Data
Clinical Data Strategy
Integrating AI into Clinical Data and Analytics

SCOPE’s 17th Annual Data stream explores how data strategy, infrastructure, and advanced analytics are reshaping clinical trials. From streamlining data collection and integration to enabling scalable AI applications, industry leaders will share practical solutions for breaking silos and accelerating decision-making. Sessions will focus on real-world use cases, governance models, and emerging tools that support innovation across the clinical trial lifecycle. 





Monday, February 2

SCOPE'S 5TH ANNUAL MASTERS OF CLINICAL RESEARCH GOLF TOURNAMENT

Golf Check-In & Breakfast Buffet*

SCOPE'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. 

Registration Open

Golf Lunch Buffet (Sponsorship Opportunities Available)*

PRE-CONFERENCE WORKSHOPS & USER GROUPS (IN-PERSON ONLY)

– 4:00 pm IQVIA Technologies Innovation Day

– 3:30 pm MaxisAI: INSPIRE Agentic AI Summit

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

– 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

Close of the Masters of Clinical Research Golf Tournament

*Limited spots available. Separate registration and fee apply.

SCOPE'S PICKLEBALL NETWORKING SESSION

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

Monday Kickoff Plenary Keynote and Participant Engagement Awards

MONDAY AFTERNOON PLENARY SESSION:
PATIENT PANEL, SITE INNOVATION AWARD, PARTICIPANT ENGAGEMENT AWARD

Grab Your Seat: Early-Bird Seat Golden Ticket Raffle & Prize Giveaway! *

*Must be present to win.

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

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

FIRESIDE CHAT:
Hope: The Double-Edged Sword of Patient Experience

Lindsay Guentzel, Multimedia Journalist & Patient Advocate , multimedia journalist & advocate , n/a

Jane Myles, Program Director, Decentralized Trials & Research Alliance (DTRA); Board Member, The Myositis Association (TMA) , Program Director , Decentralized Trials & Research Alliance (DTRA) ·

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

Tips for Getting the Most out of SCOPE

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

SCOPE's 3rd Annual Site Innovation Awards

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

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

Irfan Khan, CEO, Circuit Clinical , CEO , Circuit Clinical

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

Sean Soth, Senior Vice President, Strategy and Global Business Partnerships, SCRS , Senior Vice President , Society for Clinical Research Sites (SCRS)

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

Panel Moderator:

KEYNOTE INTERACTIVE PANEL:
SCOPE's 10th Annual Participant Engagement Awards

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

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

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

Panelists:

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

Mark Evans, Managing Director, Patient Recruitment, Faze , Managing Dir , Patient Recruitment , Faze

Jameka Hill, Senior Director, Clinical Trial Health Equity, Moderna, Inc. , Senior Director, Clinical Trial Health Equity , Patient Engagement & Advocacy , Moderna

Neha Shah Londono, Director, Clinical Trial Diversity and Community Engagement Lead, Pfizer Inc. , Director , Global Clinical Trial Diversity Equity & Inclusion , Pfizer

Jessica Perry, Senior Director, Trial Optimization, Kymera Therapeutics , Senior Director , Trial Optimization , Kymera Therapeutics

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

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

SCOPE'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!

Close of Day

Tuesday, February 3

Sunrise Yoga: In Gratitude for Clinical Research Participants

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

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

SCOPE'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. Full details to come…just don’t forget your sneakers!

Registration Open

Morning Coffee (Sponsorship Opportunities Available)

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

Tuesday Morning Opening Plenary Keynotes

TUESDAY MORNING PLENARY SESSION

Grab 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!

Welcome to SCOPE 2026—Welcome to the Clinical Trials Factory

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

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

Eliav Barr, Head, Global Clinical Development and CMO, Global Clinical Development, Merck & Co. , Head, Global Clinical Development and Chief Medical Officer , Global Clinical Dev , 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.

Panel Moderator:

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

Jeremy Goldberg, Operating Partner, Healthcare, Arsenal Capital Partners , Operating Partner , Healthcare , Arsenal Capital Partners

Panelists:

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

Shawne Moran, Head, In-Country Study Operations-Americas, EMD Serono/Merck KGaA Darmstadt, Germany , Head, Study Operations-Amercias , Clinical Delivery & Patient Centricity , Merck KGaA/EMD Sereno

Jared Saul, MD, CMO, Commercial Healthcare and Life Sciences, Amazon Web Services , Chief Medical Officer, Commercial Healthcare and Life Sciences , Healthcare & Life Sciences Start Ups , Amazon Web Svcs LLC

Grand 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: Clinical Data Strategy

RETHINKING DATA MANAGEMENT

Making a Unified Data-Management Platform a Reality

Photo of John Finn, Executive Director and Inflammation & Immunology-RAE TA Lead, Clinical Data Scientist, Pfizer Inc. , Executive Dir CDIS  Lead Inflammation & Immunology and Internal Medicine , Clinical Data and Information Sciences , Pfizer Inc
John Finn, Executive Director and Inflammation & Immunology-RAE TA Lead, Clinical Data Scientist, Pfizer Inc. , Executive Dir CDIS Lead Inflammation & Immunology and Internal Medicine , Clinical Data and Information Sciences , Pfizer Inc
Photo of Rajat Nanda, Global Head, Senior Director, Data Management Reporting & Analytics, Pfizer Inc. , Global Head, Senior Director , Data Management Reporting & Analytics , Pfizer
Rajat Nanda, Global Head, Senior Director, Data Management Reporting & Analytics, Pfizer Inc. , Global Head, Senior Director , Data Management Reporting & Analytics , Pfizer
Photo of Ralph Russo, Executive Director, Global Head, Clinical Data Collection Strategies, Pfizer Inc. , Executive Director , Clinical Database Mgmt & Standards , Pfizer Inc
Ralph Russo, Executive Director, Global Head, Clinical Data Collection Strategies, Pfizer Inc. , Executive Director , Clinical Database Mgmt & Standards , Pfizer Inc
Photo of Demetris Zambas, Vice President & Global Head, Clinical Data Sciences, Pfizer Inc. , Vice President, Global Head - Clinical Data Sciences , Clinical Data Sciences , Pfizer Inc
Demetris Zambas, Vice President & Global Head, Clinical Data Sciences, Pfizer Inc. , Vice President, Global Head - Clinical Data Sciences , Clinical Data Sciences , Pfizer Inc

This session will explore Pfizer’s journey to create an end-to-end data management, reporting, and analytics platform to support traditional and decentralized clinical trials with true real-time access to data throughout.  Hear how co-developing a new solution solved for true simplified EDC build, Direct Data Capture, non-CRF Data streamlined Acquisition, tiered query management, dynamic SDV to support study RBM, Advanced Reporting and Analytics for sponsor, study monitors and sites themselves, and SAE reporting automation eCRF Capture and flow to safety system.

Dataverse Unleashed: Empowering Global Therapeutics with AI-Ready Data

Photo of Gian Prakash, Director, Data & Analytics, Information Research, AbbVie, Inc. , Director, Information Research at R&D , Information Research , AbbVie Inc
Gian Prakash, Director, Data & Analytics, Information Research, AbbVie, Inc. , Director, Information Research at R&D , Information Research , AbbVie Inc

Discover the transformative power of Dataverse, an integrated platform designed to revolutionize AI applications in global therapeutics through AI-ready data. This presentation will highlight real-world use cases where Dataverse effectively bridges the gap between proof of concept and large-scale AI use-case implementation, enabling innovative therapeutic strategies and enhancing patient outcomes globally with robust and actionable AI-ready datasets.

Sponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break, whether you prefer Florida sunshine or the cool comfort of indoor seating.

Networking 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!

DATA SHARING AND PRODUCT-CENTRIC DATA GOVERNANCE

Chairperson's Remarks

Brandon Rufino, Computational Science Manager, Sanofi , Computational Science Manager , Sanofi

Strategic Data Sharing: Unlocking Clinical Insights through Secure Collaboration

Photo of Medha Patel, Clinical Design Analytics Director, Amgen , Clinical Design Analytics Director , Amgen
Medha Patel, Clinical Design Analytics Director, Amgen , Clinical Design Analytics Director , Amgen

Despite significant investment in clinical research, insights often remain siloed due to limited data access and fragmented efforts. This session explores how secure, de-identified data sharing can transform isolated studies into collective scientific progress, especially in rare and high-risk diseases. Amgen will share real-world applications and regulatory experiences, illustrating how privacy-protective collaboration and synthetic data innovation can accelerate trials, reduce duplication, and ethically maximize the value of historical data.

Beyond Seeing to Chatting with Our Portfolio: Accelerating Clinical Decision-Making with Performance Central

Photo of Jacqueline Habib, Senior Director, Drug Development Portfolio Management Insights, Bristol Myers Squibb , Senior Director, Portfolio Management Insights , Drug Development Portfolio Management Insights , Bristol Myers Squibb
Jacqueline Habib, Senior Director, Drug Development Portfolio Management Insights, Bristol Myers Squibb , Senior Director, Portfolio Management Insights , Drug Development Portfolio Management Insights , Bristol Myers Squibb
Photo of Leyla Rich, Senior Director, R&D Portfolio Operations, R&D Business Insights & Technology, Bristol Myers Squibb Co. , Senior Director, R&D Portfolio Operations , R&D Business Insights & Technology , Bristol Myers Squibb Co
Leyla Rich, Senior Director, R&D Portfolio Operations, R&D Business Insights & Technology, Bristol Myers Squibb Co. , Senior Director, R&D Portfolio Operations , R&D Business Insights & Technology , Bristol Myers Squibb Co

Discover how Performance Central and its embedded IRIS chatbot are revolutionizing R&D portfolio operations at BMS. This enterprise platform gives teams instant, conversational access to data on over 250 projects and 300 active studies—empowering faster, smarter decisions. We’ll share lessons learned from centralizing data and harmonizing metrics, highlight our ‘chat with’ rollout and user feedback, and reveal future milestones for scaling conversational AI across global clinical portfolios.

Powering Clinical-Study Innovation through Low-Code Platforms and Product-Centric Governance

Photo of Keith A. Wilson, Associate Director, Product Management, Global Development IT, Regeneron Pharmaceuticals, Inc. , Associate Director, Product Management , Global Development I.T. , Regeneron Pharmaceuticals Inc
Keith A. Wilson, Associate Director, Product Management, Global Development IT, Regeneron Pharmaceuticals, Inc. , Associate Director, Product Management , Global Development I.T. , Regeneron Pharmaceuticals Inc

Regeneron’s GD-IT Enabling Technologies team established a Power Platform Center of Excellence and adopted a product-centric delivery model to streamline data capture and oversight for clinical trial operations. Strategic investments in premium licensing enabled scalable, compliant solutions to centralize study tracking and integrate with enterprise systems to support protocol development and milestone management.

Welcome 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!

Close of Day

SCOPE Out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

SCOPE out the restaurants and shops at Pointe Orlando, via our courtesy Shuttle
*Times subject to change. More details closer to the event.​

Wednesday, February 4

Sunrise Yoga: In Gratitude for Clinical Research Participants

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

Registration Open

BREAKFAST PRESENTATIONS

– 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.

Transition to Sessions

AI FOR DATA MANAGEMENT

Human+AI Driven Data Review Plan: A Black Hole Experiment

Photo of Sanjay Bhardwaj, Executive Director, Head of Clinical Data Technologies, AbbVie, Inc. , Exec Dir Clinical Data Management , AbbVie Inc
Sanjay Bhardwaj, Executive Director, Head of Clinical Data Technologies, AbbVie, Inc. , Exec Dir Clinical Data Management , AbbVie Inc
Photo of Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc. , Director & Head, Clinical Systems & Digital Operations , Data Sciences , AbbVie Inc
Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc. , Director & Head, Clinical Systems & Digital Operations , Data Sciences , AbbVie Inc

As the clinical research industry steadily advances its adoption of AI-driven anomaly detection for clinical data, it is increasingly clear that artificial intelligence, while powerful, remains only one component of a comprehensive data review strategy. This session introduces a practical framework for developing an integrated clinical data review plan where inputs from both human experts and AI systems are systematically combined. Leveraging standards libraries, data review plan (DRP) libraries, and study protocols, we will explore methodologies to harmonize technology-driven insights with clinical judgment. Attendees will gain actionable guidance on creating robust data review plans that optimize accuracy, compliance, and efficiency harnessing the complementary strengths of AI models and human expertise.

Next-Generation Analytics for Feasibility Leveraging AI Agents for on-Demand Insights

Photo of Ray Zhong, PhD, Associate Director, Data Technologies & Analytics Solutions, Data & Analytics, Otsuka America Pharmaceuticals, Inc. , Associate Director, Data Technologies & Analytics Solutions , Data & Analytics , Otsuka America Pharmaceuticals Inc
Ray Zhong, PhD, Associate Director, Data Technologies & Analytics Solutions, Data & Analytics, Otsuka America Pharmaceuticals, Inc. , Associate Director, Data Technologies & Analytics Solutions , Data & Analytics , Otsuka America Pharmaceuticals Inc

Traditional approaches to feasibility analytics tools focus on the creation of rigid dashboards fit for purpose to specific metrics. In this work, we aim to change the way that study teams interact with analytics and insights for protocol feasibility and site profiling analytics by enabling an AI-driven user interaction that focusses on generating targeted insights based on the specific user's intent and preferences.

Coffee 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!

Leveraging a Data-Mesh Framework in Clinical Trials

Photo of Vishal Janani, Director, Digital Clinical Operations, BeOne Medicines , Director , Digital Clinical Operations , BeOne Medicines
Vishal Janani, Director, Digital Clinical Operations, BeOne Medicines , Director , Digital Clinical Operations , BeOne Medicines
Photo of Beenu Kapoor, Executive Director, Global Clinical Operations, BeOne Medicines USA Inc. , Executive Director , Global Clinical Operations , BeOne Medicines USA Inc
Beenu Kapoor, Executive Director, Global Clinical Operations, BeOne Medicines USA Inc. , Executive Director , Global Clinical Operations , BeOne Medicines USA Inc

Data mesh, a decentralized architectural framework that enables domain teams to own and govern their data while facilitating cross-domain analysis, addresses the unique challenges of clinical trial operations by democratizing access to trial data while maintaining strict regulatory compliance and patient privacy standards.

NEXT-GENERATION DATA-CAPTURE TECHNOLOGIES

Panel Moderator:

PANEL DISCUSSION:
The Great Data-Capture Debate: EHR, eSource, and Traditional Approaches

Photo of Doug Bain, Consulting Partner, Clinflo , Consulting Partner , Clinflo
Doug Bain, Consulting Partner, Clinflo , Consulting Partner , Clinflo

Panelists:

Photo of Derk Arts, Founder & CEO, Castor , Founder & CEO , Castor
Derk Arts, Founder & CEO, Castor , Founder & CEO , Castor
Photo of Drew Garty, CTO, Clinical Data, Veeva Systems , Chief Technology Officer, Clinical Data , Clinical Data , Veeva Systems
Drew Garty, CTO, Clinical Data, Veeva Systems , Chief Technology Officer, Clinical Data , Clinical Data , Veeva Systems
Photo of Siggi Kloos, Senior Vice President, R&D Digital, Data, & Informatics, BioNTech US , Senior Vice President , R&D Digital, Data, & Informatics , BioNTech US
Siggi Kloos, Senior Vice President, R&D Digital, Data, & Informatics, BioNTech US , Senior Vice President , R&D Digital, Data, & Informatics , BioNTech US
Photo of Michael Wenger, Chief Innovation Officer, CRIO , Chief Innovation Officer , CRIO
Michael Wenger, Chief Innovation Officer, CRIO , Chief Innovation Officer , CRIO

Sponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break, whether you prefer Florida sunshine or the cool comfort of indoor seating.

Networking 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!

Wednesday Afternoon Plenary

WEDNESDAY PLENARY AFTERNOON SESSION

SCOPE around the World: Community, Connection, Celebration

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

SCOPE’s Producer Team (Meet the Team!) https://www.scopesummit.com/meet-the-team

Panel Moderator:

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

Melody Aldred, PhD, Study Director, Community Lead, SSO GCO Development, Novartis , Study Director Community Lead , Study Leadership, SSO GCO Development , Novartis

Panelists:

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

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

Jie Zhang, Head, Global Pipeline Market Access, CSL , Head, Global Pipeline Market Access , Global Market Access , CSL

Panel Moderator:

KEYNOTE INTERACTIVE PANEL:
Change Management for AI Adoption in Pharma Clinical Development Teams

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

Panelists:

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

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

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

SCOPE'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.

Close of Day

SCOPE out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

SCOPE out the restaurants and shops at Pointe Orlando, via our courtesy Shuttle
*Times subject to change. More details closer to the event.

Thursday, February 5

Registration Open

BREAKFAST PRESENTATION

Transition to Sessions

Part 2: Integrating AI into Clinical Data and Analytics

DIGITAL DATA FLOW & DATA SCIENCE TRANSFORMATION

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

Photo of William Illis, Global Head, Collaboration & Technology Strategy Clinical Development, Novartis Pharmaceuticals , VP & Program Leader & Global Head , Collaboration & Technology Strategy Clinical Dev , Novartis Pharmaceuticals
William Illis, Global Head, Collaboration & Technology Strategy Clinical Development, Novartis Pharmaceuticals , VP & Program Leader & Global Head , Collaboration & Technology Strategy Clinical Dev , Novartis Pharmaceuticals
Photo of Donald Jennings, Senior Director, Digital Trial Foundations and Patient Engagement, Eli Lilly and Company , Sr. Director , Eli Lilly & Co
Donald Jennings, Senior Director, Digital Trial Foundations and Patient Engagement, Eli Lilly and Company , Sr. Director , Eli Lilly & Co

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

Panel Moderator:

PANEL DISCUSSION:
How to Navigate the Data-Science Transformation

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

Panelists:

Photo of Lynne Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs , Global Lead Risk Based Monitoring Program , Data Monitoring and Management , Pfizer Global R&D Groton Labs
Lynne Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs , Global Lead Risk Based Monitoring Program , Data Monitoring and Management , Pfizer Global R&D Groton Labs
Photo of Miguel Lemaire, PhD, Associate Director, Oversight Data Management, GSK , Associate Director, Oversight Data Management , GSK
Miguel Lemaire, PhD, Associate Director, Oversight Data Management, GSK , Associate Director, Oversight Data Management , GSK
Photo of Shawntel Swannack, Regional Director (Americas), Analytical Monitoring, Data Management & Central Monitoring, Integrated Data Analytics & Reporting (IDAR), Johnson & Johnson , Regional Director (Americas), Analytical Monitoring , Data Management & Central Monitoring, Integrated Data Analytics & Reporting (IDAR) , Johnson & Johnson
Shawntel Swannack, Regional Director (Americas), Analytical Monitoring, Data Management & Central Monitoring, Integrated Data Analytics & Reporting (IDAR), Johnson & Johnson , Regional Director (Americas), Analytical Monitoring , Data Management & Central Monitoring, Integrated Data Analytics & Reporting (IDAR) , Johnson & Johnson

Interactive Breakouts and Working Groups

INTERACTIVE WORKING GROUPS (IN-PERSON ONLY)

Find your Working Group

Interactive 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.

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

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

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

Everyone’s talking about AI—but what happens when AI joins the conversation? In this first-of-its-kind format, humans share the stage with agentic AI bots trained on real-world clinical trial roles—patients, investigators, and data reviewers. Together, they’ll debate the future of clinical research: Will AI be our collaborator, co-pilot, or competitor? 

This isn’t your typical panel. It’s a live, unscripted experiment where AI agents respond to audience questions, engage in real-time discussion, and reveal the logic behind their answers—offering a rare peek inside the so-called “black box.” 

Alongside seasoned industry experts, they’ll unpack how AI is not just accelerating decisions, but reimagining the very fabric of clinical development. Expect surprises. Expect disagreements. Expect to rethink what it means to be human in a machine-powered world. Whether you leave inspired or unnerved, you won’t forget this session anytime soon.

Networking 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!

AI-DRIVEN ANALYTICS

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

Photo of Omkar Dasari, Senior Technical Product Manager, Data & Analytics, Amgen , Senior Manager Information Systems , Data & Analytics , Amgen
Omkar Dasari, Senior Technical Product Manager, Data & Analytics, Amgen , Senior Manager Information Systems , Data & Analytics , Amgen
Photo of James Vernille, PhD, Director, Clinical Systems & Analytical Reporting, Global Development Operations, Amgen, Inc. , Director, Clinical Systems & Analytical Reporting , Global Development Operations , Amgen Inc
James Vernille, PhD, Director, Clinical Systems & Analytical Reporting, Global Development Operations, Amgen, Inc. , Director, Clinical Systems & Analytical Reporting , Global Development Operations , Amgen Inc

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

Panel Moderator:

PANEL DISCUSSION:
Transforming Clinical Data Analytics with Agentic GenAI

Photo of Sina Djali, Head, Data Management and Central Monitoring, Immunology and Medical Affairs, Johnson & Johnson , Sr Dir Integrated Clinical & Operations Analytics , Integrated Clinical & Operations Analytics , Janssen R&D LLC
Sina Djali, Head, Data Management and Central Monitoring, Immunology and Medical Affairs, Johnson & Johnson , Sr Dir Integrated Clinical & Operations Analytics , Integrated Clinical & Operations Analytics , Janssen R&D LLC

Panelists:

Photo of Bhargava Reddy, PhD, Senior Director, Advanced Insights and Solutions, Janssen , Senior Director, Advanced Insights and Solutions , Advanced Analytics , Janssen Research and Development
Bhargava Reddy, PhD, Senior Director, Advanced Insights and Solutions, Janssen , Senior Director, Advanced Insights and Solutions , Advanced Analytics , Janssen Research and Development
Photo of Richard Young, Chief Strategy Officer, CluePoints , Chief Strategy Officer , CluePoints
Richard Young, Chief Strategy Officer, CluePoints , Chief Strategy Officer , CluePoints

Transition to Lunch

SCOPE 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!

POST-CONFERENCE TRAINING SEMINARS*

THURSDAY, FEBRUARY 5, 2026  2:00 – 5:00 pm | FRIDAY, FEBRUARY 6, 2026  9:00 am – 4:00 pm

TS1: Service Provider Oversight: Practical Tools for Clinical Operations Teams

TS2: Quality and Process Improvement Techniques and Tools


Thursday, February 5, 2026  2:00 – 5:00 pm | Friday, February 6, 2026  9:00 am – 12:00 pm

TS3: ICH E6(R3) and E8 Implementation Workshop: Understanding Key Points and Practical Applications​

* In-Person Only, Separate registration required.

SCOPE Track Summariese

2026 Conference Programs