14th Annual Outsourcing in Clinical Trials Europe 2024

Creating a collaborative environment where pharma & biotech leaders can find solutions to current challenges through innovations and partnerships

7 - 8

May

2024
  • Hyatt Regency Barcelona Tower, Barcelona, Spain
  • Complimentary
  • Why attend?
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Featured Speakers

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Mats Sundgren​

PhD, European Institute of Innovation through Health Data (i-HD)

Mats Sundgren, PhD, MSc, is a renowned expert in Health Data Strategy for Industry and Academia. With over 37 years in the pharma industry (Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science and Data Science & AI), Mats is at the forefront of industry technology innovation. In 2022, following a 12-year tenure as global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats’ new portfolio encompasses the roles of Senior Industry Scientific Director for the i~HD (European Institute for Innovation through Health Data); Executive Strategic Advisor for IgniteData, developer of a system-agnostic EHR-to-EDC solution for clinical trials; and Chairman of the Board of the Research Foundation IMIT (Institute of Managing Innovation and Technology) across Chalmers University of Technology, Royal Institute of Technology, Lund University of Technology & Stockholm School of Business.

Mats has authored over 70 publications, books, and patents in Science, Economics & Social Science (Health Data Science, Clinical Science, Business Modelling, Innovation & Creativity Management, and Device development).

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Francis P. Crawley​

Executive Director , Good Clinical Practice Alliance - Europe (GCPA)

Francis P. Crawley is a philosopher with a career in bioethics and expertise in research policy, regulation, ethics, integrity & methodology as well as in data/AI/virtual twins ethics and law with particular attention to the life sciences: clinical trials, genomics/omics, new technologies. Expertise in EU, US, international and country-specific ethics, law, and patient and community interests in health-related research. Strong experience working closely with patients, communities, researchers, and policymakers across disciplines. domains, and geographic regions in establishing consortia, developing patient registries, contributing to the development of biobanks, drafting data management and data protection plans, and contributing to building data repositories. A strong background in the methodologies for designing and reviewing health-related research supported by effective communication and leadership skills as well as diplomacy with the ability to influence changes in bioethics and law. Additional strong background in the development of research, guidance, and ethics related to global diseases affecting resource-poor settings and orphan diseases in the context of leading and/or contributing to challenging projects. Wide experience (e.g., UNAIDS, WHO, UNESCO, European Commission, Council of Europe, and others, including local organizations and industry) in developing health-related research projects, collaborative engagements, regulatory and policy outreach, and education and training in Europe, Africa, Asia, the Americas, and Eastern Europe & Central Asia. Leading roles in the development of international and national guidelines, capacity-building, empowerment, and education programmes for health research; including GCP, ethics review systems, genetics and biobanks, and data privacy & management (a GDPR DPO), with expertise in the ELSI aspects of data AI, digital twins, and organoids. Since January 2020 highly active in the research, ethics, data sharing, and policy discussions on COVID-19, particularly in the areas of vaccines, repurposed medicines, and genetic modelling, having organised more than 40 global webinars and coordinating research across HICs and LMICs. Recently engaged in the policy, ethics, and regulation of data and AI in times of crisis. Founded and coordinates the Ukraine Clinical Research Support Initiative (UCRSI) in cooperation with leading Ukrainian, European, and international organizations. He is at the forefront of the European and global movement to reform and advance research assessment in the universities and other research institutions, with a particular emphasis on research ethics and research integrity in developing policy for data and AI in the research assessment process.

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Amelia Hursey​

Parkinson's Research Manager, Parkinson's Europe

Amelia joined the Parkinson’s Europe  team in Jan 2022 as Research Manager. Since then she has developed Parkinson’s Europe’s Research Strategy, embedding a Research Steering Group into the organisation and helping to increase the presence of Parkinson’s Europe in the clinical research world. She is also focused on bringing new initiatives to the table, such as the Parkinson’s Europe’s Engagement Network, which better connects the Parkinson’s

community with research across Europe. Parkinson’s Europe is now a partner member of EUPATI and the Critical Path for Parkinson’s as part of this action.

She has been working in the field of Neurodegenerative research since 2009 and is a Patient Organisations board member with EUPATI since Sept 2023.

She previously worked for the UK NIHR’s DeNDRoN delivering clinical trials and then at Parkinson’s UK from July 2015 as Research Participation Lead.  She was responsible for initiatives to increase research participation for people affected by Parkinson’s, health care professionals and researchers, and created the innovative Parkinson’s UK Take Part Hub and co-produced the Staying Connected toolkit in collaboration with the HRA UK.

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Mireille Ermens​

Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring

Mireille Ermens, is a seasoned leader in the field of clinical research and healthcare management with a rich background spanning over two decades. Armed with a degree of Socio Medical Science with distinction from the University Ghent, Belgium, Mireille brings a unique blend of expertise in biochemistry, mathematics, statistics, and preventive healthcare.

A true polyglot, Mireille is fluent in Dutch, French, and English, with proficiency in German and Spanish, reflecting a deep commitment to effective communication across diverse cultural landscapes.

With a leadership style centered around "Building Bridges with and for People," Mireille has led clinical development operations teams, navigating challenges in rare and chronic diseases, high-volume infectious diseases and seasonal vaccine environments.

Currently serving as the Senior Director of Global Feasibility and Start Up Support at CSL Limited, Mireille spearheads strategic assessments of clinical trial feasibility, facilitating optimal business decision-making through meticulous recruitment-time-cost analyses and evaluation of execution options.

Prior to this role, Mireille served as the Head of Global Site Management and Monitoring Oversight at CSL Seqirus, while advocating for global process consistency with a patient-oriented oversight agility. Mireille's extensive experience also includes senior positions at Eli Lilly and Hoffmann-La Roche.

Mireille began her career as an ICU Coordinator in Intensive Care at the University Hospital, Ghent, monitoring and caring for patients post-cardiac surgery, demonstrating a commitment to hands-on patient care.

With a career trajectory marked by innovation, strategic vision, and a relentless pursuit of excellence, Mireille is a dynamic speaker who brings a wealth of knowledge and expertise to any discussion on clinical research, healthcare management, and leadership in the pharmaceutical industry.

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    2024 Sponsors Include:

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    Company Information

    Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 35,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

    Company Website

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

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    Company Information

    Care Access is a global clinical research company helping to accelerate the future of medicine. With a global network of over 200 research sites, Care Access supports research studies conducted by 14 of the top 15 biopharmaceutical companies. In addition to its proven track record of globally top-enrolling sites, Care Access partners with new-to-research communities and establishes high-quality research site infrastructure locally to expand access to clinical trials and increase representation. For research sponsors, Care Access offers three core services: (1) global network of research sites, (2) community screenings to expand a study’s reach, and (3) on-demand staffing, space expansion, and training services to support all research sites on a study. To learn more about active studies at Care Access, or how Care Access helps sponsors achieve enrollment and representation goals.

    Company Website

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

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    Company Information

    KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries.   Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies.

    Company Website

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

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    Excelya is an independent CRO partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions

    Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

    Company Website

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

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    Company Information

    At IOMED we develop AI-powered technology for healthcare data activation. Our Natural Language Processing system is capable of standardizing both structured and unstructured healthcare data, adding value to healthcare organizations and leading the path to a global data-driven healthcare ecosystem.

    Company Website

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

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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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    Company Information

    Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase.

    Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006.

    The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.

    For more information or to speak to an expert team member visit www.Novotech-CRO.com

    Company Website

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

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    Company Information

    MaxisIT’s clinical data analytics platform is a purpose-fit solution developed to improve clinical trial performance, mitigate risk, and optimize clinical outcomes. This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively.

    Company Website

    To learn more, please visit our website - www.maxisit.com/ctos/

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    QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. We are passionate about our work, creating value for patients and customers while generating opportunities for employees to thrive.

    Company Website

    To learn more, please visit our website - www.qps.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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    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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    Medicover Integrated Clinical Services is a unique clinical research organization with 25 years of experience.

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

    Company Website

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

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    Zelta™ by Merative is a clinical trials solution business that includes both a clinical data management and acquisition platform and consulting, enablement, and extension services. Zelta’s unified cloud-hosted platform supports all phases and complexities of research, including over 450 phase 3 trials.

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    Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.

    Company Website

    To learn more, please visit our website - medtech.labcorp.com

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    Company Information

    MRN is focused on the delivery of patient-centric clinical trials. Through our at-home, at-site and digital decentralized trials solutions we help our pharma and site partners design more flexible and accessible clinical trials allowing them to accelerate patient recruitment and enrollment and improve patient engagement and retention around the globe.

    Company Website

    To learn more, please visit our website - https://themrn.io/

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    Ethicare Clinical Trial Services – Headquartered in Ahmedabad, India – is a leading full-spectrum service provider Clinical Research Organization that provides quality-driven End-to-End Phase I to IV Clinical Trial Management, Electronic Data Management, Clinical Trial Monitoring and Global Pharmacovigilance to Pharmaceuticals, Biotech, Medical Devices, and Nutraceutical Companies across the Globe.

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    CRScube provides customizable and modular software solutions designed to benefit trials of all clinical phases and therapeutic areas through minimizing inefficiencies and streamlining end-to-end operations, from first planning to final closure.

    Company Website

    To learn more, please visit our website - www.crscube.io/

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    Barrington James are a Global specialist recruitment consul­tancy working across the Healthcare sector.  Our structure, with separate divisions and dedicated consultants for the markets we serve ensures a thorough, professional and intelligent approach in both permanent and interim solutions.  Our tailored methodologies include Contingency database search and executive search.

    Company Website

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

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    Biotrial is a leading CRO specializing in Drug Development, offering a wide range of expertise. With hundreds of studies conducted, we provide tailor-made solutions in Non-Clinical Pharmacology, Clinical Development, Bioanalysis, Biometrics, ECG, CNS & Imaging Core Lab.

    Company Website

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

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      Why attend?

      Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 7th-8th May 2025!

      For the 14th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials.

      This conference will bring leading industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, and technology.

      WHAT TO EXPECT FOR 2024?

      With regulations ever changing and the innovative advancements of technology rapidly growing, this conference will address the everyday and perspective challenges faced when working within the clinical trial space. Legislations such as the CTIS review to Generative AI and leveraging our global trial footprint to accelerate clinical development, as well as building on our new and existing relationships within our industry.

      This conference will bring industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, technology and of course, patient centricity.

      This is a unique opportunity to network and share knowledge with the region’s leading pharmaceutical firms, biotech’s and medical device companies, to discuss operationally efficient, specifically targeted clinical trials. The 2024 program boasts 4 full streams complete with key content.

      Stream A: Outsourcing & Clinical Operations

      Stream B: Clinical Innovation & Technology

      Stream C Day 1: Patient Centricity

      500+

      Attendees

      		80+

      Exhibitors

      		40+

      Speakers
      500+

      Attendees

      		80+

      Exhibitors
      40+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 7 May 2024
      • 8 May 2024
      Expand All

      Streams

      Stream one

      Stream A: Clinical Operations and Outsourcing

      Stream two

      Stream B: Clinical Technology & Innovation

      Stream three

      Stream C: Patient Centricity

      11 AM

      PATIENT ADVOCATE KEYNOTE: Which Patients? How Centric?

       

      ·       Outsource To Us - Patients, Groups, Experts and Advocates

      ·       Trials as Treatments - Research as Routine

      ·       Involvement/Engagement - Conversation or Intervention

      • Perspectives and Expectations - QoL, PROMs, results and transparency

      Speakers

      Richard Stephens
      Veteran Patient Advocate, Trial Participant, Author, Journal Editor

      11:30 AM

      Practical Solutions for Patient Engagement in CGT Trials: Supporting Patients and Families Throughout the Journey

      • Collaborating with sites to minimise patient burden
      • Effective communication strategies for patient recruitment, education, and retention
      • Optimizing the patient experience through prolonged trial durations, from decision making to late follow up

      Speakers

      Maria-Cruz Morillo
      Global Therapeutic Operations Lead, Rare Diseases, Allucent

      12 PM

      Building clinical trials with the perspective of the patients in mind

      exploring patient collaboration and the benefits it can bring to the sponsor and the patient.

      • Discussing the collaboration that has to exist between all parties (patients, coordinators, doctors) in order to have a successful trial
      • Importance of good communication to the patients and how this can streamline trial timelines
      • Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up

       

      Speakers

      Amelia Hursey
      Parkinson's Research Manager, Parkinson's Europe

      12:30 PM

      Pioneering Gene Therapy in Rare Diseases: A Path to Revolutionary Treatments

      In this session, attendees can expect to:

      ·       Gain insights into the transformative impact of gene therapy on rare disease treatment, underscoring a new era of medical breakthroughs.

      ·       Learn about the complexities involved in conducting gene therapy trials, from the unique challenges to the innovative solutions.

      ·       Understand TFS HealthScience's approach to navigating the project management hurdles specific to gene therapy research.

      Speakers

      Lakshmi Gurduri
      Director Project Management, TFS Health Science

      1 PM

      Lunch and networking

      2 PM

      Site selection for increased patient recruitment and retention

      • Highlighting discrepancies in the distance between clinical trial sites and the disease prevalent populations using case studies.

      • Exploring the impact of appropriate and inappropriate site selection on a trial’s success through case studies.

      • Showcasing how patient
      accrual has been affected in clinical trials utilizing virtual components.

       

      Speakers

      2:30 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

      Sverre Bengtsson
      Co-Founder, Viedoc

      3 PM

      FIRESIDE CHAT: Patients at the Heart

      This session will bring together two industry experts from different sides of the drug development landscape; Innovator and Generics Pharma.  Both with a focus on advancing patient care but in unique and different ways. We will touch base on synergies as well as individual challenges and how we commonly drive forward the development of safe, effective, and affordable medicines that meet the needs of patients worldwide.

      Speakers

      Linda O’Grady
      Director Clinical Procurement, Novartis
      Saskia van Dalen
      Global head R&D procurement, Sandoz

      3:30 PM

      Afternoon refreshments and networking

      4:15 PM

      PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

      • Discover sites with a demonstrated track record of good execution in trials
      • Uncovering a strong study workforce to ensure patient enrolment and effective study start-up
      • Analysing sites access to subject population with the required eligibility measures.
      • Understanding new landscapes from a legislative perspective
      Moderator: Richard Stephens, Patient Advocate

      Panellists:
      Mireille Ermens, Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring

      Nikita Sharma, Global Clinical Sciences & Operations Innovation Manager, UCB

      Amelia Hursey, Research Manager, Parkinson's Europe

      Francis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe (GCPA)

      Robert Kurowicki, Director of Feasibility and Project Strategy, Novotech

      Speakers

      Richard Stephens
      Veteran Patient Advocate, Trial Participant, Author, Journal Editor
      Mireille Ermens
      Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring
      Nikita Sharma
      Global Clinical Sciences & Operations Innovation Manager, UCB
      Amelia Hursey
      Parkinson's Research Manager, Parkinson's Europe
      Robert Kurowicki
      Robert Kurowicki, Director of Feasibility and Project Strategy, Novotech Europe
      Francis P. Crawley
      Executive Director , Good Clinical Practice Alliance - Europe (GCPA)

      5 PM

      Putting patients at the centre of their clinical trial journey: supporting engagement, driving ePRO compliance

      • How robust, globally-deployable solutions can be designed from a 'patient-first' perspective
      • Sharing learning on achieving meaningful engagement throughout the study
      • Exploring how modern technology both retains patients and drives high eCOA/ePRO compliance
      • Case studies on embedding human-centred design to deliver faster, more flexible outcomes for sponsors

      Speakers

      Bruce Hellman
      Co-Founder and Chief Patient Officer, UMotif

      5:30 PM

      Chairperson’s closing remarks followed by Drinks Reception

      END OF DAY 1 AND NETWORKING DRINKS RECEPTION

      11 AM

      Transforming Clinical Trials: Harnessing AI for Decentralized Study Design and Operations

      In recent years, the clinical research landscape has witnessed a paradigm shift towards decentralized clinical trials (DCTs) and the integration of artificial intelligence (AI) into various aspects of drug development. This presentation aims to explore the intersection of these two transformative trends and their potential to revolutionize the way we conduct clinical studies.

       

      Speakers

      Nikita Sharma
      Global Clinical Sciences & Operations Innovation Manager, UCB

      11:30 AM

      How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors

      • +Why clinical technologies and product integration strategies are more important than ever
      • +How to eliminate redundant activities, such as data entry and reconciliation
      • +How to leverage clinical data quickly to generate insights and improve study optimization and decision-making
      • +Accelerate time to database lock with improved data quality

       

      Speakers

      Anthony Mikulaschek
      VP, Commercial Strategy, IQVIA Technologies
      Stefan Dürr
      Senior Director, Client Delivery, Cenduit IRT, an IQVIA business, Head of Drug Supply Center of Excellence

      12 PM

      Planetary Health: New paradigms for Innovation and Research

      This session will address the intersection of global health, climate change, innovation, digital health, artificial intelligence, and research in an engaging and accessible manner. The aim is to highlight how global changes and new technologies impact innovation and research, using specific examples related to clinical trials.

      Speakers

      Jordi Serrano Pons
      Medical Doctor expert in Digital and Global Health, Barcelona Health Hub Board Member

      12:30 PM

      A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

      Join us for a comprehensive exploration into Parkinson’s disease (PD) endpoint data collection, as we delve into the core elements of efficacy, safety, and quality of life. This session will highlight how the integration of different endpoint modalities provides researchers with a clear advantage in their mission to advance innovative therapeutics for this largely unmet medical need. The endpoint modalities to be discussed include:

       

      • Wearable digital endpoint solutions and their pivotal role in providing quantitative gait assessment for detection of disease progression
      • eCOA solutions for assessing efficacy and quality of life, leveraging clinical rating scales, symptom diaries, and other patient-reported outcome measures
      • Medical imaging modalities focused on accurately characterizing PD status biologically, paving the way for biomarker-guided drug development.
      • Cardiac monitoring in this unique population, collecting high-quality blood pressure and cardiac rhythm data to characterize PD-associated autonomic dysfunction.

      Speakers

      Todd Rudo, MD
      EVP & Chief Medical Officer, Clario
      Bryan McDowell
      VP, eCOA Science & Consulting, Clario

      1 PM

      Lunch and networking

      2 PM

      Great expectations and how to meet them – connected devices and ePRO in clinical trials

      • Focusing on design considerations

      • Understanding the best framework for your study

      • Considering patient ePRO assessments needed for a specific study

      • Highlighting best practice for data collection

      • Avoiding expensive mistakes that undermine your trial outcome or delay your timeline

      • Outlining Regulatory restrictions around ePro
      • Comparison vs Paper Reported Outcomes – why are companies not transitioning fully to ePro?

       

      Speakers

      Dr Mar Gomis Pastor
      Director of the Center for Digital Clinical Validation, Hospital de la Santa Creu i Sant Pau
      Alicia Borràs
      Study Coordinator, Digital Health Unit, Strategy Office Més Sant Pau, Hospital de Santa Creu i Sant Pau

      2:30 PM

      AI: A Game Changer for Clinical Operations

      Advances in Artificial Intelligence (AI) are rapidly changing our approach to clinical operations and how we work day-to-day.

      AI is being incorporated into existing clinical operation workflows to help unblock obstacles at study startup, and create and manage KPIs, provide natural language summaries of actionable insights such as threshold breaches, and more. Within Risk-Based Quality Management (RBQM), AI is enabling organizations to proactively manage risk and quality and quickly action and remediate issues as they arise at scale across their functions.

      Join this exciting session to learn how Saama's ground-breaking AI-driven platform empowers clinical operations teams to quickly identify and remove bottlenecks within their studies – accelerating their time to study completion.

      Speakers

      Sas Maheswaran
      Vice President, Product Implementation, Saama Technologies

      3 PM

      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

      Dr Sol Yates
      Associate Director, European Regulatory Affairs, Shionogi Europe

      3:30 PM

      Afternoon refreshments and networking

      4:15 PM

      PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

      • Are we making the most of Technology & Innovation in the Clinical Trial space?
      • Highlighting Innovation points of interest such as Metaverse, Blockchain and Machine Learning to name but a few
      • How are these tools being utilized?
      • The importance of exploring ethical considerations, now.
      • What’s next?

      Speakers

      Mats Sundgren
      PhD, European Institute of Innovation through Health Data (i-HD)
      Maria Reyes Boceta-Munoz
      Head Of Clinical Operations Spain, GSK
      Laura Jiménez Robledo
      Clinical Project and Innovation Manager, Novo Nordisk
      Upinder Grewal
      Strategic Lead Exploration and Discovery, DS&AI, Bayer
      Gabriel Maeztu
      Co-founder of IOMED

      5 PM

      Advantages and Challenges of New Technology in Clinical Research

      • How the integration of digital health technologies has enabled the collection of real-time data from patients outside of traditional clinical settings?

      • How can we analyze large volumes of clinical and genomic data to identify patterns, predict treatment responses, and personalize therapies?

      • Can we improve patient recruitment, protocol design optimization, adverse event prediction, and data analysis? How new technologies and processes can accelerate the trial process, improve efficiency, and reduce costs.

      • Enhance security, transparency, and integrity of clinical trial data

      • Regulatory and operational challenges

      Speakers

      Ana Moreno
      Director Global Clinical Operations, APICES

      5:30 PM

      Chairperson’s closing remarks followed by Drinks Reception

      END OF DAY 1 AND NETWORKING DRINKS RECEPTION

      7:45 AM

      Registration and refreshments

      8:20 AM

      Chairperson’s opening remarks

      Speakers

      Francis P. Crawley
      Executive Director , Good Clinical Practice Alliance - Europe (GCPA)

      8:30 AM

      KEYNOTE Revolutionizing Clinical Trials through RWD and AI: Unleashing Innovation

      In the ever-evolving realm of medical research, innovation within clinical trials is instigating a transformative wave that significantly enhances patient outcomes. Harnessing the power of advancements in trial design, digital technologies, Artificial Intelligence & Machine Learning algorithms, and data analytics, this wave of innovation is driving drug development forward. It extends the reach of experimental treatments to more patients, while simultaneously elevating the overall quality and analysis of trial data.

      This keynote presentation offers a deep dive into the multifaceted landscape of innovation, exploring groundbreaking approaches such as Federated EHR research platforms, eSource-supported trials, artificial intelligence, and patient-centric strategies. These pioneering methodologies not only optimize operational efficiency but also individualize medical approaches, fostering a continuous evolution in the trial process.

      Key Topics Covered:

      • The Changing Landscape: Exploring Paradigm Shifts in Clinical Trials
      • Advancements in Trial Design & Digital Technologies: An In-Depth Look at Federated EHR Research Platforms
      • Emerging Impact of AI in Clinical Trials: Unpacking the Role of Artificial Intelligence in Clinical Research
      • Two Use Cases: How eSource & AI-Driven Event Adjudication Can Transform Clinical Trials
      • Outlook & Conclusions: Anticipating Future Trends and Developments in Clinical Trial Innovation

      Speakers

      Mats Sundgren
      PhD, European Institute of Innovation through Health Data (i-HD)

      9 AM

      A New Paradigm for Clinical Innovation

      The clinical research industry is at an inflection point. Advancements in technology have created the opportunity to transform clinical trial outcomes, but to make this ambition a reality, we must now rethink how we engage with patients. Today, we often treat patient relationships as transactional, de-identified numbers on individual clinical trials. We need a new way of thinking about patients. A more longitudinal way, with greater pre-trial engagement and post-trial follow-up, and across multiple studies and healthcare experiences. We also need to change how we look at patient data, widening the lens to understand patients’ health and research journeys across a broad ecosystem of data sources. But how do we execute this paradigm shift when we’re also under pressure to accelerate timelines, reduce risk, lower costs, and improve quality?

      In this presentation, we’ll explore:

      ·       Industry drivers of this clinical research evolution

      ·       Challenges faced & the value of change

      ·       Reasons to believe - Improving trial experiences for patients, sites, CROs, & sponsors

      Speakers

      Richard Gray
      Managing Partner, Medidata, Dassault Systemes

      9:30 AM

      Governance of Clinical Research within the European Health Data Space

      As the European Union embarks on its journey to create a harmonized and interconnected health data ecosystem, the governance of clinical research within this evolving framework becomes paramount. This talk addresses the multifaceted challenges and opportunities associated with ensuring the ethical, legal, and efficient conduct of clinical research within a newly being carved out data space that promotes access to health-related data while safeguarding patient data privacy. The presentation emphasizes the importance of establishing a robust governance model that fosters collaboration among stakeholders, promotes data sharing, and aligns with emerging data and AI regulations. By addressing key questions regarding data access, consent frameworks, ethics review, and cross-border collaboration, the discussion provides insights into the evolving landscape of clinical research governance within the European Health Data Space, offering valuable takeaways those at the forefront needing to navigate the challenges and opportunities of this transformative era. The talk will specifically:

      • explore the ethical and legal considerations of clinical research governance within the European Health Data Space;
      • highlight the role of data protection regulations, ethics review, and consent frameworks in shaping research practices; and
      • discuss strategies for fostering cross-border collaboration and data sharing among diverse stakeholders in clinical research within the emerging governance frameworks.

      Speakers

      Francis P. Crawley
      Executive Director , Good Clinical Practice Alliance - Europe (GCPA)

      10 AM

      Going Beyond ROI: Necessary Criteria for Impactful Innovation with Decentralized Clinical Trials

      Even with high ROI, what drives widespread adoption is when sponsors and sites find the burden of an innovation to be less than the status quo. I will share different approaches of innovation within decentralized trials which showcase going beyond ROI.

      Speakers

      Martin Czakon, MSc
      EMEA Head of Commercial Strategy & Growth, Care Access

      10:30 AM

      Morning & Refreshment break

      11 AM

      Fireside chat – ask the experts! Trial Execution in 2024 and Beyond

      This fireside chat will look at funding trials, executing trials, the impact of new regulations, new treatment standards emerging, new technology, inflation, and its impact on costs.

      Speakers

      Michael Zörer
      Head of Clinical Operations, VarmX
      Sonja Weiser
      Senior Director Clinical Operations, Insmed

      11:30 AM

      Navigating the Complex Regulatory Landscape for Oncology Trials: A Focus on the European Union

      ·       Overview of the harmonized regulatory framework within the EU and its impact on oncology trials.

      ·       Discussion of the diversity in regulatory requirements across EU member states and the challenges this poses for oncology research.

      ·       Strategies for navigating the complex regulatory landscape in the EU for successful oncology trial execution.

      Speakers

      Matt Cooper
      Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials
      Sarah Bly
      Director Regulatory Science, Strategy & Innovation, Worldwide Clinical Trials

      12 PM

      Site Partnerships: Developing Site Relationships beyond Study-Level Engagement

      • Supporting the portfolio across Therapeutic Areas
      • Establishing a Strategic Role at a Regional-Level

       

      Speakers

      Christian Milliet
      Head of Site and Healthcare Ambassadors, CSL Behring

      12:30 PM

      Maximizing the Consultative Partnership Between CRO and Biotech Sponsors

      • How early engagement will improve outcomes
      • Speaking the same language – one size doesn’t fit all
      • Simplifying the complex, in a world with an awesome amount of outsourcing options

      Speakers

      Polly Cooper
      Senior Director, Project Delivery, Biotech - ICON

      1 PM

      Lunch and networking

      2 PM

      Leveraging operational expertise to enhance study design and patient centricity in clinical trials

       

      • Impact of complex clinical trial designs on study duration
      • The essential role of operations in study design decisions
      • Assessing clinical study protocol complexity
      • Fostering cultural shift during study development process
      • Investigating the relationship between operational complexity and patient burden
      • Incorporating patient insights to streamline clinical trials

      Speakers

      Alina Pszczółkowska
      Head of Late Phase Program Management Respiratory & Immunology, AstraZeneca

      2:30 PM

      Why So Slow? Insider Insights from The Clinic Floor to Speed up the Startup and Execution of Proof-Of-Concept Patient Trials

      How to:

      ·       Harness regulatory dynamics for strategic advantages.

      ·       Obtain feasibility figures true to delivery.

      ·       Employ innovative study designs to expedite the development program.

      • Customize efficient patient recruitment tactics!

      Speakers

      Louis Smikle
      Executive Director, Global Strategic Partnerships, ARENSIA

      3 PM

      Fit-for-Purpose Outsourcing Strategy in Clinical Trials and Cost Optimization

      • Outsourcing clinical activities became essential to the operational success of pharmaceutical companies
      • There is a need to continuously improve operational efficiency and reduce research and development costs
      • A fit-for-purpose outsourcing strategy will ensure an improvement in operational efficiency and optimization outsourcing costs
      • Define a clear outsourcing strategy will drive cost reduction with a targeted collaboration with CROs
      • How internally can costs be optimized when outsourcing a clinical trial? How to compare costs?

       

      Speakers

      Martin Rodriguez
      Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

      3:30 PM

      Afternoon refreshments and networking

      4:15 PM

      PANEL – Outsourcing Strategies & Relationships

      • Discussing how to approach your outsourcing strategy?
      • Uncovering if your offerings are competitive, and if this is indeed value for money.
      • Looking into what is driving the increasing costs of running your study, recognising the value associated with costs and their justifications.
      • Establishing what can be done to avoid increasing budgets including the evaluation of tools required for the type of study one is conducting.
      • What are your options if the partnership is not working as planned, mid study?
      • How to keep a healthy relationship when faced with ongoing challenges, partnership by respectful collaboration.

       

      Moderator: Silvana Giro, Senior Manager, Responsible Global Outsourcing and Contract Management Europe, Management Services, Global Medical & Regulatory Affairs, Bracco Imaging

      Panelists:
      Martin Rodriguez, Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

      Dan McVeigh, Director, Clinical Project Lead, Alexion Pharma

      Michael Zörer, Head of Clinical Operations, VarmX

      Speakers

      Silvana Giro
      Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging
      Martin Rodriguez
      Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi
      Daniel McVeigh
      Director, Clinical Project Lead, Alexion Pharma
      Michael Zörer
      Head of Clinical Operations, VarmX

      5 PM

      The Future of Regulatory Compliance: Digital Tools for Mastering EU MDR and Post-Market Challenges

      This presentation explores the evolving landscape of regulatory compliance within the European Union's Medical Device Regulation (EU MDR), focusing on the integration and benefits of digital tools. It will cover innovative strategies for navigating post-market surveillance requirements, ensuring continuous compliance, and leveraging technology to streamline the regulatory processes. Attendees will gain insights into practical solutions for overcoming the challenges associated with EU MDR, enhancing product safety, and improving market readiness through digital transformation.

      Speakers

      Enrico Perfler
      Founder, 1Med
      Páll Jóhannesson
      Executive Vice President, Greenlight Guru

      5:30 PM

      Chairperson’s closing remarks followed by Drinks Reception

      END OF DAY 1 AND NETWORKING DRINKS RECEPTION

      Streams

      Stream one

      Stream A: Clinical Operations and Outsourcing

      Stream two

      Stream B: Clinical Technology & Innovation

      8:45 AM

      Chair’s opening remarks

      Speakers

      Mats Sundgren
      PhD, European Institute of Innovation through Health Data (i-HD)

      9 AM

      Generative AI in healthcare to speed up drug discovery

      • Addressing the potential challenges using this new technology for the development, evaluation and monitoring of medicines
      • Active pilots in Generative AI
      • Data Use & Data Discovery
      • Underlining the importance of methodological, legal and ethical considerations
      • Gen-AI to develop protocols & execute trials; understanding whom enters data prior to using this

      Speakers

      Jose Manuel Ordoñez
      MD, CCO Therapeutic Area Leader Onco-Haematology, Roche

      9:30 AM

      The Cinderella of Clinical Trial Planning: Identifying Your Targeted Subpopulation

      Does one shoe fit all? Nowadays, trial planning is extremely complex, time-consuming, and requires high precision in every stage of the process. Identifying the right subpopulation is the starting point for clinical trial planning, However, compared to before, inclusion and exclusion criteria are very restrictive. Evaluating the complexity of your trial and benchmarking it against trials that target the same subpopulation is critical in order to avoid amendments, delayed timelines, increasing costs, rescuing ongoing trials, and the sponsor losing trust in the CRO. In other words, reality and expectation need to be aligned. With a better understanding of the complexity of your clinical trial, it's time to develop a recruitment strategy (site selection, feasibility, etc.) and an execution strategy (CTMS, EDC, RTSM, ePRO, etc.). This use case will highlight the importance of your clinical trial strategy as well as the execution. In this session, you will learn:

      • how to leverage data analytics to identify subpopulations
      • how to identify sites and investigators for specific subpopulations
      • how to align your clinical strategy and your operational plan

      Speakers

      Barbara Argibay
      Vice President, General Manager – Data Division, Anju Software

      10 AM

      Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

      • Strategies for sourcing components from a scattered ecosystem
      • How to develop meaningful, human-centric measures
      • Pitfalls and opportunities for analytical and clinical validation
      • Novel solutions and digital pathways for scalable regulatory qualification
      • Maximizing value: how to repurpose and extend solutions across use cases in R&D and healthcare

       

      Speakers

      Chris Jones
      CEO, DEEP Measures
      Upinder Grewal
      Strategic Lead Exploration and Discovery, DS&AI, Bayer
      John Batchelor
      Science Liaison, DEEP Measures (Digital Evidence Ecosystems and Protocols)

      10:30 AM

      Practical and personal innovation: Strategies to right-size hybrid trials for patients, sites, and sponsors

      • Look back at the push for “all virtual” approaches and the growing shift to hybrid designs
      • Explore Suvoda case studies that focus on right-sized hybrid approaches to meet patient, site, and trial needs
      • Look forward at upcoming innovations, including AI, and how learning from DCT and hybrid trials can inform strategies to use new eClinical technologies thoughtfully

      Speakers

      Daniela Duffett
      Senior Solutions Consultant, Suvoda

      11 AM

      Morning refreshments and networking

      11:30 AM

      Multi-country experience with clinical trials: A perspective from the development of complex generics.

      Development of complex generics, such as those integrating drug-device combinations, or biosimilar medicines require conducting clinical trials comprising phase I to III. These trials are highly challenging due to the requirements of certain patient populations, the need of fast pace, low budgets, and fierce competition. Most of these trials demand multi-country expertise and capabilities, at both CRO and sponsor levels.. Such clinical trials require precise articulation with sites and CROs, and each country requires a different strategy for obtaining approvals, IP logistics, patient recruitment activities, local laboratories, among others. Common hurdles in running multi country trials of complex generics will be discussed. Countries for conducting such trials traditionally involved either US, Canada, India and Central European countries. Recently, other regions have arose as equally capable, such as East Europe, Jordan, Latin America and Africa, expanding the horizons for conducting clinical trials of complex generics and biosimilars.

      • Development of complex generics requires complex clinical trials
      • Trials must be fast paced, with a low budget and competition for patients
      • Experience in multi-country studies in different regions of the world

      Speakers

      Carlos W. Bertoncini
      PhD, Biopharmaceutical and Clinical Science Manager, CHEMO

      12 PM

      Accelerating trial recruitment through EHR referrals and GP engagement

      Discover the transformative potential of leveraging primary care Electronic Health Records (EHR) and fostering GP engagement to exceed sponsor expectations and close patient recruitment months ahead of schedule.

      While the value of EHR data in enhancing patient referral quality for clinical trials is widely recognised, this session delves into the additional benefits of partnering with primary care for sponsors. By integrating the power of EHRs with proactive engagement from primary care teams, we can unlock the potential to significantly accelerate recruitment speed and surpass enrolment targets, ensuring your clinical trial launches swiftly and yields impactful results.

      Speakers

      Katie Paul
      Product Manager - Research and Life Science, EMIS

      12:30 PM

      Lunch and networking

      1:30 PM

      AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

      ·       Real-life use case – AI files documents in eTMF in the correct folders and adds metadata.

      ·       Co-pilot mode – controlling AI from user side.

      ·       Quality control and TMF oversight – demonstrating compliance, beyond just being compliant.

      ·       Validation and Hands-On AI Challenges: practical how-tos.

      Speakers

      Evgenia Michalcuk-Vrablik
      Global Director of Growth, Flex Databases

      8:10 AM

      Registration and refreshments

      8:45 AM

      Chair’s opening remarks

      Speakers

      Fiona Barry
      Editor-in-Chief and Director of PharmSource, GlobalData

      9 AM

      EU REGULATIONS Good Clinical Practice (GCP) Harmonization: Updates to ICH E6 (R3)

      What do the new proposals bring to Clinical Trials:

      Challenges & Opportunities

       

      ICH E6 GCP (R3) guideline is expected to be released along 2024 - this an opportunity to review the most relevant differences between the current version and the upcoming guideline.

      Speakers

      Silvia Perez Torres
      Director, Clinical Quality Compliance, AstraZeneca

      9:30 AM

      Charting a Course through Complexity: Leveraging Experience in Approaching Complex Clinical Trial Protocols

      The landscape of clinical trials has undergone a remarkable transformation with the introduction of eClinical solutions, fundamentally reshaping day-to-day processes from traditional approaches. Automation and the integration of cutting-edge technologies are now the standard for clinical trial teams. However, amidst these advancements, the core requirements and understanding essential for running successful clinical trials remain steadfast. Experience emerges as the primary predictor of success – experience with protocol designs, study team and site expectations, and best standard practices.

      Join Siobhan McKenna-Power, an industry veteran with 20 years of expertise in designing and delivering regulated systems, as she delves into the intricate distinctions involved in delivering these sophisticated solutions and why experience is critical.

      Discover how mastery of these crucial elements can be the key to achieving the successful implementation of technology solutions supporting modern clinical trials.

      Don't miss this opportunity to explore the perfect blend of cutting-edge technology and invaluable experience that can revolutionise the future of clinical trials

      Speakers

      Siobhan McKenna-Power
      Client Services Lead, 4G Clinical

      10 AM

      Insights on How to Reduce the Burden of Study Start Up on Study Teams

      The study start-up phase is where teams and sites cross-functional activities come together, all at once and often in combination with an internal expectation to further accelerate start up while facing the external reality of additional hold-up due to approval delays.

       

      • Focus-on-Five
      • Leverage the informed feasibility decisions.
      • Confident communication

      Speakers

      Mireille Ermens
      Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring

      10:30 AM

      Ready for January 2025? Roadmap to CTIS compliance

      • Navigating the journey towards finding the perfect timeline for trial transitions, all aimed at ensuring a seamless alignment with the January 2025 milestone.
      • Unveiling a series of compelling case studies and triumphs
      • Highlighting the challenges encountered and showcasing the resilience and innovation that have driven progress forward

      Speakers

      Diana Filipescu
      Business Development Manager, Novotech

      11 AM

      Morning refreshments and networking

      11:30 AM

      FIRESIDE CHAT What does fit-for-purpose Sponsor oversight look like?

      ICH-GCP calls out that a Sponsor may transfer any or all of the Sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the Sponsor. With this in mind, what does fit-for-purpose Sponsor oversight look like?

       

      Speakers

      Fabio Miceli
      Director Global Quality Assurance / EU QPPV, Norgine
      Jadwiga Janicka
      Director, Study Operations, AstraZeneca
      Jonathan Harris, PhD
      EVP Program Management, ICON

      12 PM

      Starting Off on the Right Foot: Top Considerations for Selecting the Right Clinical Trial Sites

      This presentation will cover several strategies that are paramount to optimizing clinical trial site selection, including:

      • The importance of a productive site identification kick-off meeting with key stakeholders
      • Understanding global standard-of-care practices and their impact on trial design and site requirements
      • Maximizing the use of patient associations and physicians for informed decision making

      Speakers

      Andrea Ochoa, M.S.,
      Senior Vice President, Global Clinical Operations, Premier Research

      12:30 PM

      Lunch and networking

      1:30 PM

      Overcoming the challenges of enrollment in the changing landscape of a rare disease

      Our presentation delves into the intricate dynamics of enrollment challenges and underscores the significance of fostering strong site relationships in the rare disease space, as these partnerships often prove instrumental in driving successful enrollment outcomes. Beginning with a compelling case study introduction, we navigate through key drivers influencing sponsor decision-making processes, often creating innovative strategies that positively impact the study. Emphasizing the paramount importance of timelines, we discuss how sponsor decisions are strategically molded to align with project deadlines. Through the lens of the “one team, one approach” philosophy, we highlight the collaborative strategies that surmounted our enrollment hurdles effectively. Key takeaways from this exploration offer actionable insights for stakeholders navigating the complex terrain of rare disease research, ultimately paving the way for enhanced enrollment outcomes.

      Speakers

      Myriam Golembo
      Vice President Regulatory Affairs, BiomX
      Maris Veldre
      Associate Vice President, Project Delivery – EU, Rho
      Sonia Lwoff
      Director Clinical Operations – EU, Rho

      2 PM

      PANEL Maximising your Sites Productivity & how to lessen the burden

      Sites are increasingly challenged with workload and resource constraints. This panel will discuss ways in which to get the best output from sites.

      What can we do for them beyond an inflated budget?

      • Addressing challenges the sites are currently facing
      • An overview of the repercussions of such challenges, and a focus on what we can do to overcome them
      • Forward thinking to strengthen site output
      • Limitations with electronic applications

      Speakers

      Fiona Barry
      Editor-in-Chief and Director of PharmSource, GlobalData
      Sonja Weiser
      Senior Director Clinical Operations, Insmed
      Estrella Garcia PhD
      Executive Director Global Clinical Operations, Almirall
      Richard Gray
      Managing Partner, Medidata, Dassault Systemes

      2:45 PM

      Afternoon refreshments and Apple Prize draw

      3:30 PM

      INTERACTIVE THINK TANKS

      Interactive think tank 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, think tanks are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. 

      Each think tank session lasts for 30 minutes, and delegates may attend up to 2.
      Think Tank 1:

       How do we apply GCP Compliance to Artificial Intelligence in Clinical Trials

      Laia Casas, Clinical Project & GCP Compliance Leader, Noucor 

       

      Think Tank 2:

      Are Preferred Suppliers really an opportunity? Pros and Cons 

      Silvana Giro, Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging

       

      Think Tank 3: 

      How might European trials make use of a local care model? 

      Stephanie Casler, Director of Clinical Innovation, Johnson & Johnson

      Speakers

      Laia Casas
      Clinical Project & GCP Compliance Leader, Noucor
      Silvana Giro
      Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging
      Stephanie Casler
      Director, Innovative Health, Johnson & Johnson

      4:30 PM

      Chairperson’s closing remarks

      END OF CONFERENCE

      Speakers

      Select a speaker to learn more

      Back
      Mats Sundgren
      PhD, European Institute of Innovation through Health Data (i-HD)

      Mats Sundgren, PhD, MSc, is a renowned expert in Health Data Strategy for Industry and Academia. With over 37 years in the pharma industry (Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science and Data Science & AI), Mats is at the forefront of industry technology innovation. In 2022, following a 12-year tenure as global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats’ new portfolio encompasses the roles of Senior Industry Scientific Director for the i~HD (European Institute for Innovation through Health Data); Executive Strategic Advisor for IgniteData, developer of a system-agnostic EHR-to-EDC solution for clinical trials; and Chairman of the Board of the Research Foundation IMIT (Institute of Managing Innovation and Technology) across Chalmers University of Technology, Royal Institute of Technology, Lund University of Technology & Stockholm School of Business.

      Mats has authored over 70 publications, books, and patents in Science, Economics & Social Science (Health Data Science, Clinical Science, Business Modelling, Innovation & Creativity Management, and Device development).

      Session Details:

      KEYNOTE Revolutionizing Clinical Trials through RWD and AI: Unleashing Innovation

      2024-05-07, 8:30 AM

      Session Details:

      PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

      2024-05-07, 4:15 PM

      Session Details:

      Chair’s opening remarks

      2024-05-08, 8:45 AM

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      Stephanie Casler
      Director, Innovative Health, Johnson & Johnson

      Stephanie is a Director in J&J’s Innovative Health Team, where she works to explore alternative options to traditional trial conduct in order to improve trial accessibility. Prior to joining Johnson & Johnson, she worked in Novartis’ Patient Experience team and spent 14 years as a management consultant with Accenture. American by birth, she has been living in Dublin, Ireland since 2016.

      Session Details:

      INTERACTIVE THINK TANKS

      2024-05-08, 3:30 PM

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      Nikita Sharma
      Global Clinical Sciences & Operations Innovation Manager, UCB

      Session Details:

      Transforming Clinical Trials: Harnessing AI for Decentralized Study Design and Operations

      2024-05-07, 11:00 AM

      Session Details:

      PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

      2024-05-07, 4:15 PM

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      Christian Milliet
      Head of Site and Healthcare Ambassadors, CSL Behring

      Christian Milliet has over 25 years of experience in the pharma industry, leading Clinical Operations teams across Europe, USA, Latin America, China and Japan. His expertise encompasses all phases of drug development in a multitude of therapeutic areas.

      He is currently Head of Site & Healthcare Ambassadors at CSL Behring. Previously, he worked for Vifor Pharma, Novartis, Serono and Covance.

      In his current role, Christian is spearheading the development and expansion of site partnerships, leveraging CSL global presence. His focus is on creating strategic relationships to successfully deliver the CSL portfolio, including clinical development and real-world evidence.

      Christian has a degree in Business Administration from Webster University in St. Louis, USA.

      Session Details:

      Site Partnerships: Developing Site Relationships beyond Study-Level Engagement

      2024-05-07, 12:00 PM

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      Antonella de Ceano
      Digital Transformation Officer, Barcelona Health Hub
      Next speaker
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      Carmela Gómez Rodríguez
      Vice President Clinical and Regulatory Affairs, Neurofix Pharma
      Next speaker
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      Dr Mar Gomis Pastor
      Director of the Center for Digital Clinical Validation, Hospital de la Santa Creu i Sant Pau

      Mar Gomis-Pastor

      PharmD, PhD. Clinical pharmacist with specialization in hospital pharmacy. International Doctor of Medicine (UAB - Autonomous University of Barcelona). Mar is currently responsible for the Digital Impulse at St. Pau's Hospital (within the Strategic Impulse and Transformation Area). She is also the Director of the Digital Health Clinical Validation Center (a joint project with the Barcelona Health Hub). She has worked as a coordinator of interdisciplinary and comprehensive eHealth projects for the last 10 years (2013-2023). Her current activity in ambulatory healthcare is focused on heart transplant care. Experience in other areas would be Research; Health Consultancy and eHealth Consultancy; Public Administrations as vocal in the National Commission of Specialties in Hospital Pharmacy, Spanish Ministry of Health Social Services; Education and Doctoral Thesis Director; among others.

      Session Details:

      Great expectations and how to meet them – connected devices and ePRO in clinical trials

      2024-05-07, 2:00 PM

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      Martin Rodriguez
      Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

      Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

      I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

      Session Details:

      PANEL – Outsourcing Strategies & Relationships

      2024-05-07, 4:15 PM

      Session Details:

      Fit-for-Purpose Outsourcing Strategy in Clinical Trials and Cost Optimization

      2024-05-07, 3:00 PM

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      Dr Sol Yates
      Associate Director, European Regulatory Affairs, Shionogi Europe

      Session Details:

      Experience with EU Clinical Trial Regulation – Updates from January 2023

      2024-05-07, 3:00 PM

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      Silvana Giro
      Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging

      From 1984 to 1988 employed by Ciba-Geigy, in the Sales Marketing of chemical products, within the Customer Services.

      Since 1988 employed by Bracco S.p.A. and then by Bracco Imaging S.p.A., developing different skills: Clinical Project Planning, Budget Control

      Since 2000 responsible for Contract Management in Europe, including contractual negotiation for all global functions within Global Medical & Regulatory Affairs.

      Since June 2002 also responsible for Global Outsourcing within Global Medical & Regulatory Affairs.

      Since 2001 Silvana Giro has been invited as speaker and moderator to several conferences and seminars.

      Session Details:

      PANEL – Outsourcing Strategies & Relationships

      2024-05-07, 4:15 PM

      Session Details:

      INTERACTIVE THINK TANKS

      2024-05-08, 3:30 PM

      View In Agenda
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      Michael Zörer
      Head of Clinical Operations, VarmX

      Michael is responsible for a team of 11 people and the overall delivery of the conducted studies. The group runs several studies in different indications with a clear focus on rare diseases. In 2016 AOP Orphan received approval for one new product (RAPIBLOC®). In 2019 AOP received the marketing authorization for their first biological (BESREMi®), after completing a series of clinical studies and successfully passing a series of EMA inspections under Michael’s responsibility.

      Before joining AOP Orphan Michael has been operations manager for Haemophilia at Baxter. Michael has many years of experience as a project manager and learned the job in clinical research from scratch starting as CRA at Amgen. Michael received his Ph. D in biochemistry from the University of Vienna. 

      Session Details:

      Fireside chat – ask the experts! Trial Execution in 2024 and Beyond

      2024-05-07, 11:00 AM

      Session Details:

      PANEL – Outsourcing Strategies & Relationships

      2024-05-07, 4:15 PM

      View In Agenda
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      Mireille Ermens
      Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring

      Mireille Ermens, is a seasoned leader in the field of clinical research and healthcare management with a rich background spanning over two decades. Armed with a degree of Socio Medical Science with distinction from the University Ghent, Belgium, Mireille brings a unique blend of expertise in biochemistry, mathematics, statistics, and preventive healthcare.

      A true polyglot, Mireille is fluent in Dutch, French, and English, with proficiency in German and Spanish, reflecting a deep commitment to effective communication across diverse cultural landscapes.

      With a leadership style centered around "Building Bridges with and for People," Mireille has led clinical development operations teams, navigating challenges in rare and chronic diseases, high-volume infectious diseases and seasonal vaccine environments.

      Currently serving as the Senior Director of Global Feasibility and Start Up Support at CSL Limited, Mireille spearheads strategic assessments of clinical trial feasibility, facilitating optimal business decision-making through meticulous recruitment-time-cost analyses and evaluation of execution options.

      Prior to this role, Mireille served as the Head of Global Site Management and Monitoring Oversight at CSL Seqirus, while advocating for global process consistency with a patient-oriented oversight agility. Mireille's extensive experience also includes senior positions at Eli Lilly and Hoffmann-La Roche.

      Mireille began her career as an ICU Coordinator in Intensive Care at the University Hospital, Ghent, monitoring and caring for patients post-cardiac surgery, demonstrating a commitment to hands-on patient care.

      With a career trajectory marked by innovation, strategic vision, and a relentless pursuit of excellence, Mireille is a dynamic speaker who brings a wealth of knowledge and expertise to any discussion on clinical research, healthcare management, and leadership in the pharmaceutical industry.

      Session Details:

      Insights on How to Reduce the Burden of Study Start Up on Study Teams

      2024-05-08, 10:00 AM

      Session Details:

      PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

      2024-05-07, 4:15 PM

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      Silvia Perez Torres
      Director, Clinical Quality Compliance, AstraZeneca

      I have a PH degree in Pharmaceutical sciences by the Barcelona University. I started my career as a researcher in Neurochemical department within the Barcelona Biomedical Research Institute (IIBB), where I developed my PH degree focused on Alzheimer’s disease and Inflammation.

      Once I completed my Ph Degree in Neuroscience, I moved to the clinical industry, working most of my career in Data Management, first in a small CRO company and later in the pharma industry.

      For along almost 12 years, I was managing phase III clinical trials acting as Global Data Manager Lead, coordinating end-to-end data management activities (including SDTM development) mainly outsourced to global CROs. Apart of the oversight of clinical trials, part of my role as an expert in DM was to lead standardization on E2E data and processes.

      On 2018, I completely changed my role and moved to the Quality area. Since then, I’m Director on Clinical Quality Compliance. On this role, I’m providing quality support to Biometrics functions (including DM, Programming and Statistics roles). Among other activities, I’m giving quality related advice and guidance, overseeing quality issues, CAPA implementation and risk management. Coordinating and supporting audit and inspections, as well as preparing teams to be inspection ready at all time.

      Since 2020, I’m Regulatory Considerations Expert Group DMEG Chair on the Association for Clinical Data Management. The aim of the Regulatory Considerations Expert Group looks at providing guidance information on several areas surrounding regulations. The expectations and recommendations on implementation and what data management needs to be prepared for in readiness for inspection.

      Session Details:

      EU REGULATIONS Good Clinical Practice (GCP) Harmonization: Updates to ICH E6 (R3)

      2024-05-08, 9:00 AM

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      Chris Jones
      CEO, DEEP Measures

      Session Details:

      Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

      2024-05-08, 10:00 AM

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      Carlos W. Bertoncini
      PhD, Biopharmaceutical and Clinical Science Manager, CHEMO

      Session Details:

      Multi-country experience with clinical trials: A perspective from the development of complex generics.

      2024-05-08, 11:30 AM

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      Fabio Miceli
      Director Global Quality Assurance / EU QPPV, Norgine

      Fabio is a Pharmaceutical Professional with almost 25 years of experience in the industry. He graduated from the University of Amsterdam with a Master’s degree in Medical Biology. He started his career in Clinical Operations working for Pharma, Biotech and various Clinical Research Organizations. Subsequently, he moved across to the Quality Assurance arena where he has spent the last 17 years of his career in various roles of increasing importance . Currently employed at Norgine as Director Global Quality, Fabio’s responsibilities include GCP, GLP, Commercial Quality / Codes of Practice, Competent Authority Inspection Management and he acts as Clinical Development, Medical Affairs and Regulatory Affairs Quality Business Partner. Following Brexit and after a 3-year tenure as deputy, Fabio assumed the role of  EU QPPV for Norgine in 2022 – a role he executes in parallel to his Quality role.

      Session Details:

      FIRESIDE CHAT What does fit-for-purpose Sponsor oversight look like?

      2024-05-08, 11:30 AM

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      Sonja Weiser
      Senior Director Clinical Operations, Insmed

      A Clinical Research Professional (Pharmacist), PhD (Medical School - Pharmacology/Toxicology) and PMP (2016) with more than 20 years’ experience in Biotech / Health Care Industry / CRO / Drug Development / Clinical Research.

      Expertise ranging from Clinical Research/Clinical Operations experience in Pharma, Biotech and CRO with focus on Oncology, Immunology, Infectious Disease, Respiratory indications and Rare/Orphan indications.

      Focused on goal achievement, constant striving for improving processes on an international / global level, strong project management background.

      Dedication to people management as the main success factor in clinical research/clinical development – foster open & trustful communication on a global level.

      Strong believer in "Manage by example" as key to success in drug development

      Session Details:

      Fireside chat – ask the experts! Trial Execution in 2024 and Beyond

      2024-05-07, 11:00 AM

      Session Details:

      PANEL Maximising your Sites Productivity & how to lessen the burden

      2024-05-08, 2:00 PM

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      Laia Casas
      Clinical Project & GCP Compliance Leader, Noucor

      Biomedical Scientist with an MSc in Monitoring Clinical trials and Medical Affairs. Have worked in several positions from top to bottom: From study coordinator to RD Project Manager at a Sponsor Company, including CRA. Work through various companies: Pharmaceutical laboratories, CROs and medical device start-ups. Have worldwide experience in clinical trials, and planned, designed, and led clinical projects for EMA and FDA.

       

      Session Details:

      INTERACTIVE THINK TANKS

      2024-05-08, 3:30 PM

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      Jadwiga Janicka
      Director, Study Operations, AstraZeneca

      Jadwiga Janicka is holding a role of Director of Study Operations at AstraZeneca, overseeing a team responsible for the execution of global clinical trials. With an extensive background spanning more than 17 years in the field of clinical trials, Jadwiga has consistently played a pivotal role in collaborative efforts with numerous CROs. Her involvement has ranged from project management to governance-level activities, contributing to the successful execution of trials. Jadwiga's expertise is particularly focused on staying abreast of current trends in outsourcing practices and evolving oversight requirements within the industry.

      Session Details:

      FIRESIDE CHAT What does fit-for-purpose Sponsor oversight look like?

      2024-05-08, 11:30 AM

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      Daniel McVeigh
      Director, Clinical Project Lead, Alexion Pharma

      A Clinical Research Professional with over 12 years’ experience across various settings such as Site, CRO, Small Biotech and Pharma. Expertise in various therapeutic areas from Oncology and Rare/Orphan Disease. Experience from early phase first in human to late phase and Nov Intervention RWE generation and Registries. Focused on Clinical Operations excellence and process improvements for the benefit of the patients we serve. Currently Director, CPL at Alexion, AZ Rare Disease leading a Cross Functional clinical team in the execution of multiple clinical studies and PASS studies.

      Session Details:

      PANEL – Outsourcing Strategies & Relationships

      2024-05-07, 4:15 PM

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      Richard Stephens
      Veteran Patient Advocate, Trial Participant, Author, Journal Editor

      Richard Stephens has been a patient advocate for 25 years, surviving two cancers and a heart emergency, plus several co-morbidities and late effects. As a patient he has participated in four interventional studies and nine others. As an Advocate he has helped design over 30 more.

      Richard Chairs the UK Cancer Research Advocates Forum (formerly the NCRI Consumer Forum) and is the former Chair of BBMRI-ERIC’s Stakeholder Forum. He works with patient groups and advocates, academics and industry, and policy-makers, funders and regulators.  

      Richard helped found the AllTrials campaign and useMYdata movement, and he is the founding co-Editor-in-Chief of the Journal of Research Involvement and Engagement. His professional life has included careers in education, journalism and local government.

      Session Details:

      PATIENT ADVOCATE KEYNOTE: Which Patients? How Centric?

      2024-05-07, 11:00 AM

      Session Details:

      PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

      2024-05-07, 4:15 PM

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      Amelia Hursey
      Parkinson's Research Manager, Parkinson's Europe

      Amelia joined the Parkinson’s Europe  team in Jan 2022 as Research Manager. Since then she has developed Parkinson’s Europe’s Research Strategy, embedding a Research Steering Group into the organisation and helping to increase the presence of Parkinson’s Europe in the clinical research world. She is also focused on bringing new initiatives to the table, such as the Parkinson’s Europe’s Engagement Network, which better connects the Parkinson’s

      community with research across Europe. Parkinson’s Europe is now a partner member of EUPATI and the Critical Path for Parkinson’s as part of this action.

      She has been working in the field of Neurodegenerative research since 2009 and is a Patient Organisations board member with EUPATI since Sept 2023.

      She previously worked for the UK NIHR’s DeNDRoN delivering clinical trials and then at Parkinson’s UK from July 2015 as Research Participation Lead.  She was responsible for initiatives to increase research participation for people affected by Parkinson’s, health care professionals and researchers, and created the innovative Parkinson’s UK Take Part Hub and co-produced the Staying Connected toolkit in collaboration with the HRA UK.

      Session Details:

      Building clinical trials with the perspective of the patients in mind

      2024-05-07, 12:00 PM

      Session Details:

      PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

      2024-05-07, 4:15 PM

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      Jose Manuel Ordoñez
      MD, CCO Therapeutic Area Leader Onco-Haematology, Roche

      I studied Medicine in Universidad de Navarra (Spain) and did my especialization in oncologist in the same site between 1997 and 2001. I have work as medical oncologist during several years in Pamplona and Madrid, and I joined Roche in 2007 as Country Study Manager. My current position is Therapeutic Area Leader in Clinical Operations for Onco-Hematology studies from 2015. I have a master in coaching and talent development and another in pharmaeconomics and health economy.

      Session Details:

      Generative AI in healthcare to speed up drug discovery

      2024-05-08, 9:00 AM

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      Maria Reyes Boceta-Munoz
      Head Of Clinical Operations Spain, GSK

      Session Details:

      PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

      2024-05-07, 4:15 PM

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      Francis P. Crawley
      Executive Director , Good Clinical Practice Alliance - Europe (GCPA)

      Francis P. Crawley is a philosopher with a career in bioethics and expertise in research policy, regulation, ethics, integrity & methodology as well as in data/AI/virtual twins ethics and law with particular attention to the life sciences: clinical trials, genomics/omics, new technologies. Expertise in EU, US, international and country-specific ethics, law, and patient and community interests in health-related research. Strong experience working closely with patients, communities, researchers, and policymakers across disciplines. domains, and geographic regions in establishing consortia, developing patient registries, contributing to the development of biobanks, drafting data management and data protection plans, and contributing to building data repositories. A strong background in the methodologies for designing and reviewing health-related research supported by effective communication and leadership skills as well as diplomacy with the ability to influence changes in bioethics and law. Additional strong background in the development of research, guidance, and ethics related to global diseases affecting resource-poor settings and orphan diseases in the context of leading and/or contributing to challenging projects. Wide experience (e.g., UNAIDS, WHO, UNESCO, European Commission, Council of Europe, and others, including local organizations and industry) in developing health-related research projects, collaborative engagements, regulatory and policy outreach, and education and training in Europe, Africa, Asia, the Americas, and Eastern Europe & Central Asia. Leading roles in the development of international and national guidelines, capacity-building, empowerment, and education programmes for health research; including GCP, ethics review systems, genetics and biobanks, and data privacy & management (a GDPR DPO), with expertise in the ELSI aspects of data AI, digital twins, and organoids. Since January 2020 highly active in the research, ethics, data sharing, and policy discussions on COVID-19, particularly in the areas of vaccines, repurposed medicines, and genetic modelling, having organised more than 40 global webinars and coordinating research across HICs and LMICs. Recently engaged in the policy, ethics, and regulation of data and AI in times of crisis. Founded and coordinates the Ukraine Clinical Research Support Initiative (UCRSI) in cooperation with leading Ukrainian, European, and international organizations. He is at the forefront of the European and global movement to reform and advance research assessment in the universities and other research institutions, with a particular emphasis on research ethics and research integrity in developing policy for data and AI in the research assessment process.

      Session Details:

      Chairperson’s opening remarks

      2024-05-07, 8:20 AM

      Session Details:

      Governance of Clinical Research within the European Health Data Space

      2024-05-07, 9:30 AM

      Session Details:

      PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

      2024-05-07, 4:15 PM

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      Robert Kurowicki
      Robert Kurowicki, Director of Feasibility and Project Strategy, Novotech Europe

      Robert Kurowicki has over 12 years of experience in clinical research working for the Clinical Research Organization. Before that he spent over 18 years in the pharmaceutical and biotech industry managing sales and marketing activities in several companies including Behring, Sanofi and Celgene, focusing on the oncology, haematology and rare disease therapeutic areas.

      At his current position, he is responsible for the feasibility research. Collaborating with investigators and various team members such as Medical Experts, Regulatory and Project Managers, as well as analysing multiple data sources, Robert is responsible for strategizing the most efficient scenarios to conduct various clinical studies.

      Session Details:

      PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

      2024-05-07, 4:15 PM

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      Laura Jiménez Robledo
      Clinical Project and Innovation Manager, Novo Nordisk

      Laura is a Clinical Research Professional. She started in Novo Nordisk in 2013 as CRA and since 2020 she's exploring and defining Clinical Innovation as Clinical Innovation Manager.

      In her current position, she's leading the Innovation Strategy in her department - Clinical Operations in France, Portugal and Spain and additionally, driving the change and bringing innovation in Region Europe.

      Her superpowers: communication, innovation and collaboration.

      Session Details:

      PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

      2024-05-07, 4:15 PM

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      Upinder Grewal
      Strategic Lead Exploration and Discovery, DS&AI, Bayer

      I’ve been working in the Healthcare industry for 23 years working for various companies from Start up, mid size and large Pharma.

      During the 23 years I have worked across many areas from Supply Chain, Process Improvement/Six Sigma, IT, Vendor Management and last 3 years working in Global Clin Op’s. I am now part of Clinical Trial Technology Strategy as well as part of the DCT initiative Leadership team focusing on external innovation, collaboration and identifying new solutions for trials.

      Session Details:

      PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

      2024-05-07, 4:15 PM

      Session Details:

      Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

      2024-05-08, 10:00 AM

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      Anthony Mikulaschek
      VP, Commercial Strategy, IQVIA Technologies

      As Vice President of Commercial Strategy at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.

      Session Details:

      How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors

      2024-05-07, 11:30 AM

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      Stefan Dürr
      Senior Director, Client Delivery, Cenduit IRT, an IQVIA business, Head of Drug Supply Center of Excellence

      Senior Director, Client Delivery at Cenduit IRT, an IQVIA business, Head of Drug Supply Center of Excellence

      Stefan has worked in IRT for 15 years and has been with Cenduit IRT, an IQVIA business, since its inception in 2007. He has worked in various project management roles including leading the global project management team at Cenduit. Stefan currently is responsible for client delivery of key customer accounts and heads the Cenduit drug supply center of excellence. He is very passionate about finding innovative solutions for clinical supply challenges.

      Stefan holds a master of science in molecular biology and an international executive MBA of the University of St. Gallen.

      Session Details:

      How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors

      2024-05-07, 11:30 AM

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      Alina Pszczółkowska
      Head of Late Phase Program Management Respiratory & Immunology, AstraZeneca

      Alina Pszczółkowska is a medical graduate with a distinguished diploma in management from Polish Open University and Oxford Brookes University. Since 1997, she's been involved with clinical research – working in Poland and in various global roles

      After spending some time as acting physician she joined pharma industry  and AstraZeneca in 1999, where she has held various leadership roles in clinical operations across site, study and programm management  leading projects and organisations across the globe. 

      She also worked in  Gothenburg, Sweden, overseeing delivery of  cardiovascular, kidney, and gastrointestinal portfolio.

      As of 2023, Alina is the Head of Late Phase Program Management organization in Respiratory and Immunology.

      Alina is also the Site Leader of for AstraZeneca Cross functional site in Poland, and Vice-President at AstraZeneca Pharma Poland.

      Session Details:

      Leveraging operational expertise to enhance study design and patient centricity in clinical trials

      2024-05-07, 2:00 PM

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      Siobhan McKenna-Power
      Client Services Lead, 4G Clinical

      Siobhan McKenna-Power has over 20 years of experience designing and delivering regulated systems, with over 8 years designing and delivering RTSM systems for clinical trials.   She first developed an interest in clinical trials when her father took part in multiple Phase III drug and device trials due to his progressive Chronic Obstructive Pulmonary Disease and was eager to contribute in her own way when the opportunity presented herself.

      Siobhan is a strong believer in first time quality and works with our sponsors to understand complex protocols.  Siobhan has a keen understanding of what the needs of the end user are and works to ensure that even the most complex trials are easy for Investigators to work with, and that patient safety is the foremost priority of any RTSM system.

      Siobhan is a graduate of Maynooth University (formerly National University of Ireland, Maynooth) with a BSc in Computer Science and Software Engineering. She is currently working on a Level 7 Diploma in Risk Management.

      Session Details:

      Charting a Course through Complexity: Leveraging Experience in Approaching Complex Clinical Trial Protocols

      2024-05-08, 9:30 AM

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

       

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      Dr. Claudia Hesselmann
      Founder and CEO, ARENSIA Exploratory Medicine

      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.

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      Todd Rudo, MD
      EVP & Chief Medical Officer, Clario

      As Clario’s Chief Medical Officer, Dr. Todd Rudo provides medical and scientific leadership across the organization. Passionate about leveraging our scientific expertise to support our customers’ success, Dr. Rudo has focused efforts on optimizing our solutions across the therapeutic areas. His team supports Clario’s clients by providing expert consulting services on scientific and regulatory strategy, and ensures our product portfolio is scientifically robust, generating high quality data to support clinical trial endpoints. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden. With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has focused his career predominantly on drug safety. He has worked within therapeutic areas including oncology, immuno-inflammatory diseases, urology, and cardiometabolic diseases, and has achieved board certifications in internal medicine, cardiology, cardiac electrophysiology, nuclear cardiology, and adult echocardiography.

      Session Details:

      A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

      2024-05-07, 12:30 PM

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      BRYAN MCDOWELL
      VP, ECOA Science & Consulting, Clario

      In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma wide industry necessity for smarter drug & device development and life cycle management.

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      Katie Paul
      Product Manager - Research and Life Science, EMIS

      Kaite Paul is the Product Manager for Research and Life Sciences at EMIS Health, where she works to explore how data and technology can be harnessed to increase the participation of primary care in research and deliver fast, diverse and effective recruitment to trials. Prior to EMIS, Katie was Chief of Staff at a medical technology start-up and a consultant in Accenture UK’s Health team, advising on NHS digital, data and cybersecurity strategy.

      Session Details:

      Accelerating trial recruitment through EHR referrals and GP engagement

      2024-05-08, 12:00 PM

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      Barbara Argibay
      Vice President, General Manager – Data Division, Anju Software

      Barbara Argibay brings over 15 years of experience in Data and Research to her position as Vice President, General Manager – Data Division at Anju Software. She leads the Anju Data Division, overseeing TA Scan and data sciences product development, engineering, operations, and business development. Barbara’s education and experience makes her an irreplaceable member of the Anju Software team, empowering life sciences companies through the power of data and innovation.

      Throughout her career, she has been involved in diverse roles where data-driven strategies paired with actionable insights had a remarkable impact on research and clinical operations. With high commitment to excellence, at the core of Barbara’s experience lies the ability to understand market challenges and push the status quo to drive positive change within the life sciences industry. As people leader, Barbara has nurtured a culture of trust, collaboration, and innovation, fostering a high-performing and engaged team.

      Barbara holds a PhD in Medicine, with honors cum laude and special mention to Extraordinary PhD award, MS and BSc in Physics by the University of Santiago de Compostela.

      Session Details:

      The Cinderella of Clinical Trial Planning: Identifying Your Targeted Subpopulation

      2024-05-08, 9:30 AM

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      Ana Moreno
      Director Global Clinical Operations, APICES
      Ana Moreno has a degree in Biology and 21 years of experience in Clinical Research across CRO sector, Big Pharma and Academic Groups. Throughout her career she has supported medical and scientific teams, clinical development programs and operations worldwide for the success of oncology treatments. Ana’s career include ClinOps manager career at Pharma (Gilead Sciences) and CROs (Biometrica and APICES) leading scientific programs and supporting the development of clinical trials in breast, colorectal, lung, liver, pancreas and ovarian cancer among others.

      Session Details:

      Advantages and Challenges of New Technology in Clinical Research

      2024-05-07, 5:00 PM

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      Myriam Golembo
      Vice President Regulatory Affairs, BiomX

      Myriam Golembo is VP Regulatory Affairs at BiomX, a microbiome drug discovery company developing customized phage therapies that seek and destroy harmful bacteria in chronic diseases. Myriam holds a PhD in Molecular and Developmental Genetics from the Weizmann Institute and has over 20 years’ experience in the biotech industry. Prior to BiomX, she was VP Regulatory and Clinical Operations at a company developing immunotherapy for cancer and viral disease, and VP Product Development at a company developing new formulated antibiotics for ear, nose and throat. Previous to these, she served as Director of Products Development at Protalix, a company developing and marketing FDA approved recombinant therapeutic proteins with clinically improved profiles produced in a plant cell-based protein expression platform, where she focused in regulatory and clinical development of products targeting orphan indications, for USA and EU.

      Session Details:

      Overcoming the challenges of enrollment in the changing landscape of a rare disease

      2024-05-08, 1:30 PM

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      Maris Veldre
      Associate Vice President, Project Delivery – EU, Rho

      Maris Veldre earned his BSC and PT degrees from the Medical Academy of Latvia and later studied for an international MPH at University of Kuopio, Finland. He has over 24 years of experience in the industry, both at CRO and Pharma companies holding regional and global management positions in clinical operations and strategic sourcing. Prior to his tenure at Rho, Maris managed clinical operations at Dokumeds, a mid-sized European CRO, operating in over 30 countries. Under his leadership, the company expanded into new geographic regions both within and outside Europe, thus significantly increasing capabilities and the company’s strategic footprint. Currently, Maris serves as a strategic partner to Rho operations, overseeing project delivery in Europe and helping Rho deliver high-quality global programs.

      Session Details:

      Overcoming the challenges of enrollment in the changing landscape of a rare disease

      2024-05-08, 1:30 PM

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      Sonia Lwoff
      Director Clinical Operations – EU, Rho

      Sonia Lwoff has a BsC degree in Chemistry from the Autonoma University in Madrid and a master’s degree in clinical trials by Pharmaceutical Association in Madrid. She has over 19 years of experience in research. Sonia has developed her career in Clinical Operations, from the CRA level through various management positions to leading global Clinical Operations teams in several regions. Sonia’s therapeutic area expertise includes Oncology, Neurology and Psychiatry, Rare Diseases, Gastroenterology, and Immunology (PID) among others. She is currently the Director of Clinical Operations in EU, working on timely and high-quality delivery in projects, process improvement, and expanding Rho’s footprint in EU.

      Session Details:

      Overcoming the challenges of enrollment in the changing landscape of a rare disease

      2024-05-08, 1:30 PM

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      Gabriel Maeztu
      Co-founder of IOMED

      Gabriel is a Medical Doctor, from the International University of Catalonia, and holds a degree in Mathematics from the UNED. At IOMED, he provides leadership and strategic guidance to the organization.

      Session Details:

      PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

      2024-05-07, 4:15 PM

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      Enrico Perfler
      Founder, 1Med

      With a Master of Science in Biomedical Engineering, Enrico Perfler boasts 20 years of professional experience specializing in medical device technology. His profound knowledge and innovative approach have significantly shaped the landscape of this field.

      In 2014, Enrico founded 1MED SA, an innovative international company that provides regulatory support, digital solutions, and comprehensive CRO services to the medical device and pharmaceutical industry, with a particular emphasis on IVD and medical products. Under his leadership, 1MED SA has successfully overseen the development and regulatory approval of over 500 medical devices in Europe, solidifying his status as a prominent figure in the MedTech sector.

      Beyond his remarkable entrepreneurial achievements, Enrico serves as a contract professor of "Regulatory Affairs" at the Faculty of Engineering, University of Pavia. His expertise is further highlighted by his participation in the ISO/TC 194 technical committee for the biological evaluation of medical devices, and in national esteemed standardization groups, including UNI and ABHI. This involvement not only showcases his commitment to advancing industry standards but also underlines his influential role in shaping the future of medical device regulation and safety.

      Session Details:

      The Future of Regulatory Compliance: Digital Tools for Mastering EU MDR and Post-Market Challenges

      2024-05-07, 5:00 PM

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      Páll Jóhannesson
      Executive Vice President, Greenlight Guru

      Páll Jóhannesson, M.Sc. in Medical Market Access, is the Executive Vice President at Greenlight Guru. Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices

      Session Details:

      The Future of Regulatory Compliance: Digital Tools for Mastering EU MDR and Post-Market Challenges

      2024-05-07, 5:00 PM

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      Andrea Ochoa, M.S.,
      Senior Vice President, Global Clinical Operations, Premier Research

      Andrea Ochoa is Senior Vice President, Global Clinical Operations, at Premier Research. Ms. Ochoa has more than 20 years of clinical operations experience in a variety of positions. In her current role, she oversees operational delivery across Europe and Asia-Pacific. She provides expert advice and strategies to operationalize and navigate the complex regulatory and start-up environment.

      Prior to joining Premier Research, Ms. Ochoa held several positions of increasing responsibility at MDS Pharma Services and INC Research. She has a master’s degree in Cognitive-Behavioral Therapy from the Luria Institute in Madrid, Spain, and bachelor’s degrees in psychology (UNED, Madrid) and law (Complutense University of Madrid). Ms. Ochoa is certified as Lean Sigma Green Belt since 2009.

      Session Details:

      Starting Off on the Right Foot: Top Considerations for Selecting the Right Clinical Trial Sites

      2024-05-08, 12:00 PM

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      Lakshmi Gurduri
      Director Project Management, TFS Health Science

      Lakshmi is a seasoned professional with an impressive 16-year tenure in the pharmaceutical, biotech, and CRO industries. With over a decade of global project management experience, she excels in leading cross-functional teams and managing the intricate balance between operational demands and financial constraints to successfully execute programs from inception to completion. Her extensive knowledge spans all trial phases across various global markets, including APAC, Europe and North America. Lakshmi's experience spans several therapeutic areas, including gene therapy, rare diseases, respiratory, chronic inflammation, immunology, oncology, dermatology, CVM, and endocrinology.

      Session Details:

      Pioneering Gene Therapy in Rare Diseases: A Path to Revolutionary Treatments

      2024-05-07, 12:30 PM

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      Sas Maheswaran
      Vice President, Product Implementation, Saama Technologies

      Sas Maheswaran is a clinical operations leader with more than 17 years of experience. He incorporates unique perspectives gained from his time working at sponsors, sites, and software vendors to formulate practical approaches to digital transformation, including in the adoption of AI driven solutions in Clinical Development. In his current role as Vice President of Product Implementation at Saama Technologies, Sas is responsible for ensuring that sponsors and CRO partners are optimally utilizing Saama’s industry leading AI capabilities.

       

      Session Details:

      AI: A Game Changer for Clinical Operations

      2024-05-07, 2:30 PM

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      Jonathan Harris, PhD
      EVP Program Management, ICON

      Session Details:

      FIRESIDE CHAT What does fit-for-purpose Sponsor oversight look like?

      2024-05-08, 11:30 AM

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      Matt Cooper
      Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials

      Matt Cooper is the Executive Director, Therapeutic Strategy Lead, Oncology and has 25 years of experience in the life science industry conducting clinical trials across all phases. His experience spans roles at sponsors, sites, and the NHS, and he has extensive experience in site management and expanded use of oncology therapies. He is passionate about building effective relationships between industry stakeholders to drive innovation and patient access.

      Session Details:

      Navigating the Complex Regulatory Landscape for Oncology Trials: A Focus on the European Union

      2024-05-07, 11:30 AM

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      Polly Cooper
      Senior Director, Project Delivery, Biotech - ICON

      Polly brings her perspective on clinical trials from 34 years of experience in drug development with roles in Research, Early Compound Evaluation, Formulation Development, Resource Management and Clinical phase I – IV. Polly holds an MBA (specializing in Marketing, Finance and Strategy), a Masters Certificate in Project Management from George Washington University and a BSc (hons) in Pharmacology. Energized by the CRO world of constant learning, she is currently part of ICON Biotech since May 2021, where she is supporting sponsor’s outsourcing decisions, listening and interpreting sponsor requirements into successful and enjoyable study delivery.

      Session Details:

      Maximizing the Consultative Partnership Between CRO and Biotech Sponsors

      2024-05-07, 12:30 PM

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      Maria-Cruz Morillo
      Global Therapeutic Operations Lead, Rare Diseases, Allucent

      Maria-Cruz Morillo, M.S. Pharmacy, has acquired a deep knowledge of drug development during her 28 years of experience in Project Management and Strategy and IMP Supply in both biotech and CROs. Her design and implementation of effective study protocols has contributed significantly to the successful market authorizations for numerous rare endocrinology and hematology autoimmune programs. Maria-Cruz is currently working as the head of Allucent’s team of Rare Disease experts, integrating cross functional expertise to provide strategic solutions that foster successful outcomes in rare disease clinical trials and ensure excellence in delivery.

      Session Details:

      Practical Solutions for Patient Engagement in CGT Trials: Supporting Patients and Families Throughout the Journey

      2024-05-07, 11:30 AM

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      Diana Filipescu
      Business Development Manager, Novotech

      Diana Filipescu is from Bucharest, România. Diana has a regulatory background, with 11 years of experience in clinical trials. She worked in Regulatory for almost 8 years and then transitioned from Regulatory Line Manager to Business Development Manager. She has earned two BSc., one in Management and the other one in Law. In addition, she also has a MSc. in Health Management. She is very passionate about finding new ways to improve the healthcare industry by ensuring compliance with all applicable laws and regulations. Her goal is to make sure that all medical products are safe for consumers.

      Session Details:

      Ready for January 2025? Roadmap to CTIS compliance

      2024-05-08, 10:30 AM

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      Alicia Borràs
      Study Coordinator, Digital Health Unit, Strategy Office Més Sant Pau, Hospital de Santa Creu i Sant Pau

      Session Details:

      Great expectations and how to meet them – connected devices and ePRO in clinical trials

      2024-05-07, 2:00 PM

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      Sarah Bly
      Director Regulatory Science, Strategy & Innovation, Worldwide Clinical Trials

      Sarah Bly is Director of Regulatory Science, Strategy and Innovation at Worldwide Clinical Trials. Based in the UK with over 19 years’ experience in the pharmaceutical industry.  Sarah is a lead in providing high level strategic regulatory strategies, risk assessments and solutions including driving health equity strategies.  Sarah is also an active volunteer and stakeholder for initiatives such as EU-X-CT which aims to improve cross-border access to clinical trials for patients in the EU.

      Session Details:

      Navigating the Complex Regulatory Landscape for Oncology Trials: A Focus on the European Union

      2024-05-07, 11:30 AM

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      Martin Czakon, MSc
      EMEA Head of Commercial Strategy & Growth, Care Access

      Martin Czakon, MSc, brings extensive clinical research and business development expertise to his role as EMEA Head of Commercial Strategy & Growth at Care Access. With over 12 years in executive roles within global CRO providers and patient enrollment organizations, Martin excels in strategical planning, leadership, and patient recruitment, maximizing study efficiency.

      As Therapeutic Area Head at Julius Clinical and former Senior Business Development Director at Bioclinica, Martin leveraged executive experience to position companies as industry leaders. With a background as a former board-certified physiotherapist, he offers a unique perspective on clinical research challenges. Martin excels in developing relationships and navigating complexities in CRO service offerings, driving successful outcomes.

      Session Details:

      Going Beyond ROI: Necessary Criteria for Impactful Innovation with Decentralized Clinical Trials

      2024-05-07, 10:00 AM

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      Saskia van Dalen
      Global head R&D procurement, Sandoz

      Session Details:

      FIRESIDE CHAT: Patients at the Heart

      2024-05-07, 3:00 PM

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      Linda O’Grady
      Director Clinical Procurement, Novartis

      Session Details:

      FIRESIDE CHAT: Patients at the Heart

      2024-05-07, 3:00 PM

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      John Batchelor
      Science Liaison, DEEP Measures (Digital Evidence Ecosystems and Protocols)

      John combines more than 20 years experience in clinical data management, PCOR science and clinical trial operations with expertise leading the development of data pipelines, knowledge management products and new processes to advance the use of eCOA & digital measures in clinical trials.

      John is an expert in the execution and scaling of patient and site facing clinical trial technologies who gained a BSc in Biology from the University of Bristol in the UK. Before joining DEEP John worked for Roche for over 9 years where he led external industry collaborations and played a leadership role in the co-creation of a new operational framework and ecosystem of data/ technology products to support the digital health technology lifecycle.

      John now works for DEEP as a Science Liaison where he partners closely with DEEP’s existing customers, helping them to maximize value gain through collaboration.

      Session Details:

      Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

      2024-05-08, 10:00 AM

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