2025 ARCHIVES

Cambridge Healthtech Institute’s 2nd Annual

Trial Design and Protocol Development

Novel Approaches to Trial Design and Patient-Centric Protocol Development

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

Drug development organizations understand the need to include patient and site perspective in protocol design and planning. Incorporating patient voice, as well as site perspectives, into clinical trial design and protocol development leads to better recruitment, retention, satisfaction, and to increased likelihood of trial success. The Trial Design and Protocol Development conference evaluates new strategies to improve and optimize protocol design, methods to incorporate participant voice, and collaborative approaches to reduce site and patient burden.

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
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

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 recognise 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

Kate Wheeler, Managing Partner, Clinical Trial Experience, Langland

09:00

Revolutionising Clinical Operations: A Glimpse into the Year 2050

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

Have you ever wondered what the future holds for clinical operations? Currently, the industry is laser-focused on decentralised trials, patient diversity, risk-based monitoring, real-world evidence, and digitalization, but where, exactly, is all this going to lead? More importantly, how can we prepare for what lies ahead? Based on experience, market, and business intelligence, Bernhard will dare to give us a glimpse into the future by exploring the challenges to come and recommending solutions to implement now in preparation for tomorrow.

09:25

Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden

Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck

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

This session presents the results of a recently completed TransCelerate Biopharma - Tufts CSDD collaborative study in which 15 pharmaceutical companies contributed data from 105 protocols. The results show rising total protocol data volume over time in step with increasing levels of protocol complexity, and changing proportions of procedures supporting primary, secondary, and exploratory endpoints. The study also introduces a new variable: data collected that supports core, standard and required endpoints but that is not deemed essential by clinical teams and protocol authors. The impact of protocol procedures by endpoint type on site and patient participation burden, use of protocol data by endpoint type in the clinical study report, and reasons why procedures supporting non-core and non-essential core, standard and required procedures are conducted will be discussed. Presenters will also discuss the implications of the study findings and new strategies to optimize protocol designs.

09:50

Digitalizing Protocols: Driving Efficiencies across Clinical Development

Samreen Haque, Associate Director, Product Implementation, Saama

Protocol development is central to clinical trial planning, yet today’s workflows remain fragmented and resource-intensive. As trials become increasingly complex, digital protocol solutions can streamline operations and create downstream efficiencies across the study lifecycle. This session explores how protocol digitalization supports structured content capture, automation, and optimization, enabling reuse across key processes. Rather than replacing expert oversight, digital approaches enhance it by accelerating workflows, reducing errors, and improving quality. Attend this session to gain practical insights into how organizations are leveraging protocol digitalization for efficiencies in DDF generation and through Agentic applications such as the EDC Builder, RACT Builder, and Site Selection, while ensuring governance, traceability, and scalability in adoption.

10:15 PANEL DISCUSSION:

Operationalising Precision Medicine: A Best-Practice Discussion with the Biospecimen Industry Collaboration

PANEL MODERATOR:

Brenda Yanak, Founder & Principal, Clinical Transformation Partners LLC

Despite overwhelming investment in AI and recognition of the need for quality data, the source of lab data—specimens—is overlooked. The Biospecimen Industry Collaboration is comprised of over a dozen top global biopharma companies who have agreed to partner together to correct this oversight: we are working to develop best practice and standards in this rising domain area, resulting in protocol optimisation, additional measures of site health, and acceleration of data exchange. In this panel we will discuss our top recommendations from our first set of workshops, and where we plan to focus future efforts.

PANELISTS:

Xavier Briand, Associate Director, Novartis Pharma AG

Abi Hunter, Senior Director, Head of Clinical Sampling, AstraZeneca

Catherine Mela, PhD, Executive Director, Head Precision Medicine Operations, GSK

Magdalena Jodlowska, Biosample Operations Portfolio Lead, F. Hoffmann-La Roche Ltd.

10:40

AI-Powered Virtual Assistants to Accelerate Clinical Trials: From Protocol to Study Build in Days, Not Months

Tim Lyons, General Manager, Anju Clinical

Clinical trial start-up is often slowed by lengthy builds, complex validation, and resource bottlenecks. Anju will showcase Luminee, a self-serve AI ecosystem of virtual assistants designed to eliminate repetitive tasks, auto-generate study objects, and deliver audit-ready validation. By accelerating database go-live timelines and ensuring data sovereignty, Luminee empowers trial teams to focus on strategic work and bring therapies to patients faster.

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

Maria Bowen, Chief of Staff, Senior Director, Clinical Science, Daiichi Sankyo

14:40

Incorporating QbD (Quality-by-Design) Principles into Protocol Development

Nicolas Le Bec, Director, Quality Risk Immunology / Neuroscience / Cardiovascular, Bristol Myers Squibb

Marion Wolfs, Executive Director, Trial Risk and Integrity Management, Bristol Myers Squibb

When developing clinical study protocols, it is important to ensure that studies are robust, risk-aware, and aligned with regulatory expectations. Incorporating Quality by Design (QbD) principles into protocol development can help ensure study quality at the outset. This proactive approach not only enhances data integrity and trial efficiency, but also paves the way for reliable outcomes and inspection readiness.

15:05

From Study Design to ICH M11 Protocol: Seamless Digital Transformation through CDISC USDM and Structured Component Authoring Integration

Murali Menon, Chief Revenue Officer, Docuvera

Guido Radack, Senior Life Sciences Consultant, InConsult

This presentation demonstrates an end-to-end digital workflow integrating Open Study Builder (OSB) with Docuvera to automatically generate ICH M11-compliant protocols from CDISC USDM-structured study designs. Our implementation leverages Digital Data Flow (DDF) principles to establish live links between study design components and protocol authoring systems, enabling real-time synchronization and reusable content management. The integration supports component-based authoring with automated FHIR export capabilities, transforming traditional document-centric processes into data-driven workflows. We demonstrate the complete journey from structured study design creation in OSB through automated protocol generation, review/approval workflows, and regulatory-compliant FHIR output, showcasing how USDM standards enable seamless clinical trial digitization.

15:30

Revolutionising Protocol Creation in Pharmaceutical Drug Development with Generative AI

Maria Bowen, Chief of Staff, Senior Director, Clinical Science, Daiichi Sankyo

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

Discover how generative AI is transforming protocol creation in pharmaceutical drug development. This session explores the integration of AI technologies to streamline protocol design, enhance accuracy, and expedite the drug development process, paving the way for innovative therapeutic solutions.

15:55

Next-Gen AI: The Future of Clinical Trial Financial Management

Zee Zee Gueddar, Senior Director & Commercial Lead, Financial Strategy, IQVIA Technologies

Rajesh Patel, Senior Director, Product Management, IQVIA Technologies

In today’s rapidly evolving clinical research landscape, organisations are under pressure to deliver efficiency, flexibility, and scalability. Sponsors are shifting towards models where intelligent software and AI play a significant role in managing trial finances, driven by the need for streamlined, automated processes. This presentation will review how a powerful combination of advanced technology, specialised services, and deep clinical-trial financial expertise can be used to improve your clinical financial management wherever you are in your development journey.

16:20

Bringing Research to Every Neighborhood: Expanding Reach to Improve Outcomes

Jeff Huntsman, Chief Commercial Officer, EmVenio Research

Clinical trials succeed when they reflect the realities of everyday patient experiences. That begins with who participates, where they’re reached, and how they’re supported. This session will explore how expanding access, extending geographic reach, and embedding research in local communities leads to stronger data, lower dropout rates, and more representative outcomes. We’ll unpack how EmVenio’s community-based model improved trial accessibility and dramatically reduced patient dropout in an ongoing Phase 3 influenza study. We’ll also review industry data that challenges traditional assumptions about trial design and site strategy, offering a scalable, inclusive blueprint for future trials.

16:32

Can You Hear Me Now—Amplifying the Patient Voice in Trial Design

Reamonn Madden, Innovation Capability Director, Global Clinical Operations Innovation, Novartis Pharmaceuticals

Who doesn’t want to feel heard, really? It’s good for our minds and bodies, and when it comes to clinical trials, it’s good science. When patients feel—and are—heard in the early stages of trial design, we set the stage for future success. The session will provide a clear distillation of not only why amplifying the patient voice is worthwhile but also how to do it at a practical level. Our goal is to leave session participants energized and equipped with the confidence and tools to turn up the volume on patient voices in designing their next trials. We will focus on sharing freely available solutions that can support effective partnership and decision-making between patients and participants.

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

Roger Legtenberg, PhD, Co-Founder, Partners4Patients Foundation UG

08:50 PANEL DISCUSSION:

Beyond Checkboxes: Powering Patient-Relevant Clinical Trials through Meaningful Co-Creation & Authentic Collaboration

PANEL MODERATOR:

Roger Legtenberg, PhD, Co-Founder, Partners4Patients Foundation UG

This session will explore the behaviors and mindsets that can undermine meaningful involvement of persons living with the disease in clinical trial design. It will challenge traditional approaches—such as patient advisory boards—as the default for patient engagement, and instead offer strategies for truly embedding patient perspectives throughout the planning process. The discussion will also address why patient involvement should not end once the trial design is finalized, but must continue throughout the trial lifecycle to ensure continued relevance and impact. Finally, the session will highlight some of the most pressing real-world challenges in making clinical trials genuinely meaningful to those who matter most: the patients themselves.

PANELISTS:

Estrella Garcia Alvarez, PhD, Executive Director, Global Clinical Operations, R&D, Almirall SA

Toni Mathieson, Chief Executive, Niemann-Pick UK

Bob Stevens, MPS Society and Rare Disease Research Partners

09:40

From Sample to Strategy: Holistic Laboratory Partnership to Enable Delivery of Modern Trial Designs

Viviane Manghi, Director, Strategy & Site Solutions, Global Operations & Strategic Transformation, Labcorp

Clinical trial design often overlooks central laboratory insight, risking fragmented workflows and avoidable delays. This presentation advocates for integrating laboratory expertise early in trial design. Case studies will show how proactive collaboration with lab providers enhances efficiency, reduces costly amendments, and optimizes biomarker strategy. We'll demonstrate lab providers as co-authors of research success, offering actionable insights on biomarkers, assays, sample and data flow. We'll also showcase how central lab integration ensures protocols are scientifically robust and operationally feasible.

10:05

How AI-Powered Protocol Design Influences Outcomes

Mette Andersen, General Manager, Data, Analytics & Insights Solutions, WCG

This session examines practical approaches for optimizing protocol design to improve patient outcomes and trial performance. More specifically: How AI and machine learning analyze protocol choices using WCG’s comprehensive protocol and benchmarking databases. Strategic insights on country and site selection and their influence on recruitment and trial efficiency. Which protocol decisions most significantly affect clinical trial timelines, recruitment, and operational success.

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

Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck

13:15

Addressing EHR Challenges with Embedding Trials into Clinical Practice

Gracy Crane, PhD, International Regulatory Policy Lead for RWD, Roche Products Ltd.

Jesper Kjaer, Global Director Public & Private Partnerships, Strategic Operations Global Medical Affairs, Novo Nordisk; Co-Chair, Vulcan Advisory Committee

TransCelerate BioPharma is a non-profit organization that serves as a catalyst for change in clinical research. TransCelerate members working on our Embedded Pragmatic Trials initiative will discuss recent work and our engagement with Health Authorities to overcome challenges that trial sponsors may experience when designing trials with pragmatic elements and embedding them into clinical practice. This will include discussion of recent publications and changes from FDA and ACT EU.

13:40

Planning and Deploying Decentralised and Hybrid Trials

Reamonn Madden, Innovation Capability Director, Global Clinical Operations Innovation, Novartis Pharmaceuticals

Leveraging experiences from the cross-divisional DCT team at Novartis to explore how decisions should be made to include DCT elements in trial protocols, the key steps to make it easy for trial teams and sites to deploy, and a perspective on how DCT principles can be applied in future of trials.

14:05

The Evolution of Adaptive Protocols: Early Clinical Development

Emma Field, Director, Project Management EDS, Trialmed

In traditional early phase studies, discrete protocols and studies have been used for healthy volunteer and patient populations. However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drug developers.

Instead of the standard approach where studies are designed to address a primary focus, a parallel study method — a format that incorporates multiple endpoints and objectives, modifications, treatment arms and dose selections into a single protocol — is being rapidly adopted. This results in more complex protocols but provides a flexible, adaptive and proactive approach.

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