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11th Annual Clinical Trials in Oncology Europe 2024

3 - 4

December

2024

Sofitel Munich Bayerpost, Munich, Germany
Free

Why attend?
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Speakers
Plan Your Visit
Event Gallery
Sponsors
Media Centre
Why partner?
Download Agenda
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Company Information

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 34,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,200 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

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To learn more, please visit our website - https://www.medidata.com

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ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

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To learn more, please visit our website - http://www.arensia-em.com/

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SGS is a leading life sciences CRO providing clinical research and bioanalytical testing with a specific focus on early stage development and biometrics. Delivering solutions in Europe and in Americas, SGS offers clinical trial (Phase I to IV) services encompassing full early phase drug development consultancy, clinical project management and monitoring, biometrics, PK/PD modeling & simulation and regulatory & medical affairs services. SGS has its own clinical unit in Belgium including a viral challenge testing facility and two phase I patients units based in Belgium and Hungary.

SGS has a wealth of expertise in FIH studies, viral challenge testing, biosimilars and complex PK/PD studies with a high therapeutic focus in Infectious Diseases, Vaccines, and Respiratory.

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To learn more, please visit our website - http://www.sgs.com/en/life-sciences/clinical-research-services

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Simply sourcing comparators – we offer a unique blend of small company flexibility and speed, backed with the large-scale buying power of the Orifarm Group, which is one of the largest pharmaceutical suppliers in Europe. With over €1.4B products sold in 2021 and more than 4,000 unique product lines sourced on a monthly basis, we have unparalleled access to “out of market” and manufacturer direct buying capability, both in the US and Europe.

Company website: www.Orifarm-CTS.com

Company Website

To learn more, please visit our website - www.Orifarm-CTS.com

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Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com.

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To learn more, please visit our website - www.SyneosHealth.com

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Scout empowers the life sciences industry with people-first solutions: Scout Meetings, Scout Clinical, and Scout Academy. We specialize in face-to-face, virtual, and hybrid clinical meeting planning, patient payment, travel, and logistics support, and virtual collaboration and education. Since 1995, we have been a trusted partner excelling in customer service, regulatory compliance, and project delivery for leading pharmaceutical and biotechnology companies. Our deep understanding of international regulations and adaptable network of resources is built on operational experience in 109 countries. With white-glove attention to detail and a customizable, comprehensive range of services, Scout makes the complex easier. Learn more at scoutclinical.com.

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Science4Tech is a dynamic scaleup dedicated to advancing clinical trials through innovative technology and rigorous data management. Our cutting-edge AI solutions empower life science companies to streamline drug development, reducing time and costs significantly. We prioritize the highest scientific standards and unwavering regulatory compliance across all phases of clinical trials.

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To learn more, please visit our website - https://s4t.health/

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Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

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To learn more, please visit our website - https://www.worldwide.com

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Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company’s Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,000 trials across 80 countries.

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To learn more, please visit our website - https://www.suvoda.com/

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Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

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To learn more, please visit our website - https://www.fortrea.com/

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Medicover Integrated Clinical Services is a unique clinical research organization with 25 years of experience.

We offer Patient Recruitment services through our own Clinical Research Network in Central and Eastern Europe with comprehensive Global Central Lab Services and access to over 8,000 tests from routine to advanced diagnostics including genetics, biomarkers, PK and PD, and PBMC isolation in more than 120 laboratories in Europe and India.

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To learn more, please visit our website - https://medicover-mics.com/

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Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. We leverage our proprietary payments platform and workflow automation to help clients improve operational efficiency, reduce costs, mitigate regulatory risks, improve the patient and site experience and produce quantifiable results that improve clinical operations and strategic planning.

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To learn more, please visit our website - http://greenphire.com/

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Myonex provides tailored services and solutions to advance medicine through clinical to commercial stages with tailored drug sourcing and ancillary supply, to packaging, labeling, and distribution. With ten global locations, we offer flexible, efficient, and cost-effective support for clients across the pharmaceutical and biotech sectors.

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To learn more, please visit our website - www.myonex.com

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LabConnect provides global central laboratory services including routine and esoteric lab testing, kit building, sample management, biostorage and scientific support services for our biopharmaceutical clients. LabConnect’s unique combination of state-of-the-art technology, world-class laboratories, easy access to emerging markets and extensive specialized testing expertise means the drug development industry can rely on a single provider for all of their central lab needs.

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To learn more, please visit our website - http://www.labconnectllc.com/

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PSI is a privately-owned, full-service contract research organization (CRO), operating globally. PSI’s reputation on the market place is that of a no-nonsense CRO, capable of saving pharmaceutical sponsors millions of development dollars by consistently meeting clinical trial timelines. PSI’s global reach supports the operations of clinical trials across multiple countries.

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To learn more, please visit our website - http://www.psi-cro.com/

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To learn more, please visit our website - www.evidentiq.com

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Zanteris offers Clinical Operations, Project Management resourcing, and Consulting services within the Pharmaceutical industry, we use our deep expertise to identify quality solutions that help you execute your clinical study on time. Utilizing our experience of managing clinical trials across a range of medical conditions, we apply a tailored customer experience backed by strong data. Dedicated to optimized studies and risk management, our goal is to support your race in drug development.

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To learn more, please visit our website - www.zanteris.com

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Endpoint Clinical is an interactive response technology (IRT) solutions provider that supports the life sciences industry. Our innovative, high-quality randomization and clinical trial management technologies are backed by over a decade of award-winning experience and expertise. Endpoint is headquartered in Wakefield, MA, with offices across the US, EU, and Asia.

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To learn more, please visit our website - http://www.endpointclinical.com/

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Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite – an evolution built on more than 20 years of proven clinical research technology. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality – helping them bring life-changing therapies to our families and communities around the world.

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To learn more, please visit our website - www.signanthealth

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To learn more, please visit our website - mediantechnologies.com

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Why attend?

Arena International are delighted to announce 11th Annual Clinical Trials in Oncology Europe will be returning to Munich on 03-04 December 2024!

The programme will, through a variety of interactive session formats, offer insight on promoting successful collaboration between the clinical trials community and once again offer attendees practical take-aways that they can apply to their own studies.

Our Munich event will cover different perspectives of operational challenges meaning there truly is something for everyone!

Don’t miss out; join us in Munich on December 3rd and 4th ! We can’t wait to see you there!

WHAT TO EXPECT FOR 2024?

At the Clinical Operations in Oncology Trials Europe event, taking place on 3rd-4th December 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

WHY ATTEND?

NETWORK

This is an exceptional networking opportunity for industry accelerators. Meet industry C-Suite and Director level executives to make valuable connections at this annual thought leadership platform.

LEARN

Join like-minded peers to hear new perspectives and case studies through presentations, panel discussions and interactive round tables

ACTION

The conference discusses the vital connections between process, tools and techniques to manage change. Update your knowledge to create new strategies enabling you to enact change.

See What It's All About

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 and 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

Reserved for Science4Tech

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