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DAY ONE

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DAY ONE

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13:00 - 13:5050 mins
Registration and Coffee
    13:50 - 13:555 mins
    Conference Opening and Welcome
      13:55 - 14:005 mins
      EARLY CLINICAL DEVELOPMENT
      Chairperson’s Opening Remarks
      • Christer Gottfridsson - ECG Centre Cardiologist, Astrazeneca, Sweden
      13:55 - 14:005 mins
      OPENING PLENARY SESSION
      Chairperson’s Opening Remarks
      • Jeannett Dimsits - Formerly Senior Director, Trial Management Anchor,, Novo Nordisk A/S, Denmark
      14:00 - 14:4040 mins
      OPENING PLENARY SESSION
      Change as an opportunity - Better project management of your clinical Trials
      • Stephen Carver - Senior Lecturer in Change Project and Programme Management, Cranfield University, UK
      14:00 - 14:3030 mins
      EARLY CLINICAL DEVELOPMENT
      Clinical trial regulations 2020: anticipating the impact on early phase clinical development
      • Massimiliano Sarra - Preclinical and clinical assessor, AIFA Agenzia Italiana del farmaco, Italy
      14:30 - 15:0030 mins
      EARLY CLINICAL DEVELOPMENT
      FIH guideline update: regulators insight
      • Camilla Svensson - Non-Clinical Assessor, Dept of Clinical Trials, The Swedish Medical Products Agency (MPA), Sweden
      14:40 - 15:2040 mins
      OPENING PLENARY SESSION
      PATIENT STORY: Frankie’s Journey: A parents perspective on their son who has Dravets who went on a clinical trial
      • Stacey Williamson - is mum to Frankie who has the rare genetic disease, Dravets syndrome, UK
      15:00 - 15:3030 mins
      EARLY CLINICAL DEVELOPMENT
      Regulator’s perspective on innovative protocol designs in early phase designs: basket, umbrella and platform designs
      • Khadija Rantell - Accredited Statistical Assessor, Medicines and Health Care Products Regulatory Agency (MHRA), UK
      15:20 - 16:1050 mins
      OPENING PLENARY SESSION
      PANEL: Trials of the future
      • Phil Hammond - Doctor, Journalist, Broadcaster,, Campaigner and Comedian, UK
      • Christian Born Djurhuus - Vice President, Head of Digital Transformation, Global Development, Novo Nordisk A/S, Denmark
      • Lode Dewulf - Chief Patient Officer, Servier, France
      • Donna Graham - Honorary Consultant in Medical Oncology, Experimental Cancer Medicine Team (ECMT), The University of Manchester, UK
      • Richard Stephens, National Cancer Research Institute Consumer Forum, UK
      • Ben Quartley - Vice President, Feasibility, Recruitment, Patient Engagement & M-Health, Covance, UK
      • Disa Lee Choun - Head of GCSO Innovation, UCB, UK
      • Alastair MacDonald - SVP Real World & Late Phase Client Engagement, Syneos Health
      15:30 - 16:0030 mins
      EARLY CLINICAL DEVELOPMENT
      Improving regulator confidence for novel early phase clinical development
      • Olivier Collignon - Statistical Leader, GSK, UK
      16:10 - 16:2010 mins
      Networking Refreshment Break
        16:20 - 16:4020 mins
        Partnerships and Outsourcing in Clinical Trials (1)
        Networking Refreshment Break
          16:20 - 16:5030 mins
          EARLY CLINICAL DEVELOPMENT
          The changing regulatory landscape for cardiac safety assessments
          • Boaz Mendzelevski - President, Cardiac Safety Consultants Ltd, UK
          16:20 - 16:4020 mins
          Technology in Clinical Trials (2): Artificial Intelligence
          Networking Refreshment Break
            16:20 - 16:4020 mins
            Technology in Clinical Trials (1)
            Networking Refreshment Break
              16:20 - 16:4020 mins
              Operations in Clinical Trials (1)
              Networking Refreshment Break
                16:40 - 16:455 mins
                Operations in Clinical Trials (1)
                Chairperson’s Opening Remarks
                • Jennifer Burgess - Vice President, Global Engagement & Communications, TransCelerate Biopharma Inc, USA
                16:40 - 16:455 mins
                Partnerships and Outsourcing in Clinical Trials (1)
                Chairperson’s Opening Remarks
                • Estrella García - Director Global Clinical Operation, Almirall, S.A.
                16:40 - 16:455 mins
                Technology in Clinical Trials (1)
                Chairperson’s Opening Remarks
                • Kenneth Getz - Senior Reseach Fellow, Tufts Center for the Study of Drug Development Tufts University, USA
                16:40 - 16:455 mins
                Technology in Clinical Trials (2): Artificial Intelligence
                Chairperson’s Opening Remarks
                • Mishal Patel - Senior Director & Head of Health Informatics, AstraZeneca, UK
                16:45 - 17:1530 mins
                Partnerships and Outsourcing in Clinical Trials (1)
                CASE STUDY: Can Mid-size Pharma leverage Innovation and embrace Digitalization when partnering with CROs?
                • Estrella García - Director Global Clinical Operation, Almirall, S.A.
                16:45 - 17:1530 mins
                Technology in Clinical Trials (1)
                KEYNOTE: Digitalisation of clinical trial study – how this will revolutionise how clinical trials are done
                • Rasmus Hogreffe - Head of Virtual Clinical Trials, Leo Innovation Lab, Denmark
                16:45 - 17:1530 mins
                Technology in Clinical Trials (2): Artificial Intelligence
                ∆elta : A clinical tool for early detection and monitoring of cognitive disorders such as dementia on the basis of automatic speech analysis
                • Nicklas Linz, MSc. - CEO, ki elements
                16:45 - 17:1530 mins
                Operations in Clinical Trials (1)
                Novel ways of improving patient recruitment and patient participation in clinical research
                • Eric Roos - Executive Board Member, Dutch Clinical Research Foundation (DCRF), The Netherlands
                16:50 - 17:2030 mins
                EARLY CLINICAL DEVELOPMENT
                Harnessing innovation to accelerate progress for phase I to phase IIa clinical trials
                • Jorg Taubel - CEO, Richmond Pharmacology, UK
                17:15 - 17:4530 mins
                Technology in Clinical Trials (1)
                CASE STUDY: Benefit and risks of adding wearables and other remote monitoring devices into clinical trials
                • Matthew Bonam - Head of R&D Digital, AstraZeneca R&D, UK
                17:15 - 17:4530 mins
                Partnerships and Outsourcing in Clinical Trials (1)
                JOINT PRESENTATION: Engaging patient by providing access to Patient Data Access in Clinical Trials: from concept to implementation
                • Caroline Feys - R&D Operations Innovation Leader, Janssen, Belgium
                • Sofie Swinnen - Investigator & Patient Engagement Project Lead, Janssen, Belgium
                17:15 - 17:4530 mins
                Technology in Clinical Trials (2): Artificial Intelligence
                Application of Artificial Neural Networks to Infer Pharmacological Molecular-level Mechanisms of Drug evoked Clinical Responses
                • Jonathan Wagg - Disease Therapeutic Area Modeling Leader - Oncology, Roche Pharmaceutical Research and Early Development, Clinical Pharmacology-Pharmaceutical Sciences, Roche Innovation Centre Basel, Switzerland
                17:15 - 17:4530 mins
                Operations in Clinical Trials (1)
                CASE STUDY: How to manage cultural differences, site engagement and patient recruitment when running a global study in a biotech company
                • Robert Corbé - Clinical Trial Manager, Isofol Medical, Sweden
                17:20 - 17:3515 mins
                EARLY CLINICAL DEVELOPMENT
                Concentration QT analysis to slim down or replace the thorough QT study in early clinical development
                • Georg Ferber - Statistical Consultant, Statistik Georg Ferber GmbH, Switzerland
                17:45 - 19:1590 mins
                Grand Opening of the CTE Exhibition Hall with Covance Networking Drinks Reception
                  NextDAY TWO

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