Patient-Centric Trial Design & Inclusive Research

2026 ARCHIVES

Patient Voice in Trial Design and Protocol Development

Technology, Data, and AI/ML for Intelligent Trial Design

Clinical trial success increasingly depends on thoughtful protocol design that prioritizes input from patients and sites while leveraging the power of data, technology, and innovative trial models. Engaging patients and sites early in the design process leads to more practical, efficient, and participant-friendly protocols—ultimately improving recruitment, retention, and trial outcomes. SCOPE’s 3rd Annual Trial Design & Protocol Development stream offers a focused look at strategies and frameworks to modernize trial design by integrating stakeholder feedback, digital tools, and new and emerging designs such as decentralized, hybrid, and pragmatic trials. Attendees will gain actionable insights into designing trials that are not only operationally effective but also aligned with the real-world needs and experiences of patients and sites.

Part 1: Patient and Site Voice in Protocol Design

Part 2: Technology, Data and AI/ML for Intelligent Trial Design

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: Patient and Site Voice in Protocol Design

11:00 am Chairperson's Remarks

Shelby Davidson, Global Account Director, Sales, H1

11:05 am PANEL DISCUSSION:

How to Transform an Organization from Sporadic to Systematic Patient Centricity in Clinical Research

PANEL MODERATOR:

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

Every clinical research organization talks about patient centricity—but few have cracked the code to make it scalable, repeatable, and truly embedded. Too often, efforts remain one-off, disconnected pilots. This dynamic panel will explore how leading organizations are moving from sporadic success stories to fully integrated patient-centric strategies that deliver measurable results. Hear from clinical operations and patient engagement leaders on how they are reshaping culture, building internal infrastructure, and leveraging partnerships and technology to ensure the patient voice is central—not peripheral—across the entire trial life cycle. Leave with actionable ideas and a clearer roadmap to move beyond intent and into implementation, ensuring patient centricity isn’t just a value, but a competitive advantage.

PANELISTS:

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

Dana Iommazzo, Global Head, Clinical Operations Program Management, Novartis

Sema Sgaier, PhD, Co-Founder & CEO, Surgo Health

11:30 am

Elevating the Patient Voice in Clinical Trials: What Patients Want Us to Know

Christina Brennan, MD, MBA, Senior Vice President, Clinical Research, Northwell Health

Jesse Hoffman, Chief Business Officer, AMR Clinical

The importance of measuring patient experience in clinical research is widely recognized, yet limited research has asked patients directly what matters most to them when participating in a trial. This presentation shares findings from a national study designed to capture patient perspectives on their clinical trial experiences and highlight what they want sponsors, sites, and CROs to know. This session will elevate the voice of patients themselves—revealing what they identify as critical to feeling cared for, supported, and respected throughout their participation. Attendees will gain actionable insights that can inform quality improvement initiatives, strengthen engagement strategies, and ultimately foster more patient-centered trial designs.

11:55 am

PANEL DISCUSSION:

Future-Proofing Clinical Trials: Designing Protocols for Flexibility

PANEL MODERATOR:

Maria Florez, Senior Consultant, Tufts University

Modern clinical trials face growing operational, regulatory, and patient engagement complexities, making early planning essential. Early protocol development is key to building adaptability that can make the difference between a smooth pivot and a costly overhaul.This panel explores strategies for embedding flexibility in early trial design, allowing sponsors to incorporate alternative operational models or approaches without extensive amendments. Hear from sponsors, investigators, technology, and logistics partners on how to proactively design trials that are robust and agile, setting the stage for future optionality and seamless execution.

PANELISTS:

Debra Weinstein, MD, Chief Medical Officer, Science 37

Arthur Van Leerberghe, Executive Director, Business Development Operations, Mirum Pharmaceuticals AG

Michelle Giovannucci, Director, Pharmacist in Charge, Manufacturing, Catalent Pharma Solutions

John Reites, CEO, THREAD

12:20 pm PANEL DISCUSSION:

From Insight to Impact: Bringing Patient Voice into Our Clinical Trials

PANEL MODERATOR:

Tuba Bas, PhD, Senior Director, Clinical Center of Excellence, Bristol Myers Squibb Co.

This panel explores how Bristol Myers Squibb integrates patient voice and advocacy insights into clinical trial design. Experts will present a framework aligned with diversity and inclusion regulations, supported by real-world examples. Attendees will gain practical strategies for enhancing study design, improving recruitment, and advancing health equity—demonstrating how patient-informed approaches strengthen scientific rigor and drive global trial success.

PANELISTS:

Amy Fesmire-Baus, Global Patient Recruitment, Research & Drug Development, Global Patient Outreach, Bristol Myers Squibb

Josee Pelletier, Senior Director, Research & Drug Development, Global Patient Advocacy, Bristol Myers Squibb

Ashish Shah, Director, Clinical Science Lead, Neuroscience, Bristol Myers Squibb

12:45 pm

Bridging the Gap: Using AI and Real-World Evidence to Optimize Clinical Trial Protocols

Tabby Khan, MD, MPH, Senior Director, Analytics, Komodo Health

As the integration of Real-World Data (RWD) accelerates across the industry, forward-thinking sponsors are moving beyond post-approval applications to utilize Real-World Evidence (RWE) at the earliest stages of clinical development. This presentation examines the evolution of RWE and its critical role in informing protocol development to create trials that are more efficient, patient-relevant, and aligned with market access requirements.

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

Jon Himoff, Chief Product Officer, Image Analysis Group

3:05 pm

Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden

Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck

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

This session presents the results of a recently completed TransCelerate Biopharma - Tufts CSDD collaborative study in which 15 pharmaceutical companies contributed data from 105 protocols. The results show rising total protocol data volume over time in step with increasing levels of protocol complexity, and changing proportions of procedures supporting primary, secondary, and exploratory endpoints. The study also introduces a new variable: data collected that supports core, standard, and required endpoints but that is not deemed essential by clinical teams and protocol authors. The impact of protocol procedures by endpoint type on site and patient participation burden, use of protocol data by endpoint type in the clinical study report, and reasons why procedures supporting non-core and non-essential core, standard and required procedures are conducted will be discussed. Presenters will also discuss the implications of the study findings and new strategies to optimize protocol designs.

3:30 pm

Implementation of Digital Protocols Enables Automation and Analytics-Powered Study Designs…It’s Here and It's Now!

Chris Decker, President & CEO, CDISC

Robert DiCicco, Vice President, Portfolio Management, TransCelerate BioPharma, Inc.

The digital transformation of clinical research is redefining how protocols are developed, managed, and executed across trials. A digital protocol can empower research teams to design studies with an increased probability of success by integrating real-time analytics and streamlining collaboration among stakeholders. This approach requires the adoption of standards to lower the transactional cost to aggregate protocol information. This paradigm shift enables unprecedented efficiency in study startup, faster and more representative patient recruitment, automation, and superior data quality throughout the clinical trial lifecycle. This session highlights key industry initiatives that are establishing digital protocols, how they streamline collaboration and regulatory review, and reduce redundancies. A real-world case study will show how one organization is already using a digital protocol to boost efficiency and success rates across their trials.

3:42 pm

Driving Speed and Efficiency in Clinical Development with Digital Protocols

Monica Bartucci, Associate Director, Clinical Capabilities, Bristol Myers Squibb

Neha Begum, Associate Director, Drug Development IT, Bristol Myers Squibb

Discover how BMS is transforming clinical operations by adopting Digital Protocols powered by Digital Data Flow (DDF). This approach accelerates study startup, enhances collaboration, and delivers measurable business value, shortening timelines and improving trial quality through a standardized data model.

3:55 pm

The Unified Digital Protocol: One Solution for Operational Planning, Cost Control, and Site Feasibility

Luke Mann-O'Hallaran, Senior Director, Product, Evidence Generation, Medidata, a Dassault Systemes company

The clinical protocol is a trial’s blueprint, yet its operational, financial, and logistical impacts are often assessed in silos leading to unpredictable enrollment, budget overruns, and reactive decisions. This session shows how to turn a static protocol into an agile asset by uniting activity-based modeling for budgeting and enrollment timelines with site-level feasibility data – enabling proactive risk mitigation and more predictable, smarter trials.

4:20 pm

Reducing Trial Friction at Scale: Case Studies in AI-Native Automation

Amber Hill, PhD, CEO and Founder, Research Grid

Clinical trial success depends on protocols designed around real-world patient and site needs and enabled by data and technology. In this session, CEO and Founder Dr. Amber Hill shares three case studies showing how AI-native automation improves feasibility, participant experience, and execution. Learn how early integration of automation supports patient-informed sourcing, site-friendly workflows, and scalable, participant-centric trial designs that improve recruitment, retention, and outcomes.

4:45 pm

Amplifying Patient Voice: Optimizing Clinical Trial Design through Analytics & Patient Insights

Hugh Dai, Director, Patient Engagement, Clinical Trial Design Capability, Eli Lilly & Company

Jade Dennis, Executive Director, Patient Engagement, Eli Lilly & Company

Patients’ perspectives are critical to the success of modern clinical research, yet they can be underrepresented in trial design. This presentation explores how integrating advanced analytics with direct patient insights can amplify the patient voice and create more patient-focused studies. We will demonstrate how real-world data, patient-reported outcomes, and engagement analytics can identify pain points in trial design—such as visit burden, eligibility barriers, and adherence challenges—leading to optimized protocol design which could improve recruitment, retention, and greater trial accessibility. By bridging quantitative analytics with qualitative patient perspectives, we can foster trial designs that are not only scientifically rigorous but also aligned with patient needs, ultimately accelerating development and enhancing the relevance of outcomes.

5:10 pm

Design with Enrollment in Mind: The Feasibility‑Informed Protocol

Claire Riches, Vice President, Clinical Solutions, Citeline

Melissa Harris, Global Head, Patient Recruitment & Engagement, Fortrea

Costly amendments and slow start-up often trace back to protocols that look sound on paper but fail in practice. This session introduces a feasibility-informed design loop that connects scientific intent to operational reality before protocols are finalized. We’ll show how teams define endpoints and eligibility criteria, then immediately stress-test those choices against cohort availability, geography, patient burden, and diversity targets. Through real examples, you’ll see how small adjustments can significantly reduce screen failures and cycle times. We’ll also cover how to operationalize this loop across clinical, feasibility, and operations using shared signals and documented trade-offs. The outcome is fewer amendments, faster start-up, and protocols built to enroll from day one.

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

Skyler Sajewski, Clinical Solutions Specialist, Commercial, Biorce

8:35 am

Accelerating Enrollment through Patient-Directed Strategies—A Global Phase IIb Tourette Syndrome Case Study (US, Spain & Germany)

Jill Pellegrino, CEO, AutoCruitment

Kristina Johnson, Vice President & Global Head, Clinical Development Operations, Noema Pharma

With over 70% of randomizations remaining and only 5 months left of a 12-month enrollment window, a global Phase IIb Tourette study needed a new approach. In this session, you'll learn how patient-directed strategies across three countries increased average monthly randomizations by 255% and cut enrollment timelines by a year.

8:47 am

The Future of Global Patient Engagement: A Patient Experience Platform to Accelerate Clinical Trials through Creativity, Global Reach, Site Support Services, and Technology

Fred Martin, CEO, SubjectWell

Patient recruitment and engagement are major bottlenecks in clinical research. This session reveals how a Patient Experience Platform—integrating creative strategy, global reach, site/patient support, and advanced technology—transforms these challenges. Discover proven strategies to build trust, improve trial access, and retain patients. Learn how this approach leads to faster, more inclusive, and successful global clinical trials, with real-world examples.

9:00 am

From Engagement to Strategy: An Evidence -Based Framework for Operationalizing Patient-Centeredness in Pharma

Jen Miller, Director, Program for Biomedical Ethics; Professor, Yale School of Medicine; Founder, Bioethics International; CEO, Good Pharma Scorecard

Pharmaceutical companies emphasize patient centricity, yet consensus on a comprehensive corporate strategy and standardized evaluation frameworks is lacking. We present a framework and performance indicators, developed through a systematic literature review and focus groups with patients and clinicians. Findings highlight definitions, initiatives, outcomes, implementation strategies, barriers, facilitators, metrics, and case examples. Together, these insights provide an evidence-based foundation to guide, benchmark, and advance patient-centered practices across the pharmaceutical sector.

9:20 am

Begin at the Beginning: Integrating Patient Voices to Accelerate ICH E6/E8 Implementation

Amy Fesmire-Baus, Global Patient Recruitment, Research & Drug Development, Global Patient Outreach, Bristol Myers Squibb

ICH E6/E8 guidelines are enabling a new era of innovation in trial design and conduct. For many, operationalizing the guidelines is spurring a shift in mindsets and processes in the early stages of trial design. This includes rethinking when and how to engage patients. We’ll not only share how early consideration of patient perspectives can support the development of fit-for purpose, quality-by-design trials, but also spotlight tools (long-time favorites and newly published, alike) to help organizations accelerate the move from guidance to implementation.

9:35 am

Using Clinical Studies to Power Reverse Translation Projects

Radhesh Nair, Director, Data & Statistical Sciences, Clinical Development, AbbVie, Inc.

Edward Price, PhD, Principal Research Scientist, AbbVie, Inc.

Reverse translational approaches are rapidly gaining ground as a means to identify drug targets, segment patients, and validate unmet medical needs. Clinical studies offer one of the richest sources of data to support such analyses. We share examples of "bedside to bench" research programs where scientific insight is generated through the secondary use of clinical study data and documents.

9:50 am

From Parents to Participants: Precision Recruitment Strategies Powered by First-Party Data

Megan Preovolos, Director, Partner Operations, Patient Recruitment, Everyday Health Group

In an age of increasing pharma skepticism, vaccine hesitancy, and fragmented rare disease care, how can sponsors succeed in enrolling the most complex audiences in clinical research? Drawing from new proprietary research, the team behind What to Expect and BabyCenter will share findings powered by an unmatched reach to 9 in 10 first-time pregnant women in the US and 36 million new and expecting parents globally each month.

This session will reveal key behavioral and attitudinal indicators of trial participation across critical segments. We’ll explore factors such as vaccine confidence, interest in specific content topics, and use of digital health tools that signal openness to clinical research. Discover how these deep audience insights grounded in first-party data translate into actionable strategies for successful recruitment and ultimately get life-changing therapies to families faster.

10:02 am

Designing for Real People: How a Pharma Company and Biorce are Using AI to Build Truly Patient-Centric Trials

Dennis Velasquez, Chief Commercial Officer, Biorce

Tired of hearing “patient-centric” with no real change? This session shows how a top pharma and Biorce are actually doing it, using AI to co-design trials with patients in mind. Think faster protocols, fewer burdens, real-world inclusivity, and documents people can understand. Join us to see what happens when empathy meets automation.

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

Kelly Haenlein, Vice President of Commercial Business, Paradigm Health Inc

11:15 am

The Promise of Disease Progression Modeling to Impact Medical Product Development

Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative

Using modeling and simulations, researchers can make more informed decisions when planning and executing clinical trials. This session will highlight the unique value of DPM in medical product development, when it should be considered over other tools or approaches, and provide considerations for what is needed to advance its consistent use.

11:40 am

Translating Patient Insights into Action

Trish Davidson, Director, PALADIN Consortium, Tufts CSDD

Ellyn Getz, MPH, Director, Patient Partnerships, CSL Behring

Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS

Hear how insights from patients and advocates shaped study designs and materials across three indications. This session will highlight how patient insights informed protocol development, addressed study burden, and improved recruitment. Attendees will walk away with a roadmap for replicating this success in their own programs.

12:05 pm

Leveraging Innovation to Optimize the Protocol Development Process

Jennifer Poon, Director, Clinical Capabilities Lead, Clinical Center of Excellence, Bristol Myers Squibb Co.

Hillary Rose, Associate Director, Product Manager, Global Clinical Development, Bristol Myers Squibb Co.

In this session, BMS presents its innovative development and application of AI to streamline and automate clinical protocol development. As industry data reveals increasing protocol complexity, frequent amendments, and prolonged timelines, BMS’s approach addresses these challenges head-on. Protocol automation enables time savings, reduces manual effort, and enhances consistency and quality across documentation. This presentation will highlight how AI supports operational efficiency and elevates the standard of clinical protocol development.

12:30 pm

Designing Patient-First Digital Strategies to Accelerate Clinical Trials

Jenna McDonnell, Executive Director, Strategy & Insights, Patient First Digital Solutions, Thermo Fisher Scientific

Discover how patient-first digital strategies are reshaping clinical trial recruitment and retention. This session explores how AI-driven social listening and patient population science insights help identify and engage the most demographically and epidemiologically appropriate patients—faster and more effectively. Learn how precision pre-screeners, SMART screening and digital approaches reduce burden enhancing broader trial accessibility, improve retention, and enhance scientific validity and data quality, ultimately delivering more inclusive, efficient, and higher-quality clinical trials.

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: Technology, Data and AI/ML for Intelligent Trial Design

8:30 am Chairperson's Remarks

Suzanne Harris, Senior Vice President, Marketing & Communications, SubjectWell

8:35 am

AI/ML-Based Strategies for Enhancing Equity, Diversity, and Inclusion in Randomized Clinical Trials

Shashidar Reddy Abbidi, Senior Manager, Clinical Data Management, Global Data Operations, Bristol Myers Squibb Co.

This session addresses the critical lack of diversity in clinical trials, which undermines the validity and fairness of medical evidence. Explore a novel AI/ML framework that operationalizes equity by using predictive modeling for targeted recruitment, adaptive designs, and real-time bias monitoring. Integrated with ethical safeguards, this approach ensures more representative and generalizable results. It offers a practical, responsible pathway to enhance both the scientific rigor and ethical integrity of clinical research, delivering more trustworthy evidence for all populations.

9:00 am

AI & Innovation in Clinical Trial Financial Management

Zahiah Gueddar, Senior Director Commercialization, Clinical Trial Financial Suite, IQVIA Technologies

Rajesh Patel, Senior Director, Product Management, IQVIA

Join industry leaders to discover how innovation is transforming clinical trial financial management and accelerating site and patient success. Hear firsthand about the key features and tools they’re most excited to implement and get an insider’s look at early improvements, including streamlined payment automation and stronger site outcomes. Whether you’re exploring AI in clinical trial financial management or seeking ways to boost results for sites and patients, this session delivers forward-looking insights and practical lessons from the field.

9:25 am

Optimizing Clinical Trials with Process Change and AI Innovation

Ophelia Mok, Senior Manager, Business Analytics and Insights, Global Development Organization, Takeda Pharmaceuticals, Inc.

Discover how quantifying patient burden through the Schedule of Activities (SOA) can transform protocol design at Takeda. This session will showcase how actionable insights on study burden informed early discussions, have guided complexity reduction, and minimized protocol amendments; explore strategies for leveraging competitive intelligence to optimize protocols and improve patient experience.

9:50 am

Empirical Evidence: Impact of Protocol Complexity on Operational Outcomes in Clinical Trials

Speaker to be Announced, PwC

Eduardas Valaitis, Managing Director Pharma & Life Sciences Analytics, PwC US

Mary Carroll, Director, Protocol Optimization, Clinical Acceleration & Performance, AbbVie, Inc.

We developed a multi-dimensional, quantitative framework to measure protocol complexity and applied it to digitized data from thousands of clinical trials conducted over the past decade. Using empirical models, we quantified how specific complexity dimensions influence enrollment speed and patient-initiated withdrawal. Scenario-based analyses demonstrate how targeted protocol simplification can improve operational performance and support more efficient prospective trial design.

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:

Simplify to Elevate: Designing Leaner, Smarter Clinical Protocols

Tuba Bas, PhD, Senior Director, Clinical Center of Excellence, Bristol Myers Squibb Co.

Ann Hegarty, Clinical Project Manager, Clinical Center of Excellence, Bristol Myers Squibb Co.

Vibhuti Mehta, Associate Director, PRC Lead, Bristol Myers Squibb Co.

Kissondra Morris, Associate Director, Protocol Review Committee Lead, BMS

This workshop brings together cross-functional teams to identify actionable ways to simplify protocols while preserving scientific integrity and regulatory rigor. Through collaborative exercises and real-world case examples, participants will explore strategies to reduce complexity, improve execution, and enhance the patient and site experience.

Participants will explore key focus areas, including:

Data Optimization – Identifying what’s essential and eliminating what’s not·
Reduce Burden – Crafting lean protocols that are easier to conduct & eliminate avoidable amendments
Smart Assessment Planning– Prioritize must-haves and eliminate noise, reduce complexity & ensure compliance

Together, we’ll explore ways to achieve leaner protocol design—turning simplification from a talking point into a systematic, sustainable practice.

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

Lydia Matombo, BSN, RN, PMP, ACRP-CP, Associate Director, Sumitomo Pharma

11:35 am PANEL DISCUSSION:

Site Input to DCT Use in Trials: Pathways to Protocol Input and Implementation Insights

PANEL MODERATOR:

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

Site adoption of DCT elements is critical to the success of driving these new methods to scale. Sites shared they often don't learn that DCT elements are included until the investigator meeting or initiation meeting. So, sites are not always set up to succeed using DCT elements. Two initiative teams have focused on how to include the site voice in protocol design and planning, by collecting high-level retrospective data and making clear how to gather prospective input. The aim is to help increase collaboration and insight to optimize best-fit DCT element use and implementation in trials.

PANELISTS:

Deena E. Bernstein, Vice President, Site Choice Account Development, TPS Global

Caroline Redeker, Chief Strategy & Commercial Officer, Advanced Clinical

Michelle Shogren, CEO & Owner, Innovate in What You Do!; former Senior Director of Innovation, Pharma R&D Clinical Operations, Bayer

12:00 pm

Optimizing Clinical Trials: Leveraging Payer Insights and Real-World Data for Recruitment and Site Planning

Shawn Edmonds, MBA, Executive Director & COO, CVS Healthspire Life Sciences Solutions

Yosef Khan, MD, PhD, Head of Product Strategy, CVS Healthspire Life Sciences Solutions

Sravanthi Mikkilineni, Clinical Trial Recruitment Delivery Lead, CVS Healthspire Life Sciences Solutions

In an industry where 85% of clinical trials fail to recruit or retain enough participants, precision targeting is crucial. This session explores how robust pharmacy and medical claims data – enhanced by payer insights – can be used to rapidly identify patient cohorts that match detailed study criteria and pinpoint where those patients reside. By leveraging real-world data and payer insights in study planning, sponsors can avoid protocol revisions and costly delays. Attendees will learn how a data-driven approach to clinical criteria and site selection ensures that only the most relevant patients enter the pipeline. Attendees will learn how data-driven clinical criteria and site selection ensures only the most relevant patients enter the pipeline, and they will understand how payer-informed targeting and outreach improves speed, scalability and overall trial performance.

12:25 pm PANEL DISCUSSION:

Many Voices, One Goal: Responsible AI in Clinical Trials across Stakeholders

PANEL MODERATOR:

Sharlene Carnegie, Senior Vice President, Engineering, Medidata Platform, Medidata a Dassault Systemes Co.

This multi-stakeholder panel, featuring perspectives from a sponsor, patient, and site, examines responsible integration of AI and its impact on clinical trials. Key topics include balancing innovation, privacy, and regulatory concerns, with practical implementation of AI tools. We’ll explore patient-centric strategies for trust, transparency, and equitable access, as well as industry best practices for data integrity and compliance that can streamline operations, enhance data, and improve patient engagement.

PANELISTS:

Shashidar Reddy Abbidi, Senior Manager, Clinical Data Management, Global Data Operations, Bristol Myers Squibb Co.

Andrea Downing, Founder, Light Collective

David M. Vulcano, Vice President, Research Compliance & Integrity, HCA Healthcare

12:50 pmTransition to Lunch

12:55 pm

LUNCHEON PRESENTATION: Orchestrating Site Management with Agentforce Life Sciences

Sharmin Nasrullah, General Manager, Life Sciences & Clinical, Salesforce.com, Inc.

Lorie McClain, Principal Strategic Solution Engineer, Salesforce.com, Inc.

Transform clinical operations from systems of record to systems of action. Discover how AI agents embedded in the workflow automate study start-up, feasibility, and site management. By reducing administrative burden and predicting operational and data risks, Agentforce Life Sciences connects sponsors and sites to replace manual hurdles with autonomous collaboration, accelerating trial timelines from enrollment to close-out.

1:25 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!