Clinical Supply & Logistics

2025 ARCHIVES

Data Technology for End-to-End Clinical Supply Management

Clinical Supply Chain Strategies to Align Process, Products and Patients

Patient-centric clinical trials rely on efficient, streamlined supply chain processes to ensure investigational drugs are delivered to the right patient, at the right time, and in the right place. SCOPE’s 8th annual Clinical Supply & Logistics stream presents case studies and best practices that highlight the pivotal role of supply chain management in navigating the complexities of modern clinical trials. The 6th Annual Data Technology for End-to-End Clinical Supply Management conference explores how digitalization is transforming relationships across the clinical trial supply chain ecosystem. By integrating insights from multiple data sources, organizations can enhance data quality and volume, leading to more accurate forecasting, improved efficiency, and significant time and cost savings. The 8th Annual Clinical Supply Management to Align Process, Products, and Patients conference focuses on the critical role of patients and their biospecimens, gathering supply chain logistics experts who are constantly challenged to innovate and make swift, effective decisions. Discover strategies to optimize supply planning, gain actionable insights, implement cutting-edge tools, and ultimately, ensure the best outcomes for patients.

Part 1: Data Technology for End-to-End Clinical Supply Management

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

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 pm– 1:45 pm WORKSHOP 2: Exploring ClinEco—SCOPE’s Growing Online B2B Clinical Trial Community

PRESENTERS:
Marina Filshstinsky, MD, Executive Director, SCOPE Summit; Co-Founder, ClinEco
Micah Lieberman, Executive Director and Team Lead, SCOPE Summit; Co-Founder, ClinEco
Erik Yorke, Marketing Lead and Scientific Writer, ClinEco

Discover how you can stay connected and extend your SCOPE conference conversations year-round in this interactive workshop focused on ClinEco—the dynamic online B2B marketplace bringing together sponsors, CROs, site networks, and innovative solution providers to streamline partnering.

This workshop will help you understand how to take full advantage of ClinEco’s capabilities. Through real-world case studies, we'll demonstrate how ClinEco members streamlined their outsourcing processes, discovered new partners, and expanded their global reach. Whether you're a sponsor seeking new collaborations or a vendor looking to stand out, this session will provide actionable insights to boost your success.

Join us to experience the future of clinical trial networking and collaboration!

1:00 pm– 2:30 pm WORKSHOP 3: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials

INSTRUCTORS:

Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific

Thierry Escudier, Portfolio Lead, Pistoia Alliance

Hannah Sieber, Co-Founder, CEO, Artyc

Diana Steinbuesch, BioX Operations Portfolio Lead (Oncology), Roche

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. Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.

1:00 pm– 2:30 pm WORKSHOP 4: Efficient Importation of Biological Materials into the U.S.

INSTRUCTORS:
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.
Brandy Porter, Assistant Director, Pharmaceuticals, Health, and Chemicals Center of Excellence & Expertise, U.S. Customs and Border Protection
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: Data Technology for End-to-End Clinical Supply Management

11:00 am Chairperson's Remarks

Luke Basta, Associate Director, Clinical Data Management, IRT & COA Services, Merck & Co Inc

11:05 am

Unlocking IRT Potential for Maximum Leverage

Alminaz Noorani, Associate Director Clinical Systems, Ultragenyx Pharmaceutical, Inc.

Unlocking IRT Potential for Maximum Leverage explores the impact of Interactive Response Technology (IRT) in clinical trials. This talk focuses on how IRT can streamline the trial, enhance data accuracy, and improve patient management. Share insights into leveraging IRT systems for more efficient data collection, real-time monitoring, critical considerations ultimately boosting trial efficacy and accelerating the path to therapeutic discoveries.

11:35 am

Connecting Teams and Promoting Collaboration around IRT

Dawn Sorenson, Director, IRT Center of Excellence, Innovation Management, CSP & O, Daiichi Sankyo, Inc.

This presentation aims to empower teams at any stage of their Interactive Response Technology (IRT) journey by sharing effective strategies for enhancing collaboration. Attendees will learn practical tips for establishing global IRT standards, fostering alignment among study teams, and optimizing partnerships with internal and external collaborators. By promoting a culture of connectivity, the session will equip participants with the tools needed to streamline communication and enhance overall project success.

12:05 pm

Automating Invoice Reconciliation for Clinical Trial Material Distribution

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

Kyle Skillins, Associate Director, Clinical Drug Supply & Logistics, Regeneron Pharmaceuticals, Inc.

Daniel Truxler, Associate Director, Clinical Supply Systems, Regeneron Pharmaceuticals, Inc.

The Clinical Drug Supply and Logistics group at Regeneron faced significant challenges in reconciling a high volume of vendor invoices (3000-5000 per year) for distribution of clinical supply materials, which required significant manual effort. Regeneron has developed automation of reconciliation tasks, integrated with Clinical Supply information stored in IRT (Interactive Response Technology) using RPA (Robotic Process Automation) and AI (Artificial Intelligence) to bring efficiency in clinical trial financial compliance.

12:35 pm

Bridging the Gap: How Consistent Data Integrations Improve the End-to-End Experience

Sean Roy, PhD, Senior Director of Consulting, Life Sciences, Oracle

Luke Basta, Associate Director, Clinical Data Management, IRT & COA Services, Merck & Co Inc

Claire Rivera, MS, Director, Delivery Management, Merck & Co., Inc.

Consistent data integrations streamline clinical trial processes, enhancing efficiency and accuracy in data collection and analysis, ultimately benefiting patient outcomes. This session will also provide practical strategies for overcoming common data integration challenges, fostering collaboration among stakeholders, and ultimately improving patient outcomes.

Key Learning Objectives:

Assess and identify gaps in existing clinical trial data integration systems to improve efficiency and accuracy
Understand the importance of collaboration between IT, clinical, and operational teams
Learn strategies to align objectives and streamline the data integration process to improve patient outcomes

1:05 pm

Enhancing Clinical Supply and Logistics to Advance Patient-Centric Care and DEI in Clinical Trials

Samit Bhatt, Vice President, Clinical Trial Patient Solutions, Myonex, Inc.

Clinical trials are critical to advancing medical innovation and improving patient outcomes. Attendees will gain insights into optimizing supply chain and logistics to improve the patient experience, emphasizing patient-centric approaches that align with the goals of DEI.

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

Lisamarie Georgen, Senior Director Clinical Supplies Operations, MacroGenics, Inc.

3:25 pm

Partnering with Internal Stakeholders and Vendors

Luis Vargas, IRT Manager, Global Clinical Drug Supply, Genmab US, Inc.

In today's dynamic organizational landscape, the ability to effectively partner with internal stakeholders and vendors is paramount to achieving organizational success. This discussion delves into the critical aspects of forming and nurturing these strategic alliances, providing insights and strategies to enhance collaboration, communication, and mutual benefit.

3:55 pm

From Insight to Excellence: Leveraging Deep Domain Knowledge, Operational Leadership, and Clinical Supplies Expertise for Strategic Trial Success

Stephanie Russell, Senior Director RTSM Solution Services, Professional Services, Medidata, a Dassault Systemes Co.

This session will explore how deep industry expertise and operational leadership can transform clinical trial design and execution, ensuring strategic success. By leveraging adaptive approaches and real world experiences, it highlights how expert-led teams collaborate with study teams to overcome challenges, optimize outcomes and maintain trial integrity.

Key Learnings:

The importance of aligning trial design to anticipate and address challenges proactively.
How experienced teams help sponsors avoid common pitfalls, such as randomization errors, to ensure trial success.
Insights into navigating complex scenarios like First-In-Human (FIH) trials with expert-driven risk management.
The role of operational excellence in maintaining data integrity and trial credibility.

4:25 pm

To Outsource or Not to Outsource, That Is the Question

Lisamarie Georgen, Senior Director Clinical Supplies Operations, MacroGenics, Inc.

Should you outsource Clinical Supplies Management? Should you keep Clinical Supplies Management in-house? Come join this presentation as we dive into the debate of outsourcing Clinical Supplies Management and discuss the pros and cons of each scenario.

4:55 pm

Clinical Sample Logistics Best Practices

Genoa Garcia, Senior Business Development Manager, US Clinical Services, Avantor

Looking at supply-chain logistics options for emerging biopharma. Focusing on sample-collection kit design to sample logistics to help with process efficiency and minimize sample risk and spending.

5:25 pm

PAIN POINTS PANEL: Peer-to-Peer Resolutions

PANEL MODERATOR:

Lisamarie Georgen, Senior Director Clinical Supplies Operations, MacroGenics, Inc.

Clinical Supplies serves as the crucial link between numerous stakeholders, both internal and external. As clinical trials become increasingly complex, the pressure to deliver rapidly and efficiently intensifies. Consequently, Clinical Supplies teams are expected to be highly flexible and responsive. This session will delve into strategies for enhancing collaboration between Clinical Supplies and key partners, including Clinical Operations/Clinical Program teams, CMC/Manufacturing Teams, Vendors/CMOs, CDMOs, and IRT/RTSM developers.

PANELISTS:

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

Mia Carter, Senior Manager, Product Delivery IRT & CSM, ICON Clinical Research LLC

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

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

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

9:20 am

Chairperson's Remarks

Lee Buckler, Senior Vice President, Advanced Therapies, Blood Centers of America

9:25 am

Cell Therapy Patient Operations: Enhancing Customer Experience Through Data-Driven Support

Michael Mehler, Director, Cell Therapy Operations, AstraZeneca

In cell and gene therapy, the vein-to-vein process involves multiple teams and touchpoints, requiring seamless coordination and robust data collection and analysis to ensure efficiency and patient success. For CGT clinical supply chain logistics professionals, data-driven insights help identify bottlenecks, optimize workflows, and improve decision-making across the supply chain. Manufacturers must provide consistent support throughout the entire journey, from apheresis to infusion, to ensure therapies are delivered on time. By combining high-touch operational support with data-driven insights, manufacturers can create a positive patient experience while improving the efficiency and reliability of cell therapy delivery.

9:55 am

Mitigating Risk and Complexity in Cell & Gene Therapy Trials with IRT

Cara Woodruff, Director, Product Management, IT Design & Development, Clinical Technologies, IQVIA Technologies

Cell and Gene Therapies (CGT) promise critical and transformative benefits to patients. However, even with record funding and new launches in this sector, trial and patient journey complexities pose significant barriers to the success and sustainability of these treatments. CGT pioneers require supply chain partnerships that deliver experience in mitigating trial risk and complexity, along with a consultative approach to protocol execution. Let’s explore how to succeed by optimizing pre-trial and pre-screening activities and reducing trial cost and risk with your IRT solution.

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

11:25 am

Ensuring Precision and Safety: Vein-to-Vein Tracking in Cell and Gene Therapy

Christine M. Fernandez, Consultant, Cell & Gene Therapy

Tracking cell and gene therapy (CGT) products from vein-to-vein is crucial to ensure their safety, efficacy, and regulatory compliance. Proper storage conditions and specialized containers are used to preserve cell products, with real-time tracking during transit to ensure timely and safe delivery to clinical sites. Before infusion, product identity and patient match are verified to ensure accuracy. Advanced tracking technologies enhance accuracy and data integration, facilitating seamless information flow. This comprehensive vein-to-vein tracking process underscores the critical role of precision and reliability in the successful delivery of CGT products.

11:55 am

Innovative Strategies for a More Robust (Yet Adaptable, Accessible, and Cost-Effective) Global Advanced Therapies Supply Chain

Lee Buckler, Senior Vice President, Advanced Therapies, Blood Centers of America

Cell therapies require unique and complex starting material, production, and affordability supply chain challenges. This presentation will discuss innovative strategies being tested and employed to optimise the production and delivery of these therapies to patients in community settings—outside of large urban research centers—across the globe.

12:25 pm PANEL DISCUSSION:

Scaling CGT: Cracking the Supply Chain Code

PANEL MODERATOR:

Lee Buckler, Senior Vice President, Advanced Therapies, Blood Centers of America

The cell and gene therapy (CGT) supply chain presents distinct challenges that require specialized strategies. As demand for CGT continues to grow, scaling production while ensuring product integrity and quality is paramount. Success depends on maintaining cell viability and functionality throughout the process. This panel will focus on practical solutions for overcoming scaling obstacles, preserving product integrity, and fostering collaboration among stakeholders—spanning from patient to manufacturing and back.

PANELISTS:

Christine M. Fernandez, Consultant, Cell & Gene Therapy

Michael Mehler, Director, Cell Therapy Operations, AstraZeneca

Cara Woodruff, Director, Product Management, IT Design & Development, Clinical Technologies, IQVIA Technologies

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

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