Outsourcing - 2026 Archive

2026 ARCHIVES

Relationship and Alliance Management in Outsourced Clinical Trials

How pharma and biotech sponsors approach their outsourcing strategy continues to adapt as the industry responds to business goals, technological advances, and patient needs. Outsourcing models, exploring new technologies and needs, as well as CRO and third-party provider relationships are being re-examined with an eye towards efficiency and adaptability. SCOPE’s 10th Annual Mastering an Outsourcing Strategy stream will dive into agile outsourcing models, working with technology vendors, and exploring the nuances of outsourcing for diversity and inclusion. SCOPE’s 12th Annual Relationship and Alliance Management for Clinical Trials stream is dedicated to exploring strategies for turning a failing relationship around, navigating challenges in acquisitions, and tackling operational challenges with outsourced partners.

Part 1: Mastering an Outsourcing Strategy

Part 2: Relationship and Alliance Management in Outsourced Clinical Trials

Monday, February 2

7:00 amGolf Check-In & Breakfast Buffet*

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

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

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

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

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

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

9:00 amRegistration Open

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

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

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

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

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

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

*Limited spots available. Separate registration and fee apply.

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

*Must be present to win.

3:50 pm

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

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

3:58 pm Chairperson's Introduction

Rob Goodwin, COO, Parexel

4:00 pm FIRESIDE CHAT:

Hope: The Double-Edged Sword of Patient Experience

Lindsay Guentzel, Multimedia Journalist & Patient Advocate

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

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

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

4:25 pm

Tips for Getting the Most out of SCOPE

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

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

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

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

4:35 pm

SCOPE's 3rd Annual Site Innovation Awards

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

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

Irfan Khan, CEO, Circuit Clinical

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

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

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

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

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

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

5:10 pm KEYNOTE INTERACTIVE PANEL:

SCOPE's 10th Annual Participant Engagement Awards

PANEL MODERATORS:

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

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

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

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

PANELISTS:

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

Mark Evans, Managing Director, Patient Recruitment Expert

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

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

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

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

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

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

7:00 pmClose of Day

Tuesday, February 3

6:00 amSunrise Yoga: In Gratitude for Clinical Research Participants (IN-PERSON ONLY)

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

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

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

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

7:30 amRegistration Open

7:30 amMorning Coffee (Sponsorship Opportunities Available)

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

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

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

8:30 am

Welcome to SCOPE 2026—Welcome to the Clinical Trials Factory

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

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

Lisa Moneymaker, Chief Strategy Officer, Medidata

8:40 am

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

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

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

Interviewed By:

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

9:05 am

SCOPE’s Stretch Break & Annual T-Shirt Toss

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

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

9:15 am KEYNOTE PANEL DISCUSSION:

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

PANEL MODERATOR:

Jeremy Goldberg, Operating Partner, Healthcare, Arsenal Capital Partners

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

PANELISTS:

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

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

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

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

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

Part 1: Mastering an Outsourcing Strategy

11:00 am Chairperson's Remarks

George Sawicki, COO, KPS Life LLC

11:05 am

How M&A Strategies Shape the Clinical Trial Landscape

James West, Managing Director, Bourne Partners

Dive into the intricate world of mergers and acquisitions (M&A) and discover how these strategic moves are reshaping the clinical trial outsourcing landscape. This talk will share insights on how leading research companies' M&A strategies have defined the industry and explore the emerging trends that will shape its future. Learn how fast-growing companies are leveraging M&A and financing to gain market share and capitalize on pharma's propensity for outsourcing critical projects. Equip yourself with the knowledge to navigate the evolving clinical research vendor landscape and anticipate the M&A landscape ahead.

11:30 am

Building an Agile Outsourcing Operating Model: Yesterday’s Model, Evolved for Tomorrow

Michelle Verhaeghe, Vice President, FSP Clinical Operations, Parexel

Russell Bland, MBA, CMS, SSLP, PME, Strategy, Outsourcing, and Procurement Leader, Jazz Pharmaceuticals

The future of outsourcing lies in flexibility, customization, and true partnership. Jazz Pharmaceuticals and Parexel will share how they’re achieving this, moving beyond a transactional model to build a more strategic, agile operating model. Learn key considerations for creating a collaborative framework tailored to your company’s unique needs, supported by the right expertise and designed to generate both immediate and long-term success.

11:55 am PANEL DISCUSSION:

Navigating the Complexities of M&A and Outsourcing in Clinical Trials

PANEL MODERATOR:

Rosalie Filling, Vice President, Senior Global Head, R&D Operations, Keenova Therapeutics

This insightful panel discussion examines the intricate dynamics of outsourcing models, strategies, and experiences from the perspectives of both acquired and acquiring organizations in the clinical trial operations space. Leveraging real-world case studies and expert insights, this panel offers a comprehensive understanding of the challenges and best practices for biopharmaceutical executives managing the intersection of mergers, acquisitions, and outsourcing.

PANELISTS:

Gus Miller, Director, Clinical Labs Global Procurement, Regeneron

Stephanie Pfister, Vice President, Clinical Operations, Biohaven

Charles Semenchuk, Senior Director, Head of GCDO Business & Technology Capabilities, Global Clinical Development Operations, Jazz Pharmaceuticals

Laura Whitmore, Senior Director, Business Operations and Clinical Outsourcing, Kailera Therapeutics

12:45 pm

Building an Industry Destination: Strategic Talent Realignment to Optimize Study Management Delivery

Diana Cucos, President, FSP 360, Syneos Health

Bardia Akbari, AbbVie

Discover how AbbVie and Syneos Health partnered to transform clinical resourcing through data-driven market analysis and strategic collaboration. This session explores how identifying Specialized Talent Destinations and co-designing scalable transition models can optimize delivery, support workforce globalization, and examine what’s next for flexible delivery models—and how strategic design and partnership can unlock long-term value.

1:10 pmSponsored Networking Luncheon

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

2:10 pmNetworking Coffee & Dessert Break in the Exhibit Hall

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

2:15 pmSpecial Book Launch & Signing

Barnett's Good Clinical Practice: A Question & Answer Guide 2026/2027
Editor-In-Chief: Donna Dorozinsky, RN, MSN, CCRC
Location: Booth #129 (Free copies for the first 30 visitors!)

3:00 pm Chairperson's Remarks

Michelle Verhaeghe, Vice President, FSP Clinical Operations, Parexel

3:05 pm CO-PRESENTATION:

Transforming Bayer's Supplier Ecosystem: Driving Efficiency and Capability in Clinical Trials

James Chennells, Strategic Alliances Lead, Product Development & Performance Excellence, Clinical Development & Operations, Bayer

Nick Lewis, Head, Clinical Vendor Management, Bayer

Discover how Bayer is revolutionizing its clinical trial outsourcing strategy by transforming its supplier ecosystem. Explore cutting-edge tools to boost operational efficiency, a robust, portfolio-aligned clinical development strategy, and future-proofing capabilities for evolving market demands. Uncover actionable insights to stay ahead in an increasingly complex outsourcing landscape.

3:30 pm

Scaling Patient‑Centered Trials through Strategic Innovation Partnerships

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

Selecting the right innovative partners is essential to expanding clinical trials into the communities where participants live. This presentation will explore how to identify scalable solutions and evaluate companies positioned to support decentralized and patient‑centric research models. It will highlight strategies for building long‑term collaborations grounded in transparency, trust, and shared purpose. Attendees will gain practical insights for cultivating strong partnerships that enhance trial accessibility, quality, and sustainability.

3:55 pm

The AI Advantage in Clinical Business Operations

Anca Copaescu, CEO, Clinical Maestro by Strategikon

AI is transforming clinical trials by automating manual tasks, improving budget accuracy, and accelerating study planning and sourcing. It enhances—not replaces—human expertise. This session explores how AI streamlines clinical operations, strengthens oversight of vendors, timelines, and risks, and delivers practical ways to boost efficiency, cut costs, and enable faster, data-driven trial execution.

4:20 pm

Reimagining the Resourcing FSP Continuum

Nicole Duffey, Chief Strategy & Growth Officer, KPS Life

Sponsors must have information to make the right resourcing decisions, yet many find themselves stuck between traditional staffing models and evolving delivery needs. This session outlines how a continuum-based diagnostic can help teams assess where they are today, identify internal misalignment, and shift toward modern, scalable workforce strategies that enhance speed, structure, and cross-functional collaboration.

4:45 pm CO-PRESENTATION:

How Key Clinical-Operations Experts Can Partner to Successfully and Efficiently Deliver Outsourced Clinical Trials

Melody Aldred, PhD, Study Director, Community Lead, SSO GCO Development, Novartis

Heidi Pereira, Vendor Program Strategy Director, Novartis

How does an organization strike a balance between fully insourced vs. outsourced clinical-trial-delivery models? The right balance varies amongst companies. We will hear from two roles that offer a unique collaboration and perspective on how we ensure successful delivery within our organization. This session will focus on strategic engagement, efficient processes, and robust oversight to create a sustainable outsourcing model that remains effective amidst industry changes.

5:10 pm

Structuring Outsourcing Models for Efficiency, Clarity, and Cost Control

Nicole Stansbury, Senior Vice President, Global Clinical Operations, Premier Research

Choosing the right outsourcing model can significantly influence study efficiency, cost control, and the overall sponsor–CRO working dynamic. This session will break down the strengths and limitations of full-service, FSP, and hybrid approaches, highlighting how each model shapes resourcing planning, role clarity, and operational continuity. We will outline how sponsors can determine the most effective mix of insourced and outsourced roles and how pricing structures reflect these choices. The session will also explore how integrated oversight capabilities—such as centralized monitoring—can strengthen quality, risk detection, and visibility across models. Attendees will walk away with practical guidance to select and configure outsourcing approaches that support smoother collaboration and more reliable study delivery.

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

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

7:00 pmClose of Day

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

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

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

Wednesday, February 4

6:00 amSunrise Yoga: In Gratitude for Clinical Research Participants (IN-PERSON ONLY)

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

7:30 amRegistration Open

8:00 am

BREAFAST PRESENTATION OPTION #1:

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

Tobias Kruse, PhD, Managing Director, Europe, SubjectWell

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

8:00 am

BREAKFAST PRESENTATION OPTION #2:

From Elusive to Enrolled: A Case Study in Precision Recruitment

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

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

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

8:00 amSponsored Breakfast Presentation (Opportunity Available)

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

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

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

8:25 amTransition to Sessions

8:30 am Chairperson's Remarks

Lisa Jennings, Senior Director Business Development, Catalyst Flex - Catalyst Clinical Research

8:35 am

Doing the Right Thing: Delivering Individual Data Records to Participants at Scale

Brian Deighan, Program Lead, Program Management, Teckro

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

Regulatory expectations are evolving and patient engagement continues to be a focal point in clinical trials. Global regulatory bodies, including ICH E6(R3), are stressing the importance of providing patients with access to their clinical trial data. Furthermore, there is increased interest from Patients themselves regarding access to their personalized study results, allowing them to inform their own treatment journeys. Designing a clinical trial that delivers meaningful outputs for patients while remaining focused on engaging sites and reducing their burden is a big challenge. In this session, Teckro and Biogen will explore how scalable technology can support meaningful patient insights alongside site engagement, to run operationally feasible, patient-friendly studies. We’ll share practical tools and approaches for gathering and returning this data, and outline a repeatable process that bridges scientific intent with real-world execution.

9:00 am

Gaining AI Literacy to Drive Operational Efficiency and Excellence

Katrina Arceta, Category Manager, Development, R&D Procurement, Astellas Pharma, Inc.

AI literacy is rapidly becoming a core competency for outsourcing leaders. This session shows how understanding AI enables executives to evaluate CRO and vendor solutions, strengthen contract negotiations, and ensure that innovation translates into real-world efficiency. Participants will see how AI literacy drives operational excellence, enhances vendor oversight, and delivers value in outsourced clinical operations.

9:25 am

Accelerating Clinical Procurement with Generative AI for Market Reviews and Complex RFIs

Martina Endzhova, Global Category Lead, Clinical Trial Technologies, Bayer

Learn how a complex RFI process was transformed with a tailored generative AI approach—cutting time and effort while enhancing, not replacing, human expertise. This session will reveal tangible results and real metrics, showing how Clinical Procurement can speed market reviews, reduce operational burden, and drive smarter, faster decisions for Clinical Development teams.

9:50 am

The Partnership Playbook: Aligning CROs, Imaging, and AI for Smarter Trials

Justin Chadwell, Senior Director, Business Development, Perceptive, Inc.

Doug Fulling, CEO, Imaging, Perceptive

Wendy Roberts, Senior Director, Therapeutic Strategy & Offering Development, IQVIA

Katrina Arceta, Senior Sourcing Manager, R&D Procurement, Astellas Pharma US, Inc.

The panel will focus on how imaging CROs, CROs and pharma can strengthen collaboration through effective governance and innovative technology. It will explore practical governance models that balance flexibility and standardization, and highlight how AI and real-time data are transforming operational efficiency and decision-making in outsourced clinical trials. The discussion aims to share lessons learned, best practices, and strategies for aligning partnerships to deliver faster, smarter trials.

10:15 amCoffee Break in the Exhibit Hall (Sponsorship Opportunities Available)

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

Part 2: Relationship and Alliance Management in Outsourced Clinical Trials

11:10 amChairperson's Remarks (Sponsorship Opportunity Available)

11:15 am

AI + Humans for Delivery-Ready Clinical and Financial Feasibility

Emily McInturf, Director, Feasibility, Clinical, PSI CRO AG

Nicolas Schneider, Senior Director, Global Vendor Management, Isotope Technologies Munich (ITM)

With the vast amounts of data and expertise accumulated in the industry and the power of AI, there’s a potential to eradicate clinical trial delays and change orders. We’ll demonstrate how one platform connects two worlds: financial forecasting and feasibility modeling. The methodology enables accurate feasibility data analysis, data-driven study models with their budgets, and increases the probability of hitting the operational and financial targets.

11:40 am

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

Jimmy Bechtel, Chief Site Success Officer, Society for Clinical Research Sites (SCRS)

Rosalie Filling, Vice President, Senior Global Head, R&D Operations, Keenova Therapeutics

Denise Gascard, Head of Operational Excellence and Translation Management, Sanofi

Max Ghez, Global Head, Clinical Business Development, Syneos Health

Scott Sawicki, 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.

12:30 pm

Reclaiming Control: A Modern FSP Outsourcing Model for Emerging Biopharma

Nithiyanandhan Ananthakrishnan, Senior Vice President, Biometrics, Precision for Medicine

Monica Garvin, Executive Director Operational Strategy, Precision for Medicine

Successful biotech trials need speed, capital efficiency, and operational control. Our FSP model, tuned for biotech, delivers transparent governance, disciplined execution, and a clear value proposition for reliable delivery. Our presentation provides the playbook for integrating FSP resources in a way that enables retention of scientific and operational ownership and risk reduction while gaining scalable functional expertise across clinical operations, biometrics, medical writing, and safety.

12:55 pmSponsored Networking Luncheon

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

1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)—Best of Show Winner to be Announced

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

2:30 pm

SCOPE around the World: Community, Connection, Celebration

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

2:40 pm Chairperson's Introduction:

Rethinking Trial Design

Matthew Rich, Principal, Pharma & Life Sciences Technology Leader, PwC US

2:42 pm KEYNOTE INTERACTIVE PANEL:

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

PANEL MODERATOR:

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

Clinical operations leaders face increasing pressure to design trials that not only deliver clean data but also support downstream market success. This keynote panel explores how biopharma organizations can break down functional silos by integrating insights from Medical Affairs, Market Access, and field-facing roles like MSLs and CRAs. Panelists will discuss how early cross-functional collaboration improves protocol design, enhances site and prescriber engagement, supports feasibility, and aligns clinical development with real-world needs—ultimately creating a competitive edge. Learn how forward-thinking teams are redefining roles and relationships across the clinical-commercial continuum.

PANELISTS:

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

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

Jie Zhang, Head, Global Pipeline Market Access, CSL

3:12 pm

SCOPE Award Winners & Announcements (Sponsorship Opportunity Available)

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

3:23 pm Chairperson's Introduction:

AI Adoption in eClinical Technology

Nagaraja "Sri" Srivatsan, CEO, Endpoint Clinical, Inc.

3:25 pm KEYNOTE INTERACTIVE PANEL:

Change Management for AI Adoption in Pharma Clinical Development Teams

PANEL MODERATOR:

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

AI is rapidly entering clinical development, but the real challenge isn’t the technology—it’s managing the people, processes, and culture shifts required for adoption. This panel will share practical lessons from pharma leaders on how to align stakeholders, upskill teams, and build trust in AI-driven tools across clinical operations. Discussion will focus on real-world strategies that move beyond theory to accelerate adoption, improve decision-making, and deliver measurable impact in drug development.

PANELISTS:

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

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

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

3:55 pmSCOPE's Closing Ceremony Booth Crawl (Sponsorship Opportunities Available). Last Chance for Exhibit Viewing

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

4:55 pmClose of Day

5:00 pmSCOPE out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

Enjoy an evening exploring the restaurants and shops at Pointe Orlando with transportation provided by our courtesy shuttle. Shuttles will run until 9:00 pm, with the last pick-up at 8:30 pm.

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

Thursday, February 5

7:30 amRegistration Open

8:00 am

BREAKFAST PRESENTATION:

From Burden to Breakthrough: Innovative Strategies for Site and Patient Support

Shelby Stillwagon, Vice President, Decentralized Clinical Trials, ProPharma Group

This presentation explores strategies to strengthen clinical trial site capacity and improve patient engagement. It emphasizes delivering customized solutions through specialized roles that integrate with site teams, flexible resourcing, and operational support across key activities such as prescreening, recruitment, data entry, and remote study visits. Additionally, it highlights the importance of global scalability combined with local expertise, supported by an oversight structure that ensures consistency worldwide. The ultimate goal is to drive measurable improvements in site performance, operational efficiency, patient engagement, and retention, creating a more effective and patient-centric trial experience.

8:25 amTransition to Sessions

8:30 am

Chairperson's Remarks

Jennifer Merriman, Senior Manager, R&D Global Trade Compliance, DPDS Therapeutics Development & Supply, Johnson & Johnson

8:35 am

Navigating Regulatory Requirements across Multiple US Agencies for Importing Biological Materials

Sean Smith, Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, CBP

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.

9:00 am

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

Sarah L. Sawyer, Supervisory Import Specialist & IPR Coordinator, CBP

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.

9:25 am

Shared Learnings on Methods to Decrease Temperature Excursions

Barbara Versage, Senior Manager, 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.

9:50 amFind your Think Tank Working Group

Step away from the slide decks and into the conversation. Where in the world is . . . . .? Have you encountered confusion or churning around logistics for clinical trials? Didn’t know where to turn? This is your opportunity to learn from industry experts and each other. Join a Think Tank facilitated small group discussion to share pain points and solutions.

9:55 am THINK TANK 1:

Preparing for the Unexpected

Edye Edens, CEO, EEDEE Law

Sean Smith, Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, CBP

Barbara Versage, Senior Manager, Supply Chain Sourcing, Immunocore LLC

Discussion Points:

What early indicators do we tend to ignore before a logistics disruption occurs?
How to manage import requirements when good science is moving faster than compliance
Documentation for infectious and non-infectious biological materials
In unexpected situations, where do people—not systems—make the biggest difference?

9:55 am THINK TANK 2:

Preparing for the Unexpected

Pablo Caiceo, Director, Global Clinical Supplies, PPD Clinical Research Services, Thermo Fisher Scientific Inc

Thomas J. McDonald, MS, Biospecimens Operations & Logistics Director, Amgen

Liza Micioni, Senior Director, Head of Clinical Operations, Tris Pharma

Discussion Points:

Dealing with global regulatory requirement challenges or governmental restrictions
Does early budgeting and outsourcing decisions impact real-world execution in global transport logistics?
Breaking the mold: creative problem-solving in ClinOps
In unexpected situations, where do people—not systems—make the biggest difference?

9:55 am THINK TANK 3:

Preparing for the Unexpected

Leila Cupersmith, CEO, Choice ClinOps; Fractional Executive – Global Clinical Trial Operations (Cancer & Rare Disease Clinical Trials)

Jennifer Merriman, Senior Manager, R&D Global Trade Compliance, DPDS Therapeutics Development & Supply, Johnson & Johnson

Discussion Points:

Importer and exporter of record determination for clinical supply chain
Vendor ecosystem orchestration: The hidden cost of misaligned vendor ecosystems and how to get it right the first time
In unexpected situations, where do people—not systems—make the biggest difference?

9:55 am THINK TANK 4:

Preparing for the Unexpected

Suzanne Vyvoda, Founder and Principal, Concordia BioStrategies

Brenda Yanak, Founder & Principal, Clinical Transformation Partners LLC

Discussion Points:

What are areas of value that are overlooked within clinical trial logistics?
In unexpected situations, where do people—not systems—make the biggest difference?

10:30 amThink 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?

11:00 amNetworking Coffee Break

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

11:30 amChairperson's Remarks (Sponsorship Opportunity Available)

11:35 am

Strengthening Sponsor-Site Partnerships in Outsourced Trials

Liza Micioni, Senior Director, Head of Clinical Operations, Tris Pharma

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.

12:00 pm PANEL DISCUSSION:

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

PANEL MODERATOR:

Suzanne Vyvoda, Founder and Principal, Concordia BioStrategies

As outsourcing continues to play a central role in clinical trial execution, biopharma leaders face increasing pressure to strike the right balance between efficiency, cost control, and stakeholder alignment. This panel will explore practical approaches to vendor selection and governance models that foster transparency, accountability, and long-term collaboration. Speakers will share strategies for engaging investigative sites as true partners, ensuring operational success while managing costs and timelines. Perspectives from sponsors, outsourcing leaders, and the site community will provide a 360° view of how to design outsourcing relationships that drive quality, performance, and trust.

PANELISTS:

Kristin M. Ferrigno, Director of Clinical Operations, Clinical Research Site Development & Operations, Veda Clinical Trials

Tim Foley, Chief Business Officer, Scailyte

Melanie Goodwin, Director, Clinical Outsourcing, Immunocore

12:50 pmSCOPE Summit 2026 Adjourns

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