Clinical Supply & Logistics
Communication & Digitization for End-to-End Clinical Supply Management
Clinical Supply-Chain Strategies to Align Process, Products, and Patients

As clinical trials grow more complex and personalized medicine advances, clinical trial supply chains face increasing pressure to adapt. From fragmented planning and drug demand variability to evolving site and patient needs, supply logistics must be agile, proactive, and patient-centric. Seamless communication between internal and external stakeholders is essential. SCOPE’s 9th Annual Clinical Supply & Logistics stream showcases case studies, best practices, and innovations in clinical trial supply management. Discover how digital tools, real-time data, and cross-functional collaboration enhance forecasting, streamline distribution, and reduce waste. Join industry leaders to explore strategies that align supply planning with patient/site enrollment and protocol design—ensuring timely, precise delivery of investigational products and trial success. 





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 Enhancing the Efficiency of Pipeline Delivery: Disruptive Scenarios and Strategic Responses

– 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, Vice President, Programs and Initiatives, Decentralized Trials & Research Alliance (DTRA); Vice Chair, The Myositis Association (TMA) Board of Directors , Vice President, Programs and Initiatives , 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, Vice President, Strategy & Transformation, Science 37; Co-Creator of the SCOPE Participant Engagement Award , Vice President, Strategy & Transformation , Science37

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

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!  Meet us in the Rosen Hotel’s Gatlin Terrace at 6:30 am sharp!

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 Serono

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: Communication & Digitization for End-to-End Clinical Supply Management

IRT/RTSM: NAVIGATING THE DIGITAL NEIGHBORHOOD

Getting RTSM Right: Why and How

Photo of Paul F. Hughes, Director, Randomization & Trial Supply Management (RTSM), J&J Innovative Medicine , Director , RTSM , Johnson & Johnson
Paul F. Hughes, Director, Randomization & Trial Supply Management (RTSM), J&J Innovative Medicine , Director , RTSM , Johnson & Johnson

Randomization and Trial Supply Management (RTSM) Systems are the most important clinical trial systems.  A single error with a drug assignment may impact the subject directly and compromise the trial’s integrity. A mistake in the overall randomization scheme could invalidate the entire study. Meanwhile, an effective RTSM system can be a powerful tool for optimizing material utilization, leading to substantial cost savings. To truly harness RTSM’s value, sponsors and suppliers need to implement strategic steps that minimize risks and maximize benefits. Success hinges on getting RTSM right—so let's discuss the “Hows” to make that happen.

Onboarding RTSM/IRT Vendors: The Sponsor POV

Photo of Imran Shakur, Director, IRT and Technology Lead, Clinical Supply Management, Alexion Pharmaceuticals , Assoc Dir Clinical Supply Capabilities , Clinical Supply Capabilities , Biogen
Imran Shakur, Director, IRT and Technology Lead, Clinical Supply Management, Alexion Pharmaceuticals , Assoc Dir Clinical Supply Capabilities , Clinical Supply Capabilities , Biogen

Taming the Chaos: Standardizing IRT/RTSM Systems across Multiple Vendors

Photo of J. Derek Thornton, Associate Director, Clinical Services & Analytical Reporting (IRT), Amgen , Associate Director, Clinical Systems (IRT) , Amgen Inc
J. Derek Thornton, Associate Director, Clinical Services & Analytical Reporting (IRT), Amgen , Associate Director, Clinical Systems (IRT) , Amgen Inc

With over 22 different RTSM/IRT vendors available in the marketplace, standardizing system designs is a daunting but necessary challenge. This presentation explores how sponsors and vendors can identify which elements are best to standardize, align on a unified approach, and deploy standards across diverse platforms. Learn how to balance adaptability with consistency, navigate supplier differences, and evaluate the impact of standardization efforts across the industry.

RTSM 2075: Imagining the Future of Clinical Supply Chain

Photo of Barry Moore, Head, RTSM, R&D, GSK , Head of RTSM , RTSM, R&D , GSK
Barry Moore, Head, RTSM, R&D, GSK , Head of RTSM , RTSM, R&D , GSK

RTSM has advanced from IVRS to today’s digital platforms, but what lies ahead? This session imagines the future of RTSM. How will science, technology, and culture transform RTSM and how will it adapt to meet the future of clinical research.

Panel Moderator:

PANEL DISCUSSION:
Untangling Complexity in IRT/RTSM: Pain Points and Progress

Photo of Paul F. Hughes, Director, Randomization & Trial Supply Management (RTSM), J&J Innovative Medicine , Director , RTSM , Johnson & Johnson
Paul F. Hughes, Director, Randomization & Trial Supply Management (RTSM), J&J Innovative Medicine , Director , RTSM , Johnson & Johnson

Panelists:

Photo of Barry Moore, Head, RTSM, R&D, GSK , Head of RTSM , RTSM, R&D , GSK
Barry Moore, Head, RTSM, R&D, GSK , Head of RTSM , RTSM, R&D , GSK
Photo of Imran Shakur, Director, IRT and Technology Lead, Clinical Supply Management, Alexion Pharmaceuticals , Assoc Dir Clinical Supply Capabilities , Clinical Supply Capabilities , Biogen
Imran Shakur, Director, IRT and Technology Lead, Clinical Supply Management, Alexion Pharmaceuticals , Assoc Dir Clinical Supply Capabilities , Clinical Supply Capabilities , Biogen
Photo of J. Derek Thornton, Associate Director, Clinical Services & Analytical Reporting (IRT), Amgen , Associate Director, Clinical Systems (IRT) , Amgen Inc
J. Derek Thornton, Associate Director, Clinical Services & Analytical Reporting (IRT), Amgen , Associate Director, Clinical Systems (IRT) , Amgen Inc

Sponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break.

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!

Special 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!)

THE CRITICAL ROLE OF COLLABORATION AND COMMUNICATION IN CLINICAL-SUPPLIES MANAGEMENT

Participant and Site Receptivity to Direct-to-Patient (DTP) Shipments of Investigational Treatments in Clinical Trials

Photo of Maria Florez, Senior Consultant, Tufts CSDD , Senior Consultant , Tufts University
Maria Florez, Senior Consultant, Tufts CSDD , Senior Consultant , Tufts University

During this interactive session, we will discuss results from a recent study conducted by the Tufts Center for the study of Drug Development, focusing on (1) how U.S. clinical trial participants and sites perceive and experience Direct-to-Patient (DTP) shipments of investigational treatments, (2) the key benefits and challenges, and (3) actionable insights to improve patient satisfaction, site receptivity, and operational efficiency when using DTP shipments in clinical trials.

Adapting to Change: TMF and Clinical Supply Management in the ICH E6 R3 Landscape

Photo of Denise Moak, Principal Consultant, Alexander-Moak Consulting Services , Principal Consultant , Alexander Moak Consulting Svcs
Denise Moak, Principal Consultant, Alexander-Moak Consulting Services , Principal Consultant , Alexander Moak Consulting Svcs

This presentation addresses how we can best prepare to align our processes to the risk-based requirements explicit in ICH E6 R 3? We will dive into meaningful steps and TMF documentation that will demonstrate Sponsor oversight in a quality-first clinical supply chain.

Supply Plan Agreements between Clin Ops and Clinical Supply

Photo of Pamela Osborne, Consultant, LTD Consulting LLC , Consultant , LTD Consulting LLC
Pamela Osborne, Consultant, LTD Consulting LLC , Consultant , LTD Consulting LLC

The fastest way to break trust in the vital Clin Ops/Clinical Supply relationship is when one party doesn't live up to their side of the deal. But where is "the deal" agreed to? What's in "the deal"? What happens when things change? What happens when assumptions are made that aren't the same on both sides? A Supply Plan Agreement can help reduce risk in the supply chain and create clarity and rules to operate. This session walks participants through things to include in an agreement and lifecycle management.

Team Building in a Virtual World

Photo of Lisamarie Georgen, President, GuidedPath Consulting , President , GuidedPath Consulting, LLC
Lisamarie Georgen, President, GuidedPath Consulting , President , GuidedPath Consulting, LLC

In today’s globalized and hybrid work environment, virtual teams have become essential to the success of Clinical Supply Operations. This presentation explores the key strategies for building and sustaining high-performing virtual teams within the clinical supplies domain. Drawing on real-world examples and industry best practices, we will examine how to foster trust, accountability, and clear communication across geographically dispersed teams.

Panel Moderator:

PANEL DISCUSSION:
PAIN POINTS PANEL: Peer-to-Peer Resolutions

Photo of Lisamarie Georgen, President, GuidedPath Consulting , President , GuidedPath Consulting, LLC
Lisamarie Georgen, President, GuidedPath Consulting , President , GuidedPath Consulting, LLC

Panelists:

Photo of Paul F. Hughes, Director, Randomization & Trial Supply Management (RTSM), J&J Innovative Medicine , Director , RTSM , Johnson & Johnson
Paul F. Hughes, Director, Randomization & Trial Supply Management (RTSM), J&J Innovative Medicine , Director , RTSM , Johnson & Johnson
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

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)

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

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

Part 2: Clinical Supply Chain Strategies to Align Process, Products and Patients

BUILDING THE SUPPLY INFRASTRUCTURE FOR CELL AND GENE THERAPIES

The Role of Blood Centers in the Cell and Gene Therapy Pipeline—Current State and Future Directions

Christopher M. Lough, Vice President, Medical Services, Lifesouth Community Blood Centers , VP , Medical Svcs , Lifesouth Community Blood Ctrs

By the Providers, For the Providers: How FACT is Using Physician Input to Expand Infrastructure

Photo of Kara Wacker, Strategic Planning Administrator, Foundation for the Accreditation of Cellular Therapy , Strategic Planning Administrator , Foundation for the Accreditation of Cellular Therapy
Kara Wacker, Strategic Planning Administrator, Foundation for the Accreditation of Cellular Therapy , Strategic Planning Administrator , Foundation for the Accreditation of Cellular Therapy

FACT accreditation strengthens cell and gene infrastructure and is used as a measure of quality and safety by many stakeholders. This presentation will describe how FACT has leveraged its peer-to-peer framework to gather and act upon input from physicians providing or seeking to provide cellular therapies to make accreditation accessible to a growing diversity of providers. Solutions to this feedback will be outlined, including fit-for-purpose community clinical standards, provisional clinical accreditation, hub-and-spoke apheresis accreditation, education, and increased dialogue with industry and payers.

CO-PRESENTATION: Delivering a Nationally Supported Environment for Cell and Gene Therapy (CGT) Studies

Photo of Tracy Harman, Deputy Director of Strategic Development, National Institute for Health & Care Research (NIHR), Research Delivery Network (RDN) Coordinating Centre , Deputy Director of Strategic Development , NIHR RDN Coordinating Centre (RDNCC) , National Institute for Health & Care Research (NIHR)
Tracy Harman, Deputy Director of Strategic Development, National Institute for Health & Care Research (NIHR), Research Delivery Network (RDN) Coordinating Centre , Deputy Director of Strategic Development , NIHR RDN Coordinating Centre (RDNCC) , National Institute for Health & Care Research (NIHR)
Photo of Emily Merrell, Director, ATTC Network Coordination, Cell and Gene Therapy Catapult , Director , Advanced Therapy Treatment Centre network Coordination , Cell and Gene Therapy Catapult
Emily Merrell, Director, ATTC Network Coordination, Cell and Gene Therapy Catapult , Director , Advanced Therapy Treatment Centre network Coordination , Cell and Gene Therapy Catapult

We will outline how the ATTCs and the NIHR Research Delivery Network (RDN) are developing a robust site and sponsor support package for CGT studies. This includes providing faster and easier access to experts for advice, offering early feedback on protocols to fit the UK health pathways, supporting improved site selection through a web-based portal, enabling patient involvement in study design, and offering bespoke training programmes for research delivery staff.

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!

FROM APPROVALS TO ACCESS: CLOSING THE CGT ADOPTION GAP

Cleanrooms That Enable Access: Practical Infrastructure for Cell Therapy Manufacturing

Carol Houts, Chief Strategy Officer, Germfree Labs , VP Quality & Regulatory & Bus Dev , Quality & Regulatory & Bus Dev , Germfree Labs

Developing a Cell Therapy cGMP Program for Early Phase Trials within a Hospital Setting

Photo of Tatyana Matveeva, PhD, Director of cGMP Cell Production Operations, Neurosurgery, Massachusetts General Hospital , Director of cGMP Cell Production Operations , Neurosurgery , Harvard Medical School and Massachusetts General Hospital
Tatyana Matveeva, PhD, Director of cGMP Cell Production Operations, Neurosurgery, Massachusetts General Hospital , Director of cGMP Cell Production Operations , Neurosurgery , Harvard Medical School and Massachusetts General Hospital

Neurodegenerative conditions are prevalent and devastating diseases with severe economic, personal, and healthcare expense consequences. Cell replacement therapies have offered a route to functional recovery, but clinical cell manufacturing frequently requires distributed production and oversight associated with substantial financial burden. The present report will outline an in-hospital cGMP cell manufacturing facility with adjacent quality control and in direct proximity to patients, and demonstrate the challenges of developing a compliant and all-inclusive program at cost.

Panel Moderator:

PANEL DISCUSSION:
We Don’t Have a Supply Problem—We Have a Demand Problem

Photo of Joe DePinto, Head, Cell Gene Advanced Therapies, McKesson Bioservices , Head , Cell, Gene, and Advanced Therapies , McKesson
Joe DePinto, Head, Cell Gene Advanced Therapies, McKesson Bioservices , Head , Cell, Gene, and Advanced Therapies , McKesson

Panelists:

Photo of Lee Buckler, Senior Vice President, Advanced Therapies, Blood Centers of America , SVP , Advanced Therapies , Blood Centres of America
Lee Buckler, Senior Vice President, Advanced Therapies, Blood Centers of America , SVP , Advanced Therapies , Blood Centres of America
Photo of Tracy Harman, Deputy Director of Strategic Development, National Institute for Health & Care Research (NIHR), Research Delivery Network (RDN) Coordinating Centre , Deputy Director of Strategic Development , NIHR RDN Coordinating Centre (RDNCC) , National Institute for Health & Care Research (NIHR)
Tracy Harman, Deputy Director of Strategic Development, National Institute for Health & Care Research (NIHR), Research Delivery Network (RDN) Coordinating Centre , Deputy Director of Strategic Development , NIHR RDN Coordinating Centre (RDNCC) , National Institute for Health & Care Research (NIHR)
Photo of Tatyana Matveeva, PhD, Director of cGMP Cell Production Operations, Neurosurgery, Massachusetts General Hospital , Director of cGMP Cell Production Operations , Neurosurgery , Harvard Medical School and Massachusetts General Hospital
Tatyana Matveeva, PhD, Director of cGMP Cell Production Operations, Neurosurgery, Massachusetts General Hospital , Director of cGMP Cell Production Operations , Neurosurgery , Harvard Medical School and Massachusetts General Hospital
Photo of Kim Tedesco, Director, Gene & Cell Therapy Pharmacy Operations, Walgreens Gene & Cell Services , Dir of Gene & Cell Therapy Pharmacy Operations , Gene & Cell Therapy Pharmacy Operations , Walgreens Gene & Cell Services
Kim Tedesco, Director, Gene & Cell Therapy Pharmacy Operations, Walgreens Gene & Cell Services , Dir of Gene & Cell Therapy Pharmacy Operations , Gene & Cell Therapy Pharmacy Operations , Walgreens Gene & Cell Services

Sponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break.

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)

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

Registration Open

BREAKFAST PRESENTATION

Transition to Sessions

SUPPLY-CHAIN LOGISTICS: STREAMLINING DISTRIBUTION

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.

Overview of the Pharmaceutical, Health, Chemical Center and Classification of Biologic Imports

Sarah L. Sawyer, Supervisory Import Specialist & IPR Coordinator, US Customs & Border Protection , Supervisory Import Specialist & IPR Coordinator , US Customs & Border Protection

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.

Presentation to be Announced

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!

SITE COLLABORATION: MANAGING THE COMPLEXITIES OF TRIAL SUPPLIES

CO-PRESENTATION:
Site Partnerships: The Power of Collaboration for Clinical Trial Supply Management Success

Photo of Latoya Marshall, Director, Clinical Research, Neely Center for Clinical Cancer Research, Tufts Medical Center , Dir Clinical Research , Neely Center for Clinical Cancer Research , Tufts Medical Ctr
Latoya Marshall, Director, Clinical Research, Neely Center for Clinical Cancer Research, Tufts Medical Center , Dir Clinical Research , Neely Center for Clinical Cancer Research , Tufts Medical Ctr
Photo of Stephanie Russell, Senior Director, RTSM Solution Services, Medidata , Sr Dir RTSM Solution Svcs , RTSM Solution Svcs , Medidata a Dassault Systemes Co
Stephanie Russell, Senior Director, RTSM Solution Services, Medidata , Sr Dir RTSM Solution Svcs , RTSM Solution Svcs , Medidata a Dassault Systemes Co

This co-presentation offers a rare and valuable site-centric perspective on one of the most underrepresented yet critical aspects of clinical trials: supply management. While much of the industry dialogue focuses on sponsor or CRO-led innovations, this session flips the narrative by elevating the site’s voice.

Waste Not, Want Not: Innovative Strategies to Minimize Specimen Kit Wastage in Clinical Trials

Photo of Margaret Suhanovsky, Associate Director & Alliance Lead, Global Development Operations, Bristol Myers Squibb Co. , Assoc Director of Outsourcing, Alliance Lead , Global Dev Operations , Bristol Myers Squibb Co
Margaret Suhanovsky, Associate Director & Alliance Lead, Global Development Operations, Bristol Myers Squibb Co. , Assoc Director of Outsourcing, Alliance Lead , Global Dev Operations , Bristol Myers Squibb Co

Panel Moderator:

PANEL DISCUSSION:
From Sites to Sponsors: Overcoming Supply Challenges Together

Photo of Latoya Marshall, Director, Clinical Research, Neely Center for Clinical Cancer Research, Tufts Medical Center , Dir Clinical Research , Neely Center for Clinical Cancer Research , Tufts Medical Ctr
Latoya Marshall, Director, Clinical Research, Neely Center for Clinical Cancer Research, Tufts Medical Center , Dir Clinical Research , Neely Center for Clinical Cancer Research , Tufts Medical Ctr

Panelists:

Photo of Stephanie Russell, Senior Director, RTSM Solution Services, Medidata , Sr Dir RTSM Solution Svcs , RTSM Solution Svcs , Medidata a Dassault Systemes Co
Stephanie Russell, Senior Director, RTSM Solution Services, Medidata , Sr Dir RTSM Solution Svcs , RTSM Solution Svcs , Medidata a Dassault Systemes Co
Photo of Kate Trigg, PhD, Clinical Research Supervisor, Internal Medicine, University of California Davis , Clinical Research Supv , Internal Medicine , Univ of California Davis
Kate Trigg, PhD, Clinical Research Supervisor, Internal Medicine, University of California Davis , Clinical Research Supv , Internal Medicine , Univ of California Davis

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