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DAY TWO
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DAY TWO
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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
09:00 - 09:3030 mins
Partnerships and Outsourcing in Clinical Trials (1)
CASE STUDY: Good partnership relationship with industry and investigator site with an Investigator initiative trial
- Wolfgang Eglmeier - Head ZKS-UW/H, Witten Herdecke University, Germany
09:00 - 09:3030 mins
Partnerships and Outsourcing in Clinical Trials (2)
CASE STUDY: Inspection preparation -conduct, organisation and managing a Regulatory Inspection and hear experiences of inspections
- Karin Tulzer - Global Quality Strategy Lead, Merck KGaA, Austria
09:00 - 09:3030 mins
Operations in Clinical Trials (1)
Patient engagement from the patient perspective: examples from real life
- Ben Cromarty - North Yorkshire AIDS Action (NYAA), Medical Research Council Clinical Trials Unit at University College London Patient and Public Involvement Group, UK
09:00 - 09:3030 mins
Operations in Clinical Trials (2)
Covid-19 related impact on drug development?
- Maren von Fritschen - Regulatory Affairs, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium
09:00 - 09:3030 mins
Technology in Clinical Trials (1)
KEYNOTE: Build a collaborative development framework for novel digital endpoints
- Kai Langel - Director, Janssen Clinical Innovation (JCI), Janssen, Spain
09:00 - 09:3030 mins
Technology in Clinical Trials (2): Artificial Intelligence
AI-powered recruitment of a digital readiness cohort for Alzheimer’s Disease (AD)
- Nicklas Linz - Researcher, German Research Centre for Artificial Intelligence (DFKI), Germany
09:00 - 09:3030 mins
Early Clinical Develoment
Keynote: Regulator’s Perspective for Complex Clinical Trials and Innovative Trial Designs
- Maria Beatrice Panico - Senior Medical Assessor, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency, UK
09:30 - 10:0030 mins
Partnerships and Outsourcing in Clinical Trials (1)
CASE STUDY: Environmental sustainability - Novartis
- Mairead Lyons - Group Lead, Clinical Project Management, Novartis, Ireland
09:30 - 10:0030 mins
Partnerships and Outsourcing in Clinical Trials (2)
Facilitating optimisation of the performance of clinical trials through enhanced analysis of data from audits and inspections of clinical trials
- Joanne North - Analytics Lead, Metrics, Reporting and Analytics, BioResearch Quality and Compliance, Johnson & Johnson, UK
09:30 - 10:0030 mins
Operations in Clinical Trials (1)
Impact patient centered initiatives in clinical trial design and execution
- Sebastian Stratmann - Senior Manager Clinical Innovation, Merck Healthcare KGaA Biopharma, Germany
09:30 - 10:0030 mins
Operations in Clinical Trials (2)
Designing cancer trials for the 21st century
- Sarah Blagden - Associate Professor of Medical Oncology, University of Oxford, UK
09:30 - 10:0030 mins
Technology in Clinical Trials (1)
How digital health technology will shape the trials of 2030
- Pamela Tenaerts - Executive Director, Clinical Trials Transformation Initiative (CTTI), USA
09:30 - 10:0030 mins
Technology in Clinical Trials (2): Artificial Intelligence
Deep machine understanding and predictive modeling of clinical trial quality data to drive consistency and efficiency
- Deepak Bandyopadhyay - Associate Director of Quality Analytics,, Janssen, USA
09:30 - 10:0030 mins
Early Clinical Develoment
New FDA and EMA Guidance for Adaptive Design Clinical Trials: Areas of Divergence
- Cornelia Urusla Kunz - Biostatistics & Data Sciences Corp., Boehringer Ingelheim, Germany
10:00 - 10:4040 mins
Partnerships and Outsourcing in Clinical Trials (1)
PANEL: What type of CRO is the right fit for small pharma/biotech
- Michael Zorer - Head of Clinical Operations, AOP Orphan Pharmaceuticals AG, Austria
- Paul Bouten - Managing Director, PharmCMed, The Netherlands
- Nancy Meyerson-Hess - Consultant Clinical Research, Chief Compliance & Regulatory Officer, eMQT, Expert Partner, admedicum, Germany
- Amer Alghabban - Senior Director, Clinical Compliance and Training, Freeline Therapeutics, Switzerland
10:00 - 10:4040 mins
Partnerships and Outsourcing in Clinical Trials (2)
PANEL: Regulatory challenges for clinical trials
- Nurcan Coskun - Global Risk Based Monitoring & Technology Solutions Program Manager, Formerly Medtronic, Switzerland
- Maren von Fritschen - Regulatory Affairs, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium
- Rebecca Stanbrook - Global Head, Quality Regulatory Strategy, Novartis, Switzerland
- Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
10:00 - 10:4040 mins
Operations in Clinical Trials (1)
PANEL: KPI’s (Key Performance Indicator) - Quality assessment if undertaking patient engagement correctly?
- Marta Garcia - Patient Officer-Clinical Development, Patient In R&D, Servier International, Spain
- Sebastian Stratmann - Senior Manager Clinical Innovation, Merck Healthcare KGaA Biopharma, Germany
- Hans van Delden - Prof in Medical Ethics, Vice-Chair, The Central Committee on Research Involving Human Subjects (CCMO), Utrecht University, The Netherlands
10:00 - 10:3030 mins
Operations in Clinical Trials (2)
PANEL: Adaptive Trials – what are the operational challenges from all stakeholder’s perspective
- Suzanne van de Vathorst - Professor in Ethics, Erasmus University, The Netherlands
- Richard Stephens - Chair of the National Cancer Research Institute's Consumer Forum, National Cancer Research Institute’s Consumer Forum (NCRI), UK
10:00 - 10:4040 mins
Technology in Clinical Trials (1)
PANEL: IMI Trials@Home: Reshaping remote decentralised clinical trials in Europe
- Kai Langel - Director, Janssen Clinical Innovation (JCI), Janssen, Spain
10:00 - 10:4040 mins
Technology in Clinical Trials (2): Artificial Intelligence
PANEL: What are the main challenges of AI and what advancements have been made?
- Nicklas Linz - Researcher, German Research Centre for Artificial Intelligence (DFKI), Germany
- Alexandra Konig - Clinical Researcher, Memory Clinic at Nice University Hospital, University of Côte d'azur, and INRIA Nice, France
- Corrette Ploem - Assistant Professor, University Medical Centre (UMC) Amsterdam, Netherlands
- Michel Arnoult - Chairman, Arnoult.org, France
10:00 - 10:3030 mins
Early Clinical Develoment
Spotlight Presentation
10:40 - 11:3050 mins
Refreshment Break in the Exhibit Hall
11:30 - 12:0030 mins
Partnerships and Outsourcing in Clinical Trials (1)
Conducting clinical trials in world version 2, world with COVID-19
- Amer Alghabban - Senior Director, Clinical Compliance and Training, Freeline Therapeutics, Switzerland
11:30 - 12:0030 mins
Partnerships and Outsourcing in Clinical Trials (2)
BREXIT – What impact will this have on clinical trials in the UK?
- Sheuli Porkess - Executive Director Research Medical & Innovation, Association of the British Pharmaceutical Industry (ABPI), UK
11:30 - 12:0030 mins
Operations in Clinical Trials (1)
CASE STUDY: The importance of giving feedback to patients and results about the transparency of the clinical work
- Amelia Hursey - Research Participation Lead, Parkinson’s UK
11:30 - 12:0030 mins
Operations in Clinical Trials (2)
Regulator’s perspective for complex clinical trials and innovative trial designs
- Maria Beatrice Panico - Senior Medical Assessor, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency, UK
11:30 - 12:0030 mins
Technology in Clinical Trials (1)
An applied framework for evaluating connected sensor technologies
- Jennifer Goldsack - Executive Director, Digital Medicine Society (DiMe), USA
11:30 - 12:0030 mins
Technology in Clinical Trials (2): Artificial Intelligence
A real world evaluation using NHS data to compare 100% remote digitally-enabled Type 2 Diabetes structured education & behaviour change programmes Vs face to face Type 2 diabetes structured education programmes
- Ralphael Oghagbon - Health Economist, Imperial College Health Partners, UK
11:30 - 12:0030 mins
Early Clinical Develoment
Alternative Methods to Support FiH Trials: In silico Clinical Trials
12:00 - 12:3030 mins
Partnerships and Outsourcing in Clinical Trials (1)
Spotlight Presentation: CASE STUDY: Different outsourcing models- success stories
12:00 - 12:3030 mins
Partnerships and Outsourcing in Clinical Trials (2)
Spotlight Presentation
12:00 - 12:3030 mins
Operations in Clinical Trials (1)
Spotlight Presentation: Sponsor considerations when including mobile research nursing in clinical trials
- Helen Springford - Chief Executive Officer, Illingworth Research, UK
12:00 - 12:3030 mins
Operations in Clinical Trials (2)
Spotlight Presentation: Optimizing the entire clinical trial financial lifecycle through automation
- Jim Murphy - CEO, Greenphire, USA
12:00 - 12:3030 mins
Technology in Clinical Trials (1)
Spotlight Presentation: Covance
12:00 - 12:3030 mins
Technology in Clinical Trials (2): Artificial Intelligence
Spotlight Presentation
12:00 - 12:3030 mins
Early Clinical Develoment
Challenges and Opportunities of Early Drug Development: A Regulatory Perspective
- Khadija Rantell - Statistical Assessor, Medicines and Health Care Products Regulatory Agency (MHRA), UK
12:30 - 13:5080 mins
Networking Luncheon in the Exhibit & Poster Hall
- Rosamund Round - Vice President, Patient Innovation Center, Parexel International, UK
13:50 - 14:0010 mins
Partnerships and Outsourcing in Clinical Trials (1)
Chairperson’s Opening Remarks
13:50 - 14:0010 mins
Partnerships and Outsourcing in Clinical Trials (2)
Chairperson’s Opening Remarks
13:50 - 14:0010 mins
Operations in Clinical Trials (1)
Chairperson’s Opening Remarks
13:50 - 14:0010 mins
Operations in Clinical Trials (2)
Chairperson’s Opening Remarks
13:50 - 14:0010 mins
Technology in Clinical Trials (1)
Chairperson’s Opening Remarks
13:50 - 14:0010 mins
Technology in Clinical Trials (2): Artificial Intelligence
Chairperson’s Opening Remarks
14:00 - 14:3030 mins
Partnerships and Outsourcing in Clinical Trials (1)
Patient Diversity - Huge push to improve the representation of participant demographics (race and ethnicity)
- Kenneth Getz - Deputy Director and Professor, Tufts Center for the Study of Drug Development Tufts University, USA
14:00 - 14:3030 mins
Partnerships and Outsourcing in Clinical Trials (2)
European Medical Device Regulation - May 2020- what will be the requirements?
- Nurcan Coskun - Global Risk Based Monitoring & Technology Solutions Program Manager, Formerly Medtronic, Switzerland
14:00 - 14:3030 mins
Operations in Clinical Trials (1)
Patient engagement in reviewing applications for research: pro's and con's
- Richard Dekhuijzen - Professor of Pulmonology, Radboud University Medical Center in Nijmegen, Netherlands
14:00 - 14:3030 mins
Operations in Clinical Trials (2)
Adaptive clinical trials from an ethics perspective
- Suzanne van de Vathorst - Professor in Ethics, Erasmus University, The Netherlands
14:00 - 14:3030 mins
Technology in Clinical Trials (1)
CASE STUDY: Actual experiences working with Virtual trials
- Rasmus Hogreffe - Head of Virtual Clinical Trials, Leo Innovation Lab, Denmark
14:00 - 14:3030 mins
Technology in Clinical Trials (2): Artificial Intelligence
The ethics of clinical trials and the ethics of AI: Establishing real-world common ground between researchers and patients
- Francis Crawley - Executive Director, Good Clinical Practice Alliance - Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Review (SIDCER); Leuven/Brussels, Belgium
14:00 - 14:3030 mins
Early Clinical Develoment
Panel: Regulatory Science to Accelerate and Influence Early Clinical Trial Practice
- Khadija Rantell - Statistical Assessor, Medicines and Health Care Products Regulatory Agency (MHRA), UK
- Cornelia Urusla Kunz - Biostatistics & Data Sciences Corp., Boehringer Ingelheim, Germany
14:30 - 15:0030 mins
Partnerships and Outsourcing in Clinical Trials (1)
CASE STUDY: The future of research in primary care and collaborations with primary care federations/primary care networks to facilitate recruitment
- Andre Krzeminski - Lead Research GP, Albany Health, UK
14:30 - 15:0030 mins
Partnerships and Outsourcing in Clinical Trials (2)
What is the Regulators’ view on the future of clinical research
- Nikolai Brun - Director of Division, Chair HMA-EMA Taskforce on Big Data, Copenhagen Area, Capital Region, Denmark Medical Evaluation and Biostatistics, DKMA, Denmark
14:30 - 15:0030 mins
Operations in Clinical Trials (1)
How sites can develop a harmonized program for digital readiness
- Jennifer Nielsen - Process Development Specialist, Novo Nordisk AS, Denmark
14:30 - 15:0030 mins
Operations in Clinical Trials (2)
Real world trials and RWD in trials and healthcare data related topics
- Amanda Lucas - Programme Director, Imperial College Health Partners, UK
14:30 - 15:0030 mins
Technology in Clinical Trials (1)
CASE STUDY: AstraZeneca learnings from a decentralized hybrid trial in adolescent patients with asthma
- Henrik Forsman - Clinical Innovation Director, AstraZeneca, Sweden
14:30 - 15:0030 mins
Technology in Clinical Trials (2): Artificial Intelligence
Clinical applications of AI and automatic speech and language analysis with dementia patients to better detect early signs of cognitive decline as well as monitoring disease progression
- Alexandra Konig - Clinical Researcher, Memory Clinic at Nice University Hospital, University of Côte d'azur, and INRIA Nice, France
14:30 - 15:0030 mins
Early Clinical Develoment
Achieve Critical Go/No Go Decisions Faster in Early Clinical Development
- John Connell - Chief Scientific Officer, MAC Clinical Research, UK
15:00 - 15:3030 mins
Partnerships and Outsourcing in Clinical Trials (1)
Spotlight Presentation: IQVIA Technologies
15:00 - 15:3030 mins
Partnerships and Outsourcing in Clinical Trials (2)
Spotlight Presentation:
15:00 - 15:3030 mins
Operations in Clinical Trials (1)
Spotlight Presentation:
15:00 - 15:3030 mins
Operations in Clinical Trials (2)
Spotlight Presentation:
15:00 - 15:1515 mins
Technology in Clinical Trials (1)
Spotlight Presentation: How current decentralized studies will influence clinical research? Where we are and where we need to be
- Alexandre Malouvier - Director Global Data Strategy, PRA Health Sciences, France
15:00 - 15:3030 mins
Technology in Clinical Trials (2): Artificial Intelligence
Spotlight Presentation:
15:00 - 15:3030 mins
Early Clinical Develoment
PANEL DISCUSSION: Addressing the Challenge of Patient Recruitment in Early Clinical Development
- Tamzin Blagbrough - Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly and Company Limited, UK
15:15 - 15:3015 mins
Technology in Clinical Trials (1)
Spotlight Presentation:
15:30 - 15:5525 mins
Afternoon Coffee Break and Networking
15:55 - 16:005 mins
AFTERNOON PLENARY
Chairperson’s Opening Remarks
16:00 - 16:3030 mins
AFTERNOON PLENARY
The drug development paradigm and ways that the pandemic is facilitating major change
- Kenneth Getz - Deputy Director and Professor, Tufts Center for the Study of Drug Development Tufts University, USA
16:30 - 17:0030 mins
AFTERNOON PLENARY
Future of Medicine- Cell and Gene Therapy/Precision Medicine /Personalised Medicine
- Anita Nelsen - Senior Vice President, Translational Medicine, Parexel International, UK
17:00 - 17:4040 mins
AFTERNOON PLENARY
PANEL: The future of clinical trials
- Richard Stephens - Chair of the National Cancer Research Institute's Consumer Forum, National Cancer Research Institute’s Consumer Forum (NCRI), UK
17:40 - 17:455 mins
AFTERNOON PLENARY
Christine Pierre Lifetime Achievement Award in Association with mdgroup
17:45 - 17:505 mins
AFTERNOON PLENARY
Clinical Trials Europe Best Exhibition Stand Award
17:50 - 18:3040 mins
AFTERNOON PLENARY
Inspirational Speaker: Medical Aspects of Space travel
- André Kuipers - Astronaut, Physician, Ambassador of the Earth, The Netherlands
18:30 - 20:0090 mins
Drinks and CTE Party
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