Real World Evidence - 2026 Archive

2026 ARCHIVES

The 16th Annual Real World Evidence stream at the SCOPE Summit will explore the evolving landscape of RWD integration into clinical research. Building on previous discussions, this stream will focus on how diverse data sources are increasingly shaping study design and regulatory decisions. As the boundary between traditional clinical trials and real-world data research continues to shift, innovative data technologies, advanced analytics, and strategic collaborations are critical to unlocking actionable insights. The role of AI in analyzing complex RWD sets the stage for more efficient, patient-centric research and accelerated product development. This program aims to foster collaboration among healthcare providers, biopharma, regulators, and data partners, driving forward the strategic use of RWD in clinical and observational studies.

Part 1: Accessing and Generating RWD

Part 2: Leveraging RWD for Clinical Research

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: Accessing and Generating RWD

11:00 am Chairperson's Remarks

Brett Kleger, CEO, Inspire

11:05 am

Fit-for-Purpose RWD

Thomas Dougherty, Real World Data Strategy Lead, Novo Nordisk

Stakeholders of RWE (including regulatory agencies, HTAs, payors, providers, patients) are increasing their expectations on the rigor we put into generating meaningful evidence from RWD. Therefore, we need to increase our efforts around demonstrating the data we select are truly fit for the "purposes" of the evidence we are generating.

11:25 am

Emerging Themes in the Use of AI/ML in Causal Inference Based on RWD

Demissie Alemayehu, PhD, Vice President, Biostatistics, Pfizer Inc.

The increasing availability of real-world data (RWD), including electronic health records, claims data, patient registries, and digital health sources, has broadened the applications for causal inference in biomedical and public health research. Artificial intelligence (AI) and machine learning (ML) methods are increasingly adopted in these areas, providing approaches for high-dimensional data integration, feature selection, bias reduction, and modeling treatment-outcome relationships. Current research topics include deep learning and ensemble methods for confounding adjustment and counterfactual prediction; combining heterogeneous RWD sources to enhance generalizability; developing interpretable ML techniques for transparent causal analysis; and using AI-driven simulations to evaluate causal assumptions. Issues being addressed include data quality, algorithmic bias, reproducibility, and the relationship between ML-based causal inference and conventional epidemiologic frameworks. The presentation will examine these developments and emphasize the importance of multidisciplinary collaboration among industry, academia, and regulatory agencies.

11:40 am

Trial Benchmarking and External Control Arms from Real World Data

Dorothee B. Bartels, PhD, Strategist, Global Real World Evidence and (Gen)AI in Healthcare

Nils Kruger, Physician Scientist, Cardiovascular Medicine, Technischen Universitat Munchen (TUM); Instructor, Pharmacoepidemiology and Pharmacoeconomics, Harvard Medical School, Brigham and Women's Hospital

Randomized controlled trials (RCTs) provide critical evidence on treatment efficacy and safety, but they often leave important questions unanswered, particularly regarding broader patient populations and head-to-head (H2H) treatment comparisons. Although additional trials to address these gaps would be ideal, they may not always be available for various reasons. This presentation discusses the use of real-world data (RWD) to complement RCT evidence, including applications in label expansion, H2H comparisons, and the development of external control arms (ECAs). It highlights methods to accelerate evidence generation while maintaining clinical rigor, and discusses how to strengthen confidence among decision makers.

11:55 am

Innovating Siteless Registries: How Payors, Pharma, and Analytics Are Shaping the Future of Evidence Generation

Ria Westergaard, Head of Product Strategy and Innovation, Clinical Trial and RWE Solutions, Evernorth Health Services

Krystyna Amalfe, Client Services Clinical Trial and RWE Solutions, Evernorth Health Services

Sameer Ghate, Director, Center for Observational & Real World Evidence, Merck

Mei Sheng Duh, Managing Principal & Chief Epidemiologist, Health Care Consulting, Analysis Grp

As virtual patient registries continue to evolve from concept to operational reality, payor generated data has emerged as a transformative asset for improving evidence quality, patient identification, and real world insights. Yet the path to building a scalable, payor based data ecosystem requires tight collaboration across the healthcare value chain. Attendees will gain a clear understanding of what it takes to build a sustainable, multi stakeholder data ecosystem.

12:20 pm PANEL DISCUSSION:

The Use of Real-World Data and Evidence in Clinical Trials: Industry Use Cases

PANEL MODERATOR:

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

Tufts CSDD and sponsors will discuss the adoption and use of RWE/RWD in trials across select therapeutic areas based on industry use cases. Areas addressed will include types and sources of data and applications, as well as focus of clinical trial activities for usage of RWD/RWE. In addition, key approaches that are being leveraged across pharma companies; organizational resources available to support RWD/RWE initiatives and challenges and opportunities will be discussed. Areas of highest return on investment (ROI) and future trends will also be explored as usage continues to evolve.

PANELISTS:

Alex Asiimwe, PhD, Head of Evidence Generation, Innovation and Partnerships, Gilead Sciences

Emily Carter, Director, Trial Execution Data Science & Analytics, Data Science & Statistics, AbbVie, Inc.

Ashley Daigneau, Head of Clinical Trials, Commercial, Verana Health

12:45 pm

Making Real-World Evidence Work for Clinical Operations

Jocelyn August, Vice President, Product Management, Life Sciences, PurpleLab

Scott DuVall, Senior Vice President Real World Evidence, PurpleLab

Melissa Wissner, Principal, Clinical Trial Solutions, Datavant Inc

Clinical operations teams have access to more real-world data than ever before, yet turning that data into trusted, reusable evidence remains difficult. Disconnected datasets, inconsistent definitions, and limited linkage continue to slow feasibility, complicate cohort strategy, and increase operational risk.

This session explores how linking multiple real-world data sources through privacy-preserving technologies, combined with a common data language such as OMOP, enables clinical teams to move from fragmented inputs to decision-ready evidence. Attendees will learn how standardized and linked real-world data supports earlier feasibility assessment, stronger cohort design, and more defensible operational decisions.

The discussion will focus on practical, execution-ready approaches for accessing and generating real-world evidence that can be applied directly within clinical operations workflows.

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

Krystyna Amalfe, Client Services Clinical Trial and RWE Solutions, Evernorth Health Services

3:05 pm

Implementing AI to Accelerate the Next Era of RWD/RWE!

Aaron W. Kamauu, MD, MS, MPH, CEO, Navidence LLC

Vladimir Turzhitsky, PhD, Director, Data Science and Outcomes Research, Merck & Co.

Real-world data is vast and expanding, but fragmented. By applying AI techniques, we can bridge gaps, reduce complexity, and create actionable real-world evidence more efficiently. Drawing on a pharmaceutical RWD/RWE program, this talk covers implementation of AI tools across key workflows: programming assistants (SQL, R/SAS/Python), protocol and report authoring, and systematic literature review. The session also describes the design of fit‑for‑purpose knowledge bases to ground LLMs in organizational standards.

3:25 pm

The Future of Clinical Research: Innovative Study Designs through Pharma-Provider Partnerships by Integrating Real-World Data (RWD) Collection in Randomized Clinical Trials (RCTs)

Chris Blanchette, PhD, Vice President, Clinical Data Science and Evidence, NNI, Novo Nordisk AS

Novo Nordisk is building cross-country collaborations with healthcare providers to maximize the value of real-world data. This session will highlight case studies from the US, UK, Denmark, and Sweden, showing how Pharma–HCP partnerships advance evidence generation, enable broader patient insights, and address practical challenges in governance, data access, and alignment, delivering scalable models for global research.

3:40 pm

Stronger Together: Pharma-Healthcare Provider Collaborations Advancing Vaccine Research and Protecting Vulnerable Populations

Sylvia M. Taylor, PhD, Executive Director, Head, Real-World Evidence & Health Outcomes, Vaccines, GSK

GSK has developed innovative collaborations with healthcare providers in the US and UK to unlock the value of real-world data. This session will share case studies demonstrating how Pharma–HCP partnerships enhance evidence generation, streamline data access, and address key challenges—highlighting lessons learned, mutual benefits, and emerging solutions for advancing research beyond traditional trials.

3:55 pm

Defensible AI‑Enabled RWE: Managing Risk and Leading the Future

Sherrine Eid, Global Head, Real World Evidence & Epidemiology, SAS Institute, Inc.

Real-world evidence is now accepted to be utilized in decision-grade, transparent, and defensible regulatory activities and approvals. This session shows how modern RWE platforms unify multimodal data, mitigate bias, and govern AI to deliver reproducible insights across feasibility, study design, regulatory submission, and post-market evaluation. Learn how SAS Viya enables traceable analytics, controlled machine learning, and scalable RWE aligned with evolving regulatory expectations and real-world complexity.

4:20 pm

From Asset-Level to Portfolio-Level IEGP: Transforming Integrated Evidence Generation into a Strategic Enterprise Capability

Michael del Aguila, Vice President, Evidinno Evidence Development Solutions, UBC

A portfolio‑level IEGP aligns evidence needs across assets and lifecycle stages, reducing fragmentation and improving strategic value. AI‑enabled evidence synthesis increases speed and accuracy, saving significant time while maintaining quality. This approach transforms evidence generation into a scalable enterprise capability.

4:45 pm PANEL DISCUSSION:

Advancing Clinical Research through Pharma–Healthcare Provider Collaborations: RWD + RCT Innovations for Better Evidence

PANEL MODERATOR:

Aaron W. Kamauu, MD, MS, MPH, CEO, Navidence LLC

As life science companies increase their use of real-world data (RWD), access to RWD has also increased in both quantity and complexity. Healthcare provider (HCP) systems manage a robust source of RWD via their electronic health records and practice management systems. Traditionally, the use of these data for life science clinical research has been quite limited, requiring complicated contracts and a lack of alignment. However, in recent years, Pharma and HCPs have established meaningful partnerships that go beyond traditional clinical trials into the use of RWD. This session will share examples of real studies where Pharma–HCP collaborations were essential for effective evidence generation. In addition, this session will provide perspectives from both Pharma and HCP on the benefits of such collaborations, as well as challenges and possible solutions.

PANELISTS:

Chris Blanchette, PhD, Vice President, Clinical Data Science and Evidence, NNI, Novo Nordisk AS

Richard Nelson, Professor, Department of Internal Medicine, Co-Director, Health Economics Core, Clinical and Translational Science Institute, University of Utah

Sylvia M. Taylor, PhD, Executive Director, Head, Real-World Evidence & Health Outcomes, Vaccines, GSK

5:10 pm

Bridging Real-World Evidence Gaps: The Role of Literature-Derived RWE in Rare or Complex Indications

Mark Kiel, PhD, Co-Founder & CSO, Science, Genomenon

The biomedical literature reflects decades of global clinical practice and millions of patient records, with deep characterization of demographics, clinical features, biomarkers, and genetics. Especially for rare or complex indications, where traditional sources of RWE may lack coverage or sufficient detail, this evidence can fill critical gaps. We reveal how literature-derived RWE can complement other sources and optimize natural history studies, trial design, and label expansion strategies.

5:23 pm

Beyond Patient Finding: EMR-Based Clinical Truth for Fewer Screen Failures

Robert Chu, CEO, Embleema

Real-world evidence can find patients, but recruitment succeeds when clinical truth confirms inclusion criteria—especially when key signals live in longitudinal history and unstructured EMR notes, not coded proxies. We studied where proxy prescreens fail and applied EMR-based clinical characterization to verify inclusion/exclusion before site screening. A real Phase 3 case study shows fewer screen fails, less site burden, faster enrollment—without changing sponsor/CRO workflows.

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

Scott Chavers, PhD, Senior Director, Epidemiology, Real-World Evidence Clinical Trials, Walgreens Co.

8:35 am

Design with the Defense in Mind: A Practical Playbook for Prospective Evidence Generation

Pierre Meyer, RWE Strategy Director, Syneos Health

Regulators are scrutinizing real-world evidence more closely than ever—so how do you design RWD that stands up to that level of review? This session breaks down what regulators actually look for, why even strong RWE efforts often fall short, and a practical playbook for generating prospective, regulatory-grade RWD across clinical development. Through real case examples and clear design principles, attendees will learn how to build real-world evidence that is audit-ready, analytically sound, and aligned with the decisions it ultimately needs to support.

9:00 am

From Tabletop to Trial: Collaborative Solutions for Real-World Pragmatic Studies

Meghana Chalasani, Associate Director for Clinical Trial Innovation, Office of New Drugs, FDA CDER

Zhanna Jumadilova, MD, Biopharmaceutical Physician Executive, Pragmatic Clinical Trials, R&D, Pfizer

Stacy Tegan, Program Director, TransCelerate Biopharma, Inc.

Pragmatic trials have arguably been characterized more by promise than actual progress. New developments are poised to help shift the balance. The use of pragmatic elements in clinical trials—including electronic health records, patient reported outcomes, and wearables—has been a popular topic of conversation, but also a source of great hesitation. While these options create new opportunities for regulatory decision-making, they also present challenges around sponsor oversight and selective safety data reporting. To address these challenges, TransCelerate, in collaboration with FDA’s CDER Center for Clinical Trial Innovation, conducted tabletop exercises to test trial designs under real-world conditions. This session will share key insights and approaches to support more effective design and execution of pragmatic trials. This session will also touch on a new TransCelerate effort to shed light on the use of pragmatic designs to improve safety data collection in connection with ICH E19.

9:20 am

Redefining Research: Real-World Evidence at the Pharmacy Counter

Scott Chavers, PhD, Senior Director, Epidemiology, Real-World Evidence Clinical Trials, Walgreens Co.

Krisha Patel, MPH, Lead Epidemiologist, RWE Clinical Trials, Walgreens

As patients seek deeper engagement with healthcare, RWE is reshaping how data informs drug development and patient experience. Since June 2022, Walgreens Clinical Trials has led innovation by using pharmacy-rooted registries to drive evidence generation and patient recruitment. This has enabled solutions like in-pharmacy biospecimen collection and helped address key research challenges through its extensive pharmacy network.

9:35 am

Not All Real-World Data Is Created Equal: Why Source Matters

Shawn Murphy, MD, PhD, Chief Research Information Officer, Mass General Brigham

As real-world evidence becomes central to clinical and regulatory strategies, too much reliance remains on fragmented, decontextualized data. This session will share how Academic Medical Centers (AMCs), through integrated research platforms like MGB HIRO, provide traceable, audit-ready, clinically rich data at the point of care. Attendees will learn why AMCs are essential partners in generating credible evidence—and how to unlock speed, quality, and trust across the R&D lifecycle.

9:50 am

Claims Data, Patient-Reported Experiences, and Data Portability Can Improve Care, Chronic Conditions, and Clinical Trials

Adam Mariano, General Manager, Healthcare, LexisNexis Risk Solutions

Julie Ross, President & CEO, StuffThatWorks

Yael Elish, Founder & Chief Product Officer, StuffThatWorks

Healthcare is drowning in data but starving for insights. While the potential of AI is encouraging, its impact will ultimately be limited unless we solve for data fragmentation. Join leaders from LexisNexis Risk Solutions and StuffThatWorks to discuss how data portability can unlock the true promise of AI. As an example, they’ll highlight how combining claims data and patient experiences can lead to smarter clinical trials that accelerate drug development, cut costs, and improve outcomes.

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

Jimeng Sun, CEO, Keiji AI

11:15 am

Reimagining Clinical Research with Connected RWE Data Streams

Myla Maloney, Chief Growth Officer, Premier Applied Sciences, Premier, Inc.

Amy Elliott, PhD, Chief Clinical Research Officer, Avera Health

Christina Brennan, Senior Vice President, Clinical Research, Office of Clinical Research, Northwell Health

As clinical research rapidly evolves, the ability to link and activate real-world data has become a critical differentiator. In this session, researchers from leading health systems join Premier Applied Sciences to share how they are connecting rich patient data streams across care settings to transform trial design, execution, and outcomes research. Learn how integrated evidence infrastructures are breaking down barriers, accelerating timelines, and driving more inclusive, patient-centered research.

11:40 am

Innovative Approaches to Real-World Evidence/Data Proficiency through Case-Based Learning

Hayden Bosworth, PhD, Vice Chair and Professor, Population Health Science, Duke University

This session presents a proven case-based training approach to build internal capacity and literacy in real-world evidence (RWE) generation and interpretation. Using pragmatic case studies covering patient-reported outcomes, comparative effectiveness, registries, and post-marketing surveillance, this scalable model equips attendees with foundational and intermediate RWE skills. Designed for cross-functional teams, the session will foster collaboration and better decision-making using RWD across the product lifecycle.

12:00 pm

The Use of Negative Controls to Inform Regulatory Decision-Making

Yun Lu, PhD, Deputy Division Director, CBER/OBPV/DABRA, FDA

Real-world evidence (RWE) has been increasingly used to answer scientific and regulatory questions. The Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023-27 mandated the U.S. Food and Drug Administration (FDA) to develop negative control methodology to support causal inference when RWE are used for studying safety and effectiveness. In this talk, we review the current landscape and use cases of using negative controls to inform regulatory decision-making.

12:15 pm

Negative Control for Real-World Evidence: Methods and Best Practices

Hongwei Wang, PhD, Senior Research Fellow, Medical Affairs & Health Technology Assessment Statistics, AbbVie, Inc.

Unmeasured confounding is a major threat to the validity of real-world evidence. Methods via negative control have been proposed to detect and, more importantly, adjust for unmeasured confounders. In this talk, we review the latest methodology development, including their advantages, limitations, and recommend best practices in leveraging negative control during the design, analysis of real-world studies.

12:30 pm

Accelerating Clinical Trial Design and Execution with Complete Real-World Data

Ryan Ahern, CMO & Co-Founder, Truveta

Traditional trials are slow, costly, and face persistent recruitment challenges. This session will explore how life sciences organizations are modernizing study design and execution using Truveta’s complete, daily updated, and trusted real-world data. Learn how longitudinal linkage across EHR, claims, mortality, and SDOH enables faster recruitment, smarter feasibility modeling, and long-term evidence generation to reduce trial time, cost, and complexity.

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.

8:25 amTransition to Sessions

Part 2: Leveraging RWD for Clinical Research

8:30 am

Chairperson's Remarks

Valerie Balosso, Director, Data Management, Infectious Diseases, GSK

8:35 am

Yes, You Can (Digitalize That): Streamlining Study Design through Protocol Digitalization

William Illis, Global Head, Collaboration & Technology Strategy Clinical Development, Novartis Pharmaceuticals

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

Too often, clinical trial protocols are held together by a patchwork of disconnected platforms and manual workarounds, a system built on repeated data entry, mismatched formats, and limited data consistency. It’s inefficient, error-prone, and a major barrier to accelerating study start-up. This session will explore how biopharmaceutical companies are changing that by digitalizing protocol design and authoring. Using an open-source, vendor-agnostic data model, organizations are automating data flow, improving interoperability across systems, and gaining insight to inform better study design. Join us to see how this approach can unlock new use cases from registry submission to statistical analysis; automate data flow and interoperability between systems; reduce study start-up effort, cycle time, and complexity; improve quality and compliance.

9:00 am

From Trial Data to Confident Decisions: AI-Enabled Clinical Oversight

Christie Quarles, Clinical Analytics Product Manager, Clinical Analytics, Revvity Signals

Clinical teams face growing trial complexity, fragmented data, and increasing pressure to make timely, defensible decisions. This session explores how an integrated, data-driven approach to clinical oversight can simplify review workflows and improve visibility across data, medical, and operational review. Learn how governed, AI-enabled analytics, including natural-language custom listings, can reduce manual effort, strengthen collaboration, and support consistent, transparent decision-making across the trial lifecycle

9:25 am PANEL DISCUSSION:

How to Navigate the Data-Science Transformation

PANEL MODERATOR:

Valerie Balosso, Director, Data Management, Infectious Diseases, GSK

With the introduction of AI in Data Management and its significant impact on efficiency and decision-making, traditional Data Management must evolve toward a more analytics-driven, risk-based approach. This panel will explore the transformative shift from traditional Data Management to Clinical Data Science, highlighting the necessity to use centralized statistical monitoring, the importance of change management, workforce upskilling, and fostering collaboration to ensure the seamless integration of innovative methodologies.

PANELISTS:

Lynne Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs

Miguel Lemaire, PhD, Associate Director, Oversight Data Management, GSK

Shawntel Swannack, Regional Director (Americas), Analytical Monitoring, Data Management & Central Monitoring, Integrated Data Analytics & Reporting (IDAR), Johnson & Johnson

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.

THINK TANK:

AI-Powered COA Translation: Transforming Global Clinical Trials

Joseph Im, Head of Digital Health Technologies Operations, Regeneron Pharmaceuticals, Inc.

Discuss how AI can transform the world of COA translations.

What are the most effective AI technologies in translations?
AI vs. Human translator—competitive or complementary?
What quality risks should we consider and how can we mitigate them?
Regulatory or legal considerations
What can we do as an industry to optimize AI translations for COA?

THINK TANK:

AI-powered Advances in RWD

Demissie Alemayehu, PhD, Vice President, Biostatistics, Pfizer Inc.

Discuss some of the emerging issues in the use of AI/ML in drug development.

How do we move from AI/ML-based prediction to causal inference using RWE?
What is the most significant regulatory hurdle for AI-powered synthetic and external controls?
How can we ensure that AI-powered RWE does not worsen healthcare disparities?
Where is Generative AI most likely to transform use of RWE in drug development?

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!