Digital Health Technologies

2025 ARCHIVES

Digital Biomarkers and Endpoints in Clinical Trials

Digital Measurements Implementation at Scale

SCOPE’s 8th Annual Digital Health Technologies stream features clinical trial case studies that employ the use of sensors and wearables. The conference will also discuss future steps needed to implement digital biomarkers and endpoints in clinical trials. Topics to be explored are analytical validity and clinical evaluation of wearables, data integration for digital biomarkers, the end-to-end journey of digital measures, and driving DHT adoption and utility. This conference provides experts the opportunity to showcase DHTs and facilitates discussion on what the future of DHTs looks like.

Part 1: Digital Biomarkers and End Point in Clinical Trials

Part 2: Digital Measurements Implementation at Scale

Monday, February 3

6:30 amGolf Check-In & Breakfast Buffet (Sponsorship Opportunities Available)

8:00 amSCOPE's 4th Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)

Connect with your peers and colleagues at SCOPE's 4th Annual Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.
*Limited space available. Separate registration and fee required for golf.

9:00 amRegistration Open

12:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)

12:00 pm– 4:00 pm WORKSHOP 1: Innovation Day with IQVIA Technologies: Hear the vision. See the products. Join the journey.

Clinical trial sponsors are invited to join digital product leaders and industry colleagues for an afternoon of discussions, demos, and networking. This interactive event has been carefully curated to help clinical trial professionals crack key challenges across the clinical trial lifecycle: from participant and site user journeys to data security and workflows. Pharmaceutical executives with various roles in clinical operations, innovation, technology, finance/budgeting, data analytics, strategic sourcing, trial managers, medical directors, or patient and site engagement will enjoy an industry panel, interactive roundtables, live demos with product experts, and more! Pre-registration is requested, and IQVIA reserves the right to decline requests that don’t fall within attendee guidelines above: Learn more and register here.

1:00 pm– 1:45 pm WORKSHOP 2: Exploring ClinEco—SCOPE’s Growing Online B2B Clinical Trial Community

PRESENTERS:
Marina Filshstinsky, MD, Executive Director, SCOPE Summit; Co-Founder, ClinEco
Micah Lieberman, Executive Director and Team Lead, SCOPE Summit; Co-Founder, ClinEco
Erik Yorke, Marketing Lead and Scientific Writer, ClinEco

Discover how you can stay connected and extend your SCOPE conference conversations year-round in this interactive workshop focused on ClinEco—the dynamic online B2B marketplace bringing together sponsors, CROs, site networks, and innovative solution providers to streamline partnering.

This workshop will help you understand how to take full advantage of ClinEco’s capabilities. Through real-world case studies, we'll demonstrate how ClinEco members streamlined their outsourcing processes, discovered new partners, and expanded their global reach. Whether you're a sponsor seeking new collaborations or a vendor looking to stand out, this session will provide actionable insights to boost your success.

Join us to experience the future of clinical trial networking and collaboration!

1:00 pm– 2:30 pm WORKSHOP 3: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials

INSTRUCTORS:

Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific

Thierry Escudier, Portfolio Lead, Pistoia Alliance

Hannah Sieber, Co-Founder, CEO, Artyc

Diana Steinbuesch, BioX Operations Portfolio Lead (Oncology), Roche

While developing leading and innovative therapies, we must not lose sight of the environmental impacts and greenhouse gas emissions. We can reduce the environmental impact of our studies by prioritizing remote visits and monitoring, by reducing kit wastage, and working together to find ‘greener’ solutions. This workshop will provide a brief overview of research and introductory strategies for reducing emissions as well as a 'Sustainability 101' to help anyone in our industry get started towards developing more environmentally responsible clinical trials. Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.

1:00 pm– 2:30 pm WORKSHOP 4: Efficient Importation of Biological Materials into the U.S.

INSTRUCTORS:
Jessica Hammes, Branch Chief, Biological Threat Exclusion, Agriculture Safeguarding and Risk Management, Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
Jennifer Merriman, Senior Manager, Strategic Biospecimen & Vendor Logistics, Consent, Biospecimens, & Imaging, Global Development Operations, Bristol Myers Squibb Co.
Brandy Porter, Assistant Director, Pharmaceuticals, Health, and Chemicals Center of Excellence & Expertise, U.S. Customs and Border Protection
U.S. Customs and Border Protection and partner government agencies regulate the importation of biological materials into the United States. The efficient importation of these items can be challenging, as Clinical Trial landscape is ever-evolving. The purpose of this workshop is to discuss current challenges, best practices, and possible solutions to navigate this landscape.

2:00 pm– 3:30 pm WORKSHOP 5: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing

INSTRUCTORS:
Dawn Anderson, Partner, Consulting, Deloitte LLP
Ming Shen, Managing Director, Deloitte Consulting LLP
This workshop will explore sponsor and site perspectives on current challenges and future opportunities in clinical trial financing. It will address complexities in managing trial finance including estimation, budgeting, forecasting, invoicing, payments, reconciliation and others in clinical trial management. The workshop aims to identify innovative solutions to enhance finance management in clinical trials, fostering more accurate projections. Through discussions and interactive sessions, it seeks to provide insights for future opportunities to improve clinical trial finance.

3:50 pm

Organizer's Welcome Remarks & 4th Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

3:58 pm

Chairperson's Introduction

Jenny Denney, Executive Vice President, Global Head Parexel FSP, Parexel

4:00 pm KEYNOTE PRESENTATION:

Fast-Forward to 2035: What Success Could Look like in Converging Clinical Research and Care—And How to Get There

Janice Chang, CEO, TransCelerate Biopharma, Inc.

Mark McClellan, MD, PhD, Director, Duke-Margolis Institute for Health Policy; Former Commissioner, FDA

On this stage in 2024, we spoke about our mission to converge clinical research and clinical care for the benefit of patients worldwide. We envision a world in which patients participate in research at the point of care as seamlessly as possible. And although we’ve set our vision, and organized the work we are undertaking accordingly, the real fruits of those efforts will not be seen in the short term. We will use this session to talk about where we hope we will be by 2035. What might we reasonably achieve? What does success look like? And what will it take to get there? This session is designed to help us all to raise our gaze beyond the near-term and find inspiration in the future possibilities.

4:25 pm

Tips for Getting the Most out of SCOPE

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

Visit our FAQ page! We hope this page answers some of your questions related to SCOPE. It consolidates a lot of info for speakers, attendees, and vendors into one page. We look forward to seeing you at SCOPE on February 3-6, 2025, at the Rosen Shingle Creek in Orlando, Florida!

https://www.scopesummit.com/faq-how-to-succeed-at-scope

4:33 pm

Chairperson's Introduction

Fiona Geiger, Vice President, Operational Delivery, Operations, Endpoint Clinical, Inc.

4:35 pm INTERACTIVE KEYNOTE PANEL:

What Do Real Patients Actually Talk About?

PANEL MODERATOR:

T. Hephner, CRO, Inspire

Whether at an industry event, a focus group, or another venue, we’ve all heard “real” patients share stories of their conditions, treatment journeys, and lives. But how accurate is what you’ve heard? Are the patients who speak on the podium or in a focus group truly representative of the majority of patients, or do they represent just a small sample? Our panel of patient engagement experts from some of the country’s leading patient advocacy groups and other representative organizations will give the story of what it’s like for most patients to live with illness, including rare and chronic diseases. Join us and learn about the true challenges of disease burden, unmet needs, treatment progression, the challenges–and rewards–of clinical trials, and more.

PANELISTS:

Emily McCormack, Social Media Director, New York Blood Center Enterprises

Fabian Sandoval, PhD, President & CEO, Emerson Clinical Research Institute

Quynh Tran, Director of Patient Activation, Cystic Fibrosis Foundation

5:05 pmSCOPE's 9th Annual Participant Engagement Awards Introduction (Sponsorship Opportunity Available)

5:10 pm

SCOPE's 9th Annual Participant Engagement Awards

PANEL MODERATORS:

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

Kelly McKee, Head of Innovative Patient Recruitment, Evinova, an AstraZeneca Company; Co-Creator of the SCOPE Participant Engagement Award

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Now in its 9th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2025 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/participant-engagement-award

PANELISTS:

Tricia Barrett, CEO, Praxis

Brian Burkhardt, Co-Founder & Executive Director, Oliver Patch Project, Inc.

Michelle Everill, Vice President, Global Trial Optimization, Alnylam Pharmaceuticals

Gretchen Goller, Head, Enrollment Strategy, Oncology, Pfizer Inc.

Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative

Stacy Hurt, Chief Patient Officer, Patient Engagement, Parexel International

Kim Ribeiro, Chief Client Officer, Inside Edge Consulting Group

5:45 pmSCOPE's Kickoff Reception: A Luau to Remember!

Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, we're turning up the tropical vibes with a luau theme.

DRESS CODE: Hawaiian shirts are encouraged! Show off your brightest, boldest, most tropical attire (grass skirts optional!) Let's bring the aloha spirit to life as we kick off another amazing SCOPE conference experience. Join us to reconnect with your old friends, make some new ones, and soak up the Florida sunshine in style!

7:00 pmClose of Day

Tuesday, February 4

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

Join SCOPE’s Coordinators on Tuesday, February 4 for our 5K Rise and Shine Fun Run! Don’t forget to pack your sneakers.
All of us at Cambridge Healthtech Institute recognize the importance of integrating well-being and fitness into our work travel routines. We're excited to offer our support to faculty, sponsors, and attendees in fostering a culture of wellness. This is an easygoing, informal running (or walking) event. No time chips, running bibs, or energy bars—just a laid-back opportunity for a small group to start the day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk—the goal is to get up and get moving! Meet us in the Rosen Hotel’s front lobby near the birdcage at 6:30 am sharp!
RUN COORDINATORS:
Eileen Murphy, Conference Producer, Production, Cambridge Healthtech Institute
Steve Wimmer, Vice President of Partnerships, 1nHealth

7:30 amRegistration Open

7:30 amMorning Coffee (Sponsorship Opportunities Available)

Get Up and Go! Jumpstart your morning with a specialty made-to-order coffee and some delicious treats, courtesy of our sponsors.

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

*Must be present to win.

8:30 am

Welcome to SCOPE 2025—Who’s Here and Why, What’s New, Annual Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

8:40 am

Chairperson's Introduction

Jonathan Rowe, Principal & Head, R&D Quality Operations & Risk Management, ZS Associates, Inc.

8:42 am KEYNOTE PRESENTATION:

Exquisite Clinical Trial Delivery in an Ever-Changing World—Evolution and Opportunity for Sustained Performance

Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.

This talk focuses broadly on Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. More specifically, how has Merck decided to optimize clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams? What are key considerations for clinical trial planning, site selection, and protocol design? And, what and why did Merck keep many core capabilities “in-house”?

9:10 am THE CLINICAL TRIAL DATING GAME:

Beyond the Real-World Data, What Are Patients Saying?
Special LIVE Episode with Studio Audience–Patient Contestants will be Announced Onsite!

Brett Kleger, CEO, Inspire

The Bachelor: Kristopher Sarajian, Vice President, Marketing, Trialbee

SCOPE’s Gameshow Host: Brett Kleger, a man whose dream it was to be a wedding singer or gameshow host

In today’s episode of “The Clinical Trial Dating Game” we have our pharma industry bachelor looking for a volunteer for his trial. He must question and choose from among three patients, who are hidden from view. He has access to all of their data, but there is more to this person than data, so how will he know which questions to ask? How will he avoid bias? How will he recruit on time? Knowing how important patient centricity is to the clinical research industry and with so much on the line, will our bachelor land a date? What could go wrong?

9:20 am KEYNOTE PANEL DISCUSSION:

How Patients Can—and Must—Disrupt Traditional Pharma Clinical Trials

PANEL MODERATOR:

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

Should biopharma companies be the only "sponsors" for clinical trials of new medicines? Does the current model limit opportunities for unmet needs in small populations or leveraging repurposed drugs? This panel will gather leaders demonstrating ways that patient-led non-profit organizations are challenging assumptions and taking a leadership position in medicine development. No longer can we think of patients as guests at pharma's table—is the next transformation in medicine development going to be entirely patient-led?

PANELISTS:

Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL

Heidi Bjornson-Pennell, Senior Program Manager, Science in Society and Lead, Rare As One Network, Chan Zuckerberg Initiative LLC

Nasha Fitter, Co-Founder & CEO, FOXG1 Research Foundation

Craig Martin, Founder, CEO, The Orphan Therapeutics Accelerator

Tracey U. Sikora, Vice President, Research & Clinical Programs, National Organization for Rare Disorders; Co-Founder, Every Cure

9:50 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall—Best of Show Voting Opens

Join us for the Grand Opening Networking Coffee break in our biggest SCOPE Exhibit Hall ever! Mingle with friends, forge new connections, and exchange ideas over your morning cup of joe. Visit exhibitors and learn about their latest and greatest innovations and products...voting opens for our Best of Show awards so don’t forget to vote.

Part 1: Digital Biomarkers and End Point in Clinical Trials

11:00 am

Chairperson's Remarks

Brett Kleger, CEO, Inspire

11:05 am

Harnessing Digital Biomarkers and Data Science: Paving the Way for Accelerated Drug Development in Parkinson’s Disease

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

Jie Ren, PhD, Director, Data Science, Global Digital Analytics & Technologies, Merck & Co., Inc.

Digital biomarkers have the potential to track Parkinson’s Disease (PD) progression with increased objectivity, sensitivity, and reduced variability compared to standard clinical scales. We discuss considerations in the development of PD progression digital biomarkers and present a machine learning-based framework for developing composite digital measures. We apply this framework to longitudinal PD study data and demonstrate the potential for digital biomarkers to enable smaller PoC trials and accelerated drug development.

11:35 am

Variability in Human Signal Device Readings: An Analysis of Contributing Factors and Experimental Design

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

Karthik Nakkeeran, Lead Data Scientist, Lingo, Abbott Labs

This study explores variability in human signal device readings due to factors such as sensor placement, tissue composition differences, calibration errors, and external interferences. By fitting subjects with devices from different manufacturers and collecting data over 14 days, the research analyzes significant differences in readings using parametric and non-parametric tests. The findings, illustrated with simulated data, highlight broader applicability of these methods in synthetic data-generation and drug-simulation studies.

11:55 am PANEL DISCUSSION:

eCOA BYOD: Exploring the Pros and Cons

PANEL MODERATOR:

Melissa Sesi, MBA, Associate Director, R&D Sourcing & Procurement, Merck & Co., Inc.

Electronic Clinical Outcome Assessments (eCOA) bring significant advancements in clinical trials, and the Bring Your Own Device (BYOD) approach has gained traction in the industry. It is crucial to understand the potential benefits and challenges associated with eCOA BYOD to have a comprehensive understanding of its implications in clinical research.

PANELISTS:

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

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

Dan Kearney, CEO, CNS Healthcare

Pankaj Shukla, Senior Director, Strategic Accounts, Clario

12:35 pm

An Overview of Pi Health

Bobby Reddy, Co-Founder & COO, Pi Health

Pi Health is a health technology and clinical research organization that is committed to transforming global access to innovative medicines and clinical trials starting with Oncology.

Pi Health has a unique software platform that connects sites and sponsors around the world enabling breakthrough efficiencies and cost savings for clinical trials.

Pi Health's mission is to drive innovation and enable access to patients around the globe equalizing access and opportunities for the highest quality of care and research.

1:35 pmSponsored Networking Luncheon

Take this opportunity to refresh and refuel and network, compliments of SCOPE sponsors! Take a well-deserved break outdoors in the sun, or indoors in the air conditioning.

2:35 pmNetworking Coffee & Dessert Break in the Exhibit Hall

SCOPE’s hall this year is bigger than ever; there’s no way to cover it all in just one break. So, after lunch, grab some dessert and a cup of coffee and visit all those booths that you just couldn’t make it to this morning. Stay to hear our Best of Show Winner announcement and congratulate the winner!

3:20 pm

Chairperson's Remarks

Adam Butler, SVP For Strategic and Corporate Development, ActiGraph

3:25 pm

Digital Health Technology (DHT)-Derived Physical Activity and Performance in Cancer Cachexia

Carrie A. Northcott, PhD, Head of Digital Sciences, Biomeasures, Endpoints and Study Technologies (BEST), Pfizer

Cachexia is prevalent across cancer types and results in weight loss, muscle wasting, reduced physical activity (PA), and increased mortality. DHTs provide passive, unbiased, patient-focused, and quantitative measures of continuous PA/function. We will share evidence on the importance of PA to patients, and what a meaningful change is in cancer patients with cachexia. Moreover, we will discuss the use of the DHT-derived PA measures to assess function and support clinical trials.

3:55 pm

LLS Sponsored Use of a Medical-Grade Wearable into the Beat AML Master Trial—The Oncology Journey

Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS

LLS/BAML began a sub-study to evaluate shortening the treatment cycle from 28 to 14 days in a Phase 2 trial for AML patients aged 60 and above. The study compares a 28-day schedule (Arm A) with a 14-day schedule (Arm B) of Venetoclax and Azacitidine, focusing on complete remission rates (CRs) and incorporating a wearable medical device. This FDA-cleared device collects physiological data continuously for up to two cycles and is complemented by Patient-Reported Outcomes (PRO) assessments and daily fatigue questionnaires. The study seeks to determine if wearable data aligns with patient-reported outcomes in oncology.

4:25 pm

Digital Health Solutions & Digital Accessibility

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

With the increase in demand for personalized patient therapies through digital health-solution apps, digital accessibility design standards for patients with disabilities can be critical to drug dosage, adherence, verification, and information. With the Web Content Accessibility Guidelines (WCAG) design standards for Information & Communication Technologies (ICT)—inclusive of digital health solutions and software as a medical device—explore the why, the what, and the how for digital accessibility.

4:50 pm PANEL DISCUSSION:

Building the Business Case for Adopting Digital Endpoints in Clinical Trials

PANEL MODERATOR:

Rachel Chasse, Associate Director, Digital Science Strategy, AbbVie

FDA recently qualified the first digital endpoint for clinical trials, and recent research has shown that digital endpoints can reduce the timelines and cost of clinical trials. However, to date, decision-makers have not had the clear value assessments, routine use cases, and efficient deployment strategies needed to confidently deploy digital endpoints at scale. In this session, collaborators from the Digital Medicine Society (DiMe)'s Building the Business Case for Digital Endpoints team will unveil new insights and project resources designed to shed light on the full return on investment of digital endpoints and to drive adoption in high-quality, fit-for-purpose digital measures as endpoints in clinical research.

Discussion points:

Learn about DiMe’s value framework for including digital endpoints in clinical research, including when and how digital endpoints can show true value during medicinal product development
Understand how to measure and evaluate the return on investment generated by digital endpoints
Cultivate expertise towards making informed decisions and sustain investment in integrating digital endpoints into successful digital health strategies

PANELISTS:

Stephen Ruhmel, Director, Clinical Strategy Lead for Digital Endpoints, Sanofi

Sarah Valentine, Partnerships Lead, Life Sciences, Digital Medicine Society (DiMe)

Elisabeth Piault-Louis, Scientific Lead, Digital Science, Evinova

Rinol Alaj, Director, Head of COA and Patient Innovation, Regeneron

5:25 pm

Practical Innovations with AI and Automation

Sanjiv Waghmare, Chief Product Officer, Signant Health

The clinical research landscape is evolving rapidly, driven by demands for faster, more efficient trials. This presentation explores how automation and AI are transforming the clinical technology stack, and ultimately transforming clinical trial operations through enhanced efficiency without sacrificing data quality. Join us to discover how these technologies are shaping the future of clinical research and accelerating treatment development.

5:40 pm

The Wearable Revolution: Meet the Smart Ring, Unlocking Objective Data

Christer Nilsson, CEO, Replior

Discover how wearable sensor technology is revolutionizing data collection in clinical trials. Join Christer Nilsson, CEO of Replior, as he introduces the Scratch Ring—an innovative finger-worn device designed to capture continuous, objective, and actionable patient data. Learn how this cutting-edge platform reduces patient burden, enhances compliance, and delivers deeper insights into scratching behavior, sleep, and overall health metrics. Explore the future of patient-centric, real-time analytics and its transformative impact on trial outcomes.

5:55 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)

Wind down at the end of a busy session day with colleagues and old and new friends. Networking is always in full swing at this reception, so raise a glass with your favorite exhibitors and take a chance at winning one of our fabulous raffle prizes (must be present to win). Continue your networking over dinner at one of the Rosen Shingle Creek's fine dining or casual restaurants and eliminate the need to face Orlando traffic.

7:15 pmClose of Day

7:15 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop from 7:00pm-11:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.

On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

Wednesday, February 5

7:45 amRegistration Open

8:15 am

BREAKFAST PRESENTATION OPTION #1:Digital Innovation’s Role in Pediatric and Elderly Clinical Trials

Kyle Hogan, CEO, Datacubed Health

This presentation examines how targeted digital tools improve retention rates among pediatric and elderly participants. Our pediatric focus reveals how gamification can create meaningful connections and enhance the trial experience while engaging caregivers. For elderly participants, we examine the use of accessible interfaces and remote monitoring solutions to address age-specific challenges. Attendees will discover strategies for implementing these solutions within their research programs.

8:15 am

BREAKFAST PRESENTATION OPTION #2:Expanding the Patient Universe: Transforming Clinical Trials through Inclusive, Data-Driven Design

Christopher Riley, Director, Strategic Insights, Solutions, H1

In today’s complex clinical research landscape, achieving patient-centricity and inclusivity is more critical than ever. This presentation introduces Patient Universe, a groundbreaking solution designed to optimize trial feasibility while addressing health equity challenges. Attendees will learn how leveraging real-world health equity data can transform patient recruitment strategies, create inclusive trial designs, and improve participant engagement. Through actionable insights and use cases, this session will demonstrate how advanced analytics and innovative technologies can bridge gaps in representation, support diversity action planning and enhance trial outcomes.

8:15 am

BREAKFAST PRESENTATION OPTION #3:

Scaling Success: How Sanofi and Trialbee Drive Patient-Centric Recruitment and Reduce Site Burden in Global Asthma Programs

Whitley Albright, Clinical Innovation and Operations Strategy Lead, Sanofi

Gaynor Anders, Chief Delivery Officer, Trialbee

Join Whitley Albright (Sanofi) and Gaynor Anders (Trialbee) to discuss how to keep patients at the center of focus while reducing site burden in a complex global asthma program by: connecting patients to the right trials with targeted outreach and a highly efficient global process; pre-qualifying all patients with live medical secondary screening to reduce the volume sent to sites, improve trust, and increase referral-to-consent ratio; keeping disqualified patients ready to enroll with program-level rematching; centralizing activity in a Patient Recruitment Platform (PRP) to manage progress, evaluate site performance, and measure campaign ROI; building a collaborative, supportive, and meaningful relationship.

Learn how these organizations are scaling recruitment success globally while achieving diversity and inclusion goals, reducing site burden, and keeping patients at the center of care.

8:45 amTransition to Sessions

8:50 am

Chairperson's Remarks

Shawn Mishra, PhD, Senior Lead, Digital Biomarkers, Regeneron Pharmaceuticals

8:55 am

Analytical Validity and Clinical Evaluation of the Moticon Insole System for Assessing Gait in Parkinson’s Disease

Rolando J. Acosta Nuñez, PhD, Manager, Biostatistician, Regeneron Pharmaceuticals

Shawn Mishra, PhD, Senior Lead, Digital Biomarkers, Regeneron Pharmaceuticals

This study explores the clinical potential of digital insoles for continuous, real-world gait assessment in Parkinson's disease (PD) patients. We evaluated 21 PD patients using digital insoles and a reference system during ON and OFF levodopa states. Results showed excellent reliability for key gait parameters and sensitivity to medication effects. The technology offers potential for more frequent, objective assessments in clinical and home environments, aiming to improve personalized care strategies, enhance disease monitoring, and optimize treatment in PD.

9:25 am

Internal Development to Phase 1 Clinical Validation of Bend Ease, a Novel Digital Measure of Morning Stiffness in Axial Spondyloarthritis

Dee-Dee Shiller, DO, Medical Director, AbbVie, Inc.

Dan Webster, PhD, Director, Digital Sciences, AbbVie, Inc.

Morning joint stiffness presents a problem for clinical measurement: By the time a patient presents in a rheumatology clinic for assessment, morning stiffness has subsided and mobility appears more "normal." To address this measurement problem, our cross-functional team initiated Project Bend Ease, involving internal development and Phase 1 clinical validation of a smartphone app for self-measurement of spinal mobility at home in axial spondyloarthritis patients.

9:55 am

Ready, Set, Localize: Smarter Strategies for Global Trials

Jonathan Norman, Director Localisation Services, Linguistic Validation & eCOA SME, YPrime

In an industry striving to innovate with AI and other new technologies, achieving operational efficiencies are a pressing need for clinical trial leaders. This session explores practical strategies to accelerate globalization of clinical trials and expand patient diversity through proven tools and methodologies.

Key Takeaways:

Global Trial Efficiencies: How leveraging pre-built libraries and modernized localization processes can cut startup timelines while maintaining quality and compliance.
Diversity through Language: The role of comprehensive language and cultural adaptation in reaching underrepresented populations and improving trial outcomes.
Simplifying AI: AI-driven efficiencies in clinical trial localization that are possible today without the controversy surrounding the creation of target language content.

10:25 amCoffee Break in the Exhibit Hall

SCOPE is ALL about networking—with clients, colleagues, sponsors and exhibitors. Take this chance to visit booths you haven't been to, build new relationships, and fuel up with coffee for the rest of the busy day ahead. Last chance to vote for the Best of Show award! Make your vote count!

10:45 amSpecial Book Signing

Fundamentals of Decentralized Clinical Trials
Editors: Isaac R. Rodriguez-Chavez & Anna Yang

Location: Gatlin Foyer, ClinEco Booth #1

11:20 am

Chairperson's Remarks

Sukhwant Khanuja, Carematix Inc

11:25 am

Accelerating Innovation in Sleep Measurement through Sibel’s Integrated Digital Health Platform

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

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

Reliable and user-friendly sleep measurement is essential for assessing patients' quality of life in various clinical indications. Polysomnography (PSG), while offering detailed data, is impractical for many clinical trials, especially when longitudinal monitoring is needed. Wrist-based actigraphy provides a convenient alternative but often lacks accuracy. This presentation highlights the collaboration between AbbVie and Sibel Health to develop and validate innovative adhesive sensor technology, offering PSG-like accuracy without complexity. The discussion will cover the technology’s validation, clinical applications, and its potential to transform sleep measurement, enhancing precision and expanding measurable metrics for improved patient care and clinical development.

11:55 am

Validating a DHT for Late-Stage Clinical Trials

David Morra, Senior Director, Regulatory Digital Health, Merck & Co., Inc.

Discover the intricacies of validating a late-stage clinical trial's primary endpoint in this captivating talk. This talk will showcase a real-world use case, exploring the FDA feedback that led to a Complete Response Letter, and share their experience in negotiating with global pharmaceutical and medical device health authorities to develop and execute a successful validation plan.

12:25 pm

From Data to Discovery: AI-Powered Trials in the Digital Health Era

Noble Shore, Vice President Technology Strategy & Product Adoption, Customer Success, Emmes

Explore how AI and real-world data (RWD) are transforming clinical trials. Learn how sponsors can accelerate startup with tools like Generative AI for protocol authoring and leverage RWD to ease site burdens and unify trial data. See how AI-enabled data platforms streamline processes, improve data quality, and provide real-time insights. Discover a roadmap to modernize trials, reduce timelines, and deliver results faster in the digital health era.

12:55 pmSponsored Networking Luncheon

Once again, join us for lunch, courtesy of our generous sponsors.

1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall—Best of Show Winner Announced

SCOPE's Networking Coffee and Dessert Break is the perfect time to pick up a sweet treat, courtesy of our sponsors, and fuel up for the afternoon with a cup of coffee or soft drink. Visit our Game Card Sponsors to fill your Game Card with stickers and get in a little more networking time before afternoon sessions!

2:30 pm

SCOPE around the World, Faces from the Community

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute; Co-Founder, ClinEco

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

2:35 pm

Chairperson's Introduction

Brad Stefanovic, PhD, Head Clinical Innovation, Pro-ficiency, a Simulations Plus Company

2:37 pm KEYNOTE PRESENTATION:

Fostering Clinical Innovation in a Large Pharmaceutical Organization

James Gallagher, Senior Director, Innovative Health, Johnson & Johnson Innovative Medicine

This presentation explores strategies for fostering innovation within a large pharmaceutical organization by focusing on four key areas: developing a clear mandate and compelling vision to guide innovation efforts; designing and engineering an infrastructure that supports creativity and collaboration; building a high-performance, diverse team empowered to drive innovation; and seeking opportunities for true patient-centricity and sponsor-agnostic innovation. By aligning these elements, the organization can create a sustainable innovation ecosystem that prioritizes patient outcomes and drives transformative breakthroughs in healthcare.

3:00 pm KEYNOTE PRESENTATION:

Harnessing Tech & AI for Quality and Performance in Clinical Trial Operations

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

Sponsors can leverage increasing technology capabilities to enhance quality by integrating advanced data analytics, AI, and automation into their drug development and manufacturing processes. These technologies enable real-time monitoring, predictive analytics, and streamlined workflows, ensuring higher precision and consistency in product quality. Additionally, digital tools facilitate better compliance with regulatory standards and more efficient management of clinical trials, ultimately accelerating time-to-market while maintaining rigorous quality standards.

3:20 pm

SCOPE Award Winners & Announcements

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

3:25 pmSponsored Presentation (Opportunity Available)

3:30 pm KEYNOTE PANEL DISCUSSION:

The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond

PANEL MODERATOR:

Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Johnson & Johnson

Gen AI, a groundbreaking approach that seamlessly merges artificial intelligence into our daily lives, holds immense potential for transforming the pharmaceutical and healthcare industries. This paradigm shift not only demands a thorough understanding of the ethical implications, potential biases, and social consequences of AI systems— it also requires a steadfast focus on creating tangible value that benefits individuals and society at-large. By harnessing advanced AI technologies, Gen AI can pave the way for unparalleled breakthroughs, elevating patient care, enabling personalized medicine, streamlining processes, and revolutionizing the way we approach healthcare as a whole. Join the debate on the real value-based use cases and explore the endless possibilities that Gen AI brings to the table.

PANELISTS:

James Gallagher, Senior Director, Innovative Health, Johnson & Johnson Innovative Medicine

Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.

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

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

4:00 pmBooth Crawl & Refreshment Break in the Exhibit Hall (Sponsorships Available) Last Chance for Exhibit Viewing

We know you're tired, we know the Exhibit Hall is huge, and we know you still have some booths to visit, some connections to make, some networking to do. SCOPE's Networking Booth Crawl is the time to do it! Crawl if you must, but be sure to visit our sponsored booths for some food, drinks, and enough energy to finish SCOPE strong! Our final Networking Exhibit Hall break is the final time to see the exhibits you haven't seen and meet the people you haven't yet met. The break ends with another amazing raffle prize, so be sure to get your Game Cards in and the lucky winner (must be present to win) could be you!

5:00 pmClose of Day

5:00 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop from 5:00pm-9:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.

On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

Thursday, February 6

7:15 amRegistration Open

7:45 am

BREAKFAST PRESENTATION:What Sites Really Need to Deliver Successful Patient Engagement Strategies

Leslie Ives, Senior Director, Patient Recruitment, Patient Strategy and Insights, Parexel International

Brittany Harvey, Clinical Project Mgr, Clinical Operations, UCB Inc

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites

Sites have shared that delivering successful patient recruitment is arguably one of the most persistent challenges they face. Despite this being well-known, not enough of the right support is provided to them, causing more than half of sites to pay out of pocket for unreimbursed recruitment expenses, all while the one-size-fits-all recruitment materials provided to them collect dust. By rethinking how we support sites in their patient engagement activities, sponsors and CROs can shift the paradigm to make patient enrollment delays and declining retention rates outliers, instead of the norm. This breakfast session will discuss strategies to transform patient engagement by leveraging site experience, incorporating patient insights and motivations, as well as AI solutions, to improve patient retention and deliver better study outcomes.

8:15 amTransition to Sessions

Part 2: Digital Measurements Implementation at Scale

8:20 am

Chairperson's Remarks

Kai Langel, CEO, DEEP Measures

8:25 am

The Future of Regulatory Acceptance of Digital Measures Is Happening Now: Continuing the Journey

Martha Azer, PharmD, Associate Director, Regulatory Policy NA, Johnson & Johnson

Digital measures can enhance drug development by potentially unlocking new ways of measuring efficacy and safety for medicinal products. The regulatory pathways for digital measures in R&D are emerging along with regulatory guidance on evidence generation of digital endpoints. To ensure the successful use of digital measures in R&D, these need to be further shaped to accelerate implementation of digital measures in R&D in drug development and health authority acceptance.

8:50 am PANEL DISCUSSION:

Driving DHT Adoption and Utility through Advocacy and Multi-Organizational Collaboration

PANEL MODERATOR:

Kai Langel, CEO, DEEP Measures

Digitally derived measures of health can help unlock a whole new perspective into human health, but developing them is a complex effort needing involvement from multiple stakeholders. This session brings together the entire journey and illustrates the key pitfalls and solutions through real-world examples shared by leaders from key pharmaceutical and technology companies.

PANELISTS:

Martha Azer, PharmD, Associate Director, Regulatory Policy NA, Johnson & Johnson

Scottie Kern, Executive Director, eCOA Consortium, Critical Path Institute

Carrie A. Northcott, PhD, Head of Digital Sciences, Biomeasures, Endpoints and Study Technologies (BEST), Pfizer

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

9:25 am

Unifying Multi-Vendor Wearables/Sensors Data Collection for Clinical Trial Regulatory Compliance

Steve Polyak, Senior Vice President, Head of Global Production Innovation, Engineering, Clinical Ink

The adoption of wearables/sensors in clinical trials remains low despite the relatively recent predictions of their success. Why is that? What are the challenges e.g. regulatory hurdles, usability, security, etc. we are facing and what benefits do we perceive we might have if we can overcome these aspects? Adding to that is the fact that several trials may need to integrate across multiple vendor solutions that can have different wearables/sensor integration patterns and needs. How can clinical trial technology companies leverage their partnership agreements to act as a DHT integration hub saving the need for pharmaceutical companies to explore/establish their own point-to-point integrations.

9:55 am

Generative AI-Powered Medical Writing

Sharon Chen, Founder and CEO, AlphaLife Sciences

Generative AI is reshaping clinical documentation. Join our session to see how AuroraPrime—AlphaLife Sciences’ trusted Word add-in used by five of the Top 10 pharma companies—cuts first-draft writing time for CSRs and protocols by up to 90%, with overall time savings of 30–70%. Experience a live demo featuring GenAI, seamless RIM and Microsoft Word integration, our Agentic AI approach, and a quality framework built for regulatory writing. Learn how AuroraPrime accelerates clinical development without compromising on quality or compliance.

10:10 am

Magnol.AI—Shaping the Future of Connected Clinical Trials

Andrew D. Kaczorek, Data Engineer, Eli Lilly & Co.

While many industry players promote the ability to ingest wearable sensor data, what matters more than that is how to uncover data insights and turn these data into intelligence. Come hear about one of the industry's best examples of what a Sensor Cloud should (and can) do to ensure dBM research is done efficiently and rigorously.

10:40 am PANEL DISCUSSION:

Unlocking New Frontiers in Alzheimer’s Disease Research through Digital Measures

PANEL MODERATOR:

Sarah Valentine, Partnerships Lead, Life Sciences, Digital Medicine Society (DiMe)

Imagine a world where the relentless progression of Alzheimer's disease and related dementias (ADRD) could be detected earlier, monitored more precisely, and treated more effectively—all through the power of digital health technologies. In this session, we will share some of the exciting findings from a recent DiMe pre-competitive collaboration, involving experts from academia, industry, clinical practice, and patient advocacy groups, to support leaders engaging in ADRD research to harness the power of digital innovation to accelerate scientific progress and improve outcomes for patients and caregivers impacted by ADRD.

PANELISTS:

Ann M. Hake, MD, Executive Director, Digital Health Research and Development, Eli Lilly & Co.

Jeffrey A. Kaye, MD, Director, ORCATECH (Oregon Center for Aging & Technology), Oregon Health & Science University

Mark Matson, Managing Partner, Patient Cloud, Medidata

11:10 amNetworking Coffee Break

11:50 am

Chairperson's Remarks

Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative

11:55 am

Applying Social Determinants of Health (SDoH) in Clinical Study Planning and Execution

Daoying Hu, PhD, MBA, Director, Data Science and Digital Health, Johnson & Johnson Innovative Medicine

SDoH data can enhance our understanding of the barriers to participation in clinical trials and improve access for study participants. This presentation examines various types of SDoH data for site and patient strategies, and discusses how to effectively leverage these insights in clinical studies.

12:25 pm PANEL DISCUSSION:

Achieving Flexibility and Expanding Access While Preserving Data Quality

PANEL MODERATOR:

Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative

Is trial flexibility truly a threat to data quality? Concerns are often raised that offering flexible approaches to clinical trial design and conduct, such as collecting data in various settings and offering a flexible schedule of visits, will result in risks to data quality. This session will explore multi-partner perceptions around when and how data quality is maintained when flexible approaches are introduced and how flexibility can improve access to clinical trials.

PANELISTS:

Pamela Tenaerts, MD, MBA, CSO, Medable

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)

Wes Burian, Patient

1:25 pmTransition to Lunch

1:30 pm

LUNCHEON PRESENTATION: From Sync to Swim: Alimentiv’s Journey with Zelta ePRO

Wes Fishburne, Principal Product Manager, Zelta by Merative

Chris Walker, Director, Data Sciences, Alimentiv

Amid growing responsibilities and expanding clinical operations, data managers are increasingly challenged by the increasing number of eClinical solutions required to support a clinical trial. Join us to learn how the data managers at Alimentiv have leveraged Zelta’s ePRO module to streamline their eClinical data collection scheme to include patient-reported outcomes with the rest of their study data, achieving more control over their clinical trials and confidence in their outcomes. 

2:00 pmSCOPE Summit 2025 Adjourns