SCOPE Europe 2024

Workshop

Innovation Day with IQVIA Technologies at SCOPE Europe

Workshop

The Path towards Sustainable Clinical Trials: How to Minimise Environmental Impact and Stay Ahead of Future Regulatory Requirements

Networking

SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps

Networking

Registration and Morning Coffee

Other · Clinical Data and Technology

Chairperson's Remarks

Stefan Duerr, IQVIA Technologies

Talk · Clinical Data and Technology

Test-Start-Scale: The Data-Driven Technology Maturity Approach

Farrell Healion, OptiTrial

Other · Feasibility, Site Selection and Study Activation

Chairperson's Remarks

Abhishek Chatterjee, H1

Other · Patient Engagement and Recruitment

Chairperson's Remarks

Robert Loll, Praxis

Other · Risk-Based Quality Management

Chairperson's Remarks

Keith Dorricott, Dorricott Metrics & Process Improvement Limited

Other · Trial Design and Protocol Development

Chairperson's Remarks

Léa Proulx, Roche

Other · Clin Ops in Europe's Emerging Biopharma

Chairperson's Remarks

Christina Karunaratne, Karuna Integrated Clinical Services

Talk · Patient Engagement and Recruitment

A Global Approach to DEI in Clinical Trials

Estelle Jobson, EUPATI

Talk · Risk-Based Quality Management

Are Your KRIs Detecting Issues Early Enough? How Simple Definition Changes Can Impact Whether Your KRIs Are Leading or Lagging

Keith Dorricott, Dorricott Metrics & Process Improvement Limited

Talk · Feasibility, Site Selection and Study Activation

Feasibility and Site Identification Powered by Data and Gen AI

Carole Ackermann, Novartis Pharma

Talk · Clin Ops in Europe's Emerging Biopharma

Strategic Navigation for Clinical Trials in Mid-Size Biopharma—Insights from an Executive Director’s Perspective

Estrella A Garcia Alvarez, Almirall SA

Talk · Trial Design and Protocol Development

Unleashing Valuable Patient Insights: The Transformative Power of Patient Perspective in Operationalising Decentralised Clinical Trials

Marisa Minetti, Chiesi

Talk · Clinical Data and Technology

Digital Data Flow: Digitalising Clinical Protocol Information to Accelerate Clinical Research and Enable Healthcare Interoperability

Julius Kusserow, Bayer AG

Talk · Risk-Based Quality Management

Applying Critical Thinking to QTL and KRI Definitions: Lagging QTLs and Composite KRIs

Jenny Christal, Jazz Pharmaceuticals Inc

Talk · Patient Engagement and Recruitment

Diversity in Clinical Trials (DICT) EMEA—A Multiple-Country Approach

Paul P Duffy, MSD Ltd

Talk · Feasibility, Site Selection and Study Activation

Embedding Digital Tools and Data-Driven Approaches for Site Selection: Change Management, Training Needs, and Implementation Strategy

Susannah Finney, Roche

Talk · Clin Ops in Europe's Emerging Biopharma

Identifying Efficiencies and Improvement Opportunities in the Vendor Qualification Process

Zachary Smith, Tufts Center for the Study of Drug Development

Talk · Trial Design and Protocol Development

Integrating Patient Perspective in Early-Stage Development: Actions Outweigh Words

Dominik Kraus, Roche

Talk · Clinical Data and Technology

Integrating Clinical and Real-World Evidence for AI Augmented Clinical Trial Design

Amhar Jabeer, Sanofi

Talk · Trial Design and Protocol Development

Assumptions Are the Root of Mistakes: Designing Studies Whilst Avoiding ‘Unicorn’ Protocols

Melissa Harris, Fortrea

Talk · Risk-Based Quality Management

How RBQM Creates Trust between Sponsors and CROs

Duncan Hall, Triumph Research Intelligence Ltd

Talk · Clin Ops in Europe's Emerging Biopharma

Optimizing Clinical Operations: A Small Biotechnology 'Fit for Growth” Strategic Insourcing and Outsourcing Adaptive Framework

Oscar Alcantar, Maze Therapeutics

Talk · Patient Engagement and Recruitment

Optimizing the Patient Journey & Site Experience

Dan Shannon, Greenphire

Talk · Feasibility, Site Selection and Study Activation

Unlocking AI-Enriched EHR Data for Precision Psychiatry through the Akrivia Health Research Platform

Benjamin Fell, Akrivia Health

Talk · Clinical Data and Technology

The Right Patient Technology at the Right Time: Improve Your Clinical Trial Implementation Strategy

Melissa Mooney, IQVIA Technologies

Talk · Feasibility, Site Selection and Study Activation

Bridging the Gap: Integrating Data Science and Gen AI in Feasibility

Nadia Lim, Pfizer Inc

Panel · Clin Ops in Europe's Emerging Biopharma

Choosing & Managing Your Partners and Vendors: Open Forum Discussion

Liz Emmerson, Blue Earth Therapeutics Ltd · Estrella A Garcia Alvarez, Almirall SA · Zachary Smith, Tufts Center for the Study of Drug Development · Mariam Sarghini, Email Address Only · Oscar Alcantar, Maze Therapeutics

Talk · Trial Design and Protocol Development

Overcoming Access Barriers for the Sexual and Gender Minority (SGM) Community: Actionable Measures from Protocol Design through Recruitment & Retention

Terttu Haring, Johnson & Johnson Innovative Medicine

Talk · Patient Engagement and Recruitment

Recruitment & Retention of Diverse Participants across the Globe

Jameka Hill, Moderna

Panel · Risk-Based Quality Management

The Opportunities and Challenges of Outsourcing RBQM

Keith Dorricott, Dorricott Metrics & Process Improvement Limited · Natalia Buchneva, UCB Pharma · Amy R Kroeplin, PPD Part of Thermo Fisher Scientific · Linda White, Jazz Pharmaceuticals Inc · Rachel Oakley, Regeneron Pharmaceuticals

Talk · Clinical Data and Technology

Help is Here: Interpreting the ICH E6 R3 Data Governance Requirements

Hasnaa Likaoui, Bristol Myers Squibb SA

Talk · Trial Design and Protocol Development

Embracing a Patient-First Approach in Clinical Trial Design: Leveraging Granular Data for Precision Planning

Elke Ydens, Anju Software

Talk · Feasibility, Site Selection and Study Activation

Streamlining Study Start-Up: Accelerating Site Activation & Reducing Tech Burden for Sites

Tom Johnson, Exostar

Talk · Risk-Based Quality Management

The Real Cost of Delays in Drug Development and the Role of RBQM and QbD

Johann Proeve, Cyntegrity Germany GmbH

Talk · Clinical Data and Technology

Turning Clinical Trial Site Selection on its Head: A Bold New Approach

Justin North, TriNetX Inc

Talk · Patient Engagement and Recruitment

What It Takes to Successfully Recruit Patients: An Integrated Platform Approach

Jytte van Huijstee, myTomorrows

Break

Grand Opening Coffee Break in the Exhibit Hall

Other

Chairperson's Remarks

Micah Lieberman, Cambridge Healthtech Institute

Keynote

Reinventing Clinical Development and Overcoming Unnecessary Complexity

Bernhard Glombitza, Bayer

Keynote

ClinEco Commons and the Power of the Clinical Research Community

Micah Lieberman, Cambridge Healthtech Institute

Panel

Converging Clinical Research with Clinical Care: A Multi-Stakeholder Panel on Tackling This Bold Vision

Paul P Duffy, MSD Ltd · Maria Dutarte, European Patients’ Academy on Therapeutic Innovation (EUPATI) · Maria Koutsopoulou, Merck KGaA · Bari Kowal, Regeneron Pharmaceuticals Inc

Talk

SCOPE Europe 2023 Accelerator Project Update and Outcomes: Innovative Outsourcing Process for Biotech

Micah Lieberman, Cambridge Healthtech Institute

Panel

Quantifying the Collection of Non-Core and Extraneous Core Protocol Data and its Relationship with Clinical Trial Performance

Emily Botto, Tufts Center for the Study of Drug Development · Paul P Duffy, MSD Ltd · Joachim Lovin, Novo Nordisk A/S

Networking

Join Your Peers for a Networking Lunch in the Exhibit Hall

Other · Feasibility, Site Selection and Study Activation

Chairperson's Remarks

Marcy Kravet, Inato

Other · Patient Engagement and Recruitment

Chairperson's Remarks

Jodie T Allen, AstraZeneca

Other · Risk-Based Quality Management

Chairperson's Remarks

Marcin Makowski, GlaxoSmithKline

Other · Clinical Data and Technology

Chairperson's Remarks

Dorothee B Bartels, HeDa-Advisors

Other · Trial Design and Protocol Development

Chairperson's Remarks

Matthew Bonam, AstraZeneca R&D

Other · Clin Ops in Europe's Emerging Biopharma

Chairperson's Remarks

Christina Karunaratne, Karuna Integrated Clinical Services

Panel · Feasibility, Site Selection and Study Activation

Increasing Trust & Transparency to Accelerate Site Selection and Start-Up

Marcy Kravet, Inato · Rosia Shah, VCTC

Talk · Clinical Data and Technology

Navigating Data Quality in Clinical Trials: Innovations and Challenges in Audit Trail Analysis

Olgica Klindworth, Medidata, Dassault Systemes

Talk · Risk-Based Quality Management

New GCP: What to Prepare For

Natalia Buchneva, UCB Pharma

Talk · Clin Ops in Europe's Emerging Biopharma

Pioneering Trial Designs

Christina Karunaratne, Karuna Integrated Clinical Services

Talk · Trial Design and Protocol Development

Sponsor Experience Implementing Decentralised Clinical Trial (DCT) Elements: DCT Implementation Survey Results & Lessons Learned

Joachim Lovin, Novo Nordisk A/S

Fireside chat · Patient Engagement and Recruitment

The FDA's Revised Draft Guidance on Clinical Trial Diversity

Alberto F Fernandez, GSK

Talk · Clinical Data and Technology

An Overview of High-Fidelity Synthetic Data Applications

Puja Runa M Myles, CPRD, MHRA

Talk · Patient Engagement and Recruitment

Bridging the Gap: How Chiesi Leveraged External Collaboration to Get Closer to Patients

Morgan Sellars, Citeline

Talk · Feasibility, Site Selection and Study Activation

Clinical Trial Diversity: Expanding Past the FDA to the Rest of the Globe

Bryan Simmons, H1

Talk · Risk-Based Quality Management

Harnessing ML and Statistics for Smarter Risk-Based Quality Management

Laura Trotta, CluePoints SA

Talk · Trial Design and Protocol Development

Securing Patient Safety and Enhancing Clinical and Medical Operations in Hybrid and Decentralized Trial Designs

AJ Mills, Veristat

Talk · Clin Ops in Europe's Emerging Biopharma

Strategies to Mitigate Vendor-Related Risks in Your First-in-Human Clinical Trials—Real Cases with Vendors Contracting

Dawid Lyzwa, JJP Biologics

Talk · Clinical Data and Technology

The Use of Routinely Collected Electronic Healthcare Records (EHRs) for Clinical Trials Research: Opportunities and Challenges

Nada Khan, Clinical Practice Research Datalink

Talk · Patient Engagement and Recruitment

Breaking Down Boundaries and Rethinking Recruitment with Agile Research Delivery

Alex Hammond, National Institute of Health and Care Research (NIHR)

Talk · Clinical Data and Technology

How the German HDL is Enabling Health Data Research

Steffen Hess, BfarM

Talk · Risk-Based Quality Management

In Pursuit of Adoption: Risk-Based Quality Management and ICH E6 R3

Arlene Lee, Medidata

Talk · Trial Design and Protocol Development

Inconvenient Truths of Decentralised Clinical Trials (DCT)

Reamonn Madden, Novartis Pharmaceuticals

Talk · Feasibility, Site Selection and Study Activation

Long-Term Relationship Development with Clinical Research Sites

Paul P Duffy, MSD Ltd

Talk · Clin Ops in Europe's Emerging Biopharma

GDPR Rules on Vendor Selection and Management

Diana Andrade, RD Privacy

Talk · Clinical Data and Technology

Building the First Large-Scale, Structured, Patient-Centric Real-World Evidence The Waze-Way

Yael Elish, StuffThatWorks

Panel · Clin Ops in Europe's Emerging Biopharma

Take-Home Strategies for Vendor Management

Joanna Mysiak, JJP Biologics · Dawid Lyzwa, JJP Biologics · Diana Andrade, RD Privacy

Talk · Trial Design and Protocol Development

Bringing Clinical Trials to Everyone's Backyard through Community & Hybrid Trial Design

Stuart Redding, Medical Research Network Ltd

Talk · Risk-Based Quality Management

Challenges in SDV & SDR Methodology: Introducing a Technical Solution for Flexible Sampling of SDV & SDR Activity

Amy R Kroeplin, PPD Part of Thermo Fisher Scientific

Talk · Patient Engagement and Recruitment

Lessons in Chemistry: The Art of Site Engagement

Kate Wheeler, Langland

Talk · Clinical Data and Technology

Moving from Hype to Reality in Pharmaceutical AI Applications

Ian Kerman, Certara

Panel · Feasibility, Site Selection and Study Activation

The Impact of Site Tech Overload on Feasibility and Study Start-Up

Alison Liddy, IQVIA

Talk · Trial Design and Protocol Development

Unlocking the Power of Decentralised Clinical Trial (DCT): Navigating Trial Design Considerations in Modern Models

Ali Wherry, Science37

Talk · Feasibility, Site Selection and Study Activation

AI-Enabled Forecasting: Increase Confidence in Study Feasibility and Execution

Rachel Horovitz, Medidata AI

Talk · Patient Engagement and Recruitment

The Future of Medicine: Improving Grassroots Access to Health & Research

Rupi Bancil, Care Access

Panel · Clinical Data and Technology

Triple the Evidence: Real-World Evidence, Synthetic Evidence, and Patient Reported Evidence

Dorothee B Bartels, HeDa-Advisors · Yael Elish, StuffThatWorks · Steffen Hess, BfarM · Nada Khan, Clinical Practice Research Datalink · Puja Runa M Myles, CPRD, MHRA

Talk · Patient Engagement and Recruitment

Addressing Clinical Trial Diversity in a Global Context: Challenges, Opportunities, and Critical Capabilities

Jodie T Allen, AstraZeneca

Talk · Trial Design and Protocol Development

Enhancing Patient Engagement and Satisfaction: Are Decentralised Trials Delivering on This Promise?

Stefania Collamati, Bayer SPA

Talk · Feasibility, Site Selection and Study Activation

Feasibility: Process Update to Ensure Active Site Engagement

Heidi Egsgaard Frandsen, AstraZeneca

Panel · Risk-Based Quality Management

Senior Clinical Trial Leaders Discuss and Debate the Impact of ICH E6 R3, the Expected Challenges, and the Opportunities

Patricia Leuchten, Diligent Pharma · Sol Babani, Symbiosis Advisors · Sandra Smith, WCG Clinical · Joanna Florek-Marwitz, UCB Biosciences GmbH

Networking

Reception in the Exhibit Hall with Beer, Wine, and Tapas

Networking

Registration and Morning Coffee

Other · Feasibility, Site Selection and Study Activation

Chairperson's Remarks

Alison Foster, Fortrea

Other · Patient Engagement and Recruitment

Chairperson's Remarks

Tom Brazier, mdgroup

Other · Risk-Based Quality Management

Chairperson's Remarks

Pooja Chavan, Gilead

Other · Clinical Data and Technology

Chairperson's Remarks

Maria Veleva, Individual Consultant

Other · Trial Design and Protocol Development

Chairperson's Remarks

Marina A Malikova, Boston Medical Ctr

Other · Clin Ops in Europe's Emerging Biopharma

Chairperson's Remarks

Lori Ellis, BioSpace

Talk · Risk-Based Quality Management

Accelerating Open Source Initiatives in Clinical Trials: 30k Insights

Pooja Chavan, Gilead

Talk · Feasibility, Site Selection and Study Activation

Acceleration of Interactive Response Technology: Innovative Methods to Enhance Efficiency

Cezary Bregier, AstraZeneca

Talk · Clin Ops in Europe's Emerging Biopharma

Case Studies: Fast-Track Approaches to Accelerated Patient Care with the Anti-CRO

Zara Liew, Lindus Health Ltd

Talk · Patient Engagement and Recruitment

Operationalising Participant Data Return—A Step Closer to Personalised Clinical Drug Development

Nadir Ammour, Sanofi R&D

Talk · Trial Design and Protocol Development

The Benefits of Building the Use of Digital Technologies into Clinical Program Design by First Intent

Matthew Bonam, AstraZeneca R&D

Talk · Clinical Data and Technology

Transforming Clinical Research at Mass General Brigham and Beyond

Shawn Murphy, Mass General Brigham

Talk · Clinical Data and Technology

Next-Generation Research: Utilizing Technology and Data to Transform Trial Execution

Myla Maloney, Premier Inc

Talk · Patient Engagement and Recruitment

Empowering Participants: How Compassionate Protocol Design Utilizing Study Support Delivers a Patient-First Experience

Alison Liddy, IQVIA

Talk · Trial Design and Protocol Development

Integrated Trail Optimization: An Innovative Approach to Study Design Including Both the Patient and Site Voices

Jenna McDonnell, Thermo Fisher Scientific

Talk · Feasibility, Site Selection and Study Activation

Optimizing Site Operations for Better Data Outputs: Standardizing Biospecimen Management with Digital Workflows

Ben Carmel, Slope

Talk · Clin Ops in Europe's Emerging Biopharma

Redefining eConsent: From Misconceptions to Clarity

Hilde Vanaken, European Forum for Good Clinical Practice

Talk · Risk-Based Quality Management

Unlocking the Promise of RBQM: A Pathway to Excellence in Clinical Development

Sharma Ramanathan Deva Devesa, ZS Associates, Inc.

Talk · Clinical Data and Technology

Real World Data, Digital Measurements and Applications in Women's Health

Bola Grace, University College London

Talk · Patient Engagement and Recruitment

Mapping Site Recruitment Strategies for Engaging Socioeconomically Disadvantaged Populations in Clinical Research

Emily Botto, Tufts Center for the Study of Drug Development

Talk · Trial Design and Protocol Development

Optimisation of Protocol Design: A Path To Efficient, Lower Cost Clinical Trial Execution

Marina A Malikova, Boston Medical Ctr

Panel · Risk-Based Quality Management · Clin Ops in Europe's Emerging Biopharma

The EU AI Act: Death Knell or Chance to Prove Value?

Lori Ellis, BioSpace · Firas Abdessalem, Sanofi · Christopher Hart, Foley Hoag LLP · Ricardo Gaminha Pacheco, Insilico Medicine · Artemy Shumskiy, LongeVC

Talk · Feasibility, Site Selection and Study Activation

Towards an Automated Site Feasibility with Use of Ontologies

Aditya Tyagi, Pistoia Alliance

Panel · Clinical Data and Technology

Advancing Clinical Trials through Scalable eSource Integration: The eSource Scale Up Task Force

Peter Casteleyn, i~HD · Lars Fransson, AstraZeneca R&D · Paul Jacobs, Regeneron Pharmaceuticals · Joe Lengfellner, Memorial Sloan Kettering Cancer Ctr · Felix Nensa, University Hospital Essen

Talk · Patient Engagement and Recruitment

Putting Patients at the Center of Their Clinical Trial Journey: Supporting Engagement, Driving ePRO Compliance

Bruce Hellman, uMotif Ltd

Break

Coffee Break in the Exhibit Hall

Other

Chairperson's Remarks

Micah Lieberman, Cambridge Healthtech Institute

Keynote

From Documents to Data: Let’s Digitally Transform Our Clinical Trial Protocol

Frank M Berger, Boehringer Ingelheim Pharma GmbH & Co KG

Panel

Integrating Digital Health Technologies in Clinical Trials: A New Era for eCOA and ePRO

Moe Alsumidaie, Clinical Trial Vanguard · Jacqueline Bowman, Foundation for the Rights of Citizens with Obesity · Bernhard Glombitza, Bayer · Kai Langel, DEEP Measures

Panel

How to Build Meaningful Relationships and Shift to Patient-Led Conversations for Improved Study Design and Execution

Maria Dutarte, European Patients’ Academy on Therapeutic Innovation (EUPATI) · Jose Angel Aibar, Dravet Syndrome Foundation Spain · Jacqui Cannon, The Lewy Body Society · Roger J. Legtenberg, Partners4Patients Foundation UG

Networking

Join Your Peers for a Networking Luncheon in the Exhibit Hall

Other · Feasibility, Site Selection and Study Activation

Chairperson's Remarks

Mette Flindt Heisterberg, Novo

Other · Patient Engagement and Recruitment

Chairperson's Remarks

Katie Baca-Motes, GSD Health Research

Other · Risk-Based Quality Management

Chairperson's Remarks

Maria Florez, Tufts University

Other · Clinical Data and Technology

Chairperson's Remarks

Nicholas Alp, Clinical ink

Other · Trial Design and Protocol Development

Chairperson's Remarks

Robert Loll, Praxis

Other · Clin Ops in Europe's Emerging Biopharma

Chairperson's Remarks

Lori Ellis, BioSpace

Talk · Risk-Based Quality Management

Assessment of Risk-Based Quality Management Adoption in Clinical Trials

Maria Florez, Tufts University

Talk · Feasibility, Site Selection and Study Activation

How CSLs Improved Feasibility Process Helps Study Teams Improve Their Robustness in Operational Planning

Mireille Ermens, CSL

Talk · Clin Ops in Europe's Emerging Biopharma

Navigating the Complexities of Early-Phase Radiopharmaceutical Therapy (RPT) Clinical Trials

Nathaniel Scott, Blue Earth Therapeutics

Talk · Patient Engagement and Recruitment

Optimising Enrollment Forecasting: A Bayesian Approach

Xinyang Li, Johnson & Johnson

Talk · Trial Design and Protocol Development

Protocol Design Trends—Opportunities to Lower Site and Patient Burden and Optimise Trial Execution

Emily Botto, Tufts Center for the Study of Drug Development

Talk · Clinical Data and Technology

Simplicity in Technology Delivery for Clinical Trials

Sylwia Rumniak, AstraZeneca Pharma Poland Sp zoo

Talk · Clinical Data and Technology

Adapting Spirometry—Decentralised Trials and AI Integration

Patrycja Wasikiewicz, AstraZeneca

Talk · Risk-Based Quality Management

Case Study: Non-Interventional Dry-Run Study Implementing Full-Scope RBQM Methodology for Risk Mitigation

Magda Piskorska, GlaxoSmithKline

Talk · Patient Engagement and Recruitment

Digital as a Bridge (Not a Divide): Advancements in RWD Collection

Katie Baca-Motes, GSD Health Research

Talk · Clin Ops in Europe's Emerging Biopharma

Importance of Vendor Qualification and Management in Clinical Trials.

Sheri Lee, Premier Regulatory Consulting

Panel · Trial Design and Protocol Development

Innovative Design Strategies to Reduce Trial Burden

Emily Botto, Tufts Center for the Study of Drug Development · Firas Abdessalem, Sanofi

Talk · Feasibility, Site Selection and Study Activation

Optimizing our Focus on Site Facing Training

Mette Flindt Heisterberg, Novo

Talk · Feasibility, Site Selection and Study Activation

AI-Driven Augmentation for Global Strategic Clinical Trial Delivery

Lee Coram, Thermo Fisher Scientific

Talk · Patient Engagement and Recruitment

Effective Tailored Strategies for Pediatric Populations: Lessons from Global Studies

Talk · Risk-Based Quality Management

From One-Size-Fits-All to End-to-End Risk Based Quality Management

Joanna Florek-Marwitz, UCB Biosciences GmbH

Talk · Clinical Data and Technology

GlucoseReady: A Digital Platform to Integrate Connected Device Data, ePRO, and Adherence Support in Clinical Trials

Nicholas Alp, Clinical ink

Other

Clinical Research News' Best of Show Award (Sponsored by ClinEco)

Allison Proffitt, Bio-IT World

Fireside chat

Redefining Excellence: The Future of Clinical Trial Quality

Coleen Glessner

Talk

Use Case: From Theory to Therapy—Accelerating Clinical Trials with AI

Jonathan Crowther, Merck KGaA, Darmstadt, Germany

Panel

Data to Decisions: GenAI's Role in Transforming Clinical Trials

Allison Proffitt, Bio-IT World · Dorothee B Bartels, HeDa-Advisors · Jonathan Crowther, Merck KGaA, Darmstadt, Germany · Farrell Healion, OptiTrial