Real World Evidence
Accessing and Generating RWD
Leveraging RWD for Clinical Research

The 17th Annual Real World Evidence stream at the SCOPE Summit will explore the evolving landscape of RWD integration into clinical research. Building on previous discussions, this stream will focus on how diverse data sources are increasingly shaping study design and regulatory decisions. As the boundary between traditional clinical trials and real-world data research continues to shift, innovative data technologies, advanced analytics, and strategic collaborations are critical to unlocking actionable insights. The role of AI in analyzing complex RWD sets the stage for more efficient, patient-centric research and accelerated product development. This program aims to foster collaboration among healthcare providers, biopharma, regulators, and data partners, driving forward the strategic use of RWD in clinical and observational studies. 





Preliminary Agenda

THE EVIDENCE EVOLUTION: WHAT'S NEXT?

Beyond Evidence: Building the Execution Architecture for Real-World Impact

Photo of Hayden Bosworth, PhD, Vice Chair and Professor, Population Health Science, Duke University , Vice Chair and Professor , Population Health Science , Duke University
Hayden Bosworth, PhD, Vice Chair and Professor, Population Health Science, Duke University , Vice Chair and Professor , Population Health Science , Duke University

Life sciences organizations have invested heavily in generating real-world evidence (RWE), yet many struggle to translate those insights into sustained changes in clinical practice, patient behavior, and organizational decision-making. This presentation introduces the concept of execution architecture and explores how implementation science, knowledge translation, and human-centered design can bridge the gap between evidence generation and real-world impact.

Implementing AI to Accelerate Clinical Development and Real-World Evidence Generation: Lessons from a Pharmaceutical Organization

Photo of Thomas Jemielita, PhD, Principal Scientist, Biostatistics, Merck , Principal Scientist , Biostatistics , Merck
Thomas Jemielita, PhD, Principal Scientist, Biostatistics, Merck , Principal Scientist , Biostatistics , Merck
Photo of Vladimir Turzhitsky, PhD, Director, Data Science and Outcomes Research, Merck & Co. , Director, Data Science and Outcomes Research , Merck & Co
Vladimir Turzhitsky, PhD, Director, Data Science and Outcomes Research, Merck & Co. , Director, Data Science and Outcomes Research , Merck & Co

As AI capabilities rapidly advance, pharmaceutical organizations are rethinking how evidence is generated, verified, and communicated. This session compares AI adoption journeys of Clinical Development and Real-World Evidence teams, highlighting how priorities have evolved from task automation to workflow transformation. Speakers will share practical lessons on strategy, governance, and implementation, and discuss the future role of AI in enabling faster, more scalable and effective evidence generation across the research enterprise.

TOKENIZATION: FROM EARLY INVESTMENT TO LONG-TERM VALUE

Tokenization: AWS Cloud Data Discovery

Photo of Thomas Dougherty, Real-World Data Strategy Director, Novo Nordisk , Real-World Data Strategy Director , Clinical Data Science and Evidence , Novo Nordisk
Thomas Dougherty, Real-World Data Strategy Director, Novo Nordisk , Real-World Data Strategy Director , Clinical Data Science and Evidence , Novo Nordisk

Pragmatic trials increasingly use real-world data (RWD) and privacy-preserving linkage to extend follow-up beyond protocol windows, reduce participant burden, and capture outcomes from routine care. However, dataset selection often relies on simple token overlap (i.e., whether a participant appears in a dataset), which may obscure whether required variables are available with sufficient completeness. A cloud-first approach enables secure, early feasibility assessment to guide fit-for-purpose RWD selection without moving underlying data.

Beyond Database Lock: Connecting Clinical Trial Data to the Real World

Photo of Lucinda Orsini, Vice President, Value and Outcomes Research, COMPASS Pathways , Vice President Value and Outcomes Research , HEOR , COMPASS Pathways plc ·
Lucinda Orsini, Vice President, Value and Outcomes Research, COMPASS Pathways , Vice President Value and Outcomes Research , HEOR , COMPASS Pathways plc ·

Panel Moderator:

PANEL DISCUSSION:
Perspectives from Life Science Leaders on Measuring Return on Investment in Real-World Data, Evidence, and Insights

Thomas Dougherty, Real-World Data Strategy Director, Novo Nordisk , Real-World Data Strategy Director , Clinical Data Science and Evidence , Novo Nordisk

The life science industry faces growing pressure to show tangible returns on Real-World Data investments. This panel discussion showcases how leaders in the industry are conceptualizing RWD as a value-generating capability, the rigor used to measure performance, and how regulatory environments shape investment strategies. The panel will also share insights from the benchmark survey collected from several leaders in this industry.

AUGMENTING CLINICAL TRIALS WITH REAL-WORLD DATA

RWD to Inform Trial Design

Photo of Abhishek Pratap, PhD, Senior Clinical Program Leader, Central Nervous System, Boehringer Ingelheim , Sr Clinical Program Leader , Central Nervous System , Boehringer Ingelheim
Abhishek Pratap, PhD, Senior Clinical Program Leader, Central Nervous System, Boehringer Ingelheim , Sr Clinical Program Leader , Central Nervous System , Boehringer Ingelheim

A Call to Action: What Must Be True for EHR-to-EDC to Scale Globally?

Photo of Nadir Ammour, DDS, MBA, Global Lead Engagement & Strategic Collaborations, Sanofi R&D Clinical Operations , Engagement & Strategic Collaboration - Global Lead , Engagement & Strategic Collaborations , Sanofi R&D
Nadir Ammour, DDS, MBA, Global Lead Engagement & Strategic Collaborations, Sanofi R&D Clinical Operations , Engagement & Strategic Collaboration - Global Lead , Engagement & Strategic Collaborations , Sanofi R&D

Electronic health record (EHR) to electronic data capture (EDC) interoperability has been proven through pilots, established standards, and advancing technology, yet adoption remains fragmented across the clinical research ecosystem. If the technology exists, what barriers remain for EHR-to-EDC to scale globally? This session explores a shared vision for a future in which research-relevant EHR data can be exchanged and reused across sponsors, sites, studies, and technology platforms without bespoke implementations or proprietary dependencies.

Drawing on TransCelerate's EHR Connectivity initiative, presenters will share insights from ecosystem assessments and stakeholder engagement, highlighting the progress achieved and the technical, operational, governance, and validation barriers that remain. Attendees will explore what it will take to move from isolated successes to broad adoption and will be challenged to join a holistic industry effort to build the roadmap, partnerships, and reusable assets needed to make scalable EHR-to-EDC interoperability a reality

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

Sarah Bednarski, MS, Senior Director, Core Capabilities, Clinical Operations, BlueRock Therapeutics , Sr. Director Core Capabilities , Clinical Operations , BlueRock 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