2025 Keynotes
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
1:00 – 1:45 pm WORKSHOP: Join and Explore ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace
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 Cour ‘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. Open to all SCOPE attendees.
1:00 – 2:30 pm WORKSHOP: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials
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 ‘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: Efficient Importation of Biological Materials into the U.S.
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.
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.
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
Speaker to be Announced, PAREXEL International
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
Speaker to be Announced, 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
Brett Kleger, CEO, Inspire
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
5:05 pm SCOPE's 9th Annual Participant Engagement Awards Introduction: Industry Mandate and Collaboration for Expanding Access to Clinical Trials (Sponsorship Opportunity Available)
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, Senior Director, Head of Patient Recruitment, Clinical Development Operations, Seagen
Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative
Stacy Hurt, Patient Advocacy Ambassador, Patient Engagement, Parexel International
Otis Johnson, PhD, MPA, Principal Consultant, Trial Equity
Kim Ribeiro, Head, Diversity and Patient Inclusion, AbbVie
5:45 pm SCOPE's Kickoff Reception
Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! Meet your old friends, make some new ones, and soak up the Florida vibes and another amazing SCOPE conference experience.
7:00 pm Close of Day
TUESDAY, FEBRUARY 4,2025
6:30 am SCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)
Join SCOPE’s Coordinators on Tuesday, February 4 for our Fun Run! This is an informal event, and ALL abilities are welcome. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk—the goal is to get up and get moving! Details will be shared closer to the event...remember to pack your sneakers.
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)
SCOPE’s Gameshow Host: Brett Kleger, a man whose dream was to be a wedding singer or gameshow host
Brett Kleger, CEO, Inspire
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
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
Nasha Fitter, Co-Founder & CEO, FOXG1 Research Foundation
Craig Martin, Founder, CEO, The Orphan Therapeutics Accelerator
Grant Mitchell, MD, Co-Founder & CEO, Every Cure
Tania Simoncelli, Vice President, Science in Society, Chan Zuckerberg Initiative LLC
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
April Lewis, Head, Innovative Health, Global Development, 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: How Can Sponsors Leverage Increasing Technology Capabilities with Quality
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 (Sponsorship Opportunity Available)
Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI); Co-Founder, ClinEco
3:25 pm Chairperson’s Introduction (Sponsorship Opportunity Available)
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 (Sponsorship Opportunities 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 pm Close of Day
A FEW SHORTCUTS TO HELP YOU AT SCOPE: