Trial Design & Protocol Development
Patient and Site Voice in Protocol Design
Technology, Data and AI/ML for Intelligent Trial Design

Clinical trial success increasingly depends on thoughtful protocol design that prioritizes input from patients and sites while leveraging the power of data, technology, and innovative trial models. Engaging patients and sites early in the design process leads to more practical, efficient, and participant-friendly protocols—ultimately improving recruitment, retention, and trial outcomes. SCOPE’s 4th Annual Trial Design & Protocol Development stream offers a focused look at strategies and frameworks to modernize trial design by integrating stakeholder feedback, digital tools, and new and emerging designs such as decentralized, hybrid, and pragmatic trials. Attendees will gain actionable insights into designing trials that are not only operationally effective but also aligned with the real-world needs and experiences of patients and sites. 





Preliminary Agenda

TRANSFORMING TRIAL DESIGN & DELIVERY

FDA's C3TI: Advancing Innovation in Clinical Trials

Photo of Meghana Chalasani, Associate Director for Clinical Trial Innovation, Office of New Drugs, FDA CDER , Associate Director for Clinical Trial Innovation , Office of New Drugs , FDA CDER
Meghana Chalasani, Associate Director for Clinical Trial Innovation, Office of New Drugs, FDA CDER , Associate Director for Clinical Trial Innovation , Office of New Drugs , FDA CDER
Photo of Amy Abernethy, MD, PhD, Co-Founder, Highlander Health , President, Product Development & Chief Medical Officer , Product Dev & CMO , Highlander Health
Amy Abernethy, MD, PhD, Co-Founder, Highlander Health , President, Product Development & Chief Medical Officer , Product Dev & CMO , Highlander Health
Photo of Sriram Krishnamurthy, Director, GD-IT, Regeneron Pharmaceuticals, Inc. , Dir , GD-IT , Regeneron Pharmaceuticals Inc
Sriram Krishnamurthy, Director, GD-IT, Regeneron Pharmaceuticals, Inc. , Dir , GD-IT , Regeneron Pharmaceuticals Inc
Photo of Gillian Mac Lochlainn, PhD, Associate Director, Clinical Development Innovation, Regeneron , Director Development Innovation and Operations , Clinical Development Innovation , Regeneron
Gillian Mac Lochlainn, PhD, Associate Director, Clinical Development Innovation, Regeneron , Director Development Innovation and Operations , Clinical Development Innovation , Regeneron
Photo of Dilip Raghunathan, Business Solutions Partner, Regeneron , Regeneron
Dilip Raghunathan, Business Solutions Partner, Regeneron , Regeneron

INTELLIGENT & PATIENT-INFORMED TRIAL DESIGN

Intelligent Study Design Maintaining Balance with Scientific Rigor, Faster Execution, and Higher Quality

Photo of Akanksha Gupta, Head of Insights and Strategy, Novo Nordisk , Head of Insights and Strategy , Research and Development , Novo Nordisk
Akanksha Gupta, Head of Insights and Strategy, Novo Nordisk , Head of Insights and Strategy , Research and Development , Novo Nordisk
Photo of Mary Carroll, Director, Protocol Optimization, Clinical Acceleration & Performance, AbbVie, Inc. , Dir Protocol Optimization , Clinical Acceleration & Performance , AbbVie Inc
Mary Carroll, Director, Protocol Optimization, Clinical Acceleration & Performance, AbbVie, Inc. , Dir Protocol Optimization , Clinical Acceleration & Performance , AbbVie Inc
Photo of Anthony Taylor, Director, Clinical Site and Patient Insights, AbbVie, Inc. , Director Clinical Site and Patient Insights , Clinical Site and Patient Insights , AbbVie
Anthony Taylor, Director, Clinical Site and Patient Insights, AbbVie, Inc. , Director Clinical Site and Patient Insights , Clinical Site and Patient Insights , AbbVie
Photo of Vidhya Gedela, Director, Patient & Site Engagement Products, Global Development Operations IT R&D Business Insights and Technology, Bristol Myers Squibb Co. , Director - Head Patient & Site Engagement Products , Patient Site Operations & Clinical Engagement , Bristol Myers Squibb Co
Vidhya Gedela, Director, Patient & Site Engagement Products, Global Development Operations IT R&D Business Insights and Technology, Bristol Myers Squibb Co. , Director - Head Patient & Site Engagement Products , Patient Site Operations & Clinical Engagement , Bristol Myers Squibb Co

Tara Schultz, Associate Director, IT Business Partner, Patient Recruitment & Site Operations, Bristol Myers Squibb Co. , Assoc Dir IT Business Partner , Patient Recruitment & Site Operations , Bristol Myers Squibb Co

REDUCING COMPLEXITY & ACCELERATING TRIAL EXECUTION

Advancing Global Clinical Trial Efficiency through Selective Safety Data Collection

Photo of Mitchell Psotka, Senior Physician, FDA , Senior Physician , Division of Cardiology and Nephrology , FDA
Mitchell Psotka, Senior Physician, FDA , Senior Physician , Division of Cardiology and Nephrology , FDA
Photo of Bernhard Glombitza, Head, Clinical Operations EMEA and LATAM, Bayer , Head Clinical Customer Engagement and Clinical Operations EMEA/LATAM , Clinical Development & Operations , Bayer
Bernhard Glombitza, Head, Clinical Operations EMEA and LATAM, Bayer , Head Clinical Customer Engagement and Clinical Operations EMEA/LATAM , Clinical Development & Operations , Bayer
Photo of Laura Galuchie, Senior Director, Merck; Zhanna Jumadilova, Pragmatic Clinical Trials, Pfizer R&D, Pfizer , Senior Director, TransCelerate Program Lead , Oversight Committee , Merck
Laura Galuchie, Senior Director, Merck; Zhanna Jumadilova, Pragmatic Clinical Trials, Pfizer R&D, Pfizer , Senior Director, TransCelerate Program Lead , Oversight Committee , Merck

Clinical trials are collecting more data than ever—but how much is truly needed? Unnecessary or misaligned data collection can increase burden on participants and sites, add operational complexity, and divert attention from the information that matters most. As the industry seeks to improve trial efficiency and participant experience, there is growing interest in approaches that better align data collection with study objectives, participant safety, and regulatory needs.Learn how TransCelerate’s work is helping advance more fit-for-purpose data collection in clinical trials. Through case studies, cross-industry collaboration, and dialogue with global regulators, speakers will demonstrate how Selective Safety Data Collection and pragmatic trial approaches can balance risk, data quality, and operational feasibility, along with practical resources and implementation considerations.

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