Budgeting & Resources
Clinical Trial Forecasting, Budgeting and Contracting
Resource Management and Capacity Planning for Clinical Trials

 

As outsourcing models, scope of the pipeline, and complexity of protocols continue to change, so must our strategies for budgeting both finances and resources. SCOPE’s 15th Annual Clinical Trial Forecasting, Budgeting, and Contracting stream will explore the complexities of budgeting for site costs and investigator-initiated research, for sustainability, and beyond. We’ll explore particular challenges around the impact of technologies, including AI, on the budgeting and contracting process. The 8th Annual Resource Management and Capacity Planning for Clinical Trials stream will explore how companies are upskilling their workforce to prepare for more AI initiatives, strategies around navigating acquisitions, and tackling operational challenges in outsourcing. 





Monday, February 2

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

Golf Check-In & Breakfast Buffet*

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

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

Registration Open

Golf Lunch Buffet (Sponsorship Opportunities Available)*

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

– 4:00 pm IQVIA Technologies Innovation Day

– 3:30 pm MaxisAI: INSPIRE Agentic AI Summit

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

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

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

Close of the Masters of Clinical Research Golf Tournament

*Limited spots available. Separate registration and fee apply.

SCOPE'S PICKLEBALL NETWORKING SESSION

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

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

Monday Kickoff Plenary Keynote and Participant Engagement Awards

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

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

*Must be present to win.

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

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

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

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

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

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

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

Tips for Getting the Most out of SCOPE

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

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

SCOPE's 3rd Annual Site Innovation Awards

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

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

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

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

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

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

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

Panel Moderator:

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

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

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

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

Panelists:

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

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

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

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

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

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

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

SCOPE's Winter Games Opening Reception (Sponsorship Opportunities Available)

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

Close of Day

Tuesday, February 3

Sunrise Yoga: In Gratitude for Clinical Research Participants

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

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

SCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)

Lace up and join SCOPE’s Coordinators for the Fun Run on Tuesday, February 3! Sprint, jog, walk, or talk-your-way-through—ALL abilities are welcome. This informal event is all about getting moving together. 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!

Registration Open

Morning Coffee (Sponsorship Opportunities Available)

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

Tuesday Morning Opening Plenary Keynotes

TUESDAY MORNING PLENARY SESSION

Grab Your Seat—Early Bird Seat Raffle & Prize Giveaway!* (Sponsorship Opportunity Available)

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

Welcome to SCOPE 2026—Welcome to the Clinical Trials Factory

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

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

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

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

Panel Moderator:

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

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

Panelists:

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

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

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

Grand Opening Coffee & Refreshment Break in the Exhibit Hall —Best of Show Voting Opens

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

Part 1: Clinical Trial Forecasting, Budgeting and Contracting

CREATING VALUE AND REDUCING COST: ARTIFICIAL INTELLIGENCE IN CLINICAL CONTRACTING AND BUDGETING

Panel Moderator:

PANEL DISCUSSION:
AI in Clinical Outsourcing and Procurement: Creating Value, Reducing Cost, and Accelerating Timelines

Photo of Rene Stephens, Managing Director, CBO, Danforth Advisors , Managing Director, CBO , Danforth Advisors
Rene Stephens, Managing Director, CBO, Danforth Advisors , Managing Director, CBO , Danforth Advisors

Panelists:

Photo of Lisa La Luna, Founder, La Luna 4 Healthcare
Lisa La Luna, Founder, La Luna 4 Healthcare
Photo of Shawne Moran, Head, In-Country Study Operations-Americas, EMD Serono/Merck KGaA Darmstadt, Germany , Head, Study Operations-Amercias , Clinical Delivery & Patient Centricity , Merck KGaA/EMD Sereno
Shawne Moran, Head, In-Country Study Operations-Americas, EMD Serono/Merck KGaA Darmstadt, Germany , Head, Study Operations-Amercias , Clinical Delivery & Patient Centricity , Merck KGaA/EMD Sereno
Photo of Ratan Ratnesh, Senior Director, Outsourcing & Vendor Management, Taiho Oncology, Inc. , Sr. Director, Outsourcing and Vendor Management , Clinical Outsourcing , Taiho Oncology Inc.
Ratan Ratnesh, Senior Director, Outsourcing & Vendor Management, Taiho Oncology, Inc. , Sr. Director, Outsourcing and Vendor Management , Clinical Outsourcing , Taiho Oncology Inc.

From Tedious to Tech-Driven: How AI is Automating Financial Review and Contract Management

Photo of Gus Davidson, Senior Director, Supplier Relationship Management, Takeda , Senior Director , Supplier Relationship Management , Takeda
Gus Davidson, Senior Director, Supplier Relationship Management, Takeda , Senior Director , Supplier Relationship Management , Takeda

This talk explores real-world applications of tools like ChatGPT to automate financial reviews of trial budgets, accelerate contract development, and improve vendor management. Learn how your teams can reduce manual effort and errors while improving speed and compliance. Walk away with practical insights on building a strong business case for AI investment.

Sponsored Networking Luncheon

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

Networking Coffee & Dessert Break in the Exhibit Hall

Keep the conversations going in the Exhibit Hall with coffee and dessert, courtesy of SCOPE sponsors. Network with colleagues, explore new products and services, and don’t forget—Best of Show Award voting is still open, so be sure to cast your vote!

SUPPORTING SITES THROUGH EFFECTIVE BUDGETING AND CONTRACTING

Building Site Resilience in Uncertain Times: Budgeting, Contracting, and Forecasting Amid Global Pressures

Photo of Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine , Asst Prof & Exec Dir , Surgery , Boston Medical Ctr
Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine , Asst Prof & Exec Dir , Surgery , Boston Medical Ctr

Amid rising inflation, geopolitical shifts, and shrinking budgets, clinical trial sites face mounting pressures not only on finances but also on staff recruitment and retention. This session examines current trends in budgeting, contracting, and forecasting that affect site stability—from evolving cost structures to shifting sponsor expectations. Speakers will share forward-looking strategies to support workforce sustainability, strengthen site partnerships, and safeguard trial continuity in today’s climate while preparing for tomorrow’s uncertainties.

Presentation to be Announced

New German Drug Law: Improving Start-Up Timelines with Standard Contracts

Photo of Thorsten Ruppert, PhD, Senior Manager, R&D & Innovation, Verband Forschender Arzneimittelhersteller eV , Sr Mgr , R&D & Innovation , Verband Forschender Arzneimittelhersteller eV
Thorsten Ruppert, PhD, Senior Manager, R&D & Innovation, Verband Forschender Arzneimittelhersteller eV , Sr Mgr , R&D & Innovation , Verband Forschender Arzneimittelhersteller eV

Germany is accelerating clinical trial start-up—and sponsors should take note. This presentation unpacks new German legislation designed to dramatically shorten study start-up timelines, with a sharp focus on faster, more predictable contract negotiations between sponsors and sites. Attendees will gain a clear view of the new ordinance taking effect in October 2025 and why it makes Germany a more competitive, sponsor-ready trial location than ever before.

Panel Moderator:

PANEL DISCUSSION:
Weathering the Storm—Site, CRO, and Sponsor Perspectives on Current Trends in Budgets and Contracts

Photo of Kelly L. Smith, CEO, V2 Clinical Inc. , CEO , V2 Clinicial Inc.
Kelly L. Smith, CEO, V2 Clinical Inc. , CEO , V2 Clinicial Inc.

Panelists:

Photo of Gina Fulgar, Head, Clinical Operations, Epirium Bio , Head of Clinical Operations , Epirium Bio
Gina Fulgar, Head, Clinical Operations, Epirium Bio , Head of Clinical Operations , Epirium Bio
Photo of Jennifer Sydney Goldman, Clinical Business Operations, Consultant , Clinical Business Operations Consultant , Clinical Business Operations , Individual Consultant
Jennifer Sydney Goldman, Clinical Business Operations, Consultant , Clinical Business Operations Consultant , Clinical Business Operations , Individual Consultant
Photo of Kathy Mickel , Director, Membership & Programs , Society for Clinical Research Sites (SCRS)
Kathy Mickel , Director, Membership & Programs , Society for Clinical Research Sites (SCRS)

Welcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)

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

Close of Day

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

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

Wednesday, February 4

Sunrise Yoga: In Gratitude for Clinical Research Participants

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

Registration Open

BREAKFAST PRESENTATIONS

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

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

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

Transition to Sessions

OPERATIONALIZING SITE AND PATIENT INITIATIVES THROUGH EFFECTIVE BUDGETING AND CONTRACTING

Exploring the Site Contracting Experience: Breaking Down Budgets, Building Relationships

Photo of Carrie Lewis, Executive Director, Clinical Program Optimization, Keenova Therapeutics , Executive Director , Clinical Program Optimization , Keenova Therapeutics
Carrie Lewis, Executive Director, Clinical Program Optimization, Keenova Therapeutics , Executive Director , Clinical Program Optimization , Keenova Therapeutics
Photo of Suzy Montanye, Site Relationship Manager, Keenova Therapeutics , Site Relationship Manager , Clinical Operations , Keenova Therapeutics
Suzy Montanye, Site Relationship Manager, Keenova Therapeutics , Site Relationship Manager , Clinical Operations , Keenova Therapeutics

Endo will share its success in implementing a Site Operations Board, a strategic initiative designed to gather operational feedback directly from clinical sites. This approach enabled the team to make informed adjustments to site budgets and drive numerous operational improvements. Most importantly, it fostered stronger, more collaborative relationships with their clinical sites—ensuring that what matters most remains at the center of their work.

Panel Moderator:

PANEL DISCUSSION:
Beyond the Budget Line: Integrating Patient Payments and Site Strategy to Drive Trial Equity

Photo of Shelley Douros, Senior Director, Clinical Financial Management, Product & Strategy, Medidata, a Dassault Systemes Co. , Sr Dir Clinical Financial Mgmt , Financial Management , Medidata a Dassault Systemes Co
Shelley Douros, Senior Director, Clinical Financial Management, Product & Strategy, Medidata, a Dassault Systemes Co. , Sr Dir Clinical Financial Mgmt , Financial Management , Medidata a Dassault Systemes Co

Panelists:

Photo of Karen Hartman, Vice Chair, Research Administration, Mayo Clinic , Vice Chair, Research Administration , Mayo Clinic
Karen Hartman, Vice Chair, Research Administration, Mayo Clinic , Vice Chair, Research Administration , Mayo Clinic
Photo of Brian Hunter, Vice President, Contracts & Trial Management, CNS Healthcare , Vice President - Contracts & Trial Management , CNS Healthcare
Brian Hunter, Vice President, Contracts & Trial Management, CNS Healthcare , Vice President - Contracts & Trial Management , CNS Healthcare

Part 2: Resource Management and Capacity Planning for Clinical Trials

RESOURCE MANAGEMENT: HOW TOOLS AND MODELS BOTH DRIVE EFFICIENCY

From Complexity to Clarity: Leveraging Data Visualization and AI to Understand Portfolio Changes and Resource Demand

Photo of Geoff Kremer, Director, Global Resource Management, BeOne Medicines , Director , Portfolio Resourcing , Merck
Geoff Kremer, Director, Global Resource Management, BeOne Medicines , Director , Portfolio Resourcing , Merck

Understanding the ripple effects of portfolio changes on resource demand is no small feat. This session explores how data visualization techniques and artificial intelligence can transform complex information into actionable insights. Attendees will gain practical takeaways through real-world use cases and lessons learned.

Ken Bengtson, Director, Scouting & Vendor Relationships, Pfizer Inc , Dir Scouting & Vendor Relationships , Scouting & Vendor Relationships , Pfizer Inc

Coffee Break in the Exhibit Hall (Sponsorship Opportunities Available)

Fuel up and connect at SCOPE’s Coffee Break in the Exhibit Hall! Visit booths you haven’t seen, network with colleagues and exhibitors, and cast your final vote for the Best of Show Award—make your vote count!

AI MEETS HUMAN CONNECTION: THE FUTURE OF CLINICAL TRIAL PARTNERSHIP DYNAMICS

FIRESIDE CHAT: Utilizing AI and Technology to Enhance Relationships across the Clinical Trial Ecosystem

Photo of Jimmy Bechtel, Chief Site Success Officer, Society for Clinical Research Sites (SCRS) , Chief Site Success Officer , Society for Clinical Research Sites (SCRS)
Jimmy Bechtel, Chief Site Success Officer, Society for Clinical Research Sites (SCRS) , Chief Site Success Officer , Society for Clinical Research Sites (SCRS)
Photo of Rosalie Filling, Vice President, Senior Global Head, R&D Operations, Keenova Therapeutics , VP Clinical Operations , Clinical Operations , Keenova Therapeutics
Rosalie Filling, Vice President, Senior Global Head, R&D Operations, Keenova Therapeutics , VP Clinical Operations , Clinical Operations , Keenova Therapeutics
Photo of Denise Gascard, Head of Operational Excellence and Translation Management, Sanofi , Head of Operational Excellence and Translation Management , Clinical Documentation , Sanofi
Denise Gascard, Head of Operational Excellence and Translation Management, Sanofi , Head of Operational Excellence and Translation Management , Clinical Documentation , Sanofi
Photo of Max Ghez, Global Head, Clinical Business Development, Syneos Health , Global Head, Business Development , Syneos Health
Max Ghez, Global Head, Clinical Business Development, Syneos Health , Global Head, Business Development , Syneos Health
Photo of Scott Sawicki, Senior Director, Strategic Sourcing & Vendor Management, Centessa Pharmaceuticals , Senior Director , Strategic Sourcing & Vendor Management , Centessa Pharmaceuticals
Scott Sawicki, Senior Director, Strategic Sourcing & Vendor Management, Centessa Pharmaceuticals , Senior Director , Strategic Sourcing & Vendor Management , Centessa Pharmaceuticals

As artificial intelligence becomes more deeply embedded in clinical trial operations, the industry faces a critical balancing act between innovation, governance, and trust. This panel will explore how sponsors, CROs, and sites are adopting AI without outpacing validation and compliance, examining where AI can meaningfully strengthen collaboration—and where it may unintentionally strain the human relationships that clinical trials depend on. Panelists will also address the downstream impact of AI-driven decisions on sites and patients, including data accuracy, contextual relevance, and the unresolved challenges of education, access, and shared responsibility for compliant AI tools.

Sponsored Networking Luncheon

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

Networking Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)—Best of Show Winner to be Announced

Recharge with coffee, dessert, and networking at SCOPE’s Exhibit Hall Break! Grab a sweet treat courtesy of our sponsors, visit Game Card Sponsors to collect stickers, and connect with colleagues before the afternoon sessions. Plus, don’t miss the announcement of the Best of Show winner!

Wednesday Afternoon Plenary

WEDNESDAY PLENARY AFTERNOON SESSION

SCOPE around the World: Community, Connection, Celebration

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

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

Panel Moderator:

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

Rosemary Rebuli, Global Head, Study & Site Operations, Novartis Pharma AG , Global Head Study and Site Operations , Study & Site Operations , Novartis Pharma AG

Panelists:

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

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

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

Panel Moderator:

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

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

Panelists:

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

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

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

SCOPE's Closing Ceremony Booth Crawl (Sponsorship Opportunities Available). Last Chance for Exhibit Viewing

As the flame of another unforgettable SCOPE conference comes to a close, join us for our final reception, our infamous "booth crawl." Just like the Closing Ceremonies of the Games, we'll come together one last time to honor the moments of triumph, teamwork, and inspiration that made this week so special. Gather with friends, old and new, enjoy great food and drink, and celebrate the spirit of unity that connects us all. SCOPE 2026 may be ending, but the memories will last long after the torch goes out.

Close of Day

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

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

Thursday, February 5

Registration Open

BREAKFAST PRESENTATION

Transition to Sessions

NAVIGATING CLINICAL TRIAL LOGISTICS: WHAT CLINICAL STAGE OUTSOURCING LEADERS NEED TO KNOW

Navigating Regulatory Requirements across Multiple US Agencies for Importing Biological Materials

Photo of Sean Smith, Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, US Customs and Border Protection , Biological Threat Exclusion Coordinator , US Customs & Border Protection
Sean Smith, Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, US Customs and Border Protection , Biological Threat Exclusion Coordinator , US Customs & Border Protection

CBP will provide an overview of major U.S. regulatory authorities governing biological material importations, guidelines for acceptable and unacceptable cargo descriptions, examples of non-compliant shipments of biological materials and pharmaceutical products, and provide essential resources and important contacts for support.

Shared Learnings on Methods to Decrease Temperature Excursions

Photo of Barbara Versage, Senior Manager, Supply Chain Sourcing, Immunocore LLC , Sr Mgr , Supply Chain Sourcing , Immunocore LLC
Barbara Versage, Senior Manager, Supply Chain Sourcing, Immunocore LLC , Sr Mgr , Supply Chain Sourcing , Immunocore LLC

Monitoring temperature control is a vital responsibility in clinical supply, extending beyond deep-frozen storage. Even products stored at ambient conditions require monitoring to ensure they avoid freezing or overheating. This session explains how tracking at defined supply chain touchpoints enables data collection, trending, and timely intervention. By leveraging value stream checkpoints, organizations can proactively maintain product integrity, safeguarding quality while minimizing risks across distribution and storage environments.

Interactive Breakouts and Working Groups

INTERACTIVE WORKING GROUPS (IN-PERSON ONLY)

Find your Working Group

Interactive Working Groups (Sponsorship Opportunity Available)

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

THINK TANK:
Specimen in Transit: Untangling the Complexities of Global Transport Logistics

Brenda Yanak, Founder & Principal, Clinical Transformation Partners LLC , Founder and Principal , Clinical Transformation Partners

Where in the world is . . . . .?  Have you encountered confusion or churning around supply logistics for clinical trials?  Don’t know where to turn? This is your opportunity to learn from industry experts in global transport logistics, sample tracking and management, along with customs clearance on a multitude of topics. Join a Think Tank facilitated small group discussion to share experiences and solutions.

Think Tank Report Outs: Listen and Learn

During the Think Tank Table discussions, we shared our experiences and working solutions for global supply logistics. Now, as a collective community, let’s hear from the table facilitators as they share key discussion points and strategies and provide a wrap-up of their table’s discussion. What can we take away and apply?

Networking Coffee Break

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

COLLABORATIVE OUTSOURCING MODELS: BALANCING COST, GOVERNANCE, AND SITE ENGAGEMENT ACROSS STAKEHOLDERS

Strengthening Sponsor-Site Partnerships in Outsourced Trials

Photo of Liza Micioni, Senior Director, Head of Clinical Operations, Tris Pharma , Senior Director, Head of Clinical Operations , Tris Pharma, Inc.
Liza Micioni, Senior Director, Head of Clinical Operations, Tris Pharma , Senior Director, Head of Clinical Operations , Tris Pharma, Inc.

In fully outsourced trials, sponsor-site relationships might seem secondary—but for small and emerging biopharmas, they can be a key differentiator. Even when using a CRO or FSP model, sites still look to sponsors for clarity, support, and partnership. This session will explore why direct sponsor-site engagement still matters, how it impacts trial success, and practical ways to build trust and alignment—regardless of your outsourcing structure.

Panel Moderator:

PANEL DISCUSSION:
Strategic Outsourcing in Biopharma: Optimizing Vendor Partnerships, Governance, and Site Engagement

Photo of Suzanne Vyvoda, Founder and Principal , Founder and Principal , Clinical Operations , Concordia BioStrategies
Suzanne Vyvoda, Founder and Principal , Founder and Principal , Clinical Operations , Concordia BioStrategies

Panelists:

Photo of Kristin M. Ferrigno, Director of Clinical Operations, Clinical Research Site Development & Operations, Veda Clinical Trials , Director of Clinical Operations , Clinical Research Site Dev & Operations , Veda Clinical Trials
Kristin M. Ferrigno, Director of Clinical Operations, Clinical Research Site Development & Operations, Veda Clinical Trials , Director of Clinical Operations , Clinical Research Site Dev & Operations , Veda Clinical Trials
Photo of Tim Foley, Chief Business Officer, Scailyte , Chief Business Officer , Scailyte
Tim Foley, Chief Business Officer, Scailyte , Chief Business Officer , Scailyte
Photo of Melanie Goodwin, Director, Clinical Outsourcing, Immunocore , Director Clinical Outsourcing , Clinical Outsourcing , Immunocore LLC
Melanie Goodwin, Director, Clinical Outsourcing, Immunocore , Director Clinical Outsourcing , Clinical Outsourcing , Immunocore LLC

Transition to Lunch

SCOPE Summit 2026 Adjourns

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

POST-CONFERENCE TRAINING SEMINARS*

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

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

TS2: Quality and Process Improvement Techniques and Tools


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

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

* In-Person Only, Separate registration required.

SCOPE Track Summariese

2026 Conference Programs