12th Annual Clinical Trials in Oncology Europe 2025

26 - 27

November

2025
  • Munich, Germany
  • Free
  • Why attend?
  • 2024 Agenda
  • 2024 Speakers
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Why attend?

WHAT TO EXPECT FOR 2025?

At the Clinical Operations in Oncology Trials Europe event, taking place on 25th-26th November in Munich, we are pleased to bring together the definitive group of executives responsible for clinical operations in oncology and enhancing the partnership with vendors. There will be expert guidance through a first class conference programme and numerous networking opportunities.

150+

ATTENDEES TO MEET EACH YEAR

20+

EXHIBITORS TO MEET EACH YEAR

20+

SPEAKERS

150+

ATTENDEES TO MEET EACH YEAR

20+

EXHIBITORS TO MEET EACH YEAR

20+

SPEAKERS

See What It's All About

2024 Agenda

  • 3 Dec 2024
  • 4 Dec 2024
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8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

9 AM

Establishing an AI strategy for oncology clinical trials: what to consider

  • Reiterating basics of AI and its uses in pharma
  • Identification and prioritization of suitable AI and tools
  • Building a holistic AI strategy: incorporating tools, ethics and data privacy
  • Creating the roadmap: challenges and lessons learnt to overcome them

Speakers

Frank Richard
Vice President Medical, Heidelberg Pharma

9:30 AM

Clinical research needs a moonshot: What patients can teach us about innovation

In this captivating presentation, Alicia will share her experience as a three-time cancer survivor and what she’s learned about the state of clinical research from the patient perspective. Since her initial diagnosis to today, she’ll share how her journey changed the course of her career. Her focus on improving the patient experience and highlighting critical needs throughout the clinical trial ecosystem can help data management professionals find new ways to unlock value for all stakeholders.

Alicia will share how her health information and clinical trial data are still siloed and why this erodes the patient experience for all.

Without collaboration, true innovation is not possible. Alicia will inspire the audience to look for new ways to collaborate to bring efficiency and empathy to the solutions that support the industry.  That’s the essence of a moonshot - an industry wide collaboration that’s an ambitious venture to deliver profound results.

  • Understand how the patient perspective can help highlight ways to improve processes and solutions to deliver a best-in-class patient experience
  • Recognize the need for building a true collaborative framework to address key patient needs and how data management and solutions provide a crucial role in this work
  • Envision the future of data management as an industry leading innovation hub and a core function of patient centricity

Speakers

Alicia Staley
VP Patient Engagement, Medidata Dassault Systemes

10 AM

From the 1930s to today: the evolution of clinical trial regulations

This session explores the pivotal milestones in clinical trial regulation from the 1930s onward, highlighting key changes that shaped today’s standards in patient safety, ethical considerations, and scientific rigor. Participants will gain insights into how regulations evolved in response to historical events and scientific advancements, providing a comprehensive understanding of the frameworks that ensure ethical practices and patient protection in clinical trials today.

  • The early days: Establishing regulatory foundations following critical incidents in the 1930s and 1940s
  • Nuremberg Code (1947) and Declaration of Helsinki (1964): Milestones in ethical standards
  • FDA regulations and the Belmont Report (1979): Shaping patient protection in clinical trials
  • ICH-GCP guidelines (1996): Introducing a unified standard for international trials

Speakers

Cornelia Baumgartner
Head of Clinical Operations, T-CURX

10:30 AM

Morning refreshments and networking

11 AM

Partnering with academia for paediatric oncology clinical development

  • Paediatric oncology trials pose unique challenges
  • International clinical trial networks have traditionally driven the clinical development of new agents for pediatric patients
  • Partnership opportunities for study protocol preparation and patient selection: the case for basket trials
  • Regulatory implications and the case for "fit-for-filing" studies
  • Examples of collaborative approaches

Speakers

Cesare Spadoni
Founder & Chief Operating Officer, Oncoheroes Biosciences

11:30 AM

Why so slow? Insider insights from the clinic floor to speed up the conduct of proof-of-concept patient trials

  • Feasibility figures true to delivery
  • Regulatory dynamics for strategic advantages
  • Collaborate with patients and physicians to enhance access to innovative therapies
  • New study designs that accelerate development programs

Speakers

Dr. Claudia Hesselmann
Founder & CEO, ARENSIA Exploratory Medicine

12 PM

Fireside Chat: Navigating complexities of managing radioligand therapy oncology trials

  • Site selection considerations specific to Radiopharmaceutical Therapy (RPT) clinical trials
  • A sponsor’s perspective of the technical knowledge and expertise required to deliver RPT studies
  • Country specific RPT clinical trial requirements and regulations
  • Challenges with just-in-time supply for RPT investigational products

Speakers

Liz Emmerson
Director Clinical Operations, Blue Earth Therapeutics

12:30 PM

Lunch and networking

1:30 PM

Panel Discussion: Integrating imaging into oncology clinical trials

  • Selecting an imaging vendor
  • Decentralized clinical imaging
  • Multi specialist access to imaging
  • Electronic data transfer
  • Importance of patient data return

Speakers

Sarah Westall
Solutions Specialist, Medidata
Alicia Staley
VP Patient Engagement, Medidata Dassault Systemes
Justus Harris
Patient Advocate
Helen Johansen Blanco
Chief Operating Officer, Node Pharma A/S

2 PM

Technology Spotlight: Unleashing the power of data and AI to transform clinical trials

Hear from a representative at Science4Tech on how they are advancing access to numerous technological innovations, elevating the quality, rigor, and reliability of clinical research rooted in the scientific method.

 Science4Tech Representative

2:15 PM

Tailored trial designs for precise outcomes

In this presentation Matt will discuss strategies to optimize the design and delivery of early phase oncology trials, including:

  • Dose optimisation and dose selection in early phase oncology trials
  • Adaptive designs
  • Accelerated titration for early cohorts
  • Backfill strategies
  • Biomarker analysis integration

Speakers

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

2:45 PM

Fireside Chat: Considering requirements and challenges of cell therapy oncology trials as a small biotech

  • Creating strategies and operational processes
  • Addressing challenges and complexities of cell therapy oncology trials
  • Selecting fit for purpose service providers to assist

Speakers

Sarah Bischof
Head of Clinical Development, invIOs

3:15 PM

Afternoon refreshments and networking

3:45 PM

Sharing digital patient centric initiatives to enhance patient engagement in clinical trials

  • Considering touchpoints of how and when we can digitally reach patients
  • Collating digital patient input to incorporate their voice
  • Highlighting challenges and benefits of digital patient engagement

Speakers

Dr. Nicolas Schneider
Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

4:15 PM

FDA’s Project Optimus and Its Impact on Drug Development

Project Optimus, an initiative led by the FDA’s Oncology Center of Excellence, is reshaping the landscape of oncology drug development by fundamentally altering the approach to dose optimization and dose selection. Traditionally, oncology drug trials focused on identifying the maximum tolerated dose (MTD) to ensure efficacy, often at the cost of increased toxicity. However, Project Optimus challenges this paradigm, advocating for a more nuanced approach where multiple doses are rigorously tested to find the optimal balance between efficacy, safety, and patient tolerability.

The initiative’s impact extends across various stages of drug development, from preclinical studies to pivotal Phase III trials. By emphasizing early collaboration between drug developers and the FDA, Project Optimus aims to ensure that the chosen doses not only maximize therapeutic benefit but also minimize adverse effects, thereby enhancing the overall success rate of oncology therapies.

However, this shift is not without its challenges. The need for larger, more complex trials and the incorporation of innovative trial designs, such as seamless Phase I/II studies and randomized dose-ranging trials, can increase the time and cost associated with drug development. Smaller biotech companies, in particular, may face difficulties adapting to these new requirements. Yet, the long-term benefits—more effective treatments with fewer side effects—promise to transform patient outcomes and set a new standard in oncology drug development.

Introduction

  • Overview of Project Optimus and its origins within the FDA’s Oncology Center of Excellence.
  • The traditional approach to dose selection in oncology (MTD-focused) and its limitations.

Key Objectives of Project Optimus

  • Reforming dose optimization to focus on efficacy, safety, and tolerability.
  • Encouraging early and ongoing collaboration between drug developers and the FDA.
  • Integrating patient-reported outcomes (PROs) into dose-finding studies to better assess tolerability.

Impact on Early-Phase Drug Development

  • Changes in Phase I and Phase II trial designs, including the move away from 3+3 dose-escalation models.
  • The role of pharmacokinetic (PK) and pharmacodynamic (PD) data in dose selection.
  • Case studies highlighting the successful implementation of Project Optimus guidelines (e.g., Amgen’s Lumakras, GSK’s Blenrep).

Challenges and Opportunities

  • Increased trial complexity, costs, and the need for larger patient populations.
  • Implications for smaller biotech companies and strategies to navigate these challenges.
  • Potential long-term benefits, including improved patient outcomes and reduced trial failure rates.

The Future of Oncology Drug Development

  • How Project Optimus may influence global regulatory practices.
  • The evolving role of dose optimization in other therapeutic areas beyond oncology.
  • Predictions for the next decade of drug development under the Project Optimus framework.

Conclusion

  • Recap of the transformative impact of Project Optimus on oncology drug development.
  • Final thoughts on how the industry can adapt to these changes to bring safer, more effective therapies to patients.

Speakers

Rob Berg
VP Medical Management, Syneos Health

4:45 PM

Sharing a patient perspective of clinical trials and the journey to recovery

Carol was diagnosed with Hodgkins Lymphoma in 2004 and her life and music career was all put on hold. She was repeatedly told that she would not survive, but now, in remission with a different blood type and new DNA, she is one of the most in-demand session musicians in the UK.

Carol will discuss her decade-long fight with cancer, her experiences with failed treatments, transplants and clinical trials and how she has faced fear head on and beaten the odds.

Speakers

Carol Jarvis
Patient Advocate

5:30 PM

Chairperson’s closing remarks

END OF DAY 1 AND NETWORKING DRINKS

8:30 AM

Registration and Refreshments

8:50 AM

Chairperson’s opening remarks

9 AM

Speaker Hosted Roundtables

Speaker Hosted Roundtables
Interactive roundtable 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, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.

RT 1: Discussing AI strategies, benefits and challenges: experiences and future planning
Frank Richard, Vice President Medical, Heidelberg Pharma

RT 2: Collaborating between sponsor, CROs and sites effectively to increase efficiency
Marta Perez-Noguera, Director Clinical Operations EU, Luzsana

RT 3:Considering project plans in clinical trials: why are they so important?
Cornelia Baumgartner, Head of Clinical Operations,  T-CURX

 

Speakers

Frank Richard
Vice President Medical, Heidelberg Pharma
Marta Perez-Noguera
Director Clinical Operations EU, Luzsana
Cornelia Baumgartner
Head of Clinical Operations, T-CURX

10 AM

Morning refreshments and networking

10:30 AM

Panel Discussion: Negotiating vendor agreements: getting the right balance for both sponsor and service provider

  • Finding the right balance between the needs of sponsor company and vendor to ensure right fit
  • Negotiating contracts: getting the right deal
  • Dealing with change orders and managing the budget
  • Forging partnerships and relationships to enhance contract negotiations and communication

Speakers

Cesare Spadoni
Founder & Chief Operating Officer, Oncoheroes Biosciences
Dr. Claudia Hesselmann
Founder & CEO, ARENSIA Exploratory Medicine
Dr. Nicolas Schneider
Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

11:15 AM

Respecting patient and site voices: Practical steps to streamline clinical technologies

  • Examine the oncology clinical trial journey from patient and site perspectives, identifying current stressors and opportunities to solve challenges
  • Dive in on specific practices and technologies that can remove friction from the trial experience for patients and reduce workloads for sites
  • Identify future innovation spaces to streamline the trial experience and how that can lead to better care for patients and better trial outcomes for sponsors

Speakers

Daniela Duffett
Senior Solutions Consultant, Suvoda

11:45 AM

Evaluating projects starting from ideation by utilizing knowledge resources

  • Evaluating, predicting and understanding of the Innovator:
    • Product value, medical potential, product profile
    • Ongoing studies, IP intelligence
  • Defining the details of the generic development:
    • Competition level
    • Markets, generic pricing

Speakers

Bahadir Cakmak
Director Early Portfolio & Pipeline, Sandoz

12:15 PM

Voice of sites: Solving the last mile

  • Review current challenges that have a direct impact on site engagement and performance
  • Exploration of practical solutions that will enable and elevate the voice of sites into clinical trial designs
  • Case studies and examples of how a collaborative approach with sites delivers insightful study design, greater confidence of patient recruitment and strong patient retention

Speakers

Constance Jung-Stach
Head of EMEA Partnership Growth, Fortrea
Amanda Nogueira
Senior Medical Director Oncology, Fortrea

12:45 PM

Lunch, networking and Apple prize draw

2:15 PM

What is needed to build a major biotechnology/pharmaceutical company: an evaluation of the level of ambition and the possible underlying causes

  • Investing in the right people – early gap analysis
  • Financial strategy leading to success
  • Competitive Intelligence – market analysis & selection of indication
  • Common factors of management that succeed

Speakers

Helen Johansen Blanco
Chief Operating Officer, Node Pharma A/S

2:45 PM

Optimizing oncology trial efficiency through adaptive design and real-time data

  • Geographic feasibility for country selection
  • Benchmarking timelines, trial costs and recruitment rates
  • DCT complications
  • Site selection process including e-feasibility questionnaires

Speakers

Ophelia Chan
Senior Analyst, GlobalData

3:15 PM

Chairperson’s closing remarks and close of conference

2024 Speakers

Select a speaker to learn more

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Liz Emmerson
Director Clinical Operations, Blue Earth Therapeutics

Session Details:

Fireside Chat: Navigating complexities of managing radioligand therapy oncology trials

2024-12-03, 12:00 PM

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Frank Richard
Vice President Medical, Heidelberg Pharma

Session Details:

Establishing an AI strategy for oncology clinical trials: what to consider

2024-12-03, 9:00 AM

Session Details:

Speaker Hosted Roundtables

2024-12-04, 9:00 AM

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Sarah Bischof
Head of Clinical Development, invIOs

Session Details:

Fireside Chat: Considering requirements and challenges of cell therapy oncology trials as a small biotech

2024-12-03, 2:45 PM

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Sarah Westall
Solutions Specialist, Medidata

Session Details:

Panel Discussion: Integrating imaging into oncology clinical trials

2024-12-03, 1:30 PM

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Cesare Spadoni
Founder & Chief Operating Officer, Oncoheroes Biosciences

Cesare is co-founder and Chief Operating Officer of Oncoheroes Biosciences Inc., a Boston-based biotech company focused on pediatric oncology drug development. Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. Previously, he held senior positions at AMRI, Aptuit Laurus, ThalesNano and Auxiliis. Cesare started his career as research scientist in a pharmaceutical company (Eisai, London) and in academia (Institute of Enzymology, Budapest).

Following the death of his first daughter Laura to cancer, Cesare set up aPODD Foundation, a London-based charity focused on accelerating paediatric oncology drug development. As aPODD’s chairman he is actively involved on a pro-bono basis in drug repurposing projects, advocacy efforts and research collaborations.

Cesare holds an MSc in Applied Molecular Biology and a PhD in Neurosciences from UCL, University of London, as well as an MBA from the Central European University, Budapest.

Session Details:

Panel Discussion: Negotiating vendor agreements: getting the right balance for both sponsor and service provider

2024-12-04, 10:30 AM

Session Details:

Partnering with academia for paediatric oncology clinical development

2024-12-03, 11:00 AM

View In Agenda
Next speaker
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Bahadir Cakmak
Director Early Portfolio & Pipeline, Sandoz

Session Details:

Evaluating projects starting from ideation by utilizing knowledge resources

2024-12-04, 11:45 AM

View In Agenda
Next speaker
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Carol Jarvis
Patient Advocate

​Carol Jarvis was diagnosed with Hodgkins Lymphoma in 2004 - her life and music career was all put on hold.

Little did she know then, but her fight with cancer would go on for over a decade with multiple failed treatments, transplants and clinical trials and she was repeatedly told that she would not survive.

But now, in remission with a different blood type and new DNA, she has given talks across the globe, from Boston to Singapore, Brazil to Croatia and Denmark to Mexico, about facing fear head-on, setting new statistics and beating the odds.

Session Details:

Sharing a patient perspective of clinical trials and the journey to recovery

2024-12-03, 4:45 PM

View In Agenda
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Ophelia Chan
Senior Analyst, GlobalData

Session Details:

Optimizing oncology trial efficiency through adaptive design and real-time data

2024-12-04, 2:45 PM

View In Agenda
Next speaker
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​​Priya Ravisekara
Senior Analyst, GlobalData

Priya Ravisekara, MSc,is a senior analyst at GlobalData in London, UK, where her primary responsibilities include producing analytical reports, improving and maintaining database functionality through quality assurance testing, updating and monitoring Global Data’s Clinical Trials Intelligence Database, and answering queries directly from clients. Priya holds a Masters in Clinical Drug Development from Barts and The London School of Medicine and Dentistry, and a Bachelor of Science in Biochemistry from Brunel University, London.​

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Dr. Nicolas Schneider
Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

Session Details:

Sharing digital patient centric initiatives to enhance patient engagement in clinical trials

2024-12-03, 3:45 PM

Session Details:

Panel Discussion: Negotiating vendor agreements: getting the right balance for both sponsor and service provider

2024-12-04, 10:30 AM

View In Agenda
Next speaker
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Dr. Claudia Hesselmann
Founder & 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.

 

Session Details:

Why so slow? Insider insights from the clinic floor to speed up the conduct of proof-of-concept patient trials

2024-12-03, 11:30 AM

Session Details:

Panel Discussion: Negotiating vendor agreements: getting the right balance for both sponsor and service provider

2024-12-04, 10:30 AM

View In Agenda
Next speaker
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Alicia Staley
VP Patient Engagement, Medidata Dassault Systemes

Alicia Staley serves as vice president of Patient Engagement at Medidata. She oversees the Patient Insights Program and the Patient Insights Board. She works to infuse the patient perspective throughout the product development lifecycle and help engage patients in novel ways. She created Patient Centricity by Design (PCbD) in 2018 as a way to provide structure and governance for developing patient-centric technical solutions.

Alicia has over 20 years of experience in software design and information systems management.  She is also a three-time cancer survivor, first diagnosed with Hodgkin’s disease as a sophomore during college. With an extensive network of patient advocates and non-profit organizations, she collaborates with a wide range of stakeholders to help improve processes and policies that impact cancer care.

As a champion of patient advocacy and engagement, she understands the critical issues facing patients seeking to engage in clinical research.

Session Details:

Panel Discussion: Integrating imaging into oncology clinical trials

2024-12-03, 1:30 PM

Session Details:

Clinical research needs a moonshot: What patients can teach us about innovation

2024-12-03, 9:30 AM

View In Agenda
Next speaker
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Daniela Duffett
Senior Solutions Consultant, Suvoda

Daniela Duffett is the European Solutions Consultant at Suvoda, based out of our Barcelona office. She consults with clients and prospects, delivering presentations and demonstrations, while acting as a Subject Matter Expert on Suvoda’s solutions. She started at Suvoda five years ago on the Project Management side of our Services Delivery organization, so can impart her hands-on delivery experience & knowledge.

 

Session Details:

Respecting patient and site voices: Practical steps to streamline clinical technologies

2024-12-04, 11:15 AM

View In Agenda
Next speaker
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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:

Tailored trial designs for precise outcomes

2024-12-03, 2:15 PM

View In Agenda
Next speaker
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Cornelia Baumgartner
Head of Clinical Operations, T-CURX

Session Details:

From the 1930s to today: the evolution of clinical trial regulations

2024-12-03, 10:00 AM

Session Details:

Speaker Hosted Roundtables

2024-12-04, 9:00 AM

View In Agenda
Next speaker
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Marta Perez-Noguera
Director Clinical Operations EU, Luzsana

Session Details:

Speaker Hosted Roundtables

2024-12-04, 9:00 AM

View In Agenda
Next speaker
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Helen Johansen Blanco
Chief Operating Officer, Node Pharma A/S

Helén Johansen Blanco has 24 years of clinical development experience, managing Phase I to III clinical trials leading to the successful launch of several oncology products, as Revlimid, Xofigo and a Herceptin biosimilar. She has experience in project management and financial oversight of large global clinical trials conducted in all continents of the world, mainly within oncology, but also therapeutic areas as cardiovascular and gastrointestinal. Mrs. Blanco has previously worked for large international pharma companies such as AstraZeneca and Mylan, as well as small, medium to large sized biotechnology companies as Nordic Nanovector, Oncoinvent, Cantargia, Cytovation and Celgene. Currently she holds a position as Chief Operating Officer at Node Pharma AS, a small medium sized Norwegian biotech company. She holds a Diploma Engineer/MSc degree in Biophysics and medical technology and a MBA.

Session Details:

Panel Discussion: Integrating imaging into oncology clinical trials

2024-12-03, 1:30 PM

Session Details:

What is needed to build a major biotechnology/pharmaceutical company: an evaluation of the level of ambition and the possible underlying causes

2024-12-04, 2:15 PM

View In Agenda
Next speaker
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Justus Harris
Patient Advocate

Justus Harris is a designer, healthcare strategist, and artist with two decades of lived type 1 diabetes experience. His expertise lies at the intersection of data visualization and narratives, enabling him to communicate personal and public health insights effectively. His creations encompass the transformation of medical data into 3D-printed objects, augmented reality experiences, and intuitive 2D designs. Features include the Kennedy Center as a Citizen Artist Fellow, Stanford Medicine X as an ePatient Scholar, and TEDx as a speaker.

His clients range from data-driven health companies such as Teledoc (formerly Livongo), One Drop, and Medidata as a Patient Insights Board member.

As an advocate, Justus is committed to helping improve the lives of patients in the ongoing COVID pandemic, patients without access to affordable treatments, and LGBTQIA+ individuals in the EU and United States.

Session Details:

Panel Discussion: Integrating imaging into oncology clinical trials

2024-12-03, 1:30 PM

View In Agenda
Next speaker
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Constance Jung-Stach
Head of EMEA Partnership Growth, Fortrea

Session Details:

Voice of sites: Solving the last mile

2024-12-04, 12:15 PM

View In Agenda
Next speaker
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Rob Berg
VP Medical Management, Syneos Health

Session Details:

FDA’s Project Optimus and Its Impact on Drug Development

2024-12-03, 4:15 PM

View In Agenda
Next speaker
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Amanda Nogueira
Senior Medical Director Oncology, Fortrea

Session Details:

Voice of sites: Solving the last mile

2024-12-04, 12:15 PM

View In Agenda
Next speaker

Plan Your Visit

Venue

Munich, Germany

Accommodation

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2024 Sponsors

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  • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
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    Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
  • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

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  • 150+ attendees each year
  • 80% attendees C-suite level

 

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