Site Partnering, Engagement & Operations
Building Strategic Sponsor-Site Partnerships
Tech and Collaboration to Streamline Start-Up and Reduce Site Burden

The growing demand for sites with access to targeted patient populations—alongside increasingly complex protocols and the operational burden of proliferating technologies—requires new ways of working together to modernize clinical trials for the future. SCOPE’s 3rd Annual Site Partnering, Engagement & Operations stream brings together sponsors, sites, and other critical stakeholders including CROs, technology providers, and patient-facing partners to explore how stronger collaboration, aligned incentives, and shared innovation can lead to more efficient, inclusive, and sustainable trial delivery. With a strong focus on education, alignment, and collaboration, this stream equips both sites and sponsors with the tools and perspectives needed to drive more efficient, inclusive, and sustainable trial operations.





Preliminary Agenda

BUILDING STRATEGIC SPONSOR-SITE PARTNERSHIPS

Building Trust and Transparency through Communication Models, Governance Atructures, and Partnership Frameworks

Photo of Tameika Graham, Strategic Site Partnership Lead, Pfizer Inc. , Strategic Site Partnership Lead , Global Site & Study Operations , Pfizer Inc
Tameika Graham, Strategic Site Partnership Lead, Pfizer Inc. , Strategic Site Partnership Lead , Global Site & Study Operations , Pfizer Inc
Photo of Ye Chin Lee, Vice President, Strategic Research Operations, Hospital Integrated Research Organization, Mass General Brigham , VP Strategic Research Operations , Hospital Integrated Research Organization , Mass General Brigham
Ye Chin Lee, Vice President, Strategic Research Operations, Hospital Integrated Research Organization, Mass General Brigham , VP Strategic Research Operations , Hospital Integrated Research Organization , Mass General Brigham

Collaborative sponsor-site partnerships are critical to clinical research success, yet many collaborations remain transactional, study-specific, and difficult to scale. This session features an open discussion between sponsor and Mass General Brigham leaders on practical strategies for building sustainable, enterprise-wide partnerships that improve study design, accelerate startup, and streamline execution. Attendees will learn how integrated workflows, data-driven decision-making, and transparent communication foster more predictable, efficient, and mutually beneficial research collaborations.

CONNECTING SITE AND SPONSOR TECHNOLOGY

Implementing Digital Protocols: Early Findings from Site-Focused Use Cases

Photo of William Illis, Global Head, Collaboration & Technology Strategy Clinical Development, Novartis Pharmaceuticals , VP & Program Leader & Global Head , Collaboration & Technology Strategy Clinical Dev , Novartis Pharmaceuticals
William Illis, Global Head, Collaboration & Technology Strategy Clinical Development, Novartis Pharmaceuticals , VP & Program Leader & Global Head , Collaboration & Technology Strategy Clinical Dev , Novartis Pharmaceuticals
Photo of Erron Deloney, MSc, Director, CTF, eSource Capabilities, Eli Lilly and Company , Director , Eli Lilly
Erron Deloney, MSc, Director, CTF, eSource Capabilities, Eli Lilly and Company , Director , Eli Lilly
Photo of Michael Ward, Senior Director, eSource Capabilities, Eli Lilly and Company , Senior Director, eSource Capabilities , Clinical Trial Foundations , Eli Lilly & Company
Michael Ward, Senior Director, eSource Capabilities, Eli Lilly and Company , Senior Director, eSource Capabilities , Clinical Trial Foundations , Eli Lilly & Company
Photo of Joe Dustin, Senior Director, Digital Clinical Development, Sanofi , Senior Director, Digital Clinical Development , Digital Clinical Development , Sanofi
Joe Dustin, Senior Director, Digital Clinical Development, Sanofi , Senior Director, Digital Clinical Development , Digital Clinical Development , Sanofi
Photo of Rakesh Maniar, Head of eClinical Technologies, Global Data Management & Standards, Merck & Co.; Co-Lead, TransCelerate eSource Initiative; Immediate Past Co-Chair/Co-Founder, SCDM eSource Implementation Consortium , Head of eClinical Technologies, Global Data Management & Standards, Merck & Co. , Global Data Management & Standards, , MERCK & Co. Inc.
Rakesh Maniar, Head of eClinical Technologies, Global Data Management & Standards, Merck & Co.; Co-Lead, TransCelerate eSource Initiative; Immediate Past Co-Chair/Co-Founder, SCDM eSource Implementation Consortium , Head of eClinical Technologies, Global Data Management & Standards, Merck & Co. , Global Data Management & Standards, , MERCK & Co. Inc.
Photo of Michael Ward, Senior Director, eSource Capabilities, Eli Lilly and Company , Senior Director, eSource Capabilities , Clinical Trial Foundations , Eli Lilly & Company
Michael Ward, Senior Director, eSource Capabilities, Eli Lilly and Company , Senior Director, eSource Capabilities , Clinical Trial Foundations , Eli Lilly & Company

Cutting development timelines in half starts with how data leaves the site. Today sites juggle 20+ sponsor-mandated systems and transcribe source into EDC by hand, while sponsors spend months reconciling the result. Bring Your Own Technology inverts that: sites use their own validated eSource, eConsent, and eRegulatory systems and connect directly to sponsor platforms. This session presents a sponsor-side strategy for a site landscape that ranges from mature EHR/eSource environments to paper, then convenes sponsors and technology providers on validation, governance, and integration—and what changes for site staff who stop being data entry clerks.

SITE-CENTERED OPERATIONS: INSIGHTS & NEW APPROACHES

Insight to Impact: Connecting Data, Experience, and Action

Photo of Jessica Hotter Utzig, Senior Global Portfolio Strategy & Optimization Lead, Gilead Sciences, Inc. , Sr. Global Portfolio Strategy & Operations — Oncology , Gilead
Jessica Hotter Utzig, Senior Global Portfolio Strategy & Optimization Lead, Gilead Sciences, Inc. , Sr. Global Portfolio Strategy & Operations — Oncology , Gilead
Photo of Scott Welden, Associate Director, Oncology Portfolio Delivery, Gilead Sciences, Inc. , Assoc Dir Oncology Portfolio Delivery , Oncology Clinical Operations , Gilead Sciences Inc
Scott Welden, Associate Director, Oncology Portfolio Delivery, Gilead Sciences, Inc. , Assoc Dir Oncology Portfolio Delivery , Oncology Clinical Operations , Gilead Sciences Inc

Lesley Lardino, Director, Data Management, Clinical Data Management, Astellas Pharma, Inc. , Dir Data Mgmt , Clinical Data Mgmt , Astellas Pharma Inc

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

SCOPE Plenary Keynote - Monday

MONDAY GOLF, WORKSHOPS & USER GROUPS

SCOPE’s 6th Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Still Available)

*Separate Registration Required

OPEN WORKSHOP: Modernizing Informed Consent: AI, Automation, and Ethics in Global Clinical Trials

MONDAY AFTERNOON PLENARY SESSION

Grab Your Seat: Early-Bird Seat Golden Ticket Raffle & Prize Giveaway*

Photo of Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute
Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

*Must be present to win!

Organizer's Welcome Remarks & 5th Annual Masters of Clinical Research Golf Tournament Awards and Jacket Signing

Photo of Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute
Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: Solving the Enrollment Crisis: Bridging Clinical Care and Clinical Research

Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine , Executive Director and Professor, Tufts Center for the Study of Drug Development. , Tufts University School of Medicine

Panelists:

Zhanna Jumadilova, MD, Biopharmaceutical Physician Executive, Pragmatic Clinical Trials, R&D, Pfizer , Pragmatic Trials Clinical Lead , Pragmatic Clinical Trials, R&D , Pfizer

Elizabeth Rogers, Vice President, Head, R&D Clinical Operations, Portfolio Development, CSL Behring , VP , Head, R&D Clinical Operations, Portfolio Development , CSL Behring

SCOPE Announcements: Tips for Getting the Most out of SCOPE

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: SCOPE's 4th Annual Site Innovation Awards

Irfan Khan, CEO, Circuit Clinical , CEO , Circuit Clinical

Amanda Wright, Co-Founder & Senior Vice President, Healthcare Alliance, Javara , Co-Founder & SVP , Healthcare Alliance , Javara

Panelists:

Karen Correa, PhD, Vice President, Development Operations, Boehringer Ingelheim , Vice President , Clinical Development Operations , Boehringer Ingelheim

Angela DeLuca, Vice President, Global Head, Site Management & Monitoring, AstraZeneca , VP & Global Head Site Management & Monitoring , Site Management & Monitoring , AstraZeneca

Joe Dustin, Senior Director, Digital Clinical Development, Sanofi , Senior Director, Digital Clinical Development , Digital Clinical Development , Sanofi

Sean Soth, Senior Vice President, Strategy and Global Business Partnerships, SCRS , Senior Vice President , Society for Clinical Research Sites (SCRS)

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: SCOPE's 11th Annual Participant Engagement Awards

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Kelly McKee, Vice President, Strategy & Transformation, Science 37; Co-Creator of the SCOPE Participant Engagement Award , Vice President, Strategy & Transformation , Science37

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC; Co-Creator of the SCOPE Participant Engagement Award , President & CEO , Marketing , Patient Enrollment Advisors LLC

Panelists:

Andrea Bartucca, Director, Trial Awareness and Recruitment, Rapport Therapeutics , Director, Trial Awareness , Trial Awareness and Recruitment , Rapport Therapeutics

Savine DaCosta, PhD, Clinical Trial Access and Representation Site Lead, Biogen , Clinical Trial Access and Representation Site Lead , Biogen

Anita Difrancesco, Senior Vice President, Clinical Operations, Endeavor Biomedicines , SVP , Clinical Operations , Endeavor Biomedicines

Gretchen Goller, Head, Recruitment and Retention, Pfizer Inc. , Head , Recruitment and Retention , Pfizer Inc.

April Lewis, Clinical Solutions, PatientPartner; Strategic Advisor, ZS , Sr. Director, Innovative Health , Global Development , Johnson & Johnson Innovative Medicine

Wendy Lurrie, Acting Head of Comms, BestGuessistan , Acting Head of Comms

Adrienne Walstrum, Senior Director, Global Trial Optimization, Merck , Senior Director , Global Trial Optimization , Merck & Co

Kate Wilson, Senior Director, Head of Global Clinical Trial Access & Representation, Biogen , Senior Director , Head of Global Clinical Trial Access & Representation , Biogen

SCOPE's Opening Happy Hour (Sponsorship Opportunities Available)

SCOPE Plenary Keynote - Tuesday

TUESDAY MORNING EXERCISE & COFFEE

SCOPE's Morning Fun Run! (Sponsorship Opportunities Available)

COORDINATOR: 

Bridget Kotelly, Senior Director, Cambridge Healthtech Institute

Get up & Go Specialty Coffee (Sponsorship Opportunities Available)

TUESDAY PLENARY KEYNOTE SESSION

SCOPE’s Stretch Break & Annual T-Shirt Toss (Sponsorship Opportunity Available)

Photo of Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute
Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

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

Photo of Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute
Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

*Must be present to win!

KEYNOTE FIRESIDE CHAT: The Other Side of Drug Development: A Pharma Leader's Journey as a Rare Disease Parent

Craig Lipset, Co-Chair, Decentralized Trials & Research Alliance (DTRA); Advisor, Buffalo Initiative , Co-Chair , Decentralized Trials & Research Alliance (DTRA)

Michelle Werner, Executive Vice President, President, North America, Ipsen, Rare Disease Mom and Advocate , EVP , President, North America , Ipsen

For leaders who have spent their careers developing medicines, the experience of navigating a rare disease within their own family can bring an entirely different perspective to the urgency, complexity, and human impact of drug development. This fireside conversation will explore that intersection: what changes when an industry leader experiences drug development and clinical research as a parent, what the industry can learn from that perspective, and how it can inform the way we develop medicines and design clinical trials for patients and families.

KEYNOTE FIRESIDE CHAT: From Reform to Implementation: FDA’s New Clinical Trial Innovation Office and Operation Trialblazer

Photo of Kevin Bugin, PhD, Associate Vice President, Head, Global Regulatory Policy and Intelligence, Amgen , Head , Regulatory Policy and Intelligence , Amgen
Kevin Bugin, PhD, Associate Vice President, Head, Global Regulatory Policy and Intelligence, Amgen , Head , Regulatory Policy and Intelligence , Amgen

FDA’s clinical-trial modernization agenda is moving from policy ambition to implementation. This plenary discussion will explore the new clinical-trial-innovation office being established within CDER’s Office of Medical Policy, Operation Trialblazer, and related FDA priorities. The conversation will focus on the office’s intended role, near-term priorities, opportunities to leverage existing industry capabilities, and what sponsors, sites, and research partners should anticipate as the work takes shape.

Welcome to SCOPE Europe 2027—Saddle up for the Future of Clinical Trials

Photo of Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute
Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: From Years to Months: Is Radical Acceleration in Clinical Research Finally Possible?

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Panelists:

Christoph Koenen, MD, Head of Clinical Development & Operations, Pharma R&D, Bayer , Head of Clinical Development & Operations , Pharma Research & Development , Bayer

Grand Opening Coffee & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available)—Best of Show Voting Opens

SCOPE Plenary Keynote - Wednesday

WEDNESDAY PLENARY KEYNOTES

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: The Digital Transformation of Clinical Trials: From Protocol to Patient

Darren Weston, Head, Integrated Data Analytics and Reporting, Johnson & Johnson , Head , Integrated Data Analytics and Reporting , Johnson & Johnson

Panelists:

Michael Cantor, Vice President, Data Technology & Innovation, Regeneron Pharmaceuticals, Inc. , Vice President , Data Technology & Innovation , Regeneron Pharmaceuticals Inc

Justine Rochon, Senior Vice President, Head of R&D Data and Quantitative Sciences, Takeda , SVP , Head of R&D Data and Quantitative Sciences , Takeda

Sammi Rui Tang, PhD, Senior Vice President & Global Head, Quantitative Sciences & Evidence Generation, Astellas Pharma, Inc. , Sr VP & Global Head , Quantitative Sciences & Evidence Generation , Astellas Pharma Inc

Rachel Nering, Vice President, Head of Early Development and eDevelopment, Sanofi , VP , Head of Early Development and eDevelopment , Sanofi

SCOPE’s Booth Crawl (Sponsorship Opportunities Available) & Last Chance for Exhibit Viewing

SCOPE Plenary Keynote - Thursday

THURSDAY PLENARY KEYNOTES

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

KEYNOTE PRESENTATION: Case Study: AI and the R&D Revolution: Reinventing Drug Development from Discovery to Clinical Trials

Photo of Dan Sheeran, Vice President & General Manager, Healthcare & Life Sciences, AWS , VP & GM Healthcare & Life , Healthcare & Life Sciences , AWS
Dan Sheeran, Vice President & General Manager, Healthcare & Life Sciences, AWS , VP & GM Healthcare & Life , Healthcare & Life Sciences , AWS

AI is reshaping R&D from discovery through clinical development. This case study will explore how organizations are applying AI at scale to accelerate innovation, improve decision-making, and transform how new medicines are developed.

Panel Moderator:

KEYNOTE INTERACTIVE PANEL: The New Clinical Development Operating Model

Kristi Koontz, Vice President, Global Study and Site Operations, Amgen , VP , Global Study and Site Operations , Amgen

Panelists:

David Carruthers, Vice President, BioPharmaceuticals R&D Clinical Operations, AstraZeneca , Vice President , BioPharmaceuticals R&D Clinical Operations , AstraZeneca

Nick Hodges, Senior Vice President & Head, Clinical Development Operations & R&D Transformation Office, Ipsen , SVP, Head of Global Clinical Development , Global Clinical Operations , Ipsen

Henry Wei, MD, Executive Director, Development Innovation, Regeneron , Executive Director , Development Innovation , Regeneron Pharmaceuticals Inc

Closing Remarks & Lunch for Here or on the Go!

SCOPE Summit 2027 Adjourns


SCOPE Track Summariese

2027 Conference Programs