10th Annual Clinical Operations In Oncology Trials Europe 2023

28 - 29

November

2023
  • Sofitel Munich Bayerpost, Munich, Germany
  • Free
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2023 Sponsors Included:

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Company Website

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

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Company Information

HeartcoR Solutions (HCS) is a leading Cardiac Safety Core Lab serving the Medical Device and Pharmaceutical Industries. HeartcoR has conducted 32 global IDE-PMA study projects since 2018 and has extensive understanding of Cardiac Safety execution to yield high study subject compliance in support of regulatory submissions.  HCS’ also serves Bio-Pharmaceutical companies conducting intensive QT and phase I-IV safety studies. The Company’s 50 employees hold a required certifications and our Electrophysiologist/Cardiologist analysis team are recognized experts in heart rhythm analysis. HeartcoR is based in Schaumburg Illinois, twenty minutes north of O’Hare Airport.

Company Website

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

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IDDI optimizes the clinical development of drugs, biomarkers and IVD using a unique combination of advanced biostatistics and innovative data collection technology.

IDDI covers the full spectrum of trial design, clinical data collection, management, analysis and reporting for Phase I- IV clinical trials.

– IDDI’s services include: Clinical Development Plans, Protocol Development, Randomization (IWRS/IRT) with Drug Supply Management, EDC, Medical Coding, Data Management, Biostatistics, IDMC Support, Biomarker/Diagnostics Validation, Medical Writing.

– IDDI’s therapeutic areas of expertise include oncology, ophthalmology, infectious diseases and cardiology.
– Experience: 27+ years – 980+ trials (630+ in oncology) – 20 FDA/EMA approvals to-date
– HQ in Belgium with offices in the USA ( Raleigh, NC, Boston, MA and San Francisco, CA).

Company Website

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

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Precision medicine is in our blood, our cells, our genes, and our name. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there.

Company Website

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

Company Website

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

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Myonex is a global complete clinical trial solutions provider. For over 30 years, we have been the leading global clinical trial supply company and we have expanded our service portfolio to offer complete solutions around clinical trials for our partners. You might have known us as Myoderm as we have recently changed our name – but not our high-quality services as the complete clinical trial supply partner. We at Myonex add value to our clients by helping them always be prepared for what is next in their clinical trials.

Our goal each day, every day is to make sure our partners have whatever they need when and where they need it to execute a successful clinical trial, while also minimizing delays, unnecessary costs, and surprises.

With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries, Myonex is your complete partner around clinical trials around the globe – reliable, trusted and by your side.

Company Website

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

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eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

Company Website

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

Company Website

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

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To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. ARENSIA’s outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. ARENSIA’s speed and data quality provide our Partners/Sponsors with a strategic advantage across the entire lifecycle of a project, as they can progress their novel compounds much faster to later phases of research. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. ARENSIA is based with its headquarters in Düsseldorf, Germany, and operates with 400+ talented employees in 7 countries

Company Website

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

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Company Website

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

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Suvoda is a global clinical trial technology company specializing in highly complex, life-sustaining studies in therapeutic areas like oncology, CNS, and rare disease. Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through IRT, eConsent, and eCOA solutions delivered on a single platform.

Company Website

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

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Founded in 2015 Teckro provides solutions to simplify and modernize clinical research for leading pharmaceutical and emerging biotech companies. To date, Teckro manages more than 100 clinical trials and is used by more than 11,800 active study sites around the world. Teckro employs more than 100 staff across its global headquarters in Limerick, Ireland, engineering excellence hub in Dublin, Ireland and its US-based office in Nashville, Tennessee. Visit www.teckro.com for more information.

 

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

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Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

Company Website

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

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Metronomia is a German clinical research organization (CRO) committed to high quality, best service and outstanding flexibility. A service oriented, stable and highly skilled team provides e-clinical services,clinicaldata management and biostatistical services within phase I – IV and non-interventional studies in allmajor therapeutic areas.

Company Website

To learn more , please visit our website - http://www.metronomia.net/

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    Why attend?

    Arena International are delighted to announce 10th Annual Clinical Operations in Oncology Trials Europe will be returning to Munich on November 28-29 2023!

    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;

    • Patient Engagement and Recruitment 
    • Planning and Budgeting Operations 
    • Investments in Biotech and Liquidity Issues 
    • Vendor Management

     

    Don’t miss out; join us in Munich on November 28th and 29th ! We can’t wait to see you there!

    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

    WHY ATTEND?

    NETWORK

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

    LEARN

    Join like-minded peers to learn new perspectives and case studies through presentation, panel discussions, interactive round tables and workshops.

    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.

    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.

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