2025 ARCHIVES

Cambridge Healthtech Institute’s 7th Annual

Feasibility and Study Start-Up

Modernising Feasibility, Site Selection, Site Engagement, and Study Execution

14 - 15 October 2025 ALL TIMES CET (UTC +2h)

Feasibility and study start-up are critical phases in clinical trial operations, directly impacting trial timelines, site performance, and overall study success. SCOPE’s Feasibility and Study Start-Up conference will explore new tools and strategies to improve site selection, diversity in trial feasibility, and proactive collaboration with research sites to help reduce bottlenecks, improve recruitment readiness, and enhance overall study execution.

Monday, 13 October

13:00Registration Open

13:45– 15:15 WORKSHOP 1: Nuts and Bolts of AI Implementation: What to Avoid and What to Emphasise (Sponsorship Opportunity Available)

INSTRUCTORS:
Jonathan Crowther, PhD, Head, Operational Design Center, Merck KGaA, Darmstadt, Germany
Prasanna Rao, Chief Products and Innovation Officer, Saama
This interactive workshop will provide a practical overview of key considerations for implementing AI in clinical operations and beyond. Topics will include ethical implications and regulatory updates such as the EU AI Act, a clear explanation of AI APIs and how they function, and best practices for effective prompt engineering. Attendees will gain valuable insights into common pitfalls to avoid and strategies to successfully integrate AI tools in a regulated environment.

15:00– 17:00 USER GROUP: Citeline Industry Roundtable (Invitation Only)

15:30– 17:00 WORKSHOP 2: Modernising Informed Consent: AI, Automation, and Ethics in Global Clinical Trials

INSTRUCTORS:

Pooja Bholanath Pagare, Manager, Clinical Development, ZS Associates

Kirstin Goldring, Senior Director/Head, HBS Compliance and Governance, AstraZeneca

Sofiane Nacia, Director, Senior Global Process Owner, Novartis

Hilde Vanaken, Head EFGCP eConsent Initiative, EFGCP – European Forum for Good Clinical Practice

Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder, Clinical Transformation Partners LLC

As clinical trials grow in complexity and scale, the role of informed consent becomes more critical—and more challenging—than ever. This interactive workshop explores the evolving landscape of consent in the digital age, from the automation of consent form development to navigating global ethics and privacy regulations. We'll examine the responsibilities embedded in consent language, new international policies designed to uphold participant rights, and the use of AI-powered tools to review, manage, and search consent documents for transparency and compliance. Designed for the broader clinical operations community, this session will be especially valuable for professionals focused on consent processes, patient recruitment, study start-up, site activation, decentralised trials, clinical technology, and clinical data. Attendees will leave with actionable insights into how technology can safeguard ethics while streamlining consent workflows across diverse trial environments.

17:15– 18:45 WORKSHOP 3: Tackling Kit Wastage for Greener Clinical Trials (Sponsorship Opportunity Available)

INSTRUCTORS:

Michael J. Cohen, MSc, MBA, SEP, Senior Director, Lead, Environmental Sustainability, Thermo Fisher Scientific
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Celine Gervais, CEO, Quipment SAS 
Peter Morley, Clinical Sustainability Manager, Process Transformation & Digitalization, Novo Nordisk A/S
Diana Steinbuesch, Founding Member, Biospecimen Management Consortium (BMC); BioX Operations Portfolio Lead (Oncology), Roche

ESG (Environmental, Social, & Governance) Leaders in Pharma & Sustainable Trials Workshop at SCOPE. Join us for an insightful workshop on optimising clinical trial supply management. Discover strategies to minimise supply overage and kit wastage, while enhancing environmental sustainability. Learn from industry experts how to implement best practices that reduce waste, lower costs, and reduce greenhouse gas emissions in clinical trials. This workshop is essential for professionals committed to improving efficiency and sustainability in clinical research.

Tuesday, 14 October

06:45SCOPE Europe Fun Run

RUN COORDINATORS:

Bridget Kotelly, Senior Conference Director, Cambridge Healthtech Institute
Eileen Murphy, Conference Producer, Production, Cambridge Healthtech Institute
Join SCOPE’s Coordinators on Tuesday morning for our Rise and Shine Fun Run! Don’t forget to pack your sneakers. All of us at Cambridge Healthtech Institute recognizse the importance of integrating well-being and fitness into our work travel routines. We're excited to offer our support to faculty, sponsors, and attendees in fostering a culture of wellness. This is an easygoing, informal running (or walking) event. No time chips, running bibs, or energy bars—just a laid-back opportunity for a small group to start the day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk—the goal is to get up and get moving! Meet us in the front lobby near the concierge at 6:45 am sharp!

07:45Registration and Morning Coffee

08:50Organiser's Welcome Remarks

08:55 Chairperson's Remarks

Speaker to be Announced, Quipment SAS

09:00

Upstream Insights: Integrating Patient and Site Feedback Before Protocol Finalisation

Jane Twitchen, Head Clinical Trial Accelerator Unit & Executive Director, Global Clinical Operations, Biogen Ltd.

Designing a clinical trial protocol without early, meaningful input from both patients and sites risks inefficiencies, delays, and avoidable amendments. In this session, we’ll explore how incorporating structured patient insights alongside site engagement before protocol finalisation can lead to more operationally feasible, patient-friendly studies. We’ll share practical tools and approaches for gathering and integrating this feedback—ranging from digital platforms to advisory boards—and outline a replicable process that bridges scientific intent with real-world execution. Attendees will gain a clear understanding of how early insights shape better protocols, reduce downstream burdens, and ultimately support faster, more inclusive trial execution.

09:25

Site Partnerships: Engagement as Key Component of Portfolio Execution

Sven Knapinski, PhD, Director, Site Partnerships, Clinical Development, CSL Vifor

Effective Program, Study, and Site Engagement is critical to successfully deliver clinical research projects. Especially in rare diseases and hard-to-recruit patient populations, it is key to define strategies to support patients and sites in any possible way. This session will highlight how CSL aligns engagement strategies across the organisation and a way of bringing clinical trials closer to the patients and expanding CSL’s site network. Attendees will gain practical insights and inspiration to rethink their own engagement approaches across the clinical development lifecycle.

09:50

PANEL DISCUSSION:A Fresh Look at Data Sharing for Study Planning and Site Selection

PANEL MODERATOR:

Adam Levy, Director, Clinical Technology Sales, IQVIA Technologies

Data sharing consortium and the Data Query System (DQS) were launched more than a decade ago by a handful of the largest pharmaceutical companies to reduce site burden and accelerate clinical trials. In this presentation, you’ll learn how the data, technology, and companies behind DQS are evolving to match today’s needs for study planning, site identification, feasibility, investigator/site selection, and master data management: • History and structure of DQS and data sharing collaborations • Data sharing and privacy • New member company opportunities

PANELISTS:

Jonathan Crowther, PhD, Head, Operational Design Center, Merck KGaA, Darmstadt, Germany

Sarah McClure, Global Data Engagement Lead, Feasibility Management, R&D, Sanofi

Jane Twitchen, Head Clinical Trial Accelerator Unit & Executive Director, Global Clinical Operations, Biogen Ltd.

10:15

FIRESIDE CHAT:

Modernizing Feasibility with Early Site Engagement

PANEL MODERATORS:

Liz Beatty, CSO, Inato

Diedre Heine, Clinical Trial Program Early Planning Global Lead , Sanofi

The traditional feasibility and site selection model remains outdated, prolonging trial startup and relying on guesswork that creates uncertainty around enrollment. In this session, we’ll cut through the noise to explore how forward-thinking sponsors are modernizing their approach to reduce risk and move with confidence.

Inato's Liz Beatty will moderate a discussion with Sanofi’s Diedre Heine where they will challenge the status quo. They'll demonstrate how engaging with sites early leads to more efficient trials, stronger partnerships, and better outcomes.

10:40

Winning Together: Smarter Access for Sites & Sponsors

Tom Johnson, Senior Director, Life Sciences/Health IT Business Solutions, Exostar

Discover how leading sponsors and sites are partnering to reduce tech burden and accelerate study start-up. Gain the sponsor’s perspective on how Exostar is helping them streamline application provisioning and simplify site access with Industry Trusted Single Sign-On, reducing support calls and eliminating multiple logins across global trials.

10:53Grand Opening Coffee Break in the Exhibit Hall

The SCOPE Europe Exhibit Hall is the best place to fuel up with a mid-morning coffee while visiting with our many exhibitors. Learn about what’s new in the industry, connect with colleagues and partners, and make some new friends.

11:49

Grab Your Seat: Plenary Keynote Seat Raffle & Prize Giveaway!* 

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute; Co-Founder, ClinEco

*Must be present to win!

11:50

Welcome to SCOPE Europe—Who Is Here and Why?

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute; Co-Founder, ClinEco

11:55Chairperson’s Remarks: Reimagining Clinical Research: Why Innovation, Speed, and Collaboration Must Converge Now

12:00 KEYNOTE PRESENTATION:

Transformative AI: Shaping the Future of Healthcare

James Weatherall, PhD, Vice President & Chief Data Scientist, BioPharmaceuticals R&D, AstraZeneca

Artificial intelligence is transforming medicines development, paving the way for enhanced patient outcomes and organisational success. By deriving actionable insights from complex datasets, we are accelerating the discovery of novel targets, elucidating intricate disease mechanisms, and improving how we approach clinical trials. The vast and exciting future applications of AI will deliver the next frontier in healthcare, urging us to reimagine innovation and advance science, with the goal of bringing new, better medicines to patients, faster.

12:25

Meet Your Neighbor: What Is YOUR Biggest Technological or Operational Challenge Right Now?

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute; Co-Founder, ClinEco

12:30 KEYNOTE CASE STUDY CO-PRESENTATION:

Learning from Lightspeed Execution of the OCEANIC STROKE Program

Alexander Krupp, PhD, Vice President, Executive Clinical Program Excellence Lead, Bayer AG

Georgios Tsivgoulis, MD, PhD, Professor of Neurology, National & Kapodistrian University Of Athens; President, Hellenic Neurological Society

More than 14 million patients experience a stroke every year. Preventing as many stroke events as possible will retain a high quality of life for patients, their caregivers, and society—and is therefore of high relevance. For Bayer’s OCEANIC program in stroke, we have established a product-centric operational model that has resulted in the competitor feedback: “You are killing us with excellence—how are you doing this?” In this keynote, we will explore how our industry can learn from high performance operating models to serve our patients faster, better, and at lower cost.

13:05 KEYNOTE PANEL DISCUSSION:

Closing the Gap between Protocol Development and Feasibility to Ensure Downstream Success with Sites and Patients

PANEL MODERATOR:

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

What are various companies doing to improve the gaps between protocol development, feasibility, and ops? Despite pharma companies' need to maintain their competitive edge, is there an opportunity for a collaborative industry feedback loop? Can this be collaborative/pre-competitive to improve efficiency and better serve sites and patients?

PANELISTS:

Bernhard Glombitza, Head, Clinical Operations EMEA and LATAM, Bayer

Christian Milliet, Head of Site & Healthcare Ambassadors, Clinical Development Operations, CSL Behring

Susana Ramos, PhD, Global Early Planning TA Lead, Clinical Sciences & Operations, Sanofi

Matthieu Ruffin, Head Study Leadership, SSO GCO Development, Novartis

13:35Join Your Peers for a Networking Luncheon in the Exhibit Hall

Take this opportunity to refresh and refuel with our Exhibit Hall lunch. Enjoy good food and even better conversation during our walk and talk luncheon.

14:35

Chairperson's Remarks

Nadia Lim, Feasibility Strategy & Analytics Group Lead, Pfizer Inc.

14:40

Getting Ready for AI Applications in Clinical Trial Feasibility

Nadia Lim, Feasibility Strategy & Analytics Group Lead, Pfizer Inc.

Joao Goncalo Nascimento, Performance Analyst, Predictive Analytics – PRD (OARS), Pfizer Inc.

In this talk, we explore innovative approaches to streamline feasibility processes and reduce costs in clinical trial execution. We focus on how data science and generative AI can simplify workflows, enhance efficiency, and lower expenses. Automating data analysis and site selection reduces time and resources, while predictive analytics identify high-performing sites early, minimising costs from trial delays and underperforming sites.

15:05

AI + Humans for Delivery-Ready Clinical and Financial Feasibility

Alla Smyshlyaeva, Head of Proposal and Market Growth, PSI CRO

Katarzyna Moscicka, Head of Feasibility Department, PSI CRO

With the vast amounts of data and expertise accumulated in the industry and the power of AI, there’s a potential to eradicate clinical trial delays and change orders. We’ll demonstrate how one platform connects two worlds: financial forecasting and feasibility modeling. The methodology enables accurate feasibility data analysis and modeling. We’ll also show how we’re planning to integrate it with the first-of-its-kind semantic knowledge platform.

15:30

From Data to Decisions: Enhancing Decision-Making through AI and External Vendor Data Integration

Clara Mella, Data Strategy Lead, Bayer AG

Monserrat Famos, Feasibility Strategist, Feasibility, Bayer

In the rapidly evolving landscape of clinical development, leveraging data-driven methodologies has become paramount for enhancing feasibility assessments and optimising trial designs. This presentation explores an end-to-end data-driven approach that integrates machine learning techniques, external vendor data, and artificial intelligence (AI) to streamline clinical development processes. We begin by discussing the importance of feasibility studies in clinical trials and how traditional methods often fall short in accurately predicting site performance and patient recruitment. By incorporating machine learning algorithms, we can analyse vast datasets to uncover patterns and insights that inform strategic decision-making. Furthermore, the utilisation of external vendor data, such as electronic health records, claims data, and patient registries, enriches our understanding of patient populations and geographic considerations. This multifaceted approach allows for a more comprehensive evaluation of trial feasibility, ultimately leading to more efficient resource allocation and improved patient outcomes. We will also highlight the successful application of AI-driven analytics in identifying suitable trial sites, optimising patient recruitment strategies, and enhancing overall trial efficiency. The integration of these advanced technologies not only mitigates risks associated with clinical development but also fosters innovation in the design and execution of trials. In conclusion, this presentation aims to showcase the transformative potential of an end-to-end data-driven framework in clinical development, emphasising the synergistic role of machine learning, external vendor data, and AI in achieving successful trial outcomes.

15:55

The Hidden Bottleneck in Clinical Trials: Why Biospecimen Success Starts with Lab Kit Management

Ben Carmel, Chief Revenue Officer, Slope

Clinical trials hinge on biospecimen integrity, but three systemic challenges consistently emerge: excessive site burden, sample reconciliation issues, and lab kit waste. These problems stem from a common root cause: fragmented kit management across the trial ecosystem. This presentation explores how reframing biospecimen lifecycle management to start with kit oversight can reduce site burden, minimize queries, and eliminate waste—unlocking a more reliable, scalable model for clinical research.

16:20

THRIVE-20-PF: From COA Development to eCOA Library Implementation

Shawn McKown, Senior Director, Clinical Outcome Assessments, Language Solutions, IQVIA

In this talk, we explore the positive impact of approaching COA development, translation, and eCOA implementation using a coordinated, holistic approach. Using the new THRIVE-20-PF instrument as an example, we will review the strategy behind developing this fit-for-purpose oncology instrument, the proactive translation and linguistic validation of the instrument, and the incorporation of the THRIVE-20-PF into an eCOA library using AI-enabled eCOA migration and proofreading tools.

16:32

AI-Powered Strategies for Site Prioritization and Recruitment Acceleration

Malvika Gupta, Associate Director, Portfolio Strategy & Planning, Global Health Insights, Novartis

Explore new strategies and a data-driven approach by leveraging AI to improve site selection and diversity in trial feasibility, helping to reduce bottlenecks, improve recruitment readiness, and enhance overall study execution.

16:57Reception in the Exhibit Hall with Beer, Wine, and Tapas

Wind down at the end of a busy session day with colleagues, beer, wine, and tapas. Have a drink with your favorite exhibitor and take a chance at winning a fabulous raffle prize (must be present to win)!

18:00Close of Day

Wednesday, 15 October

08:15Registration and Morning Coffee

08:45

Chairperson's Remarks

Amy Froment, Head of Study Start-Up & Feasibility, Jazz Pharmaceuticals

08:50

Feasibility Process Update to Ensure Active Site Engagement

Tomasz Slaweta, Director, Strategic Feasibility, AstraZeneca

A year has passed since AstraZeneca implemented enhancements to our feasibility process, aimed at fostering active engagement from the initial interaction through site selection. Over the past year, we’ve had the opportunity to test these improvements, gather insights, and refine our approach. In this session, we will share the valuable learnings from this journey, discuss the additional updates we’ve made, and outline our future plans to further optimize the process.

09:15

Why Streamlining Feasibility Won’t Fix Feasibility

Zina Sarif, CEO, Yendou

Meri Beckwith, Co-Founder & Co-CEO, Lindus Health Ltd

Feasibility and study startup don’t stumble on slow manual processes. They stumble on leaking memory: asking the same sites the same questions until trust wears thin. Zina Sarif of Yendou opens with a diagnosis of today’s site selection and startup, taking the audience on a journey to expose the real problem behind feasibility and engagement. Then Meri Beckwith of Lindus Health shares their answer: A way of compounding knowledge across trials to match the right sites with the right protocols, and to become the CRO sites actually want to work with.

09:40

Optimising Operational Study Design Feasibility and Site Identification for Reliable Clinical Study Execution—FORCE

Galina Ershova, Director, TA Lead Feasibility and Portfolio Delivery, Oncology Portfolio Delivery, Oncology Site Management & Monitoring, AstraZeneca

Stathis Stathelos, Senior Director, Feasibility and Portfolio Delivery, Oncology Site Management & Monitoring, AstraZeneca

FORCE (Optimising Operational Study Design Feasibility and Site Identification for Reliable Clinical Study Execution) revolutionises oncology feasibility frameworks. By enhancing processes, technology, and role accountability, FORCE improves study predictability and site engagement. It integrates operational feasibility insights, aligns therapeutic area strategies, and streamlines execution, fostering a sponsor-preferred choice. Join us to explore how FORCE has transformed feasibility, driving quicker, reliable study execution in oncology clinical trials.

10:05

Fixing Feasibility: Empowering Sites and Redefining Site Selection

Andrea Bastek, PhD, Vice President, Market Strategy, Florence Healthcare

Despite growing frustration across Sponsors, CROs, and Sites, site feasibility and selection remain inefficient and resistant to change. With rising trial volumes and staffing shortages, maintaining the status quo is unsustainable. In this session, the Site Enablement League’s Feasibility Working Group shares insights to reimagine feasibility, empower sites, improve collaboration, and accelerate startup timelines.

10:17Coffee Break in the Exhibit Hall

More coffee, more exhibitors, more networking, and some delicious snacks. What’s not to love?

11:00

Networking Game, SCOPE Quiz & Prize Giveaway!

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute; Co-Founder, ClinEco

11:05Chairperson's Remarks

11:10 KEYNOTE PANEL DISCUSSION:

Embracing the Power of Networks to Expand Pharma's Research Footprint and Improve Recruitment

PANEL MODERATOR:

Terttu Haring, MD, Global Head, Engagement Strategy (Sites & Patients), Johnson & Johnson Innovative Medicine

In today’s complex clinical research landscape, strategic partnerships and connected networks are key to expanding reach and accelerating recruitment. This keynote panel brings together leaders from pharma, oncology, cardiology, and hospital networks across Europe to share how collaborative models are breaking down silos, improving patient access, and enabling faster, more inclusive trials. Panelists will discuss real-world examples of network-driven innovation and offer practical insights for scaling clinical research efficiently and equitably.

PANELISTS:

Javier Carmona, PhD, Head of Scientific Strategy & Translational Programs, Vall d’Hebron Institute of Oncology (VHIO); CSO, Cancer Core Europe

Astrid Schut, Managing Director, WCN (Werkgroep Cardiologische centra Nederland)

11:40 KEYNOTE PANEL DISCUSSION:

AI in Clinical Trials: Where Science Meets Systems—Bridging Operational Expertise with Technical Innovation

PANEL MODERATOR:

Allison Proffitt, Editorial Director, Bio-IT World and Clinical Research News

Artificial intelligence is reshaping how clinical trials are designed, executed, and analysed—offering new efficiencies and deeper insights across the research continuum. This keynote panel will explore the intersection of scientific innovation and operational execution, highlighting how AI is being integrated into clinical development to enhance trial design, streamline data analysis, and support strategic decision-making. Expert panelists will discuss real-world applications, common implementation challenges, and the organizational shifts required to fully realise AI’s potential. Attendees will gain a clear view of how leading organisations are bridging the gap between advanced technologies and clinical operations to drive smarter, faster trials.

PANELISTS:

Jonathan Crowther, PhD, Head, Operational Design Center, Merck KGaA, Darmstadt, Germany

Janie Hansen, Business Systems Transformation, Global Development Information Management, Daiichi Sankyo, Inc.

Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen

James Weatherall, PhD, Vice President & Chief Data Scientist, BioPharmaceuticals R&D, AstraZeneca

12:10Join your Peers for a Networking Luncheon in the Exhibit Hall

Join us again for lunch in the Exhibit Hall. Last chance to visit with exhibitors you missed and to enter our final raffle!

13:10 Chairperson's Remarks

David Friend, Head, Business Development, Bitfount Ltd.

13:15

Global Feasibility and Local Insights: A Holistic Data-Informed Clinical Trial Feasibility

Jessica Collins, Senior Principal Project Manager, Boehringer Ingelheim

Leigh Smith, Senior Manager, Clinical Operations, Boehringer Ingelheim

During this discussion, you will hear how Boehringer Ingelheim’s Clinical Development Operations Feasibility and Planning combines data-driven analyses with early local country feedback to reduce protocol amendments, reduce timelines, maximise protocol optimisation and enroll-ability, and develop robust Monte Carlo simulations for timeline planning.

13:40

Driving Meaningful Change: Embracing Environmental Action as a Pathway to Clinical Trial Success

Peter Morley, Clinical Sustainability Manager, Process Transformation & Digitalization, Novo Nordisk A/S

How can we harness our growing understanding of the environmental impact of clinical trials to drive meaningful change? This session will delve into the challenges and innovative strategies that empower organisations to integrate environmental metrics into clinical trial design. It will explore the opportunities to lower the environmental impact while simultaneously unlocking significant co-benefits to elevate the entire clinical trial process.

14:05

From Spec to First Patient: Fast-Tracking Global eCOA & eConsent Deployment

Speaker to be Announced, RWS Regulated Industries

Daniel Herron III, Vice President, Digital Health, RWS Group

In today’s global trials, feasibility goes beyond patient recruitment-it demands synchronized readiness of eConsent and eCOA from day one. Delays in translations, licensing, ethics or device compatibility can fragment data and stall activation. This session shows how RWS and Castor integrate linguistic, operational and tech planning to deliver global site activation with speed and quality, meeting EU CTR and global regulatory demands.

14:30Session Break

14:35

Grab Your Seat: Plenary Keynote Seat Raffle & Prize Giveaway! (Sponsorship Opportunity Available)

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute; Co-Founder, ClinEco

14:40

CLINICAL RESEARCH NEWS' BEST-OF-SHOW AWARD:

Recognising Exceptional Innovation in Technologies Used by Clinical Research Professionals

Allison Proffitt, Editorial Director, Bio-IT World and Clinical Research News

Sponsored by Clinical Research News & ClinEco
The 2025 Best-of-Show Awards offer exhibitors of the SCOPE Summit Europe an exclusive opportunity to distinguish and highlight their products, including innovative applications, technologies, tools, and solutions. The SCOPE community is invited to identify exceptional innovation in technologies used by life-science professionals, voting on the most impactful new products of the year. Submit your entry! https://www.scopesummiteurope.com/sponsor-exhibitor/best-of-show-awards

14:45 KEYNOTE FIRESIDE CHAT:

Trials Are Leaving Europe—Can We Bring Them Back?

Moe Alsumidaie, Chief Editor, Editorials, Clinical Trial Vanguard

Adama Ibrahim, Vice President, Digital Strategy & Change Management, Novo Nordisk

Tero Laulajainen, Vice President, Head of Global Clinical Operations, UCB

This keynote panel will address the decline in clinical trial activity across the European Union and what it will take to reverse the trend. Topics will include ethics review fragmentation, trial startup delays, cost pressures, site performance, and underrepresentation of EU citizens in global clinical trial data. The panel will explore how regulatory guidance, public-private collaboration, and ACT EU can collectively restore Europe's competitiveness in clinical development.

15:15 KEYNOTE FIRESIDE CHAT:

Patient Engagement to Shape Trial Design and Operations around Unmet Patients’ Needs

Alfonso Aguarón, Patient Advocate; Patient Engagement Director, Patvocates

Gonzalo Linares, Senior Director & Global Head, Patient Advocacy & External Engagement R&D, Johnson & Johnson AG

This dynamic session brings together the voices of industry and patients to explore how meaningful patient engagement can transform clinical trial design and execution. A pharma leader and a patient advocate will share real-world examples of collaboration that led to more inclusive protocols, improved recruitment, and enhanced trial experiences. Attendees will gain practical insights into embedding patient perspectives early and often to address unmet needs and drive better outcomes. Join us to learn how co-creating with patients is not just the right thing to do—it’s a strategic imperative.

15:40

Closing Remarks and Next Steps

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute; Co-Founder, ClinEco

15:45Close of Conference