2025 ARCHIVES

Cambridge Healthtech Institute's 8th Annual

Clinical Data Strategy and AI Innovation

Transforming Clinical Trials through Smarter Data and AI

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

As clinical data volume and complexity continue to grow, effective data management and advanced analytics have become critical for trial success. AI-driven innovations are opening new opportunities to streamline workflows, enhance data quality, and accelerate insights across the development lifecycle. SCOPE’s Clinical Data and AI Innovation conference explores the evolving landscape of clinical trials, with a focus on data integration, large-scale R&D governance, and the strategic application of AI and GenAI. Industry leaders will discuss how to break traditional data silos and optimize trial timelines through technology, as well as share strategies for data collaboration, smarter data collection practices, and innovative AI applications in clinical trials and real-world data. Case studies, interactive panel discussions, co-presentations, and data sharing will further enrich the value attendees gain from the gathering.

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

08:35 Chairperson's Remarks

Brian Sharkey, Business Development Director, Teckro

08:40

How to Work with Stakeholders to Define and Build a Clinical Control Tower

Philip Brown, Director, Data Visualization and Application Development, Biogen

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

This session explores how to engage cross-functional stakeholders to define, design, and implement a Clinical Control Tower—a centralized framework that enables real-time trial oversight and smarter decision-making. Attendees will learn strategies for aligning teams, selecting key data signals, and driving operational efficiency through integrated analytics, ultimately enhancing visibility, collaboration, and performance across the clinical trial lifecycle.

09:05

Enhancing Clinical Trials: Leveraging Clinical Operations Data with AI Innovations for Improved Decision-Making

Anna Majewska, Head of Product Experience, Evinova

In the evolving landscape of clinical trials, integrating clinical operations data with AI technologies is revolutionizing decision-making processes. This presentation highlights an innovative solution, showcasing real-life examples of enhanced trial efficiency and effectiveness through data integration and analysis. By envisioning a future with increased automation and machine learning, we explore the potential these technologies hold for optimising the industry, paving the way for more informed and agile clinical trials.

09:25

Fireside Chat: Accelerating Clinical Trials with AI and Decision Intelligence

Myles Kirby, Vice President, Faculty

Vijay Singh, Executive Director, Clinical Trial, Novartis Pharma SAS

In this fireside chat, Dr. Vijay Singh, Senior Global Clinical Operations Head, Novartis, and Myles Kirby, Vice President, Faculty, will explore how Novartis is reimagining trial planning and execution with decision intelligence. They’ll share more about the importance of using AI-driven simulation, optimization, and scenario planning to:

Rapidly generate strategic design scenarios earlier in the process
Optimize strategic scenarios through an unbiased exploration of the design space
Create more accurate, risk-adjusted plans to mitigate emerging risks and avoid costly delays
Complete feedback loops through a system that learns from the real world
Embed a unified approach to collaborative planning across internal teams in operations and clinical development

09:50

Why Are eCOA Studies Still So Hard? Can AI Help Solve the Operational and Implementation Challenges?

Florence Mowlem, PhD, CSO, uMotif Ltd.

Clinical trials are all about the data, which determines the effectiveness of a new treatment. eCOA has a whole host of benefits to increase data quality and integrity; however, despite decades of experience, we continue to grapple with the same operational challenges during implementation. They’re solvable—yet they persist. Why? This presentation will discuss key barriers that continue to slow progress, and consider solutions, including the potential role of AI, to gain efficiencies.

10:15

Advancing Clinical Trial Success with Data-Driven Feasibility and AI

Damian Colehan, Regional Vice President, Sales, H1

Learn how leading sponsors and CROs are advancing clinical trial planning through the strategic use of connected data and AI. Damian Colehan shares real-world case studies that demonstrate how holistic insights across patients, sites, and investigators can lead to smarter protocol design, faster study startup, and more successful enrollment—even in rare and complex diseases.

In this session, you will:

Discover new approaches to early site, investigator, and patient identification that boost efficiency and accuracy in feasibility planning.
Explore how AI is shaping the future of clinical trial planning and enabling more proactive, data-driven decision-making.
See real-world examples where comprehensive data strategies improved enrollment outcomes and avoided costly trial delays

10:28

Accelerating Clinical Trials with SAS Copilots: Enhancing Efficiency and Progress

Soundarya Palanisamy, Senior Industry Advisor, SAS Institute, Inc.

Ensuring the accuracy of clinical trial data is essential, but traditional validation methods can be time-consuming and costly. While automated tools help verify compliance, manual review remains a critical step. In this presentation we will showcase an AI-powered approach to clinical data validation, using large language models (LLMs) to automate key aspects of code and outcome review.

You will learn:

How AI can detect errors, ensure consistency, and reduce the burden of manual validation—ultimately improving efficiency and compliance in clinical research.
Optimizing validation workflows—Learn how AI minimizes manual effort while maintaining compliance and data integrity.
Addressing real-world challenges—Gain insights into overcoming regulatory, technical, and financial hurdles in AI adoption.

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

Farrell Healion, Founder & Principal Consultant, OptiTrial

14:40

Smarter Trials, Faster Setups: Unlocking Clinical Operations with AI-Created Study Assets

Farrell Healion, Founder & Principal Consultant, OptiTrial

AI is transforming how study assets are created and connected across clinical operations. This session will highlight practical GenAI use cases that streamline document creation, reduce cycle times, and improve consistency—from digital CSPs to CSRs. It will explore how Agentic AI can elevate automation across EDC, RBQM, and eTMF processes, driving real operational efficiency. The discussion will close on the key enablers—data standards, libraries, and culture—that make AI-enabled operations sustainable and scalable.

15:05

Clinical Trial Oversight at the Tipping-Point: Building an AI-Native Decision-Intelligence Layer for End-to-End Clinical Trials

Serena Fries Smith, Director of Strategic Marketing, Thermo Fisher Scientific

Chris Axford, Senior Director, Business Insights & Innovation, PPD Part of Thermo Fisher Scientific

Clinical trial oversight is approaching a breaking point, inundated by torrents of operational, clinical, and laboratory data—and further complicated by a constellation of stakeholders, each needing a different view of the truth. While sponsors still rank cross-source data harmonisation as a top pain point, global AI adoption has jumped to 72% in the past year, and Gartner projects that by 2027, half of all business decisions will be augmented or automated by AI agents. This session positions trial oversight squarely at that technological tipping point. We will explore how converging technology advances can be fused into an AI-native decision-intelligence layer, addressing existing clinical trial challenges and turning fragmented oversight into a real-time, personalized decision system. Using the forthcoming Clinical Decision Suite as an illustrative vignette, we will map the key themes to consider in order to maximize the opportunities of AI technology to support the end-to-end delivery of clinical trials.

15:30

Industrialising Clinical Trials with AI

Sidharth (Sid) Jain, Senior Vice President, Clinical Development & Data Science, Recursion

In the session, I'd share share how we're tackling clinical development by leveraging AI/ML and LLMsand with an industrial mindset with specific examples, including improved trial design, execution, and evidence generation.

15:55

Enhancing Clinical Trials through COA Expertise, Digital Technology, and End-to-End Strategic Planning

Anthony Mikulaschek, Vice President, Patient Suite Commercialization, IQVIA Technologies

Jessica Ekey, Connected Devices Strategic Solutions Lead, IQVIA

Connected devices along with their digital measures and COAs are rapidly becoming a go to strategy for trial endpoints. In this session we will explore how IQVIA has combined these 2 technologies to provide new options for study designers and trial managers.

16:20 PANEL DISCUSSION:

Building a Centralised Framework to Enable Smarter Decision-Making

PANEL MODERATOR:

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

This panel discusses building a centralised framework for clinical trials, focusing on data integration, streamlined workflows, and real-time analytics. It aims to improve decision-making, enhance trial efficiency, ensure compliance, and accelerate drug development processes through smarter, data-driven strategies.

PANELISTS:

Bhargava Reddy, PhD, Senior Director, Advanced Insights and Solutions, Janssen

Vijay Singh, Executive Director, Clinical Trials, Novartis Pharma SAS

Anna Majewska, Head of Product Experience, Evinova

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

Anthony Mikulaschek, Vice President, Patient Suite Commercialization, IQVIA Technologies

08:50

Data, Data, Everywhere, and Not a Byte to Use

Nicholas Brooke, Founder and Executive Director, The Synergist

Robert DiCicco, Vice President, Portfolio Management, TransCelerate BioPharma, Inc.

The Twenty-First Century Cures Act changed the opportunity to leverage electronic health data to improve clinical outcomes and theoretically support regulatory decision-making. Despite its passage over seven years ago that promise has been largely unfulfilled. In the Pharma R&D environment there is limited ability to unlock the potential of that data in a scalable way. Recent advances in technology along with cross sector collaborations there is a renewed opportunity to take another leap forward to accelerate clinical research.

09:15

Unlocking Clinical Expertise: Empowering Efficient EHR Search with Natural Language Queries

Justin North, Vice President, Product Management, TriNetX

Discover how natural language queries powered by LLMs are transforming EHR and RWD searches. By enabling intuitive, conversational access to clinical data, these tools improve efficiency, accuracy, and usability. This session explores challenges with traditional coding-based searches, real-world case studies, and future directions, highlighting how clinicians can retrieve insights faster and improve patient care.

09:40 PANEL DISCUSSION:

From Predictive to Proactive: Agentic AI in Clinical Trials

PANEL MODERATORS:

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

Prasanna Rao, Chief Products and Innovation Officer, Saama

Agentic AI represents a new era of intelligent systems that not only analyze data but take initiative, adapt, and collaborate autonomously. This panel will explore real-world and emerging applications of agentic AI in clinical research—from protocol design to trial monitoring—addressing opportunities, limitations, and governance challenges shaping this transformative technology.

PANELISTS:

Justin North, Director Product Management, TriNetX, Inc.

10:05

Innovative Central Lab EDC: Elevating Site Engagement and Data Integrity.

Gavin Hershaw, Director of Customer Experience, IQVIA Laboratories

As clinical trials continue to evolve in using electronic data capture to drive accuracy and efficiency in the data being obtained this presentation looks at how we can maximise the site user experience. We will explore how use of electronic systems is improving the site and customer experience and how we can continue to evolve in this area.

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!

12:55

Chairperson's Remarks

Dorothee B. Bartels, PhD, Strategist, Global Real World Evidence and (Gen)AI in Healthcare

13:00

Harnessing AI and RWD for Clinical Research and Drug Development

Thirupathi Pattipaka, Global Director, Data Science & Artificial Intelligence, Novartis Pharma AG

Drug development process is time-consuming, expensive, and success rate is low. This session explores how Artificial Intelligence (AI), combined with Real-World Data (RWD), is revolutionizing clinical research and drug development. The AI-driven methodologies to leverage RWD, enhancing study designs, protocol authoring, and accelerating trial processes. The presentation will also highlight some practical use cases for successfully adopting these transformative technologies in the clinical development and clinical research.

13:10

Next-Level Predictive Enrichment of Clinical Trials: Towards AI Characterisation of Patient Subtypes Using a Systems Biology Framework

Negin Hajizadeh, MD, MPH, RWE Research Principle Scientist, Pulmonary and Critical Care Physician, RWE Center of Excellence, Bayer

Heterogeneity of treatment effect is a known barrier to successful clinical trials. Large volumes of RWD may be synthesised within clinically informed systems biology models to characterise patient subtypes, taking into consideration dynamic changes in multiple organs and response to medications, in addition to baseline characteristics. This talk will suggest a framework for pursuing such analyses.

13:20

AI Applications in Epidemiological Research for Clinical Development: Scaling Insights, Not Mistakes

David Vizcaya, Director, Epidemiology, Development, Regulatory and Safety, Alexion Pharmaceuticals

My presentation will explore how AI is reshaping epidemiological research for clinical development. With a pragmatic approach, it will discuss how AI may support better data selection, faster cohort building, and smarter outcome prediction. It emphasises strategic benefits and limitations, including potential pitfalls downstream. I expect to offer insights for using AI to drive more efficient and ethical drug development

13:40 PANEL DISCUSSION:

Can AI Increase the Value of RWD for Clinical Development and Operations?

PANEL MODERATOR:

Dorothee B. Bartels, PhD, Strategist, Global Real World Evidence and (Gen)AI in Healthcare

In this panel senior industry leaders with backgrounds in machine learning engineering, medical informatics, and (pharmaco)epidemiology will discuss the value of Real World Data (RWD) for clinical development and operations when analyzed with established methods and with AI. We will assess both, the area of process automation and operational efficiencies, as well as the area of prediction of patient journeys, outcomes and RCT modeling. Challenges and opportunities based on the use cases from the presentations will be debated, e.g. how to detect and avoid scaling up mistakes and errors.

PANELISTS:

Negin Hajizadeh, MD, MPH, RWE Research Principle Scientist, Pulmonary and Critical Care Physician, RWE Center of Excellence, Bayer

David Vizcaya, Director, Epidemiology, Development, Regulatory and Safety, Alexion Pharmaceuticals

Thirupathi Pattipaka, Global Director, Data Science & Artificial Intelligence, Novartis Pharma AG

14:00

Trusting Instincts in a Digital World

Kendra Korte, Technical Solutions Consultant, Perceptive eClinical

Sharon Fletcher, Director, Data Management, Ergomed

Santiago Ponce-Aix, PhD, Head of Innovation, Precision Medicine & Oncology, Hospital 12 de Octubre

Explore how clinical research sites use intuition when engaging with eClinical solutions.

Chaired by Perceptive, this session features short stories from Ergomed, and the Head of Therapeutic Innovation, Precision Medicine, and Oncology at Hospital 12 de Octubre, highlighting the impact of integration and automation. Concluding with practical guidance, the session offers insights into designing more intuitive, site-friendly digital ecosystems.

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