Feasibility & Site Strategy
Data-Driven Feasibility and Investigator Selection
Tech and Collaboration to Streamline Start-Up and Reduce Site Burden

Identifying the right sites and implementing processes to streamline site activation, start-up, and operations is a complex and challenging endeavor. The convergence of evolving regulations, patient- and site-centric practices, DEI initiatives, real-world data, advanced analytics, and digital and decentralized models are reshaping traditional feasibility approaches. SCOPE’s 17th Annual Feasibility & Site Strategy stream highlights how organizations are using real-world data and predictive analytics to inform global site selection, applying inclusive frameworks to reach underrepresented populations, and adopting new tools to align site capabilities with protocol requirements. Attendees will gain practical insights into modernizing feasibility processes and making smarter, data-informed decisions that set trials up for success from the start. 





Preliminary Agenda

Breakfast

BREAKFAST PRESENTATION

AI & INTELLIGENCE-DRIVEN FEASIBILITY AND SITE SELECTION

STRIDE: Merck’s Journey to Smarter Site Selection

Photo of Amy Christine Smith, Senior Director, Global Clinical Trial Operations, Merck & Co. , Senior Director, GCTO Regional Operations Head, North America , Global Clinical Trial Operations , Merck
Amy Christine Smith, Senior Director, Global Clinical Trial Operations, Merck & Co. , Senior Director, GCTO Regional Operations Head, North America , Global Clinical Trial Operations , Merck
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
Photo of Boris Howryluk, Associate Director, Product Manager, Clinical Development IT, Bristol Myers Squibb Co. , Associate Director, Product Manager, Global Clinical Development IT , Global Clinical Development IT , Bristol Myers Squibb
Boris Howryluk, Associate Director, Product Manager, Clinical Development IT, Bristol Myers Squibb Co. , Associate Director, Product Manager, Global Clinical Development IT , Global Clinical Development IT , Bristol Myers Squibb
Photo of McKenzie Kays, Product Manager, Site Engagement, R&D IT, Bristol Myers Squibb Co. , Product Manager , Site Engagement, R&D IT , Bristol Myers Squibb
McKenzie Kays, Product Manager, Site Engagement, R&D IT, Bristol Myers Squibb Co. , Product Manager , Site Engagement, R&D IT , Bristol Myers Squibb
Photo of Saumya Mishra, Senior Product Owner, Enabling Technology, Regeneron Pharmaceuticals, Inc. , Sr Product Owner, Global Development IT , Regeneron Pharmaceuticals, Inc.
Saumya Mishra, Senior Product Owner, Enabling Technology, Regeneron Pharmaceuticals, Inc. , Sr Product Owner, Global Development IT , Regeneron Pharmaceuticals, Inc.
Photo of Tyler Steere, Associate Director, Global Trial Optimization, Regeneron Pharmaceuticals , Assoc Dir Global Trial Optimization , Global Trial Optimization , Regeneron Pharmaceuticals Inc
Tyler Steere, Associate Director, Global Trial Optimization, Regeneron Pharmaceuticals , Assoc Dir Global Trial Optimization , Global Trial Optimization , Regeneron Pharmaceuticals Inc

Partnerships & Trial Optimization and Digital & Technology partnered to implement an AI-enabled Site Feasibility Survey Platform. Built on Appian and integrated with an ecosystem of site, investigator, and country intelligence, the solution transformed Site and Investigator selection from a survey exercise into an intelligence-driven decision engine. It reduces site burden, improves response rates, streamlines workflows, and establishes a foundation for future AI-enabled study planning and site identification.

NEW APPROACHES TO SITE EVALUATION & SELECTION

Inside the Site Selection Process: What Sponsors and Sites Need from Each Other

Photo of Kisha Bush, Director, Patient & Site Engagement, Boehringer Ingelheim International GmbH , Dir Patient & Site Engagement , Patient & Site Engagement , Boehringer Ingelheim Intl GmbH
Kisha Bush, Director, Patient & Site Engagement, Boehringer Ingelheim International GmbH , Dir Patient & Site Engagement , Patient & Site Engagement , Boehringer Ingelheim Intl GmbH
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)

Emerging sites represent one of the most promising - and most misunderstood - opportunities in clinical research today. They offer access to diverse patient populations, untapped geographic reach, and motivated teams ready to grow. This session equips sponsors and CROs with practical strategies to identify, evaluate, and effectively support emerging sites - transforming hesitation into confident partnership and expanding the research ecosystem in the process.

Panel Moderator:

PANEL DISCUSSION:
4 “T”s of Collaborative Trial Dynamics between Sites, Sponsors, and CROs (Timely, Transparent, Transformative, and Tech)

Carlos E. Orantes, CEO, Alcanza Clinical Research , CEO , Alcanza Clinical Resarch

Panelists:

Andrea Bastek, Vice President, Market Strategy, Florence Healthcare

Marta León, Senior Vice President, Site Activation Center of Excellence, Parexel , Senior Vice President, Site Activation Center of Excellence , Operational Excellence, Delivery & Innovation (OEDI) , Parexel

Ian Wyglendowski, Vice President, Global Head of Strategic Clinical Partnering, UCB

ACCELERATING STUDY START-UP THROUGH BETTER PROCESSES & COLLABORATION

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 KEYNOTES

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 Kickoff Reception—Welcome to the Wild Wild West! (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 KEYNOTES

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

Photo of Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA) , Co Chair , Decentralized Trials & Research Alliance DTRA
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA) , 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