Cambridge Healthtech Institute’s 7th Annual

SUMMIT FOR CLINICAL OPS EXECUTIVES

Optimising Digital and Hybrid Trials in Europe and across the Globe
29-30 October 2024 | InterContinental Barcelona (Fira Center) in Barcelona, Spain

Conference Programs

Featured Speakers

Trial Design andProtocol Development

Christoph Koenen
Head of Clinical Development& Operations, Pharma Research& Development, Bayer

Shyard Wong
Head, Clinical Quality &Continuous Improvement,
Sanofi

Feasibility andStudy Activation

Paul Duffy
Head, Global Clinical Site
Partnerships, MSD

Jonathan Crowther, PhD
Head, Predictive Analytics,
Pfizer R&D

Patient Engagement
and Recruitment

Jacqueline Bowman
Head of Policy, European
Association for the
Study of Obesity (EASO);
Registered Expert, European
Commission and European
Medicines Agency (EMA)

Bari Kowal
Senior Vice President& Head, Development
Operations & Portfolio
Management, Global
Development, Regeneron
Pharmaceuticals, Inc.

Clinical Data andTechnology

Register by 20 September SAVE UP TO €300

Clin Ops in Europe’s
Emerging Biopharma

Risk-Based Quality
Management

Event Features• 3 Plenary keynote sessions• Senior level executives from pharma,biotech, government, and academia

PREMIER SPONSORS• Interactive panel discussions• Exclusive exhibits and networking• Best of Show Awards

LEAD SPONSORSHIP ORGANISATIONS

ScopeSummitEurope.com#SCOPEsummit

ScopeSummitEurope.com | 1

7th Annual

CONFERENCE-AT-A-GLANCE
29-30 OCTOBER 2024 | PRE-CON WORKSHOPS ON 28 OCTOBERInterContinental Barcelona (Fira Center) in Barcelona, Spain

Optimising Digital and Hybrid Trials in Europe and across the GlobeSUMMIT FOR CLINICAL OPS EXECUTIVES

Workshops and User Groups on Monday Afternoon | 28 October 2024
MONDAY
Arrive on Monday in Beautiful Barcelona and Start SCOPE Europe on Monday Afternoon!
ESG (Environmental, Social & Governance) Leaders in Pharma: Sustainable Trials Summit@SCOPE | (Monday PM)

Innovation Day at SCOPE Europe with IQVIA Technologies@SCOPE | (Monday PM)

Conference on Tuesday and Wednesday | 29-30 October 2024
TUESDAY
Morning Coffee and Conference Registration | (Tuesday AM)
TRIAL DESIGN AND
PROTOCOL DEVELOPMENTFEASIBILITY AND STUDYACTIVATIONPATIENT ENGAGEMENT
AND RECRUITMENT

CLINICAL DATA ANDTECHNOLOGY

CLIN OPS IN EUROPE’S
EMERGING BIOPHARMARISK-BASED QUALITYMANAGEMENT

Novel Approaches to Trial
Design and Patient-Centric
Protocol Development

Modernising Feasibility, Site
Selection, Site Engagement,
and Start-Up Practices

Engagement andRecruitment throughCommunities andTechnologies

Clinical Data, Technology,
and AI/ML for Digital andHybrid Trials

Optimising Clinical
Programs, Clin Ops Teams,
and Outsourcing Partners
in Europe’s Emerging
Biopharma

Risk-Based Quality
Management (RBQM) andMonitoring

Grand Opening Coffee Break in the Exhibit Hall
Morning Shared Plenary Keynotes and Panel Discussion
Interactive Discussion with Topic Champion | Join an Interactive and Facilitated Discussion with a Group of Your Peers.
Join Your Peers for a Networking Luncheon in the Exhibit Hall & Join Us for a SCOPE Europe Prize Drawing!
TRIAL DESIGN AND
PROTOCOL DEVELOPMENTFEASIBILITY AND STUDYACTIVATIONPATIENT ENGAGEMENT
AND RECRUITMENT

CLINICAL DATA ANDTECHNOLOGY

CLIN OPS IN EUROPE’S
EMERGING BIOPHARMARISK-BASED QUALITYMANAGEMENT

Welcome Reception in the Exhibit Hall with Beer, Wine, and Tapas
Join our Exhibitors for a Booth Crawl of Specialty Foods and Beverages and a SCOPE Europe Prize Drawing! | (Tuesday PM)
WEDNESDAY
Morning Coffee (Wednesday AM)
TRIAL DESIGN AND
PROTOCOL DEVELOPMENTFEASIBILITY AND STUDYACTIVATIONPATIENT ENGAGEMENT
AND RECRUITMENT

CLINICAL DATA ANDTECHNOLOGY

CLIN OPS IN EUROPE’S
EMERGING BIOPHARMARISK-BASED QUALITYMANAGEMENT

Coffee Break in the Exhibit Hall and Special Book Signing
Morning Shared Plenary Keynotes and Panel Discussion
Join Your Peers for a Networking Luncheon in the Exhibit Hall & Join Us for a SCOPE Europe Prize Drawing!
TRIAL DESIGN AND
PROTOCOL DEVELOPMENTFEASIBILITY AND STUDYACTIVATIONPATIENT ENGAGEMENT
AND RECRUITMENT

CLINICAL DATA ANDTECHNOLOGY

CLIN OPS IN EUROPE’S
EMERGING BIOPHARMARISK-BASED QUALITYMANAGEMENTClinical Research News SCOPE Best of Show Awards 2023 Recognising Exceptional Innovation in Technologies Used by Clinical Research Professionals& Closing Plenary Keynote Panel Discussions
Close of SCOPE Europe (Wednesday PM)

PARTNERING ORGANISATIONSMEDIA PARTNERS
Official Event Publication

Sponsoring Publications

CLINICALRESEARCH
NEWS

Clinical Trials to the Clinic

Lead Media Partner

Lead Sponsoring Publications

Lead Sponsoring Organisation
2 | ScopeSummitEurope.com#SCOPEsummit

Sponsorship & Exhibit Opportunities
CHI offers comprehensive packages that can be customized to your budget and objectives. Sponsorshipallows you to achieve your goals before, during, and long after the event. Packages may include presentations,exhibit space, and branding, as well as the use of delegate lists. Signing on early will maximize your exposure toqualified decision-makers and drive traffic to your website in the coming months.
Exhibitors will enjoy facilitated networking
opportunities with qualified delegates, making it theperfect platform to launch a new product, collectfeedback, and generate new leads. Exhibit space sells
out quickly, so reserve yours today!

PODIUM PRESENTATIONS —AVAILABLE WITHIN MAIN AGENDA!
Showcase your solutions to a guaranteed, targeted
audience through a 12- or 25-minute presentation.
Package includes exhibit space, on-site branding,and access to cooperative marketing efforts by CHI.
Presentations will sell out quickly! Sign on early tosecure your talk.

Additional branding and promotional opportunities
are available, including:• Exhibit Hall Reception• Exhibit Hall Break Sponsor• Tote Bags - SOLD
• Lanyards - SOLD
• Booth Crawl• Patient Lounge Sponsor• Breakout Discussion Sponsor• Branded item such pens, lip balms, or otherrelevant product

1:1 MEETINGS/ HOSPITALITY SUITE• Access to a small meeting room for one-on-one
meetings set with table and chairs.
• Your company will select invitees from theconference pre-registration list. CHI will set up 6-8
one-on-one meetings, 15-20 minutes each with yourTOP prospects, and confirm appointment.
• CHI will extend invitations, conduct follow-up, andmonitor responses.

EXHIBIT

Hotel & Travel Information
CONFERENCE VENUE AND HOTEL:InterContinental Barcelona (Fira Center)
Avenida de Rius I Taulet, 1-3
Barcelona, 08004, Spain

Discounted Room Rate:€320 Single/€350 Double (includes Wi-Fi)
Discounted Room Rate Cut-off Date:
27 September 2024

For Hotel reservations and additional travel information
please go to the Travel Page of ScopeSummitEurope.com

2023 Attendee
Demographics

COMPANY
TYPE
 Biotech28%
 Pharma
25%
 CRO
21%
 Services & Societies 12%
 Healthcare/Hospital 11%
 Academic2%
 Other1%

DELEGATE
TYPE
 Executive/Director
 Sales & Marketing Managers
 Scientist
 Other

49%
18%
18%
12%
3%

FOR ADDITIONAL INFORMATION, PLEASE CONTACT:COMPANIES A-E

COMPANIES F-J

COMPANIES K-T

COMPANIES U-Z

Ilana Quigley

Katelin Fitzgerald

Jon Stroup

Patty Rose(+1) 781-247-1824
kfitzgerald@cambridgeinnovationinstitute.com(+1) 781-972-5483
jons@healthtech.com

Director, Sales(+1) 781-972-5457
iquigley@healthtech.com#SCOPEsummit

Senior Manager,
Business Development

Senior Manager,
Business Development

Senior Director, Sales(+1) 781-972-1349
prose@healthtech.com

ScopeSummitEurope.com | 3

KEYNOTE SPEAKERS & USER GROUP INFOMONDAY, 28 OCTOBERMONDAY AFTERNOON: USER GROUP
Arrive on Monday in beautiful Barcelona and start SCOPE Europe on Monday
Afternoon! Visit our Travel page. https://www.scopesummiteurope.com/travel

14:30 – 19:00 Innovation Day with IQVIATechnologies at SCOPE Europe
More info and RSVP* Join IQVIA Technologies’ digital product leaders andcustomer success experts for an afternoon of discussions, demos, andnetworking. We’ll share our vision to transform clinical operations, the progress
we’ve made to date, and our roadmap for 2024 and beyond. *Registration is limited
to pharmaceutical, biotech companies, and research sites. IQVIA reserves the rightto decline any registration.

MONDAY EVENING IN BARCELONA
Join friends and colleagues for dinner at a spot near the conference hotel, which isin a great location. https://bit.ly/CHI-Barcelona-Restaurants
Main Conference Tuesday and Wednesday, 29-30 October 2024. Join the morning
run/walk at 07:00. Registration opens at 07:45 and the opening presentations startat 08:50.

TUESDAY, 29 OCTOBER
07:00 SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps
Join SCOPE Europe’s Coordinators for our Fun Walk/Run! All of us at Cambridge
Healthtech Institute recognise the importance of integrating well-being and fitness
into our work travel routines. This is an easygoing, informal running (or walking)event where we ascend the stairs of the iconic Magic Fountain. No time chips,
running bibs, or energy bars—just a laid-back opportunity for a small group to startthe day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walkand-talk—the goal is to get up and get moving! Meet us in the front lobby at theInterContinental at 7 am sharp!

07:45 – 09:00 Registration and Morning Coffee
08:50 – 10:50 Join Conference Sessions (6 Tracks)
10:53 Grand 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 theindustry, connect with colleagues and vendors, and make some new friends.

TUESDAY MORNING PLENARY SESSION:REINVENTING CLINICAL DEVELOPMENT & CONVERGINGRESEARCH WITH CLINICAL CARE
11:50 Chairperson’s Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute;
Co-Founder, ClinEco

11:55 KEYNOTE PRESENTATION: Reinventing Clinical Development andOvercoming Unnecessary Complexity
Christoph Koenen, Head of Clinical Development & Operations,Pharma Research & Development, Bayer
This keynote presentation proposes a paradigm shift in clinicaldevelopment, advocating for the adoption of a minimal viable
product (MVP) approach focused solely on fulfilling regulatory
requirements. By streamlining processes and resources to the essentials,
this strategy promises significant cost reductions and time efficiencies while
maintaining regulatory compliance. Through case studies and implementation
strategies, attendees will gain insights into how embracing this innovative
approach can revolutionize clinical development, paving the way for greater agility,
adaptability, and patient-centricity in the industry.

Micah Lieberman, Executive Director, Cambridge Healthtech Institute;
Co-Founder, ClinEco
The Commons is a ClinEco and SCOPE resource. It is a go-to hub
for resources, tools, news, regulatory updates, and more, designed
to support professionals in the field of clinical research. ‘The
Commons’ serves as a collaborative space where you can access, visit, sharevaluable content as well as contribute to the wealth of knowledge within the
SCOPE and ClinEco community. The “Ask a ClinEco Luminary” feature allows users
to connect directly with research leaders to learn from colleagues. One of the
Luminary sections is “Ask a Patient” (with Savvy and EUPATI).

12:30 KEYNOTE PANEL DISCUSSION: Converging Clinical Research with
Clinical Care: A Multi-Stakeholder Panel on Tackling this Bold Vision
PANEL MODERATOR:Paul Duffy, Head, Global Clinical Site Partnerships, MSD.
This plenary panel will show how stakeholders across biopharma
R&D have come together to develop pragmatic solutions thatare foundational to enabling the future of drug development andintegrating clinical research as part of the care continuum. This panel will featurebiopharma industry leaders, Health Authorities, patient advocates, and otherindustry consortia candidly discussing why everyone must work together to drive
innovation in the R&D ecosystem, shape the future of healthcare, and bridge thegap between clinical research and clinical care.
PANELISTS:
Maria Dutarte, Executive Director,
European Patients’ Academy on
Therapeutic Innovation (EUPATI)Maria Koutsopoulou, Senior Vice
President, Head of Global Development Operations, Merck KGaA
Bari Kowal, Senior Vice President & Head, Development Operations & Portfolio
Management, Global Development, Regeneron Pharmaceuticals, Inc.

12:55 SCOPE Europe 2023 Accelerator Project Update and Outcomes:
Innovative Outsourcing Process for Biotech
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder,
ClinEcoLast year at SCOPE Europe we engaged with sponsor orgs in attendance on a
project with ClinEco, our B2B clinical research marketplace and network, to help
with scoping, selection, and onboarding of outsourcing partners for a trial. The goal
was to challenge the norms of clinical trials outsourcing, improve vendor selection,and speed up the RFI process...and more. We learned a lot with our partner andsome of those key learnings apply to us all.

13:00 KEYNOTE PANEL DISCUSSION: Quantifying the Collection of
Non-Core and Extraneous Core Protocol Data and its Relationship with
Clinical Trial Performance
PANEL MODERATOR:
Emily Botto, Senior Research Assistant, Tufts University
This panel discussion provides perspectives and updates on a collaborative
research study looking at optimizing non-core and extraneous clinical researchdata collection practices, with the aim to reduce patient and site burden. The panel
will explore considerations that helped define the study methodology and insights
expected from the study findings that will inform new protocol design strategies.
PANELISTS:
Paul Duffy, Head, Global Clinical Site Partnerships, MSD
Joachim Lovin, DCT Specialist, Novo Nordisk

13:35 Join 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 – 17:00 Join Conference Sessions (6 Tracks)
16:57 Reception 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)!

12:20 ClinEco Commons and the Power of the Clinical Research Community
4 | ScopeSummitEurope.com#SCOPEsummit

WEDNESDAY, 30 OCTOBER
08:15 Registration and Morning Coffee
08:45 – 10:15 Join Conference Sessions (6 Tracks)
10:17 Coffee Break in the Exhibit Hall and Special Book Signing
More coffee, more exhibitors, more networking, and some delicious snacks. What’s
not to love?

WEDNESDAY MORNING PLENARY SESSION:INTEGRATING DIGITAL HEALTH TECH IN TRIALS &IMPROVING STUDY DESIGN WITH PATIENTS
11:00 Organiser’s Welcome Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute(CHI); Co-Founder, ClinEco

11:05 Presentation to be Announced

and ePRO

14:35 Clinical Research News’ Best of Show Award: Recognizing
Exceptional Innovation in Technologies Used by Clinical Research
Professionals
Allison Proffitt, Editorial Director, Bio-IT Worldand Clinical Research News

Sponsored by Clinical Research News & ClinEco
The 2024 Best of Show Awards offer exhibitors of the SCOPE
Summit Europe an exclusive opportunity to distinguish and highlighttheir products, ranging from an innovative application, technology, tool, or solution.
The SCOPE community is invited to identify exceptional innovation in technologies
used by life science professionals, voting on the most impactful new productsof the year. Submit your entry! https://www.scopesummiteurope.com/sponsorexhibitor/best-of-show-awards

14:40 FIRESIDE CHAT: Redefining Excellence: The Future of Clinical
Trial Quality

11:20 KEYNOTE PANEL DISCUSSION: Integrating Digital
Health Technologies in Clinical Trials: A New Era for eCOA

PANEL MODERATOR:
Moe Alsumidaie, Chief Editor, Editorials, Clinical Trial VanguardThis panel will delve into how emerging digital health technologies,
including eCOA and ePRO, are transforming patient data collection inclinical trials. It will cover the evolution of digital endpoints, patientcentric approaches, and the integration of these technologies into
clinical research frameworks. How are digital health technologies, especiallyeCOA and ePRO solutions, revolutionizing data collection in clinical trials? Havethey led to more patient-centric trials? What are the challenges in integratingthese technologies into existing clinical trial frameworks, and how have they been
overcome? What considerations should be made when selecting technology
partners? Looking towards the future, how do you see digital health technologies
evolving, and what implications will this have on clinical research?

Coleen Glessner, Executive Vice President, Quality, Ethics and Compliance,
Emergent BioSolutions
Patricia Leuchten, Founder and CEO, Diligent Pharma
Shyard Wong, Head, Clinical Quality & Continuous Improvement, sanofi-aventis
Kristi Koontz, Vice President, Global Clinical Operations, Daiichi Sankyo US
This keynote will explore milestones from the past that have shaped our present
approach to clinical trial quality. Delving into the present, we scrutinize the existing
paradigms and contemplate the ongoing transformations in our approach toensuring trial quality. As technological advancements, regulatory shifts, andsocietal demands continue to reshape the landscape, we confront the imperativeof redefining what excellence means in the realm of clinical research. How will
emerging methodologies, such as decentralized trials and real-world evidence,
redefine our benchmarks for success? What role will artificial intelligence, big data
analytics, and patient-centricity play in shaping the future of clinical trial quality?

15:05 USE CASE: From Theory to Therapy: Accelerating Clinical Trials
with AIPANELISTS:
Jacqueline Bowman, Head of Policy, European Association for the Study ofObesity (EASO); Registered Expert, European Commission and European
Medicines Agency (EMA)
Bernhard Glombitza, Head, Clinical Operations EMEA and APAC, Bayer
Kai Langel, Senior Director, Strategy and Innovation, Global Regulatory Policy andIntelligence, Global Regulatory Affairs, Janssen R&D

11:45 KEYNOTE PANEL DISCUSSION: How to Build Meaningful
Relationships and Shift to Patient-Led Conversations for Improved
Study Design and Execution
PANEL MODERATOR:Maria Dutarte, Executive Director, European Patients’ Academy on
Therapeutic Innovation (EUPATI)
Join us for a critical exploration into the transformative approachof integrating patient insights into clinical trial protocols. This panel
will explore how strong relationships and patient-led conversations can improvestudy design and execution, significantly easing the burden on sites and patients.
Learn from experts about common pitfalls and challenges in patient engagement,
gaining actionable strategies towards more effective and empathetic trials.
PANELISTS:
Jose Aibar, President, Dravet Syndrome Foundation Spain
Jacqueline Cannon, Chief Executive, The Lewy Body Society
Roger Legtenberg, PhD, Co-Founder, Partners4Patients Foundation UG

12:10 Join 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 – 14:30 Join Conference Sessions (6 Tracks)

WEDNESDAY AFTERNOON PLENARY SESSION:NEW ERA OF RISK/QUALITY (R3) & LEVERAGING AI TOACCELERATE TRIALS#SCOPEsummit

Jonathan Crowther, PhD, Head, Predictive Analytics, Pfizer R&D
This new story and real-world use case is an exploration of the
future potential of GenAI in clinical trials, focusing on optimizing trial
efficiency, reducing costs, and the broader business impact. Inspire
the audience to think about the long-term benefits of integrating
GenAI into their processes.

15:20 KEYNOTE PANEL DISCUSSION: Data to Decisions: GenAI’s Role inTransforming Clinical Trials
PANEL MODERATOR:
Allison Proffitt, Editorial Director, Bio-IT World and Clinical Research
News
Artificial intelligence, data analytics, automation and technology
have the power to connect stakeholders and applications
and enhance protocol design, study feasibility, and patient identification andrecruitment. The recent explosion of innovation with generative AI is deliveringpromising advances as we all know. However, this involves constructing a robust
data infrastructure, harnessing cutting-edge technologies, adhering to privacy anddata security regulations, and enforcing data governance principles.

PANELISTS:
Dorothee Bartels, PhD, Associate Professor (Apl. Professor) for Public Health andEpidemiology, Medizinische Hochschule HannoverJonathan Crowther, PhD, Head, Predictive Analytics, Global Product Development,
PfizerFarrell Healion, Senior Director Emerging Technologies, Global Clinical Solutions,AstraZeneca
Adama Ibrahim, Vice President, Digital Strategy & Change Management, Novo
Nordisk

15:45 Close of Conference
ScopeSummitEurope.com | 5

SPONSORSPREMIER SPONSORSCORPORATE SPONSORSCORPORATE SUPPORT SPONSORS

6| ScopeSummitEurope.com#SCOPEsummit

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CAMBRIDGE HEALTHTECH INSTITUTE’S INAUGURAL|

29 - 30 OCTOBER 2024

Trial Design and Protocol Development
Novel Approaches to Trial Design and Patient-Centric Protocol Development

MONDAY 28 OCTOBERMONDAY AFTERNOON: USER GROUP & WORKSHOP
14:30 – 19:00 Innovation Day with IQVIA Technologies at
SCOPE Europe
CO-SPEAKERS:
Kevin Landells, Vice President Patient Centered Technology Delivery, IQVIATechnologies
Stefan Dürr, Senior Director, Client Delivery, IQVIA Technologies
Petar Genov, Senior Director, Business Operations and Capabilities – Payments,
IQVIA Technologies
Tim Reily, Vice President, Clinical Data Analytics, IQVIA Technologies
Alison Liddy, Senior Vice President, Patient and Site Centric Solutions, IQVIA
Clinical trial sponsors are invited to join IQVIA Technologies’ digital productleaders and industry representatives for an afternoon of discussions, demos,and networking. IQVIA will share our vision to transform clinical operations,demonstrate our technologies that improve the patient, site, and sponsor journeys,
and ask for your input on our roadmap for future product development. Innovation
Day is complimentary and will be of interest to pharmaceutical executives orsites with roles in clinical operations, innovation, technology, finance, budgeting,data analytics, patient or site engagement, or strategic sourcing. IQVIA reserves
the right to decline registrations for those not in these categories. For more
information or to register click here.​

17:30 – 19:00 The Path towards Sustainable Clinical Trials: How to
Minimise Environmental Impact and Stay Ahead of Future Regulatory
Requirements
INSTRUCTORS:Fiona Adshead, Chair, Sustainable Healthcare Coalition
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Marisa Minetti, Patient Research Partner, Chiesi Group
Keith Moore, Programme Coordinator, Sustainable Healthcare Coalition
Developing frameworks to define and manage sustainability risks, and effective
guidelines to reduce the carbon footprint of clinical trial operations is a collaborative
effort. Beyond benefiting the environment, adopting sustainable practices isincreasingly demanded by stakeholders and can significantly influence customer
choices and talent acquisition. Perhaps more compelling are the growing
regulatory pressures and expectations, including the Corporate Sustainability
Reporting Directive (CSRD) and Task Force on Climate-related Financial Disclosures(TCFD) among others. This workshop will discuss the current hotspots of carbon
emissions in clinical research, introduce a new clinical trial carbon footprint
calculator for assessing current state, and suggest introductory reduction
strategies. Whether you are in clinical trial design clin ops, procurement, innovation,
sustainability, or resource management, this workshop is for you.

TUESDAY 29 OCTOBER
7:00 SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps

Patient Perspective in Operationalising Decentralised Clinical Trials
Marisa Minetti, Patient Research Partner, Chiesi Group
Ylenia Paleari, PhD, Patient Engagement Manager, Global Rare Diseases R&D
Clinical Development, Chiesi GroupHow insights from collaborative studies with patients and health care
professionals in the USA and Europe, revealing perspectives on the benefits
and challenges of DCTs, can help shape the future of patient-centric researchin advancing DCTs in respiratory and rare diseases. This session discusses theimplications of these results and explores actionable insights on modifying DCTs
to better address the needs and preferences of both patients and HCPs.

9:25 Integrating Patient Perspective in Early-Stage Development:
Actions Outweigh Words
Dominik Kraus, PhD, Principal Clinical Scientist, Roche
Léa Proulx, Patient Voice Partner, Strategy, Portfolio & Operations, Roche
Integrating patient insights into early protocol development is paramount inmaking key patient-inclusive development decisions in determining target patient
population, endpoint selection, eligibility criteria, and schedule of assessment.
Roche will share their approach to assess a patient-inclusive mindset, addressing
gaps from both strategic and tactical perspectives and providing concrete
examples on how to integrate patient insights in an early, systematic, and timely
manner to design and implement patient-inclusive trials.

9:50 Assumptions are the Root of Mistakes: DesigningStudies Whilst Avoiding ‘Unicorn’ Protocols
Melissa Harris, Global Head, Fortrea
Assumptions in trial design impacts everything. Headways been made with patientcentric design philosophy but ultimately its sites who must execute the study.
Listening to and incorporating input from sites and patients concurrently drives newtreatments to the right patients, faster. A duel-centric approach is a potent model
for achieving efficiency whilst meeting demands of sponsors and patients, beyond
simply listening for intelligent, and compassionate protocol measures

10:15 Overcoming Access Barriers for the Sexual and Gender Minority(SGM) Community: Actionable Measures from Protocol Design throughRecruitment & Retention
Garo Kiledjian, Founder & CEO, SGM Alliance
Kamil Kuhr, Director of R&D GxP Learning Operations, AstraZeneca
Binita Patel
This thought-provoking session kicks off with the introduction of SGM Alliance
who’s paving the way in addressing health inequities faced by the SGM community
who are often overlooked in clinical research. It then digs into actionable measures
you can take to include SGM in clinical study design, spanning from protocol
design through recruitment and retention. Together, let’s drive meaningful change
for a more inclusive and accessible landscape in clinical research.

10:40 Presentation to be Announced
10:53 Grand Opening Coffee Break in the Exhibit Hall

Join SCOPE Europe’s Coordinators for our Fun Run/Walk! All of us at Cambridge
Healthtech Institute recognise the importance of integrating well-being and fitness
into our work travel routines. This is an easygoing, informal running (or walking)event where we ascend the stairs of the iconic Magic Fountain. No time chips,
running bibs, or energy bars—just a laid-back opportunity for a small group to startthe day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walkand-talk—the goal is to get up and get moving! Meet us in the front lobby at theInterContinental at 7 sharp!

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 theindustry, connect with colleagues and vendors, and make some new friends.

7:45 Registration and Morning Coffee

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.

8:50 Organiser’s Welcome Remarks

INTEGRATING PATIENT VOICE IN EARLY-STAGE
DEVELOPMENT
8:55 Chairperson’s Remarks (Sponsorship Opportunity Available)

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

Networking Lunch in the Exhibit HallEVOLVING DCT APPROACHES: INNOVATION IN TRIAL
DESIGN AND OPERATIONS
14:35 Chairperson’s Remarks

9:00 Unleashing Valuable Patient Insights: The Transformative Power ofMatthew Bonam, Head BioPharmaceuticals R&D, Digital Patient Health &Innovation, AstraZeneca R&D

7 | ScopeSummitEurope.com

14:40 Sponsor Experience Implementing Decentralised Clinical TrialCAMBRIDGE HEALTHTECH INSTITUTE’S INAUGURAL|

29 - 30 OCTOBER 2024

Trial Design and Protocol Development
Novel Approaches to Trial Design and Patient-Centric Protocol Development(DCT) Elements: DCT Implementation Survey Results & Lessons Learned
Joachim Lovin, DCT Specialist, Novo Nordisk
To understand the current state and future direction of decentralized clinical trials
post-COVID-19, a survey was conducted across 14 sponsor companies to assess
implementation experiences, success factors, and challenges. This presentation
will focus on key trends and insights across survey respondents, including lessons
learned. While implementation challenges remain, ongoing collaboration amongindustry, regulatory authorities, and patients will play a pivotal role in shaping thefuture landscape of decentralized clinical trials.

15:05 Presentation to be Announced
15:30 Inconvenient Truths of Decentralised Clinical Trials (DCT)
Reamonn Madden, Innovation Capability Director, Global Clinical Operations
Innovation, Novartis Pharmaceuticals
The experiences of COVID-19 restrictions and a return to a “new normal” permit
a fairer perspective on opportunities and realities for decentralized clinical trials.
This talk will provide reflections on the challenges for DCT implementation andwhat these mean for its use in the near future.

15:55 Talk Title to be Announced
Stuart Redding, CEO, Medical Research Network Ltd

16:07 Unlocking the Power of Decentralised Clinical Trial (DCT):
Navigating Trial Design Considerations in Modern Models
Ali Wherry, Director, Science37
Explore the future of clinical research through a new lens on Decentralized Clinical
Trial (DCT) components. Often overlooked, the full potential of DCTs can be
unlocked by prioritizing intentional planning from the outset. Join this session to
discuss innovative trial design considerations that enhance operational feasibility
and ease patient burden. Get set for a journey towards more efficient, patientcentric clinical trials!

16:32 Enhancing Patient Engagement and Satisfaction: Are
Decentralised Trials Delivering on This Promise?
Stefania Collamati, DCT Operations Manager, Clinical Operations, Bayer SPA
Bayer has successfully implemented innovative trial designs that aim to fit thelifestyle of patients in both hybrid and fully decentralized clinical trials. With thispresentation we take a deep dive into the DCT strategies Bayer has adopted andtheir impact on patient satisfaction, experience, and willingness to participate in
future clinical trials which are offering more modern and flexible approaches.

16:57 Reception 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)!

18:00 Close of Day
WEDNESDAY 30 OCTOBER
8:15 Registration and Morning Coffee

NEW TRENDS IN PROTOCOL DESIGN: REDUCING SITE
AND PATIENT BURDEN
8:45 Chairperson’s Remarks (Sponsorship Opportunity Available)
8:50 The Benefits of Building the Use of Digital Technologies into
Clinical Program Design by First Intent
Matthew Bonam, Head BioPharmaceuticals R&D, Digital Patient Health &Innovation, AstraZeneca R&D
Digital technologies have the potential to accelerate the clinical development of
new medicines and improve the patient and site experience of participating in atrial. If applied poorly, these same technologies can have the opposite effect. Casestudies and patient testimonials will be used to describe the benefits of using
digital technologies in clinical programs. Actionable insights will aid clinical teamsin the design of digital-first clinical development programs.

9:15 Integrated Trail Optimization: An Innovative Approachto Study Design Including Both the Patient and Site Voices

Jenna McDonnell, Senior Director Strategy & Innovation, Thermo Fisher ScientificCaitlin Thomas, Research Scientist, Thermo Fisher Scientific
There are often challenges when designing clinical trials with tension between
scientific and operational considerations, patient burden and site burden. The
PPD clinical research business of Thermo Fisher Scientific offers Integrated Trial
Optimization solutions that have been built to overcome these obstacles. Join us tolearn how we use proprietary tools, data sources and capabilities together to deliver
the optimal plan for program delivery, regulatory success and market access.

9:40 Optimisation of Protocol Design: A Path To Efficient, Lower Cost
Clinical Trial Execution
Marina Malikova, PhD, Executive Director, Surgical Translational Research,
Operations and Compliance, Boston University School of Medicine
Explore the challenges clinical teams face in developing protocols to ensure thatthe right patients are enrolled and the right data are collected to demonstrate thata drug is safe and efficacious, while managing study costs and study complexity
based on proposed comprehensive scoring model. A methodology to identify
processes at planning phase, approaches to increase fiscal return and mitigate
fiscal compliance risk for clinical trials will be addressed.

10:05 Sponsored Presentation (Opportunity Available)
10:17 Coffee Break in the Exhibit Hall with Special Book Signing
More coffee, more exhibitors, more networking, and some delicious snacks.
What’s not to love?

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

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!

ENGAGING PATIENTS AND SITES FOR BETTER TRIAL DESIGN
13:10 Chairperson’s Remarks (Sponsorship Opportunity Available)
13:15 Researcher Training to Elevate Patient Engagement as theStandard for Clinical Development
Maria Dutarte, Executive Director, European Patients’ Academy on Therapeutic
Innovation (EUPATI)
Patient engagement is transforming clinical development as expert patients
increasingly delve into its complexities. Ready for substantive dialogues, theseinformed patients often find researchers unprepared for effective engagement.
Our session highlights the critical benefits and strategies of training researchers to
optimise interactions with patient experts, ensuring both sides can fully leveragethese valuable exchanges.

13:40 FIRESIDE CHAT: Protocol Design Trends—Opportunities to Lower
Site and Patient Burden and Optimise Trial Execution
Frank Berger, MD, Expert Data & Analytics Solutions, Clinical Development &Operations, Boehringer Ingelheim
Carme Esteve, EU Clinical Trial Submission Strategy Manager, Sanofi
Zachary Smith, Senior Data Scientist, Tufts Center for the Study of Drug Development
Tufts CSDD has developed assessments for the burden experienced by bothparticipants and trial sites when participating in clinical trials. These assessments(and other similar assessments) can identify sources of elevated burden andbe used to identify ways to reduce the burden of participation and improve trial
performance. They also highlight similarities and differences in the sources ofburden experienced by trial participants and sites.

14:05 Sponsored Presentation (Opportunity Available)
14:30 Session BreakPLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

15:45 Close of Summit

ScopeSummitEurope.com | 8

CAMBRIDGE HEALTHTECH INSTITUTE’S 7TH ANNUAL|

29 - 30 OCTOBER 2024

Feasibility and Study Activation

Modernizing Feasibility, Site Selection, Site Engagement, and Start-Up Practices

MONDAY 28 OCTOBERMONDAY AFTERNOON: USER GROUP & WORKSHOP
14:30 – 19:00 Innovation Day with IQVIA Technologies at
SCOPE Europe
CO-SPEAKERS:
Kevin Landells, Vice President Patient Centered Technology Delivery, IQVIATechnologies
Stefan Dürr, Senior Director, Client Delivery, IQVIA Technologies
Petar Genov, Senior Director, Business Operations and Capabilities – Payments,
IQVIA Technologies
Tim Reily, Vice President, Clinical Data Analytics, IQVIA Technologies
Alison Liddy, Senior Vice President, Patient and Site Centric Solutions, IQVIA
Clinical trial sponsors are invited to join IQVIA Technologies’ digital productleaders and industry representatives for an afternoon of discussions, demos,and networking. IQVIA will share our vision to transform clinical operations,demonstrate our technologies that improve the patient, site, and sponsor journeys,
and ask for your input on our roadmap for future product development. Innovation
Day is complimentary and will be of interest to pharmaceutical executives orsites with roles in clinical operations, innovation, technology, finance, budgeting,data analytics, patient or site engagement, or strategic sourcing. IQVIA reserves
the right to decline registrations for those not in these categories. For more
information or to register click here.​

17:30 – 19:00 The Path towards Sustainable Clinical Trials: How to Minimise
Environmental Impact and Stay Ahead of Future Regulatory Requirements
INSTRUCTORS:Fiona Adshead, Chair, Sustainable Healthcare Coalition
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Marisa Minetti, Patient Research Partner, Chiesi Group
Keith Moore, Programme Coordinator, Sustainable Healthcare Coalition
Developing frameworks to define and manage sustainability risks, and effective
guidelines to reduce the carbon footprint of clinical trial operations is a collaborative
effort. Beyond benefiting the environment, adopting sustainable practices isincreasingly demanded by stakeholders and can significantly influence customer
choices and talent acquisition. Perhaps more compelling are the growing
regulatory pressures and expectations, including the Corporate Sustainability
Reporting Directive (CSRD) and Task Force on Climate-related Financial Disclosures(TCFD) among others. This workshop will discuss the current hotspots of carbon
emissions in clinical research, introduce a new clinical trial carbon footprint
calculator for assessing current state, and suggest introductory reduction
strategies. Whether you are in clinical trial design clin ops, procurement, innovation,
sustainability, or resource management, this workshop is for you.

TUESDAY 29 OCTOBER
7:00 SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps
Join SCOPE Europe’s Coordinators for our Fun Run/Walk! All of us at Cambridge
Healthtech Institute recognise the importance of integrating well-being and fitness
into our work travel routines. This is an easygoing, informal running (or walking)event where we ascend the stairs of the iconic Magic Fountain. No time chips,
running bibs, or energy bars—just a laid-back opportunity for a small group to startthe day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walkand-talk—the goal is to get up and get moving! Meet us in the front lobby at theInterContinental at 7 sharp!

7:45 Registration and Morning Coffee
8:50 Organiser’s Welcome Remarks

DATA ANALYTICS & GEN AI: NEW APPROACHES TO
IMPROVE SITE SELECTION & ACTIVATION
8:55 Chairperson’s Remarks (Sponsorship Opportunity Available)
9:00 Feasibility and Site Identification Powered by Data and Gen AI
Carole Ackermann, EEA Cluster Portfolio Head, Novartis

9 | ScopeSummitEurope.com

Abhishek Chatterjee, Solution Design Director, GCO–Health Data Insights & Design,
Novartis
Tony Yordanov, Clinical Operations Program Director, Novartis
Despite significant advancements in clinical trial processes and technology,
industry faces challenges in delivering medicines efficiently and cost-effectively. An
AI-driven feasibility approach, combining human insights, process, and technology
can bring patients into focus. Let’s explore how AI can enhance clinical trial
feasibility and review the challenges of integrating AI into the development process.

9:25 Embedding Digital Tools and Data-Driven Approaches for Site Selection:
Change Management, Training Needs, and Implementation Strategy
Susannah Guinee, Clinical Operations Lead, Product Development Global, Roche
Effective site-selection is key for a study’s speed and success. Shifting thefoundation of this decision from a basis of personal experience to objective datarequires strategic rollout and a long-term organisation mindset shift. Roche has
embedded Sitescape: an objective data-driven site-selection tool. Join us to learn
how we navigated this change in both process and behaviour.

9:50 Presentation to be Announced
10:15 Bridging the Gap: Integrating Data Science and Gen AI in
Feasibility
Nadia Lim, Head, Feasibility Strategy & Analytics, Pfizer Inc.
Joao Goncalo Nascimento, Performance Analyst, Predictive Analytics – PRD(OARS), Pfizer Inc.
In this talk, we share new ways of working in feasibility to optimise clinical trial
execution. We address operational challenges in integrating new technologies
in feasibility, such as data science and Gen AI. We discuss how we optimise
feasibility planning while also considering the risks, alongside user adherence, andthe necessity of explainability. These considerations are crucial for the successful
application of these innovations to improve site selection.

10:40 Streamlining Study Start-Up: Unlocking Results &Benefits for Sponsors and Sites
Tom Johnson, Senior Director, Life Sciences & Health IT, Exostar
We hear you. Sponsors are challenged with lengthy study start-up processes andongoing monitoring, while the clinical trial sites are burdened with technology
redundancy and sign-on silos obstacles. In this talk, we will give the sponsor’s andsite’s perspective on the progress made to overcome these issues and share realexamples of how sponsors and sites are collaborating and streamlining the user’s
experience.

10:53 Grand 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 theindustry, connect with colleagues and vendors, and make some new friends.

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

13:35 Join Your Peers for a Networking Lunch 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.

SPONSOR/SITE COLLABORATION: SUPPORTING
SITES TO IMPROVE RECRUITMENT, RETENTION, ANDPERFORMANCE
14:35 Chairperson’s Remarks
Paul Duffy, Head, Global Clinical Site Partnerships, MSD

14:40 PANEL DISCUSSION: Increasing Trust & Transparency to
Accelerate Site Selection and Start-Up
Moderator: Marcy Kravet, Head, Oncology Strategy, Inato
In a recent global survey, 72% of sites think sponsors trust their feasibility data
while only 13% of sponsor/CROs report trusting site responses. In addition, 92%
of sponsor/CROs and 70% of site respondents reported feeling stressed duringsite selection. This sponsor and site panel will share insights from the survey

CAMBRIDGE HEALTHTECH INSTITUTE’S 7TH ANNUAL|

29 - 30 OCTOBER 2024

Feasibility and Study Activation

Modernizing Feasibility, Site Selection, Site Engagement, and Start-Up Practices

and discuss opportunities to fix feasibility by leveraging data and technology toaccelerate timelines and reduce sponsor and site burden.
Panelists:
Rosia Shah, MD, Medical Lead, VCTC
Thomas Westgate, Director, Strategic Feasibility, Clinical Research, PPD, part ofThermo Fisher Scientific

15:05 Clinical Trial Diversity: Expanding Past the FDA to theRest of the Globe

processes, leveraging linked data, and standard methodologies. This approachpromises expedited decision-making and reduced redundant efforts.

10:05 Sponsored Presentation (Opportunity Available)
10:17 Coffee Break in the Exhibit Hall with Special Book Signing
More coffee, more exhibitors, more networking, and some delicious snacks. What’s
not to love?

PLENARY KEYNOTE SESSION

Adam Wyckoff, Senior Director of Product, H1
This presentation will discuss, best practices for measuring diversity, equity, andinclusion on a clinical trial. Also included will be practical guidance for how tounderstand diversity outside of the United States, and innovate measure for how to
strategically infuse generative AI into clinical operations.

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

15:30 Long-Term Relationship Development with Clinical Research Sites

REDUCING SITE BURDEN TO OPTIMISE OPERATIONSPaul Duffy, Head, Global Clinical Site Partnerships, MSD
Overview of our company’s approach to building long-term relationships with our
high-performing clinical research institutions in order to ensure development of ourclinical research pipeline. Which approach we took to identify engagement for thelong term and ensure that these sites were given appropriate access to our clinicalresearch pipeline in order to optimise planning, engage with investigators to matchstudies, and ensure delivery of high-quality data.

For a detailed agenda, please visit pages 4-5.
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 (Sponsorship Opportunity Available)
13:15 How CSLs Improved Feasibility Process Helps Study Teams
Improve Their Robustness in Operational Planning

16:32 Sponsored Presentation (Opportunity Available)

Mireille Ermens, Senior Director, Clinical Development Operations—Global Feasibility
and Start-Up Support, CSL Behring
Mary Smith, Senior Director, Clinical Portfolio Execution, Seqirus A CSL Co.
Early planning and study start-up challenges are common across the industry andmay cause additional burden to study teams and sites with downstream impact on
recruitment, timelines, and cost. Organisational focus is required to address thesechallenges. During this session you will learn how CSL has improved the feasibility
process to help study teams improve their robustness in operational planning.

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

13:35 Feasibility: Process Update to Ensure Active Site Engagement

15:55 Presentation to be Announced
16:20 Talk Title to be Announced
Rachel Horovitz, VP, Product Strategy, Medidata AI

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)!

18:00 Close of Day
WEDNESDAY 30 OCTOBER
8:15 Registration and Morning Coffee

TECHNOLOGIES AND PROCESSES TO IMPROVEFEASIBILITY, ACTIVATION, AND OPERATIONS
8:45 Chairperson’s Remarks
Alison Foster, VP, Strategic Delivery & Growth, Fortrea

8:50 Acceleration of Interactive Response Technology: Innovative
Methods to Enhance Efficiency
Cezary Bregier Director, Global Clinical Solutions, AstraZeneca
Hubert Filipczak, Director, Global Clinical Solutions, AstraZeneca Pharma Poland Sp
zoo
This session offers an in-depth exploration of the Interactive Response Technology(IRT) setup process for clinical studies, from early engagement to system
activation. Participants will learn about the roles of both sponsors and IRT
providers and discover strategies to enhance efficiency, including process waste
identification, standardisation, and ways to improve specification document quality
to reduce lead times.

9:15 Talk Title to be Announced
Ben Carmel, Chief Revenue Officer , Slope

9:40 Towards an Automated Site Feasibility with Use of Ontologies
Aditya Tyagi, Project Manager, Pistoia Alliance
The Pistoia Alliance offers a pre-competitive platform for collaboration among
pharmaceutical members and R&D service providers. The Clinical Operations
Ontology project aims to automate clinical trial processes through machinereadable data via ontologies. Site feasibility ensures protocol-site alignment forstudy viability. Our focus is on enhancing trial planning efficiency by automating

Heidi Egsgaard Frandsen, Director, Indication/Program Lead, AstraZeneca
Karin Schiene, Director, Indication Program Lead, AstraZeneca
During this discussion, you will learn how AstraZeneca has made process changes
and shifted the mindset of the feasibility process. We will share the process andtemplate changes we have implemented to ensure we are actively engaged fromour first interaction through site selection.

13:52 Optimizing our Focus on Site Facing Training
Mette Flindt Heisterberg, PhD, Competency Development Specialist, Clinical
Operations Office, Global Trial Portfolio, Novo Nordisk AS
In the past year, Novo Nordisk has meticulously optimised site-facing training,emphasising user-centric learning journeys. By establishing a dedicated site learning
unit and refining processes, we can deliver best-in-class learning experiences. Shifting
our focus, we aim to explore optimal training delivery and foster flexible, engaging
experiences for our site staff. We invite you to join us in exploring our challenges,
solutions, and reflections, as we embark on this transformative journey.

14:05 AI-Driven Augmentation for Global Strategic Clinical
Trial Delivery
Lee Coram, Senior Director Business Insights, Thermo Fisher Scientific
Dave Hiltbrand, Associate Director Data Science, Thermo Fisher ScientificJeffrey Zimmerman, Senior Director Data Science, PPD Clinical Research , Thermo
Fisher Scientific
Optimizing clinical trial study delivery by reducing timelines and mitigating risk in bestfit global selection strategy and patient enrollment is a long-standing challenge ofCROs and Pharma. The PPD Clinical Research Business of Thermo Fisher Scientific
has nearly a decade of experience using AI and data science to meet this need.
Join us to learn how we use feasibility, start-up, enrollment, and AI to empower ourpartners to deliver faster, higher quality, and more affordable medicine.

14:30 Session BreakPLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

15:45 Close of Summit
ScopeSummitEurope.com | 10

CAMBRIDGE HEALTHTECH INSTITUTE’S 7TH ANNUAL|

29 - 30 OCTOBER 2024

Patient Engagement and Recruitment
Engagement and Recruitment through Communities and Technology
MONDAY 28 OCTOBERMONDAY AFTERNOON: USER GROUP & WORKSHOP
14:30 – 19:00 Innovation Day with IQVIA Technologies at
SCOPE Europe
CO-SPEAKERS:
Kevin Landells, Vice President Patient Centered Technology Delivery, IQVIATechnologies
Stefan Dürr, Senior Director, Client Delivery, IQVIA Technologies
Petar Genov, Senior Director, Business Operations and Capabilities – Payments,
IQVIA Technologies
Tim Reily, Vice President, Clinical Data Analytics, IQVIA Technologies
Alison Liddy, Senior Vice President, Patient and Site Centric Solutions, IQVIA
Clinical trial sponsors are invited to join IQVIA Technologies’ digital productleaders and industry representatives for an afternoon of discussions, demos,and networking. IQVIA will share our vision to transform clinical operations,demonstrate our technologies that improve the patient, site, and sponsor journeys,
and ask for your input on our roadmap for future product development. Innovation
Day is complimentary and will be of interest to pharmaceutical executives orsites with roles in clinical operations, innovation, technology, finance, budgeting,data analytics, patient or site engagement, or strategic sourcing. IQVIA reserves
the right to decline registrations for those not in these categories. For more
information or to register click here.​

17:30 – 19:00 The Path towards Sustainable Clinical Trials: How to Minimise
Environmental Impact and Stay Ahead of Future Regulatory Requirements
INSTRUCTORS:Fiona Adshead, Chair, Sustainable Healthcare Coalition
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Marisa Minetti, Patient Research Partner, Chiesi Group
Keith Moore, Programme Coordinator, Sustainable Healthcare Coalition
Developing frameworks to define and manage sustainability risks, and effective
guidelines to reduce the carbon footprint of clinical trial operations is a collaborative
effort. Beyond benefiting the environment, adopting sustainable practices isincreasingly demanded by stakeholders and can significantly influence customer
choices and talent acquisition. Perhaps more compelling are the growing
regulatory pressures and expectations, including the Corporate Sustainability
Reporting Directive (CSRD) and Task Force on Climate-related Financial Disclosures(TCFD) among others. This workshop will discuss the current hotspots of carbon
emissions in clinical research, introduce a new clinical trial carbon footprint
calculator for assessing current state, and suggest introductory reduction
strategies. Whether you are in clinical trial design clin ops, procurement, innovation,
sustainability, or resource management, this workshop is for you.

TUESDAY 29 OCTOBER
7:00 SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps
Join SCOPE Europe’s Coordinators for our Fun Run/Walk! All of us at Cambridge
Healthtech Institute recognise the importance of integrating well-being and fitness
into our work travel routines. This is an easygoing, informal running (or walking)event where we ascend the stairs of the iconic Magic Fountain. No time chips,
running bibs, or energy bars—just a laid-back opportunity for a small group to startthe day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walkand-talk—the goal is to get up and get moving! Meet us in the front lobby at theInterContinental at 7 sharp!

7:45 Registration and Morning Coffee
8:50 Organiser’s Welcome Remarks

GLOBAL APPROACHES TO RECRUITING DIVERSE
POPULATIONS: UNIQUE COUNTRY & REGIONAL CHALLENGES
8:55 Chairperson’s Remarks
Robert Loll, Senior Vice President, Praxis

9:00 A Global Approach to DEI in Clinical Trials
Estelle Jobson, EUPATI Fellow and Patient Expert

11 | ScopeSummitEurope.com

Robina Weermeijer, Global Clinical Trials Diversity & Inclusion Lead, Boehringer
Ingelheim
As the world is becoming more and more diverse there is a big need to consider
a wide audience when conducting clinical trials. In this presentation, you’ll get
insights into why it’s important to look at diversity, equity, and inclusion on a global
level and which efforts are being made by Boehringer Ingelheim in this space
through collaboration with diverse stakeholders.

9:25 Diversity in Clinical Trials (DICT) EMEA—A Multiple-Country Approach
Paul Duffy, Head, Global Clinical Site Partnerships, MSD
Laurence Garret, Therapeutic Area Lead, Clinical Operations, MSD
Diversity in Clinical Trials (DICT) a global approach for one company to ensure
access for all in their clinical research studies. Hear how our team has taken
a practical approach in different countries to identify barriers, build newcommunication pathways, and to support access for patients through healthcare
providers and their teams. Learn how different requirements and opportunities incountries ex USA have driven our approach to equity.

9:50 Presentation to be Announced
10:15 Recruitment & Retention of Diverse Participants across the Globe
Jameka Hill, Director, Patient Engagement & Advocacy, Moderna, Inc.
Katherine Norton, Director, Patient Recruitment & Feasibility, Moderna, Inc.
Inspired by its success in the US, Moderna is forging ahead with its commitment
to inclusive healthcare research in the UK and Europe. The company has madesignificant strides in patient recruitment and retention, ensuring that clinical trials
are a mirror of those most impacted and likely to benefit from new therapies.
Moderna’s approach cultivates trust and engagement, paving the way for equitable
access to future medical advancements.

10:40 What It Takes to Successfully Recruit Patients: An
Integrated Platform Approach
Jytte van Huijstee, Director Clinical Trial, myTomorrows
This engaging session will cover the following topics, recognize recruitment
challenges related to patient and physician awareness, multilingual support,
cross-border referrals, and regulatory compliance, and learn strategies to navigate
these. Also, an integrated platform approach to clinical trial recruitment should
be developed by combining patient, physician, and site flows to streamline therecruitment funnel from awareness to enrollment. We will discover tactics forengaging with different stakeholders through real-world success stories fromtreating physicians, patient advocacy groups, and clinical research sites. Join us as
we discuss these topics and more.

10:53 Grand 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 theindustry, connect with colleagues and vendors, and make some new friends.

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

13:35 Join Your Peers for a Networking Lunch 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.

ADVANCING INCLUSIVE RESEARCH: DIVERSITYPLANNING, COMMUNITY ENGAGEMENT & SITE
ENABLEMENT
14:35 Chairperson’s Remarks
Jodie Allen, PhD, Senior Director, Clinical Trial Diversity, AstraZeneca

14:40 FIRESIDE CHAT: The FDA’s Revised Draft Guidance on Clinical
Trial Diversity
Alberto Fernandez, Senior Vice President, Global Clinical Operations, GSK
Edward Ramos, PhD, Senior Director, Digital Clinical Trials, Scripps Research
We will delve into the latest insights on the FDA’s requirements for Diversity Action
Plans. We’ll discuss the implications for sponsors and explore effective strategies
to ensure diverse populations are recruited for clinical trials. Gain an understandingCAMBRIDGE HEALTHTECH INSTITUTE’S 7TH ANNUAL|

29 - 30 OCTOBER 2024

Patient Engagement and Recruitment
Engagement and Recruitment through Communities and Technologyof the process for creating and submitting a plan to the FDA, while navigating
the uncertainties surrounding FDA expectations. Explore strategies for involving
individuals impacted by the disease in clinical trials.

15:05 Presentation to be Announced

edge technology in all trials while walking through an oncology case study thatembraced decentralized study elements, empowered patients, and enhanced trial
design. Discover how IQVIA’s innovative approaches improved enrollment andshortened recruitment timelines by understanding patient needs, reducing burden,
and extending study site boundaries.

15:30 Breaking Down Boundaries and Rethinking Recruitment with Agile
Research Delivery

9:40 Mapping Site Recruitment Strategies for Engaging
Socioeconomically Disadvantaged Populations in Clinical ResearchAlex Hammond, Business Development Manager, National Institute of Health andCare Research (NIHR)
Joanne Henry, Matron, NIHR Clinical Research Network Greater Manchester
This session will take you on a research road trip—not to different locations, butinstead to different settings beyond the hospital clinic. Hear how new, flexible ways
of working and adaptable research delivery models are breaking down boundaries,
increasing accessibility, and creating opportunities to generate real-world
evidence. From places of worship to prisons, supermarkets, care homes, schools,
hospices, and festivals—direct delivery transforms research delivery by taking
research to the people.

15:55 Talk Title to be Announced
Dan Shannon, Chief Experience Officer, Greenphire

16:20 Presentation to be Announced
16:32 Addressing Clinical Trial Diversity in a Global Context: Challenges,
Opportunities, and Critical Capabilities
Jodie Allen, PhD, Senior Director, Clinical Trial Diversity, AstraZeneca
Elizabeth Bristow, Director, Patient Recruitment & Retention, AstraZeneca
The FDA has led the charge with its recently updated draft guidance. As sponsors
of global studies, ensuring that patients in our studies reflect those who may use
the medicine requires capabilities that go beyond the U.S. FDA requirements.
We will share our experience in building enterprise-level capabilities to improvediversity through design, planning, execution, and monitoring, in line with
AstraZeneca’s global diversity ambition.

16:57 Reception 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)!

18:00 Close of Day
WEDNESDAY 30 OCTOBER
8:15 Registration and Morning Coffee

INNOVATION IN PATIENT ENGAGEMENT
8:45 Chairperson’s Remarks
Speaker to be Announced, mdgroup8:50 Operationalising Participant Data Return—A Step Closer to
Personalised Clinical Drug Development
Nadir Ammour, DDS, MBA, Global Lead Clinical Innovation & External Partnership,
SanofiJohanna Blom, PhD, Associate Professor, Behavioral Neuroscience; Chair, EthicalCommittee for Research, University of Modena and Reggio Emilia
Swapna Pothula, Associate Director, Data Strategy & Management, Global Clinical
Operations, GSK
Elizabeth Theogaraj, Regulatory Senior Program Director, Roche
Discover insights into current initiatives driving change and explore available
solutions for securing leadership endorsement, integrating participant data return
into operational processes, defining the details of the data to be returned basedon organisational parameters, and acknowledging and addressing the potential
concerns or challenges with operationalising the participant data return.

9:15 Empowering Participants: How Compassionate
Protocol Design Utilizing Study Support Delivers a PatientFirst Experience
Alison Liddy, Senior Vice President, Patient & Site Centric Solutions, IQVIA
We will explore the need for an intersection of compassionate care and cutting-

Maria Florez, Research Consultant, Tufts Center for the Study of Drug Development
Learn about strategies that have been shown to improve the recruitment ofsocioeconomically disadvantaged populations into clinical trials. See recent
data on current levels of implementation of such strategies among clinical trialsites. Discuss perceived challenges associated with the implementation of thesestrategies and how to better support sites in their ability to support prospective andcurrent clinical trial participants.

10:05 Presentation to be Announced
10:17 Coffee Break in the Exhibit Hall with Special Book Signing
More coffee, more exhibitors, more networking, and some delicious snacks. What’s
not to love?

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

12:10 Join 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!

LEVERAGING DATA AND TECHNOLOGY TO MODERNISEFORECASTING AND RECRUITMENT
13:10 Chairperson’s Remarks (Sponsorship Opportunity Available)
13:15 Optimising Enrollment Forecasting: A Bayesian Approach
Xinyang Li, Senior Data Scientist, Johnson & Johnson
Mohammad Umarfaruque, Data Science Consultant, ZS Associates
A reliable enrollment forecast is key in clinical trials for resource optimisationand clinical supply planning. This proposal introduces a Bayesian methodology
for optimising enrollment forecasting in clinical trials. By incorporating real-timedata updates, such as one-month actual enrollment data and latest thinking fromsites, the proposal ensures that forecasts remain dynamic and reflective of current
trends, improving overall forecasting reliability and decision-making capabilities.

13:40 Digital as a Bridge (Not a Divide): Advancements in RWD Collection
Edward Ramos, PhD, Senior Director, Digital Clinical Trials, Scripps Research
As new technologies emerge that prove useful tools in collecting data in real-world
settings, it is important to evaluate whether they bring with them the unintended
consequence of leaving some populations behind. This panel will discuss theimportance of identifying and recognising the use of technologies that havethe potential to serve as a bridge and improve clinical trial accessibility andparticipation by populations historically left out of biomedical research.

14:05 Effective Tailored Strategies for Special Patient
Populations: Lessons from Global Studies
Lucina Tabasso, Senior Project Manager, ERCULES
Recruiting and retaining special populations, such as pediatric, rare disease, andelderly patients, in clinical trials presents unique challenges. This presentation
will showcase the strategies we employed to significantly empower, educate andinform patients, their family members and caregivers. We will discuss methods that
improved engagement and enhanced compliance in both decentralized (DCT) andtraditional clinical trial settings, drawing from our experiences in international trials.

14:30 Session BreakPLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

15:45 Close of Summit

ScopeSummitEurope.com | 12

CAMBRIDGE HEALTHTECH INSTITUTE’S 7TH ANNUAL|

29 - 30 OCTOBER 2024

Clinical Data, AI, and RWD in Digital Trials
Clinical Data, Technology, and AI/ML for Digital and Hybrid Trials

MONDAY 28 OCTOBERMONDAY AFTERNOON: USER GROUP & WORKSHOP
14:30 – 19:00 Innovation Day with IQVIA Technologies
at SCOPE Europe
CO-SPEAKERS:
Kevin Landells, Vice President Patient Centered Technology Delivery, IQVIATechnologies
Stefan Dürr, Senior Director, Client Delivery, IQVIA Technologies
Petar Genov, Senior Director, Business Operations and Capabilities – Payments,
IQVIA Technologies
Tim Reily, Vice President, Clinical Data Analytics, IQVIA Technologies
Alison Liddy, Senior Vice President, Patient and Site Centric Solutions, IQVIA
Clinical trial sponsors are invited to join IQVIA Technologies’ digital productleaders and industry representatives for an afternoon of discussions,demos, and networking. IQVIA will share our vision to transform clinicaloperations, demonstrate our technologies that improve the patient, site, andsponsor journeys, and ask for your input on our roadmap for future productdevelopment. Innovation Day is complimentary and will be of interest topharmaceutical executives or sites with roles in clinical operations, innovation,technology, finance, budgeting, data analytics, patient or site engagement, or
strategic sourcing. IQVIA reserves the right to decline registrations for those
not in these categories. For more information or to register click here.​

17:30 – 19:00 The Path towards Sustainable Clinical Trials: How
to Minimise Environmental Impact and Stay Ahead of Future
Regulatory Requirements
INSTRUCTORS:Fiona Adshead, Chair, Sustainable Healthcare Coalition
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Marisa Minetti, Patient Research Partner, Chiesi Group
Keith Moore, Programme Coordinator, Sustainable Healthcare Coalition
Developing frameworks to define and manage sustainability risks, andeffective guidelines to reduce the carbon footprint of clinical trial operations
is a collaborative effort. Beyond benefiting the environment, adopting
sustainable practices is increasingly demanded by stakeholders and cansignificantly influence customer choices and talent acquisition. Perhaps morecompelling are the growing regulatory pressures and expectations, including
the Corporate Sustainability Reporting Directive (CSRD) and Task Force on
Climate-related Financial Disclosures (TCFD) among others. This workshop
will discuss the current hotspots of carbon emissions in clinical research,
introduce a new clinical trial carbon footprint calculator for assessing
current state, and suggest introductory reduction strategies. Whether you
are in clinical trial design clin ops, procurement, innovation, sustainability, or
resource management, this workshop is for you.

TUESDAY 29 OCTOBER
7:00 SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps
Join SCOPE Europe’s Coordinators for our Fun Run/Walk! All of us at
Cambridge Healthtech Institute recognise the importance of integratingwell-being and fitness into our work-travel routines. This is an easygoing,
informal running (or walking) event where we ascend the stairs of the iconic
Magic Fountain. No time chips, running bibs, or energy bars—just a laid-backopportunity for a small group to start the day on a positive note. You cansprint, run, jog, walk, jog-and-talk, or walk-and-talk—the goal is to get up andget moving! Meet us in the front lobby at the InterContinental at 7 sharp!

7:45 Registration and Morning Coffee
8:30 Organiser’s Welcome Remarks

DRIVING SCALABLE INNOVATION
8:35 Chairperson’s Remarks
Brenda Yanak, Former Vice President, Bristol Myers Squibb Co.; Founder,
Clinical Transformation Partners LLC

8:40 Test-Start-Scale: The Data-Driven Technology Maturity
Approach
Farrell Healion, Senior Director Emerging Technologies, Global Clinical
Solutions, AstraZeneca
Test-Start-Scale is a methodology that takes digital innovation on a journeyfrom idea through refinement, all the way to wider-scale use and BAU. The
focus is on taking a data-driven approach which proves the value of thetechnology in a controlled fashion which can, in turn, help with promoting
adoption leaving study teams satisfied and confident in new digital
capabilities.

9:00 Digital Data Flow: Digitalising Clinical Protocol Information to
Accelerate Clinical Research and Enable Healthcare Interoperability
William Illis, Global Head, Collaboration & Technology Strategy ClinicalDevelopment, Novartis Pharmaceuticals
Digitising clinical protocol information can streamline study start-up, enable
analytics-assisted study design, and support more routine use of point-ofcare data. TransCelerate’s Digital Data Flow (DDF) initiative, in collaboration
with CDISC, has delivered a data model, exchange standard, and opensource reference implementation aimed at the use of digital protocols. This
presentation will highlight current DDF capabilities, use cases, and roadmap
for stakeholder collaboration to achieve interoperability across research andcare settings.

9:20 Integrating Clinical and Real-World Evidence for AI Augmented
Clinical Trial Design
Amhar Jabeer, Computational Scientist, Integrated Clinical Data, Digital R&D,
Sanofi Group
Maksim Kriukov, Computational Scientist Lead, Integrative Clinical Data Digital
R&D, Sanofi GroupThe challenge of integrating real-world data with clinical trials hinders
large-scale analysis and modeling of patient treatment journeys. Combining
both data types would enable AI applications focused on optimizing trial
patient recruitment, predicting treatment outcomes, and stratifying patient
populations. We leverage AI and machine learning algorithms to enhanceclinical trial design, repurpose treatments, and identify safety risks.

9:40 The Right Patient Technology At the Right Time:
Improve Your Clinical Trial Implementation Strategy
Melissa Mooney, Director, eCOA Solutions Engineering, IQVIA
Today’s clinical trial landscape requires the use of various technology
solutions to support patient enrollment and the collection, management,
and review of clinical data which ultimately informs clinical decisions andtrial results. In order to improve data quality, optimize workflows, and createa seamless end-user experience, it’s important to leverage the appropriate
clinical technology strategy. In this session, IQVIA patient suite expert
Melissa Mooney will explore how best-in-class clinical technology solutions
can be used independently to optimize trial conduct and when/how thesetechnologies can work together to create further workflow benefits. In thissession, she will discuss how to design and execute a patient technology
strategy that fits study needs. How to reduce clinical site burden bystreamlining processes across eConsent, IRT, and eCOA. Finally, how toquickly leverage insights collected from patient data to improve compliance,
study optimization, and decision-making.

10:00 Help is Here! Interpreting the ICH E6 R3 Data GovernanceRequirements
Hasnaa Likaoui, Director, Vendor and Digital Health Quality, Bristol Myers
SquibbMatt Thompson, Executive Director, Corporate Quality, Parexel International

13 | ScopeSummitEurope.com#SCOPEsummit

CAMBRIDGE HEALTHTECH INSTITUTE’S 7TH ANNUAL|

29 - 30 OCTOBER 2024

Clinical Data, AI, and RWD in Digital Trials
Clinical Data, Technology, and AI/ML for Digital and Hybrid Trials

The upcoming ICH E6 R3 (GCP) guideline introduces a brand-new section
related to Data Governance in clinical trials. Given the critical nature of data
in clinical research, proper governance is essential to maintain the reliabilityof the trial results. ACRO and TransCelerate collaborated to deliver a Data
Governance framework and diverse solutions to support the understanding
and interpretation of these new requirements.

10:20 Presentation to be Announced
10:40 Presentation to be Announced
10:53 Grand 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 theindustry, connect with colleagues and vendors, and make some new friends.

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

13:35 Join Your Peers for a Networking Lunch 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.

RWD, SYNTHETIC DATA, AND BEYOND
14:35 Chairperson Remarks
Dorothee B. Bartels, PhD, Associate Professor (Apl. Professor) for Public
Health and Epidemiology, Medizinische Hochschule Hannover; Founder,
HealthData-Advisors

14:40 Navigating Data Quality in Clinical Trials:
Innovations and Challenges in Audit Trail Analysis
Olgica Klindworth, Vice President, Medidata, Dassault Systemes
Amid increasing complexities in data acquisition, data managers andoperational users must adapt their approach to data quality oversight,
utilizing a wider range of data sources, including audit trails. Audit trail data
is immense, and users often struggle to identify key insights or effectively
analyze this data, even with regulatory guidance. Consequently, the industry
must innovate to find more efficient ways to scrutinize audit trail data andensure robust data integrity controls. Key challenges with audit trail data
include difficulties in gathering and processing massive audit data, pinpointing
relevant information (asking right questions), and scalable methods for wider
audit data interrogation.
However, audits offer valuable learning opportunities. This session will
share real-world examples that showcase novel tools and methodologies
for effective audit trail interrogation, and the potential for Generative AI todemocratize audit trail review that opens new avenues for more accessible
and comprehensive data oversight.

15:05 An Overview of High-Fidelity Synthetic Data Applications
Puja Myles, Director, Clinical Practice Research Datalink, CPRD
An overview of high-fidelity synthetic data applications. Outline of talk: thispresentation will provide an overview of synthetic data and applications ofhigh-fidelity synthetic data, including the use of synthetic data for sample
size boosting (data augmentation) and as synthetic control arms, in thecontext of clinical trials. The talk will reference related concepts like in silico
trial approaches and digital twins, with concluding comments on regulatory
considerations.

15:20 The Use of Routinely Collected Electronic Healthcare Records(EHRs) for Clinical Trials Research: Opportunities and Challenges
Nada Khan, Clinical Data Quality Lead, CPRD
This talk will summarise the context for clinical trials research using routinely
collected electronic health records (EHRs), including an overview of EHRs,
commonly used databases, and data quality considerations. We will discuss
advantages and limitations of using these data for clinical trials research withreal-world examples.

#SCOPEsummit

15:30 How the German HDL is Enabling Health Data Research
Steffen Hess, Head of Health Data Lab, BfarM
Research with claims data and AI isn’t just the future, it’s the now. The Health
Data Lab at the Federal Institute for Drugs and Medical Devices aims to makea significant improvement to healthcare by providing EHR and claims data ofall persons insured in statutory health care for research. Sensitive health data
will be processed in a secure processing environment to ensure the highest
level of cybersecurity and privacy.

15:45 Building the First Large-scale, Structured, Patient-Centric
Real-World Evidence The Waze-way
Yael Elish, Founder & CEO, StuffThatWorks
StuffThatWorks (STW), rooted in WAZE’s excellence, is a patient-focused
RWE platform, scaling data collection. It harnesses crowd-sourced healthdata, mirroring WAZE’s disruption in transportation, to remove treatment
barriers and boost research. With consent from three million users across1250 conditions STW is already the largest structured patient-level real world
evidence data set consisting of self reported,, geospatial and recently added
EMR data.

15:55 Presentation to be Announced
16:20 PANEL DISCUSSION: Triple the Evidence: Real World
Evidence, Synthetic Evidence, and Patient Reported Evidence
Moderator: Dorothee B. Bartels, PhD, Associate Professor (Apl. Professor) for
Public Health and Epidemiology, Medizinische Hochschule Hannover; Founder,
HealthData-Advisors
Can Synthetic Data and Patient Reported Data complement RWE generation:
The Why and the How?
Panelists:
Yael Elish, Founder & CEO, StuffThatWorks
Steffen Hess, Head of Health Data Lab, BfarM
Nada Khan, Clinical Data Quality Lead, CPRD
Puja Myles, Director, Clinical Practice Research Datalink, CPRD

16:57 Reception in the Exhibit Hall with Beer, Wine, and Tapas
Wind down at the end of a busy session day with colleagues, beer, wine, andtapas. Have a drink with your favorite exhibitor and take a chance at winning afabulous raffle prize (must be present to win)!

18:00 Close of Day
WEDNESDAY 30 OCTOBER
8:15 Registration and Morning Coffee

DATA TECHNOLOGIES TO ADVANCE ACADEMIC AND
INDUSTRY RESEARCH
8:45 Chairperson’s Remarks
Maria Veleva, Founder & Managing Director, Velev Consulting Ltd.; Individual
Consultant

8:50 HIRO: Transforming Clinical Research at Mass General Brigham
and Beyond
Merranda Logan, MD, MPH, FACP, Associate Chief Academic Officer, Mass
General Brigham
Shawn Murphy, MD, PhD, Chief Research Information Officer, Mass General
Brigham
Mass General Brigham’s HIRO revolutionises clinical research with a datadriven approach. Our platform integrates hospital-based data for robust
analytics, enhancing feasibility assessments, study design, and patient
recruitment. With over 3,700 clinical trials supported, we empower industry
sponsors, sites, and clinicians to accelerate research globally. Collaboratingwith pharmaceutical companies, we offer innovative solutions for effective
research at the point-of-care, leveraging a network of providers.

ScopeSummitEurope.com | 14

CAMBRIDGE HEALTHTECH INSTITUTE’S 7TH ANNUAL|

29 - 30 OCTOBER 2024

Clinical Data, AI, and RWD in Digital Trials
Clinical Data, Technology, and AI/ML for Digital and Hybrid Trials

9:15 Presentation to be Announced
9:40 PANEL DISCUSSION: Advancing Clinical Trials
through Scalable eSource Integration: The eSource
Scale Up Task ForceModerator: Peter Casteleyn, Director, Clinical Data Collection Solutions-EHR,
The Janssen Pharmaceutical Companies of Johnson and Johnson• Challenges & Opportunities in Clinical Trial Data Collection• Introduction to the eSource Scale Up Task Force• Collaborative Model & Stakeholder Engagement• Future Directions & Deliverables• Q&A and Closure​
Panelists:
Joe Lengfellner, Senior Director, Clinical Research Informatics, Memorial Sloan
Kettering Cancer CenterPaul Jacobs, Associate Director, Development Innovation, Regeneron
Pharmaceuticals, Inc.
Lars Fransson, Strategy Lead for CVGI Account Team, R&D Information,
AstraZeneca R&D
Felix Nensa, Essen University Hospital

10:05 Real-World Data and Digital Measurements in Women’s
Health: What Is the State-of-the-Art?
Bola Grace, PhD, MBA, Professor, University College London
The lack of attention to women’s health means that it has traditionallyexperienced less innovation compared to other therapeutic areas. Morerecently, as the digital health landscape rapidly evolves, there has been aconcerted effort from several stakeholders to improve application to women’s
health. This presentation delves into the latest advancements in real-world
evidence, digital health technologies, and the application of AI in women’s
health, addressing current challenges.

10:15 Coffee Break in the Exhibit Hall with Special Book Signing
More coffee, more exhibitors, more networking, and some delicious snacks.
What’s not to love?

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

12:10 Join 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!

#SCOPEsummit

ADAPTING NEW TECHNOLOGIES: AZ CASE STUDIES
13:10 Chairperson’s Remarks (Sponsorship Opportunity Available)
13:15 eCOA Delivery Optimisation from Sponsor’s Perspective
Sylwia Kondratiuk, Director, Digital Patient Solutions, Global Clinical Solutions,AstraZeneca Pharma Poland Sp zoo
How can we optimise operational delivery of eCOA? We have reshaped
the sponsor support model—maximising potential of early engagement—
introducing the business analyst role with internal client specification andutilising IT tools like JIRA for design, library-of-standards, and client testing.
New support structure is of value to speed up delivery and avoid unnecessary
rework.

13:35 Simplicity in Technology Delivery for Clinical Trials
Sylwia Rumniak, Director GCS Study & Digital Solutions, Global Clinical
Solutions, AstraZeneca Pharma Poland Sp zoo
Technology is playing a greater role in clinical trials. This presentation
explores the role of the AZ Solution Implementation Lead who: drives
technology solutions implementation in the most patient- and site-centric
way to drive simplicity and choice for patients; reduces patient burden froma technology perspective, utilising early design planning approach; andcontributes to streamlined processes, improved data quality, and ultimately,
successful trial outcomes.

13:50 Adapting Spirometry—Decentralised Trials and AI Integration
Patrycja Wasikiewicz, Director Global Clinical Solutions, AstraZeneca
I will delve into the evolving landscape of spirometry in clinical trials,
emphasising the shift towards decentralised trials and implementation of
remote-coached spirometry. I will explore the necessary adjustments forsponsors to stay ahead, addressing the associated risks and benefits while
highlighting the potential opportunities for improved patient engagement anddata quality. I will discuss the utilisation of AI in spirometry, contributing toefficient and accurate clinical trial outcomes.

14:05 Presentation to be Announced
14:30 Session BreakPLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

15:45 Close of Summit

ScopeSummitEurope.com | 15

CAMBRIDGE HEALTHTECH INSTITUTE’S INAUGURAL|

29 - 30 OCTOBER 2024

Clin Ops in Europe’s Emerging Biopharma

Optimising Clinical Programs, Clin Ops Teams, and Outsourcing Partners in Europe’s Emerging Biopharma

MONDAY 28 OCTOBERMONDAY AFTERNOON: USER GROUP & WORKSHOP
14:30 – 19:00 Innovation Day with IQVIA Technologies at
SCOPE Europe
CO-SPEAKERS:
Kevin Landells, Vice President Patient Centered Technology Delivery, IQVIATechnologies
Stefan Dürr, Senior Director, Client Delivery, IQVIA Technologies
Petar Genov, Senior Director, Business Operations and Capabilities – Payments,
IQVIA Technologies
Tim Reily, Vice President, Clinical Data Analytics, IQVIA Technologies
Alison Liddy, Senior Vice President, Patient and Site Centric Solutions, IQVIA
Clinical trial sponsors are invited to join IQVIA Technologies’ digital productleaders and industry representatives for an afternoon of discussions, demos,and networking. IQVIA will share our vision to transform clinical operations,demonstrate our technologies that improve the patient, site, and sponsor journeys,
and ask for your input on our roadmap for future product development. Innovation
Day is complimentary and will be of interest to pharmaceutical executives orsites with roles in clinical operations, innovation, technology, finance, budgeting,data analytics, patient or site engagement, or strategic sourcing. IQVIA reserves
the right to decline registrations for those not in these categories. For more
information or to register click here.​

17:30 – 19:00 The Path towards Sustainable Clinical Trials: How to
Minimise Environmental Impact and Stay Ahead of Future Regulatory
Requirements
INSTRUCTORS:Fiona Adshead, Chair, Sustainable Healthcare Coalition
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Marisa Minetti, Patient Research Partner, Chiesi Group
Keith Moore, Programme Coordinator, Sustainable Healthcare Coalition
Developing frameworks to define and manage sustainability risks, and effective
guidelines to reduce the carbon footprint of clinical trial operations is a collaborative
effort. Beyond benefiting the environment, adopting sustainable practices isincreasingly demanded by stakeholders and can significantly influence customer
choices and talent acquisition. Perhaps more compelling are the growing regulatory
pressures and expectations, including the Corporate Sustainability Reporting
Directive (CSRD) and Task Force on Climate-related Financial Disclosures (TCFD)
among others. This workshop will discuss the current hotspots of carbon emissions
in clinical research, introduce a new clinical trial carbon footprint calculator forassessing current state, and suggest introductory reduction strategies. Whether you
are in clinical trial design clin ops, procurement, innovation, sustainability, or resource
management, this workshop is for you.

TUESDAY 29 OCTOBER
7:00 SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps
Join SCOPE Europe’s Coordinators for our Fun Run/Walk! All of us at Cambridge
Healthtech Institute recognise the importance of integrating well-being and fitness
into our work travel routines. This is an easygoing, informal running (or walking)event where we ascend the stairs of the iconic Magic Fountain. No time chips,
running bibs, or energy bars—just a laid-back opportunity for a small group to startthe day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walkand-talk—the goal is to get up and get moving! Meet us in the front lobby at theInterContinental at 7 sharp!

7:45 Registration and Morning Coffee
8:50 Organiser’s Welcome Remarks

MASTERING PROVIDER SELECTION & VENDOR OVERSIGHT
8:55 Chairperson’s Remarks (Sponsorship Opportunity Available)
9:00 Choosing the Right Vendor for Your Project, What to Look Out for,and What to Avoid
Mags McDonagh, Head of Development Operations, Ellipses Pharma UK

16 | ScopeSummitEurope.com

Choosing the right vendor is key to the success of any project. This is particularly
the case for emerging biopharma where internal resources may be limited andtime efficiencies critical. A number of key factors must be considered including
vendor experience, relevant expertise, and organisational fit. This presentation
approaches this topic from the view of a clinical operations leader overseeing aportfolio of clinical trials.

9:25 Identifying Efficiencies and Improvement Opportunities in the
Vendor Qualification Process
Zachary Smith, Senior Data Scientist, Tufts Center for the Study of Drug
Development
Tufts CSDD convened a working group of sponsor and CRO companies to update
and expand on previous benchmarks in the vendor qualification assessment
process. Three separate surveys were used to collect data from sponsors andCROs, vendors, and clinical trial sites. Analysis of the survey results provides
insights into the time and personnel investments required, as well as trends in how
new technologies are being used in the VQA process.

9:50 Optimizing Clinical Operations: A Small Biotechnology ‘Fit for
Growth” Strategic Insourcing and Outsourcing Adaptive Framework
Oscar Alcantar, Dir Clinical Operations, Clinical Operations, Maze Therapeutics
A look into a small biotechnology “fit for growth” framework designed to optimize
efficiency and scalability. We will explore how small biotech organizations canstrategically balance functional insourcing and outsourcing to meet evolving
needs across different stages of growth and clinical trial activities. The adaptivemodel addresses key considerations in personnel hiring, vendor selection andmanagement to ensure seamless operations and maintain quality standards.

10:15 Roadmap for Vendor Management: Sponsor Oversight Problem
Prevention Tips for Small- to Mid-Size Pharma
Tomasz Kosieradzki, Owner & Principal Auditor, Kosieradzki.com; Individual
Consultant
This presentation offers step-by-step guidance on conducting vendor
qualifications, including due diligence, risk assessments, and ongoing monitoring.
It is tailored for companies without or with a limited, formal quality structure—andemphasises the role of project and trial managers in upholding quality standards.

10:40 Sponsored Presentation (Opportunity Available)
10:53 Grand 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 theindustry, connect with colleagues and vendors, and make some new friends.

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

13:35 Join Your Peers for a Networking Lunch 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
Tina Karunaratne, Founder and CEO, Karuna Integrated Clinical Services

14:40 Strategies to Mitigate Vendor-Related Risks in Your First-inHuman Clinical Trials—Real Cases with Vendors Contracting
Dawid Lyzwa, Head of Clinical Development, JJP Biologics
Joanna Mysiak, Senior Project Manager, JJP Biologics
JJP Biologics, a small biopharma company focused on monoclonal antibodies
research, emphasises mitigating vendor-related risks in clinical trials. We’ll share
best practices in vendor qualification, including due diligence, clear contracts, androbust quality management systems. Additionally, we’ll discuss risk-based vendor
oversight and offer advice on preparing and comparing Requests for Proposals toensure comprehensive and effective supplier bids.

15:05 Sponsored Presentation (Opportunity Available)
15:30 Strategic Navigation for Clinical Trials in Mid-Size Biopharma—
Insights from an Executive Director’s Perspective
Estrella Garcia Alvarez, PhD, Director, Global Clinical Operations, R&D, Almirall SA

CAMBRIDGE HEALTHTECH INSTITUTE’S INAUGURAL|

29 - 30 OCTOBER 2024

Clin Ops in Europe’s Emerging Biopharma

Optimising Clinical Programs, Clin Ops Teams, and Outsourcing Partners in Europe’s Emerging Biopharma

Complex trials strain mid-size pharma. Careful design involving all stakeholders is
key to minimise risk and ensure study success.

15:43 How to Efficiently Work with Vendors—Now the Large Pharma
Perspective—What Should You Take into Consideration While Growing
with the Number of Trials and Vendors?
Natalia Tomkiewicz, Head of Study Delivery Management Global Clinical
Operations, GSKThis presentation offers insights for clinical trial operations executives on
efficiently managing vendors from a large pharma perspective. As the number oftrials and vendors grows, key considerations include strategic vendor selection,scalable processes, and comprehensive risk management. Emphasising clear
communication, robust contracts, and continuous monitoring, these strategies
ensure operational efficiency, regulatory compliance, and sustained trial success.

16:07 Sponsored Presentation (Opportunity Available)
16:20 Presentation to be Announced
16:32 PANEL DISCUSSION: Take-Home Strategies for Vendor
Management
Moderator: Tomasz Kosieradzki, Owner & Principal Auditor, Kosieradzki.com;
Individual Consultant
Speakers from this session will share lessons learned.
Panelists:
Dawid Lyzwa, Head of Clinical Development, JJP Biologics
Joanna Mysiak, Senior Project Manager, JJP Biologics
Natalia Tomkiewicz, Head of Study Delivery Management Global Clinical
Operations, GSK

16:57 Reception 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)!

18:00 Close of Day
WEDNESDAY 30 OCTOBER
8:15 Registration and Morning Coffee

CASE STUDY: THE IMPORTANCE OF ALIGNMENT IN
CLINICAL TRIAL DESIGN
8:45 Chairperson’s Remarks (Sponsorship Opportunity Available)
8:50 Case Studies: Fast-Track Approaches to Accelerated Patient Carewith the Anti-CRO
Meri Beckwith, Co-Founder, Lindus Health Ltd.
Fernando Osorio, Associate Vice President of Medical Affairs, Pharmanovia
In 2024, clinical research faces ongoing challenges despite scientific andtechnological progress. Misaligned incentives persist among sponsors andcontract research organisations (CROs). This presentation explores innovative
business models and trial designs that lead to stronger collaborations between
sponsors and CROs, and ultimately, to better research outcomes.

9:15 Redefining eConsent: From Misconceptions to Clarity
Hilde Vanaken, Head EFGCP eConsent Initiative, EFGCP - European Forum for Good
Clinical Practice
The non-profit European Forum GCP eConsent Initiative, comprised of 50
companies, has released a suite of global tools to address the misconceptions andlack of harmonization and insight about eConsent. Harmonized terminologies andstudy documents’ requirements, insight in stakeholders’ benefits and challenges,
and a 5-step framework to design the right eConsent for a particular study andgenerate effective eConsent study data are some topics covered in this session.

UNDERSTANDING THE EU AI ACT: INSIGHTS FROM ALL

STAKEHOLDERS IN CLINICAL TRIALS, FROM EMERGINGTO LARGE PHARMA
9:40 PANEL DISCUSSION: The EU AI Act: Death Knell or Chance to Prove
Value?
Moderator: Barnaby Pickering, Managing Editor, Citeline
The EU AI Act is poised to disrupt the European tech sector, raising complianceconcerns for biotechs. Opinions are divided: some fear it will stifle innovation, whileothers believe it doesn’t go far enough. This discussion will explore compliancesteps, operational changes, long-term impacts, and strategies for de-risking theprocess, featuring insights from biotech industry leaders.
Panelists:
Matthias Alder, CEO, Gain Therapeutics, Inc.
Ricardo Gaminha Pacheco, Strategic Partnering, Business Development & Licensing
Director, Insilico Medicine
Christopher Hart, Partner, Co-Chair, Privacy and Data Security Group, Foley Hoag
LLP
Gandolf Finke, PhD, Founder & Managing Director
Sergey Jakimov, Managing Partner, LongeVC

10:05 Sponsored Presentation (Opportunity Available)
10:17 Coffee Break in the Exhibit Hall with Special Book Signing
More coffee, more exhibitors, more networking, and some delicious snacks. What’s
not to love?

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

12:10 Join 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!

NAVIGATE AND ENSURE SUCCESS IN YOUR CLINICAL
TRIALS AS A SMALL BIOPHARMA COMPANY
13:10 Chairperson’s Remarks (Sponsorship Opportunity Available)
13:15 Navigating the Complexities of Early-Phase Radiopharmaceutical
Therapy (RPT) Clinical Trials
Nathaniel Scott, MPhys, MSc, MPE, Medical Physicist, Blue Earth Therapeutics
Radiopharmaceutical Therapy (RPT) is a rapidly expanding area of interest andits future success is highly dependent on the quality of clinical trials in this space.
Early-phase RPT clinical trials require multifaceted site qualification as well as
highly technical data collection for dosimetry analysis, involving complex imaging
techniques. We propose a presentation on the complexities (and opportunities)
that these types of study present from a sponsor’s perspective.

13:40 Are You Prepared for a Regulatory Inspection from a Health
Authority?
Sheri Lee, CEO, Principal Consultant, Premier Regulatory Consulting (PRC); Former
National Program Expert, FDA
Sapna Shah, Head of Global Clinical Operations Americas, Telix Pharmaceuticals
The audience will be able to identify barriers to being inspection-ready, (i.e., staff
not understanding regulatory requirements, not conducting a Gap assessment).
The audience will understand strategies to implement to become inspection-ready.
The audience will know how to use various tools to become inspection-ready.

14:05 Sponsored Presentation (Opportunity Available)
14:30 Session BreakPLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

15:45 Close of Summit
ScopeSummitEurope.com | 17

CAMBRIDGE HEALTHTECH INSTITUTE’S 7TH ANNUAL|

29 - 30 OCTOBER 2024

Risk-Based Quality Management
Risk-Based Quality Management (RBQM) and Monitoring

MONDAY 28 OCTOBERMONDAY AFTERNOON: USER GROUP & WORKSHOP
14:30 – 19:00 Innovation Day with IQVIA Technologies at
SCOPE Europe
CO-SPEAKERS:
Kevin Landells, Vice President Patient Centered Technology Delivery, IQVIATechnologies
Stefan Dürr, Senior Director, Client Delivery, IQVIA Technologies
Petar Genov, Senior Director, Business Operations and Capabilities – Payments,
IQVIA Technologies
Tim Reily, Vice President, Clinical Data Analytics, IQVIA Technologies
Alison Liddy, Senior Vice President, Patient and Site Centric Solutions, IQVIA
Clinical trial sponsors are invited to join IQVIA Technologies’ digital productleaders and industry representatives for an afternoon of discussions, demos, andnetworking. IQVIA will share our vision to transform clinical operations and ask foryour input on our roadmap for future product development. Innovation Day will beof interest to pharmaceutical executives or sites with roles in clinical operations,innovation, technology, finance, budgeting, data analytics, patient or site
engagement, or strategic sourcing. IQVIA reserves the right to decline registrations
for those not in these categories. For more information or to register click here.

17:30 – 19:00 The Path towards Sustainable Clinical Trials: How to
Minimise Environmental Impact and Stay Ahead of Future Regulatory
Requirements
INSTRUCTORS:Fiona Adshead, Chair, Sustainable Healthcare Coalition
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Marisa Minetti, Patient Research Partner, Chiesi Group
Keith Moore, Programme Coordinator, Sustainable Healthcare Coalition
Developing frameworks to define and manage sustainability risks, and effective
guidelines to reduce the carbon footprint of clinical trial operations is a collaborative
effort. Beyond benefiting the environment, adopting sustainable practices isincreasingly demanded by stakeholders and can significantly influence customer
choices and talent acquisition. Perhaps more compelling are the growing
regulatory pressures and expectations, including the Corporate Sustainability
Reporting Directive (CSRD) and Task Force on Climate-related Financial Disclosures(TCFD) among others. This workshop will discuss the current hotspots of carbon
emissions in clinical research, introduce a new clinical trial carbon footprint
calculator for assessing current state, and suggest introductory reduction
strategies. Whether you are in clinical trial design clin ops, procurement, innovation,
sustainability, or resource management, this workshop is for you.

TUESDAY 29 OCTOBER
7:00 SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps
Join SCOPE Europe’s Coordinators for our Fun Run/Walk! All of us at Cambridge
Healthtech Institute recognise the importance of integrating well-being and fitness
into our work travel routines. This is an easygoing, informal running (or walking)event where we ascend the stairs of the iconic Magic Fountain. No time chips,
running bibs, or energy bars—just a laid-back opportunity for a small group to startthe day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walkand-talk—the goal is to get up and get moving! Meet us in the front lobby at theInterContinental at 7 sharp!

7:45 Registration and Morning Coffee
8:50 Organiser’s Welcome Remarks

LEVERAGING QTLs AND KRIs FOR CLINICAL RISKDETECTION
8:55 Chairperson’s Remarks (Sponsorship Opportunity Available)
9:00 Are Your KRIs Detecting Issues Early Enough? How Simple
Definition Changes Can Impact Whether Your KRIs Are Leading or
Lagging
18 | ScopeSummitEurope.com

Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.
Monitoring of risks/issues using metrics (KRIs/QTLs) in RBQM is fundamental tothe approach and expectations of regulators, but without critical thinking, signals
may be detected too late to change the course of the study. We will explore thedefinitions of leading and lagging indicators, look at how the KRI/QTL metricdefinition impacts how early signals are detected, and why it is important to havethe end in mind.

9:25 Applying Critical Thinking to QTL and KRI Definitions: Lagging
QTLs and Composite KRIs
Jenny Christal, PhD, Associate Director, Risk Based Quality Management, Jazz
Pharmaceuticals
We will build on the concepts of lagging and leading indicators, and consider howeach can add value to a cohesive approach to QTL management. With practicalworked examples, we aim to illustrate how careful and holistic QTL/KRI definition
can help to protect the most critical aspects of your study.

9:50 How RBQM Creates Trust between Sponsors and CROs
Duncan Hall, CEO, Triumph Research Intelligence Ltd.
We’ll be tackling some of your most-asked questions and concerns including the
big communication and trust challenges we see from hundreds of projects; what
do the ultimate customers (regulatory authorities) want to see; what is RBQM,
what are its challenges, and how can it help; and how technology makes all thedifference.

10:15 PANEL DISCUSSION: The Opportunities and Challenges of
Outsourcing RBQM
Moderator: Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.
Many organisations choose to outsource all or part of their RBQM to a CRO or
vendor. How do you decide what to outsource? How do you know if the CRO/
vendor will meet your requirements? How much input should the sponsor have?
What are the best practices for oversight? This discussion will outline a variety ofperspectives on the subject.
Panelists:
Natalia Buchneva, Risk Management Lead, Clinical Data & Innovation, UCB
Linda White, Associate Director, Risk-Based Quality Management, Jazz
Pharmaceuticals
Amy Kroeplin, MPH, Senior Director, Centralized Monitoring, PPD

10:40 The Real Cost of Delays in Drug Development and theRole of RBQM and QbD
Johann Proeve, PhD, Chief Scientific Officer, Cyntegrity
Discover how the recent Tufts CSDD study aligns with the approach Cyntegrity
embedded in their Clinical Monitoring Cost Savings Calculator, launched earlier thisyear. The study challenges the outdated $4 million/day delay cost, validating how
integrated RBQM and QbD strategies can save up to $2.8 million per study. These
strategies improve trial efficiency and ensure more effective cost management,
making them essential tools in today’s clinical research landscape.

10:53 Grand 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 theindustry, connect with colleagues and vendors, and make some new friends.

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

13:35 Join Your Peers for a Networking Lunch 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.

RBQM IN A CHANGING REGULATORY LANDSCAPE
14:35 Chairperson’s Remarks
Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics,
GlaxoSmithKline

14:40 Risk-Based Quality Management and ICH E6 R3—Through theTransCelerate Solutions FrameworkCAMBRIDGE HEALTHTECH INSTITUTE’S 7TH ANNUAL|

29 - 30 OCTOBER 2024

Risk-Based Quality Management
Risk-Based Quality Management (RBQM) and Monitoring
Arlene Lee, Director, Product Management, Data Quality and Risk Management
Solutions, Medidata
Nicole Stansbury, Senior Vice President, Global Clinical Operations, Premier
Research; Co-Lead, Risk-Based Monitoring Working Group, Association of ClinicalResearch Organizations (ACRO)
Madeleine Whitehead, Process Excellence Leader, Product Development Quality
Solutions, Roche Products Ltd.
The upcoming ICH E6 R3 guideline changes and elevates the concepts of RBQM.
This session will expand on progress for ICH E8 R1 and the transition from strategy
to operations. The audience will hear solutions developed by TransCelerate totransition the industry’s utilisation of RBQM to fulfill the requirements of ICH E6 R3;
including what is different, what is the same, and the new or changed terminology
in the guidelines.

15:05 Harnessing ML and Statistics for Smarter RiskBased Quality Management
Laura Trotta, VP Research Operations and Statistical Innovation, CluePoints SA

15:30 New GCP: What to Prepare For
Natalia Buchneva, Risk Management Lead, Clinical Data & Innovation, UCB
Revision 3 of ICH E6 R3 is an important change for the clinical trial industry, and
it is important to highlight the changes and upcoming new ways of working.
Sponsors, investigators, CRO representatives, and clinical vendors will gain anunderstanding of the new regulatory landscape for clinical trial conduct, as well ascalibrate processes to align with the release of ICH E6 R3.

15:55 Challenges in SDV & SDR methodology: Introducinga Technical Solution for Flexible Sampling of SDV & SDR
Activity
Amy Kroeplin, Senior Director Centralized Monitoring, Thermo Fisher Scientific
Reduced source document verification (SDV) and review (SDR) approaches differ
widely across the industry. Despite reduced methods being recognized as an
acceptable approach, there are still challenges with adoption. As a result, there
is a high degree of variation between sponsors, and CROs. This presentation willconsider the complementary processes of SDV and SDR and introduce a technicalsolution for providing flexibility, traceability and sampling for management of SDV& SDR activity.

16:32 PANEL DISCUSSION: Senior Clinical Trial Leaders Discuss and
Debate the Impact of ICH E6 R3, the Expected Challenges, and theOpportunities
Moderator: Patricia Leuchten, Founder & CEO, Diligent Pharma
After much anticipation, ICH E6 R3 will be released in the fall of 2024. In thispanel, quantitative and qualitative data (gathered in an industry research study by
WCG Avoca) on ICH E6 R3 implementation will serve as a catalyst for discussion
among senior leaders. The panel will cover key proposed changes and how they
will impact clinical trial execution in terms of challenges with implementation andopportunities for success.
Panelists:
Solomon Babani, CEO, Crovelis

16:57 Reception 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)!

18:00 Close of Day
WEDNESDAY 30 OCTOBER

significantly surged. In this presentation, we’ll examine the role of open-source
tools in fostering collaboration, transparency, and standardisation across industry.
We’ll also provide an overview of current open-source initiatives in the clinical trial
domain, including safety monitoring, data standardisation, and a newly-released
open source framework—containing 30k lines of code—for Risk-Based Quality
Management (RBQM).

9:15 Achieving the Promise of RBQM
Sharma Ramanathan Deva Devesa, Principal, ZS Associates, Inc.

9:40 Bridging the Gap: Enhancing Clinical Trial Data Integrity throughAdvanced Log Analytics and Metadata Extraction
Nikos Papachristou, PhD, Senior Manager, Data Science, Quality, Pfizer Inc.
This presentation introduces a forensics analysis tool that leverages log data from
CRF entries to ensure clinical trial data integrity. By applying advanced analytics
and metadata extraction, the tool bridges the communication gap between QMS
and RQA processes. The end-to-end solution automates data ingestion andmodelling, providing interactive dashboards for auditors and data managers to
identify quality issues and outlier behaviours across studies, sites, users, and CRF
elements.

10:05 Sponsored Presentation (Opportunity Available)
10:17 Coffee Break in the Exhibit Hall with Special Book Signing
More coffee, more exhibitors, more networking, and some delicious snacks. What’s
not to love?

PLENARY KEYNOTE SESSION
For a detailed agenda, please visit pages 4-5.

12:10 Join 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!

RBQM ADOPTION AND OPERATIONALISATION
13:10 Chairperson’s Remarks (Sponsorship Opportunity Available)
13:15 Assessment of Risk-Based Quality Management Adoption in
Clinical Trials
Maria Florez, Research Consultant, Tufts Center for the Study of Drug Development
This talk will focus on a new comprehensive approach to assessing RBQM
adoption; recent data on current levels of RBQM adoption among industry
sponsors and CROs; recent data on expected future levels of use of RBQM
components; perceived challenges associated with the implementation of RBQM
components; and opportunities and benefits of RBQM implementation. We will
discuss implications of these findings for the future of RBQM.

13:40 Case Study: Non-Interventional Dry-Run Study Implementing FullScope RBQM Methodology for Risk Mitigation
Magda Piskorska, Central Monitoring Lead, GlaxoSmithKline
The dry-run study serves as a preparatory phase for high-risk projects. This
non-interventional case study, enrolling 1% of the target population for theefficacy study, aimed to test processes such as eCOA and sample collection. A
comprehensive RBQM methodology was implemented. This approach not only
enhanced control over critical data collection but also facilitated swift identificationand management of both predefined and newly emerging risks.

14:05 Sponsored Presentation (Opportunity Available)
14:30 Session Break

8:15 Registration and Morning Coffee

PLENARY KEYNOTE SESSIONINTEGRATING RISK-BASED DATA MANAGEMENT (RBDM)

For a detailed agenda, please visit pages 4-5.

8:45 Chairperson’s Remarks (Sponsorship Opportunity Available)

15:45 Close of Summit

8:50 Accelerating Open Source Initiatives in Clinical Trials: 30k Insights
Pooja Chavan, Clinical Program Manager, Oncology, Gilead
In recent years, collaboration within the biotech and pharma sectors has

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