Therapeutic Area Spotlights | SCOPE Summit

SCOPE’s Inaugural Therapeutic Area Spotlights stream

Preliminary Agenda

CNS & MENTAL HEALTH TRIALS

CNS and mental health trials remain some of the most complex and challenging studies to execute. Unique patient populations, evolving diagnostic criteria, high placebo response rates, and burdensome assessments create hurdles that impact trial design, recruitment, and execution. This TA Spotlight session explores practical strategies for optimizing trial execution, from protocol design through site selection, recruitment and operations. Explore common challengesâ€”including site selection and readiness, recruitment and retention of diverse patient populations, and the operationalization of innovative digital endpoints.

METABOLIC & OBESITY TRIALS

With a record number of obesity and metabolic trials currently underway, the demand for innovative strategies to advance clinical development has never been greater. This spotlight session explores approaches to strengthen collaborations, improve trial efficiency, and address the complexities of recruitment and retention in obesity and metabolic disease studies. Presentations will highlight emerging partnership models, novel tools such as point-of-care pre-screening to reduce costly screen failures, and best practices for aligning operational execution with scientific goals. The session will feature experts from sites, sponsors, and research organizations, who will share practical insights on overcoming barriers and driving progress in obesity and metabolic trials.

ONCOLOGY TRIALS

With oncology remaining the most active area of clinical research worldwide, the complexity and volume of trials demand new operational, technological, partnering, and regulatory approaches. This spotlight session examines how oncology trials are evolving across diverse settings, from the growth of community-based and decentralized research models to innovations in regulatory workflows and data management. Expert presentations will showcase applications of AI and advanced digital tools in driving efficiency, improving data quality, and advancing precision medicine. The program culminates with a forward-looking panel discussion on the future of oncology trial design, collaboration, and patient care.

IMMUNOLOGY & INFLAMMATION TRIALS

I&I trials come with operational challenges that don't show up in other therapeutic areas. This session will convene leaders from various functional areas to weigh in on what makes them different: segmenting patients by disease severity when severity assessment is subjective across PIs, selecting sites that can deliver high-quality patients at volume, and managing specialized equipment requirements that many sites don't have on hand. Discussion will also cover eCOA/ePRO data integrity and the recruitment challenge of competing against established standard-of-care drugs in a crowded, head-to-head-driven market.

SCOPE Plenary Keynote - Monday

MONDAY GOLF, WORKSHOPS & USER GROUPS

SCOPEâ€™s 6th Annual Masters of Clinical Research Golf Tournament*â€¯(Sponsorship Opportunities Still Available)

*Separate Registration Required

OPENâ€¯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

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:Â

Bridget Kotelly, Senior Director, Cambridge Healthtech Institute

Get up & Go Specialty Coffeeâ€¯(Sponsorship Opportunities Available)

TUESDAY PLENARY KEYNOTE SESSION

SCOPEâ€™s Stretch Break & Annual T-Shirt Toss (Sponsorship Opportunity Available)

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

*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: FDAâ€™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

FDAâ€™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 CDERâ€™s Office of Medical Policy, Operation Trialblazer, and related FDA priorities. The conversation will focus on the officeâ€™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 2027â€”Saddle up for the Future of Clinical Trials

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)â€”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

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

SCOPEâ€™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.