Digital Measures in Clinical Trials

2026 ARCHIVES

Digital Measures across Studies and Labels

SCOPE’s 9th Annual Digital Measures in Clinical Trials stream features case studies and real-world use cases of digital measures—including sensors, wearables, and digital endpoints—in clinical trials, including registration studies. This year’s focus is on embedding digital biomarkers early in protocol design to support validation, regulatory acceptance, and meaningful clinical insights. Sessions will explore how digital endpoints can be scaled across studies and therapeutic areas, and how they may be incorporated into drug labels for post-trial use. Topics include validation frameworks, clinical utility, data integration, and strategies to accelerate adoption. Industry leaders will share practical experience and forward-looking approaches to advancing digital technologies in clinical research.

Part 1: Digital Endpoints and Biomarkers

Part 2: Digital Measures across Studies and Labels

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 (IN-PERSON ONLY)

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: Digital Endpoints and Biomarkers

11:00 am Chairperson's Remarks

Nikki Dardes, Senior Vice President, Global Partnerships, Sales & Marketing, YPrime

11:05 am

Scaling Innovation across the Enterprise: AbbVie’s DHT Task Force

Rachel Chasse, Associate Director, Digital Science, AbbVie

Katie Chowdhury, Global Head, Digital Health Technology Devices and Specialty Products, Regulatory Affairs, AbbVie

AbbVie set the ambitious task to simultaneously integrate digital health technologies (DHT) processes into its many existing policies. Learn how AbbVie’s DHT Task Force developed unified processes and developed AbbVie's DHT Playbook to scale innovation across the enterprise.

11:30 am

Driving Innovation: Integrating AI into Merck’s Clinical Digital Strategy

Mei Hong, Director, Business and Information Architecture, Merck Research Laboratories, Merck & Co.

AI technologies are advancing at an unprecedented pace. To fully harness their potential in clinical development, we are implementing a holistic digital strategy that seamlessly integrates Generative AI and Machine Learning into the end-to-end clinical trial data flow. This unified clinical platform enhances operational efficiency, reduces manual intervention, and speeds up data-driven decision-making, unlocking significant business value in the complex, highly regulated clinical development landscape.

11:55 am

TrialLens: Democratizing Clinical Trial Data through AI-Powered Analytics and Natural Language Querying

Mike Kantartjis, Senior Applied AI Scientist, AI & Innovation, Clinical Ink

Clinical trial data silos create inefficiencies: lengthy dashboard builds, change orders, user retraining, and fragmented insights. TrialLens solves this by unifying connected devices, operational data, and eSource into one AI-powered platform. Whether you're a PI checking patient compliance, a Site Monitor identifying training gaps, or a Sponsor tracking financials, TrialLens meets users where they are. Built on Amazon Q, it enables conversational analytics—ask a question, refine it, drill deeper—with context that persists across queries.

12:20 pm

Continuous AI-Enabled Cough Monitoring: Turning Everyday Symptoms into Objective Clinical Trial Evidence

Julia Gómez Camblor, Principal Product Manager, AI & Digital Health, Computational Sciences Center of Excellence (CS-CoE), Genentech, Inc.

This talk will share Genentech’s first end-to-end experience operationalizing a digital cough endpoint in an interventional clinical trial. We will share results from a phase 2a chronic cough trial (NCT05660850) that deployed a novel AI-enabled cough monitor alongside the current gold standard. We will present key scientific and operational learnings from continuous, 24/7 monitoring over weeks compared to the traditional single-day snapshots.

12:45 pm

How Can Digital Technology and AI Bolster the Patient-Site Relationship?

Steve Rosenberg, CEO, uMotif Ltd.

Clinical trials succeed or fail at the intersection of two communities: patients who volunteer time and body, and sites that dedicate resources, expertise, and empathy to guide them through the process.

Digital technology and AI can offer an opportunity to enhance the patient’s journey through the clinical trial and beyond, while enabling sites to better manage that journey and the growing complexities of trials. This strategy can create significant improvements in recruitment, retention, compliance, and data quality.

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

Erin Walsh, Associate Director, Digital Science Strategy, AbbVie

3:05 pm

Continuous Wearable Sensing for Bowel Movements

Shuai Steve Xu, Assistant Professor of Dermatology & Medical Director, Querrey Simpson Institute for Bioelectronics, Northwestern Memorial Hospital

In this presentation, we will discuss advances in wearable monitoring for bowel movements and bowel habits. This area is relevant as digital endpoints for GI conditions such as inflammatory bowel disease.

3:17 pm

At-Home Evaluation of DHTs for Measuring Nocturnal Scratching in Atopic Dermatitis

Stefan Avey, PhD, Senior Principal Scientist, Data Science & Digital Health, Johnson & Johnson

This presentation will showcase the analytical validation of two DHTs: the GENEActiv wrist band with Philips sleep and scratch algorithms and the Emerald radio frequency touchless sensor to measure nocturnal scratching in adults with AD.

3:30 pm PANEL DISCUSSION:

Digital Surveillance of Toxicity in Oncology Trials: Remote Toxicity and Function Tracking

PANEL MODERATOR:

Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)

Performance status and treatment-related toxicity are cornerstone endpoints in oncology trials, yet traditional assessments rely on intermittent, subjective site reporting. This session presents how wearable sensors and activity trackers are being used to derive real-time, objective proxies for performance status such as mobility, fatigue, and activity levels alongside digital capture of toxicity through ePROs. Discover how to leverage wearable and remote reporting data to support safety signal detection, reduce site burden, and align with regulatory expectations, while integrating these digital measures into trials effectively.

PANELISTS:

F. Isik Karahanoglu, PhD, Director, Quantitative Sciences, Digital Sciences & Translational Imaging, Pfizer Inc.

Joanna Kemp, Senior Director, Digital Health Strategy Lead, Oncology, GSK

Mark Matson, Managing Partner, Patient Cloud, Medidata

Jay Trudeau, PhD, Senior Director, Clinical Outcome Assessment (COA) Scientist, Eli Lilly & Co.

3:55 pm

Breaking Localization Barriers for a Faster Global Go-Live

Jonathan Norman, Director, Localization & Scale Management, Linguistic Validation & eCOA SME, YPrime

Launching a clinical trial globally requires navigating complex localization and regulatory requirements, often leading to delays that limit patient access in key regions. In this session, Jonathan Norman, Director, Localization & Scale Management at YPrime will share new strategies to enable a faster, higher-quality global go-live by combining process optimization with AI-assisted localization. He’ll highlight a case study where a sponsor added an Indic language mid-study and went live on the same timeline as major European markets—reducing what is typically weeks of work to days, or less. Discover actionable insights to increase inclusivity in multinational study launches, through AI innovations in eCOA deployments.

4:20 pm

From Reactive to Proactive: Integrating Remote Cardiac Safety Monitoring to Enhance Clinical Trial Insights

Cecilia Xi, Vice President, Clinical and Scientific Affairs, Vivalink

Sonia Ortner, VP Digital Physiology Endpoint Strategy, Digital Physiology Endpoint Strategy, Clario

Many therapeutic agents including chemotherapeutic drugs, ion channel blockers and nonsteroidal anti-inflammatory drugs (NSAIDs) carry the risk of cardiovascular harm. Traditional practice relies primarily on patient symptoms and scheduled in-clinic checkups. However, this approach can lead to significant delays in detecting asymptomatic ECG abnormalities. Through real-world case studies, we'll explore potential substantial benefits that this proactive monitoring strategy brings to trials.

4:45 pm PANEL DISCUSSION:

Bridging the Measurement Gap: Standardizing Objective Digital Measures in Mental Health

PANEL MODERATOR:

Erin Walsh, Associate Director, Digital Science Strategy, AbbVie

One in eight people globally lives with a mental health disorder, yet progress in treatment and care remains slow -hindered by outdated, subjective assessment tools. The development of standardized, sensor-based digital measures provides a powerful opportunity to bring objectivity, scalability, and patient relevance. By focusing on cross-cutting symptoms like cognition, anhedonia, and fatigue, a core set of digital measures can unify assessment across conditions, reduce trial failure, accelerate R&D innovation, and reshape trials from high-risk endeavors to high-impact opportunities. This marks a fundamental reimagining of how mental health is measured in the digital age.

PANELISTS:

Elizabeth (Nicki) Bush, Executive Director, Endpoint Strategy and COA Measurement, OPEN Health

Javiera Oyarzun, PhD, Digital Biomarker Innovation Clinical Lead, Sanofi

Shuai Steve Xu, Assistant Professor of Dermatology & Medical Director, Querrey Simpson Institute for Bioelectronics, Northwestern Memorial Hospital

5:10 pm PANEL DISCUSSION:

What is FDA's 'TEMPO' and How Will It Impact Clinical Trials?

PANEL MODERATOR:

Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

FDA’s TEMPO (Technology-Enabled Meaningful Patient Outcomes) is a new voluntary digital health pilot that lets selected device makers use certain digital tools for chronic disease care under FDA enforcement discretion while collecting real-world data, in partnership with CMS’s ACCESS model. It aims to speed innovation, expand access, and generate evidence that could shape future regulatory and clinical trial pathways.

PANELISTS:

Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)

Shuai Steve Xu, Assistant Professor of Dermatology & Medical Director, Querrey Simpson Institute for Bioelectronics, Northwestern Memorial Hospital

Katie Chowdhury, Global Head, Digital Health Technology Devices and Specialty Products, Regulatory Affairs, AbbVie

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 (IN-PERSON ONLY)

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

Todd Rudo, MD, Executive Vice President, CMO, Clario

8:35 am

Built for Trust: Responsibly Uniting Agentic and Generative AI to Optimize Data Quality and Interpretation of Clinical Outcomes Assessments

Todd Rudo, MD, Executive Vice President, CMO, Clario

Alex Boudreau, Director, AI, Clario

The crossroads of data integrity, data consistency, and accurate interpretation are ripe for the application of both agentic and generative AI. Developing and operationalize such tools requires recognition of potential risks and adherence to a responsible-use framework specifically designed for the clinical trial paradigm. A case-study-based approach will be taken, with real-world examples, demonstrating how novel applications of AI can enhance clinical outcomes assessments, delivering results sponsors and regulators can trust.

9:00 am PANEL DISCUSSION:

AI-Powered Digital Measures for Clinical Trials

PANEL MODERATOR:

Marissa Dockendorf, Executive Director, Head of Digital Clinical Measures, Merck & Co., Inc.

PANELISTS:

Stefan Avey, PhD, Senior Principal Scientist, Data Science & Digital Health, Johnson & Johnson

Julia Gómez Camblor, Principal Product Manager, AI & Digital Health, Computational Sciences Center of Excellence (CS-CoE), Genentech, Inc.

Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

9:30 am

Operationalizing a Generalizable App Platform to Streamline Data Collection Across Clinical Trial Phases

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

Sheraz Khan, PhD, Senior Director, Generative AI, Pfizer Inc.

Gurdeep Singh Rooprai, Vice President, Infosys

The integration of Digital Health Technologies (DHTs), including mobile and wearable sensors, enables the collection of rich, real-world data in clinical trials. However, the traditional approach of developing bespoke applications for each study, leads to significant redundancy, high development costs, and extended timelines. To address these operational inefficiencies, we have strategically pivoted to a unified, Generalizable Application Platform. This presentation details the development and operationalization of this platform, designed to streamline the acquisition of diverse datasets, such as Patient-Reported Outcomes (PROs), voice recordings, and inertial sensor data, within a single infrastructure. We will explore the platform’s architecture, which is built on core principles of modularity, configurability, and extensibility. This design allows the same core application to be rapidly adapted and deployed across the entire development lifecycle, from Phase 0 early clinical studies to Phase 4 market studies. The system comprises a patient-facing mobile app for data collection and a site-facing web application integrated with existing clinical trial management infrastructure, ensuring seamless participant management and the linking of clinical and DHT data. Furthermore, we will share insights from the deployment in a clinical study, outlining the standardized operational workflow, Configuration (Web and Mobile), End-to-End Testing, UAT, and deployment. This generalized strategy demonstrates a significant reduction in development costs and accelerates the deployment of digital tools in clinical research.

9:55 am

Digital Endpoints Are No Longer Optional: DiMe Launches FDA-Funded sDHT Adoption Navigator

Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)

If you've ever stared at a sensor dataset wondering which FDA guidance applies, argued with your team about V3+ validation, or watched a promising digital measure get axed in the name of "lean trial design" because decision makers didn't understand the ROI, this session is for you.

Join DiMe CEO Jennifer Goldsack as she unveils the sDHT Adoption Navigator: the first open-access, end-to-end, LLM-powered roadmap for teams building or adopting sensor-based digital health technologies in clinical trials. This interactive resource was built to answer the exact question you're asking right now, whether you're selecting endpoints, planning validation, or trying to figure out what regulators actually want to see.

The Navigator gives you role-specific guidance, plain-language explanations, and real cases mapped directly to FDA requirements. Plus, get a first look at NaVi, the specialized AI search assistant that can get you to the answer you need in minutes, rather than hours.

Don't miss it - this will be the resource every team will want to bookmark in 2026!

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

F. Isik Karahanoglu, PhD, Director, Quantitative Sciences, Digital Sciences & Translational Imaging, Pfizer Inc.

11:15 am

From Tool to Teammate—Unlocking the Power of AI Agents

Andrew Mackinnon, Executive General Manager, Customer Value, Medable, Inc.

We’ll cover three main objectives in this talk: Unlock Innovation: Discover how to overcome the initial hurdle of implementing AI, using intelligent agents to unlock new levels of efficiency and innovation in clinical development; Supercharge Your Team: Learn how to augment human effort and automate routine tasks with intelligent agents, enabling your teams to focus on high-value activities where their expertise is needed most; Explore Practical Use Cases: Gain a clear understanding of low-risk, high-impact scenarios for intelligent agents, with actionable examples including protocol automation, translations, and site monitoring.

11:40 am

Endpoint Selection in Mobility and Activity: Statistical Sensitivity and Patient Relevance

Jay Trudeau, PhD, Senior Director, Clinical Outcome Assessment (COA) Scientist, Eli Lilly & Co.

This talk examines the process of selecting endpoints for mobility and activity in clinical studies. It emphasizes balancing statistical sensitivity with patient relevance to ensure meaningful outcomes.

12:05 pm

Validating a Novel Digital Endpoint for Cancer Cachexia

F. Isik Karahanoglu, PhD, Director, Quantitative Sciences, Digital Sciences & Translational Imaging, Pfizer Inc.

This work explores how digital health technologies and novel digital endpoints can objectively measure physical activity and functional changes in cancer patients and cancer patients with cachexia. The findings support the use of these digital measures in clinical trials, providing more patient-centric assessments of treatment effectiveness in cancer cachexia.

12:30 pm

From Subjective Itch to a Digital Endpoint: Live Demo of Replior’s ScratchSense Ring

Christer Nilsson, CEO, Replior AB

Itch remains one of the most subjective and intermittent trial outcomes, typically captured via scales, diaries, and recall.

This session introduces Replior’s wearable ring sensor platform and demonstrates ScratchSense live, showing real-time detection and quantification of scratching behavior.

We will share early validation/accuracy results and discuss how continuous sensor signals can be translated into fit-for-purpose digital endpoints to improve sensitivity, reduce missingness, and lower patient burden.

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: Digital Measures across Studies and Labels

8:30 am

Chairperson's Remarks

Ruby Madison Ford, MPH, Research Analyst, Tufts Center for Study Drug Development

8:35 am

Evidence on Investigative Site Usage and Experience with Virtual and Remote Solutions

Roula Krayem, MS, Senior Research Analyst, Tufts Center for the Study of Drug Development (CSDD), Tufts University

The Tufts CSDD team has compiled recently published empirical evidence on investigative site use and experience with decentralized clinical trial components including their impact on clinical trial cycle times and enrollment performance. Quantitative data has been gathered and aggregated across several primary areas including technology adoption, workforce changes, IT infrastructure, and patient and staff satisfaction. This session will review evidence across these domains and summarize key takeaways and their implications.

8:50 am

Assessing Investigative-Site Experiences and Perceptions of the Use of Digital Tools

Ruby Madison Ford, MPH, Research Analyst, Tufts Center for Study Drug Development

This study examines the value of decentralized clinical trial (DCT) and digital solutions across global investigative sites. Findings show sites are independently investing in DCTs, signaling a need for sponsors to adapt partnership strategies. The research assesses current and emerging solutions for their ability to deliver richer insights, faster data access, improved patient participation, system integration, and enhanced data quality and integrity.

9:00 am

The DHT Tubestop: Creating a Playbook to Optimize DHT Use in Trials

Moulik Shah, Senior Vice President, Product, Data, and PMO Lead, Advanced Clinical

Lauren Tobe, Director, Regulatory Policy and Strategy, Eli Lilly and Company

This initiative team developed a comprehensive digital toolkit (DHT Tubestop) that streamlines the integration and implementation of digital health technologies in clinical trials, enabling optimized trial design, improved data collection modalities, enhanced patient engagement, and more efficient trial operations while ensuring compliance with regulatory requirements and data security standards.

9:25 am

AI Agent-Driven Approach to Informed Consent

Aparna Swaminathan, MD, Assistant Professor, Medicine, Duke University

Current methods for informed consent are inadequate, requiring substantial staff availability and using lengthy, non-informative documents, leading to poor understanding and engagement. Advances in technology, particularly generative AI, can drive the transformation of consent processes. We have developed and evaluated an AI agent driven consent process, for informed consent, which has potential to enhance transparency, understanding, and accessibility to clinical trials.

9:50 am

Beyond the Data Silo: Paving the Way for Future Digital Health Foundation Models with Scalable Cloud Infrastructure

Bahador Marzban, PhD, Principal Data Scientist, Innovative Medicine R&D, Johnson & Johnson

We present a systems-focused pipeline that converts population-scale biosensor-based actigraphy and PPG data (i.e., biosensor data) into reproducible, high-throughput training datasets for multimodal digital health foundation models. We implement a two-stage design: preprocessing and chunking the time series into binned window sizes using scalable EKS clusters, followed by distributed multi-GPU transformer training with a GPU-aware DataLoader and a time-series database to reduce I/O contention, sustain higher GPU utilization, and enable fast metadata-driven retrieval across multi-terabyte storage. In brief, this work emphasizes the infrastructure and data engineering trade-offs, as well as the operational patterns required to convert siloed time series into reproducible, high-throughput training pipelines—independent of model architecture or downstream performance metrics.

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 GROUPS:

Bringing Digital Health Measures to Life in Clinical Development

Viprali Bhatkar, PhD, Senior Director, Global Digital Health Lead, Bristol Myers Squibb

Bola Grace, PhD, MBA, Senior Director, Digital Biomarkers, GSK; Professor, University College London

Kai Langel, CEO, DEEP Measures

Sonia Ortner, Vice President, Digital Physiology Endpoint Strategy, Clario

Jared Worful, Head, Digital Health Technology, Real-World Science, Bayer

Discover how digital measures of health are developed and embedded into clinical development programs. Join us for an immersive, hands-on session that goes beyond theory. Through story-driven case studies, gamified panels, and live audience participation, you’ll experience the full journey of integrating digital measures - from concept to implementation.

What to Expect:

Real-world insights from top industry experts
Experience the process firsthand through interactive, decision-driven scenarios
Engaging storytelling that makes complex processes come alive
A chance to collaborate, compete, and co-create in a fun, educational setting

Whether you're a digital health innovator, clinical strategist, or just curious about the future of clinical trials - this session is your gateway to actionable knowledge and unforgettable engagement.

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

Jie Shen, PhD, Research Fellow, Digital Science, AbbVie, Inc.

11:35 am

Operationalizing Digital Accessibility in Global Pharma

Stephen Framil, Corporate Global Head of Accessibility, Office of Corporate Accessibility, Merck & Co., Inc.

With the Americans with Disability Act (ADA) in place for over 35 years, the practice of digital accessibility has experienced a crescendo in recent years, and has become a central tenet in corporate values and ways of working. While the Web Content Accessibility Guidelines provide the global standards, the mobilization of a global pharma company to adopt accessibility best practices across its Information & Communication Technology (ICT) landscape throughout the drug development lifecycle can be quite overwhelming. Explore key components of a digital accessibility program, including where digital accessibility sits within a large global pharma company; steps to creating a digital accessibility policy and governance; and workstreams in a digital accessibility program.

12:00 pm PANEL DISCUSSION:

The Past as Prologue: What AI Innovators of Today Can Learn from DHT Innovators of the Past

PANEL MODERATOR:

Rachel Chasse, Associate Director, Digital Science, AbbVie

Today’s hottest innovation topic is AI in which the field is working hard to understand and build safe and effective solutions. It wasn’t too long ago when the hottest innovation trend was DHTs and some innovators may be feeling a sense of déjà vu. In this session, we will share lessons learned for the ‘new’ field of AI from the ‘less new’ field of DHTs.

PANELISTS:

Brinnae Bent, PhD, Faculty Director, Duke TRUST Lab, Duke University

Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)

Kushal Gohil, Senior Vice President, Global Project Leadership & Launch Excellence, Parexel

Jie Shen, PhD, Research Fellow, Digital Science, AbbVie, Inc.

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!