Market Access, Reimbursement & Licensing

2026 ARCHIVES

New for this year, SCOPE is introducing a dedicated conference on Market Access, Reimbursement & Licensing—designed to bridge the gap between clinical development and commercial strategy. As drug developers face growing pressure to demonstrate not only safety and efficacy but also value and affordability, this conference will explore how early evidence generation, pipeline planning, payer-aligned trial design, and real-world outcomes are shaping the future of access and reimbursement. Senior leaders in market access, clinical development, clinical operations, HEOR, RWE, and commercial planning will share strategies for embedding access thinking into clinical planning—ensuring that innovation is not only approved, but also reimbursed, adopted, and sustained. Join a diverse group of experts working to align development decisions with market realities from day one.

Part 1: Trial Design & Real World Evidence

Part 2: Market Access, Pricing & Reimbursement

Monday, February 2

7:00 amGolf Check-In & Breakfast Buffet*

8:00 am– 3:30 pm MaxisAI: INSPIRE Agentic AI Summit

12:00 pm– 4:00 pm IQVIA Technologies Innovation Day

1:00 pm– 3:30 pm Using Data and AI to Accelerate Trials: WCG User Group and Product Roadmap Discussion

1:00 pm– 3:30 pm Enhancing the Efficiency of Pipeline Delivery: Disruptive Scenarios and Strategic Responses

2:00 pm– 3:30 pm OPEN WORKSHOP: Modernizing Informed Consent: AI, Automation, and Ethics in Global Clinical Trials

For more details on Pre-Conference Events, please visit: Workshops/User Groups

9:00 amRegistration Open

9:00 amSCOPE's 5th Annual Masters of Clinical Research Golf Tournament* SOLD OUT (Sponsorship Opportunities Still Available)

Network on the greens at SCOPE's 5th Annual Golf Tournament! Visit the SCOPE Summit website for player and sponsorship opportunities.

1:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)*

1:00 pm– 3:45 pm SCOPE'S Pickleball Networking Session: Paddles & Partnerships

Kick off the SCOPE 2026 conference with food, fun, and pickleball! Whether you're a pickleball pro or have never picked up a paddle, this event is perfect for everyone. Limited spots available. Register Here

2:00 pmClose of the Masters of Clinical Research Golf Tournament

*Limited spots available. Separate registration and fee apply.

3:45 pmGrab Your Seat: Early-Bird Seat Golden Ticket Raffle & Prize Giveaway! *

*Must be present to win.

3:50 pm

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

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

3:58 pm Chairperson's Introduction

Rob Goodwin, COO, Parexel

4:00 pm FIRESIDE CHAT:

Hope: The Double-Edged Sword of Patient Experience

Lindsay Guentzel, Multimedia Journalist & Patient Advocate

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

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

In this fireside chat, two CAR T trial participants and a patient advocate/clinical research professional unpack the journey: find the trial, fight the insurer, cross state lines, then live the trial reality, along with your family. Careful research, long consent forms, and great care teams can still miss key things that matter. For clinical researchers, we share a clear look at what we ask—and what patients still can’t see.

4:25 pm

Tips for Getting the Most out of SCOPE

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

Visit our FAQ page! We hope this page answers some of your questions related to SCOPE. It consolidates a lot of info for speakers, attendees, and vendors into one page. We look forward to seeing you at SCOPE on February 2-5, 2026, at the Rosen Shingle Creek in Orlando, Florida! https://www.scopesummit.com/faq-how-to-succeed-at-scope

4:33 pm Chairperson’s Introduction: Developing Site Relationships beyond Study-Level Engagement

Elisa Cascade, Chief Growth Officer, Head of Americas, TrialScreen

4:35 pm

SCOPE's 3rd Annual Site Innovation Awards

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

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

Irfan Khan, CEO, Circuit Clinical

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

Sean Soth, Senior Vice President, Strategy and Global Business Partnerships, SCRS

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

We are excited to announce our 3rd Annual Site Innovation Award, recognizing sites and partnerships pioneering new approaches to improve clinical trials. This is an opportunity to highlight your successes and be recognized by your peers for your dedication to advance clinical research. By sharing your actionable solutions, you will inform the broader Clinical Operations Community at SCOPE. Our definition of innovation is inclusive of low-tech or high-tech solutions, or any site operations-related process improvements that effectively reduce site burden and improve a site’s ability to advance clinical research while providing patient-centered care. The Site Innovation Awards program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/site-innovation-award

5:05 pm SCOPE's 10th Annual Participant Engagement Awards Introduction: Industry Mandate and Collaboration for Expanding Access to Clinical Trials

Mike Martin, Drug Development Practice Area Lead, R&D Consulting, ZS Associates

5:10 pm KEYNOTE INTERACTIVE PANEL:

SCOPE's 10th Annual Participant Engagement Awards

PANEL MODERATORS:

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

Kelly McKee, Vice President, Strategy & Transformation, Science 37; Co-Creator of the SCOPE Participant Engagement Award

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

Now in its 10th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2026 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/participant-engagement-award

PANELISTS:

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

Mark Evans, Managing Director, Patient Recruitment Expert

Jameka Hill, Senior Director, Clinical Trial Health Equity, Moderna, Inc.

Neha Shah Londono, Director, Clinical Trial Diversity and Community Engagement Lead, Pfizer Inc.

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

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

5:40 pmSCOPE's Winter Games Opening Reception (Sponsorship Opportunities Available)

Break out your coolest Winter Games—inspired look—no snow required! Think country flag t-shirts, Olympic colors, or your favorite team gear. While we may be in sunny Florida, let’s ignite the spirit of unity, energy, and excitement—as we toast to teamwork and triumph!

7:00 pmClose of Day

Tuesday, February 3

6:00 amSunrise Yoga: In Gratitude for Clinical Research Participants

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

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

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

Lace up and join SCOPE’s Coordinators for the Fun Run on Tuesday, February 3! Sprint, jog, walk, or talk-your-way-through—ALL abilities are welcome. This informal event is all about getting moving together. New meet-up location for 2026! Meet outside at the back of the Gatlin Terrace by the paved path. We will do three loops around the property, do as few or as many as you have time for, but we will start promptly at 6:30 am! Meet us in the Rosen Hotel’s Gatlin Terrace at 6:30 am sharp!

7:30 amRegistration Open

7:30 amMorning Coffee (Sponsorship Opportunities Available)

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

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

Don’t miss your chance to win! Arrive early, grab your seat, and take part in SCOPE’s Early Bird Seat Raffle & Prize Giveaway. Exciting prizes are up for grabs—must be present to win!

8:30 am

Welcome to SCOPE 2026—Welcome to the Clinical Trials Factory

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

8:38 am Chairperson's Plenary Keynote Introduction: Patient Engagement as a Guiding Principle in Research

Lisa Moneymaker, Chief Strategy Officer, Medidata

8:40 am

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

Eliav Barr, Head, Global Clinical Development and CMO, Global Clinical Development, Merck & Co.

Pharma’s mission to deliver life-changing therapies depends on its ability to innovate while staying grounded in execution. This keynote will highlight how companies are aligning purpose with investment in new clinical models and technologies. The conversation will focus on where big pharma is directing innovation strategy—and how operational alignment ensures impact for patients and the healthcare system.

Interviewed By:

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

9:05 am

SCOPE’s Stretch Break & Annual T-Shirt Toss

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

Take a quick pause to stretch, recharge, and enjoy a little SCOPE tradition—our Annual T-Shirt Toss! Watch for the t-shirt slingshot sending giveaways into the audience as we add some fun to your day.

9:15 am KEYNOTE PANEL DISCUSSION:

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

PANEL MODERATOR:

Jeremy Goldberg, Operating Partner, Healthcare, Arsenal Capital Partners

Clinical development timelines remain one of the biggest barriers between breakthrough innovation and patients in need. Incremental process tweaks won’t cut it—what’s required is a step-change in how trials are designed, executed, and financed. This keynote will push beyond theory into bold, actionable strategies for compressing timelines, rethinking operational models, and deploying capital where it can have the greatest impact. Leaders will examine how smarter investment, data integration, and operational transformation can turn years into months—and what will truly move the needle for the future of clinical research.

PANELISTS:

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

Shawne Moran, Head, In-Country Study Operations-Americas, EMD Serono/Merck KGaA Darmstadt, Germany

Jared Saul, MD, CMO, Commercial Healthcare and Life Sciences, Amazon Web Services

9:45 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall —Best of Show Voting Opens

Step into SCOPE’s one-of-a-kind exhibit hall! With 300+ leading clinical trial technology and service companies, it’s the place to discover new partners and reconnect with familiar ones. Cast your vote for SCOPE’s Best of Show, recharge with coffee, snap a photo, and don’t forget your comfy shoes—you’ll have miles to explore!

Part 1: Trial Design & Real World Evidence

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

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

3:05 pm

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

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

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

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

3:25 pm

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

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

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

3:40 pm

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

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

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

3:55 pm

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

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

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

4:20 pm

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

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

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

4:45 pm PANEL DISCUSSION:

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

PANEL MODERATOR:

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

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

PANELISTS:

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

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

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

5:10 pm

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

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

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

5:23 pm

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

Robert Chu, CEO, Embleema

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

5:35 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)

Wrap up the day with colleagues, friends old and new at SCOPE’s Welcome Reception in the Exhibit Hall. Enjoy drinks, network with exhibitors, and enter to win fabulous raffle prizes (must be present to win). Keep the evening going with dinner at Rosen Shingle Creek’s restaurants—no Orlando traffic required!

7:00 pmClose of Day

7:00 pmSCOPE Out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

Enjoy an evening exploring the restaurants and shops at Pointe Orlando with transportation provided by our courtesy shuttle. Shuttles will run until 11:00 pm, with the last pick-up at 10:30 pm.

*Times subject to change. More details closer to the event.

Wednesday, February 4

6:00 amSunrise Yoga: In Gratitude for Clinical Research Participants

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

7:30 amRegistration Open

8:00 am

BREAFAST PRESENTATION OPTION #1:

Reaching the Unreachable: Proven Strategies You Can Apply to Engage Underserved Populations in Global Clinical Trials

Tobias Kruse, PhD, Managing Director, Europe, SubjectWell

Underserved populations are often excluded from clinical trials, limiting engagement, scientific validity, and real-world relevance. Traditional strategies often rely on outdated assumptions and overlook patient realities. This session reveals proven, globally scalable strategies to engage these communities through real-world data (RWD), behavioral insights, and human-centered approaches—replacing guesswork with precision to accelerate inclusive trial enrollment and shorten study timelines.

8:00 am

BREAKFAST PRESENTATION OPTION #2:

From Elusive to Enrolled: A Case Study in Precision Recruitment

Matthew Graffeo, Managing Director, Healthcare & Digital, GCI Health

Nikki Buchmayer, Senior Vice President, Digital, Clinical Trial Recruitment, GCI Health

As the pace of innovation accelerates, scientific breakthroughs bring new hope to patients. Effectively including and supporting underrepresented populations is critical for the success of clinical trials designed to benefit these communities. GCI Health’s experts will share their “secret sauce” for building meaningful engagement with niche communities along with a real-world example of its methodology in action through its work with the University of Florida’s traumatic brain injury trial.

8:00 amSponsored Breakfast Presentation (Opportunity Available)

8:00 am– 9:00 am WORKING GROUP BREAKFAST: Pharma Leadership Forum: Overcoming Geopolitical Challenges in Clinical Development (Invite Only)

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

Global clinical development is increasingly vulnerable to geopolitical forces. Sponsors face rising risks in running global trials, requiring proactive and diversified strategies to maintain momentum and safeguard patients. A group of top clinical research leaders from biopharma companies will get together at SCOPE to exchange ideas and case studies and to explore opportunities for sponsor companies to unify their efforts. Some of the challenges to be discussed include regulatory divergence, supply chain disruptions, patients recruitment in global trials, data security & sovereignty, IP protection, and cyber threats.

8:25 amTransition to Sessions

8:30 am

Chairperson's Remarks

Nikesha Harrington, Director Site Operations Americas, Abbott Labs

8:35 am

From Approval to Access: Embedding Market Access into Clinical Development—Accelerated by Real-World Data and Artificial Intelligence

Mei Yang, Co-Founder, NouStarX

In today’s value-driven healthcare environment, regulatory approval is no longer the finish line—timely reimbursement and broad patient access are now essential measures of success. Yet many development programs still delay market access planning until late stages, risking misaligned evidence, launch delays, and restricted coverage. This opening talk launches SCOPE’s inaugural Market Access, Pricing & Reimbursement track by spotlighting why access strategy must be integrated early and how it directly shapes study design, endpoint selection, and data capture. It explores how real-world data (RWD) and artificial intelligence (AI) are accelerating the shift toward access-ready trials. From early economic modeling to AI-driven evidence synthesis, these technologies help anticipate payer needs, align evidence strategies early, and support faster, smarter launch decisions. Embedding market access into clinical development from the start is now a strategic imperative for launch success.

9:00 am PANEL DISCUSSION:

Access-Ready by Design: Aligning Evidence Generation with Payer Needs

PANEL MODERATOR:

Mei Yang, Co-Founder, NouStarX

Clinical trials are no longer designed solely for regulatory approval. They must also generate the right evidence for payers, HTA bodies, and real-world value demonstration. This panel will explore how clinical development, HEOR, and market access teams can work together earlier in the process to ensure that access considerations shape trial design from the start. Panelists will share practical insights on aligning endpoints, data collection strategies, and operational timelines with reimbursement expectations across global markets. The discussion will also highlight how AI and real-world data are enabling more predictive, efficient, and payer-relevant evidence generation—helping teams reduce delays, avoid redundant studies, and accelerate time to access. Both U.S. and global perspectives will be discussed to reflect the evolving landscape of access planning and evidence requirements.

PANELISTS:

Laurence Djatche, Global Value Evidence and Access Lead, Sanofi

Wayne Su, Global Value Lead, Zanidatamab, Jazz Pharmaceuticals

Jon Weber, PhD, Senior Director & Market Access Lead, Cell & Gene Therapy, Bayer AG

Jie Zhang, Head, Global Pipeline Market Access, CSL

9:50 am

Beyond Approval: Designing Trials for Access—Optimizing Clinical Development to Maximize Pricing & Reimbursement Potential

Wayne Su, Global Value Lead, Zanidatamab, Jazz Pharmaceuticals

To optimize market access, clinical trials must align with payer expectations beyond regulatory requirements. This includes selecting payer-relevant comparators, ensuring trial sites in key markets, and incorporating long-term follow-up for robust outcomes. Moreover, tokenization can enable real-world data collection during and post-trial. Collecting healthcare resource use (HCRU) and implementing comprehensive patient-reported outcomes (PROs) further support the demonstration of economic and patient value.

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

Nikesha Harrington, Director Site Operations Americas, Abbott Labs

11:15 am

From Clinic to Market Access: Designing Trials that Secure Global Success

Brian J. Cuffel, PhD, Vice President, Market Access & Health Economics Outcomes Research, Ambros Therapeutics

Market access success is not won at launch—it is built years earlier in the clinic. Smart decisions regarding clinical trial design can address the needs of regulators as well as payers in the US and globally. The alternative, risks delayed reimbursement, restricted access, and costly post-hoc studies to fill evidence gaps. Breaking down silos between clinical development, medical, HEOR, and market access functions is no longer optional; it is the decisive factor in determining whether innovation reaches patients rapidly and at target prices. This session will share case-based lessons from global launches where both market access and development milestones were accelerated by the way trials were designed.

Case Study 1: The First Tissue-Agnostic Global Oncology Launch—Leading Innovation in HTA

The first global launch of a tissue-agnostic oncology therapy moved rapidly through regulators, but payers demanded data the trials were not designed to generate. While the product was historic in its clinical development program—taking only three years to FDA approval—delays in reimbursement threatened to keep patients waiting and required shifting traditional ways of addressing HTA evidence requirements without increasing the cost, complexity, or time required for drug development.

Case Study 2: Third-to-Market Oncology Asset—Smart Trial Design Wins

Despite being third to market in a crowded class, smart trial design—careful endpoint selection, careful timing and selection of the endpoint hierarchy and OS readouts, and integration of supportive real-world evidence—enabled a differentiated value story that secured superior reimbursement in the U.S. and with challenging HTA organizations globally. Insights into the role of early payer engagement, cross-functional leadership and dialogue, efficient alignment across regions in evidence planning, and trial design that matters at launch will be provided. Attendees will leave with practical insights and frameworks they can apply immediately to better align clinical trial programs with the realities of global market access.

11:40 am

Embedding Market Access into Clinical Development Is a Team Sport: Sequencing of Events for Optimal Outcome

Josephine Li-McLeod, RPH, PhD, Chief Strategy Officer, Stratevi

Market access planning is an iterative process; clinical development activities should inform the access plan and vice versa. To do this successfully, market access and clinical development teams should work in an integrated fashion to ensure timing and tactics are aligned. Learn about access activities happening during clinical development, as well as practical strategies for the timely connection of stakeholder insights, clinical data, and real-world evidence to support access success.

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: Market Access, Pricing & Reimbursement

8:30 am

Chairperson's Remarks

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

8:35 am

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

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

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

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

9:00 am

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

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

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

9:25 am PANEL DISCUSSION:

How to Navigate the Data-Science Transformation

PANEL MODERATOR:

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

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

PANELISTS:

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

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

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

10:15 amFind your Working Group

10:20 amInteractive Working Groups (Sponsorship Opportunity Available)

Step away from the slide decks and into the conversation.
After a full agenda of case studies, technical talks, and panels, SCOPE’s Interactive Working Groups offer a unique chance to roll up your sleeves and engage. Choose the topic that interests you—whether it aligns with your expertise or challenges you to think differently. Each group will explore a distinct theme using collaborative formats like hackathons, open innovation challenges, or problem-solving sprints. The only requirement: jump in and contribute.

THINK TANK:

AI-Powered COA Translation: Transforming Global Clinical Trials

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

Discuss how AI can transform the world of COA translations.

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

THINK TANK:

AI-powered Advances in RWD

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

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

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

11:00 amNetworking Coffee Break

Take a break and reconnect at SCOPE’s Networking Coffee Break! Grab a cup of coffee, meet colleagues old and new, and fuel up before the next sessions. A perfect pause to spark conversations and make connections!

11:30 am Chairperson's Remarks

Alex Liu, Director of Product Management, Life Sciences AI Data Platform

11:35 am

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

Omkar Dasari, Senior Technical Product Manager, Data & Analytics, Amgen

James Vernille, PhD, Director, Clinical Systems & Analytical Reporting, Global Development Operations, Amgen, Inc.

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

12:00 pm

From Proven Results to Product Vision: Advancing Clinical Trial Data Exchange with IgniteData Archer

Joe Lengfellner, Chief Product Officer, IgniteData

Clinical trial data exchange has long limited the pace of innovation in research. This session explores how IgniteData Archer is redefining what’s possible, drawing on proven results from live trials at Memorial Sloan Kettering Cancer Center. Presented by Joe Langfellner, IgniteData’s Chief Product Officer, the talk connects real-world impact to a forward-looking product vision—explaining why Archer’s success led him to join IgniteData and how he and the team are shaping the future of clinical trial data exchange.

12:13 pm PANEL DISCUSSION:

Transforming Clinical Data Analytics with Agentic GenAI

PANEL MODERATOR:

Sina Djali, Managing Partner, Axcellion.ai

This panel explores how Agentic Generative AI (GenAI) is reshaping clinical data analytics by enabling autonomous and adaptive systems that streamline data processing, uncover complex patterns, and generate actionable insights. The discussion will address the opportunities and risks of integrating Agentic and Applied GenAI into regulated clinical research environments, highlighting their potential to drive innovation while maintaining data integrity and patient safety.

PANELISTS:

Bhargava Reddy, PhD, Senior Director, Advanced Insights and Solutions, Janssen

Richard Young, Chief Strategy Officer, CluePoints

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

12:50 pmSCOPE Summit 2026 Adjourns

And that’s a wrap! Thank you for joining us at SCOPE Summit 2026. We hope you leave inspired, connected, and energized for what’s next in clinical trials. Safe travels, and we can’t wait to see you at the next SCOPE event!