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 10th 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, March 1

SCOPE'S 6TH ANNUAL MASTERS OF CLINICAL RESEARCH GOLF TOURNAMENT

– 1:00 pm SCOPE's 6th Annual Masters of Clinical Research Golf Tournament (Sponsorship Opportunities Available)*

Network on the greens at SCOPE's 6th Annual Golf Tournament!  Visit the SCOPE website for player and sponsorship opportunities.*
*Limited space available. Must be registered for SCOPE. Separate registration and fee required.

6:30 am – 7:45 am Golf Check-in and Breakfast Buffet (Sponsorship Opportunities Available)

8:00 am – 12:00 pm Tee Time, Hit the Green (Sponsorship Opportunities Available)

12:00 pm Golf Lunch Buffet (Sponsorship Opportunities Available)

1:00 pm Close of the Masters of Clinical Research Golf Tournaments

Registration Open

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

– 3:00pm Evinova Workshop

See the Workshops & User Groups page for details.

– 3:30 MAXIS AI Workshop

See the Workshops & User Groups page for details.

– 3:30 IQVIA Innovation Day

See the Workshops & User Groups page for details.

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

Kick off the SCOPE 2027 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. See the Workshops & User Groups page for details.

Monday Plenary Keynote Session

MONDAY OPENING PLENARY: PATIENTS, SITES & THE FUTURE OF CLINICAL RESEARCH

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

*Must be present to win.

Organizer's Welcome Remarks & 6th Annual Masters of Clinical Research Golf Tournament Awards and Jacket Signing

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: SCOPE's 4th Annual Site Innovation Awards

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

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

Panelists:

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

Angela DeLuca, Vice President, Global Head, Site Management & Monitoring, AstraZeneca , VP & Global Head Site Management & Monitoring , Site Management & Monitoring , AstraZeneca

Joe Dustin, Senior Director, Digital Clinical Development, Sanofi , Senior Director, Digital Clinical Development , Digital Clinical Development , Sanofi

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

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: SCOPE's 11th Annual Participant Engagement Awards

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , 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:

Andrea Bartucca, Director, Trial Awareness and Recruitment, Rapport Therapeutics , Director, Trial Awareness , Trial Awareness and Recruitment , Rapport Therapeutics

Sarah Bednarski, MS, Senior Director, Head Clinical Operations (ad interim), BlueRock Therapeutics , Sr. Director, Head Clinical Operations (ad interim) , Clinical Operations , BlueRock Therapeutics

Savine DaCosta, PhD, Clinical Trial Access and Representation Site Lead, Biogen , Clinical Trial Access and Representation Site Lead , Biogen

Anita Difrancesco, Senior Vice President, Clinical Operations, Endeavor Biomedicines , SVP , Clinical Operations , Endeavor Biomedicines

Gretchen Goller, Head, Recruitment and Retention, Pfizer Inc. , Head , Recruitment and Retention , Pfizer Inc.

April Lewis, Clinical Solutions, PatientPartner; Strategic Advisor, ZS , Sr. Director, Innovative Health , Global Development , Johnson & Johnson Innovative Medicine

Wendy Lurrie, Acting Head of Comms, BestGuessistan , Acting Head of Comms

Adrienne Walstrum, Senior Director, Global Trial Optimization, Merck , Senior Director , Global Trial Optimization , Merck & Co

Kate Wilson, Senior Director, Head of Global Clinical Trial Access & Representation, Biogen , Senior Director , Head of Global Clinical Trial Access & Representation , Biogen

KEYNOTE FIRESIDE CHAT: From Reform to Implementation: FDA’s New Clinical Trial Innovation Office and Operation Trialblazer

Kevin Bugin, PhD, Associate Vice President, Head, Global Regulatory Policy and Intelligence, Amgen , Head , Regulatory Policy and Intelligence , Amgen

Dianne Paraoan, Director, Office of Medical Policy, Office of New Drugs, CDER, FDA , Director , Office of Medical Policy, Office of New Drugs, CDER , FDA

FDA’s clinical-trial modernization agenda is moving from policy ambition to implementation. This plenary discussion will explore the new clinical-trial-innovation office being established within CDER’s Office of Medical Policy, Operation Trialblazer, and related FDA priorities. The conversation will focus on the office’s intended role, near-term priorities, opportunities to leverage existing industry capabilities, and what sponsors, sites, and research partners should anticipate as the work takes shape.

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: Solving the Enrollment Crisis: Bridging Clinical Care and Clinical Research

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

Panelists:

Nikki Amaratunge, Vice President, Clinical Development Operations, Head of Clinical Site Management, AbbVie, Inc. , VP Clinical Dev Operations , Head of Clinical Site Management , AbbVie

Susan Griffing, Vice President, Late Development Oncology Clinical Operations, AstraZeneca , VP, Clinical Operations - Late Stage Oncology , Late Development Oncology Clinical Operations , AstraZeneca

Elizabeth Rogers, Vice President, Head, R&D Clinical Operations, Portfolio Development, CSL Behring , VP Global Head of Clinical Operations , Head, R&D Clinical Operations, Portfolio Development , CSL Behring

Melinda M. Rottas, Vice President, Head of Optimization, Analytics & Recruitment Solutions, Pfizer Inc. , VP, Head of Optimization , Analytics & Recruitment Solutions , Pfizer Inc

SCOPE's Kickoff Reception—Welcome to the Wild Wild West! (Sponsorship Opportunities Available)

Saddle up and kick off SCOPE the right way! Reunite with friends, make new connections, and soak up the Florida vibes at a Wild Wild West showdown you won't want to miss.

Close of Day

Tuesday, March 2

TUESDAY MORNING EXERCISE & COFFEE

Sunrise Yoga: In Gratitude for Clinical Research Participants

Start your day with movement, mindfulness, and gratitude. Join us at sunrise for an all-levels yoga session honoring the invaluable contributions of clinical research participants. Led by a trained instructor, this restorative practice will focus on mindful movement, breath, and grounding—no experience necessary. Yoga begins at 6:30 am; mats and towels are provided.
Stay afterward for a complimentary breakfast and fitness-inspired gift! Proceeds from this event help support CISCRP's mission. 

Registration Link Coming Soon!

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

Lace up and start your SCOPE day on the move! Join SCOPE's Coordinators for the 5K Rise and Shine Fun Run/Walk. Run, jog, walk, or chat your way through the course—ALL abilities are welcome. It's a fun, informal way to get moving and connect with fellow attendees. Full details to come, so don't forget your sneakers! 

Registration Open

Get Up and Go Specialty Coffee (Sponsorship Opportunities Available)

Start your day with a little extra fuel! Grab made-to-order specialty coffee and sweet bites, courtesy of our sponsors.

Tuesday Morning Opening Plenary Keynotes

TUESDAY PLENARY: RETHINKING THE SPEED AND SHAPE OF CLINICAL DEVELOPMENT

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

Arrive early and you could leave a winner! Grab your seat and enter SCOPE’s Early Bird Seat Raffle for a chance to win an exciting prize. Don’t be late—*Must be present to win!

Welcome to SCOPE 2027—Saddle up for the Future of Clinical Trials

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

KEYNOTE FIRESIDE CHAT: The Other Side of Drug Development: Pharma Leader's Journey as a Rare Disease Parent

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

Casey McPherson, CEO and Founder, AlphaRose Therapeutics , CEO and Founder , AlphaRose Therapeutics

Michelle Werner, Executive Vice President & President North America, Ipsen; Rare Disease Mom and Advocate , EVP , President, North America , Ipsen

For leaders who have spent their careers developing medicines, the experience of navigating a rare disease within their own family can bring an entirely different perspective to the urgency, complexity, and human impact of drug development. This fireside conversation will explore that intersection: what changes when an industry leader experiences drug development and clinical research as a parent, what the industry can learn from that perspective, and how it can inform the way we develop medicines and design clinical trials for patients and families.

Panel Moderator:

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

Micky Cohen-Wolkowiez, MD, PhD, Executive Director, i-Cubed, Duke Clinical Research Institute , i-Cubed Executive Director , Duke Clinical Research Institute

Panelists:

Meghana Chalasani, Associate Director for Clinical Trial Innovation, Office of New Drugs, FDA CDER , Associate Director for Clinical Trial Innovation , Office of New Drugs , FDA CDER

Zhanna Jumadilova, MD, Biopharmaceutical Physician Executive, Pragmatic Clinical Trials, R&D, Pfizer Inc. , Pragmatic Trials Clinical Lead , Pragmatic Clinical Trials, R&D , Pfizer

Christoph Koenen, MD, Head of Clinical Development & Operations, Pharma R&D, Bayer , Head of Clinical Development & Operations , Pharma Research & Development , Bayer

Patrick Loerch, Senior Vice President, Clinical Data Science, Gilead Sciences , SVP Clinical Data Science , Clinical Data Science , Gilead Sciences

Michelle Werner, Executive Vice President & President North America, Ipsen; Rare Disease Mom and Advocate , EVP , President, North America , Ipsen

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

Tuesday AM Tracks

THE NEXT ERA OF CLINICAL SUPPLY TECHNOLOGY

A Smarter Approach to Multi-Study Supply Management

Lindsey Place, MS, Director, Clinical Drug Supply & Logistics, Regeneron Pharmaceuticals, Inc. , Director , Clinical Drug Supply & Logistics , Regeneron Pharmaceuticals Inc

Managing clinical supply across multiple studies can reduce overages, ease manufacturing capacity pressure, and simplify packaging, but the benefits depend on decisions made early. This session examines a shared approach when studies start-up independently, and what to standardize in advance: labels, IRT configuration, master kit lists, and randomization lists. It also explores extending the model to investigator-initiated studies.

From People Running Systems to People Supported by AI: Mapping the Clinical Supply Landscape on the Road to an AI-Based Control Tower

Photo of Bryan Clayton, Founder, BC Consulting Group , Founder , BC Consulting Group
Bryan Clayton, Founder, BC Consulting Group , Founder , BC Consulting Group
Photo of Kyle Skillins, Director, Clinical Forecasting & Planning, Regeneron Pharmaceuticals, Inc. , Director, Clinical Forecasting & Planning , Regeneron
Kyle Skillins, Director, Clinical Forecasting & Planning, Regeneron Pharmaceuticals, Inc. , Director, Clinical Forecasting & Planning , Regeneron

Clinical supply has been built on processes designed around people and systems; the next operating model is people supported by AI. This session shows the unglamorous first step: how a top-20 biopharma's clinical supply group mapped 88 business processes to 132 system relationships in six weeks, surfaced 37 current gaps and 17 future risks, and used that grid to scope an AI-based control tower and prioritize where AI genuinely helps.

Going Global, Staying Agile: Configurable IRT for Evolving Supply Needs

Sarosh Anjum, Associate Director, Information & Systems Strategy, Astellas Pharma, Inc. , Associate Director , Information & Systems Strategy , Astellas Pharma 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!

Tuesday PM Tracks

NAVIGATING THE LOGISTICS ECOSYSTEM

What if we Stopped Solving the Same Problem Twice? A Cross-Functional Methodology for Solving Enterprise Logistics Challenges

Photo of Carol Shultz, PhD, Senior Director, Global Clinical Supplies, Merck & Co. , Senior Director , Global Clinical Supplies , Merck & Co
Carol Shultz, PhD, Senior Director, Global Clinical Supplies, Merck & Co. , Senior Director , Global Clinical Supplies , Merck & Co

One-off sample handling is often viewed as a Clinical Supply challenge, but logistics, tracking, and disposition issues exist across commercial samples, analytical testing materials, and product complaint investigations. A methodology was developed to bring together leaders from traditionally disconnected organizations, align on shared pain points and commitments, and identify solutions. The approach created a repeatable framework for enterprise problem-solving, reducing redundancy, and accelerating implementation through collective ownership and execution.

Beyond Logistics: Embedding Quality-by-Design and CDISC’s New TMF Standard Model into Clinical Supply Management

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

ICH E6(R3) elevates quality-by-design, proactive risk management, and risk-based oversight from regulatory expectations to operational imperatives. This session demonstrates how clinical supply leaders can design supply processes that proactively identify and mitigate risks while generating inspection-ready evidence throughout the trial lifecycle. Attendees will gain early understanding of the clinical supply document structure within the new Trial Master File (TMF) standard model and strategies for aligning documentation with evolving regulatory expectations.

Panel Moderator:

PANEL DISCUSSION:
Navigating the Next Era of Clinical Trial Logistics

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

Panelists:

Photo of Jennifer Merriman, Senior Manager, R&D Global Trade Compliance, DPDS Therapeutics Development & Supply, Johnson & Johnson , Sr Mgr R&D Global Trade Compliance , DPDS Therapeutics Dev & Supply , Johnson & Johnson
Jennifer Merriman, Senior Manager, R&D Global Trade Compliance, DPDS Therapeutics Development & Supply, Johnson & Johnson , Sr Mgr R&D Global Trade Compliance , DPDS Therapeutics Dev & Supply , Johnson & Johnson
Photo of Thomas J. McDonald, MS, Biospecimens Operations & Logistics Director, Amgen , Biospecimen Operations & Logistics Director , Precision Medicine , Amgen
Thomas J. McDonald, MS, Biospecimens Operations & Logistics Director, Amgen , Biospecimen Operations & Logistics Director , Precision Medicine , Amgen

Welcome Reception in the Exhibit Hall

Raise a glass and celebrate Day 1 of SCOPE! Reconnect with friends, meet new colleagues, and enjoy drinks with exhibitors at the Welcome Reception in the Exhibit Hall. Enter to win fabulous raffle prizes (must be present to win), then 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, March 3

Sunrise Yoga: In Gratitude for Clinical Research Participants

Start your day with movement, mindfulness, and gratitude. Join us at sunrise for an all-levels yoga session honoring the invaluable contributions of clinical research participants. Led by a trained instructor, this restorative practice will focus on mindful movement, breath, and grounding—no experience necessary. Yoga begins at 6:30am; mats and towels are provided. Stay afterward for a complimentary breakfast and fitness-inspired gift!  Proceeds from this event help support CISCRP's mission. 

Registration Link Coming Soon!

Registration Open

Wednesday Sponsored Breakfasts

BREAKFAST PRESENTATIONS

– 9:00 am In-Person Only Working Group Breakfast (Invitation Only)

Transition to Sessions

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

Wednesday AM Tracks

COLLABORATION IN CLINICAL SUPPLIES MANAGEMENT

Building Resilient, Patient‑Centric Clinical Supply Chains in an Era of Digital Transformation and Global Disruption

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

Clinical supply chains are being reshaped by decentralized trials, temperature‑sensitive biologics, and ongoing global logistics challenges. At the same time, digital transformation—AI forecasting, real‑time visibility tools, and advanced RTSM integrations—is redefining how sponsors plan and execute supply strategies. This session explores how organizations can evolve from traditional efficiency‑focused operations to resilient, patient‑centric clinical supply ecosystems capable of adapting to disruption. Attendees will gain practical insight into risk‑based inventory planning, sustainable packaging, and digital tools that strengthen continuity and support direct‑to‑patient delivery. The session provides a clear framework for building agile, future‑ready clinical supply chains.

Clinical Supply Chain Strategies: Working to find Efficient Solutions for Emerging to Mid-Sized Sponsors 

Photo of Carol Lee, Executive Director, Global Clinical Supplies, Clinical Program Management, Ascentage Pharma , Executive Director, Global Clinical Supplies , Clinical Program Management , Ascentage Pharma
Carol Lee, Executive Director, Global Clinical Supplies, Clinical Program Management, Ascentage Pharma , Executive Director, Global Clinical Supplies , Clinical Program Management , Ascentage Pharma

Focused towards smaller organizations, where resourcing may be limited and defined roles and responsibilities murky, this presentation will explore practical approaches to build understanding and partnerships across stakeholders and construct efficient solutions to manage clinical supplies.

Coffee Break in the Exhibit Hall (Sponsorship Opportunities Available)

Refuel, reconnect, and make the most of your time in the Exhibit Hall! Grab a cup of coffee, visit booths you haven’t explored, and connect with colleagues and exhibitors. It’s your final chance to cast your vote for SCOPE’s Best of Show Award—make your vote count!

Wednesday Mid AM Tracks

COLLABORATION IN CLINICAL SUPPLIES MANAGEMENT (CONT.)

Transforming the Clinical Supply Operating Model at a Global Scale

Photo of Arnaud Dourlens, Global Head, Clinical Supply Chain Operations, Sanofi , Global Head of Clinical Supply Chain Operations , Clinical Supply Chain Operations , Sanofi
Arnaud Dourlens, Global Head, Clinical Supply Chain Operations, Sanofi , Global Head of Clinical Supply Chain Operations , Clinical Supply Chain Operations , Sanofi

This session will describe a significant transformation of the clinical supply operating model at a large international organization supporting clinical development across multiple therapeutic areas and regions. This presentation shares the story of aligning clinical supply, clinical operations, and R&D to strengthen resilience, accelerate delivery, and maximize digital capabilities and cost efficiency.

Panel Moderator:

PANEL DISCUSSION:
Clinical Supply Nightmares – What’s Keeping Us Up at Night?

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

Panelists:

Photo of Carol Lee, Executive Director, Global Clinical Supplies, Clinical Program Management, Ascentage Pharma , Executive Director, Global Clinical Supplies , Clinical Program Management , Ascentage Pharma
Carol Lee, Executive Director, Global Clinical Supplies, Clinical Program Management, Ascentage Pharma , Executive Director, Global Clinical Supplies , Clinical Program Management , Ascentage Pharma
Photo of Arnaud Dourlens, Global Head, Clinical Supply Chain Operations, Sanofi , Global Head of Clinical Supply Chain Operations , Clinical Supply Chain Operations , Sanofi
Arnaud Dourlens, Global Head, Clinical Supply Chain Operations, Sanofi , Global Head of Clinical Supply Chain Operations , Clinical Supply Chain Operations , Sanofi

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, reconnect, and satisfy your sweet tooth! Grab coffee and a treat, courtesy of our sponsors, then visit Game Card Sponsors to collect stickers and connect with colleagues before the afternoon sessions. And don't miss the big reveal-the Best of Show winner will be announced during the break!

Wednesday PM Tracks

UNPACKING BIOLOGICAL IMPORT REQUIREMENTS

Importing Biological Materials into the United States: Documentation, Declaration, and Compliance

Photo of Corey Lash, Branch Chief, Biological Threat Exclusion, DHS/CBP/APTL , Branch Chief , Biological Threat Exclusion , DHS/CBP/APTL
Corey Lash, Branch Chief, Biological Threat Exclusion, DHS/CBP/APTL , Branch Chief , Biological Threat Exclusion , DHS/CBP/APTL

This presentation equips clinical research professionals with practical CBP guidance for importing biological and research materials into the United States. It addresses agricultural, public health, and national security considerations and outlines requirements for permits, documentation, packaging, labeling, and declarations. Participants will learn how early coordination with CBP and partner government agencies can support compliant clinical trial operations, prevent shipment delays, protect specimens, and reduce risks of penalties, seizures, or enforcement consequences.

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

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

The presentation outlines the role of the Pharmaceutical, Health, and Chemicals Center of Excellence and Expertise (PHC CEE) within CBP. It details the center’s structure, industry collaboration, enforcement responsibilities, and classification guidance for various pharmaceutical, healthcare, and chemical imports. It also highlights coordination with other government agencies and provides resources for compliance and trade facilitation.

Transition to Plenary Keynote

Wednesday Afternoon Plenary

WEDNESDAY PLENARY: THE DIGITAL TRANSFORMATION OF CLINICAL TRIALS

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: The Digital Transformation of Clinical Trials: From Protocol to Patient

Darren Weston, Head, Integrated Data Analytics and Reporting, Johnson & Johnson , Head , Integrated Data Analytics and Reporting , Johnson & Johnson

Panelists:

Michael Cantor, Vice President, Data Technology & Innovation, Regeneron Pharmaceuticals, Inc. , Vice President , Data Technology & Innovation , Regeneron Pharmaceuticals Inc

Justine Rochon, Senior Vice President, Head of R&D Data and Quantitative Sciences, Takeda , SVP , Head of R&D Data and Quantitative Sciences , Takeda

Sammi Rui Tang, PhD, Senior Vice President & Global Head, Quantitative Sciences & Evidence Generation, Astellas Pharma, Inc. , Sr VP & Global Head , Quantitative Sciences & Evidence Generation , Astellas Pharma Inc

Rachel Nering, Vice President, Head of Early Development and eDevelopment, Sanofi , VP , Head of Early Development and eDevelopment , Sanofi

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

One last trip through the Exhibit Hall! Join SCOPE's Booth Crawl for food, drinks, networking, and one final chance to explore the exhibits and connect with sponsors and colleagues. Be sure to visit your must-see booths and enter the raffle for a chance to win (must be present to win)-let's finish SCOPE strong!

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 9:45 pm, with the last pick-up at 9:15 pm.

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

Thursday, March 4

Registration Open

BREAKFAST PRESENTATION

Transition to Sessions

DOING MORE WITH LESS: RESOURCING, OUTSOURCING, AND BIOTECH CLINICAL TRIALS STRATEGY

Big Trials, Small Teams: Innovative Resourcing Models to Deliver Phase 3 Excellence

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.

Advancing a Phase 3 clinical program within a small biotech requires a fundamentally different operating model than that of large pharmaceutical organizations. This session explores practical and innovative approaches to maximizing limited resources, leveraging strategic partnerships, building agile teams, and prioritizing high-value activities. Attendees will learn how creative thinking, cross-functional collaboration, and disciplined decision-making can enable small biotechs to execute large, complex trials without compromising quality, timelines, or patient experience.

Panel Moderator:

PANEL DISCUSSION:
Real Talk: The Changing Truths of Outsourcing Partnerships in 2027 and Beyond

Photo of Caroline Redeker, Chief Commercial Officer, StuffThatWorks , Chief Commercial Officer , StuffThatWorks
Caroline Redeker, Chief Commercial Officer, StuffThatWorks , Chief Commercial Officer , StuffThatWorks

Innovation in clinical development demands agility, yet traditional vendor management often relies on rigid checklists, long vendor approval processes, and KPIs. Small biotechs and large pharmas alike must navigate distinct operational hurdles, from securing dedicated resource allocation to streamlining multi-provider workflows. How can sponsors build CRO/FSP relationships that deliver true strategic alignment, including how to integrate other providers? This expert panel explores how forward-thinking sponsors are reimagining vendor selection and governance. Panelists will share insights on how innovation is moving fast and changing the game, how you adapt internally or alongside your partners, and how to create an environment for the best operational performance on your programs.

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.

Networking Coffee Break and Transition to Closing Keynote

Pause, connect, and get ready for the grand finale! Grab a cup of coffee, catch up with colleagues, and make a few final connections before heading into SCOPE’s Closing Keynote. It’s the perfect chance to recharge and refocus before we wrap up an incredible conference.

Closing Plenary Keynote

THURSDAY CLOSING PLENARY: REINVENTING R&D AND CLINICAL DEVELOPMENT

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

KEYNOTE PRESENTATION: Case Study: AI and the R&D Revolution: Reinventing Drug Development from Discovery to Clinical Trials

Patrick Loerch, Senior Vice President, Clinical Data Science, Gilead Sciences , SVP Clinical Data Science , Clinical Data Science , Gilead Sciences

Dan Sheeran, Vice President & General Manager, Healthcare & Life Sciences, AWS , VP & GM Healthcare & Life , Healthcare & Life Sciences , AWS

AI is reshaping R&D from discovery through clinical development. This case study will explore how organizations are applying AI at scale to accelerate innovation, improve decision-making, and transform how new medicines are developed.

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: The New Clinical Development Operating Model

Kristi Koontz, Vice President, Global Study and Site Operations, Amgen , VP , Global Study and Site Operations , Amgen

Panelists:

David Carruthers, Vice President, BioPharmaceuticals R&D Clinical Operations, AstraZeneca , Vice President , BioPharmaceuticals R&D Clinical Operations , AstraZeneca

Nick Hodges, Senior Vice President & Head, Clinical Development Operations & R&D Transformation Office, Ipsen , SVP, Head of Global Clinical Development , Global Clinical Operations , Ipsen

Henry Wei, MD, Executive Director, Development Innovation, Regeneron , Executive Director , Development Innovation , Regeneron Pharmaceuticals Inc

Community Luncheon and Last Hurrah

Wrap up SCOPE with closing remarks and lunch, courtesy of our sponsors! Enjoy your lunch here with us or grab it to go as you head out for the day. The poolside is calling.

Wrap up SCOPE with Closing Remarks and Lunch, Courtesy of Our Sponsors!

That’s a wrap! Thank you for joining us at SCOPE Summit 2027. We hope you leave inspired, connected, and energized by the conversations and ideas shared throughout the week. Safe travels, and we look forward to seeing you at the next SCOPE event!

Scope Summit 2027 Adjourns

#SCOPEsummit
SCOPE Track Summariese
SCOE Europe
SCOE Europe
Coming Soon - SCOPE X
SCOPE 365 ClinEco Connect
SCOPE of Things Podcast
Participant Engagement Award
Best of Show Award
Site Innovation Award
Join SCOPE LinkedIn Group
Event at a Glance
Media Partners
Attendee List
attendee profile

2027 Conference Programs

TRIAL DESIGN & PROTOCOL OPTIMIZATION

◆ Patient and Site Voice in Protocol Design

◆ Technology, Data and AI/ML for Intelligent Trial Design

FEASIBILITY & SITE STRATEGY

◆ Data-Driven Feasibility and Investigator Selection

◆ Tech and Collaboration to Streamline Start-Up and Reduce Site Burden

RECRUITMENT & ENGAGEMENT

◆ Enrollment Strategy and Trial Readiness

◆ Access, Trust, and Participant Engagement

SITE PARTNERING & OPERATIONS

◆ Building Strategic Sponsor-Site Partnerships

◆ Tech and Collaboration to Streamline Start-Up and Reduce Site Burden

BUDGETING & RESOURCES

◆ Clinical Trial Budgeting, Contracting, and Payments

◆ Clinical Trial Resource Management and Operational Planning

OUTSOURCING

◆ Mastering an Outsourcing Strategy

◆ Relationship and Alliance Management in Outsourced Clinical Trials

SCOPE BIOTECH FORUM

◆ Building Early-Stage Study Infrastructure

◆ Scaling Clinical Capabilities for Late-Stage Development

DATA

◆ Clinical Data Strategy

◆ Integrating AI into Clinical Data and Analytics

ADVANCING TRIAL DELIVERY

◆ Operational Excellence in Trial Execution

◆ Point-of-Care, Remote, and Decentralized Models

DIGITAL MEASURES & eCLINICAL TECHNOLOGIES

◆ Digital Endpoints and Biomarkers

◆ Digital Trials in a Connected Health Ecosystem

REAL WORLD EVIDENCE

◆ Accessing and Generating RWD

◆ Leveraging RWD for Clinical Research

AI IN CLINICAL RESEARCH

◆ Agentic AI in Clinical Research

◆ AI for Trial Optimization and Data Management

QUALITY & MONITORING

◆ Risk-Based Quality Management

◆ Central Monitoring and Signal Detection

SAFETY & PHARMACOVIGILANCE

◆ Building a Unified Safety Ecosystem

◆ Next-Generation Technologies and Intelligent Signal Detection

BIOSPECIMEN STRATEGY & OPERATIONS

◆ Modernizing Lab, Biospecimen & Data Management Operations

◆ Biomarker & Biospecimen Technology & Innovation

CLINICAL SUPPLY & LOGISTICS

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

◆ Clinical Supply Chain Strategies to Align Process, Products, and Patients

THERAPEUTIC AREA SPOTLIGHTS

◆ CNS & Mental Health Trials

◆ Metabolic & Obesity Trials

◆ Oncology Trials

◆ Immunology & Inflammation Trials

INVESTOR CONFERENCE

◆ Clinical Trial Venture, Innovation & Partnering

PRE-CON EVENTS

◆ Monday Golf,  Opening Keynote with Site Innovation Awards & Participant Engagement Award

◆ SCOPE’s Opening Reception

◆ Pre-Con User Group & Workshops