hidden data flows behind AI tools in clinical research and asks why our industry's obsession with data integrity seems to stop at the AI layer. You'll leave with practical questions to ask your vendors.

5:35 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)

Wrap up the day with colleagues, friends old and new at SCOPE’s Welcome Reception in the Exhibit Hall. Enjoy drinks, network with exhibitors, and enter to win fabulous raffle prizes (must be present to win). Keep the evening going with dinner at Rosen Shingle Creek’s restaurants—no Orlando traffic required!

7:00 pmClose of Day

7:00 pmSCOPE Out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

Enjoy an evening exploring the restaurants and shops at Pointe Orlando with transportation provided by our courtesy shuttle. Shuttles will run until 11:00 pm, with the last pick-up at 10:30 pm.

*Times subject to change. More details closer to the event.

Wednesday, February 4

6:00 amSunrise Yoga: In Gratitude for Clinical Research Participants

Registration Link: https://www.ciscrp.org/sunrise-yoga

7:30 amRegistration Open

8:00 am

BREAFAST PRESENTATION OPTION #1:

Reaching the Unreachable: Proven Strategies You Can Apply to Engage Underserved Populations in Global Clinical Trials

Tobias Kruse, PhD, Managing Director, Europe, SubjectWell

Underserved populations are often excluded from clinical trials, limiting engagement, scientific validity, and real-world relevance. Traditional strategies often rely on outdated assumptions and overlook patient realities. This session reveals proven, globally scalable strategies to engage these communities through real-world data (RWD), behavioral insights, and human-centered approaches—replacing guesswork with precision to accelerate inclusive trial enrollment and shorten study timelines.

8:00 am

BREAKFAST PRESENTATION OPTION #2:

From Elusive to Enrolled: A Case Study in Precision Recruitment

Matthew Graffeo, Managing Director, Healthcare & Digital, GCI Health

Nikki Buchmayer, Senior Vice President, Digital, Clinical Trial Recruitment, GCI Health

As the pace of innovation accelerates, scientific breakthroughs bring new hope to patients. Effectively including and supporting underrepresented populations is critical for the success of clinical trials designed to benefit these communities. GCI Health’s experts will share their “secret sauce” for building meaningful engagement with niche communities along with a real-world example of its methodology in action through its work with the University of Florida’s traumatic brain injury trial.

8:00 amSponsored Breakfast Presentation (Opportunity Available)

8:00 am– 9:00 am WORKING GROUP BREAKFAST: Pharma Leadership Forum: Overcoming Geopolitical Challenges in Clinical Development (Invite Only)

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

Global clinical development is increasingly vulnerable to geopolitical forces. Sponsors face rising risks in running global trials, requiring proactive and diversified strategies to maintain momentum and safeguard patients. A group of top clinical research leaders from biopharma companies will get together at SCOPE to exchange ideas and case studies and to explore opportunities for sponsor companies to unify their efforts. Some of the challenges to be discussed include regulatory divergence, supply chain disruptions, patients recruitment in global trials, data security & sovereignty, IP protection, and cyber threats.

8:25 amTransition to Sessions

8:30 am Chairperson's Remarks

Jason Casavant, Head of Innovation, Innovation, Synterex

8:35 am

The RBQM Copilot: A Framework for Human-Agent Collaboration in Clinical Review

Usama Dar, Chief Product & Technology Officer, CluePoints

Nicolas Huet, Machine Learning Senior Manager, Research & Development, CluePoints

As AI and GenAI enter clinical development, most efforts focus on generating artifacts like protocols and CRFs. This talk asks a complementary question: how can agentic AI act as a trusted co-pilot for clinical quality and patient safety across the trial lifecycle? We present a practical “oversight co-pilot” architecture spanning protocol digitalization, AI agents for deviation and anomaly detection, safety surveillance, and human-in-the-loop scenario design—enabling continuous, risk-based prioritization. We conclude with key validation, governance, and change-management principles for regulated use.

9:00 am

Clinical Trial Compliance through Autonomous Agents

Sujan Gowda, Senior Manager, Engineering, Global Clinical Development, Bristol Myers Squibb

Shuba Simha, Senior Director, Head, Engineering & Operations, Bristol Myers Squibb Co.

An enterprise-grade intelligent automation solution modernizes protocol amendment assessment by shifting manual reviews to an autonomous, agent-driven model. The application compares approved Protocol Amendments with ClinicalTrials.gov listings to identify and manage changes. Powered by seven specialized AI agents, the solution integrates with protocol authoring systems, ClinicalTrials.gov, and the Clinical Trials Registration & Results platform to enable efficient data extraction, automated comparison, and controlled updates—improving operational efficiency, scalability, and compliance.

9:25 am

Transforming Clinical-Development Decision-Making with AI/ML and Clinical Statistical Modeling

Yifan Zhu, PhD, Director, Clinical Statistical Modeling, Sanofi

AI/ML and clinical predictive modeling play increasingly vital roles in accelerating and increasing PoS in drug development. AI/ML enables more robust decision-making by integrating evidence from data sources, biological, disease physiology, clinical trial and real-world. Statistical prediction modeling embraces AI/ML and provides a unified framework for insights generation. This talk explores the transformative impact of these innovations using applications in clinical trial planning, patient enrollment, and decision-making. By harnessing AI/ML and clinical predictive modeling, clinical development becomes more efficient, data-driven, and adaptive, ultimately enhancing the success of new therapies.

9:50 am

PROJECT LOOM: Evaluating End-to-End Agentic AI Workflows for Clinical Trials

Moulik Shah, CEO, Software, Maxis AI

Susan Bornstein, MPH, Agentic AI Advisor, Maxis AI; Principal, SMB Consulting & Board Advisory

Michael Cohen-Wolkowiez, Distinguished Prof, Childrens Health Ctr, Duke Univ

The commoditization of intelligence is inevitable. Organizations that strategically apply frameworks like Verifier’s Law and The Jagged Edge will thrive, transforming their business model from labor arbitrage to technology-enabled strategic partnership. This case study demonstrates that by automating the verifiable and empowering human oversight for the complex, CROs can reverse the effects of Eroom’s Law, achieve significant competitive differentiation, and create a future where human skills are amplified, not replaced. The key to success is not merely adopting AI but architecting a collaborative ecosystem where human and machine intelligence work in a state of productive asymmetry.

10:15 amCoffee Break in the Exhibit Hall (Sponsorship Opportunities Available)

Fuel up and connect at SCOPE’s Coffee Break in the Exhibit Hall! Visit booths you haven’t seen, network with colleagues and exhibitors, and cast your final vote for the Best of Show Award—make your vote count!

11:10 am Chairperson's Remarks

Jamuna Thimmarayappa, Director, Product Management, Oracle Corp.

11:15 am

Engineering for Speed and Trust: AI Agents in Clinical Operations Data Pipelines

Arnab Roy, Associate Principal, R&D, ZS Associates

Rajiv Harpalani, Associate Director, BTS R&D Data Governance, AbbVie

Sunanda Teeparti, Associate Director, BTS R&D Data Engineering & Analytics, AbbVie

Jinit Shah, Assoc Principal, ZS Associates India Pvt Ltd

Rapid, effective, and high‑quality data infrastructure for clinical operations is a critical success factor in enabling teams to make data‑driven decisions faster. This session will highlight how we are implementing AI agents across the clinical operations data engineering pipeline to deliver trustworthy insights and empower high‑quality decisions and actions at lightning speed.

11:40 am

Accelerating CRF and Edit Check Generation Using an Agentic AI Framework

Jeremy Zhang, PhD, Senior Director, Data Science, Data & Analytics, Otsuka America Pharmaceuticals, Inc.

Case report forms (CRFs) and edit checks are critical components of database build during study start. In this implementation of agentic AI frameworks - we demonstrate how generative AI can be used to significantly accelerate the creation of CRFs and edit checks and decrease study startup timelines.

11:58 am

AI for Enhanced Patient Matching, Community-Based Trial Monitoring, and Engagement

Ramita Tandon, Chief Biopharma Officer, Walgreens

AI is transforming the way clinical trials are designed, conducted and analyzed. This session will explore the various applications of AI in clinical trials and its potential to accelerate innovation in research, optimize outcomes, and reduce costs. Walgreens Clinical Trials can discuss its approach of “trust and verify” to ensure the AI results are accurate and free of bias.

12:15 pm

From Manual to Intelligent: The Role of AI in Modernizing Trial Activation

Karen Hartman, Vice Chair, Research Administration, Mayo Clinic

This presentation provides an overview of artificial intelligence (AI) and its potential to transform clinical trial activation. Practical examples of AI tools currently in use will be shared, highlighting how they streamline workflows, automate routine tasks, and reduce administrative burden. We'll explore the broader implications of AI adoption, including its impact on teams, costs, and regulatory considerations.

12:30 pm

The Next Era of eCOA: How AI Can Power Efficient, Streamlined eCOA Implementation

Paul O'Donohoe, Senior Director, eCOA Product and Science, Medidata, a Dassault Systemes Co.

With AI entering the landscape of clinical research, new opportunities are taking shape for transforming the eCOA experience for patients, sites, and sponsors. This session will share learnings from how AI is being leveraged today for smarter and more efficient end-to-end eCOA study builds, reducing the timeline to go-live, and the transformative possibilities on the horizon for technology-driven data capture.

12:55 pmSponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break.

1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)—Best of Show Winner to be Announced

Recharge with coffee, dessert, and networking at SCOPE’s Exhibit Hall Break! Grab a sweet treat courtesy of our sponsors, visit Game Card Sponsors to collect stickers, and connect with colleagues before the afternoon sessions. Plus, don’t miss the announcement of the Best of Show winner!

2:30 pm

SCOPE around the World: Community, Connection, Celebration

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

2:40 pm Chairperson's Introduction:

Rethinking Trial Design

Matthew Rich, Principal, Pharma & Life Sciences Technology Leader, PwC US

2:42 pm KEYNOTE INTERACTIVE PANEL:

Clinical Is Not an Island: How Med Affairs and Access Can Transform Trial Success

PANEL MODERATOR:

Rosemary Rebuli, Global Head, Study & Site Operations, Novartis Pharma AG

Clinical operations leaders face increasing pressure to design trials that not only deliver clean data but also support downstream market success. This keynote panel explores how biopharma organizations can break down functional silos by integrating insights from Medical Affairs, Market Access, and field-facing roles like MSLs and CRAs. Panelists will discuss how early cross-functional collaboration improves protocol design, enhances site and prescriber engagement, supports feasibility, and aligns clinical development with real-world needs—ultimately creating a competitive edge. Learn how forward-thinking teams are redefining roles and relationships across the clinical-commercial continuum.

PANELISTS:

Karen Correa, PhD, Vice President, Development Operations, Boehringer Ingelheim

Raza Zaheer, Medical Head, Next Gen Immunology, North America, Sanofi

Jie Zhang, Head, Global Pipeline Market Access, CSL

3:12 pm

SCOPE Award Winners & Announcements (Sponsorship Opportunity Available)

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

3:23 pm Chairperson's Introduction:

AI Adoption in eClinical Technology

Nagaraja "Sri" Srivatsan, CEO, Endpoint Clinical, Inc.

3:25 pm KEYNOTE INTERACTIVE PANEL:

Change Management for AI Adoption in Pharma Clinical Development Teams

PANEL MODERATOR:

Mike Sullivan, Executive Director, Global Development Operations Business Insights & Technology, Bristol Myers Squibb

AI is rapidly entering clinical development, but the real challenge isn’t the technology—it’s managing the people, processes, and culture shifts required for adoption. This panel will share practical lessons from pharma leaders on how to align stakeholders, upskill teams, and build trust in AI-driven tools across clinical operations. Discussion will focus on real-world strategies that move beyond theory to accelerate adoption, improve decision-making, and deliver measurable impact in drug development.

PANELISTS:

Chris Sinclair, PhD, Vice President, Global Therapeutic Platforms, AbbVie, Inc.

Susie Stephens, PhD, Head of Client Facing Technology R&D, Amgen

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

3:55 pmSCOPE's Closing Ceremony Booth Crawl (Sponsorship Opportunities Available). Last Chance for Exhibit Viewing

As the flame of another unforgettable SCOPE conference comes to a close, join us for our final reception, our infamous "booth crawl." Just like the Closing Ceremonies of the Games, we'll come together one last time to honor the moments of triumph, teamwork, and inspiration that made this week so special. Gather with friends, old and new, enjoy great food and drink, and celebrate the spirit of unity that connects us all. SCOPE 2026 may be ending, but the memories will last long after the torch goes out.

4:55 pmClose of Day

5:00 pmSCOPE out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

Enjoy an evening exploring the restaurants and shops at Pointe Orlando with transportation provided by our courtesy shuttle. Shuttles will run until 9:00 pm, with the last pick-up at 8:30 pm.

*Times subject to change. More details closer to the event.

Thursday, February 5

7:30 amRegistration Open

8:00 am

BREAKFAST PRESENTATION:

From Burden to Breakthrough: Innovative Strategies for Site and Patient Support

Shelby Stillwagon, Vice President, Decentralized Clinical Trials, ProPharma Group

This presentation explores strategies to strengthen clinical trial site capacity and improve patient engagement. It emphasizes delivering customized solutions through specialized roles that integrate with site teams, flexible resourcing, and operational support across key activities such as prescreening, recruitment, data entry, and remote study visits. Additionally, it highlights the importance of global scalability combined with local expertise, supported by an oversight structure that ensures consistency worldwide. The ultimate goal is to drive measurable improvements in site performance, operational efficiency, patient engagement, and retention, creating a more effective and patient-centric trial experience.

Part 2: AI for Trial Optimization

8:25 amTransition to Sessions

8:40 am

Chairperson's Remarks

Chris Decker, President & CEO, CDISC

8:45 amPeer Networking Session

8:55 am

Design Once, Execute Everywhere: Leveraging AI and PwC’s Digital Trial Core Vision to Orchestrate Modern Trials

Matthew Markman, Manager, Pharma & Life Sciences R&D Analytics, PwC US

Joe Ricks, Senior Associate, Pharma & Life Sciences R&D Analytics, PwC US

The next wave of clinical trial acceleration will not come from isolated AI tools, but from a cross-functionally-integrated, end-to-end approach. This session explains how PwC’s Digital Trial Core solution enables bidirectional data flow across planning, protocol design, and execution, with AI augmenting clinical operations teams. Learn how other sponsors reduce manual effort, minimize amendment impact, and accelerate study start-up using AI-ready, standardized trial data.

9:20 am

Why Robust Standards Are Critical to Leveraging AI to Accelerate Clinical Research

Chris Decker, President & CEO, CDISC

Artificial intelligence (AI) has rapidly emerged as a transformative force in clinical research, offering the potential to accelerate discoveries, improve patient outcomes, and enhance the efficiency of trials. However, the effectiveness and reliability of AI systems are fundamentally dependent on the quality and interoperability of the underlying data. Data standards play a critical role in ensuring that clinical data is consistent, accurate, and comparable across diverse sources. Robust data standards facilitate seamless data integration, sharing, and validation, which are essential for training robust AI models and fostering trust in AI-driven insights. Without unified data standards, AI applications may yield biased, irreproducible, or clinically irrelevant results, undermining their value to research and patient care. Therefore, the adoption and enforcement of rigorous data standards are pivotal for maximizing the benefits of AI and ensuring its responsible use in clinical research. This presentation will provide a baseline for why standards are important, an overview of use cases where AI can be applied to standards to improve the process, and future opportunities to have AI driven standards.

9:35 am

Evaluating Generative AI Output: Toward Robust Assessment with Human and Automated Methods

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

The rapid adoption of generative AI in clinical research necessitates rigorous evaluation to ensure outputs meet professional standards. We propose a structured framework comprising three foundational pillars: Accuracy (factual correctness, completeness, and source attribution), Quality (natural language use, writing style, consistency, and avoidance of repetition), and Reasoning (causal inference and contextual understanding). To achieve comprehensive evaluation, we advocate a combined approach leveraging both human expertise and automated measures. Expert review methods, such as direct assessment, pairwise comparison, and summative evaluation, provide nuanced insights but are resource-intensive. Automated evaluation has advanced from traditional metrics (ROUGE, BLEU, METEOR), which focus on surface overlap, to large language model-based approaches like G-eval that better capture semantic and contextual dimensions.

9:50 am

Harnessing Gen AI for Clinical Development

Scott Chetham, CEO & Co-Founder, Faro

AI agents are moving from hype to reality in clinical development, but success requires far more than building a model. In this session, Faro’s CEO will share real examples of how multiple Top 5 and Top 10 biopharma companies have moved beyond pilots to deploy AI agents that automate complex scientific, operational and regulatory functions, structure scientific intent into operational data, and accelerate core development workflows. We will break down the transformation required across four critical dimensions: organizational change management, technical and data readiness, regulatory expectations for transparency and traceability, and the security and compliance foundations needed to operate safely in a regulated environment. Attendees will leave with a clear blueprint for responsibly implementing AI agents at scale and the lessons learned from teams that are already succeeding.

10:15 amFind your Working Group

10:20 amInteractive Working Groups (Sponsorship Opportunity Available)

Step away from the slide decks and into the conversation.
After a full agenda of case studies, technical talks, and panels, SCOPE’s Interactive Working Groups offer a unique chance to roll up your sleeves and engage. Choose the topic that interests you—whether it aligns with your expertise or challenges you to think differently. Each group will explore a distinct theme using collaborative formats like hackathons, open innovation challenges, or problem-solving sprints. The only requirement: jump in and contribute.

IN-PERSON ONLY WORKING GROUP:

Humans, Meet Your Co-Panelists: AI Takes the Mic in Clinical Trials

Munther H. Baara, Vice President, Product Strategy & Innovation, EDETEK, Inc.

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

Everyone's talking about AI, but what happens when AI joins the conversation? In this live, interactive format, two role-based AI co-panelists, a Patient Burden Auditor and a Site Coordinator Advocate, join Munther Baara and Craig Lipset to pressure-test a clinical trial operational challenge chosen live by the audience (such as protocol complexity, enrollment drag, data flow friction, or RBQM signal/noise).

This isn't a typical panel; it's a working session. We'll quickly "autopsy" what's breaking today, make assumptions explicit, surface tradeoffs, and rebuild a practical path forward across process, protocol, and data. AI outputs are treated as hypotheses, the humans challenge feasibility, risks, and incentives in real time.

You'll leave with a one-page Field Guide tailored to the selected problem: likely root causes, actionable fixes, ownership prompts, and a primary metric with guardrails you can use Monday morning, whether you leave inspired or skeptical.

11:00 amNetworking Coffee Break

Take a break and reconnect at SCOPE’s Networking Coffee Break! Grab a cup of coffee, meet colleagues old and new, and fuel up before the next sessions. A perfect pause to spark conversations and make connections!

11:30 am Chairperson's Remarks

Alex Liu, Director of Product Management, Life Sciences AI Data Platform

11:35 am

Building a Transformative, AI-Driven Analytics Capability for Clinical Trial Insights

Omkar Dasari, Senior Technical Product Manager, Data & Analytics, Amgen

James Vernille, PhD, Director, Clinical Systems & Analytical Reporting, Global Development Operations, Amgen, Inc.

At Amgen, we are transforming our analytics ecosystem with AI-driven tools that enable near real-time, self-service insights for Global Development stakeholders. Our next-generation analytics engine features a rebuilt metrics platform, centralized data governance, and a streamlined dashboard landscape leveraging Power BI with Co-Pilot and custom AI interfaces. By implementing AI/ML bots and natural language queries, we are shifting from static reporting to a dynamic, AI-driven experience.

12:00 pm

From Proven Results to Product Vision: Advancing Clinical Trial Data Exchange with IgniteData Archer

Joe Lengfellner, Chief Product Officer, IgniteData

Clinical trial data exchange has long limited the pace of innovation in research. This session explores how IgniteData Archer is redefining what’s possible, drawing on proven results from live trials at Memorial Sloan Kettering Cancer Center. Presented by Joe Langfellner, IgniteData’s Chief Product Officer, the talk connects real-world impact to a forward-looking product vision—explaining why Archer’s success led him to join IgniteData and how he and the team are shaping the future of clinical trial data exchange.

12:13 pm PANEL DISCUSSION:

Transforming Clinical Data Analytics with Agentic GenAI

PANEL MODERATOR:

Sina Djali, Managing Partner, Axcellion.ai

This panel explores how Agentic Generative AI (GenAI) is reshaping clinical data analytics by enabling autonomous and adaptive systems that streamline data processing, uncover complex patterns, and generate actionable insights. The discussion will address the opportunities and risks of integrating Agentic and Applied GenAI into regulated clinical research environments, highlighting their potential to drive innovation while maintaining data integrity and patient safety.

PANELISTS:

Bhargava Reddy, PhD, Senior Director, Advanced Insights and Solutions, Janssen

Richard Young, Chief Strategy Officer, CluePoints

Donald Jennings, Senior Director, Digital Trial Foundations and Patient Engagement, Eli Lilly and Company

12:50 pmSCOPE Summit 2026 Adjourns

And that’s a wrap! Thank you for joining us at SCOPE Summit 2026. We hope you leave inspired, connected, and energized for what’s next in clinical trials. Safe travels, and we can’t wait to see you at the next SCOPE event!