7th Annual Outsourcing in Clinical Trials DACH 2024

Providing a specific platform for the clinical trials community in the DACH region to develop innovative clinical operations and outsourcing strategies.

  • Munich, Germany
  • Ticketed
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Robert Corbé​

Evidence Delivery Associate Director, AstraZeneca

Robert Corbé is an Evidence Delivery Associate Director at AstraZeneca with over 20 years of experience from Pharma, Med Tech and Bio Tech companies. In the current role he is responsible for the operational delivery of Phase IV and Observational studies. In addition he is the Patent Safety Subject Matter Expert for all post marketing studies within AstraZeneca BioPharmaceuticals. By focusing on both study delivery and safety data collection he can support the AstraZeneca study teams to achieve their delivery goals with the appropriate level of safety data collection to comply with both business needs and regulatory requirements.

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Dr. Frank Richard​

MD, MBA, Senior Medical Director, Sotio Biotech

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Francois Curtin​

CMO/Medical Director for Personalized Health Programmes, Swiss Federal Institute of Technology Zurich

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Giulia Rancati​

Market Solutions Lead for R&D, Roche

Giulia Rancati worked across biotech, academia and government organisations in the USA, Europe and South-East Asia. In 2021, she then transitioned to F. Hoffmann - La Roche where she leads the R&D Market Solutions Lead in Insights and Solutions. Here, Giulia is coaching a global team that focuses on co-creating and delivering R&D solutions to increase preclinical and clinical efficiency.

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Rolf Banholzer​

Global Head Development Operations QA, Novartis Pharma

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Sotirios Perdikeas​

Global Head Resource Management & Analytics, Strategy, Portfolio & Clinical Operations, Roche

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    2023 Sponsors Include:

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    Company Information

    Medidata is leading the digital transformation of life science, with the world’s most used platform for clinical development, commercial, and real-world data. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/

    Company Website

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

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    Company Information

    Established in 1997, Novotech is a global CRO recognized for its partnership with sponsors in clinical trial development and management. The Company offers a comprehensive suite of services, including laboratories, Phase I facilities, drug development consulting, and regulatory expertise, Novotech has executed over 5,000 clinical projects, spanning Phase I to Phase IV trials and bioequivalence studies.

    With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech supports clinical trials across Asia Pacific, the United States, and Europe. Leveraging a vast global footprint, deep relationships, and a robust operational framework, Novotech enables small to medium-sized biotech, biopharma, and pharma sponsors to accelerate the speed and scope of their clinical development endeavours.

    Discover more at www.novotech-cro.com

    Company Website

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

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    Company Information

    ARENSIA Exploratory Medicine, a German company, specializes in “first-in-patient” Phase IB and II/PROOF-OF-CONCEPT clinical trials spanning various patient populations. Equipped with 14 proprietary research clinics and advanced Phase I infrastructure, ARENSIA exceptionally accelerates the detection of initial efficacy signals for novel compounds at an unrivalled speed. ARENSIA’s streamlined approach significantly slashes patient recruitment time and costs by at least 50%, as opposed to overcrowded and understaffed conventional trial sites. The company’s remarkable efficiency is underscored by its 93% repeat business rate, propelling its growth and collaborations with leading pharmaceutical companies, biotechs, and global CROs. H3.eadquartered in Düsseldorf, ARENSIA operates with a workforce of over 450 employees across 8 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 - www.huma.com

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    Company Information

    At Viedoc, we design engaging software that modernizes clinical research so that necessary treatments can reach the people who need them faster. We believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies.

    Company Website

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

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    Company Information

    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.

    Company Website

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

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    Company Information

    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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    Company Information

    The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

    Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

    The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

    The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

    To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

    Company Website

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

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    BSI Life Sciences offers smart eClinical software for CTMS, eTMF and more. BSI makes life science software for people – and has done so for over 25 years. BSI’s software solution is made in Switzerland, Germany, USA and anywhere else clients need to be, and focused on being innovative and user-friendly. They focus on staying ahead of the industry trends and delivering a functional, compliant, and leading edge eClinical solution. This way, BSI helps its customers continuously optimize and accelerate the clinical development process. And that’s what they love! www.bsi-lifesciences.com

    Company Website

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

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    Company Information

    Clinical ink is the global life science company that brings data, technology, and patient science together.

    Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials.

    By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience.

    Company Website

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

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    Company Information

    EMIS Recruit is an integrated solution that connects Research, Life Sciences and healthcare by embedding clinical research recruitment tools directly into the point of care systems.  EMIS recruit gives research organisations clear visibility of clinically relevant patients based on your study protocol. This enables us to provide you with qualified patients that streamline your recruitment process

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    Company Information

    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.

    Company Website

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

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    Company Information

    Complex innovative clinical trial designs require an integrated synergetic approach to assess novel drug compounds for safety and effectiveness which often span esoteric, regulated and safety outcomes in all phases of the drug development life-cycle.

    The companies of Eurofins BioPharma Services provide a seamless solutions-based approach in support of phase I to IV clinical trials with a unique analytical testing portfolio for Central Laboratory Services, Bioanalytical Services and complex Biomarker Assay Development and Testing Services for drug and vaccine development.

    Company Website

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

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    Company Website

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

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    Company Website

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

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    Company Information

    FyoniBio (the service spin-off of Glycotope) offers clinical sample analysis under GCLP. Our focus are PK, ADA and biomarker assays, its development and validation with strong expertise in complex cellular assays. Additionally, FyoniBio is the ideal partner for development of complex biotherapeutics with our innovative GlycoExpress® technology.

    Company Website

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

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    Company Information

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

    Company Website

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

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    Company Website

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

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    Company Information

    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?

      ‘Providing a specific platform for the clinical trials community in the DACH region to develop innovative clinical operations and outsourcing strategies’

       

      After a hugely successful 2023 conference, we are pleased to announce that the Outsourcing Clinical Trials DACH event will be returning to Munich. This event will focus upon the operational challenges in clinical development found within Germany, Austria and Switzerland. Over two days, delegates will discuss the common challenges and trends impacting the region, including steps for defining contractual relationships and getting the maximum from external providers, incentivising good relationships with CROs and constructing defined deadlines.

       

      Why Join?

      • Focused conference for the DACH pharma market– Unlike other conferences, our event specifically focuses on the local pharma industry in Switzerland, Germany and Austria, highlighting the current challenges and exciting innovations and opportunities within the market
      • Excellent speaker line up – Senior level speakers from leading organisations such as Roche, AstraZeneca and Novartis along with exciting biotechs like Medac and Medigene
      • Great and Diverse Sessions – Our OCT DACH covers a variety of topics ranging from updated EMA Guidance to Direct to Patient and Data management innovation to CRO relationship
      • Unbeatable Networking Opportunities – Meet and network with over 150 senior industry decision makers during our dedicated networking breaks, round tables and interactive sessions

      WHAT TO EXPECT FOR 2024?

      Join pharma and biotech experts to discuss new trends and opportunities and learn how they optimize their clinical operations enabling you to stay ahead of the game. Find the right solution providers to partner with, allowing you to accelerate your trial timelines.

      200+

      Attendees

      		40+

      Speakers

      		20+

      Exhibitors
      200+

      Attendees

      		40+

      Speakers
      20+

      Exhibitors

      Testimonials

      See What It's All About

      Agenda

      • 1 Dec 2023
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      Streams

      Stream one

      Clinical Operations

      Stream two

      Innovation & Technology

      10:30 AM

      Morning refreshments and networking

      11 AM

      Presentation and Q&A: The 2023 EMA Guidance on computerized systems and electronic data in clinical trials: A clinical trial-risk-centric review and perspective

       

       In this session, the new EMA guidance doc will be discussed as follows:

      • Purpose and scope: Is it a technical guidance on computerized systems, tools, data, or is it more?
      • Principles vs requirements: How can we deal with it?
      • The pro’s and con’s from a clinical trial centric point of view:
        • How can we benefit from this guidance?
        • What are the pain-points?
      • Can we learn something new on Health Authority inspection readiness?
        • g. by applying a hierarchical approach to Clinical trial risk management and the role of technology and computerized systems?
        • Are sponsor’s and CROs structured well enough to comply with the guidance?

      The session will address elements of clinical trial data-flow between CROs and sponsors, data quality management and assurance and thoughts on (business) audit trail review(s)

      Speakers

      11:30 AM

      Reserved for Session Sponsor

      12:30 PM

      15-minute Tech Spotlight: Accessibility functionalities: Using scientific validation to maintain data integrity in clinical trials

       

       

      ·     Share results of research based on FDA demand for greater patient accessibility to clinical trials

      ·     Review an industry-first clinical research study on the ePRO instrument equivalence across accessibility features and patient communication modality preferences

      ·     Demonstrate how to ensure data integrity can be maintained once accessibility functionalities are implemented

      Speakers

      12:45 PM

      15-minute Tech Spotlight: Re-discovering the patient journey in decentralized clinical trials

       

       

      • Role of patient-centered, dynamic, and intuitive symptom tracking as well as corresponding ePROs in decentralized clinical trial settings
      • Medidux patient platform : Accurate, timely, and integrated data collection
        • Enrichment of data through IoT wearables & laboratory parameters
      • Medidux reports: Enabling efficient patient-physician collaboration
        • Ensuring ePRO reliability through patient-physician symptom review
        • Towards an Early Warning System in “patient at home” settings

      Speakers

      1 PM

      Lunch and networking

      2 PM

      How does Regulation Help or Hinder Innovation?

      • Looking into aligning regulation with innovation at the pre-conceptual stage
      • Discussing the regulatory environment for innovative products or services
      • Examining the relationship between innovation, creativity, and regulations.
      • Looking at what our selling points as a region are and what can be improved

      Speakers

      2:30 PM

      Session Reserved for Event Sponsor

      3 PM

      Fireside Chat: Data Generation in Post Marketing setup

      • Spectrum of medical research possibilities, from Independent Investigator Sponsored Research to Collaborative to fully company sponsored.
      • Defining areas of interest, Scientific data gap and strategies from global – regional - local
      • Setting up registries; opportunities and challenges when working with RWE
      • Tracking and reviewing Performance and outcomes

       

      Moderator: Sonnika Lamont, GlobalData Analyst – Trials Intelligence, GlobalData

      Speakers

      3:30 PM

      Afternoon refreshments and networking

      4 PM

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

      This presentation will highlight:

      • 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

      8 AM

      Registration and refreshments

      8:40 AM

      Chairperson’s opening remarks

      Speakers

      8:45 AM

      KEYNOTE PRESENTATION with Q&A

      DACH REGULATIONS

      Revision of the guidelines on good clinical practice

      ICH E6 (R3) guideline has been released for consultation on the 19th May 2023 - this an opportunity to review the differences between the current version and the draft guideline.

      Speakers

      9:30 AM

      Clinical Trial Information System(CTIS) Unveiled: Helping Biotech/Pharma to Streamline Regulatory processes in EU

      •                      Success Stories and Lessons Learned in CTIS Implementation

      •                      Real-World Insights: Case Studies that Unravel the CTIS Landscape

      Speakers

      10 AM

      Solving the Clinical Data Challenge

      Patient centricity requires data centricity to integrate and manage a growing variety of data sources. The challenge lies in integrating and managing those sources to deliver high-quality data. How do we overcome this?

       

      • Moving from manual, reactive data review and cleaning to proactive, risk-based approaches based on integrated data
      • Providing clinical data management and monitoring teams with workflows and analytics that support their day-to-day functions
      • Leveraging technologies that incorporate AI to automate manual tasks and identify potential issues sooner

      Speakers

      10:30 AM

      Morning refreshments and networking Sponsored by Aixial

      11 AM

      Strategies for Site Selection; enhancing one’s knowledgebase for the best move forward

      • Robust feasibility for clinical trials; from protocol design to site selection
      • Access to sites and site selection within the DACH region
      • Analysing whether to choose a full-service provider or a network of providers, is there any rational behind this decision making
      • Looking into the driving force of site selection; finances, talent, internal resources, competing studies at sites, investigator interests

      Speakers

      11:30 AM

      Delivering oncology studies – challenges and considerations

      This session will highlight the trends we have seen over the last 6 months in oncology and describe some of the new developments and issues we have seen and the ways Worldwide are addressing them. The main themes will be based around

       

      ·       Project Optimus (FDA requirements for taking 2 doses into phase II)

      ·       Design trends (more push into BOIN)

      ·       Cohort management considerations (especially in CGT studies)

      ·       Treatment modalities (immune-oncology, bi-specific antibodies – biomarkers)

      Speakers

      12 PM

      Update on EHDS Regulative process, consequence for clinical trial

      • What is European Health Data Space?
      • Result of legislative process
      • Consequence for RWD for clinical trials
      • Consequence for clinical trial data sharing

       

      Speakers

      12:30 PM

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

      • Global challenges & industry trends
      • ARENSIA’S concept: research clinics dedicated to early patient trials
      • Key elements to consider when planning a phase ib/iia patient trial
      • Case studies

      Speakers

      1 PM

      Lunch and networking

      2 PM

      Case Study – Training and engagement of study volunteers for the study execution – key success factor

      • How to find volunteers?
      • Appropriate training of volunteers in order to standardize administration of the product
      • Looking at study design – appropriate procedures
      • Considering experienced CRO

      Speakers

      2:30 PM

      Where Science and Operations Meet: Delivering Complex Clinical Trials

      • Disruptors, the new normal and challenges ahead
      • Collaborating in new ways to create life-changing approaches
      • The intersection of science and operations: a case study

      Speakers

      3 PM

      Interactive Session: Targeted approach in dose selection and development in oncology – clinical and regulatory aspects

      • FDA Project Optimus and ESMO Guidelines
      • Systemic approach to increase R&D productivity
      • AI & Machine Learning transforming drug development in future

      Speakers

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Managing Teams Successfully in new modern remote working environment

      • How to build a hybrid team
      • Challenges & Successes to meet upfront ensuring productivity
      • Keeping team motivated and driven
      • Always thinking ahead but being in the moment

      Speakers

      4:30 PM

      Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

      We’ve all had to sit through several pitches from vendor companies telling us what they can do for us, but now it’s time to reverse the conversation! Hear from the trial industry as they discuss the services, they would like to see from their solution providers, including:

      • What they like to see in an outsourced partner organization
      • What they would like a partner to know about them / how they work
      • What things do they need a partner to do and what they don’t need!
      • What things can be best done in house?

       

       

       

      Speakers

      5:15 PM

      Chairperson’s closing remarks

      Speakers

      DRINKS RECEPTION

      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      9 AM

      PANEL Pinpointing how the DACH region can “lobby” to enhance our leadership role in global clinical trials

      • Exploring maintenance and growth of research delivery
      • Unlocking costing for commercial contract research
      • Addressing localised site selection and accessibility
      • Concentrating on streamlining DACH processes of running trials with those globally

       

      Moderator: Dr. Frank Richard, MD, MBA, Senior Medical Director, Sotio Biotech

      Speakers

      9:45 AM

      How a combined CTMS and eTMF will optimize the Collaboration across Clinical Study Teams!

      The digitalization of clinical trials and operations has been at the forefront of pharmaceutical and med-tech modernization strategies over the last two decades.

      However, many companies are still struggling to digitize their clinical operations for various reasons: old habits, fear of adopting, rolling out and maintaining an electronic solution, potential delays on deadlines, or concerns about quality, data security and compliance.

      During this presentation Harald and Jan would like to share with you how a combined CTMS and eTMF will not only optimize the overall trial and regulatory document management across the boarders but as well optimize the collaboration with the involved site organizations.

      Speakers

      10:15 AM

      Experience with EU Clinical Trial Regulation – Updates from January 2023

      • Submitting a study within the framework of the new regulations, what are the differences?
      • Understanding the updated CTR guidelines to enable sponsors to submit one application and gain approval to run a clinical trial in several European countries
      • Working with the CTIS portal for trial applications
      • Examples and common issues
      • Sharing experiences with various Health Authorities

      Speakers

      10:45 AM

      Morning refreshments and networking

      11:15 AM

      Overview of AI applications for clinical trials, what are today’s possibilities?

      This presentation offers a concise exploration of current AI applications to augment and accelerate clinical trials. By highlighting tangible areas of implementations, the overview underscores the transformative potential across diverse aspects of clinical research, and how AI can increase efficiency, accuracy, and innovation within this critical domain.

      Speakers

      11:45 AM

      Building CRO Relationships. What are the critical factors to consider when procuring from a CRO?

      • Choosing the right CRO for you – one or many?
      • Ensuring your CRO is fit for purpose
      • Establishing common ground with your CRO
      • Ascertaining the critical factors to think about when you collaborate with a CRO
      • Exploring how the concept of Co-development between Pharma & CRO is working best
      • Overcoming the differences between Pharma & CRO business models to work in harmony
      • Underlining the factors which could be limiting what choice you make?

      Speakers

      12:15 PM

      Digitalization in clinical trials, a 360 view

      • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
      • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
      • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
      • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
      • Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

      Speakers

      12:45 PM

      Lunch and networking

      1:45 PM

      Baking patient-centricity into clinical development and trial design

      • Discussing the personal experiences of the patient
      • Considering the patient’s voice during study planning
      • Defining 'patient centricity'
      • Exploring how inclusion in trials and boosting of diversity may impact recruitment and retention
      • Patients' roles in the reconceptualising of hybrid trials
      • Gender bias in trial design and preclinical R&D and how this plays out in inclusion / exclusion criteria
      • What are the benefits of using multi-stakeholder approaches

      Speakers

      2:15 PM

      Session Reserved for Event Sponsor

      2:45 PM

      Safety collection in non-interventional studies

      • Non-interventional vs. Low-interventional studies
      • Primary data collection vs. Secondary use of data
      • Interpreting GVP
      • Limitations and possibilities in non-interventional study design

      Speakers

      3:15 PM

      Afternoon refreshments and networking

      3:45 PM

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      During the roundtable discussion session, the conference hall will be divided into two ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      ROUNDTABLE 1: Discussion around the consultation release of ICH E6 (R3) guideline
      Natalia Buchneva, Risk Management Lead, Clinical Data & Innovations, UCB and European Federation of Pharmaceutical Industries and Associations Working Team Member

      ROUNDTABLE 2: How can clinical trial designs accelerate oncology drug development?
      Francois Curtin, CMO/Medical Director for Personalized Health Programmes, Swiss Federal Institute of Technology Zurich

      ROUNDTABLE 3: What do patients want for a better clinical trial experience, and how can we address the gaps and expectations?
      Pauline Frank, Patient Engagement and Insights Director, Oncology Worldwide Medical Affairs, Novartis

      ROUNDTBALE 4: A discussion addressing Site Burden in Clinical Trials
      Dr Nicole Woik, Global Clinical Operations – Clinical Country & Site Lead, Biogen

      Speakers

      4:45 PM

      Chairperson’s closing remarks

      Speakers

      END OF CONFERENCE

      2023 Speakers

      Select a speaker to learn more

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      Dr. Frank Richard
      MD, MBA, Senior Medical Director, Sotio Biotech

      Session Details:

      Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

      2023-11-21, 4:30 PM

      Session Details:

      Interactive Session: Targeted approach in dose selection and development in oncology – clinical and regulatory aspects

      2023-11-21, 3:00 PM

      Session Details:

      Chairperson’s closing remarks

      2023-11-21, 5:15 PM

      Session Details:

      Chairperson’s opening remarks

      2023-11-21, 8:40 AM

      Session Details:

      Chairperson’s opening remarks

      2023-11-22, 8:50 AM

      Session Details:

      PANEL Pinpointing how the DACH region can “lobby” to enhance our leadership role in global clinical trials

      2023-11-22, 9:00 AM

      Session Details:

      Chairperson’s closing remarks

      2023-11-22, 4:45 PM

      View In Agenda
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      Sonnika Lamont
      GlobalData Analyst – Trials Intelligence, GlobalData

      Sonnika Lamont, MRes, is a a Clinical Trials Analyst at GlobalData, where her primary responsibilities include the review and update of clinical trial information presented on GlobalData’s Trials Intelligence Platform, the production of analytical reports and insights, testing database releases, and providing comprehensive conference coverage. She has a firm understanding of all aspects of clinical research, and the drug development process. Prior to joining GlobalData, Sonnika worked as a Clinical Trials Research Assistant at University College London’s Cancer Institute. Sonnika holds a Master of Research in Drug Design with a concentration in rare diseases from University College London, and a Bachelor of Science in Biochemistry from Nottingham Trent University.

      Session Details:

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

      2023-11-21, 4:00 PM

      Session Details:

      Fireside Chat: Data Generation in Post Marketing setup

      2023-11-21, 3:00 PM

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      Cornelia Baumgartner
      Diolaiuti, Clinical Operation Manager, T-CURX

      Session Details:

      Building CRO Relationships. What are the critical factors to consider when procuring from a CRO?

      2023-11-22, 11:45 AM

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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

      2023-11-21, 12:30 PM

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      Sotirios Perdikeas
      Global Head Resource Management & Analytics, Strategy, Portfolio & Clinical Operations, Roche
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      Benoît Marchal
      Founder & CEO, PicAps (Patient in control, anonymity privacy secure)

      Benoît has a Master degree in IT from the University of Compiègne France and has worked 25+ years for the digitalisation of the clinical trials process for start-ups and world leading medical device and pharmaceutical companies.

      As Chief Digital Trust Officer for Partners for Patients, Benoît aims at proposing disruptive digital approaches to specific challenges in the industry like health data access.

      As the founder of the PicAps association, Benoît intends to implement one of such propositions: empowering the patients while keeping their anonymity well protected

      Session Details:

      Update on EHDS Regulative process, consequence for clinical trial

      2023-11-21, 12:00 PM

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      Sol Yates
      Associate Director, European Regulatory Affairs, Shionogi Europe

      Session Details:

      Experience with EU Clinical Trial Regulation – Updates from January 2023

      2023-11-22, 10:15 AM

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      Leon Hooftman
      Chief Medical Officer, ISA Pharmaceuticals
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      Klaus Peter Kammerer
      Global Clinical Program Leader, Boehringer Ingelheim CRO Contributor

      Improving Clinical Drug Development. Physician specialized in Clinical Pharmacology. Long standing experience in clinical drug development

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

      Session Details:

      PANEL Pinpointing how the DACH region can “lobby” to enhance our leadership role in global clinical trials

      2023-11-22, 9:00 AM

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      Robert Corbé
      Evidence Delivery Associate Director, AstraZeneca

      Robert Corbé is an Evidence Delivery Associate Director at AstraZeneca with over 20 years of experience from Pharma, Med Tech and Bio Tech companies. In the current role he is responsible for the operational delivery of Phase IV and Observational studies. In addition he is the Patent Safety Subject Matter Expert for all post marketing studies within AstraZeneca BioPharmaceuticals. By focusing on both study delivery and safety data collection he can support the AstraZeneca study teams to achieve their delivery goals with the appropriate level of safety data collection to comply with both business needs and regulatory requirements.

      Session Details:

      PANEL Pinpointing how the DACH region can “lobby” to enhance our leadership role in global clinical trials

      2023-11-22, 9:00 AM

      Session Details:

      Safety collection in non-interventional studies

      2023-11-22, 2:45 PM

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      Edward Walsh
      Senior Director, Regional Clinical Trial Operations Europe, Seagen

      With over 20 years’ experience in clinical research - my career started within NHS UK Study Project Management diversifying into a range of operational and strategic focused positions. Currently leading European Head Quarters Operations Teams across Europe/International region.

      I have had the pleasure of working through all phases in major pharmaceutical companies. I pride myself in being a motivational leader with strong vision on teamwork, delivery and respect, focusing on scientific delivery to patients. I have operationally led GCP inspections, also additional country/site inspections with a strong focus on quality excellence and oversight. I have a passion for collaborating with all sites globally, partnering and bringing the best relationships forward for investigators, their teams and our patients.

      Session Details:

      Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

      2023-11-21, 4:30 PM

      Session Details:

      Managing Teams Successfully in new modern remote working environment

      2023-11-21, 4:00 PM

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      Eric Hajjar
      Associate Director, Global Medical Research Operations, Biogen

      Session Details:

      Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

      2023-11-21, 4:30 PM

      Session Details:

      Fireside Chat: Data Generation in Post Marketing setup

      2023-11-21, 3:00 PM

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      TOMASZ KOWALCZYK
      Regional Director, Clinical Sites Liaison Consultant , Agenus Bio

      Session Details:

      How does Regulation Help or Hinder Innovation?

      2023-11-21, 2:00 PM

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      Magdalena Gołos
      PhD, Head of Clinical Study Management Team, Polpharma S.A.

      Head of Clinical Study Management Team with over 15-years of experience within the clinical research industry.

      Extensive scientific experience in planning of pre-clinical-, bioequivalence-, phase III and IV - studies design. Experienced project leader in preclinical and clinical studies execution. Supervisor of GCP compliant system, author of SOPs and auditor of vendors.

      Leading a group of clinical specialist responsible for studies execution according to EMA/TPF/FDA regulations and GCP/GMP requirements.

      Session Details:

      Case Study – Training and engagement of study volunteers for the study execution – key success factor

      2023-11-21, 2:00 PM

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      Andy Gurd
      Senior Director, Product Marketing, Medidata

      Andy is responsible for product marketing strategy, messaging, and content for the Medidata Platform, Rave EDC, and Medidata’s next-generation clinical data management solutions. Andy has over 23 years of technology product marketing experience, the last 10 years working with clinical research technologies and services, including 6 years with a leading contract research organization, Parexel. Before entering life sciences, Andy spent 13 years in product marketing/management roles for systems and software engineering technologies, including 5 years with IBM.

      Session Details:

      Solving the Clinical Data Challenge

      2023-11-21, 10:00 AM

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      Harald Wagner
      Director Clinical Operations, AMS Advanced Medical Services

      Harald Wagner, has 30 years of experience in drug manufacturing, research & development in various sponsor- and CRO functions with his background in pharmaceutical technology. During the recent decades his focus has been on Clinical Operations of large scale and long-term Clinical Studies, as well as pioneer projects establishing new processes and clinical systems early, such as EDC, Risk-based Monitoring, eTMF, CTMS, wearables, ePROs or Decentralized Clinical Trials, leading the Clinical Operations department of the European CRO AMS Advanced Medical Services

      Session Details:

      How a combined CTMS and eTMF will optimize the Collaboration across Clinical Study Teams!

      2023-11-22, 9:45 AM

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      Jan Klint Nielsen
      Community Manager Life Sciences, BSI Business Systems

      Jan Nielsen, has more than 16 years of experience in product design, validation, implementation, and support of eClinical and CRM software systems at international pharma, biotech, med-tech and CRO. He graduated from Copenhagen University College of Engineering in 1990 and started his career in Switzerland in a global industrial company , soon becoming head of electrical and software development. In 2007 Jan moved to BSI to help build up their life sciences business as provider of eClinical software systems, where he is today working as Community Manager Life Sciences.

      Session Details:

      How a combined CTMS and eTMF will optimize the Collaboration across Clinical Study Teams!

      2023-11-22, 9:45 AM

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      Giulia Rancati
      Market Solutions Lead for R&D, Roche

      Giulia Rancati worked across biotech, academia and government organisations in the USA, Europe and South-East Asia. In 2021, she then transitioned to F. Hoffmann - La Roche where she leads the R&D Market Solutions Lead in Insights and Solutions. Here, Giulia is coaching a global team that focuses on co-creating and delivering R&D solutions to increase preclinical and clinical efficiency.

      Session Details:

      Overview of AI applications for clinical trials, what are today’s possibilities?

      2023-11-22, 11:15 AM

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      Rolf Banholzer
      Global Head Development Operations QA, Novartis Pharma

      Session Details:

      Presentation and Q&A: The 2023 EMA Guidance on computerized systems and electronic data in clinical trials: A clinical trial-risk-centric review and perspective

      2023-11-21, 11:00 AM

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      Pauline Frank
      Patient Engagement And Insights Director, Novartis

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-11-22, 3:45 PM

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      Francois Curtin
      CMO/Medical Director for Personalized Health Programmes, Swiss Federal Institute of Technology Zurich

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-11-22, 3:45 PM

      Session Details:

      PANEL Pinpointing how the DACH region can “lobby” to enhance our leadership role in global clinical trials

      2023-11-22, 9:00 AM

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      Valdo Arnera
      Medical Scientific Advisor and General Manager, Geneva Office, Clario

      A medical doctor by training, Dr. Valdo Arnera has over 35 years of experience in the pharmaceutical industry. Starting his career as a clinical pharmacologist in a Ciba-Geigy’s daughter company, he then founded the first European Central clinical laboratory dedicated to clinical trials, SciCor (now Covance central laboratory). Always passionate about how to improve the clinical trial process, Valdo joined PHT in 2000, and founded the European affiliate of PHT Corporation in January 2001. PHT was acquired by ERT in 2015 and then merged with Bioclinica to form Clario. Valdo has always taken care of the eCOA portion of Clario and is seen as one of the pioneers of the ePRO business.

      Session Details:

      15-minute Tech Spotlight: Accessibility functionalities: Using scientific validation to maintain data integrity in clinical trials

      2023-11-21, 12:30 PM

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      Estelle Jobson
      EUPATI Fellow and Patient Expert

      Estelle Jobson is a EUPATI Fellow and patient expert, living with endometriosis. She has an MSc in Publishing, from New York University, attended on a Fulbright scholarship, and decades of experience in editing and managing publications for health-related, academic, and educational institutions.

      Since 2019, she has been a patient partner at the Geneva University Hospitals (HUG), notably exploring how investigators can embed patient-centricity in their studies. Estelle works as Account Director and Patient Lead at a Geneva-based health communications agency, Infinity Communications. Her key interests include: patient engagement in R&D and trial design, lay summaries, patient-centric resources, patient-reported outcomes, and risk–benefit communications.

      Session Details:

      Baking patient-centricity into clinical development and trial design

      2023-11-22, 1:45 PM

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      Claudine Rigal
      PharmD, ClinBio Vice President, Global Testing Services, Labcorp

      Claudine Rigal is vice president of the Global Lab Operations for Labcorp Central Laboratory Services. Claudine received her Doctor of Pharmacy degree from René Descartes Paris V University, France, and further completed a residency program to become a Clinical Biologist. She also obtained an Executive MBA from Emlyon Business School (Lyon, France).

      Claudine joined Labcorp in 2017 (Covance at that time) bringing over 25 years of experience in leadership both in diagnostic and central laboratory services supporting clinical trials. Before joining Labcorp, she held positions of increasing responsibilities such as Laboratory Director, Chief Scientific Officer and Deputy Managing Director. Based in Singapore over the past 5 years, Claudine positioned our Asia Pacific laboratories for success delivering high quality services and developing talents in region. She is now leading central lab operations globally, based in Geneva.

      Session Details:

      Where Science and Operations Meet: Delivering Complex Clinical Trials

      2023-11-21, 2:30 PM

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      Dr. Malgorzata Szerszeniewska
      Head of Operations, Europe, Novotech

      Szerszeniewska is a co-founder of EastHORN. Previously, she was president of AbCRO, Inc., an American-owned CRO operating in Europe. Prior to that Dr. Szerszeniewska spent more than 10 years at Covance, where she held various positions including Regional Resource Manager, Project Manager, Director of Strategic Development and Clinical Operations in Europe, and was responsible for development of the company’s Clinical Development Services in the European region.

      Before joining the CRO industry, she worked as an Anesthesiology and Intensive Care Specialist at Warsaw University Hospital. Dr. Szerszeniewska’s therapeutic experience includes oncology, neurology, cardiovascular, psychiatry and gastrointestinal medicine. Dr. Szerszeniewska received her Medical Diploma from the Warsaw Medical University.

      Session Details:

      Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

      2023-11-21, 4:30 PM

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      Prof. Dr. med. Andreas Trojan
      Co-Founder and CMO, Mobile Health AG, Medical Oncologist and Leading Physician, Breast Center Zürichsee

      Prof. Dr. Trojan graduated from Medical School in Zurich, Switzerland in 1992. From 1997 to 1999, he was a Research Associate in oncology at the Dana Farber Cancer Institute, Harvard Medical School. As a resident in oncology, Co-Head ABMT-Laboratory, PI and head of a translational research group, Dr. Trojan has spent more than 10 years at the University Hospital of Zurich. He has also continued most of his research at the University of Zurich, with a focus on immunology, pharmacogenetics, and breast cancer.

      Furthermore, he was assigned as the leading oncologist for Breast Centers in Zurich and has conducted a variety of clinical trials involving patient communication and shared decision making, with integration of electronic patient reported outcomes (ePROs). Dr. Trojan now holds a titular professorship at the University of Zurich medical faculty and has been awarded with national and international prizes for his patient-centered work and outcome research. He is the founder of Mobile Health AG, as well as the initiator of a number of randomized trials and registries involving the MediduxTM app for ePROs. Currently, Dr. Trojan focuses on patient@home digital support, study registries for biosimilars and implementation of decentralized clinical trials.

      Session Details:

      15-minute Tech Spotlight: Re-discovering the patient journey in decentralized clinical trials

      2023-11-21, 12:45 PM

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      Natalia Buchneva
      Risk Management Lead, Clinical Data & Innovations, UCB and European Federation of Pharmaceutical Industries and Associations Working Team Member

      >20 years of working experience in clinical research in various positions in quality assurance and clinical operations. Recently focusing on risk-based quality management at UCB as part of the Clinical Data and Innovations team.  UCB´s representative in EFPIA working group for ICH E6 R3 “GCP Renovation” since 2020.

      Session Details:

      Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

      2023-11-21, 4:30 PM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-11-22, 3:45 PM

      Session Details:

      KEYNOTE PRESENTATION with Q&A

      2023-11-21, 8:45 AM

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      Plan Your Visit

      Venue

      Im Zentrum 2 8105 ZURICH REGENSDORF Switzerland

      Accommodation

      Mövenpick Zurich Regensdorf Im Zentrum 2 8105 ZURICH REGENSDORF Switzerland

      Guests can book accommodation only by sending email to reservation.regensdorf@movenpick.com or call +41 44 871 5111. If you wish for your booking to be guaranteed, please provide full name, full home or company address and credit card details. Rate is CHF 189 inclusive of breakfast plus CHF 2.50 city tax per person per night.

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      WHAT TO EXPECT FOR 2023

      Join pharma and biotech experts to discuss new trends and opportunities and learn how they optimize their clinical operations enabling you to stay ahead of the game.

       

      Find the right solution providers to partner with, allowing you to accelerate your trial timelines.

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