Budgeting & Resources - 2026 Archive

2026 ARCHIVES

Clinical Trial Forecasting, Budgeting and Contracting

Resource Management and Capacity Planning for Clinical Trials

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

Part 1: Clinical Trial Forecasting, Budgeting and Contracting

Part 2: Resource Management and Capacity Planning for 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

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: Clinical Trial Forecasting, Budgeting and Contracting

11:00 am Chairperson's Remarks

Gary Steidl, Head of Clinical Strategies & Development, Spaulding Clinical Research

11:05 am PANEL DISCUSSION:

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

PANEL MODERATOR:

Rene Stephens, Managing Director, CBO, Danforth Advisors

Maximizing the value of every outsourcing decision is critical as clinical trial costs continue to rise. This panel will explore how AI is transforming procurement and outsourcing to deliver measurable cost savings and stronger ROI. Hear how leading clinical operations teams are using AI to optimize budgets, negotiate smarter contracts, and streamline workflows—unlocking both financial and operational value while keeping trials on track.

PANELISTS:

Lisa La Luna, Founder, La Luna 4-Healthcare

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

Ratan Ratnesh, Senior Director, Outsourcing & Vendor Management, Taiho Oncology, Inc.

11:55 am

Sites Are Walking Away: Why Payment Experience Is Now Your Competitive Advantage (Or Liability)

Holly Leslie, Executive Director, Clinical Solutions, LedgerRun

Theo Emmanuel-Mari, Senior Director, Clinical Outsourcing, Site Contracts & Payments, Jazz Pharmaceuticals

The power dynamic in clinical trials has fundamentally shifted: sites now choose sponsors, not the other way around. In an environment where 73% of trials struggle to meet enrollment timelines and site capacity is the limiting factor, your payment and contracting experience directly determines whether top sites will work with you. This session exposes why leading sites are rejecting sponsors with antiquated payment systems and what best-in-class sponsors are doing to win and retain site partnerships.

Moderator: Holly Leslie, VP of Services, Ledger Run Panelists: Melissa Easy (COO, TrialScreen), Theo Emmanuel-Mari (Sr. Director, Jazz Pharma), Justin Purvis (Sr. Director, PPD)

12:20 pm

Practical Applications of AI: Site Contracting & Budgeting

Matthew Harrington, Senior Vice President, Technology Solutions, Syneos Health

This session explores how AI can streamline the end-to-end Site Contracts & Payments process by reducing contracting delays, automating administrative tasks, and improving payment accuracy. We’ll highlight practical AI applications across budgeting, contract creation, negotiation, and reconciliation, along with early results showing faster cycle times and better decision quality. The goal: demonstrate how AI can modernize manual workflows and accelerate site activation with greater clarity and consistency.

12:45 pm

Case Study: How to Use Your Clinical Data to Track Investigator Grants

Erin Guill, President & COO, Auxilius

Clinical operations teams manage investigator grant budgets they have incomplete visibility into. With vendor reports lagging an average of 7 months behind work performed, sponsors are making critical decisions based on incomplete data. This means you can't properly manage your site relationships until they call with complaints. This session presents a case study showing how one large biopharma used their own clinical and budget data to independently track investigator grants. Attendees of this session will learn practical approaches to leverage their own clinical data to track investigator grants, improving their ability budget, forecast, and plan.

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

Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine

3:05 pm

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

Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine

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

3:30 pm

Bridging the Gap: Budget and Contract Realities from Both Sides of the Table

Griffin Lewis, Director, Site Operations, Valiance Clinical Research

3:55 pm

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

Thorsten Ruppert, PhD, Senior Manager, R&D & Innovation, Verband Forschender Arzneimittelhersteller eV

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

4:20 pm PANEL DISCUSSION:

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

PANEL MODERATOR:

Kelly L. Smith, CEO, V2 Clinical, Inc.

Economic uncertainty and shifting global dynamics are reshaping how clinical trial budgets and forecasts are managed. In this panel, leaders from a site, a CRO, and a sponsor share candid perspectives on today’s financial pressures and the trade-offs they face. Together, they’ll explore strategies for fair contracting, sustainable site support, and stronger collaboration to keep trials moving forward despite turbulent conditions.

PANELISTS:

Gina Fulgar, Head, Clinical Operations, Epirium Bio

Jennifer Sydney Goldman, Clinical Business Operations, Consultant

Marco Macente, Senior Contract Manager, Global Site Contracts, Catalyst Clinical Research

Kathy Mickel, Director, Membership & Programs, Society for Clinical Research Sites (SCRS)

Justin Purvis, Senior Director, Site Contracts and Payments, PPD

5:10 pm

From Protocol to Budget: Faster Than This Session

Clara Bernardes, Co-Founder & CSO, Scientific, Biorce

Discover how Biorce’s AI-powered solution is revolutionizing the way pharmaceutical and biotech companies launch clinical trials. By fully automating contract and budget negotiations, Biorce cuts startup timelines by nearly 70%—empowering sponsors and CROs to accelerate trial activation, boost collaboration, and stay ahead in a rapidly evolving industry.

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

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

7:00 pmClose of Day

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

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

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

Wednesday, February 4

6:00 amSunrise Yoga: In Gratitude for Clinical Research Participants

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

7:30 amRegistration Open

8:00 am

BREAFAST PRESENTATION OPTION #1:

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

Tobias Kruse, PhD, Managing Director, Europe, SubjectWell

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

8:00 am

BREAKFAST PRESENTATION OPTION #2:

From Elusive to Enrolled: A Case Study in Precision Recruitment

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

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

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

8:00 amSponsored Breakfast Presentation (Opportunity Available)

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

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

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

8:25 amTransition to Sessions

8:30 am

Chairperson's Remarks

Sol Babani, Founder & CEO, Symbiosis Advisors

8:35 am

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

Carrie Lewis, Executive Director, Clinical Program Optimization, Keenova Therapeutics

Suzy Montanye, Site Relationship Manager, Keenova Therapeutics

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

9:00 am PANEL DISCUSSION:

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

PANEL MODERATOR:

Shelley Douros, Senior Director, Clinical Financial Management, Product & Strategy, Medidata, a Dassault Systemes Co.

As patient diversity moves from a scientific goal to a regulatory and ethical mandate, the conversation must shift to financial execution. How do we fund and sustain these critical initiatives? This discussion brings together senior leaders from sponsors, CROs, and sites to dissect the financial framework of inclusive research. We will move beyond high-level strategy to explore the tactical challenges of budgeting for diversity and structuring site contracts that support the whole patient. Panelists will share practical insights on designing compensation models that reduce patient burden by moving beyond the stipend to include timely and seamless support for costs such as travel, lodging, childcare, and translation services. We will explore how to empower sites with the resources and flexibility needed to become true partners in creating equitable access to clinical trials.

PANELISTS:

Karen Hartman, Vice Chair, Research Administration, Mayo Clinic

Brian Hunter, Vice President, Contracts & Trial Management, CNS Healthcare

Irfan Khan, CEO, Circuit Clinical

Chelsey Ryan, Director, Clinical Operations and Pharmacovigilance, PROMETRIKA, LLC

Part 2: Resource Management and Capacity Planning for Clinical Trials

9:50 am

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

Geoff Kremer, Director, Global Resource Management, BeOne Medicines

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

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

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

11:10 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!