Clinical Operations In Oncology Trials Europe 2023

28 - 29

November

2023
  • 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.

 

Company Website

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 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.

    Previous Agenda

    • 22 Nov 2022
    • 23 Nov 2022
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    8:15 AM

    Registration and Refreshments

    8:50 AM

    Chair’s Opening Remarks

    9 AM

    KEYNOTE Unveiling The Importance Of Clinical Trial Diversity For Inclusive Oncology Research And Treatment

    • Investigating ways to adapt to EU regulatory frameworks for clinical trial diversity in oncology
    • Ensuring the participation of diverse set of countries in clinical trials for representative trial findings
    • Identifying different obstacles for inclusive clinical studies in small and big clinical oncology trials
    • Understanding and tackling the scientific skepticism, as well as its potential impact on the diversity of oncology trials

    Speakers

    9:30 AM

    Flexible by Design: Tools to Manage Uncertainty & Complexity in Early Phase Oncology Trials

    • Examine common challenges in early phase oncology trials that can be mitigated with technology tools
    • Explore functionality that can help manage the uncertainty in trial duration, treatment variability and protocol amendments
    • Discuss how an early phase oncology trial case study leveraged IRT functionality to address the protocol complexities

    Speakers

    10 AM

    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

    10:30 AM

    Morning Refreshments and Networking

    11 AM

    Challenging Your Vendor And Understanding Their Mind-Set To Better That Partnership

    • Emphasising the importance of vendor transparency from the start and not over promising, focussing on capabilities
    • Exploring the use of a patient recruitment portal to achieve early or on time study start up
    • Looking at country-specific stats for grass roots vs digital recruitment and planning your digital outreach accordingly
    • Improving the quality of patients through additional vetting to improve your recruitment process

    Speakers

    11:30 AM

    Data-Driven Operations and Oversight with elluminate

    Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. Learn how elluminate delivers:

    • Operational analytics including enrolment, protocol compliance and safety
    • Risk-based analyses and insights with elluminate RBQM
    • Operational knowledge for data-driven development with elluminate CTMS
    • Centralized issue management across roles in operations, data and medical review
    • Sample tracking, data forecasting and site performance insights

    Speakers

    12 PM

    Proposing a new strategy in oncology clinical development to decrease lead times and trial failures, enabling efficacious and safe drug delivery to patients

    • Use of real world evidence data in clinical trials
    • Endpoints differentiated based on indications and disease stage
    • On going regulatory authorities review to allow early access to novel treatments for patients in need

    Speakers

    12:30 PM

    Lunch and Networking

    1:30 PM

    Panel Discussion: Patients as Partners: Understanding the Importance of Enhancing Patient Engagement to be a Leader in the Oncology Industry

    • Understanding the effects of patient engagement to achieve faster recruitment and lesser drop-outs in oncology trials
    • Discovering ways to improve communication and understanding patients’ preferences
    • Evaluating patient engagement techniques as a mean of differentiation in competitive oncology markets
    • Exploring developments in patient engagement such as Innovative Medicines Initiative (IMI)’s PREFER initiative

    Speakers

    2:15 PM

    Session Reserved for Event Sponsor: Eclinical Solutions

    2:45 PM

    Vendor Selection and Management In Clinical Oncology Trials: How To Find the Best Fit for Your Clinical Operations?

    • Discovering various outsourcing models for different clinical oncology trials and biotech firms
    • Discussing key aspect to include in your contract in order to achieve effective oversight
    • Understanding ways to utilize technology and data in Vendor Selection
    • Exploring the implications of user-friendly CRO interfaces in vendor selection

    Speakers

    3:15 PM

    Afternoon Refreshments and Networking

    3:45 PM

    Panel Discussion: Discovering Methods for Planning and Budgeting Operations in Clinical Oncology Trials to Increase Operational Performance

    • Understanding different ways to design the planning phase efficiently for a clinical oncology trial: lessons learned from Big Pharma
    • Utilizing technology and agile budget planning tools for clinical oncology: the case of ClearTrial
    • Uncovering ways to negotiate a well-planned budget with the study sights to ensure good relationships with vendors

    Speakers

    4:15 PM

    Shorten timelines and improve likelihood of approval through intelligent clinical study design

    Clinical development is a process fraught with challenges and uncertainty. We believe there are four criteria which, when applied, can reduce both:

    • Understanding the landscape of the disease including current standard of care and approval status of other agents
    • Enhancing efforts for effective patient identification and recruitment using existing genetic data and data generated from perspective patients
    • Evaluating the intended market application strategically
    • Leveraging relationships with KOLs, insights about the regulatory environment, and geographic analysis and reach

    Speakers

    4:45 PM

    Uncovering Ways To Keep Your Patient At The Heart Of Your Oncology Trial

    • Are pharma companies making assumptions on patient needs and requirements? The importance of including patients’ views in decision-making
    • Assessing patient experience in clinical trials: how can we reduce obstacles for participants?
    • Patients as Research Partners: a collaborative working model

    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 as a whole. 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
    • Evaluating the Concept of E-Consent: Ensuring Operational Efficiency in Oncology Trials by Creating an E-space to Fasten and Optimize patients’ Consent Process
    • Roundtable 2
    • Discussion of Clinical Career Development: Investigating the Importance of Leadership for Successful Clinical Project Management Marianne Keessen, Director of Clinical Operations, Modra Pharmaceuticals
    • Roundtable 3
    • Understanding the New European Central System: Challenges for Submitting Oncology Trials and Ways to Adjust Quickly Cesare Spadoni, Founder and COO, Oncoheroes Biosciences
    • Roundtable 4
    • Discovering the role of Technology and Remote Monitoring for Increased Patient Enrolment for Clinical Oncology Trials: Can Decentralized Trials Enrol More Patient Population from Underrepresented Countries?

    Speakers

    10 AM

    Morning Refreshments and Networking

    10:30 AM

    Targeting TACAs – a novel class of tumor-specific antigens: How to de-risk first clinical trials

    • TACAS (Tumor-Associated Carbohydrate Antigens) are a novel class of cancer-specific antigens that drive tumor virulence
    • As they represent 2ndary gene products their expression can hardly be predicted by genetic screening
    • The presentation will address which measures will be taken to de-risk clinical development

    Speakers

    11 AM

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

    • Unique model of dedicated research clinics in Eastern Europe
    • Strategies for fast patient enrollment and retention
    • Operational tips for flawless study conduct
    • Takeaways after operating under unprecedented circumstances / case studies

    Speakers

    11:30 AM

    Panel Discussion: An investors perspective: Understanding the Investors Motivations for Funding Clinical Trials and Evaluating the Oncology Market

    • Understanding the downturn of Markets in the Oncology Industry and its underlying reasons
    • Exploring the causes of liquidity issues in clinical oncology trials and identifying feasible solutions
    • Discussing the investors’ incentives for fund allocation and value creation in clinical oncology trials

    Speakers

    12:15 PM

    Strategies for successful oncology recurrence trials

    This presentation will address successful strategies for oncology recurrence trials including a review of operational and read recommendations to help you improve efficiency and quality for your recurrence studies. The speaker will discuss:

    • Imaging in the context of surveillance;
    • Other procedures for detection of recurrence not discussed;
    • Clinical trials design, including disease-free status;
    • Central imaging evaluation including: establishing disease free status, detection of recurrence and characterization of recurrence; and Operational considerations

    Speakers

    12:45 PM

    Lunch and Networking

    1:45 PM

    Legal challenges of decentralized clinical trials (EU perspective)

    • First regulatory responses on the management of clinical trials during COVID-19 (FDA, EMA/HMA, local authorities’ approach)
    • Most important aspects of the EU Guidance of management of clinical trials during COVID-19
    • Legal challenges of decentralized clinical trials following COVID-19
    • ACT EU’s (Accelerating Clinical Trials in the EU) planned publication of a recommendation paper governing decentralized clinical trials – multi stakeholder perspectives

    Speakers

    2:15 PM

    From molecule to the clinic: Key points to consider for small biotechs

    • Reviewing key parameters required to enable you to successfully bring an NCE/NBE to the clinic and beyond
    • Considering the science, pharmacology, regulatory advice and marketplace to differentiate your product
    • Identifying key partners, stakeholder needs and management tools to assist in developing your NCE/NBE
    • Creating an effective TPP to increase the likelihood of progressing from bench to bedside

    Speakers

    2:45 PM

    Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

    • Discussing ways to choose the right CRO for small biotech firms outsourcing their operations
    • Tackling the communication issues with large, multi-layered stakeholders Keeping up with technical advances in the field by seeking cost-effective strategies to invest in new technology.
    • Investigating time and cost management approaches to deal with out-of-scope work outsourced to vendors

    Speakers

    3:15 PM

    Chairman’s Summation and Close of Conference

    Previous Speakers

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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

    2022-11-22, 10:00 AM

    Session Details:

    Panel Discussion: Patients as Partners: Understanding the Importance of Enhancing Patient Engagement to be a Leader in the Oncology Industry

    2022-11-22, 1:30 PM

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    Yildiray Tanriver
    Medical Director, Oncologist, Acik Holding
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    Stefano Ferrara
    Director Of Clinical Science, BeiGene

    Session Details:

    Panel Discussion: Discovering Methods for Planning and Budgeting Operations in Clinical Oncology Trials to Increase Operational Performance

    2022-11-22, 3:45 PM

    Session Details:

    Proposing a new strategy in oncology clinical development to decrease lead times and trial failures, enabling efficacious and safe drug delivery to patients

    2022-11-22, 12:00 PM

    Session Details:

    Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

    2022-11-23, 2:45 PM

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    Sotirios Perdikeas
    Global Head Resource Management & Analytics, Strategy, Portfolio & Clinical Operations, Roche
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    Silvio Costanzo
    Head Of Clinical Operations, ANAVEON AG

    Session Details:

    Panel Discussion: Discovering Methods for Planning and Budgeting Operations in Clinical Oncology Trials to Increase Operational Performance

    2022-11-22, 3:45 PM

    Session Details:

    Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

    2022-11-23, 2:45 PM

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    Peter Sondermann
    CEO, Tacalyx GmbH

    Session Details:

    Panel Discussion: An investors perspective: Understanding the Investors Motivations for Funding Clinical Trials and Evaluating the Oncology Market

    2022-11-23, 11:30 AM

    Session Details:

    Targeting TACAs – a novel class of tumor-specific antigens: How to de-risk first clinical trials

    2022-11-23, 10:30 AM

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    Peter Lichtlen
    Chief Medical Officer, Numab

    Session Details:

    From molecule to the clinic: Key points to consider for small biotechs

    2022-11-23, 2:15 PM

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

    Session Details:

    KEYNOTE Unveiling The Importance Of Clinical Trial Diversity For Inclusive Oncology Research And Treatment

    2022-11-22, 9:00 AM

    Session Details:

    Panel Discussion: Patients as Partners: Understanding the Importance of Enhancing Patient Engagement to be a Leader in the Oncology Industry

    2022-11-22, 1:30 PM

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    Milena Kanova
    Vice President Clinical Operations, Palladio Biosciences, Inc., A Centessa Company

    Session Details:

    Vendor Selection and Management In Clinical Oncology Trials: How To Find the Best Fit for Your Clinical Operations?

    2022-11-22, 2:45 PM

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    Michele Marzola
    Co-Founder And CEO, Interceptin Srl
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    Matteo Fiorentini
    Head Of Oncology Lung Franchise, AstraZeneca
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    Marianne Keessen
    Modra Pharmaceuticals B.V.
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    Laura Beni
    Head Of Clinical Operations, Cellestia Biotech AG

    Laura Beni has over 15 years’ experience in pharma, CRO and academic setting of which 10+ years in the Clinical Operations. During her career progression she took on more and more responsibilities not solely limited to the Clin Ops.  Currently, she holds the position of Head of Clinical Operations at Cellestia Biotech AG, a privately-owned clinical-stage Biopharma Company located in Basel (Switzerland) whose drug candidate platform is a first-in-class solution targeting orphan cancers.

    She is a hospital pharmacist by training and a strong believer that learning is a never-ending process

    Session Details:

    Panel Discussion: Discovering Methods for Planning and Budgeting Operations in Clinical Oncology Trials to Increase Operational Performance

    2022-11-22, 3:45 PM

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    Kumar Ashesh
    CEO, Paras Biopharmaceuticals

    Session Details:

    Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

    2022-11-23, 2:45 PM

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    John McAdory
    Head Of Clinical Operations, SillaJan, Inc
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    Denis Brkic
    Senior Director, Head Of Clinical Operations, Nouscom AG
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    Dagmar Siebold
    Managing Director, Biopath GmbH

    Session Details:

    Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

    2022-11-23, 2:45 PM

    Session Details:

    Speaker Hosted Roundtables

    2022-11-23, 9:00 AM

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    Christine Sturchler
    Global Head Patient Engagement, Novartis

    Session Details:

    Uncovering Ways To Keep Your Patient At The Heart Of Your Oncology Trial

    2022-11-22, 4:45 PM

    Session Details:

    Panel Discussion: Patients as Partners: Understanding the Importance of Enhancing Patient Engagement to be a Leader in the Oncology Industry

    2022-11-22, 1:30 PM

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    Dr. Monika Kouba
    Director of Clinical Operations

    Session Details:

    Challenging Your Vendor And Understanding Their Mind-Set To Better That Partnership

    2022-11-22, 11:00 AM

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    PAUL VAN MEURS
    Director, Medical & Scientific Affairs Oncology, Clario

    Paul van Meurs, MD, is currently the Director of Medical & Scientific Affairs, Oncology and is responsible for the oversight of Clario’s medical imaging and specialty solutions. Dr. Muers is a qualified MD with more than 20 years of experience in clinical development within the pharmaceutical industry. He has previous experience at BiOrion as their Chief Business Officer as well as Keosys Medical Imaging and Julius Clinical where he was responsible for business development activities. He is also the editor of the Dutch Textbook of Pharmaceutical Medicine (Published 2014).

    Session Details:

    Strategies for successful oncology recurrence trials

    2022-11-23, 12:15 PM

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    Dr. Claudia Hesselmann
    Founder And CEO, ARENSIA Exploratory Medicine GmbH

    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

    2022-11-23, 11:00 AM

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    BOB MILLHAM
    President, Clinical Trial Operations, Allucent

    Bob Millham is currently President of Clinical Trial Operations, at Allucent, a global provider of comprehensive drug development solutions. He has more than 20 years of leadership experience across global pharmaceutical, biotech and contract research organizations. Throughout his career he has spearheaded scientific teams, clinical development programs and operations worldwide to drive the success of cancer therapeutics. Highlights of Bob’s career include:

    a 17-year career at Pfizer, leading and contributing to the development of compounds against multiple indications of cancer, including lung, breast, colorectal and ovarian.
    overseeing drug development activities and opening a pivotal phase 3 clinical trial in metastatic breast cancer while COO of Odonate Therapeutics.
    leading the Oncology Center of Excellence, as well as clinical trial management initiatives for a variety of biotech and pharmaceutical clients as senior vice president at Syneos Health.
    while in position as vice president of strategic alliances for Caris Life Sciences, growing and developing the organization’s Precision Oncology Alliance network
    Bob has authored and co-authored multiple peer-reviewed articles, abstracts, and presentations. He earned a master’s degree in pharmaceutical medicine from Hibernia College in Dublin, Ireland, as well as a master’s degree in microbiology from the University of New Hampshire. He holds a bachelor’s degree in biology from Middlebury College.

    Session Details:

    Shorten timelines and improve likelihood of approval through intelligent clinical study design

    2022-11-22, 4:15 PM

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    Daniela Duffett
    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 three years ago on the Project Management side of our Services Delivery organisation, so can impart her hands-on delivery experience & knowledge.

     

    Session Details:

    Flexible by Design: Tools to Manage Uncertainty & Complexity in Early Phase Oncology Trials

    2022-11-22, 9:30 AM

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    Achilleas Zaras
    Solutions Consultant, 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:

    Data-Driven Operations and Oversight with elluminate

    2022-11-22, 11:30 AM

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    ESZTER TAKÁCSI-NAGY
    Senior Associate, Kinstellar

    Eszter Takácsi-Nagy is a Senior Associate in the Budapest office focusing on life sciences and healthcare matters. Her expertise includes in-depth knowledge of the pharmaceutical, biotechnological, healthcare and medical devices sectors and the related regulatory environment. Eszter also regularly advises on competition and state aid matters, and has leveraged that experience to deliver a broader and deeper service offering to the firm’s life sciences clients. She has advised domestic and international clients on licensing, compliance, enforcement as well as sector related M&A.

    Session Details:

    Legal challenges of decentralized clinical trials (EU perspective)

    2022-11-23, 1:45 PM

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