10th Annual Clinical Operations In Oncology Trials Europe 2023

28 - 29

November

2023
  • Sofitel Munich Bayerpost, Munich, Germany
  • Free
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Why attend?

WHAT TO EXPECT FOR 2023

At the Clinical Operations in Oncology Trials Europe event, taking place on the 28th-29th 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

Agenda

  • 28 Nov 2023
  • 29 Nov 2023
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8:15 AM

Registration and Refreshments

8:50 AM

Chair’s Opening Remarks

Speakers

9 AM

Situational assessment on the current state of play for the oncology clinical trials industry.

  • Examining the fundamental shifts that have emerged in recent years in the realm of oncology clinical studies
  • Highlighting the key areas impacted in trial design and what the current major challenges are facing the industry
  • Recognizing the importance of prioritizing patients' needs, experiences, and perspectives in clinical trials
  • Lessons learned in the past few years and how we as an industry can adapt and improve

Speakers

9:30 AM

Session Reserved for Suvoda

10 AM

Innovative Approaches for Patient Recruitment in Oncology Trials

  • Strategies for improving patient awareness and engagement in oncology trials through effective communication and outreach campaigns
  • Leveraging social media, patient registries, and community networks for targeted patient recruitment
  • Role of patient advocacy groups and patient-centric trial design in enhancing recruitment rates
  • Addressing barriers and challenges in recruiting diverse patient populations for oncology trials

Speakers

10:30 AM

Morning Refreshments and Networking

11 AM

Advances in Real-World Data and Evidence (RWD/RWE) integration in oncology trials

  • Discussing the pros and cons of using RWD/RWE in all stages of a clinical trial
  • Methods for capturing, analyzing, and integrating RWD/RWE in oncology trial design and decision-making
  • Regulatory guidelines and considerations for utilizing RWD in oncology trials
  • Examples of integration of RWE to support oncology trials

Speakers

11:30 AM

Accelerated performance of complex exploratory patient studies: practical insights from investigational site

• Global challenges & industry trends
• Research clinics dedicated to early patient trials
• Key elements to consider when planning a phase Ib/IIa patient trial
• Case studies

Speakers

12 PM

Investigating the patient perspective for better patient experience and recruitment in Oncology Trials

  • Key challenges and barriers for patient participation in clinical trials – including patient & HCP awareness and engagement, and approaches to more inclusive clinical trial design/conduct
  • Solutions proposed by patients based on actual trial experience
  • In-person vs digital patient preferences
  • Role and expectations of patient organizations in patient-centric oncology trials

Speakers

12:30 PM

Lunch and Networking

1:30 PM

Workshop : What small and mid-size Pharma/Biotechs could do to help foster patient collaboration in Oncology Trials

  • Working in group format to share ideas and needs from a smaller company perspective on what you require from patients
  • What you need to do internally and externally to foster patient collaboration – identify the gaps, challenges, resources, services and skills required
  • How can stakeholders in clinical research and development (Pharma/Biotech, CRO, investigators, healthcare providers, etc) have an influential part to play in the overall patient experience

Speakers

2:15 PM

Running up that hill: accelerate cycle times & reach patients faster with elluminate

• Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
• Improved study oversight with a holistic view of risk across all data sources
• 50 out-of-the-box visualizations to support supports cross-study analysis for deeper insights with self-service access to clinical and operational analytics
• Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

Speakers

2:30 PM

15 Minute Tech Spotlight by TCRS

2:45 PM

Panel: Analysing key functions to reduce study start-up time and bring your drug to market quicker

  • Preparing for possible hurdles which can often slow down trials and in turn, result in increased costs
  • Identifying innovative technologies that can assist in the swift startup of a clinical trial
  • Sharing experiences in trial design, the do’s and don’ts of early-stage trials

Speakers

3:15 PM

Afternoon Refreshments and Networking

3:45 PM

Discovering The Challenges Of Clinical Trials In Paediatric Oncology

  • When To Approach Regulators: Importance Of Early Interaction With Regulators
  • Understanding The Role Of International Networks: Where Do We Find Investigators?
  • Unveiling The Differences: First In Human vs. First In Child
  • Uncovering Ways To Plan A Study In A Heterogeneous Population
  • Formulation Issues: How Do We Tackle It?
  • Assessing Potential Rewards For Paediatric Regulatory Approval

Speakers

4:15 PM

Session Reserved for Precision for Medicine

4:45 PM

Case Study: A modern T-Cell Therapy study and how to plan from preclinical and beyond

  • Highlighting the key differences when creating a novel trial in this indication
  • What steps to avoid when creating your study protocol
  • Finding a partner for your T-Cell study
  • Inevitable changes in study design and how best to adapt at the worst times

Speakers

5:15 PM

Chairman’s Summation and Drinks Reception

8:30 AM

Registration and Refreshments

8:50 AM

Chair’s Opening Remarks

9 AM

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.

Roundtable 1
Navigating trial budgets in times of uncertainty, strategies for effective management

Roundtable 2
Improving patient enrolment in new trials, enhancing your trial uptake

Roundtable 3
Selecting the ideal CRO for your study: ways to create an effective partnership Roundtable 4
Designing studies with clear endpoints, methods of defining study objectives

10 AM

Morning Refreshments and Networking

10:30 AM

Identifying CROs / Vendors as a small biotech, how to ensure you pick the right vendor

  • Finding the right solution for your companies needs
  • Ensuring your partner is interested in working with a smaller biotech
  • Working alongside both smaller and larger vendors for overall success
  • Managing your partners after a deal, how to ensure a mutually beneficial relationship

Speakers

11 AM

Demystifying Site Engagement: Best Practice Communication and Enhanced Oversight 

  • Recognize the barriers: Increasingly complex protocols, a lack of answers, frustrating portals… are just a few of the known site challenges.
  • Shift your focus: Sponsors and study teams know that PIs and site staff are overwhelmed. Are you ready to think differently about site engagement?
  • Prioritize authenticity: Hear how authentic, enduring site relationships are a game-changer for complex oncology trials
  • Transform your approach: Learn how sponsor study teams are embracing communication best practices and pursuing a higher standard of study oversight

Speakers

11:30 AM

Negotiating with CROs as a small biotech; ensuring how to get the most value out of your contracts

  • Collaborating with your partner to achieve mutual benefits
  • How to qualify your vendors as a small company
  • How to safely proceed with contracts as a small company
  • Ensuring that your CRO is taking accountability

Speakers

12:15 PM

Optimizing Study Planning to Drive More Efficient and Diverse Oncology Trials

• Overview of complexities in the oncology clinical trial landscape today, current industry trends, and data that can be leveraged to address challenges
• Methods to meet regulatory requirements around diversity while taking into account operational needs
• Tools pharmaceutical companies and CROs can utilize to leverage operational and clinical data along with patient insights and achieve clinical trial and diversity goals

Speakers

12:45 PM

Lunch Break & Apple Prize Draw

2:15 PM

Handling IVDR regulations and their impacts on running early stage clinical trials

  • Overview of the growing importance of new regulations for conducting oncology clinical studies
  • Highlighting the key challenges to be faced in clinical trials which incorporate an IVD system
  • Strategies for design planning when running a trial requiring the use of IVD’s
  • Key trends, innovations, and challenges shaping the future of oncology research
  • Case studies showcasing successful adherence to IVDR in oncology trials
  • Exploring the challenges faced by smaller biotechs in optimizing trial timelines and budgets with accordance to new regulations
  • Perspectives on the future of IVD’s in cancer treatment and its impact on clinical trial design

Speakers

2:45 PM

Session Reserved for Event Sponsor

3:15 PM

The Landscape of Precision and Personalized Medicine (PM) Clinical Trials

  • The competitive landscape of PM indicating the top industry sponsors, CROS, non-industry sponsors, regions and countries leading the way
  • The research landscape of PM included the top therapy areas, indications, drugs in PM clinical trials
  • Use of virtual components in PM studies
  • Leading causes of trial termination/suspension/withdrawal (Low accrual, financial, business/strategic decision)

Speakers

3:45 PM

Chairman’s Summation and Close of Conference

Speakers

Select a speaker to learn more

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Michael Forstner
Global Head of Clinical Safety and Pharmacovigilance, BBU, Biogen International GmbH

Session Details:

Advances in Real-World Data and Evidence (RWD/RWE) integration in oncology trials

2023-11-28, 11:00 AM

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Robert Dobosz
Director Clinical Trials Solutions, Ryvu Therapeutics

Session Details:

Negotiating with CROs as a small biotech; ensuring how to get the most value out of your contracts

2023-11-29, 11:30 AM

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Sonnika Lamont
GlobalData Analyst – Trials Intelligence, GlobalData

Session Details:

Chair’s Opening Remarks

2023-11-28, 8:50 AM

Session Details:

The Landscape of Precision and Personalized Medicine (PM) Clinical Trials

2023-11-29, 3:15 PM

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Nicolas Schneider
Director, Clinical Operations and Alliance Management, ITM Isotope Technologies Munich SE

To date, I am bringing 18 years of experiences in oncology, of which 5 years contribute to pre-clinical and 13 years to clinical research. I have worked at CRO, Biotech and Big Pharma. In my career, I was involved in the entire drug development starting from preclinical, moving to Phase I, II and III going to market authorization and followed by non-interventional studies. In my current role as Director Clinical Operations & Alliance Management, I am responsible for a study program and vendor relations.

Session Details:

Identifying CROs / Vendors as a small biotech, how to ensure you pick the right vendor

2023-11-29, 10:30 AM

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Monika Kouba
Vice President Head Clinical Operations, T-Knife Therapeutics

Session Details:

Case Study: A modern T-Cell Therapy study and how to plan from preclinical and beyond

2023-11-28, 4:45 PM

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Andriy Krendyukov
VP Medical Affairs and Clinical Development, Apogenix AG

Session Details:

Panel: Analysing key functions to reduce study start-up time and bring your drug to market quicker

2023-11-28, 2:45 PM

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Malte Oppermann
Senior Director Clinical Operations, Medigene

Session Details:

Handling IVDR regulations and their impacts on running early stage clinical trials

2023-11-29, 2:15 PM

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Pauline Frank
Patient Engagement And Insights Director, Oncology Worldwide Medical Affairs, Novartis

Session Details:

Investigating the patient perspective for better patient experience and recruitment in Oncology Trials

2023-11-28, 12:00 PM

Session Details:

Workshop : What small and mid-size Pharma/Biotechs could do to help foster patient collaboration in Oncology Trials

2023-11-28, 1:30 PM

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Cesare Spadoni
Founder And 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:

Discovering The Challenges Of Clinical Trials In Paediatric Oncology

2023-11-28, 3:45 PM

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Stefano Ferrara
Director Of Clinical Science, BeiGene

Session Details:

Situational assessment on the current state of play for the oncology clinical trials industry.

2023-11-28, 9:00 AM

Session Details:

Panel: Analysing key functions to reduce study start-up time and bring your drug to market quicker

2023-11-28, 2:45 PM

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Dr. Claudia Hesselmann
Founder and CEO, Arensia

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:

Accelerated performance of complex exploratory patient studies: practical insights from investigational site

2023-11-28, 11:30 AM

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Stefanie Schier-Mumzhiu,
Director Global Program Operational Head, MorphoSys

Session Details:

Innovative Approaches for Patient Recruitment in Oncology Trials

2023-11-28, 10:00 AM

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Sumeet Ambarkhane
Chief Medical Officer, Alligator Bioscience AB
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Rachel Horovitz
VP, Medidata AI Strategy

Session Details:

Optimizing Study Planning to Drive More Efficient and Diverse Oncology Trials

2023-11-29, 12:15 PM

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Achilleas Zaras
Senior Manager, Solution Consulting, eClinical Solutions

Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions.

Session Details:

Running up that hill: accelerate cycle times & reach patients faster with elluminate

2023-11-28, 2:15 PM

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Brian Deighan
Program Director, Teckro

Brian is the Teckro program director for several key accounts, bringing over 17 years of industry experience to his role. He collaborates with study teams globally to ensure Teckro is broadly adopted and fully leveraged for enhanced site engagement, delivering success across our current trials.

Session Details:

Demystifying Site Engagement: Best Practice Communication and Enhanced Oversight 

2023-11-29, 11:00 AM

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Jessica Cordes
Head of Clinical Operations

Jessica Cordes studied Molecular Life Science in Luebeck and started her business career for 2 years at the Central Lab MDS Pharma Services as project manager.

She moved then to GlaxoSmithKline where she worked as country project leader for 4 years.

In 2013, she moved to MorphoSys, working in an international role as clinical trial leader overseeing clinical trials with antibodies.

2017 she moved to Medigene as clinical trial manager, planning and implementing a cell therapy clinical trial and in 2018 took over the leadership for Clinical Operations while building the group. In 2021, she joined Immatics being responsible for building a global cohesive Clinical Operations department and leading the operational strategy for the global conduct of all clinical trials.

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Plan Your Visit

Venue

Sofitel Munich Bayerpost

Bayerstraße 12, 80335 München, Germany

Accommodation

Please contact the reservation department and provide the Booking Code: CTOEU23. Please be aware that should you be contacted by any 3rd party housing companies that they are not affiliated with us or the hotel.

Sponsors

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FEATURED SPONSOR

SESSION SPONSORS

TECHNOLOGY SPOTLIGHT SPONSOR

Roundtable Sponsor

EXHIBITORS

CO-SPONSORS

Tote Bag Sponsor

Media Centre

MEDIA PARTNERS

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Conor Taylor

+44 (0)20 7936 6870

SPEAKING OPPORTUNITIES

Ruth Atterbury

Portfolio Manager

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

SPONSORSHIP ENQUIRIES

To enquire about sponsorship opportunities for the conference, please contact:

Conor Taylor


+44 (0)20 7936 6870

SPEAKER ENQUIRES

The program for the event is underway. Please get in touch with the program director if you would like to be part of the program

Niki Khoshkbary

Conference Producer