15th Annual Outsourcing in Clinical Trials Europe 2024

Creating a collaborative environment where pharma & biotech leaders can find solutions to current challenges through innovations and partnerships

7 - 8

May

2024
  • Hyatt Regency Barcelona Tower, Barcelona, Spain
  • Complimentary
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Why attend?

WHAT TO EXPECT FOR 2024?

With regulations ever changing and the innovative advancements of technology rapidly growing, this conference will address the everyday and perspective challenges faced when working within the clinical trial space. Legislations such as the CTIS review to Generative AI and leveraging our global trial footprint to accelerate clinical development, as well as building on our new and existing relationships within our industry.

This conference will bring industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, technology and of course, patient centricity.

This is a unique opportunity to network and share knowledge with the region’s leading pharmaceutical firms, biotech’s and medical device companies, to discuss operationally efficient, specifically targeted clinical trials. The 2024 program boasts 4 full streams complete with key content.

Stream A: Outsourcing & Clinical Operations

Stream B: Clinical Innovation & Technology

Stream C Day 1: Patient Centricity

500+

Attendees

80+

Exhibitors

40+

Speakers

500+

Attendees

80+

Exhibitors

40+

Speakers

See What It's All About

Agenda

  • 7 May 2024
  • 8 May 2024
Expand All

Streams

Stream one

Stream A: Clinical Operations and Outsourcing

Stream two

Stream B: Clinical Technology & Innovation

Stream three

Stream C: Patient Centricity

11 AM

PATIENT ADVOCATE KEYNOTE: Which Patients? How Centric?

 

·       Outsource To Us - Patients, Groups, Experts and Advocates

·       Trials as Treatments - Research as Routine

·       Involvement/Engagement - Conversation or Intervention

  • Perspectives and Expectations - QoL, PROMs, results and transparency

Speakers

Richard Stephens
Veteran Patient Advocate, Trial Participant, Author, Journal Editor

11:30 AM

Practical Solutions for Patient Engagement in CGT Trials: Supporting Patients and Families Throughout the Journey

  • Collaborating with sites to minimise patient burden
  • Effective communication strategies for patient recruitment, education, and retention
  • Optimizing the patient experience through prolonged trial durations, from decision making to late follow up

Speakers

Maria-Cruz Morillo
Global Therapeutic Operations Lead, Rare Diseases, Allucent

12 PM

Building clinical trials with the perspective of the patients in mind

exploring patient collaboration and the benefits it can bring to the sponsor and the patient.

• Discussing the collaboration that has to exist between all parties (patients, coordinators, doctors) in order to have a successful trial
• Importance of good communication to the patients and how this can streamline trial timelines
• Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up

 

Speakers

Amelia Hursey
Parkinson's Research Manager, Parkinson's Europe

12:30 PM

Pioneering Gene Therapy in Rare Diseases: A Path to Revolutionary Treatments

In this session, attendees can expect to:

·       Gain insights into the transformative impact of gene therapy on rare disease treatment, underscoring a new era of medical breakthroughs.

·       Learn about the complexities involved in conducting gene therapy trials, from the unique challenges to the innovative solutions.

·       Understand TFS HealthScience's approach to navigating the project management hurdles specific to gene therapy research.

Speakers

Lakshmi Gurduri
Director Project Management, TFS Health Science

1 PM

Lunch and networking

2 PM

Site selection for increased patient recruitment and retention

• Highlighting discrepancies in the distance between clinical trial sites and the disease prevalent populations using case studies.

• Exploring the impact of appropriate and inappropriate site selection on a trial’s success through case studies.

• Showcasing how patient
accrual has been affected in clinical trials utilizing virtual components.

 

Speakers

2:30 PM

Digitalization In Clinical Trials, A 360 View

  • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
  • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
  • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
  • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
  • Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

Speakers

Sverre Bengtsson
Co-Founder, Viedoc

3 PM

FIRESIDE CHAT: Patients at the Heart

This session will bring together two industry experts from different sides of the drug development landscape; Innovator and Generics Pharma.  Both with a focus on advancing patient care but in unique and different ways. We will touch base on synergies as well as individual challenges and how we commonly drive forward the development of safe, effective, and affordable medicines that meet the needs of patients worldwide.

Speakers

Linda O’Grady
Director Clinical Procurement, Novartis
Saskia van Dalen
Global head R&D procurement, Sandoz

3:30 PM

Afternoon refreshments and networking

4:15 PM

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

• Discover sites with a demonstrated track record of good execution in trials
• Uncovering a strong study workforce to ensure patient enrolment and effective study start-up
• Analysing sites access to subject population with the required eligibility measures.
• Understanding new landscapes from a legislative perspective
Moderator: Richard Stephens, Patient Advocate

Panellists:
Mireille Ermens, Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring

Nikita Sharma, Global Clinical Sciences & Operations Innovation Manager, UCB

Amelia Hursey, Research Manager, Parkinson's Europe

Francis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe (GCPA)

Robert Kurowicki, Director of Feasibility and Project Strategy, Novotech

Speakers

Richard Stephens
Veteran Patient Advocate, Trial Participant, Author, Journal Editor
Mireille Ermens
Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring
Nikita Sharma
Global Clinical Sciences & Operations Innovation Manager, UCB
Amelia Hursey
Parkinson's Research Manager, Parkinson's Europe
Robert Kurowicki
Robert Kurowicki, Director of Feasibility and Project Strategy, Novotech Europe
Francis P. Crawley
Executive Director, Good Clinical Practice Alliance - Europe (GCPA)

5 PM

Putting patients at the centre of their clinical trial journey: supporting engagement, driving ePRO compliance

  • How robust, globally-deployable solutions can be designed from a 'patient-first' perspective
  • Sharing learning on achieving meaningful engagement throughout the study
  • Exploring how modern technology both retains patients and drives high eCOA/ePRO compliance
  • Case studies on embedding human-centred design to deliver faster, more flexible outcomes for sponsors

Speakers

Bruce Hellman
Co-Founder and Chief Patient Officer, UMotif

5:30 PM

Chairperson’s closing remarks followed by Drinks Reception

END OF DAY 1 AND NETWORKING DRINKS RECEPTION

11 AM

Transforming Clinical Trials: Harnessing AI for Decentralized Study Design and Operations

In recent years, the clinical research landscape has witnessed a paradigm shift towards decentralized clinical trials (DCTs) and the integration of artificial intelligence (AI) into various aspects of drug development. This presentation aims to explore the intersection of these two transformative trends and their potential to revolutionize the way we conduct clinical studies.

 

Speakers

Nikita Sharma
Global Clinical Sciences & Operations Innovation Manager, UCB

11:30 AM

How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors

  • +Why clinical technologies and product integration strategies are more important than ever
  • +How to eliminate redundant activities, such as data entry and reconciliation
  • +How to leverage clinical data quickly to generate insights and improve study optimization and decision-making
  • +Accelerate time to database lock with improved data quality

 

Speakers

Anthony Mikulaschek
VP, Commercial Strategy, IQVIA Technologies
Stefan Dürr
Senior Director, Client Delivery, Cenduit IRT, an IQVIA business, Head of Drug Supply Center of Excellence

12 PM

Planetary Health: New paradigms for Innovation and Research

This session will address the intersection of global health, climate change, innovation, digital health, artificial intelligence, and research in an engaging and accessible manner. The aim is to highlight how global changes and new technologies impact innovation and research, using specific examples related to clinical trials.

Speakers

Jordi Serrano Pons
Medical Doctor expert in Digital and Global Health, Barcelona Health Hub Board Member

12:30 PM

A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

Join us for a comprehensive exploration into Parkinson’s disease (PD) endpoint data collection, as we delve into the core elements of efficacy, safety, and quality of life. This session will highlight how the integration of different endpoint modalities provides researchers with a clear advantage in their mission to advance innovative therapeutics for this largely unmet medical need. The endpoint modalities to be discussed include:

 

  • Wearable digital endpoint solutions and their pivotal role in providing quantitative gait assessment for detection of disease progression
  • eCOA solutions for assessing efficacy and quality of life, leveraging clinical rating scales, symptom diaries, and other patient-reported outcome measures
  • Medical imaging modalities focused on accurately characterizing PD status biologically, paving the way for biomarker-guided drug development.
  • Cardiac monitoring in this unique population, collecting high-quality blood pressure and cardiac rhythm data to characterize PD-associated autonomic dysfunction.

Speakers

Todd Rudo, MD
EVP & Chief Medical Officer, Clario
Bryan McDowell
VP, eCOA Science & Consulting, Clario

1 PM

Lunch and networking

2 PM

Great expectations and how to meet them – connected devices and ePRO in clinical trials

• Focusing on design considerations

• Understanding the best framework for your study

• Considering patient ePRO assessments needed for a specific study

• Highlighting best practice for data collection

• Avoiding expensive mistakes that undermine your trial outcome or delay your timeline

• Outlining Regulatory restrictions around ePro
• Comparison vs Paper Reported Outcomes – why are companies not transitioning fully to ePro?

 

Speakers

Dr Mar Gomis Pastor
Director of the Center for Digital Clinical Validation, Hospital de la Santa Creu i Sant Pau
Alicia Borràs
Study Coordinator, Digital Health Unit, Strategy Office Més Sant Pau, Hospital de Santa Creu i Sant Pau

2:30 PM

AI: A Game Changer for Clinical Operations

Advances in Artificial Intelligence (AI) are rapidly changing our approach to clinical operations and how we work day-to-day.

AI is being incorporated into existing clinical operation workflows to help unblock obstacles at study startup, and create and manage KPIs, provide natural language summaries of actionable insights such as threshold breaches, and more. Within Risk-Based Quality Management (RBQM), AI is enabling organizations to proactively manage risk and quality and quickly action and remediate issues as they arise at scale across their functions.

Join this exciting session to learn how Saama's ground-breaking AI-driven platform empowers clinical operations teams to quickly identify and remove bottlenecks within their studies – accelerating their time to study completion.

Speakers

Sas Maheswaran
Vice President, Product Implementation, Saama Technologies

3 PM

Experience with EU Clinical Trial Regulation – Updates from January 2023

• Submitting a study within the framework of the new regulations, what are the differences?
• Understanding the updated CTR guidelines to enable sponsors to submit one application and gain approval to run a clinical trial in several European countries
• Working with the CTIS portal for trial applications
• Examples and common issues
• Sharing experiences with various Health Authorities

 

Speakers

Dr Sol Yates
Associate Director, European Regulatory Affairs, Shionogi Europe

3:30 PM

Afternoon refreshments and networking

4:15 PM

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

• Are we making the most of Technology & Innovation in the Clinical Trial space?
• Highlighting Innovation points of interest such as Metaverse, Blockchain and Machine Learning to name but a few
• How are these tools being utilized?
• The importance of exploring ethical considerations, now.
• What’s next?

Speakers

Mats Sundgren
PhD, European Institute of Innovation through Health Data (i-HD)
Maria Reyes Boceta-Munoz
Head Of Clinical Operations Spain, GSK
Laura Jiménez Robledo
Clinical Project and Innovation Manager, Novo Nordisk
Upinder Grewal
Strategic Lead Exploration and Discovery, DS&AI, Bayer
Gabriel Maeztu
Co-founder of IOMED

5 PM

Advantages and Challenges of New Technology in Clinical Research

• How the integration of digital health technologies has enabled the collection of real-time data from patients outside of traditional clinical settings?

• How can we analyze large volumes of clinical and genomic data to identify patterns, predict treatment responses, and personalize therapies?

• Can we improve patient recruitment, protocol design optimization, adverse event prediction, and data analysis? How new technologies and processes can accelerate the trial process, improve efficiency, and reduce costs.

• Enhance security, transparency, and integrity of clinical trial data

• Regulatory and operational challenges

Speakers

Ana Moreno
Director Global Clinical Operations, APICES

5:30 PM

Chairperson’s closing remarks followed by Drinks Reception

END OF DAY 1 AND NETWORKING DRINKS RECEPTION

7:45 AM

Registration and refreshments

8:20 AM

Chairperson’s opening remarks

Speakers

Francis P. Crawley
Executive Director, Good Clinical Practice Alliance - Europe (GCPA)

8:30 AM

KEYNOTE Revolutionizing Clinical Trials through RWD and AI: Unleashing Innovation

In the ever-evolving realm of medical research, innovation within clinical trials is instigating a transformative wave that significantly enhances patient outcomes. Harnessing the power of advancements in trial design, digital technologies, Artificial Intelligence & Machine Learning algorithms, and data analytics, this wave of innovation is driving drug development forward. It extends the reach of experimental treatments to more patients, while simultaneously elevating the overall quality and analysis of trial data.

This keynote presentation offers a deep dive into the multifaceted landscape of innovation, exploring groundbreaking approaches such as Federated EHR research platforms, eSource-supported trials, artificial intelligence, and patient-centric strategies. These pioneering methodologies not only optimize operational efficiency but also individualize medical approaches, fostering a continuous evolution in the trial process.

Key Topics Covered:

  • The Changing Landscape: Exploring Paradigm Shifts in Clinical Trials
  • Advancements in Trial Design & Digital Technologies: An In-Depth Look at Federated EHR Research Platforms
  • Emerging Impact of AI in Clinical Trials: Unpacking the Role of Artificial Intelligence in Clinical Research
  • Two Use Cases: How eSource & AI-Driven Event Adjudication Can Transform Clinical Trials
  • Outlook & Conclusions: Anticipating Future Trends and Developments in Clinical Trial Innovation

Speakers

Mats Sundgren
PhD, European Institute of Innovation through Health Data (i-HD)

9 AM

A New Paradigm for Clinical Innovation

The clinical research industry is at an inflection point. Advancements in technology have created the opportunity to transform clinical trial outcomes, but to make this ambition a reality, we must now rethink how we engage with patients. Today, we often treat patient relationships as transactional, de-identified numbers on individual clinical trials. We need a new way of thinking about patients. A more longitudinal way, with greater pre-trial engagement and post-trial follow-up, and across multiple studies and healthcare experiences. We also need to change how we look at patient data, widening the lens to understand patients’ health and research journeys across a broad ecosystem of data sources. But how do we execute this paradigm shift when we’re also under pressure to accelerate timelines, reduce risk, lower costs, and improve quality?

In this presentation, we’ll explore:

·       Industry drivers of this clinical research evolution

·       Challenges faced & the value of change

·       Reasons to believe - Improving trial experiences for patients, sites, CROs, & sponsors

Speakers

Richard Gray
Managing Partner, Medidata, Dassault Systemes

9:30 AM

Governance of Clinical Research within the European Health Data Space

As the European Union embarks on its journey to create a harmonized and interconnected health data ecosystem, the governance of clinical research within this evolving framework becomes paramount. This talk addresses the multifaceted challenges and opportunities associated with ensuring the ethical, legal, and efficient conduct of clinical research within a newly being carved out data space that promotes access to health-related data while safeguarding patient data privacy. The presentation emphasizes the importance of establishing a robust governance model that fosters collaboration among stakeholders, promotes data sharing, and aligns with emerging data and AI regulations. By addressing key questions regarding data access, consent frameworks, ethics review, and cross-border collaboration, the discussion provides insights into the evolving landscape of clinical research governance within the European Health Data Space, offering valuable takeaways those at the forefront needing to navigate the challenges and opportunities of this transformative era. The talk will specifically:

  • explore the ethical and legal considerations of clinical research governance within the European Health Data Space;
  • highlight the role of data protection regulations, ethics review, and consent frameworks in shaping research practices; and
  • discuss strategies for fostering cross-border collaboration and data sharing among diverse stakeholders in clinical research within the emerging governance frameworks.

Speakers

Francis P. Crawley
Executive Director, Good Clinical Practice Alliance - Europe (GCPA)

10 AM

Going Beyond ROI: Necessary Criteria for Impactful Innovation with Decentralized Clinical Trials

Even with high ROI, what drives widespread adoption is when sponsors and sites find the burden of an innovation to be less than the status quo. I will share different approaches of innovation within decentralized trials which showcase going beyond ROI.

Speakers

Martin Czakon, MSc
EMEA Head of Commercial Strategy & Growth, Care Access

10:30 AM

Morning & Refreshment break

11 AM

Fireside chat – ask the experts! Trial Execution in 2024 and Beyond

This fireside chat will look at funding trials, executing trials, the impact of new regulations, new treatment standards emerging, new technology, inflation, and its impact on costs.

Speakers

Michael Zörer
Head of Clinical Operations, VarmX
Sonja Weiser
Senior Director Clinical Operations, Insmed

11:30 AM

Navigating the Complex Regulatory Landscape for Oncology Trials: A Focus on the European Union

·       Overview of the harmonized regulatory framework within the EU and its impact on oncology trials.

·       Discussion of the diversity in regulatory requirements across EU member states and the challenges this poses for oncology research.

·       Strategies for navigating the complex regulatory landscape in the EU for successful oncology trial execution.

Speakers

Matt Cooper
Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials
Sarah Bly
Director Regulatory Science, Strategy & Innovation, Worldwide Clinical Trials

12 PM

Site Partnerships: Developing Site Relationships beyond Study-Level Engagement

• Supporting the portfolio across Therapeutic Areas
• Establishing a Strategic Role at a Regional-Level

 

Speakers

Christian Milliet
Head of Site and Healthcare Ambassadors, CSL Behring

12:30 PM

Maximizing the Consultative Partnership Between CRO and Biotech Sponsors

  • How early engagement will improve outcomes
  • Speaking the same language – one size doesn’t fit all
  • Simplifying the complex, in a world with an awesome amount of outsourcing options

Speakers

Polly Cooper
Senior Director, Project Delivery, Biotech - ICON

1 PM

Lunch and networking

2 PM

Leveraging operational expertise to enhance study design and patient centricity in clinical trials

 

  • Impact of complex clinical trial designs on study duration
  • The essential role of operations in study design decisions
  • Assessing clinical study protocol complexity
  • Fostering cultural shift during study development process
  • Investigating the relationship between operational complexity and patient burden
  • Incorporating patient insights to streamline clinical trials

Speakers

Alina Pszczółkowska
Head of Late Phase Program Management Respiratory & Immunology, AstraZeneca

2:30 PM

Why So Slow? Insider Insights from The Clinic Floor to Speed up the Startup and Execution of Proof-Of-Concept Patient Trials

How to:

·       Harness regulatory dynamics for strategic advantages.

·       Obtain feasibility figures true to delivery.

·       Employ innovative study designs to expedite the development program.

  • Customize efficient patient recruitment tactics!

Speakers

Louis Smikle
Executive Director, Global Strategic Partnerships, ARENSIA

3 PM

Fit-for-Purpose Outsourcing Strategy in Clinical Trials and Cost Optimization

• Outsourcing clinical activities became essential to the operational success of pharmaceutical companies
• There is a need to continuously improve operational efficiency and reduce research and development costs
• A fit-for-purpose outsourcing strategy will ensure an improvement in operational efficiency and optimization outsourcing costs
• Define a clear outsourcing strategy will drive cost reduction with a targeted collaboration with CROs
• How internally can costs be optimized when outsourcing a clinical trial? How to compare costs?

 

Speakers

Martin Rodriguez
Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

3:30 PM

Afternoon refreshments and networking

4:15 PM

PANEL – Outsourcing Strategies & Relationships

• Discussing how to approach your outsourcing strategy?
• Uncovering if your offerings are competitive, and if this is indeed value for money.
• Looking into what is driving the increasing costs of running your study, recognising the value associated with costs and their justifications.
• Establishing what can be done to avoid increasing budgets including the evaluation of tools required for the type of study one is conducting.
• What are your options if the partnership is not working as planned, mid study?
• How to keep a healthy relationship when faced with ongoing challenges, partnership by respectful collaboration.

 

Moderator: Silvana Giro, Senior Manager, Responsible Global Outsourcing and Contract Management Europe, Management Services, Global Medical & Regulatory Affairs, Bracco Imaging

Panelists:
Martin Rodriguez, Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

Dan McVeigh, Director, Clinical Project Lead, Alexion Pharma

Michael Zörer, Head of Clinical Operations, VarmX

Speakers

Silvana Giro
Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging
Martin Rodriguez
Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi
Daniel McVeigh
Director, Clinical Project Lead, Alexion Pharma
Michael Zörer
Head of Clinical Operations, VarmX

5 PM

The Future of Regulatory Compliance: Digital Tools for Mastering EU MDR and Post-Market Challenges

This presentation explores the evolving landscape of regulatory compliance within the European Union's Medical Device Regulation (EU MDR), focusing on the integration and benefits of digital tools. It will cover innovative strategies for navigating post-market surveillance requirements, ensuring continuous compliance, and leveraging technology to streamline the regulatory processes. Attendees will gain insights into practical solutions for overcoming the challenges associated with EU MDR, enhancing product safety, and improving market readiness through digital transformation.

Speakers

Enrico Perfler
Founder, 1Med
Pall Johannesson
Managing Director, Greenlight Guru

5:30 PM

Chairperson’s closing remarks followed by Drinks Reception

END OF DAY 1 AND NETWORKING DRINKS RECEPTION

Streams

Stream one

Stream A: Clinical Operations and Outsourcing

Stream two

Stream B: Clinical Technology & Innovation

8:45 AM

Chair’s opening remarks

Speakers

Mats Sundgren
PhD, European Institute of Innovation through Health Data (i-HD)

9 AM

Generative AI in healthcare to speed up drug discovery

  • Addressing the potential challenges using this new technology for the development, evaluation and monitoring of medicines
  • Active pilots in Generative AI
  • Data Use & Data Discovery
  • Underlining the importance of methodological, legal and ethical considerations
  • Gen-AI to develop protocols & execute trials; understanding whom enters data prior to using this

Speakers

Jose Manuel Ordoñez
MD, CCO Therapeutic Area Leader Onco-Haematology, Roche

9:30 AM

The Cinderella of Clinical Trial Planning: Identifying Your Targeted Subpopulation

Does one shoe fit all? Nowadays, trial planning is extremely complex, time-consuming, and requires high precision in every stage of the process. Identifying the right subpopulation is the starting point for clinical trial planning, However, compared to before, inclusion and exclusion criteria are very restrictive. Evaluating the complexity of your trial and benchmarking it against trials that target the same subpopulation is critical in order to avoid amendments, delayed timelines, increasing costs, rescuing ongoing trials, and the sponsor losing trust in the CRO. In other words, reality and expectation need to be aligned. With a better understanding of the complexity of your clinical trial, it's time to develop a recruitment strategy (site selection, feasibility, etc.) and an execution strategy (CTMS, EDC, RTSM, ePRO, etc.). This use case will highlight the importance of your clinical trial strategy as well as the execution. In this session, you will learn:

  • how to leverage data analytics to identify subpopulations
  • how to identify sites and investigators for specific subpopulations
  • how to align your clinical strategy and your operational plan

Speakers

Barbara Argibay
Vice President, General Manager – Data Division, Anju Software

10 AM

Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

  • Strategies for sourcing components from a scattered ecosystem
  • How to develop meaningful, human-centric measures
  • Pitfalls and opportunities for analytical and clinical validation
  • Novel solutions and digital pathways for scalable regulatory qualification
  • Maximizing value: how to repurpose and extend solutions across use cases in R&D and healthcare

 

Speakers

Chris Jones
CEO, DEEP Measures
Upinder Grewal
Strategic Lead Exploration and Discovery, DS&AI, Bayer
John Batchelor
Science Liaison, DEEP Measures (Digital Evidence Ecosystems and Protocols)

10:30 AM

Practical and personal innovation: Strategies to right-size hybrid trials for patients, sites, and sponsors

  • Look back at the push for “all virtual” approaches and the growing shift to hybrid designs
  • Explore Suvoda case studies that focus on right-sized hybrid approaches to meet patient, site, and trial needs
  • Look forward at upcoming innovations, including AI, and how learning from DCT and hybrid trials can inform strategies to use new eClinical technologies thoughtfully

Speakers

Daniela Duffett
Senior Solutions Consultant, Suvoda

11 AM

Morning refreshments and networking

11:30 AM

Multi-country experience with clinical trials: A perspective from the development of complex generics.

Development of complex generics, such as those integrating drug-device combinations, or biosimilar medicines require conducting clinical trials comprising phase I to III. These trials are highly challenging due to the requirements of certain patient populations, the need of fast pace, low budgets, and fierce competition. Most of these trials demand multi-country expertise and capabilities, at both CRO and sponsor levels.. Such clinical trials require precise articulation with sites and CROs, and each country requires a different strategy for obtaining approvals, IP logistics, patient recruitment activities, local laboratories, among others. Common hurdles in running multi country trials of complex generics will be discussed. Countries for conducting such trials traditionally involved either US, Canada, India and Central European countries. Recently, other regions have arose as equally capable, such as East Europe, Jordan, Latin America and Africa, expanding the horizons for conducting clinical trials of complex generics and biosimilars.

  • Development of complex generics requires complex clinical trials
  • Trials must be fast paced, with a low budget and competition for patients
  • Experience in multi-country studies in different regions of the world

Speakers

Carlos W. Bertoncini
PhD, Biopharmaceutical and Clinical Science Manager, CHEMO

12 PM

Accelerating trial recruitment through EHR referrals and GP engagement

Discover the transformative potential of leveraging primary care Electronic Health Records (EHR) and fostering GP engagement to exceed sponsor expectations and close patient recruitment months ahead of schedule.

While the value of EHR data in enhancing patient referral quality for clinical trials is widely recognised, this session delves into the additional benefits of partnering with primary care for sponsors. By integrating the power of EHRs with proactive engagement from primary care teams, we can unlock the potential to significantly accelerate recruitment speed and surpass enrolment targets, ensuring your clinical trial launches swiftly and yields impactful results.

Speakers

Katie Paul
Product Manager - Research and Life Science, EMIS

12:30 PM

Lunch and networking

1:30 PM

AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

·       Real-life use case – AI files documents in eTMF in the correct folders and adds metadata.

·       Co-pilot mode – controlling AI from user side.

·       Quality control and TMF oversight – demonstrating compliance, beyond just being compliant.

·       Validation and Hands-On AI Challenges: practical how-tos.

Speakers

Evgenia Michalcuk-Vrablik
Global Director of Growth, Flex Databases

8:10 AM

Registration and refreshments

8:45 AM

Chair’s opening remarks

Speakers

Fiona Barry
Editor in Chief & Director Pharmsource, GlobalData

9 AM

EU REGULATIONS Good Clinical Practice (GCP) Harmonization: Updates to ICH E6 (R3)

What do the new proposals bring to Clinical Trials:

Challenges & Opportunities

 

ICH E6 GCP (R3) guideline is expected to be released along 2024 - this an opportunity to review the most relevant differences between the current version and the upcoming guideline.

Speakers

Silvia Perez Torres
Director, Clinical Quality Compliance, AstraZeneca

9:30 AM

Charting a Course through Complexity: Leveraging Experience in Approaching Complex Clinical Trial Protocols

The landscape of clinical trials has undergone a remarkable transformation with the introduction of eClinical solutions, fundamentally reshaping day-to-day processes from traditional approaches. Automation and the integration of cutting-edge technologies are now the standard for clinical trial teams. However, amidst these advancements, the core requirements and understanding essential for running successful clinical trials remain steadfast. Experience emerges as the primary predictor of success – experience with protocol designs, study team and site expectations, and best standard practices.

Join Siobhan McKenna-Power, an industry veteran with 20 years of expertise in designing and delivering regulated systems, as she delves into the intricate distinctions involved in delivering these sophisticated solutions and why experience is critical.

Discover how mastery of these crucial elements can be the key to achieving the successful implementation of technology solutions supporting modern clinical trials.

Don't miss this opportunity to explore the perfect blend of cutting-edge technology and invaluable experience that can revolutionise the future of clinical trials

Speakers

Siobhan McKenna-Power
Client Services Lead, 4G Clinical

10 AM

Insights on How to Reduce the Burden of Study Start Up on Study Teams

The study start-up phase is where teams and sites cross-functional activities come together, all at once and often in combination with an internal expectation to further accelerate start up while facing the external reality of additional hold-up due to approval delays.

 

  • Focus-on-Five
  • Leverage the informed feasibility decisions.
  • Confident communication

Speakers

Mireille Ermens
Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring

10:30 AM

Ready for January 2025? Roadmap to CTIS compliance

  • Navigating the journey towards finding the perfect timeline for trial transitions, all aimed at ensuring a seamless alignment with the January 2025 milestone.
  • Unveiling a series of compelling case studies and triumphs
  • Highlighting the challenges encountered and showcasing the resilience and innovation that have driven progress forward

Speakers

Diana Filipescu
Business Development Manager, Novotech

11 AM

Morning refreshments and networking

11:30 AM

FIRESIDE CHAT What does fit-for-purpose Sponsor oversight look like?

ICH-GCP calls out that a Sponsor may transfer any or all of the Sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the Sponsor. With this in mind, what does fit-for-purpose Sponsor oversight look like?

 

Speakers

Fabio Miceli
Director Global Quality Assurance / EU QPPV, Norgine
Jadwiga Janicka
Director, Study Operations, AstraZeneca
Jonathan Harris, PhD
EVP Program Management, ICON

12 PM

Starting Off on the Right Foot: Top Considerations for Selecting the Right Clinical Trial Sites

This presentation will cover several strategies that are paramount to optimizing clinical trial site selection, including:

  • The importance of a productive site identification kick-off meeting with key stakeholders
  • Understanding global standard-of-care practices and their impact on trial design and site requirements
  • Maximizing the use of patient associations and physicians for informed decision making

Speakers

Andrea Ochoa, M.S.,
Senior Vice President, Global Clinical Operations, Premier Research

12:30 PM

Lunch and networking

1:30 PM

Overcoming the challenges of enrollment in the changing landscape of a rare disease

Our presentation delves into the intricate dynamics of enrollment challenges and underscores the significance of fostering strong site relationships in the rare disease space, as these partnerships often prove instrumental in driving successful enrollment outcomes. Beginning with a compelling case study introduction, we navigate through key drivers influencing sponsor decision-making processes, often creating innovative strategies that positively impact the study. Emphasizing the paramount importance of timelines, we discuss how sponsor decisions are strategically molded to align with project deadlines. Through the lens of the “one team, one approach” philosophy, we highlight the collaborative strategies that surmounted our enrollment hurdles effectively. Key takeaways from this exploration offer actionable insights for stakeholders navigating the complex terrain of rare disease research, ultimately paving the way for enhanced enrollment outcomes.

Speakers

Myriam Golembo
Vice President Regulatory Affairs, BiomX
Maris Veldre
Associate Vice President, Project Delivery – EU, Rho
Sonia Lwoff
Director Clinical Operations – EU, Rho

2 PM

PANEL Maximising your Sites Productivity & how to lessen the burden

Sites are increasingly challenged with workload and resource constraints. This panel will discuss ways in which to get the best output from sites.

What can we do for them beyond an inflated budget?

  • Addressing challenges the sites are currently facing
  • An overview of the repercussions of such challenges, and a focus on what we can do to overcome them
  • Forward thinking to strengthen site output
  • Limitations with electronic applications

Speakers

Fiona Barry
Editor in Chief & Director Pharmsource, GlobalData
Sonja Weiser
Senior Director Clinical Operations, Insmed
Estrella Garcia PhD
Executive Director Global Clinical Operations, Almirall
Richard Gray
Managing Partner, Medidata, Dassault Systemes

2:45 PM

Afternoon refreshments and Apple Prize draw

3:30 PM

INTERACTIVE THINK TANKS

Interactive think tank sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry. Hosted by industry experts and each focused on a single issue, think tanks are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. 

Each think tank session lasts for 30 minutes, and delegates may attend up to 2.

Think Tank 1:

 How do we apply GCP Compliance to Artificial Intelligence in Clinical Trials

Laia Casas, Clinical Project & GCP Compliance Leader, Noucor 

 

Think Tank 2:

Are Preferred Suppliers really an opportunity? Pros and Cons 

Silvana Giro, Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging

 

Think Tank 3: 

How might European trials make use of a local care model? 

Stephanie Casler, Director of Clinical Innovation, Johnson & Johnson

Speakers

Laia Casas
Clinical Project & GCP Compliance Leader, Noucor
Silvana Giro
Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging
Stephanie Casler
Director, Innovative Health, Johnson & Johnson

4:30 PM

Chairperson’s closing remarks

END OF CONFERENCE

Speakers

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Mats Sundgren
PhD, European Institute of Innovation through Health Data (i-HD)

Mats Sundgren, PhD, MSc, is a renowned expert in Health Data Strategy for Industry and Academia. With over 37 years in the pharma industry (Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science and Data Science & AI), Mats is at the forefront of industry technology innovation. In 2022, following a 12-year tenure as global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats’ new portfolio encompasses the roles of Senior Industry Scientific Director for the i~HD (European Institute for Innovation through Health Data); Executive Strategic Advisor for IgniteData, developer of a system-agnostic EHR-to-EDC solution for clinical trials; and Chairman of the Board of the Research Foundation IMIT (Institute of Managing Innovation and Technology) across Chalmers University of Technology, Royal Institute of Technology, Lund University of Technology & Stockholm School of Business.

Mats has authored over 70 publications, books, and patents in Science, Economics & Social Science (Health Data Science, Clinical Science, Business Modelling, Innovation & Creativity Management, and Device development).

Session Details:

KEYNOTE Revolutionizing Clinical Trials through RWD and AI: Unleashing Innovation

2024-05-07, 8:30 AM

Session Details:

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

2024-05-07, 4:15 PM

Session Details:

Chair’s opening remarks

2024-05-08, 8:45 AM

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Stephanie Casler
Director, Innovative Health, Johnson & Johnson

Stephanie is a Director in J&J’s Innovative Health Team, where she works to explore alternative options to traditional trial conduct in order to improve trial accessibility. Prior to joining Johnson & Johnson, she worked in Novartis’ Patient Experience team and spent 14 years as a management consultant with Accenture. American by birth, she has been living in Dublin, Ireland since 2016.

Session Details:

INTERACTIVE THINK TANKS

2024-05-08, 3:30 PM

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Nikita Sharma
Global Clinical Sciences & Operations Innovation Manager, UCB

Session Details:

Transforming Clinical Trials: Harnessing AI for Decentralized Study Design and Operations

2024-05-07, 11:00 AM

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Christian Milliet
Head of Site and Healthcare Ambassadors, CSL Behring

Christian Milliet has over 25 years of experience in the pharma industry, leading Clinical Operations teams across Europe, USA, Latin America, China and Japan. His expertise encompasses all phases of drug development in a multitude of therapeutic areas.

He is currently Head of Site & Healthcare Ambassadors at CSL Behring. Previously, he worked for Vifor Pharma, Novartis, Serono and Covance.

In his current role, Christian is spearheading the development and expansion of site partnerships, leveraging CSL global presence. His focus is on creating strategic relationships to successfully deliver the CSL portfolio, including clinical development and real-world evidence.

Christian has a degree in Business Administration from Webster University in St. Louis, USA.

Session Details:

Site Partnerships: Developing Site Relationships beyond Study-Level Engagement

2024-05-07, 12:00 PM

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Antonella de Ceano
Digital Transformation Officer, Barcelona Health Hub
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Carmela Gómez Rodríguez
Vice President Clinical and Regulatory Affairs, Neurofix Pharma
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Dr Mar Gomis Pastor
Director of the Center for Digital Clinical Validation, Hospital de la Santa Creu i Sant Pau

Mar Gomis-Pastor

PharmD, PhD. Clinical pharmacist with specialization in hospital pharmacy. International Doctor of Medicine (UAB - Autonomous University of Barcelona). Mar is currently responsible for the Digital Impulse at St. Pau's Hospital (within the Strategic Impulse and Transformation Area). She is also the Director of the Digital Health Clinical Validation Center (a joint project with the Barcelona Health Hub). She has worked as a coordinator of interdisciplinary and comprehensive eHealth projects for the last 10 years (2013-2023). Her current activity in ambulatory healthcare is focused on heart transplant care. Experience in other areas would be Research; Health Consultancy and eHealth Consultancy; Public Administrations as vocal in the National Commission of Specialties in Hospital Pharmacy, Spanish Ministry of Health Social Services; Education and Doctoral Thesis Director; among others.

Session Details:

Great expectations and how to meet them – connected devices and ePRO in clinical trials

2024-05-07, 2:00 PM

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Martin Rodriguez
Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

Session Details:

PANEL – Outsourcing Strategies & Relationships

2024-05-07, 4:15 PM

Session Details:

Fit-for-Purpose Outsourcing Strategy in Clinical Trials and Cost Optimization

2024-05-07, 3:00 PM

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Dr Sol Yates
Associate Director, European Regulatory Affairs, Shionogi Europe

Session Details:

Experience with EU Clinical Trial Regulation – Updates from January 2023

2024-05-07, 3:00 PM

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Silvana Giro
Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging

From 1984 to 1988 employed by Ciba-Geigy, in the Sales Marketing of chemical products, within the Customer Services.

Since 1988 employed by Bracco S.p.A. and then by Bracco Imaging S.p.A., developing different skills: Clinical Project Planning, Budget Control

Since 2000 responsible for Contract Management in Europe, including contractual negotiation for all global functions within Global Medical & Regulatory Affairs.

Since June 2002 also responsible for Global Outsourcing within Global Medical & Regulatory Affairs.

Since 2001 Silvana Giro has been invited as speaker and moderator to several conferences and seminars.

Session Details:

PANEL – Outsourcing Strategies & Relationships

2024-05-07, 4:15 PM

Session Details:

INTERACTIVE THINK TANKS

2024-05-08, 3:30 PM

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Michael Zörer
Head of Clinical Operations, VarmX

Michael is responsible for a team of 11 people and the overall delivery of the conducted studies. The group runs several studies in different indications with a clear focus on rare diseases. In 2016 AOP Orphan received approval for one new product (RAPIBLOC®). In 2019 AOP received the marketing authorization for their first biological (BESREMi®), after completing a series of clinical studies and successfully passing a series of EMA inspections under Michael’s responsibility.

Before joining AOP Orphan Michael has been operations manager for Haemophilia at Baxter. Michael has many years of experience as a project manager and learned the job in clinical research from scratch starting as CRA at Amgen. Michael received his Ph. D in biochemistry from the University of Vienna. 

Session Details:

Fireside chat – ask the experts! Trial Execution in 2024 and Beyond

2024-05-07, 11:00 AM

Session Details:

PANEL – Outsourcing Strategies & Relationships

2024-05-07, 4:15 PM

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Mireille Ermens
Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring

Mireille Ermens, is a seasoned leader in the field of clinical research and healthcare management with a rich background spanning over two decades. Armed with a degree of Socio Medical Science with distinction from the University Ghent, Belgium, Mireille brings a unique blend of expertise in biochemistry, mathematics, statistics, and preventive healthcare.

A true polyglot, Mireille is fluent in Dutch, French, and English, with proficiency in German and Spanish, reflecting a deep commitment to effective communication across diverse cultural landscapes.

With a leadership style centered around "Building Bridges with and for People," Mireille has led clinical development operations teams, navigating challenges in rare and chronic diseases, high-volume infectious diseases and seasonal vaccine environments.

Currently serving as the Senior Director of Global Feasibility and Start Up Support at CSL Limited, Mireille spearheads strategic assessments of clinical trial feasibility, facilitating optimal business decision-making through meticulous recruitment-time-cost analyses and evaluation of execution options.

Prior to this role, Mireille served as the Head of Global Site Management and Monitoring Oversight at CSL Seqirus, while advocating for global process consistency with a patient-oriented oversight agility. Mireille's extensive experience also includes senior positions at Eli Lilly and Hoffmann-La Roche.

Mireille began her career as an ICU Coordinator in Intensive Care at the University Hospital, Ghent, monitoring and caring for patients post-cardiac surgery, demonstrating a commitment to hands-on patient care.

With a career trajectory marked by innovation, strategic vision, and a relentless pursuit of excellence, Mireille is a dynamic speaker who brings a wealth of knowledge and expertise to any discussion on clinical research, healthcare management, and leadership in the pharmaceutical industry.

Session Details:

Insights on How to Reduce the Burden of Study Start Up on Study Teams

2024-05-08, 10:00 AM

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Silvia Perez Torres
Director, Clinical Quality Compliance, AstraZeneca

I have a PH degree in Pharmaceutical sciences by the Barcelona University. I started my career as a researcher in Neurochemical department within the Barcelona Biomedical Research Institute (IIBB), where I developed my PH degree focused on Alzheimer’s disease and Inflammation.

Once I completed my Ph Degree in Neuroscience, I moved to the clinical industry, working most of my career in Data Management, first in a small CRO company and later in the pharma industry.

For along almost 12 years, I was managing phase III clinical trials acting as Global Data Manager Lead, coordinating end-to-end data management activities (including SDTM development) mainly outsourced to global CROs. Apart of the oversight of clinical trials, part of my role as an expert in DM was to lead standardization on E2E data and processes.

On 2018, I completely changed my role and moved to the Quality area. Since then, I’m Director on Clinical Quality Compliance. On this role, I’m providing quality support to Biometrics functions (including DM, Programming and Statistics roles). Among other activities, I’m giving quality related advice and guidance, overseeing quality issues, CAPA implementation and risk management. Coordinating and supporting audit and inspections, as well as preparing teams to be inspection ready at all time.

Since 2020, I’m Regulatory Considerations Expert Group DMEG Chair on the Association for Clinical Data Management. The aim of the Regulatory Considerations Expert Group looks at providing guidance information on several areas surrounding regulations. The expectations and recommendations on implementation and what data management needs to be prepared for in readiness for inspection.

Session Details:

EU REGULATIONS Good Clinical Practice (GCP) Harmonization: Updates to ICH E6 (R3)

2024-05-08, 9:00 AM

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Chris Jones
CEO, DEEP Measures

Session Details:

Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

2024-05-08, 10:00 AM

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Carlos W. Bertoncini
PhD, Biopharmaceutical and Clinical Science Manager, CHEMO

Session Details:

Multi-country experience with clinical trials: A perspective from the development of complex generics.

2024-05-08, 11:30 AM

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Fabio Miceli
Director Global Quality Assurance / EU QPPV, Norgine

Fabio is a Pharmaceutical Professional with almost 25 years of experience in the industry. He graduated from the University of Amsterdam with a Master’s degree in Medical Biology. He started his career in Clinical Operations working for Pharma, Biotech and various Clinical Research Organizations. Subsequently, he moved across to the Quality Assurance arena where he has spent the last 17 years of his career in various roles of increasing importance . Currently employed at Norgine as Director Global Quality, Fabio’s responsibilities include GCP, GLP, Commercial Quality / Codes of Practice, Competent Authority Inspection Management and he acts as Clinical Development, Medical Affairs and Regulatory Affairs Quality Business Partner. Following Brexit and after a 3-year tenure as deputy, Fabio assumed the role of  EU QPPV for Norgine in 2022 – a role he executes in parallel to his Quality role.

Session Details:

FIRESIDE CHAT What does fit-for-purpose Sponsor oversight look like?

2024-05-08, 11:30 AM

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Sonja Weiser
Senior Director Clinical Operations, Insmed

A Clinical Research Professional (Pharmacist), PhD (Medical School - Pharmacology/Toxicology) and PMP (2016) with more than 20 years’ experience in Biotech / Health Care Industry / CRO / Drug Development / Clinical Research.

Expertise ranging from Clinical Research/Clinical Operations experience in Pharma, Biotech and CRO with focus on Oncology, Immunology, Infectious Disease, Respiratory indications and Rare/Orphan indications.

Focused on goal achievement, constant striving for improving processes on an international / global level, strong project management background.

Dedication to people management as the main success factor in clinical research/clinical development – foster open & trustful communication on a global level.

Strong believer in "Manage by example" as key to success in drug development

Session Details:

Fireside chat – ask the experts! Trial Execution in 2024 and Beyond

2024-05-07, 11:00 AM

Session Details:

PANEL Maximising your Sites Productivity & how to lessen the burden

2024-05-08, 2:00 PM

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Laia Casas
Clinical Project & GCP Compliance Leader, Noucor

Biomedical Scientist with an MSc in Monitoring Clinical trials and Medical Affairs. Have worked in several positions from top to bottom: From study coordinator to RD Project Manager at a Sponsor Company, including CRA. Work through various companies: Pharmaceutical laboratories, CROs and medical device start-ups. Have worldwide experience in clinical trials, and planned, designed, and led clinical projects for EMA and FDA.

 

Session Details:

INTERACTIVE THINK TANKS

2024-05-08, 3:30 PM

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Jadwiga Janicka
Director, Study Operations, AstraZeneca

Jadwiga Janicka is holding a role of Director of Study Operations at AstraZeneca, overseeing a team responsible for the execution of global clinical trials. With an extensive background spanning more than 17 years in the field of clinical trials, Jadwiga has consistently played a pivotal role in collaborative efforts with numerous CROs. Her involvement has ranged from project management to governance-level activities, contributing to the successful execution of trials. Jadwiga's expertise is particularly focused on staying abreast of current trends in outsourcing practices and evolving oversight requirements within the industry.

Session Details:

FIRESIDE CHAT What does fit-for-purpose Sponsor oversight look like?

2024-05-08, 11:30 AM

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Daniel McVeigh
Director, Clinical Project Lead, Alexion Pharma

A Clinical Research Professional with over 12 years’ experience across various settings such as Site, CRO, Small Biotech and Pharma. Expertise in various therapeutic areas from Oncology and Rare/Orphan Disease. Experience from early phase first in human to late phase and Nov Intervention RWE generation and Registries. Focused on Clinical Operations excellence and process improvements for the benefit of the patients we serve. Currently Director, CPL at Alexion, AZ Rare Disease leading a Cross Functional clinical team in the execution of multiple clinical studies and PASS studies.

Session Details:

PANEL – Outsourcing Strategies & Relationships

2024-05-07, 4:15 PM

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Richard Stephens
Veteran Patient Advocate, Trial Participant, Author, Journal Editor

Richard Stephens has been a patient advocate for 25 years, surviving two cancers and a heart emergency, plus several co-morbidities and late effects. As a patient he has participated in four interventional studies and nine others. As an Advocate he has helped design over 30 more.

Richard Chairs the UK Cancer Research Advocates Forum (formerly the NCRI Consumer Forum) and is the former Chair of BBMRI-ERIC’s Stakeholder Forum. He works with patient groups and advocates, academics and industry, and policy-makers, funders and regulators.  

Richard helped found the AllTrials campaign and useMYdata movement, and he is the founding co-Editor-in-Chief of the Journal of Research Involvement and Engagement. His professional life has included careers in education, journalism and local government.

Session Details:

PATIENT ADVOCATE KEYNOTE: Which Patients? How Centric?

2024-05-07, 11:00 AM

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Amelia Hursey
Parkinson's Research Manager, Parkinson's Europe

Amelia joined the Parkinson’s Europe  team in Jan 2022 as Research Manager. Since then she has developed Parkinson’s Europe’s Research Strategy, embedding a Research Steering Group into the organisation and helping to increase the presence of Parkinson’s Europe in the clinical research world. She is also focused on bringing new initiatives to the table, such as the Parkinson’s Europe’s Engagement Network, which better connects the Parkinson’s

community with research across Europe. Parkinson’s Europe is now a partner member of EUPATI and the Critical Path for Parkinson’s as part of this action.

She has been working in the field of Neurodegenerative research since 2009 and is a Patient Organisations board member with EUPATI since Sept 2023.

She previously worked for the UK NIHR’s DeNDRoN delivering clinical trials and then at Parkinson’s UK from July 2015 as Research Participation Lead.  She was responsible for initiatives to increase research participation for people affected by Parkinson’s, health care professionals and researchers, and created the innovative Parkinson’s UK Take Part Hub and co-produced the Staying Connected toolkit in collaboration with the HRA UK.

Session Details:

Building clinical trials with the perspective of the patients in mind

2024-05-07, 12:00 PM

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Jose Manuel Ordoñez
MD, CCO Therapeutic Area Leader Onco-Haematology, Roche

I studied Medicine in Universidad de Navarra (Spain) and did my especialization in oncologist in the same site between 1997 and 2001. I have work as medical oncologist during several years in Pamplona and Madrid, and I joined Roche in 2007 as Country Study Manager. My current position is Therapeutic Area Leader in Clinical Operations for Onco-Hematology studies from 2015. I have a master in coaching and talent development and another in pharmaeconomics and health economy.

Session Details:

Generative AI in healthcare to speed up drug discovery

2024-05-08, 9:00 AM

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Maria Reyes Boceta-Munoz
Head Of Clinical Operations Spain, GSK

Session Details:

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

2024-05-07, 4:15 PM

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Francis P. Crawley
Executive Director, Good Clinical Practice Alliance - Europe (GCPA)

I am a philosopher in Leuven specializing in research ethics, data/AI ethics, and clinical trials. My career began with pioneering Good Clinical Practice (GCP) implementation in Europe. I collaborated closely with researchers, regulators, and patients to tackle fundamental ethics questions while overseeing research projects.

I was invited to chair the committee that authored the first Europe-wide ethics review guidelines. The WHO then asked me to produce the inaugural global ethics guidelines for health research. I spearheaded the SIDCER program with WHO that for the implementation of best practices in ethics review globally.

Over 20+ years, I have actively served on ethics committees for HIV, cancer, global health, and pediatric research. Through European Commission projects worldwide, I significantly contributed to clinical trial registries, biobanks, patient databases, and best practices for specific populations while addressing evolving ethical issues around consent, inclusiveness and transparency.

I have extensively collaborated with international organizations (WHO, UNAIDS, UNESCO, CIOMS, European Commission, EDCTP, NIH) to advance research ethics and oversight. With the European Academy of Paediatrics, I spent two decades developing pediatric clinical and research ethics policies.

Recently, I have been at the forefront of data, AI, and open science ethics, policy, and governance. As an EOSC-Future/RDA working group co-chair, I am producing deliverables on AI regulation, consent guidelines, and bills of rights. During COVID-19, I engaged crucial research on genetics, AI, and disease severity, as well as in ethics and policy for clinical trials (vaccines and therapeutics) to address the pandemic.

Recently, I helped to establish a CODATA/UNESCO group on data policies for open science in crisis situations aimed at enriching UNESCO’s toolkit. My career has demonstrated an unwavering commitment to research ethics and integrity through impactful leadership, expertise, and global collaborations.

Session Details:

Chairperson’s opening remarks

2024-05-07, 8:20 AM

Session Details:

Governance of Clinical Research within the European Health Data Space

2024-05-07, 9:30 AM

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Robert Kurowicki
Robert Kurowicki, Director of Feasibility and Project Strategy, Novotech Europe

Robert Kurowicki has over 12 years of experience in clinical research working for the Clinical Research Organization. Before that he spent over 18 years in the pharmaceutical and biotech industry managing sales and marketing activities in several companies including Behring, Sanofi and Celgene, focusing on the oncology, haematology and rare disease therapeutic areas.

At his current position, he is responsible for the feasibility research. Collaborating with investigators and various team members such as Medical Experts, Regulatory and Project Managers, as well as analysing multiple data sources, Robert is responsible for strategizing the most efficient scenarios to conduct various clinical studies.

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Laura Jiménez Robledo
Clinical Project and Innovation Manager, Novo Nordisk

Laura is a Clinical Research Professional. She started in Novo Nordisk in 2013 as CRA and since 2020 she's exploring and defining Clinical Innovation as Clinical Innovation Manager.

In her current position, she's leading the Innovation Strategy in her department - Clinical Operations in France, Portugal and Spain and additionally, driving the change and bringing innovation in Region Europe.

Her superpowers: communication, innovation and collaboration.

Session Details:

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

2024-05-07, 4:15 PM

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Upinder Grewal
Strategic Lead Exploration and Discovery, DS&AI, Bayer

I’ve been working in the Healthcare industry for 23 years working for various companies from Start up, mid size and large Pharma.

During the 23 years I have worked across many areas from Supply Chain, Process Improvement/Six Sigma, IT, Vendor Management and last 3 years working in Global Clin Op’s. I am now part of Clinical Trial Technology Strategy as well as part of the DCT initiative Leadership team focusing on external innovation, collaboration and identifying new solutions for trials.

Session Details:

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

2024-05-07, 4:15 PM

Session Details:

Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

2024-05-08, 10:00 AM

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Anthony Mikulaschek
VP, Commercial Strategy, IQVIA Technologies

As Vice President of Commercial Strategy at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.

Session Details:

How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors

2024-05-07, 11:30 AM

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Stefan Dürr
Senior Director, Client Delivery, Cenduit IRT, an IQVIA business, Head of Drug Supply Center of Excellence

Senior Director, Client Delivery at Cenduit IRT, an IQVIA business, Head of Drug Supply Center of Excellence

Stefan has worked in IRT for 15 years and has been with Cenduit IRT, an IQVIA business, since its inception in 2007. He has worked in various project management roles including leading the global project management team at Cenduit. Stefan currently is responsible for client delivery of key customer accounts and heads the Cenduit drug supply center of excellence. He is very passionate about finding innovative solutions for clinical supply challenges.

Stefan holds a master of science in molecular biology and an international executive MBA of the University of St. Gallen.

Session Details:

How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors

2024-05-07, 11:30 AM

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Alina Pszczółkowska
Head of Late Phase Program Management Respiratory & Immunology, AstraZeneca

Alina Pszczółkowska is a medical graduate with a distinguished diploma in management from Polish Open University and Oxford Brookes University. Since 1997, she's been involved with clinical research – working in Poland and in various global roles

After spending some time as acting physician she joined pharma industry  and AstraZeneca in 1999, where she has held various leadership roles in clinical operations across site, study and programm management  leading projects and organisations across the globe. 

She also worked in  Gothenburg, Sweden, overseeing delivery of  cardiovascular, kidney, and gastrointestinal portfolio.

As of 2023, Alina is the Head of Late Phase Program Management organization in Respiratory and Immunology.

Alina is also the Site Leader of for AstraZeneca Cross functional site in Poland, and Vice-President at AstraZeneca Pharma Poland.

Session Details:

Leveraging operational expertise to enhance study design and patient centricity in clinical trials

2024-05-07, 2:00 PM

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Siobhan McKenna-Power
Client Services Lead, 4G Clinical

Siobhan McKenna-Power has over 20 years of experience designing and delivering regulated systems, with over 8 years designing and delivering RTSM systems for clinical trials.   She first developed an interest in clinical trials when her father took part in multiple Phase III drug and device trials due to his progressive Chronic Obstructive Pulmonary Disease and was eager to contribute in her own way when the opportunity presented herself.

Siobhan is a strong believer in first time quality and works with our sponsors to understand complex protocols.  Siobhan has a keen understanding of what the needs of the end user are and works to ensure that even the most complex trials are easy for Investigators to work with, and that patient safety is the foremost priority of any RTSM system.

Siobhan is a graduate of Maynooth University (formerly National University of Ireland, Maynooth) with a BSc in Computer Science and Software Engineering. She is currently working on a Level 7 Diploma in Risk Management.

Session Details:

Charting a Course through Complexity: Leveraging Experience in Approaching Complex Clinical Trial Protocols

2024-05-08, 9:30 AM

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Daniela Duffett
Senior Solutions Consultant, Suvoda

As Director of Services Delivery, Ben oversees services delivery out of Suvoda’s Bucharest office. Ben has over 11 years of experience in the software industry, holding a variety of positions in professional services, global operations, and business development. He has consulted with Fortune 2000 clients across a variety of industries on how to best leverage technology to solve mission-critical business challenges.

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Dr. Claudia Hesselmann
Founder and CEO, ARENSIA Exploratory Medicine

Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

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Todd Rudo, MD
EVP & Chief Medical Officer, Clario

As Clario’s Chief Medical Officer, Dr. Todd Rudo provides medical and scientific leadership across the organization. Passionate about leveraging our scientific expertise to support our customers’ success, Dr. Rudo has focused efforts on optimizing our solutions across the therapeutic areas. His team supports Clario’s clients by providing expert consulting services on scientific and regulatory strategy, and ensures our product portfolio is scientifically robust, generating high quality data to support clinical trial endpoints. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden. With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has focused his career predominantly on drug safety. He has worked within therapeutic areas including oncology, immuno-inflammatory diseases, urology, and cardiometabolic diseases, and has achieved board certifications in internal medicine, cardiology, cardiac electrophysiology, nuclear cardiology, and adult echocardiography.

Session Details:

A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

2024-05-07, 12:30 PM

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BRYAN MCDOWELL
VP, ECOA Science & Consulting, Clario

In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma wide industry necessity for smarter drug & device development and life cycle management.

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Katie Paul
Product Manager - Research and Life Science, EMIS

Kaite Paul is the Product Manager for Research and Life Sciences at EMIS Health, where she works to explore how data and technology can be harnessed to increase the participation of primary care in research and deliver fast, diverse and effective recruitment to trials. Prior to EMIS, Katie was Chief of Staff at a medical technology start-up and a consultant in Accenture UK’s Health team, advising on NHS digital, data and cybersecurity strategy.

Session Details:

Accelerating trial recruitment through EHR referrals and GP engagement

2024-05-08, 12:00 PM

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Barbara Argibay
Vice President, General Manager – Data Division, Anju Software

Barbara Argibay brings over 15 years of experience in Data and Research to her position as Vice President, General Manager – Data Division at Anju Software. She leads the Anju Data Division, overseeing TA Scan and data sciences product development, engineering, operations, and business development. Barbara’s education and experience makes her an irreplaceable member of the Anju Software team, empowering life sciences companies through the power of data and innovation.

Throughout her career, she has been involved in diverse roles where data-driven strategies paired with actionable insights had a remarkable impact on research and clinical operations. With high commitment to excellence, at the core of Barbara’s experience lies the ability to understand market challenges and push the status quo to drive positive change within the life sciences industry. As people leader, Barbara has nurtured a culture of trust, collaboration, and innovation, fostering a high-performing and engaged team.

Barbara holds a PhD in Medicine, with honors cum laude and special mention to Extraordinary PhD award, MS and BSc in Physics by the University of Santiago de Compostela.

Session Details:

The Cinderella of Clinical Trial Planning: Identifying Your Targeted Subpopulation

2024-05-08, 9:30 AM

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Ana Moreno
Director Global Clinical Operations, APICES
Ana Moreno has a degree in Biology and 21 years of experience in Clinical Research across CRO sector, Big Pharma and Academic Groups. Throughout her career she has supported medical and scientific teams, clinical development programs and operations worldwide for the success of oncology treatments. Ana’s career include ClinOps manager career at Pharma (Gilead Sciences) and CROs (Biometrica and APICES) leading scientific programs and supporting the development of clinical trials in breast, colorectal, lung, liver, pancreas and ovarian cancer among others.

Session Details:

Advantages and Challenges of New Technology in Clinical Research

2024-05-07, 5:00 PM

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Myriam Golembo
Vice President Regulatory Affairs, BiomX

Myriam Golembo is VP Regulatory Affairs at BiomX, a microbiome drug discovery company developing customized phage therapies that seek and destroy harmful bacteria in chronic diseases. Myriam holds a PhD in Molecular and Developmental Genetics from the Weizmann Institute and has over 20 years’ experience in the biotech industry. Prior to BiomX, she was VP Regulatory and Clinical Operations at a company developing immunotherapy for cancer and viral disease, and VP Product Development at a company developing new formulated antibiotics for ear, nose and throat. Previous to these, she served as Director of Products Development at Protalix, a company developing and marketing FDA approved recombinant therapeutic proteins with clinically improved profiles produced in a plant cell-based protein expression platform, where she focused in regulatory and clinical development of products targeting orphan indications, for USA and EU.

Session Details:

Overcoming the challenges of enrollment in the changing landscape of a rare disease

2024-05-08, 1:30 PM

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Maris Veldre
Associate Vice President, Project Delivery – EU, Rho

Maris Veldre earned his BSC and PT degrees from the Medical Academy of Latvia and later studied for an international MPH at University of Kuopio, Finland. He has over 24 years of experience in the industry, both at CRO and Pharma companies holding regional and global management positions in clinical operations and strategic sourcing. Prior to his tenure at Rho, Maris managed clinical operations at Dokumeds, a mid-sized European CRO, operating in over 30 countries. Under his leadership, the company expanded into new geographic regions both within and outside Europe, thus significantly increasing capabilities and the company’s strategic footprint. Currently, Maris serves as a strategic partner to Rho operations, overseeing project delivery in Europe and helping Rho deliver high-quality global programs.

Session Details:

Overcoming the challenges of enrollment in the changing landscape of a rare disease

2024-05-08, 1:30 PM

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Sonia Lwoff
Director Clinical Operations – EU, Rho

Sonia Lwoff has a BsC degree in Chemistry from the Autonoma University in Madrid and a master’s degree in clinical trials by Pharmaceutical Association in Madrid. She has over 19 years of experience in research. Sonia has developed her career in Clinical Operations, from the CRA level through various management positions to leading global Clinical Operations teams in several regions. Sonia’s therapeutic area expertise includes Oncology, Neurology and Psychiatry, Rare Diseases, Gastroenterology, and Immunology (PID) among others. She is currently the Director of Clinical Operations in EU, working on timely and high-quality delivery in projects, process improvement, and expanding Rho’s footprint in EU.

Session Details:

Overcoming the challenges of enrollment in the changing landscape of a rare disease

2024-05-08, 1:30 PM

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Gabriel Maeztu
Co-founder of IOMED

Gabriel is a Medical Doctor, from the International University of Catalonia, and holds a degree in Mathematics from the UNED. At IOMED, he provides leadership and strategic guidance to the organization.

Session Details:

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

2024-05-07, 4:15 PM

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Enrico Perfler
Founder, 1Med

With a Master of Science in Biomedical Engineering, Enrico Perfler boasts 20 years of professional experience specializing in medical device technology. His profound knowledge and innovative approach have significantly shaped the landscape of this field.

In 2014, Enrico founded 1MED SA, an innovative international company that provides regulatory support, digital solutions, and comprehensive CRO services to the medical device and pharmaceutical industry, with a particular emphasis on IVD and medical products. Under his leadership, 1MED SA has successfully overseen the development and regulatory approval of over 500 medical devices in Europe, solidifying his status as a prominent figure in the MedTech sector.

Beyond his remarkable entrepreneurial achievements, Enrico serves as a contract professor of "Regulatory Affairs" at the Faculty of Engineering, University of Pavia. His expertise is further highlighted by his participation in the ISO/TC 194 technical committee for the biological evaluation of medical devices, and in national esteemed standardization groups, including UNI and ABHI. This involvement not only showcases his commitment to advancing industry standards but also underlines his influential role in shaping the future of medical device regulation and safety.

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The Future of Regulatory Compliance: Digital Tools for Mastering EU MDR and Post-Market Challenges

2024-05-07, 5:00 PM

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Pall Johannesson
Managing Director, Greenlight Guru

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The Future of Regulatory Compliance: Digital Tools for Mastering EU MDR and Post-Market Challenges

2024-05-07, 5:00 PM

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Andrea Ochoa, M.S.,
Senior Vice President, Global Clinical Operations, Premier Research

Andrea Ochoa is Senior Vice President, Global Clinical Operations, at Premier Research. Ms. Ochoa has more than 20 years of clinical operations experience in a variety of positions. In her current role, she oversees operational delivery across Europe and Asia-Pacific. She provides expert advice and strategies to operationalize and navigate the complex regulatory and start-up environment.

Prior to joining Premier Research, Ms. Ochoa held several positions of increasing responsibility at MDS Pharma Services and INC Research. She has a master’s degree in Cognitive-Behavioral Therapy from the Luria Institute in Madrid, Spain, and bachelor’s degrees in psychology (UNED, Madrid) and law (Complutense University of Madrid). Ms. Ochoa is certified as Lean Sigma Green Belt since 2009.

Session Details:

Starting Off on the Right Foot: Top Considerations for Selecting the Right Clinical Trial Sites

2024-05-08, 12:00 PM

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Lakshmi Gurduri
Director Project Management, TFS Health Science

Lakshmi is a seasoned professional with an impressive 16-year tenure in the pharmaceutical, biotech, and CRO industries. With over a decade of global project management experience, she excels in leading cross-functional teams and managing the intricate balance between operational demands and financial constraints to successfully execute programs from inception to completion. Her extensive knowledge spans all trial phases across various global markets, including APAC, Europe and North America. Lakshmi's experience spans several therapeutic areas, including gene therapy, rare diseases, respiratory, chronic inflammation, immunology, oncology, dermatology, CVM, and endocrinology.

Session Details:

Pioneering Gene Therapy in Rare Diseases: A Path to Revolutionary Treatments

2024-05-07, 12:30 PM

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Sas Maheswaran
Vice President, Product Implementation, Saama Technologies

Sas Maheswaran is a clinical operations leader with more than 17 years of experience. He incorporates unique perspectives gained from his time working at sponsors, sites, and software vendors to formulate practical approaches to digital transformation, including in the adoption of AI driven solutions in Clinical Development. In his current role as Vice President of Product Implementation at Saama Technologies, Sas is responsible for ensuring that sponsors and CRO partners are optimally utilizing Saama’s industry leading AI capabilities.

 

Session Details:

AI: A Game Changer for Clinical Operations

2024-05-07, 2:30 PM

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Jonathan Harris, PhD
EVP Program Management, ICON

Session Details:

FIRESIDE CHAT What does fit-for-purpose Sponsor oversight look like?

2024-05-08, 11:30 AM

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Matt Cooper
Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials

Matt Cooper is the Executive Director, Therapeutic Strategy Lead, Oncology and has 25 years of experience in the life science industry conducting clinical trials across all phases. His experience spans roles at sponsors, sites, and the NHS, and he has extensive experience in site management and expanded use of oncology therapies. He is passionate about building effective relationships between industry stakeholders to drive innovation and patient access.

Session Details:

Navigating the Complex Regulatory Landscape for Oncology Trials: A Focus on the European Union

2024-05-07, 11:30 AM

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Polly Cooper
Senior Director, Project Delivery, Biotech - ICON

Polly brings her perspective on clinical trials from 34 years of experience in drug development with roles in Research, Early Compound Evaluation, Formulation Development, Resource Management and Clinical phase I – IV. Polly holds an MBA (specializing in Marketing, Finance and Strategy), a Masters Certificate in Project Management from George Washington University and a BSc (hons) in Pharmacology. Energized by the CRO world of constant learning, she is currently part of ICON Biotech since May 2021, where she is supporting sponsor’s outsourcing decisions, listening and interpreting sponsor requirements into successful and enjoyable study delivery.

Session Details:

Maximizing the Consultative Partnership Between CRO and Biotech Sponsors

2024-05-07, 12:30 PM

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Maria-Cruz Morillo
Global Therapeutic Operations Lead, Rare Diseases, Allucent

Maria-Cruz Morillo, M.S. Pharmacy, has acquired a deep knowledge of drug development during her 28 years of experience in Project Management and Strategy and IMP Supply in both biotech and CROs. Her design and implementation of effective study protocols has contributed significantly to the successful market authorizations for numerous rare endocrinology and hematology autoimmune programs. Maria-Cruz is currently working as the head of Allucent’s team of Rare Disease experts, integrating cross functional expertise to provide strategic solutions that foster successful outcomes in rare disease clinical trials and ensure excellence in delivery.

Session Details:

Practical Solutions for Patient Engagement in CGT Trials: Supporting Patients and Families Throughout the Journey

2024-05-07, 11:30 AM

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Diana Filipescu
Business Development Manager, Novotech

Diana Filipescu is from Bucharest, România. Diana has a regulatory background, with 11 years of experience in clinical trials. She worked in Regulatory for almost 8 years and then transitioned from Regulatory Line Manager to Business Development Manager. She has earned two BSc., one in Management and the other one in Law. In addition, she also has a MSc. in Health Management. She is very passionate about finding new ways to improve the healthcare industry by ensuring compliance with all applicable laws and regulations. Her goal is to make sure that all medical products are safe for consumers.

Session Details:

Ready for January 2025? Roadmap to CTIS compliance

2024-05-08, 10:30 AM

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Alicia Borràs
Study Coordinator, Digital Health Unit, Strategy Office Més Sant Pau, Hospital de Santa Creu i Sant Pau

Session Details:

Great expectations and how to meet them – connected devices and ePRO in clinical trials

2024-05-07, 2:00 PM

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Sarah Bly
Director Regulatory Science, Strategy & Innovation, Worldwide Clinical Trials

Sarah Bly is Director of Regulatory Science, Strategy and Innovation at Worldwide Clinical Trials. Based in the UK with over 19 years’ experience in the pharmaceutical industry.  Sarah is a lead in providing high level strategic regulatory strategies, risk assessments and solutions including driving health equity strategies.  Sarah is also an active volunteer and stakeholder for initiatives such as EU-X-CT which aims to improve cross-border access to clinical trials for patients in the EU.

Session Details:

Navigating the Complex Regulatory Landscape for Oncology Trials: A Focus on the European Union

2024-05-07, 11:30 AM

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Martin Czakon, MSc
EMEA Head of Commercial Strategy & Growth, Care Access

Martin Czakon, MSc, brings extensive clinical research and business development expertise to his role as EMEA Head of Commercial Strategy & Growth at Care Access. With over 12 years in executive roles within global CRO providers and patient enrollment organizations, Martin excels in strategical planning, leadership, and patient recruitment, maximizing study efficiency.

As Therapeutic Area Head at Julius Clinical and former Senior Business Development Director at Bioclinica, Martin leveraged executive experience to position companies as industry leaders. With a background as a former board-certified physiotherapist, he offers a unique perspective on clinical research challenges. Martin excels in developing relationships and navigating complexities in CRO service offerings, driving successful outcomes.

Session Details:

Going Beyond ROI: Necessary Criteria for Impactful Innovation with Decentralized Clinical Trials

2024-05-07, 10:00 AM

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Saskia van Dalen
Global head R&D procurement, Sandoz

Session Details:

FIRESIDE CHAT: Patients at the Heart

2024-05-07, 3:00 PM

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Linda O’Grady
Director Clinical Procurement, Novartis

Session Details:

FIRESIDE CHAT: Patients at the Heart

2024-05-07, 3:00 PM

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John Batchelor
Science Liaison, DEEP Measures (Digital Evidence Ecosystems and Protocols)

John combines more than 20 years experience in clinical data management, PCOR science and clinical trial operations with expertise leading the development of data pipelines, knowledge management products and new processes to advance the use of eCOA & digital measures in clinical trials.

John is an expert in the execution and scaling of patient and site facing clinical trial technologies who gained a BSc in Biology from the University of Bristol in the UK. Before joining DEEP John worked for Roche for over 9 years where he led external industry collaborations and played a leadership role in the co-creation of a new operational framework and ecosystem of data/ technology products to support the digital health technology lifecycle.

John now works for DEEP as a Science Liaison where he partners closely with DEEP’s existing customers, helping them to maximize value gain through collaboration.

Session Details:

Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

2024-05-08, 10:00 AM

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