Feasibility & Study Start-Up

2026 ARCHIVES

Data-Informed Feasibility and Investigator Selection

Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

Identifying the right sites and implementing processes to streamline site activation, start-up, and operations is a complex and challenging endeavor. The convergence of evolving regulations, patient- and site-centric practices, DEI initiatives, real-world data, advanced analytics, and digital and decentralized models are reshaping traditional feasibility approaches. SCOPE’s 16th Annual Feasibility & Site Selection stream highlights how organizations are using real-world data and predictive analytics to inform global site selection, applying inclusive frameworks to reach underrepresented populations, and adopting new tools to align site capabilities with protocol requirements. Attendees will gain practical insights into modernizing feasibility processes and making smarter, data-informed decisions that set trials up for success from the start.

Part 1: Data-Informed Feasibility and Investigator Selection

Part 2: Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

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: Data-Informed Feasibility and Investigator Selection

11:00 am Chairperson's Remarks

Christine Senn, Senior Vie President, Site Sponsor Innovation, Global Delivery, Advarra

11:05 am

Site Feasibility of the Future—Site Intelligence from the Source

Ashley Davidson, Vice President, Product Lead, Advarra

Tammy D'Lugin-Monroe, Global Head, Site Activation, Syneos Health

Access to site performance data is transforming how we evaluate and qualify clinical trial sites. By integrating these insights with feasibility workflows, sponsors and CROs can achieve a more holistic, data-driven approach that reduces site burden, accelerates decision-making, and redefines site feasibility for the future.

11:30 am

Human Trial Navigation, Data Reciprocity, and the Future of Trial Access

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

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

Johanna Blom, PhD, Facilitate Project Academic Lead; Associate Professor, Behavioral Neuroscience; Chair, Ethical Committee for Research, University of Modena and Reggio Emilia

Van Crocker, Founder and President, Agonist Health, Senior Strategic Advisor, Evernorth CTS RWE

Jean Stimola-Sposaro, Vice President, Memberships & Partnerships, DTRA

Feasibility isn’t a data problem. It’s a fragmented data sharing, harmonization and competition problem, impacting patient burden, experience, safety and trust in the healthcare enterprise.This panel explores how human-centered, cross-sponsor, and data-driven trial planning frameworks and risk based, compliant data sharing infrastructures can support more inclusive and sustainable trial execution, leaving no patients behind and enabling innovation at the speed of trust.Join the robust dialog! What is different about these proposals and how can we enable the cultural and operational change now? If not now, when?Experts will ensure an interactive discussion on how the healthcare and Pharma industry can shift from transactional recruitment to a sustainable ethical stakeholder partnership model. Interactive discussion will center on the role of evolving global public-private partnerships and pre-competitive consortia models in accelerating enablement of digital capabilities, adoption of harmonized data models, ethical data sharing governance practices and compliant infrastructures advancing health equity, scientific innovation and timely access.

12:05 pm FIRESIDE CHAT:

Third Era of Feasibility—The AI-Enabled Workforce

PANEL MODERATOR:

Ronald Du, Associate Principal, ZS Associates

Feasibility has evolved from experience-driven to data-informed and now to AI-enabled. Learn how trial optimization and feasibility organizations are evolving the workforce and the work-to-be-done in this new era of AI while keeping patients and the human element at the center.

PANELISTS:

Katie Bonner, Director of Strategic Feasibility, AstraZeneca

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

Alex Weir, Senior Director, Head of Operational Design, Amgen

Morgan Wooten, Director, Head of Patient Engagement, Recruitment and Retention, Daiichi Sankyo

John Yannone, Director, Feasibility Strategy, Innovative Health Engagement and Advocacy, Johnson and Johnson

12:45 pm

How Data-Driven Sites Are Proving Patient Access to Win Trials and Accelerate Enrollment

Liz Beatty, Chief Strategy Officer, Inato

Aneesh Vaze, Managing Director, Clinical Research Philadelphia

Mari Livermore, Site Director & CEO, Pantheon Clinical Research

Lily Palladino, Business Development Manager, Discovery Clinical Trials Synergyst Research Group

Clinical research is entering a new era, where data transparency and AI are beginning to reshape how sponsors evaluate and select site partners. As sites start to invest in AI-powered tools and explore ways to leverage their own patient-level data, they’re positioning themselves to demonstrate proven patient access, differentiate their capabilities, and build sponsor confidence — even before a trial begins.

This session will explore how forward-thinking sites are laying the groundwork to become more data-driven. Panelists will discuss the value of investing in AI and patient data, share how they’re beginning to approach this shift, and reflect on how these efforts can support faster, more informed decisions with sponsors.

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

Christina Masturzo, Senior Vice President, C&R Product, Citeline

3:05 pm

Reshaping Feasibility: Actions to Accelerate the Process

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

Reshaping Feasibility represents a strategic transformation of clinical trial process, moving from a study-by-study, questionnaire-driven approach to a holistic, data-driven, and indication-level strategy. This evolution integrates early protocol optimization, global site prioritization, and advanced analytics to enhance efficiency, reduce operational burden, and accelerate trial start-up. By leveraging AI, real-world data, and centralized site intelligence, the reshaped process aims to improve patient recruitment, foster diversity, and enable proactive engagement with high-performing sites. The new approach aligns feasibility with broader organizational goals, ensuring scalability, adaptability, and measurable impact across therapeutic areas.

3:30 pm PANEL DISCUSSION:

Breaking Down Barriers: Streamlining CDAs to Accelerate Clinical Research

PANEL MODERATOR:

Christine Senn, Senior Vice President, Site-Sponsor Innovation, Advarra

Study start-up delays remain a major barrier to clinical trial efficiency and patient access. The Site-Sponsor Consortium (SSC)—a collaboration among sponsors, CROs, and institutional and commercial sites—was formed to address these persistent challenges. This panel will unveil SSC’s inaugural whitepaper, outlining actionable strategies to streamline and harmonize CDA processes. Panelists will explore ethical and operational imperatives for reform, the role of master and bilateral CDAs, and the collaborative journey to consensus. Attendees will gain practical insights to accelerate start-up timelines and promote transparency, shared responsibility, and industry-wide alignment.

PANELISTS:

Jennifer Byrne, CEO, Javara, Inc.

Patrick A. Floody, Vice President, Global Clinical Trial Services, Regeneron Pharmaceuticals, Inc.

Alison Liddy, Senior Vice President, Patient and Site Cenric Solutions, IQVIA

Kristie Moffett, Senior Director, Moffitt Cancer Center

3:55 pm

Start with Patients, End with Confidence: Rewiring Feasibility for Real‑World Enrollment

Christina Masturzo, Senior Vice President, C&R Product, Citeline

Anjani Varma, Citeline

Feasibility breaks when it relies on protocol assumptions instead of real-world patient access. This session reframes feasibility as a patient-first discipline—one that starts with understanding who and where eligible patients truly are. Using a Phase 3 pancreatic cancer study as an example, we’ll show how AI-powered analysis of RWD, protocol viability, and predictive site intelligence surfaced restrictive criteria, expanded eligibility by 15–20%, and identified overlooked investigators within 48 hours. Attendees will learn practical steps to validate protocol feasibility, pressure-test enrollment assumptions with data-driven forecasts, diversify site networks, and set early guardrails that surface risk before timelines slip. The result is a repeatable, confidence-building approach without added complexity.

4:20 pm

Winning Together: Smarter Access for Sites & Sponsors

Tom Johnson, Sr Dir Life Sciences & Health IT, Life Sciences, Exostar

We hear you. Sponsors are challenged with lengthy study start-up processes and ongoing monitoring, while the clinical trial sites are burdened with technology redundancy and sign-on silos obstacles. In this talk, we will give the sponsor's and site's perspective on the progress made to overcome these issues and share real examples of how sponsors and sites are collaborating and streamlining the user’s experience.

4:32 pm

Five-Minute Feasibility—Too Good to Be True?

Alexandra Rosario, Clinical Director, Scientific, Biorce

Traditional feasibility in clinical trials is slow, manual, and costly—often delaying study start-up and driving frequent amendments. This session will explore how innovative, data-driven approaches can transform feasibility assessments into faster, smarter, and more accurate processes, reducing timelines, optimizing budgets, and ultimately accelerating patients’ access to new treatments.

4:45 pm PANEL DISCUSSION:

Practical Insight on Site-Led Clinical Trial Innovations

PANEL MODERATOR:

Sean Lynch, Clinical Innovation Head, Innovative Trial Operations, Novartis Pharmaceuticals

This discussion explores how the collaborative role between Sponsor Innovation teams and clinical trial sites drives innovation through real-world feedback, tech adoption, and design collaboration. Panelists will share insights on tactics, sponsor-provided tools, and site-led technology. Learn how sites may influence user acceptance testing, engage with vendor design teams, and pitch their own ideas.

PANELISTS:

Kaye Doiron, Founder, CEO, Samaras & Research Works, Inc.

Jamie Bendrick-Peart, Senior Director, Innovation and Strategic Projects, AstraZeneca

Arpana White, Site Partnership Head, US Study & Site Operations, Novartis

5:10 pm

PANEL DISCUSSION:

When the Data Talks Back—Rethinking Feasibility through Site Tech Insights

PANEL MODERATOR:

Gabriela Feldberg, Head, Portfolio & Commercial Strategy, Evinova An AstraZeneca Healthtech Co

What happens when real-world site data challenges long-standing feasibility assumptions? Drawing on new global findings from a Tufts study on site technology adoption and experience, this panel will examine where feasibility has kept pace—and where it hasn’t. Panelists will discuss concrete ways organizations can rethink and refine feasibility approaches to better align with today’s rapidly evolving clinical trial environment.

PANELISTS:

Steven Lee Clemons Jr, Liason, Marketing & Bus Dev, ObjectiveHealth

Ken Getz, Exec Dir & Prof, Tufts Univ

Dana Iommazzo, Exec Dir & Global Head, Innovation & Strategy & Operations & Trial Mgmt, Novartis Pharmaceuticals

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

Scott Arceri, Vice President, Strategic Solutions, Science 37

8:35 am

Engaging Community Sites in Oncology Clinical Trials: Obstacles and Solutions

Tameika Graham, Strategic Site Partnership Lead, Pfizer Inc.

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

When it comes to cancer research, academic medical centers (AMCs) are a valuable mainstay. However, data shows us greater than 70% of cancer patients live over 2 hours away from their nearest AMC—making clinical trials far less accessible to some. We will discuss the obstacles Sponsors may face when seeking to bring more oncology trials to a community setting and methods implemented to overcome them, including approaches to identifying research capable community sites, protocol complexity and operationalizing cancer trials in the community, sponsor systems of belief: myths, truths, and taking action, and onward to scalability?

9:00 am

Feasibility & Start-Up Risk in Practice: Managing What Emerges

Donna Hanson, Vice President, Strategy & Optimization, Advanced Clinical

Cheryle Evans, President, Advanced Clinical

In clinical development, the path from feasibility to first patient is like entering a dense forest—you rarely see the full trail from the start. Blind spots such as compressed feasibility, tech gaps, and overreliance on imperfect data derail timelines. This session reveals the myths, risks, and practical plays to keep studies on track. Join us to learn how to spot hidden obstacles and build adaptive strategies before delays appear.

9:25 am PANEL DISCUSSION:

A Fresh Look at Data Sharing for Study Planning and Site Selection

PANEL MODERATOR:

Nick Whitney, Senior Director, Trial Management, IQVIA

Data sharing consortium and the Data Query System (DQS) were launched more than a decade ago by a handful of the largest pharmaceutical companies to reduce site burden and accelerate clinical trials. In this presentation, you’ll learn how the data, technology, and companies behind DQS are evolving to match today’s needs for study planning, site identification, feasibility, investigator/site selection, and master data management: Learn about the history and structure of DQS and data sharing collaborations, data sharing and privacy,and new member company opportunities.

PANELISTS:

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

Sarah McClure, Global Data Engagement Lead, Feasibility Management, R&D, Sanofi

Jane Twitchen, Head Clinical Trial Accelerator Unit & Executive Director, Global Clinical Operations, Biogen Ltd.

9:50 am

Laying the Process Groundwork to Achieve a 24-Hour Study Build

Mark Laney, Senior Director, Sales Engineering & Partnerships, Sales, Zelta by Merative

Chris Walker, Senior Director, Clinical Data Sciences, Data Sciences, Alimentiv

Zelta by Merative, in partnership with Alimentiv, will explore how to optimize study-start-up processes as a key enabler and accelerator in creating an end-to-end vision for how Digital Data Flow (DDF) can impact the industry. Discover practical strategies to reimagine your clinical trial processes through advanced technology that supports protocol ingestion, AI-informed design, smart validation, and standards-informed data flow—accelerating validated study builds within 24 hours.

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

Jeff Golden, Vice President, Strategic Solutions, Elixia Health

11:15 am

Why Your Site Feasibility Strategy Is Failing—and How AI Can Fix It

Robert Buka, Senior Director, Product Management, Medidata a Dassault Systemes Co.

Feasibility teams operate on outdated assumptions, like experience equals better performance and public site data is reliable. Analysis of 12,000 clinical trial sites reveals 43% never enroll a single patient and in 80% of studies, site experience doesn’t correlate to enrollment success. This session debunks myths and shows why site-specific, indication-level performance data is necessary to improve site selection, reduce non-enrollers, and turn feasibility into a competitive advantage.

11:40 am PANEL DISCUSSION:

Strategic Site Relationship Management: Tailoring Engagement Models for Diverse Site Needs

PANEL MODERATOR:

Rachel Ovens, Global Head of Feasibility & Planning, Boehringer Ingelheim Pharmaceuticals

The site landscape is more diverse than ever, with sponsors and CROs engaging with academic centers, community practices, multi-site research organizations, site networks, and decentralized site models. Each brings unique strengths, challenges, and operational considerations. This panel will explore strategies for effectively managing these different types of site relationships—from building trust and ensuring transparent communication to tailoring support and resources to fit each model. Speakers will share lessons learned, best practices, and forward-looking approaches to foster stronger partnerships that ultimately drive more efficient and patient-centered clinical trials.

PANELISTS:

Shannon Duffany, Clinical Trial Early Planning Lead – Global Oncology, Sanofi

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

Christina (Christy) Greene, Executive Director and Head, Regional Operations, Merck

12:05 pm PANEL DISCUSSION:

Optimizing Clinical Research through Strategic Site Collaboration: Tools and Tactics for Success with MCRCs

PANEL MODERATOR:

Carlos E. Orantes, CEO, Alcanza Clinical Research

Effective site partnerships are central to trial success, and Multi-Site Research Corporations (MCRCs) play an increasingly important role within the broader site landscape. This panel will provide practical insights into how sponsors and CROs can best engage MCRCs as part of a diversified site portfolio. Panelists will highlight the framework recently developed by the Association of Multi-Site Research Corporations (AMRC) to guide effective MCRC partnerships, focusing on practical steps for site selection, onboarding, and ongoing collaboration. The discussion will also explore strategies for integrating MCRCswith community and academic sites, improving communication, and aligning expectations. Attendees will walk away with actionable tools to strengthen partnerships, streamline operations, and optimize recruitment across the clinical trial ecosystem.

PANELISTS:

Jamie Bendrick-Peart, Senior Director, Innovation and Strategic Projects, AstraZeneca

Kari Delahunty, CEO, AMR Clinical

Marisa Rackley, Vice President, Clinical Site Start-Up, Site Engagement, Trial Optimization, Takeda

Karen McIntyre, VP Global Site Alliance, Global Site Alliance, Parexel

12:30 pm

Precision Feasibility: Data-Driven Planning across Program, Trial & Site to Reduce Burden and Optimize Site Selection

Cristin MacDonald, Vice President, Client Delivery, WCG

Explore how strategic data use across program, trial, and site-level feasibility planning can streamline clinical trial execution. Learn how to reduce site burden by eliminating repetitive queries and ensure site selection aligns with the unique needs of the molecule and trial strategy. This session highlights how differentiated feasibility layers—program, trial, and site—can work together to drive smarter, more efficient planning.

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: Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

8:30 am Chairperson's Remarks

Kaye Doiron, Founder, CEO, Samaras & Research Works, Inc.

8:35 am

Unlocking Community Site Potential through Geo-Clustered Referral Networks in Oncology Trials

Sharri Glloxhani, Data Scientist, Pfizer

Javiera Kettlun, Director, Pfizer Chile SA

Community oncology sites are often the first point of care for patients but are underused in clinical trials due to infrastructure gaps, limited staffing, and fragmented planning. This initiative addresses this by using real-world data, historical trial insights, and geospatial analytics to identify promising clusters of community and academic sites. By mapping patient flow, referrals, and site capabilities, it creates a scalable model where community sites act as referral hubs to core research centers. This approach expands trial access, accelerates start-up, improves diversity, and reduces burden—positioning community sites as empowered partners in precision oncology.

9:00 am

Is AI Enough? Why Smarter Site Identification Still Needs Human-Centred Strategies

Travis Caudill, Vice President, Feasibility, Site Selection & Medical Informatics, ICON

Artificial intelligence has transformed site identification, helping sponsors find high-performing sites faster. ICON’s OneSearch uses predictive analytics and historical data to speed feasibility—but AI alone can’t solve study start up challenges. Finding the “right site” is just the start. With demand exceeding site capacity, success requires creating value for site partners, addressing real constraints, and building sustainable site communities. This session explores ICON’s five year evolution combining AI with human centred strategies.

9:25 am

Optimizing Site Engagement through Strategic Portfolio Management and AI-Driven Trial Matching

Milijana Ugrenovic-Petrovic, MPM Senior Director, Clinical Research Operations, Moffitt Cancer Center

Explore how clinical research operations can be transformed by integrating strategic portfolio oversight with AI-powered trial matching tools and standardized feasibility workflows. Drawing on real-world examples from Moffitt Cancer Center, we will highlight how data-driven decision-making, dashboard tools, and structured intake processes improve trial selection, resource allocation, and site engagement. Attendees will gain actionable insights into aligning trial feasibility with institutional priorities and enhancing operational efficiency across disease programs.

9:50 am

From Spec to First Patient: Fast-Tracking Global eCOA & eConsent Deployment

Daniel Herron III, Vice President, Digital Health, RWS Group Ltd.f

Erin Strouse, Associate Director, Copyright & Translations, Eli Lilly and Company

Lisa Charlton, Chief Product Officer, Marketing, Castor

Global trial feasibility now requires eConsent and eCOA readiness from first patient in every country. Translation, licensing, ethics, and device issues can delay sites and fragment data. This session shows how integrated operational, linguistic, and technical planning - supported by RWS’s scale and Castor’s validated, automated, device‑ready platform - enables fast, harmonized global site activation.

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!