ACCELERATE YOUR CLINICAL DEVELOPMENT THROUGH …Robert Dingwall, Professor of Sociology, Nottingham...

Be Part of Europe's Largest Event Dedicated to Streamlining Clinical Trials and Improving Patient Outcomes, Without the Need to Travel

Including Leading Perspectives on the Clinical Developments Surrounding COVID-19

KEYNOTE SPEAKERSProfessor Kenneth Getz Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA

Professor Robert Dingwall Professor of Sociology at Nottingham Trent University, UK

Janis A. Little Vice President, Global R&D Quality, Allergan, UK

Pamela Tenaerts Executive Director, Clinical Trials Transformation Initiative (CTTI), USA

informaconnect.com/clinical-trials-europe@ClinTrialsIC #CLINTRIALS

ACCELERATE YOUR CLINICAL DEVELOPMENT THROUGH PARTNERSHIPS, OUTSOURCING, OPERATIONS & TECHNOLOGY

2-4 November 2020Now Delivered as a 100% Virtual Conference & Exhibition

https://informaconnect.com/clinical-trials-europe/

For more information about Clinical Trials Europe please visit: informaconnect.com/clinical-trials-europe/ 2

Virtual Content

Virtual Networking

⊲ Access 115+ pre-recorded & live case studies and new data presentations and view at your own pace

⊲ Engage with speakers during live Q&A and interactive surveys. Plus, access on-demand content for future viewing

⊲ View 80+ technology showcases & speak with live product specialists in our virtual exhibition

⊲ Access 30+ scientific posters showcasing unpublished research from bioprocessing scientists from around the globe

⊲ Utilise our built-in networking platform to browse the full attendee list and send private messages before, during and after the virtual event

⊲ Gain answers to your current R&D and manufacturing challenges by scheduling 1-1 meetings with fellow attendees, speakers and exhibitors.

⊲ Invite people into to your own private “room” to talk - where you can screenshare and share annotations to collaborate.

Now Delivered as a 100% Virtual Conference & Exhibition

CLINICAL TRIALS EUROPE AT A GLANCE

2 NOVEMBER 2020PLENARY: Covid-19 - Impact on Clinical Development

Future of Medicine

3 - 4 NOVEMBER 2020Regulatory Updates

Different Partnership Approaches

Sustainability

Covid-19

Patient Diversity

Lean Methadology

Risk Based Everything

Regulatory Updates

Inspections

Privacy and Data Protection

Patient Engagement

Patient Recruitment and Retention

Site Selection & Site Perspective

New Innovative Trial Designs for Clinical Trials

Real World Evidence & Real World Data

Rare Diseases

Paediatrics

Covid-19

Decentralized Trials/Hybrid Trials

Digital Health Technology

Artificial Intelligence, Machine Learning & Data Management

Data Flow & Analytics


Now Delivered as a 100% Virtual Conference & Exhibition


CONFIRMED SPEAKERS TO DATE

Amer Alghabban, Senior Director, Clinical Compliance and Training, Freeline Therapeutics, UK

Michel Arnoult, Chairman, Arnoult.org, France

Dr Philipp Badorrek, Head of Department, Clinical Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany

Deepak Bandyopadhyay, Associate Director of Quality Analytics, Janssen, USA

Olivia Barnes, Senior Research Nurse, Sherbourne Medical Centre, UK

Dr Sarah Blagden, Associate Professor of Medical Oncology, University of Oxford, Lead Author of the ECMC Consensus Paper, UK

Diderik Boot, Director Global Clinical Development Operations, Neuroscience, Janssen Biologics B.V., The Netherlands

Graeme Boyle, Senior R&D Manager, Tayside Medical Science Centre (TASC), UK

Nurcan Coskun, Global Risk Based Monitoring Program & Technology Solutions Manager, formerly Medtronic Plc., Switzerland

Anthony Costello, Senior Vice President, Medidata, USA

Francis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Review (SIDCER); Leuven/Brussels, Belgium

Professor Richard Dekhuijzen, Professor of Pulmonology, Radboud University Medical Center in Nijmegen, The Netherlands

Professor Hans van Delden, Prof in Medical Ethics, Vice-Chair, The Central Committee on Research Involving Human Subjects (CCMO), Utrecht University, Amsterdam

Birgitte Denlow, GCP Advisor Specialist, Global Clinical Quality & Intelligence, Novo Nordisk A/S, Denmark

Elizabeth Eagling-Vose, Senior Director, Head of Clinical Operations, Vaccitech, UK

Dr Wolfgang Eglmeier, Head ZKS-UW/H (Centre for Clinical Studies), Witten/Herdecke University, Germany

Begonya Nafria Escalera, Patient Engagement in Research Coordinator, Hospital Sant Joan de Déu, Spain

Henrik Forsman, Clinical Innovation Director, AstraZeneca, Sweden

Professor Kenneth Getz, Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA

Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe), USA

Danny Hasselbaink, Global Feasibility Lead, Janssen Biologics B.V., The Netherlands

Rasmus Hogreffe, Head of Virtual Clinical Trials, Leo Innovation Lab, Denmark

Amelia Hursey, Research Participation Lead, Parkinson’s UK

Alexandra König, Clinical Researcher, Memory Clinic at Nice University Hospital, University of Côte d’azur, and INRIA Nice, France

Dr Andre Krzeminski, Lead Research GP, Albany House Medical Centre, UK

Kai Langel, Director, Janssen Clinical Innovation (JCI), Janssen, Spain

Nicklas Linz, Researcher, German Research Centre for Artificial Intelligence (DFKI), Germany

Janis A. Little, Vice President, Global R&D Quality, Allergan, UK

Amanda Lucas, Programme Director, Imperial College, UK

Mariangela Lupo, Communication and Patient Advocacy Manager, TEDDY European Network of Excellence for Paediatric Research, Italy

Dr Bodo Lutz, Clinical Risk Management and Data Integrity QA, Novartis Global Development Quality, Germany

Mairéad Lyons, Group Lead, Clinical Project Management, Novartis, Ireland

Alexandre Malouvier, Director Global Data Strategy, PRA Healthsciences, France

Marta Garcia Manrique, Patient Officer-Clinical Development, Patient In R&D, Servier International, Spain

Anita Nelsen, Senior Vice President and Head, Translational Medicine, Parexel International, USA

Jennifer Logue Nielsen, Process Development Specialist, Novo Nordisk, Denmark

Joanne North, Analytics Lead, Metrics, Reporting and Analytics, BioResearch Quality and Compliance, Johnson & Johnson, UK

Ralphael Oghagbon, Health Economist, Imperial College Health Partners, UK

Elinor Olesen, VP DM Change Management, Novo Nordisk, Denmark

Beatrice Panico, Senior Medical Assessor, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency, UK

Dr Corrette Ploem, Assistant Professor, University Medical Centre (UMC) Amsterdam, The Netherlands

Sheuli Porkess, Executive Director Research Medical & Innovation, Association of the British Pharmaceutical Industry (ABPI), UK

Diana Sims-Silbermann, Specialist General and Emergency Medicine, Anesthesie, SeniorTrial Manager, Early Development and Clinical Pharmacology, Janssen-Cilag GmbH, Johnson & Johnson

Sebastian Stratmann, Senior Manager Clinical Innovation, Merck Healthcare KGaA Biopharma, Germany

Pamela Tenaerts, Executive Director, Clinical Trials Transformation Initiative (CTTI), USA

Helen Todman, Associate Project Director, Parexel International, UK

Joana Claverol Torres, Clinical Research Unit Manager, Hospital Sant Joan de Déu

Karin Tulzer, Global Quality Strategy Lead, Merck KGaA, Austria

Kristof Van Quathem, Of Counsel – Advocaat, Covington & Burling LLP

Professor Suzanne van de Vathorst, Professor in Ethics, Erasmus University, The Netherlands

Virginie van de Velde, Senior Manager Oversight Data Manager, GSK, Belgium

Dr Maren von Fritschen, Regulatory Affairs, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium

Professor Hans van Delden, Prof in Medical Ethics, Vice-Chair, The Central Committee on Research Involving Human Subjects (CCMO), Utrecht University, The Netherlands

Michael Walega, Director, Centralized Monitoring, Global Data Management & Centralized Monitoring, BMS, USA

Marion Wolfs, Head/Senior Director Risk Management & Central Monitoring, Janssen, The Netherlands

Dr Sol Yates, Associate Director Global Regulatory Affairs, Grünenthal GmbH, Germany



11:00 Opening to Clinical Trials Europe Louisa Maitland, Conference Director, Informa

11:10 Opening from Chairperson Professor Kenneth Getz, Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA

OPENING PLENARY: COVID-19 – IMPACT ON CLINICAL DEVELOPMENT11:20 Changes and challenges to clinical trials during and after a worldwide pandemic

Janis A. Little, Vice President, Global R&D Quality, Allergan, UK

11:40 Biotech experience of the rapid and nimble acceleration of clinical programmes in the light of SARS CoV2Elizabeth Eagling-Vose, Senior Director, Head of Clinical Operations, Vaccitech, UK

12:00 Vaccine acceptabilityProfessor Robert Dingwall, Professor of Sociology, Nottingham Trent University, UK

12:20 - 13:20

LIVE Networking Forum

13:20 Change of operational model during COVID-19 pandemicDr Bodo Lutz, Clinical Risk Management and Data Integrity QA, Novartis Global Development Quality, Germany

13:40 Spotlight Presentation: Effects of an unpredictable pandemic on clinical trials and the need for virtualization Anthony Costello, Senior Vice President, Medidata, USA

14:00

LIVE Plenary Panel with Q&Q: PANEL: Combating Coronavirus – Lessons learnt and challenges ahead Janis A. Little, Vice President, Global R&D Quality, Allergan, UK

Elizabeth Eagling-Vose, Senior Director, Head of Clinical Operations, Vaccitech, UK

Professor Robert Dingwall, Professor of Sociology, Nottingham Trent University, UK

Dr Bodo Lutz, Clinical Risk Management and Data Integrity QA, Novartis Global Development Quality, Germany

Anthony Costello, Senior Vice President, Medidata, USACovance

15:00-16:00


16:00-17:00

LIVE Networking Reception

17:00 End of Day One

DAY ONE • Monday 2nd November 2020



DAY TWO • Tuesday 3rd November 2020

10:00 Welcome to Day Two of Clinical Trials Europe Louisa Maitland, Conference Director, Informa

LEAN METHODOLOGY PRIVACY AND DATA PROTECTION

PATIENT RECRUITMENT & RETENTION

NEW INNOVATIVE TRIAL DESIGN

DECENTRALIZED/HYBRID TRIALS

ARTIFICIAL INTELLIGENCE, MACHINE LEARNING & DATA MANAGEMENT

10:10 How to reduce the lead time and improve the DM processes using a lean methodology approachVirginie van de Velde, Senior Manager Oversight Data Manager, GSK, Belgium

GDPR: General overview, implementation, debated issues and learnings so farKristof Van Quathem, Of counsel – advocaat, Covington & Burling LLP, BelgiumDr Corrette Ploem, Assistant Professor, Amsterdam University Medical Centre, University of Amsterdam, The Netherlands

Managing recruitment expectation, the difficulty of reliable feasibility questionnaires and the need for a good recruitment strategyDr Philipp Badorrek, Head of Department, Clinical Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany

Adaptive clinical trials from an ethics perspectiveProfessor Suzanne van de Vathorst, Professor in Ethics, Erasmus University, The Netherlands

Actual experiences working with Virtual trialsRasmus Hogreffe, Head of Virtual Clinical Trials, Leo Innovation Lab, Denmark

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 programmesRalphael Oghagbon, Health Economist, Imperial College Health Partners, UK

10:30 How can Quality Tolerance Limits support COVID-19 impact assessments• What are QTLsMarion Wolfs, Head/Senior Director Risk Management & Central Monitoring, Janssen, The Netherlands

REGULATORY UPDATES The application of data Science in Feasibility - how to get a better predictability of average recruitment and retention rate? Danny Hasselbaink, Global Feasibility Lead, Janssen Biologics B.V., The Netherlands

Collaborative working from the very start –view from a primary care site perspective.Olivia Barnes, Senior Research Nurse, Sherbourne Medical Centre, UK

AstraZeneca learnings from a decentralized hybrid trial in adolescent patients with asthmaHenrik Forsman, Clinical Innovation Director, AstraZeneca, Sweden

The ethics of clinical trials and the ethics of AI: Establishing real-world common ground between researchers and patientsFrancis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Review (SIDCER); Leuven/Brussels, Belgium

EU Clinical Trials Regulation; An update of the current status and some thoughts on its implementationDr Sol Yates, Associate Director Global Regulatory Affairs, Grünenthal GmbH, Germany

10:50 Spotlight Presentation Please contact: Nick Matthews: [email protected] +44 (0) 20 337 73905 if you are interested in participating as a speaker, panellist, moderator or hosting webinar

Spotlight Presentation Please contact: Nick Matthews: [email protected] +44 (0) 20 337 73905 if you are interested in participating as a speaker, panellist, moderator or hosting webinar

Spotlight Presentation: Covance


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 Healthsciences, France

Spotlight Presentation Please contact: [email protected], 44 (0)20 3377 3237 if you are interested in participating as a speaker, panellist, moderator or hosting webinar

11:10

LIVE Q&A with Session Speakers






11:40 - 12:40




11:40 - 12:10

Content Hub: Improving clinical research access: Lessons learned from minority patient and physician feedbackRosamund Round, Vice President, Patient Innovation Center, Parexel

11:55 Medable




COVID-19 REGULATORY UPDATES SITE SELECTION REAL WORLD EVIDENCE & REAL WORLD DATA

DECENTRALIZED/HYBRID TRIALS

ARTIFICIAL INTELLIGENCE, MACHINE LEARNING & DATA MANAGEMENT

12:40 Quantifying participant diversity in clinical trialsProfessor Kenneth Getz, Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA

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

How sites can develop a 2armonized program for digital readiness Jennifer Logue Nielsen, Process Development Specialist, Novo Nordisk, Denmark

Real world trials and RWD in trials and healthcare data related topicsAmanda Lucas, Programme Director, Imperial College, UK

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 A/S, Denmark

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

13:00 Spotlight PresentationIQVIA




Spotlight Presentation Medable

Spotlight PresentationPlease contact: Nick Matthews: [email protected] +44 (0) 20 337 73905 if you are interested in participating as a speaker, panellist, moderator or hosting webinar

13:20







13:50-14:50




13:50-14:10

Content HubPlease contact: Nick Matthews: [email protected] +44 (0) 20 337 73905 if you are interested in participating as a speaker, panellist, moderator or hosting webinar






RISK BASED EVERYTHING REGULATORY UPDATES SITE PERSPECTIVE PAEDIATRICS DECENTRALIZED /HYBRID TRIALS

DATA FLOW AND ANALYTICS

14:50 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

European Medical Device Regulation - May 2020- what will be the requirements?Nurcan Coskun, Global Risk Based Monitoring Program & Technology Solutions Manager, Formerly Medtronic Plc., Switzerland

Patient Engagement- Site selection and recruitment- from a site perspective Graeme Boyle, Senior R&D Manager, Tayside Medical Science Centre (TASC), UK

The Patient Centricity Effect – How it benefits Patients, Sites and Sponsors – Practical cases from paediatric studiesMariangela Lupo, Communication and Patient Advocacy Manager, TEDDY European Network of Excellence for Paediatric Research, Italy

How digital health technology will shape the trials of 2030 Pamela Tenaerts, Executive Director, Clinical Trials Transformation Initiative (CTTI), USA

What’s really needed to transform information flow in clinical development Elinor Olesen, VP DM Change Management, Novo Nordisk, Denmark

15:10 The future of research in primary care and collaborations with primary care federations/primary care networks to facilitate recruitmentDr Andre Krzeminski, R&D Lead, Albany House Research, UK

Covid-19 related impact on drug development in the EU?Dr Maren von Fritschen, Regulatory Affairs, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium

PATIENT ENGAGEMENT & CENTRICITY

Pilot study/simulation using paediatric patients input in clinical trial development Joana Claverol Torres, Clinical Research Unit Manager, Hospital Sant Joan de Déu, SpainBegonya Nafria Escalera, Patient Engagement in Research Coordinator, Hospital Sant Joan de Déu, Spain


Regulatory challenges of using of new technologies in clinical trials Michel Arnoult, Chairman, Arnoult.org, FranceThe importance of giving

feedback to patients and results about the transparency of the clinical work Amelia Hursey, Research Participation Lead, Parkinson’s UK

15:30COVID-19

Regulatory expectations of working with audit trails Jennifer Logue Nielsen, Process Development Specialist, Novo Nordisk, Denmark



Learnings from a paediatric decentralised clinical trialHelen Todman, Associate Project Director, Parexel International, UK

Clinical research in low resource settings Melissa Menke, Founder and CEO, Access Afya., KenyaConducting clinical trials in a

world with COVID-19Amer Alghabban, Senior Director, Clinical Compliance and Training, Freeline Therapeutics, UK

15:50







16:30 – 17:30




17:30 End of Day Two



DAY THREE • Wednesday 4th November 2020

10:00 Welcome to Day Two of Clinical Trials Europe Louisa Maitland, Conference Director, Informa

DIFFERENT PARTNERSHIP APPROACHES INSPECTIONS PATIENT ENGAGEMENT &

CENTRICITYNEW INNOVATIVE TRIAL

DESIGN DIGITAL HEALTH

TECHNOLOGYARTIFICIAL INTELLIGENCE,

MACHINE LEARNING & DATA MANAGEMENT

10:10 Good partnership relationship with industry and investigator site with an Investigator initiative trial Dr Wolfgang Eglmeier, Head ZKS-UW/H (Centre for Clinical Studies), Witten/Herdecke University, Germany

Inspection preparation -conduct, organisation and managing a Regulatory Inspection and hear experiences of inspectionsKarin Tulzer, Global Quality Strategy Lead, Merck KGaA, Austria

Patient engagement in reviewing applications for research: pro’s and con’s Professor Richard Dekhuijzen, Professor of Pulmonology, Radboud University Medical Center in Nijmegen, The Netherlands

Designing cancer trials for the 21st centuryDr Sarah Blagden, Associate Professor of Medical Oncology, University of Oxford, Lead Author of the ECMC Consensus Paper, UK

KEYNOTE: Build a collaborative development framework for novel digital endpointsKai Langel, Director, Janssen Clinical Innovation (JCI), Janssen, Spain

AI-powered recruitment of a digital readiness cohort for Alzheimer’s Disease (AD)Nicklas Linz, Researcher, German Research Centre for Artificial Intelligence (DFKI), Germany

10:30 SUSTAINABILITY Facilitating optimisation of the performance of clinical trials through enhanced analysis of data from audits and inspections of clinical trialsJoanne North, Analytics Lead, Metrics, Reporting and Analytics, BioResearch Quality and Compliance at Johnson & Johnson, UK

Impact of patient centered initiatives in clinical trial design and execution Sebastian Stratmann, Senior Manager Clinical Innovation, Merck Healthcare KGaA Biopharma, Germany

Regulator’s perspective for complex clinical trials and innovative trial designsBeatrice Panico, Senior Medical Assessor, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency, UK

An applied framework for evaluating connected sensor technologies Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe), USA

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 progressionAlexandra König, Clinical Researcher, Memory Clinic at Nice University Hospital, University of Côte d’azur, and INRIA Nice, France

Environmental sustainability - NovartisMairéad Lyons, Group Lead, Clinical Project Management, Novartis, Ireland

10:50 Spotlight Presentation: Different outsourcing models- success stories QPS


Spotlight Presentation: Sponsor considerations when including mobile research nursing in clinical trialsHelen Springford, Chief Executive Officer, Illingworth Research, UK

Spotlight Presentation: Optimizing the entire clinical trial financial lifecycle through automationJim Murphy, Chief Executive Officer, Greenphire, USA

Spotlight Presentation: Covance


11:10







11:40-12:40




11:40-12:10






DAY THREE • Wednesday 4th November 2020

AFTERNOON PLENARY

12:40Chairperson’s Opening Remarks

12:50Accelerating the drug development paradigm during and post pandemicProfessor Kenneth Getz, Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA

13:10BREXIT – 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

13:30Future of medicine- Cell and gene therapy, precision medicine and personalised medicineAnita Nelsen, Senior Vice President and Head, Translational Medicine, Parexel International, USA

13:50

LIVE Q&A with Plenary Speakers

14:20 - 15:20


15:20Christine Pierre Lifetime Achievement Award in Association with mdgroup

15:30Clinical Trials Europe Virtual Exhibition Stand Award Sponsored by PharmaTargeting

15:40Inspirational Speaker: Medical Aspects of Space travelAndré Kuipers, Astronaut, Physician and Ambassador of the Earth

16:10 – 17:10


17:10End of Conference



THANK YOU TO OUR SPONSORS

CORPORATE SPONSORS

EXHIBITORS

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CONFERENCE SPONSORS

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ASSOCIATE SPONSORS SUPPORTING SPONSORS

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ACCELERATE YOUR CLINICAL DEVELOPMENT THROUGH …Robert Dingwall, Professor of Sociology, Nottingham...

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Transcript of ACCELERATE YOUR CLINICAL DEVELOPMENT THROUGH …Robert Dingwall, Professor of Sociology, Nottingham...