2025 Keynotes
(The New 2026 Keynotes will be Posted Soon)
MONDAY, FEBRUARY 3, 2025
8:00 am SCOPE’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 am Registration Open
Co-locate your User Group, Workshop, or even your company’s Annual Meeting with SCOPE Summit: www.scopesummit.com/scope-user-group-meetings
12:00 – 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 – 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 – 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 ‘Sustainability 101’ to help anyone in our industry to 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 – 4:00 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 – 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 (CHI); 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 (CHI); 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 MODERATORS:
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:
Otis Johnson, PhD, MPA, Principal Consultant, Trial Equity
Emily McCormack, Social Media Director, New York Blood Center
Quynh Tran, MPH, Director of Patient Activation, Cystic Fibrosis Foundation
Fabian Sandoval, PhD, President & CEO, Emerson Clinical Research Institute
Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Boots Alliance
5:05 pm SCOPE's 9th Annual Participant Engagement Awards Introduction: Industry Mandate and Collaboration for Expanding Access to Clinical Trials
5:10 pm SCOPE's 9th Annual Participant Engagement Awards
PANEL MODERATORS:
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
Kelly McKee, Head of Innovative Patient Recruitment, Evinova; Co-Creator of the SCOPE Participant Engagement Award
David Sall, President & CEO, Patient Enrollment Advisors LLC; Co-Creator of the SCOPE Participant Engagement Award
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, Parexel International
Otis Johnson, PhD, MPA, Principal Consultant, Trial Equity
Kim Ribeiro, Chief Client Officer, Inside Edge Consulting Group
5:45 pm SCOPE'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 are optional !). Let’s bring the aloha spirit to life as we kick off another amazing SCOPE conference experience.
Join us to reconnect with old friends, make new ones, and soak up the Florida sunshine in style!
7:00 pm Close of Day
TUESDAY, FEBRUARY 4,2025
6:30 am SCOPE's 5K Rise and Shine Fun Run!
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 am Registration Open
7:30 am Morning 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 am Grab 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 (CHI); Co-Founder, ClinEco
SCOPE and Clinical Research News Best of Show Awards
SCOPE Site Innovation Award
SCOPE Participant Engagement Award
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!
SCOPE’s Gameshow Host: Brett Kleger, CEO, Inspire
The Bachelor: Kristopher Sarajian, Vice President, Marketing, Trialbee
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 what 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 a guest 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 Behring GmbH
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 am Grand 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.
WEDNESDAY, FEBRUARY 5, 2025
1:55 pm Networking Coffee & Dessert Break in the Exhibit Hall—Best of Show Winner to be Announced
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!
2:30 pm SCOPE Around the World, Faces from the Community
Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI); Co-Founder, ClinEco
Marina Filshtinsky, MD, Executive Director, Cambridge Healthtech Institute (CHI); Co-Founder, ClinEco
2:35 pm Chairperson’s Introduction
Brad Stefanovic, PhD, Head of 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 (CHI); Co-Founder, ClinEco
3:25 pm Chairperson’s Introduction
Gary Lubin, CEO, Ledger Run, Inc.
3:30 pm KEYNOTE PANEL DISCUSSION: The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond
PANEL MODERATOR:
Disa Lee Choun, Head, Integrated Clinical and Operational Analytics (ICOA), J&J Innovative Medicine
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 pm Booth Crawl & Refreshment Break in the Exhibit Hall. 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 pm Close of Day
A FEW SHORTCUTS TO HELP YOU AT SCOPE: