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DAY THREE
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DAY THREE
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08:50 - 09:0010 mins
Partnerships and Outsourcing in Clinical Trials (1)
Chairperson’s Opening Remarks
08:50 - 09:0010 mins
Partnerships and Outsourcing in Clinical Trials (2)
Chairperson’s Opening Remarks
08:50 - 09:0010 mins
Operations in Clinical Trials (1)
Chairperson’s Opening Remarks
08:50 - 09:0010 mins
Operations in Clinical Trials (2)
Chairperson’s Opening Remarks
08:50 - 09:0010 mins
Technology in Clinical Trials (1)
Chairperson’s Opening Remarks
08:50 - 09:0010 mins
Technology in Clinical Trials (2): Artificial Intelligence
Chairperson’s Opening Remarks
08:50 - 09:0010 mins
Early Clinical Develoment
Opening Chair Remarks
- Chris Twelves - Head of Oncology Clinical Research, Leeds Cancer Research Centre, UK
09:00 - 09:3030 mins
Partnerships and Outsourcing in Clinical Trials (1)
Embedding quality holistically: How do quality risk management and risk based monitoring work together?
- Michael Walega - Director, Centralized Monitoring, Global Data Management & Centralized Monitoring, BMS, USA
09:00 - 09:3030 mins
Partnerships and Outsourcing in Clinical Trials (2)
GDPR: General overview, implementation, debated issues and learnings so far
- Corrette Ploem - Assistant Professor, University Medical Centre (UMC) Amsterdam, Netherlands
- Kristof Van Quathem - Senior Privacy and Technology Lawyer, Covington & Burling LLP, Belgium
09:00 - 09:3030 mins
Operations in Clinical Trials (1)
Patient Engagement- Site selection and recruitment- from a site perspective
- Graeme Boyle - Senior R&D Manager, Tayside Medical Science Centre (TASC), UK
09:00 - 09:3030 mins
Operations in Clinical Trials (2)
The Patient Centricity Effect – How it benefits Patients, Sites and Sponsors – Practical cases from paediatric studies
- Mariangela Lupo - Communication and Patient Advocacy Manager, TEDDY European Network of Excellence for Paediatric Clinical Research, Italy
09:00 - 09:3030 mins
Technology in Clinical Trials (1)
CASE STUDY: Novo Nordisk’s learnings from implementing DTP (Shipment of IMP from site to patients’ home)
- Birgitte Denlow - GCP Advisor Specialist, Global Clinical Quality & Intelligence, Novo Nordisk, Denmark
09:00 - 09:3030 mins
Technology in Clinical Trials (2): Artificial Intelligence
CASE STUDY: What’s really needed to transform information flow in clinical development
- Elinor Olesen - VP DM Change Management, Novo Nordisk, Denmark
09:00 - 09:3030 mins
Early Clinical Develoment
Inclusion of Special Patient Populations in Phase I Oncology Trials
- Chris Twelves - Head of Oncology Clinical Research, Leeds Cancer Research Centre, UK
09:30 - 10:0030 mins
Partnerships and Outsourcing in Clinical Trials (1)
How can Quality Tolerance Limits support COVID-19 impact assessments
- Marion Wolfs - Associate Director Risk Management and Central Monitoring, Janssen, The Netherlands
09:30 - 10:0030 mins
Partnerships and Outsourcing in Clinical Trials (2)
EU Clinical Trials Regulation; An update of the current status and some thoughts on its implementation
- Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
09:30 - 10:0030 mins
Operations in Clinical Trials (1)
Collaborative working from the very start –view from a primary care site perspective.
- Olivia Barnes - Senior Research Nurse, Sherbourne Medical Centre, UK
09:30 - 10:0030 mins
Operations in Clinical Trials (2)
JOINT CASE STUDY: Pilot study/simulation using paediatric patients input in clinical trial development
- Joana Claverol - Clinical Research Unit Manager, Barcelona Children’s Hospital Sant Joan de Déu, Spain
- Begonya Nafria Escalera - Patient Engagement in Research Coordinator, Barcelona Children’s Hospital Sant Joan de Déu, Spain
09:30 - 10:0030 mins
Technology in Clinical Trials (1)
Clinical trials go virtual in Trial Nation
- Pia Nørrisgaard - Project Leader, Trial Nation, Denmark
09:30 - 10:0030 mins
Technology in Clinical Trials (2): Artificial Intelligence
Regulatory challenges of using of new technologies in clinical trials
- Michel Arnoult - Chairman, Arnoult.org, France
09:30 - 10:0030 mins
Early Clinical Develoment
Models to Support FiH Studies: Preclinical Efficacy and Toxicity for New Therapeutic Modalities
- Meagan O'Brien - Director of Early Clinical Development and Clinical Experimental Sciences, Regeneron Pharmaceuticals, UK
10:00 - 10:3030 mins
Partnerships and Outsourcing in Clinical Trials (1)
Spotlight Presentation:
10:00 - 10:3030 mins
Partnerships and Outsourcing in Clinical Trials (2)
Spotlight Presentation:
10:00 - 10:3030 mins
Operations in Clinical Trials (1)
Spotlight Presentation: Covance
10:00 - 10:3030 mins
Operations in Clinical Trials (2)
Spotlight Presentation:
10:00 - 10:3030 mins
Technology in Clinical Trials (1)
Spotlight Presentation: Medable
10:00 - 10:3030 mins
Technology in Clinical Trials (2): Artificial Intelligence
Spotlight Presentation: Implementing IoT in support of patient-centric virtual trials
- Ad Dijkhoff - Head of Business Development, Philips, USA
10:00 - 10:3030 mins
Early Clinical Develoment
Spotlight Presentation
10:30 - 11:2050 mins
Refreshment Break in the Exhibit & Poster Hall
11:20 - 11:5030 mins
Partnerships and Outsourcing in Clinical Trials (1)
How to reduce the lead time and improve the DM processes using a lean methodology approach
- Virginie Van de Velde - Senior Manager Oversight Data Manager, GSK Vaccines, Belgium
11:20 - 11:5030 mins
Partnerships and Outsourcing in Clinical Trials (2)
Please Move to a Different Stream
11:20 - 11:5030 mins
Operations in Clinical Trials (1)
CASE STUDY: The application of data Science- how to get a better predictability of average recruitment and retention rate?
- Danny Hasselbaink - Global Feasibility Lead, Janssen Biologics B.V., The Netherlands
11:20 - 11:5030 mins
Operations in Clinical Trials (2)
Please Move to a Different Stream
11:20 - 11:5030 mins
Technology in Clinical Trials (1)
Learnings from a paediatric decentralized clinical trial
- Helen Todman - Associate Project Director, Parexel International, UK
11:20 - 11:5030 mins
Technology in Clinical Trials (2): Artificial Intelligence
Please Move to a Different Stream
11:20 - 11:5030 mins
Early Clinical Develoment
Randomisation Methods to Minimise Placebo Responses in Early Phase Development
- Peter Van Der Ark - Clinical Research Manager, Experimental Medicine Neuroscience, Janssen, Belgium
11:50 - 12:2030 mins
Partnerships and Outsourcing in Clinical Trials (1)
Regulatory expectations of working with audit trails
- Jennifer Nielsen - Process Development Specialist, Novo Nordisk AS, Denmark
11:50 - 12:2030 mins
Partnerships and Outsourcing in Clinical Trials (2)
Please Move to a Different Stream
11:50 - 12:2030 mins
Operations in Clinical Trials (1)
CASE STUDY: Managing recruitment expectation, the difficulty of reliable feasibility questionnaires and the need for a good recruitment strategy
- Philipp Badorrek - Head of Department, Clinical Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany
11:50 - 12:2030 mins
Operations in Clinical Trials (2)
Please Move to a Different Stream
11:50 - 12:2030 mins
Technology in Clinical Trials (1)
Clinical research in low resource settings
- Melissa Menke - Founder and CEO, Access Afya, Kenya
11:50 - 12:2030 mins
Technology in Clinical Trials (2): Artificial Intelligence
Please Move to a Different Stream
11:50 - 12:2030 mins
Early Clinical Develoment
Integrating Study Designs for QTc and Hemodynamic Assessments
- Corina Dota - Head of Cardiovascular Safety Centre of Excellence, AstraZeneca, Sweden
12:20 - 13:0040 mins
Partnerships and Outsourcing in Clinical Trials (1)
PANEL: Ensuring adequate oversight and overcoming the challenges of using external versus internal staff
- Anna Matranga - Strategic Sourcing R&D, Senior Director, Global Scientific Affairs & Strategic Sourcing, AMC Alliances & Consulting, France
- Stephen Walker - Outsourcing Programme Director, Alliance Management, AstraZeneca, UK
- Karin Tulzer - Global Quality Strategy Lead, Merck KGaA, Austria
- Virginie Van de Velde - Senior Manager Oversight Data Manager, GSK Vaccines, Belgium
12:20 - 13:0040 mins
Operations in Clinical Trials (1)
PANEL: Ensuring a good recruitment strategy - How to successfully recruit patients?
- Philipp Badorrek - Head of Department, Clinical Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany
- Wolfgang Eglmeier - Head ZKS-UW/H, Witten Herdecke University, Germany
- Diana Sims-Silbermann - Specialist General and Emergency Medicine, Anesthesie, SeniorTrial Manager, Early Development and Clinical Pharmacology, Janssen-Cilag GmbH, Johnson & Johnson, Germany
- Olivia Barnes - Senior Research Nurse, Sherbourne Medical Centre, UK
12:20 - 13:0040 mins
Technology in Clinical Trials (1)
PANEL: Interaction between all stakeholders on decentralized/hybrid trials
- Birgitte Denlow - GCP Advisor Specialist, Global Clinical Quality & Intelligence, Novo Nordisk, Denmark
- Jennifer Goldsack - Executive Director, Digital Medicine Society (DiMe), USA
- Maria Kuthning - Executive Global Clinical Operations - Digital Transformation, Formerly Johnson & Johnson, Germany
- Andy Coravos - Co-Founder, Digital Medicine Society (DiMe), USA
12:20 - 12:5030 mins
Early Clinical Develoment
Cardio-Oncology: Strategies for Early Detection and Mitigation of Anticancer Agents Induced Cardiotoxicity
- Boaz Mendzelevski - President, Cardiac Safety Consultants Ltd, UK
13:00 - 13:055 mins
End of Conference
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