Biomarkers & Precision Medicine Trials

2025 ARCHIVES

Modernizing Lab, Biomarker & Data Management Operations

Biomarker & Biospecimen Technology & Innovation

The rise of precision medicine has fueled a dramatic increase in biomarker-driven clinical trials requiring new processes and technologies for biospecimen collection and management. SCOPE’s 9th Annual Biomarkers & Precision Medicine Trials stream brings together biospecimen and biomarker management leaders to share best practices to effectively navigate the complex operational requirements of biomarker-driven clinical trials. The Modernizing Lab, Biomarker & Data Management Operations conference explores strategies and solutions for tracking samples and data, data management and data standardization, as well as regulatory, privacy, consent, and governance considerations to guide frameworks and policies for operating biomarker-driven trials. The Biomarker & Biospecimen Technology & Innovation conference highlights the latest advancements in biospecimen collection technologies, patient-centric operational approaches, and IT solutions to deliver high-quality biological specimens, laboratory access, and diagnostics services.

Part 1: Modernizing Lab, Biomarker & Data Management Operations

Part 2: Biomarker & Biospecimen Technology & Innovation

Monday, February 3

6:30 amGolf Check-In & Breakfast Buffet (Sponsorship Opportunities Available)

8:00 amSCOPE's 4th Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)

Connect with your peers and colleagues at SCOPE's 4th Annual Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.
*Limited space available. Separate registration and fee required for golf.

9:00 amRegistration Open

12:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)

12:00 pm– 4:00 pm WORKSHOP 1: Innovation Day with IQVIA Technologies: Hear the vision. See the products. Join the journey.

Clinical trial sponsors are invited to join digital product leaders and industry colleagues for an afternoon of discussions, demos, and networking. This interactive event has been carefully curated to help clinical trial professionals crack key challenges across the clinical trial lifecycle: from participant and site user journeys to data security and workflows. Pharmaceutical executives with various roles in clinical operations, innovation, technology, finance/budgeting, data analytics, strategic sourcing, trial managers, medical directors, or patient and site engagement will enjoy an industry panel, interactive roundtables, live demos with product experts, and more! Pre-registration is requested, and IQVIA reserves the right to decline requests that don’t fall within attendee guidelines above: Learn more and register here.

1:00 pmOPEN WORKSHOP: Join and Explore ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace (IN-PERSON ONLY)

Join this hands-on session with ClinEco, SCOPE’s B2B clinical trial community and marketplace featuring 850+ companies. ClinEco unites sponsors, CROs, service providers, and sites to streamline partnering, vendor research, innovation, and learning. At SCOPE 2024 we introduced the ClinEco Commons, a collaborative space where you can access, visit, and share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco Community. This year we launch our “Ask a ClinEco Luminary” program where members can connect directly, and discreetly, with industry leaders and receive insights on a wide range of clinical trial topics. Join now at: clineco.io/register. To register for the workshop, please opt into this workshop by selecting the checkbox under ‘Conference Selection.' Open to all SCOPE attendees.

1:00 pmOPEN WORKSHOP: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trial (IN-PERSON ONLY)

INSTRUCTORS:
Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)
Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific
While developing leading and innovative therapies, we must not lose sight of the environmental impacts and greenhouse gas emissions. We can reduce the environmental impact of our studies by prioritizing remote visits and monitoring, by reducing kit wastage, and working together to find ‘greener’ solutions. This workshop will provide a brief overview of research and introductory strategies for reducing emissions as well as a “Sustainability 101” to help anyone in our industry get started towards developing more environmentally responsible clinical trials. To register, please opt into this workshop by selecting the checkbox under ‘Conference Selection. Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.

1:00 pmOPEN WORKSHOP: Efficient Importation of Biological Materials into the U.S. (IN-PERSON ONLY)

SPEAKERS:
Jessica Hammes, Branch Chief, Biological Threat Exclusion, Agriculture Safeguarding and Risk Management, Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
Jennifer Merriman, Senior Manager, Strategic Biospecimen & Vendor Logistics, Consent, Biospecimens, & Imaging, Global Development Operations, Bristol Myers Squibb Co.
(Additional speakers to be announced.)
U.S. Customs and Border Protection and partner government agencies regulate the importation of biological materials into the United States. The efficient importation of these items can be challenging, as Clinical Trial landscape is ever-evolving. The purpose of this workshop is to discuss current challenges, best practices, and possible solutions to navigate this landscape.

2:00 pm– 3:30 pm WORKSHOP 5: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing

INSTRUCTORS:
Dawn Anderson, Partner, Consulting, Deloitte LLP
Ming Shen, Managing Director, Deloitte Consulting LLP
This workshop will explore sponsor and site perspectives on current challenges and future opportunities in clinical trial financing. It will address complexities in managing trial finance including estimation, budgeting, forecasting, invoicing, payments, reconciliation and others in clinical trial management. The workshop aims to identify innovative solutions to enhance finance management in clinical trials, fostering more accurate projections. Through discussions and interactive sessions, it seeks to provide insights for future opportunities to improve clinical trial finance.

3:50 pm

Organizer's Welcome Remarks & 4th Annual Masters of Clinical Research Golf Tournament Awards

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

3:58 pm

Chairperson's Introduction

Jenny Denney, Executive Vice President, Global Head Parexel FSP, Parexel

4:00 pm KEYNOTE PRESENTATION:

Fast-Forward to 2035: What Success Could Look like in Converging Clinical Research and Care—And How to Get There

Janice Chang, CEO, TransCelerate Biopharma, Inc.

Mark McClellan, MD, PhD, Director, Duke-Margolis Institute for Health Policy; Former Commissioner, FDA

On this stage in 2024, we spoke about our mission to converge clinical research and clinical care for the benefit of patients worldwide. We envision a world in which patients participate in research at the point of care as seamlessly as possible. And although we’ve set our vision, and organized the work we are undertaking accordingly, the real fruits of those efforts will not be seen in the short term. We will use this session to talk about where we hope we will be by 2035. What might we reasonably achieve? What does success look like? And what will it take to get there? This session is designed to help us all to raise our gaze beyond the near-term and find inspiration in the future possibilities.

4:25 pm

Tips for Getting the Most out of SCOPE

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

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 3-6, 2025, at the Rosen Shingle Creek in Orlando, Florida!

https://www.scopesummit.com/faq-how-to-succeed-at-scope

4:33 pm

Chairperson's Introduction

Fiona Geiger, Vice President, Operational Delivery, Operations, Endpoint Clinical, Inc.

4:35 pm INTERACTIVE KEYNOTE PANEL:

What Do Real Patients Actually Talk About?

PANEL MODERATOR:

T. Hephner, CRO, Inspire

Whether at an industry event, a focus group, or another venue, we’ve all heard “real” patients share stories of their conditions, treatment journeys, and lives. But how accurate is what you’ve heard? Are the patients who speak on the podium or in a focus group truly representative of the majority of patients, or do they represent just a small sample? Our panel of patient engagement experts from some of the country’s leading patient advocacy groups and other representative organizations will give the story of what it’s like for most patients to live with illness, including rare and chronic diseases. Join us and learn about the true challenges of disease burden, unmet needs, treatment progression, the challenges–and rewards–of clinical trials, and more.

PANELISTS:

Emily McCormack, Social Media Director, New York Blood Center Enterprises

Fabian Sandoval, PhD, President & CEO, Emerson Clinical Research Institute

Quynh Tran, Director of Patient Activation, Cystic Fibrosis Foundation

5:05 pmSCOPE's 9th Annual Participant Engagement Awards Introduction (Sponsorship Opportunity Available)

5:10 pm

SCOPE's 9th Annual Participant Engagement Awards

PANEL MODERATORS:

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

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

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Now in its 9th 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 2025 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:

Tricia Barrett, CEO, Praxis

Brian Burkhardt, Co-Founder & Executive Director, Oliver Patch Project, Inc.

Michelle Everill, Vice President, Global Trial Optimization, Alnylam Pharmaceuticals

Gretchen Goller, Head, Enrollment Strategy, Oncology, Pfizer Inc.

Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative

Stacy Hurt, Chief Patient Officer, Patient Engagement, Parexel International

Kim Ribeiro, Chief Client Officer, Inside Edge Consulting Group

5:45 pmSCOPE's Kickoff Reception: A Luau to Remember!

Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, we're turning up the tropical vibes with a luau theme.

DRESS CODE: Hawaiian shirts are encouraged! Show off your brightest, boldest, most tropical attire (grass skirts optional!) Let's bring the aloha spirit to life as we kick off another amazing SCOPE conference experience. Join us to reconnect with your old friends, make some new ones, and soak up the Florida sunshine in style!

7:00 pmClose of Day

Tuesday, February 4

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

Join SCOPE’s Coordinators on Tuesday, February 4 for our 5K Rise and Shine Fun Run! Don’t forget to pack your sneakers.
All of us at Cambridge Healthtech Institute recognize the importance of integrating well-being and fitness into our work travel routines. We're excited to offer our support to faculty, sponsors, and attendees in fostering a culture of wellness. This is an easygoing, informal running (or walking) event. No time chips, running bibs, or energy bars—just a laid-back opportunity for a small group to start the day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk—the goal is to get up and get moving! Meet us in the Rosen Hotel’s front lobby near the birdcage at 6:30 am sharp!
RUN COORDINATORS:
Eileen Murphy, Conference Producer, Production, Cambridge Healthtech Institute
Steve Wimmer, Vice President of Partnerships, 1nHealth

7:30 amRegistration Open

7:30 amMorning Coffee (Sponsorship Opportunities Available)

Get Up and Go! Jumpstart your morning with a specialty made-to-order coffee and some delicious treats, courtesy of our sponsors.

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

*Must be present to win.

8:30 am

Welcome to SCOPE 2025—Who’s Here and Why, What’s New, Annual Awards

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

8:40 am

Chairperson's Introduction

Jonathan Rowe, Principal & Head, R&D Quality Operations & Risk Management, ZS Associates, Inc.

8:42 am KEYNOTE PRESENTATION:

Exquisite Clinical Trial Delivery in an Ever-Changing World—Evolution and Opportunity for Sustained Performance

Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.

This talk focuses broadly on Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. More specifically, how has Merck decided to optimize clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams? What are key considerations for clinical trial planning, site selection, and protocol design? And, what and why did Merck keep many core capabilities “in-house”?

9:10 am THE CLINICAL TRIAL DATING GAME:

Beyond the Real-World Data, What Are Patients Saying?
Special LIVE Episode with Studio Audience–Patient Contestants will be Announced Onsite!

Brett Kleger, CEO, Inspire

The Bachelor: Kristopher Sarajian, Vice President, Marketing, Trialbee

SCOPE’s Gameshow Host: Brett Kleger, a man whose dream it was to be a wedding singer or gameshow host

In today’s episode of “The Clinical Trial Dating Game” we have our pharma industry bachelor looking for a volunteer for his trial. He must question and choose from among three patients, who are hidden from view. He has access to all of their data, but there is more to this person than data, so how will he know which questions to ask? How will he avoid bias? How will he recruit on time? Knowing how important patient centricity is to the clinical research industry and with so much on the line, will our bachelor land a date? What could go wrong?

9:20 am KEYNOTE PANEL DISCUSSION:

How Patients Can—and Must—Disrupt Traditional Pharma Clinical Trials

PANEL MODERATOR:

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

Should biopharma companies be the only "sponsors" for clinical trials of new medicines? Does the current model limit opportunities for unmet needs in small populations or leveraging repurposed drugs? This panel will gather leaders demonstrating ways that patient-led non-profit organizations are challenging assumptions and taking a leadership position in medicine development. No longer can we think of patients as guests at pharma's table—is the next transformation in medicine development going to be entirely patient-led?

PANELISTS:

Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL

Heidi Bjornson-Pennell, Senior Program Manager, Science in Society and Lead, Rare As One Network, Chan Zuckerberg Initiative LLC

Nasha Fitter, Co-Founder & CEO, FOXG1 Research Foundation

Craig Martin, Founder, CEO, The Orphan Therapeutics Accelerator

Tracey U. Sikora, Vice President, Research & Clinical Programs, National Organization for Rare Disorders; Co-Founder, Every Cure

9:50 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall—Best of Show Voting Opens

Join us for the Grand Opening Networking Coffee break in our biggest SCOPE Exhibit Hall ever! Mingle with friends, forge new connections, and exchange ideas over your morning cup of joe. Visit exhibitors and learn about their latest and greatest innovations and products...voting opens for our Best of Show awards so don’t forget to vote.

Part 1: Modernizing Lab, Biomarker & Data Management Operations

11:00 am Chairperson's Remarks

Ryan Gifford, Vice President, Global Laboratory Services, CTI

11:05 am

Biospecimen Industry Collaboration: Pioneering Best Practices to Standardize, Accelerate, and Transform Clinical Research

Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC

Specimen Management is a critical, yet often overlooked function within clinical trials. The overwhelming majority of industry discussion currently focuses on quality data management practices and how build automated data pipelines, yet there is almost no corollary discussion of quality specimen management practices that would not only facilitate building those pipelines, but would also reduce queries (thus cost), increase quality and speed, and improve reproducibility of research, leading to higher confidence in the use of AI. The Biospecimen Industry Collaboration was formed by a dozen biopharma companies who recognize this key gap, and are building a best practices framework to enable the industry and its partners to standardize where possible, paving the way for the next-generation of tools and technology to transform clinical trials.

11:10 am

Operationalizing Precision Medicine: Best Practice from Protocol Design through Study Start-Up

Nancy DeFusco, Director, Specimen Lifecycle Management, Merck Sharp & Dohme LLC

Kenna Sayers, Director, Vendor Management, Integrated Biomarker Operations, Merck

This presentation will review the output of a workshop attended by 10 major global biopharma companies discussing areas of opportunity for industry standardization from Protocol Design through Study Start-Up, to streamline clinical trial operations.

11:35 am

Operationalizing Precision Medicine: Best Practice from Site Activation through Study Closeout and Final Disposition of the Specimen

Deborah Shepard, PhD, Director, Group Lead—Biomarkers Clinical Data Acquisition, Pfizer Inc.

John Smutko, Head of Specimen Management Oncology, GSK

This presentation will review the output of a workshop attended by 10 major global biopharma companies discussing areas of opportunity for industry standardization during Study Conduct through Closeout, to streamline clinical trial operations.

12:05 pm PANEL DISCUSSION:

Biospecimen Industry Collaboration Q&A

PANEL MODERATOR:

Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC

Don't know where your specimens are? Frustrated with the status quo? Come hear from specimen management, data management, and biobanking experts who participate in the Biospecimen Industry Collaboration about how the best practices they are developing can benefit you and your team!

PANELISTS:

Nancy DeFusco, Director, Specimen Lifecycle Management, Merck Sharp & Dohme LLC

Arkady Gusev, PhD, Head, Lab Excellence & Operations in Biomarker Development, Novartis Institutes for BioMedical Research, Inc.

Anna Kosenko, Associate Director, Biomarker Operations, BioNTech US Inc.

Rose Redfield, Director, Support & Optimization Biosample Management, Daiichi-Sankyo

Heather Shih, PhD, MBA, Senior Director Biomarker Operations, Global Clinical Development Operations, BioNTech US, Inc.

Michael Tanen, Director, Head of Laboratory Operations and Logistics, Merck

12:35 pm

From Site to Result: Real-Time Sample Intelligence Unlocked with GenAI

Tobias Guennel, Senior Vice President, Product & Chief Architect, Data Management & Systems Integration & Innovation, QuartzBio

With QuartzBio’s Biomarker Intelligence Platform, you can ask questions, get answers, and gain insights across the entire precision medicine data ecosystem. Powered by an ensemble of Precision Medicine Large Language Models (LLMs), QuartzBio’s platform supercharges efforts of operations, translational, and informatics teams, using AI-driven integration of biomarker, sample, and clinical data. This unified, scalable, and interoperable solution enables real-time sample intelligence from point of collection to data generation.

1:05 pm

The Road Less Traveled: Bridging the Research Gap in Rural and Tribal Communities

Jonathan Ernst, Vice President, Business Development, PCM Trials

This session will explore the unique challenges of conducting clinical trials in rural and tribal communities, inspired by insights from the Montana Pathways to Health Equity initiative. We will discuss logistical hurdles, such as extreme weather and long travel distances, and highlight innovative community-based research strategies to overcome these barriers. This discussion aims to provide a deeper understanding of the importance of inclusivity in clinical research through real-world examples and forward-thinking strategies, particularly for underrepresented populations. Attendees will:

Understand the logistical and geographical challenges of conducting clinical trials in rural areas, illustrated through case studies.
Identify innovative solutions and strategies to overcome these challenges.
Recognize the importance of inclusivity in clinical research and the role of community-based research models in achieving it.

1:35 pmSponsored Networking Luncheon

Take this opportunity to refresh and refuel and network, compliments of SCOPE sponsors! Take a well-deserved break outdoors in the sun, or indoors in the air conditioning.

2:35 pmNetworking Coffee & Dessert Break in the Exhibit Hall

SCOPE’s hall this year is bigger than ever; there’s no way to cover it all in just one break. So, after lunch, grab some dessert and a cup of coffee and visit all those booths that you just couldn’t make it to this morning. Stay to hear our Best of Show Winner announcement and congratulate the winner!

3:20 pm

Chairperson's Remarks

Maria Gujral, Senior Director, Biospecimen & Imaging Management, Bristol Myers Squibb Co.

3:25 pm

Optimizing Specimen Reconciliation to Improve Compliance and Data Integrity

Maria Gujral, Senior Director, Biospecimen & Imaging Management, Bristol Myers Squibb Co.

In clinical trials, accurate and timely biospecimen reconciliation is crucial for compliance and data integrity. This presentation explores strategies and best practices to enhance reconciliation processes, addressing common challenges like discrepancies, delays, and data inconsistencies. We will highlight innovative solutions, including automated tracking systems and real-time monitoring tools, to streamline these processes. Gain insights into robust protocols that improve compliance and enhance the quality and reliability of clinical trial data.

3:50 pm

Deploying a Modernized Enterprise-Level Biospecimen Lifecycle Management System

Roger Craveiro, Associate Director Specimen Lifecycle Management, Global Clinical Trial Operations, Merck Animal Health

This presentation will outline the processes and challenges Merck Sharp & Dohme, LLC, encountered while deploying a biospecimen lifecycle management system. Successful deployment was achieved through a comprehensive data ingestion plan, robust training sessions, timely system updates, and enthusiastic system adoption across the organization.

4:15 pm

Specimen Lifecycle Management: Overcoming Challenges to Launch Biospecimen Management Technology

Nancy DeFusco, Director, Specimen Lifecycle Management, Merck Sharp & Dohme LLC

The new platform technology provides reporting, forecasting, and real-time dashboards to support sample assessments, which will enable proactive decision-making in our clinical trials. Leadership engagement and promotion was critical to the organization’s acceptance and adherence. Our workstreams, sites, clinical, data management, quality, and suppliers continue to assess end-user feedback to improve additional efficiencies to the overall sample management process. Our deployment efforts of this platform enhanced our Change Management Process to support uptake within the organization, improving customer service to our stakeholders in the existing system, while further enhancements are tested directly, related to the feedback provided.

4:40 pm

Using Gen AI for Content Extraction from ICFs to Ensure Compliance for Individual Site and Country to Meet Sample Destruction Timelines

Lisa Hersh, Senior Manager, Precision Medicine, Regeneron

Anamika Sarkar, PhD, Intelligent Automation Lead, Global Development Solutions, Regeneron Pharmaceuticals, Inc.

Generative AI used to extract country and site-specific sample retention timelines from individual ICFs across sponsored clinical trials resulting in a user-friendly dashboard created to document differences in sample retention timelines and to ensure compliance with sample destruction for all subjects. Using a sample destruction countdown feature, end users can see upcoming sample expiration dates and ensure sample destruction approvals and actions are completed and documented appropriately.

5:05 pm

FDA Regulation of LDTs: The Impact on Clinical Trials for Precision Medicine

Christine P. Bump, JD, MPH, Principal, Penn Avenue Law & Policy

In May 2024, the FDA issued a final rule amending the definition of in vitro diagnostic products (IVDs) to include laboratory developed tests (LDTs). This change subjects LDTs to the agency’s medical device regulations, including for investigational uses and clinical trials. Many tests for biomarkers and precision medicine are LDTs. This session will explain the new requirements for laboratories and the impact on clinical trials for precision medicine.

5:25 pm

Leveraging Digital Samples in Precision Medicine Trials—An Operational Perspective

Henry Hoffman, Senior Vice President R&D, BASE Life Science

Dr. Shibeshih Belachew, Chief Medical Officer, Indivi

From targeted treatment to precision medicine – how did clinical trials change over time. We will cover the below aspects: 1) What are the challenges of precision trials? 2) How can digital samples be leveraged in precision medicine trials from a medical or scientific point of view? 3) What is required to utilize digital samples in precision medicine trials? 4) We'll take a quick look at the benefits of a cross-industry platform vs individual solutions

5:55 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)

Wind down at the end of a busy session day with colleagues and old and new friends. Networking is always in full swing at this reception, so raise a glass with your favorite exhibitors and take a chance at winning one of our fabulous raffle prizes (must be present to win). Continue your networking over dinner at one of the Rosen Shingle Creek's fine dining or casual restaurants and eliminate the need to face Orlando traffic.

7:15 pmClose of Day

7:15 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop from 7:00pm-11:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.

On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

Wednesday, February 5

7:45 amRegistration Open

8:15 am

BREAKFAST PRESENTATION OPTION #1:Digital Innovation’s Role in Pediatric and Elderly Clinical Trials

Kyle Hogan, CEO, Datacubed Health

This presentation examines how targeted digital tools improve retention rates among pediatric and elderly participants. Our pediatric focus reveals how gamification can create meaningful connections and enhance the trial experience while engaging caregivers. For elderly participants, we examine the use of accessible interfaces and remote monitoring solutions to address age-specific challenges. Attendees will discover strategies for implementing these solutions within their research programs.

8:15 am

BREAKFAST PRESENTATION OPTION #2:Expanding the Patient Universe: Transforming Clinical Trials through Inclusive, Data-Driven Design

Christopher Riley, Director, Strategic Insights, Solutions, H1

In today’s complex clinical research landscape, achieving patient-centricity and inclusivity is more critical than ever. This presentation introduces Patient Universe, a groundbreaking solution designed to optimize trial feasibility while addressing health equity challenges. Attendees will learn how leveraging real-world health equity data can transform patient recruitment strategies, create inclusive trial designs, and improve participant engagement. Through actionable insights and use cases, this session will demonstrate how advanced analytics and innovative technologies can bridge gaps in representation, support diversity action planning and enhance trial outcomes.

8:15 am

BREAKFAST PRESENTATION OPTION #3:

Scaling Success: How Sanofi and Trialbee Drive Patient-Centric Recruitment and Reduce Site Burden in Global Asthma Programs

Whitley Albright, Clinical Innovation and Operations Strategy Lead, Sanofi

Gaynor Anders, Chief Delivery Officer, Trialbee

Join Whitley Albright (Sanofi) and Gaynor Anders (Trialbee) to discuss how to keep patients at the center of focus while reducing site burden in a complex global asthma program by: connecting patients to the right trials with targeted outreach and a highly efficient global process; pre-qualifying all patients with live medical secondary screening to reduce the volume sent to sites, improve trust, and increase referral-to-consent ratio; keeping disqualified patients ready to enroll with program-level rematching; centralizing activity in a Patient Recruitment Platform (PRP) to manage progress, evaluate site performance, and measure campaign ROI; building a collaborative, supportive, and meaningful relationship.

Learn how these organizations are scaling recruitment success globally while achieving diversity and inclusion goals, reducing site burden, and keeping patients at the center of care.

8:45 amTransition to Sessions

8:50 am

Chairperson's Remarks

Karina Bienfait, PhD, Executive Director, Consent, Biospecimen & Imaging Management, Bristol Myers Squibb Co.

8:55 am

The Other Side of the Protocol: Insights from a Clinical Research Site

Suzin Webb, Site Director, Velocity Clinical Research

In the era of precision medicine, we are witnessing a significant change in how clinical trials are designed and conducted. Advances in many areas including AI, laboratory testing, sample collection, digital health, and decentralized trials are truly transforming clinical research. Research sites will likely need to work creatively, take on new technologies, and adapt standard practices. Real world challenges and solutions will be discussed from the research site’s perspective.

9:25 am PANEL DISCUSSION:

Biospecimen Management Consortium: Driving Sample Excellence in Clinical Research

PANEL MODERATOR:

Amy Ripston, Founder & Executive Director, Biospecimen Management Consortium

The Biospecimen Management Consortium (BMC) was founded to drive sample excellence in clinical research—by setting standards and developing best practices, streamlining biospecimen operations and data, and shaping regulatory policy. This panel of founding members will discuss the goals and objectives of the consortium, progress on its initiatives, how industry can contribute, and its roadmap for the upcoming year.

PANELISTS:

Karina Bienfait, PhD, Executive Director, Consent, Biospecimen & Imaging Management, Bristol Myers Squibb Co.

Stephanie Wylie, Senior Scientist, Sample Management, Bioanalytical and Biomarker Sciences and Technologies, Takeda Pharmaceuticals, Inc.

Mark Melton, Co-Chair, Biospecimen Management Consortium

Roshan Yadama, Strategic Business Operations, Profound Research

9:55 am

PANEL DISCUSSION:Unifying the Ecosystem: A Collaborative Approach to Agnostic Data Sharing in Clinical Research

Mark Melton, Vice President, Biospecimen Data & Operations, Slope

Anne MacNeil, Senior Director, Operations Lab Logistics, CellCarta

John Mapel, Senior Vice President, Client Services, LabConnect LLC

Analyze the challenges of a fragmented clinical ecosystem on data sharing and quality. Understand the status quo and the need for agnostic data sharing. Case study examples: Collaborations for inventory and sample metadata continuity. Unlock the power to transform clinical research.

10:25 amCoffee Break in the Exhibit Hall

SCOPE is ALL about networking—with clients, colleagues, sponsors and exhibitors. Take this chance to visit booths you haven't been to, build new relationships, and fuel up with coffee for the rest of the busy day ahead. Last chance to vote for the Best of Show award! Make your vote count!

10:45 amSpecial Book Signing

Fundamentals of Decentralized Clinical Trials
Editors: Isaac R. Rodriguez-Chavez & Anna Yang

Location: Gatlin Foyer, ClinEco Booth #1

11:20 am

Chairperson's Remarks

Karina Bienfait, PhD, Executive Director, Consent, Biospecimen & Imaging Management, Bristol Myers Squibb Co.

11:25 am

IC-Scope: Use of LLMs to Evaluate Local Consent Scope and Enable Additional Research Use of Clinical Data and Samples

Dmitri Mikhailov, PhD, Director & Global Head, Biomarker Coordination, Novartis Institutes for BioMedical Research, Inc.

Use of clinical data and sample in research may go beyond what is planned in trial protocols. To respect participants rights, additional research projects should be covered by informed consents used locally at sites. Understanding local consent changes can be a daunting task for a project team seeking to use trial data or samples. This talk describes how LLMs can be used to streamline evaluation of local consent scope changes.

11:55 am

Leveraging AI to Codify Informed Consent

Cristin Freeman, Head, Informed Consent Management, Bristol Myers Squibb Co.

Informed consent codification to determine permissions and restrictions to utilize biospecimens and data is a manual and time-consuming task, but essential to ensure compliance and uphold commitments to participants. To increase efficiency and speed, BMS has developed an innovative AI tool to assist in IC Codification. The tool can identify relevant IC documents, scan and assess restrictive language to inform sample storage for clinical trial samples, and provide outputs to inform expedited reviews.

12:25 pm

The Role of Radiology Imaging Biomarkers in Clinical Trials

Aline Lutz, Vice President, Medical Affairs, Segmed, Inc.

Imaging biomarkers are highly relevant in drug clinical trials due to their ability to provide objective, quantifiable, and usually non-invasive measures of biological processes, disease progression, and treatment response. This talk explores the role of radiology and nuclear medicine in clinical trials, highlighting their impact on patient inclusion, stratification, endpoint assessment, and their use as predictive biomarkers to evaluate treatment response.

12:55 pmSponsored Networking Luncheon

Once again, join us for lunch, courtesy of our generous sponsors.

1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall—Best of Show Winner Announced

SCOPE's Networking Coffee and Dessert Break is the perfect time to pick up a sweet treat, courtesy of our sponsors, and fuel up for the afternoon with a cup of coffee or soft drink. Visit our Game Card Sponsors to fill your Game Card with stickers and get in a little more networking time before afternoon sessions!

2:30 pm

SCOPE around the World, Faces from the Community

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute; Co-Founder, ClinEco

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

2:35 pm

Chairperson's Introduction

Brad Stefanovic, PhD, Head Clinical Innovation, Pro-ficiency, a Simulations Plus Company

2:37 pm KEYNOTE PRESENTATION:

Fostering Clinical Innovation in a Large Pharmaceutical Organization

James Gallagher, Senior Director, Innovative Health, Johnson & Johnson Innovative Medicine

This presentation explores strategies for fostering innovation within a large pharmaceutical organization by focusing on four key areas: developing a clear mandate and compelling vision to guide innovation efforts; designing and engineering an infrastructure that supports creativity and collaboration; building a high-performance, diverse team empowered to drive innovation; and seeking opportunities for true patient-centricity and sponsor-agnostic innovation. By aligning these elements, the organization can create a sustainable innovation ecosystem that prioritizes patient outcomes and drives transformative breakthroughs in healthcare.

3:00 pm KEYNOTE PRESENTATION:

Harnessing Tech & AI for Quality and Performance in Clinical Trial Operations

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

Sponsors can leverage increasing technology capabilities to enhance quality by integrating advanced data analytics, AI, and automation into their drug development and manufacturing processes. These technologies enable real-time monitoring, predictive analytics, and streamlined workflows, ensuring higher precision and consistency in product quality. Additionally, digital tools facilitate better compliance with regulatory standards and more efficient management of clinical trials, ultimately accelerating time-to-market while maintaining rigorous quality standards.

3:20 pm

SCOPE Award Winners & Announcements

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

3:25 pmSponsored Presentation (Opportunity Available)

3:30 pm KEYNOTE PANEL DISCUSSION:

The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond

PANEL MODERATOR:

Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Johnson & Johnson

Gen AI, a groundbreaking approach that seamlessly merges artificial intelligence into our daily lives, holds immense potential for transforming the pharmaceutical and healthcare industries. This paradigm shift not only demands a thorough understanding of the ethical implications, potential biases, and social consequences of AI systems— it also requires a steadfast focus on creating tangible value that benefits individuals and society at-large. By harnessing advanced AI technologies, Gen AI can pave the way for unparalleled breakthroughs, elevating patient care, enabling personalized medicine, streamlining processes, and revolutionizing the way we approach healthcare as a whole. Join the debate on the real value-based use cases and explore the endless possibilities that Gen AI brings to the table.

PANELISTS:

James Gallagher, Senior Director, Innovative Health, Johnson & Johnson Innovative Medicine

Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.

Brian Martin, Chief AI Product Owner, BTS; Head of AI, R&D Information Research; Senior Research Fellow, AbbVie, Inc.

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

4:00 pmBooth Crawl & Refreshment Break in the Exhibit Hall (Sponsorships Available) Last Chance for Exhibit Viewing

We know you're tired, we know the Exhibit Hall is huge, and we know you still have some booths to visit, some connections to make, some networking to do. SCOPE's Networking Booth Crawl is the time to do it! Crawl if you must, but be sure to visit our sponsored booths for some food, drinks, and enough energy to finish SCOPE strong! Our final Networking Exhibit Hall break is the final time to see the exhibits you haven't seen and meet the people you haven't yet met. The break ends with another amazing raffle prize, so be sure to get your Game Cards in and the lucky winner (must be present to win) could be you!

5:00 pmClose of Day

5:00 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop from 5:00pm-9:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.

On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

Thursday, February 6

7:15 amRegistration Open

7:45 am

BREAKFAST PRESENTATION:What Sites Really Need to Deliver Successful Patient Engagement Strategies

Leslie Ives, Senior Director, Patient Recruitment, Patient Strategy and Insights, Parexel International

Brittany Harvey, Clinical Project Mgr, Clinical Operations, UCB Inc

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites

Sites have shared that delivering successful patient recruitment is arguably one of the most persistent challenges they face. Despite this being well-known, not enough of the right support is provided to them, causing more than half of sites to pay out of pocket for unreimbursed recruitment expenses, all while the one-size-fits-all recruitment materials provided to them collect dust. By rethinking how we support sites in their patient engagement activities, sponsors and CROs can shift the paradigm to make patient enrollment delays and declining retention rates outliers, instead of the norm. This breakfast session will discuss strategies to transform patient engagement by leveraging site experience, incorporating patient insights and motivations, as well as AI solutions, to improve patient retention and deliver better study outcomes.

8:15 amTransition to Sessions

8:20 am

Chairperson's Remarks

Jarod Prince, Senior Manager, R&D Operations, Amgen, Biospecimen Strategy and Operations

8:25 am

Logistics Considerations in a Global Clinical & Biospecimen Supply Chain

Thomas J. McDonald, MS, Consultant—Clinical Trials, Biospecimen & Vendor Relationship Management

Data derived from our clinical trial samples is essential to primary, secondary, and exploratory endpoints. Injecting human biospecimens into the global supply chain, however, can be a harrowing proposition. Often with limited stability, temperature control considerations, and analysis being performed on a different continent, we will review strategies and approaches to demystify the logistics and ensure maximum efficiency in your global biospecimen supply chain.

8:55 am

Exploratory Biomarkers in Clinical Trials: Right Clinical Site, Right Lab, Right Data, Right Time, and Right Quality

Arkady Gusev, PhD, Head, Lab Excellence & Operations in Biomarker Development, Novartis Institutes for BioMedical Research, Inc.

Exploratory biomarkers enable clinical decision making and often paves the way for precision medicine approaches in drug development. This presentation will focus on systematic approaches to biomarker (soluble, cellular, and digital endpoints) implementation in clinical trials, de-risking and ensuring biomarker deliverables and impact. Planning and feasibility process, clinical site training, CRO selections, data flow considerations, quality, and compliance standards will be presented and discussed.

9:25 am

Accelerating Clinical Trials with Smart Variation Management

Ankit Bajpai, Associate Principal, ZS

Changes in clinical trials due to regulatory updates, logistical hurdles, & site-specific issues, are inevitable, leading to delays & inefficiencies. Effective variation management requires tailored strategies like process automation, workflow standardization, and enhanced oversight to address these complexities. This discussion explores how these solutions help reduce variation timelines by nearly 50%, optimizing resources and ensuring efficient trial execution.

9:40 am

Cell & Gene Therapy Orchestration—A Solution to Track and Manage the End-to-End Patient and Product Journey

Raj G, Head Clinical Solutions, Healthcare & Life Sciences, Hexaware Technologies

Mike Wheeler, Product Marketing, Life Sciences, SAP

Cell and Gene Therapy is a rapidly growing sector within the Life Sciences industry. CGTs offer the potential to treat various diseases including cancers and rare diseases. CGT value chain is more complex than traditional pharma, requiring more stakeholders and touchpoints throughout the patient and product journey. This presentation discusses the cell and gene therapy orchestration solution developed by Hexaware and SAP, designed to track and manage the E2E patient and product journey to ensure that patients receive the right treatments at the right time without errors.

9:55 am

Tissue and Blood Biospecimen Journey: Strategies to Avoid Logistical Uncertainty

Michael Tanen, Director, Head of Laboratory Operations and Logistics, Merck

A critical part of any complex, biomarker rich clinical trial is the ability to de-risk the logistical uncertainties related to biospecimens. From collection, processing, tracking, analysis, and storage the lifecycle of a biospecimen can be complex and filled with potential obstacles. All of which are at times assigned or outsourced to various clinical teams, sites, CROs, third party vendors, and biorepositories. To minimize such obstacles, we will discuss various strategies to plan, de-risk, track and set up for biospecimen success in these complex clinical trials.

10:25 am PANEL DISCUSSION:

Where Are My Samples? Deconvoluting Biospecimen Supply Chain Logistics

PANEL MODERATOR:

Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC

The rise of diagnostics and biomarker-based medicines shifts the conversation from "Where are my results?" to "Where are my specimens?" This is especially true of cell and gene therapies, in which the specimen is the drug. However, trial managers, clin pharm & biomarker operations leads, cell and gene manufacturing professionals, and data managers all know that this is not an easy question to answer. Come listen to a panel of experts, whose entire focus is understanding where your specimens are, all around the globe, demystify specimen logistics. This is your opportunity to get your questions answered!

PANELISTS:

Christine P. Bump, JD, MPH, Principal, Penn Avenue Law & Policy

Thomas J. McDonald, MS, Consultant—Clinical Trials, Biospecimen & Vendor Relationship Management

Jarod Prince, Senior Manager, R&D Operations, Amgen, Biospecimen Strategy and Operations

11:10 amNetworking Coffee Break

Part 2: Biomarker & Biospecimen Technology & Innovation

11:50 am Chairperson's Remarks

Rachel Wagner, Vice President, Business Development, Care Access

11:55 am

Incorporating Patient-Centric Sampling into Multicenter Clinical Trials: Output from the PCSIG Workshop

Jas Bajwa, Manager, Biosample Operations, Roche

The Patient Centric Sampling Interest Group PCSIG) is a not-for-profit organization that brings together a variety of interested parties who wish to develop and promote the use of patient centric sampling technologies for blood, plasma, urine and other human matrices to better facilitate the advancement of human healthcare and well-being. With this in mind PCSIG held a workshop bringing together individuals with various expertise and backgrounds, with a common passion for making patient-centric sampling a reality in decentralized clinical trials, and a vision of creating a roadmap to guide the industry to overcome associated challenges. The meeting was a great success and a roadmap was developed end to end from conception to delivery and this presentation will explore the findings. If you want to implement or build in the area of patient-centric sampling within your organization then this presentation is not to be missed and will provide valuable insights and rapidly advance your progress and learn from the experiences of many.

12:25 pm

Learnings and Performance of a 50,000 Patient-Activated Community, Centered around Vaccine Clinical Trial Participation

Manuri Gunawardena, CEO, Executive, HealthMatch

Nick Spittal, COO, Exec, Velocity Clinical Research

HealthMatch & Velocity Clinical Research created a 50,000 patient activated vaccine community in 2024, months in advance of any specific study launch. The community was educated, nurtured and insights gathered to ultimately shape recruitment strategy and outcomes across multiple vaccine studies at the end of 2024. The speakers will share learnings from the project including performance around randomizations and patient education and discuss how this methodology can be applied successfully to other therapeutic areas

12:55 pm

“This Won’t Work”: Establishing Study Conduct at Retail Pharmacy

Adam Samson, Head Clinical Delivery Operations, Walgreens Clinical Trials

Walgreens Clinical Trials is standing up study sites at retail pharmacies across the country. Learn how these community-centered research locations are set up and how they impact the communities they’re in.

1:25 pmTransition to Lunch

1:30 pm

LUNCHEON PRESENTATION: Future of Medicine: Community Health Screenings and Research Education Across America

Ralph Passarella, Co-Founder, Care Access

Get an on-the-ground view into the Future of Medicine program and how Care Access is making advanced health screenings, research education, and study opportunities accessible to hundreds of communities across the nation and beyond.

2:00 pmSCOPE Summit 2025 Adjourns