CLINICAL TRIALS: NAVIGATE THE PATH TO GROUNDBREAKING … · 2019-11-12 · Anca Copaescu, Chief Executive Officer, Strategikon Pharma, USA Professor Steven Carver, Senior Lecturer

19-21 November 2019CCIB

Barcelona, Spain

CLINICAL TRIALS: NAVIGATE THE PATH TO GROUNDBREAKING THERAPEUTIC DEVELOPMENTOvercome partnership, outsourcing, operational and technological challenges to advance your clinical strategy

The Next Generation of Partnerships in Clinical Trials Europe

KEYNOTE SPEAKERSVanessa Pott Director, Patient Advocacy & Strategic Partnerships, Merck KGaA, Germany

Dr. Leonard Sacks Associate Director for Clinical Methodology, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, USA

Matthew Bonam Head of R&D Digital, AstraZeneca R&D, UK

Professor Steven Carver Senior Lecturer in Change Project and Programme Management, Cranfield University School of Management, UK

lifesciences.knect365.com/clinical-trials-europe/@ ClinTrials365 #CLINTRIALS

http://lifesciences.knect365.com/clinical-trials-europe/

Clinical Trials Europe At A Glance

DAYS 1 AND 2: 19-20 NOVEMBER 2019Establishing and Managing an Outsourcing StrategyGO TO PAGE

OversightRegulatory UpdatesPost BREXITProtocolGO TO PAGE

Patient RecruitmentRBMRare DiseasesVirtual Trials

GO TO PAGE

Patient Engagement & CentricityGO TO PAGE

DigitalisationWearables and SensorsBYODVirtual and Patient-Centered Trials

GO TO PAGE

Artificial Intelligence:

RWE

Data Science

Patient

Recruitment & Risk Mitigation GO TO PAGE

Regulations for Early Clinical Development Cardiac Safety AssessmentsNovel BiomarkersStatistical Analysis AI, Big Data & Wearables GO TO PAGE

DAY 3: 21 NOVEMBER 2019Risk ManagementPartnershipsGO TO PAGE

Site ManagementData ManagementData PrivacyGO TO PAGE

Real World EvidenceGO TO PAGE

Site and Investigator EngagementPatient Engagement & TrustGO TO PAGE

Data SharingNew TechnologiesGO TO PAGE

Artificial Intelligence:NLP

Automation & the Application of EMR/HER GO TO PAGE

Collaborative Frameworks Multi-site Early Clinical Development & Patient RecruitmentOutsourcingPatient Engagement GO TO PAGE

Clinical TrialsEurope

19-21 November 2019 CCIB

Barcelona, Spain

For more information about Clinical Trials Europe please visit: lifesciences.knect365.com/clinical-trials-europe/ 2


CONFIRMED SPEAKERS TO DATE

Sara Aguilar, Senior Specialist, Risk management and Central Monitoring, Janssen Pharmaceutical Companies of J&J, BelgiumSammy Ainsworth, Youth and Family Participation Officer, University of Liverpool/NIHR Alder Hey, UK Larry Ajuwon, Clinical Development and Outsourcing Consultant, RHIEOS-Ventures, The NetherlandsValdo Arnera, Scientific Advisor, ERT, SwitzerlandGeor Bakker, Senior Development Scientist, Sosei Heptares, United KingdomZsofia Bakonyi, Senior Manager Partnerships, EFPIA, BelgiumOlivia Barnes, Senior Research Nurse, Sherbourne Medical Centre, UKJeff Barrett, Head of Quantitative Sciences, Bill & Melinda Gates Medical Research Institute, USAPaul Bouten, Managing Director, PharmCMed, The NetherlandsRiccardo Belli, Director, Novartis Oncology, SwitzerlandDr Frank Berger, Head of Analytics, Global Clinical Operations, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany Nigel A Blackburn, Director of Drug Development, Centre for Drug Development, Cancer Research, United KingdomTamzin Blagbrough, Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly, UKDr Christian Born Djurhuus, Vice President, Head of Digital Transformation, Global Development, Novo Nordisk A/S, DenmarkMatthew Bonam, Head of R&D Digital, AstraZeneca R&D, UKAlison Bond, Director, Global Regulatory Policy & Intelligence, Janssen, UKDr Diderik Boot, Director – Global Clinical Development Operations, Neuroscience, Janssen Biologics B.V., The NetherlandsNicholas Brooke, Executive Director, PFMD (Patient Focused Medicines Development, BelgiumHelene Buckley, Managing Director, Triacle, UK Jennifer Burgess, Senior Director, Vice President, Global Engagement & Communications, TransCelerate Biopharma Inc, USAJane Bushell, Associate Director, CQA, Eisai, UKAnca Copaescu, Chief Executive Officer, Strategikon Pharma, USA Professor Steven Carver, Senior Lecturer in Change Project and Programme Management, Cranfield University School of Management, UKOlivier Collignon, Statistical Leader, GSK, UKRobert Corbé, Clinical Trial Manager, Isofol Medical, Sweden Jacqueline Corrigan-Curay, Director, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, USA

Dr Nurcan Coskun, Global Risk Based Monitoring, Program and Technology Solutions Manager, Medtronic, SwitzerlandFrancis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Review (SIDCER); Leuven/Brussels, BelgiumBen Cromarty, UK Community Advisory Board (UK-CAB), Medical Research Council Clinical Trials Unit, University College London Patient and Public Involvement GroupKyle Cunningham, Chief Product Officer, Greenphire, USAMarisol Montolio del Olmo, Scientific Director, Duchenne Parent Project, SpainChristophe Depierreux, Director Quality, Head of Strategic Alliances & Third Party Quality oversight for Labs & Process Development, GSK, BelgiumLode Dewulf, Chief Patient Officer, Servier, BelgiumJeannett Dimsits, Formerly Senior Director, Trial Management Anchor, Novo Nordisk A/S, DenmarkKeith Dorricott, Contractor for the Metrics Champion Consortium, Metrics Champion Consortium, UKKristy Draper, Global Trial Lead for the Proof of Concept Trial, European Prevention of Alzheimer's Dementia (EPAD), United KingdomDiane Driver, Head Program Delivery, Development & Medical (Patient Value) Practices, UCB, UKStefan Dürr, Senior Director, Head of Drug Supply Center of Excellence, Cenduit, SwitzerlandElizabeth Eagling-Vose, Director, Head of Clinical Operations, Vaccitech, UKChibby Ebhogiaye, Head, Feasibility Delivery, IQVIA Technologies, USABegonya Nafria Escalera, Patient Engagement in Research Coordinator, Hospital Sant Joan de Déu, SpainDr Estrella García, Director Global Clinical Operation, Almirall, Spain Marta Garcia, ICTR Director, UK & Ireland, International Centre for Therapeutic Research (ICTR), Servier, UK & IrelandProfessor Kenneth Getz, Founder and Board Chair, CISCRP, Director of Sponsored Programs, Tufts CSDD, USADr Scott Gillingwater, Programme Manager, UK Chemicals and Pharmaceuticals, Intertek, UK Christer Gottfridsson, ECG Centre Cardiologist, Astrazeneca, SwedenDr Donna Graham, Honorary Consultant in Medical Oncology, Experimental Cancer Medicine Team (ECMT), The University of Manchester, UKMelissa Harris, Associate Director, Global Patient Recruitment & Engagement, Covance, UK

Dr Phil Hammond, Doctor, Journalist, Broadcaster, Campaigner and ComedianIsobel Hawley, Senior Clinical Research Associate, Centre for Drug Development, Cancer Research UK, UKBruce Hellman, CEO and Co-Founder, Umotif, UKRasmus Hogreffe, Head of Virtual Clinical Trials, Leo Innovation Lab, DenmarkProfessor Bernhard Holzner, Department of Psychiatry, Psychotherapy and Psychosomatics, Innsbruck Medical University, Austria Stacey Hutchinson, mother to Frankie who has the rare genetic disease Dravets syndromeAdama Ibrahim, Associate Director, POC, Global Clinical Operations, Women in Innovation UK, Biogen, UKDr Vikas Jaitely, Global Regulatory Affairs CMC, Biopharma, Global Regulatory Affairs and R&D Quality, Merck, SwitzerlandStuart Kilpatrick a patient who has not participated in a clinical trialJesper Kjær, Director DM Anchor, Novo Nordisk, DenmarkAlexandra König, Neuropsychologist, PhD, Clinical Research Associate, CoBTeK (Cognition-Behaviour-Technology) Research Lab, Université Côte d'azur, FranceMaria Kuthning, Executive Global Clinical Operations, Former Johnson & Johnson GermanyCatherine Laing, Senior Clinical Scientist, Medical and Scientific Affairs, Covance, UKKai Langel, Director, Janssen Clinical Innovation (JCI), Janssen, SpainMichelle Longmire, CEO, Medable, USAMariangela Lupo, Communication and Patient Advocacy Manager, TEDDY European Network of Excellence for Paediatric Clinical Research, ItalyDr Bodo Lutz, Clinical Risk Management and Data Integrity QA Novartis Global Development Quality, Novartis, GermanyAnna Matranga, Strategic Sourcing R&D, Senior Director, Global Scientific Affairs & Strategic Sourcing Consultant, FranceDr Vladimir Misik, Board Member, SanaClis, Slovakia Dr Marcello Moccia, Department of Neurosciences, Federico II University, ItalyPatricia Moenaert, Director, Portfolio Sourcing and Relationship Management (PSRM), Celgene Intl, SwitzerlandHeidi Muller, Director Patient Engagement Strategy, The Janssen Pharmaceutical Companies of Johnson & Johnson, Belgium Stephen Nabarro, Clinical Operations Manager, Cancer Research UK, UKIsabelle Naeije, Associate Global Trial Director, Novartis, Switzerland


For more information about Clinical Trials Europe please visit: lifesciences.knect365.com/clinical-trials-europe/ 3 For more information about Clinical Trials Europe please visit: lifesciences.knect365.com/clinical-trials-europe/ 4

CONFIRMED SPEAKERS TO DATE (continued)

Pradeep Nathan, Vice President, CNS Clinical Development and Experimental Medicine, Sosei Heptares, United KingdomJennifer Nielsen, Transcelerate eSource, NovoNordisk, DenmarkClaire Nolan, Patient Involvement Facilitator, Charities Research Involvement Group, UKAlison Northern, Leicester Diabetes Centre, University Hospitals Of Leicester NHS Trust, UKNicole Noyens, R&D Clinical Innovation Director, Janssen Pharmaceuticals, BelgiumKate O’Brien, Former Senior Research Nurse, Site Performance Consultant, UKPhilip Overend, Director, Early Oncology Biometrics Team Leader, AstraZeneca, UKJonathan Palmer, Senior Director, Product Strategy, Digital Trials, Oracle, UKMishal Patel, Head of Health Informatics, AstraZeneca, UKPasi Piitulainen, Former Head of Global Procurement, Actelion Pharmaceuticals Ltd (J&J), SwitzerlandMartin Popovic, Researcher, Medical University of Vienna, AustriaVanessa Pott, Director, Patient Advocacy & Strategic Partnerships, Global Healthcare Government & Public Affairs, Merck KGaA, Germany Gareth Powell, Patient Engagement Project Lead, The National Institute for Health Research (NIHR), UKJennifer Preston, Senior Patient and Public Involvement Manager, University of Liverpool/NIHR Alder Hey, UKMichael Prinz, Deputy Head of IT4Science Department, Medical University of Vienna, AustriaDr Ben Quartley, Vice President, Feasibility, Recruitment, Patient Engagement & M-Health, Covance, UKDr Khadija Rantell, Statistical Assessor, Medicines and Health Care Products Regulatory Agency (MHRA), United Kingdom (subject to final confirmation)Natasha Ratcliffe, Research Involvement Manager, Parkinson’s UK Benjamin Ribba, Pharma Research and Early Development, F. Hoffmann-La Roche Ltd, SwitzerlandDr Eric Roos, Executive Board Member, Dutch Clinical Research Foundation (DCRF), Denmark Rosamund Round, Director, Patient Innovation Center, Parexel International, UKAndrew Rubis, Clinical Functional Consultant, Eli Lilly, United Kingdom

Dr Leonard Sacks, Associate Director for Clinical Methodology, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, USA Marco Salami, Head of Clinical Outsourcing Management, Chiesi Farmaceutici, ItalyMassimiliano Sarra, Pre-clinical and Clinical Assessor, Italian Medicine Agency (AIFA) and Secretary, Clinical Trial Facilitation Group, Italy (subject to confirmation)Lisa Shafe, Clinical Programme Leader, Strategy, Portfolio & Clinical Operations, Pharma Research & Early Development, Roche, UKWojciech Smoron, Associate Global Trial Director, Novartis, SwitzerlandMichael Song, Sr. Manager R&D, Device Development, Dosage Form Design and Development, BioPharmaceutical Development, MedImmune, USASiobhan Southam, Strategic Engagement Leader, digitalECMT, CRUK Manchester Institute, and The Christie NHS Foundation Trust, UKKristin Stallcup, Senior Director, Informatics, Covance, UKRichard Stephens, National Cancer Research Institute Consumer Forum, UKCatherine Stewart, Executive Director, Clinical Sciences, Pfizer, UKMats Sundgren, Scientific Advisor, AstraZeneca, Sweden Cathy Sutherland, Director, Drug Development Operations – Ophthalmology, Allergan, UKDr Camilla Svensson, Non-Clinical Assessor, Dept of Clinical Trials, The Swedish Medical Products Agency (MPA), SwedenSofie Swinnen, Investigator & Patient Engagement Project Lead, Janssen, BelgiumAmrit Takhar, GP Partner, Wansford and Kings Cliffe Practice, UKMykhaylo Tatarenko, Manager, Risk management and Central Monitoring, Janssen Pharmaceutical Companies of J&J, Belgium Karin Tulzer, Global Quality Strategy Lead (Immuno-Oncology), Biopharma, Global Research & Development Quality (RDQ), Merck KGaA, AustriaChris Twelves, Professor of Clinical Cancer Pharmacology and Oncology, Leeds Institute of Cancer and Pathology and Head of Oncology Clinical Research, Leeds Cancer Reseach Centre, UK Natacha Udo-Beauvisage, Global Data Protection Officer, Compliance Department, Servier, FranceViviënne van de Walle, Director of Education at SCRS – USA / PI at research site PT&R, The NetherlandsPeter Van Der Ark, Clinical Research Manager, Experimental Medicine Neuroscience, Janssen, Belgium

Sigrid Viergutz, Senior Manager, Global Clinical Program Resource Management, Amgen, GermanyMałgorzata Szczodrak, Centralized Monitoring Manager, AstraZeneca, Poland Maksims Vlasenko, Head of International Trade/Strategic Comparator Sourcing, RP Clinical, LatviaDr Maren von Fritschen, Director Regulatory Affairs, EUCOPE, BelgiumJonathan Wagg, Disease Therapeutic Area Modelling Leader – Oncology, Roche Pharmaceutical Research and Early Development, Clinical Pharmacology-Pharmaceutical Sciences, Roche Innovation Center Basel, SwitzerlandDr Stephen Walker, Outsourcing Programme Director, Alliance Management, AstraZeneca, UKDr Chris Watson, Director of Product Strategy, Digital Patient, ERT, UKRicha Wilson, Pharma Partnering, Digital and Personalized Healthcare, F. Hoffmann-La Roche Ltd, USAMarion Wolfs, Director Risk Management and Central Monitoring at Janssen, The NetherlandsMichala Worrell, Group Senior Director, Project Management Oncology & Cell Therapeutics, Clinical Research Services, ICON plc, USADr Sol Yates, Associate Director Global Regulatory Affairs, Grünenthal GmbH, GermanyAlain Zogheib, President of Middle East Clinical Research Association, LebanonMichael Zoerer, Head of Clinical Operations, AOP Orphan Pharmaceuticals AG, Austria


DAY ONE • Tuesday 19th November 2019 13:00 Registration and Coffee 13:50 Conference Opening and Welcome Jeannett Dimsits, Formerly Senior Director, Trial Management Anchor, Novo Nordisk A/S, Denmark

OPENING PLENARY SESSION 14.00 Change as an opportunity - better project management of your clinical trials

Professor Steven Carver, Senior Lecturer in Change Project and Programme Management, Cranfield University School of Management, UK

14:40 PATIENT STORY: Frankie’s Journey: A Parents perspective on their son who has Dravets who went on a Clinical TrialStacey Hutchinson is mum to Frankie who has the rare genetic disease Dravets syndrome

15:20 PANEL: Trials of the future

16:10 Networking Refreshment Break

MANAGING AN OUTSOURCING STRATEGY PATIENT RECRUITMENT KEYNOTE CLINICAL INFORMATION AND AUTOMATION 16:40 Chairperson’s Opening Remarks

Kenneth Getz, Founder and Board Chair, CISCRP, Director of Sponsored Programs, Tufts, CSDD, USA

Chairperson’s Opening RemarksJennifer Burgess, Senior Director, Vice President, Global Engagement & Communications, TransCelerate Biopharma Inc, USA

Chairperson’s Opening RemarksDr Estrella García, Director Global Clinical Operation, Almirall, Spain

Chairperson’s Opening RemarksMishal Patel, Head of Health Informatics, AstraZeneca, UK

16:45 CASE STUDY: Can Mid-size Pharma leverage Innovation and embrace Digitalization when partnering with CROs?Dr Estrella García, Director Global Clinical Operations, Global Clinical Operations – R&D, Almirall, Spain

Novel ways of improving patient recruitment and patient participation in clinical research Dr Eric Roos, Executive Board Member, Dutch Clinical Research Foundation (DCRF), Denmark

Digitalisation of clinical trial study – how this will revolutionise how clinical trials are doneRasmus Hogreffe, Head of Virtual Clinical Trials, Leo Innovation Lab, Denmark

∆elta : A clinical tool for early detection and monitoring of cognitive disorders such as dementia on the basis of automatic speech analysisAlexandra König, Clinical Research Associate, CoBTeK Research Lab, Université Côte d'azur, France

17:15 JOINT PRESENTATION: Engaging patient by providing access to Patient Data Access in Clinical Trials: from concept to implementationCaroline Feys, R&D Operations Innovation Leader, Janssen, Belgium

Sofie Swinnen, Investigator & Patient Engagement Project Lead, Janssen, Belgium

CASE STUDY: How to manage cultural differences, site engagement and patient recruitment when running a global study in a biotech companyRobert Corbé, Clinical Trial Manager, Isofol Medical, Sweden

WEARABLES & SENSORS Application of Artificial Neural Networks to Infer Pharmacological Molecular-level Mechanisms of Drug evoked Clinical ResponsesJonathan Wagg, Disease Therapeutic Area Modelling Leader – Oncology, Roche Innovation Center Basel, Switzerland

CASE STUDY: Benefit and risks of adding wearables and other remote monitoring devices into clinical trialsMatthew Bonam, Head of R&D Digital, AstraZeneca R&D, AstraZeneca R&D, UK

17:45 Grand Opening of the CTE Exhibition Hall with Covance Networking Drinks Reception

Moderator: Dr Phil Hammond, Doctor, Journalist, Broadcaster, Campaigner and Comedian Dr Christian Born Djurhuus, Vice President, Head of Digital Transformation, Global Development, Novo Nordisk A/S, DenmarkLode Dewulf, Chief Patient Officer, Servier, BelgiumDr Donna Graham, Medical Oncology Consultant, Experimental Cancer Medicine Team (ECMT), The University of Manchester, UK

Richard Stephens, National Cancer Research Institute Consumer Forum, UKDiane Driver, Head Program Delivery, Development & Medical (Patient Value) Practices, UCB, UK Dr Ben Quartley, Vice President, Feasibility, Recruitment, Patient Engagement & M-Health, Covance, UKSyneos Health


DAY TWO • Wednesday 20th November 2019

08:50 Chairperson’s Opening RemarksAnna Matranga, Strategic Sourcing R&D, Senior Director, Global Scientific Affairs & Strategic Sourcing Consultant, France

Chairperson’s Opening RemarksAnca Copaescu, Chief Executive Officer, Strategikon Pharma, USA

Chairperson’s Opening RemarksAndrew Benson, Senior Director at Trial Trove, Citeline, UK

Chairperson’s Opening RemarksStephen Nabarro, Clinical Operations Manager, Cancer Research UK, UK

Chairperson’s Opening RemarksJesper Kjær, Director DM Anchor, Novo Nordisk, Denmark

Chairperson’s Opening RemarksRuby Saharan, Senior Medical Advisor - Melanoma, RWE, Novartis Oncology UK and Ireland, UK

OVERSIGHT REGULATORY UPDATES RISK BASED MONITORINGPATIENT ENGAGEMENT

& CENTRICITYVIRTUAL AND

PATIENT-CENTERED REMOTE TRIALS

PLATFORMS FOR RECRUITMENT,

FEASIBILITY AND RISK MITIGATION

09:00 Benchmarking the vendor qualification processKenneth Getz, Founder and Board Chair, CISCRP, Director of Sponsored Programs, Tufts CSDD, USA

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

CASE STUDY: Risk Based Everything? Małgorzata Szczodrak, Centralized Monitoring Manager, AstraZeneca, Poland

KEYNOTE: Future of patient engagement and clinical research: A few global societal trends and new challenges resulting from patient engagementLode Dewulf, Chief Patient Officer, Servier, France

Gain insight to the conduct ofpatient-centric trialsDr Bodo Lutz, Clinical Risk Management and Data Integrity QA, Novartis Global Development Quality, Novartis, Germany

Data for leveraging site selectionJeff Barrett, Head of Quantitative Sciences, Bill & Melinda Gates Medical Research Institute, USA

MANAGING PARTNERSHIPS

09:30 CASE STUDY: How to manage your partnerships?Christophe Depierreux, Director Quality, Head of Strategic Alliances & Third Party Quality oversight for Labs & Process Development, GSK, Belgium

CASE STUDY: New requirements for drug-device combination products under the Medical Devices RegulationDr Vikas Jaitely, Global Regulatory Affairs CMC, Biopharma, Global Regulatory Affairs and R&D Quality, Merck, Switzerland

CASE STUDY: Risk Based Monitoring – Fit for PurposeMykhaylo Tatarenko, Manager, Risk Management and Central Monitoring, Janssen Pharmaceutical Companies of J&J, Belgium

CASE STUDY: How collaboration can improve patient engagementCatherine Sutherland Director, Drug Development Operations – Ophthalmology, Allergan, UK

CASE STUDY: Patientcentered trials - What can we do remotely to minimise burden and conduct research in a more real-life setting?Kai Langel, Director, Janssen Clinical Innovation (JCI), Janseen, Spain

Utilize Machine Learning and Artificial Intelligence to Understand the Quality Risk Performance of Clinical TrialsAlex Hsieh, Director, Clinical Trial Process and Quality, Pfizer, USA

10:00 PANEL: How are patient-centric trials changing how the Industry Is working with third party suppliers?Moderator: Adama Ibrahim, Associate Director, POC, Global Clinical Operations, Women in Innovation UK, Biogen, UK Marta Garcia, ICTR Director, UK & Ireland, International Centre for Therapeutic Research (ICTR), Servier, UK & IrelandMartin Popovic, Researcher, Medical University of Vienna, AustriaElizabeth Eagling-Vose, Director, Head of Clinical Operations, Vaccitech, UKGareth Powell, Patient Engagement Project Lead, The National Institute for Health Research (NIHR), UK

PANEL: How to approach CRO Oversight and RBM in light of ICH E6 R2Moderator: Paul Bouten, Managing Director, PharmCMed, The Netherlands Marco Salami, Head of Clinical Outsourcing Management, Chiesi Farmaceutici, ItalyMykhaylo Tatarenko, Manager, Risk Management and Central Monitoring, Janssen Pharmaceutical Companies of J&J, BelgiumIsabelle Naeije, Associate Global Trial Director, Novartis, SwitzerlandDr Sol Yates, Associate Director Global Regulatory Affairs, Grünenthal GmbH

PANEL: Young patient and family involvement in paediatric drug developmentModerator: Patient: Sammy Ainsworth, Youth and Family Participation Officer, University of Liverpool/NIHR Alder Hey, UKMariangela Lupo, Communication and Patient Advocacy Manager, TEDDY European Network of Excellence for Paediatric Clinical Research, Italy Begonya Nafria Escalera, Patient Engagement in Research Coordinator, Hospital Sant Joan de DéuJennifer Preston, Senior Patient and Public Involvement Manager, University of Liverpool/NIHR Alder Hey, UK

PANEL: Taking part in a trial - Myths and Reality Moderator: Eamonn O’Brien, Patient Liaison Manager, Independent Research Advisor, UK

Dawn Sutton a patient who has participated in trials

Stuart Kilpatrick a patient who has not participated in a clinical trial

Kate O’Brien, Former Senior Research Nurse, Site Performance Consultant, UK

Alison Northern, Leicester Diabetes Centre, University Hospitals Of Leicester NHS Trust, UK

PANEL: The dilemma of collecting massive amounts of dataModerator: Bruce Hellman, Umotif, UK

Matthew Bonam, Head of R&D Digital, AstraZeneca R&D, AstraZeneca R&D, UK

Jonathan Palmer, Senior Director, Product Strategy, Digital Trials, Oracle, UK

Michael Zoerer, Head of Clinical Operations, AOP Orphan Pharmaceuticals AG, Austria

PANEL: Consortia, big data and pre-competitive useRuby Saharan, Senior Medical Advisor - Melanoma, RWE, Novartis Oncology UK and Ireland, UK

Richa Wilson, Pharma Partnering, Digital and Personalized Healthcare, F. Hoffmann-La Roche Ltd, USA

10:40 Networking Refreshment Break in the Exhibit Hall plus CLINICAL CONTENT HUB (see next page)



10:40 CLINICAL CONTENT HUB in the Exhibit Hall(10:40 -10:55) Patient clinical trial journey and why data capture and analysis are so important Richard Maguire, Head of Data Science, mdgroup, UK(10:55 -11:10) Adapting partnerships towards the new world of real-world evidence Andrew Ecob, Vice President, Real-World Evidence Strategy, Parexel, USA

11:30 CASE STUDY: How to measure the Partnerships performance?Patricia Moenaert, Director, Portfolio Sourcing and Relationship Management (PSRM), Celgene IntlMichala Worrell, Group Senior Director, Project Management Oncology & Cell Therapeutics, Clinical Research Services, ICON plc, USA

Surviving a regulatory inspection Jane Bushell, Associate Director, CQA, Eisai, UK

What are the opportunities of undertaking commercial trials in primary care?Amrit Takhar, GP Partner, Wansford and Kings Cliffe Practice, UK

Community Advisory Boards…a Possible Way Forward for Improving Patient Engagement?Ben Cromarty, UK Community Advisory Board (UK-CAB), Medical Research Council Clinical Trials Unit at University College London Patient and Public Involvement Group

CASE STUDY: Digitalizing patient engagementAlison Bond, Director, Global Regulatory Policy & Intelligence, Janssen, UK

DATA SCIENCE:ANALYTICAL SKILLS

Teleconference: Creative Artificial Intelligence - Teaching Computers to be WritersMadhavi Gidh-Jain, Head, Medical Writing- Multiple Therapeutic Areas, Clinical Documentation, Sanofi, USA

12:00 Latest geographic trends in global Industry clinical trials: Who is winning, who is losing? Dr Vladimir Misik, Board Member, SanaClis, Slovakia

Maintaining compliance in a GCP accredited Bioanalytical LaboratoryDr Scott Gillingwater, Programme Manager, UK Chemicals and Pharmaceuticals, Intertek, UK

Measuring success of a quality risk management approachKristin Stallcup, Senior Director, Informatics, Covance, UK

Sites, what does the shift towards virtual trials mean for you?Rosamund Round, Director, Patient Innovation Center, Parexel International, UK

Engaging patients with BYOD, wearables, and sensorsValdo Arnera, Scientific Advisor, ERT, Switzerland

Spotlight Presentation:Please contact [email protected], Tel +44 (0) 20 7017 6631 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.

12:30 Networking Luncheon in the Exhibit & Poster Hall andCLINICAL CONTENT HUB in the Exhibit Hall (12:35- 13:05) Jens Harald Kongsoe, Founder, CEO, Clinical Survey Outcomes, Denmark(13:05-13:20) Stefan Dürr, Senior Director, Head of Drug Supply Center of Excellence, Cenduit, Switzerland(13:20-13:35) TBA(13:35–13:50) Lumis International

MANAGING AN OUTSOURCING STRATEGY

& PARTNERSHIPPROTOCOL VIRTUAL & SITE-LESS TRIALS

PATIENT ENGAGEMENT& CENTRICITY

BRING YOUR OWN DEVICE (BYOD)

GENERATION OF PATIENT COHORTS

13:50 Chairperson’s Opening RemarksViviënne van de Walle, Director of Education at SCRS – USA / PI at research site PT&R, The Netherlands

Chairperson’s Opening RemarksIsabelle Naeije, Associate Global Trial Director, Novartis, Switzerland

Chairperson’s Opening RemarksAndrew Benson, Senior Director at Trial Trove, Citeline, UK

Chairperson’s Opening RemarksStephen Nabarro, Clinical Operations Manager, Cancer Research UK, UK

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

Chairperson’s RemarksRuby Saharan, Senior Medical Advisor - Melanoma, RWE, Novartis Oncology UK and Ireland, UK

14:00 CASE STUDY: Managing outsourcing and partnership in the Quality Assurance areaKarin Tulzer, Global Quality Strategy Lead (Immuno-Oncology), Biopharma, Global Research & Development Quality (RDQ), Merck KGaA, Austria

CASE STUDY: Transforming protocol deviation and management Catherine Stewart, Executive Director, Clinical Sciences, Pfizer, UK

CASE STUDY: Operational challenges of Virtual Trials from Leo InnovationRasmus Hogreffe, Head of Virtual Clinical Trials, Leo Innovation Lab, Denmark

CASE STUDY: Successful patient partnerships with sponsors- Patient Centricity- Hear how it has made a differenceVanessa Pott, Director, Patient Advocacy & Strategic Partnerships, Global Healthcare Government & Public Affairs, Merck KGaA, Germany

Technology clinical trials: Innovation in care pathways for clinical developmentSiobhan Southam, Strategic Engagement Leader, digitalECMT, CRUK Manchester Institute, and The Christie NHS Foundation Trust, UK

Using machine learning to identify patient sub-populations of interest from multi-layered clinical dataCarolyn Cho, Pharmacometrics Immunology Therapeutic Area Lead, Merck, USA


14:30 CASE STUDY: How to manage change management when implementing a new technologyJeannett Dimsits, Formerly Senior Director, Trial Management Anchor, Novo Nordisk A/S, Denmark

CASE STUDY: Protocol ComplexityDr Frank Berger, Head of Analytics, Global Clinical Operations, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Decentralised and virtual (hybrid) trials - What's the financial and economic impact for sponsors and patients?Larry Ajuwon, Clinical Development and Outsourcing Consultant, RHIEOS-Ventures, The Netherlands

Practicalities of patient engagement: How can you collaborate to maximise success?Natasha Ratcliffe, Research Involvement Manager, Parkinson’s UK, UK

CASE STUDY: Smart Technology Innovation in Clinical Trials at Janssen: Learnings of the implementation of iSTEP and the evaluation of the first clinical trialsCaroline Feys, R&D Operations Innovation Leader, Janssen, Belgium

Building models to engage more and ‘better’ patients in clinical trials Michael Song, Sr. Manager R&D, Device Development, Dosage Form Design and Development, BioPharmaceutical Development, MedImmune, USA

15:00 Partnering to deliver complex, multi-country virtual clinical trialsJosh Rose, IQVIA Technologies

Implementation of patient centricity in Clinical Development “from theory to practice”Marta Garcia Manrique, Patient Officer-Clinical Development, Patient In R&D, Servier International, Spain

Do you hear what I hear? Applying methodology and partnering technology for optimal patient engagementMelissa Harris, Associate Director, Global Patient Recruitment & Engagement, Covance, UK

Addressing their needs: Putting sites first when implementing new trial technologyChibby Ebhogiaye, Head, Feasibility Delivery, IQVIA Technologies, UK

Spotlight Presentation:Anca Copaescu, Chief Executive Officer, Strategikon Pharma, USA

Spotlight Presentation:Please contact [email protected], Tel +44 (0) 20 7017 6631 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.

15:30 Afternoon Coffee Break and Networking

PLENARY SESSION15:55 Chairperson’s Opening Remarks

Bruce Hellman, CEO and Co-Founder, Umotif, UK

16:00 Mapping the drug development operating environment’s future stateKenneth Getz, Founder and Board Chair, CISCRP, Director of Sponsored Programs, Tufts, CSDD, USA

16:30 Regulatory- where we are with Digital Health Technology and Decentralized Clinical Trials? Dr Leonard Sacks, Associate Director for Clinical Methodology, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, USA

17:00 PANEL: The digital revolution – Are science and technology advancing at such a rapid rate Clinical Development is unable to keep up?Moderator: Dr Christian Born Djurhuus, Vice President, Head of Digital Transformation, Global Development, Novo Nordisk A/S, Denmark Dr Leonard Sacks, Associate Director for Clinical Methodology, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, USA Kai Langel, Director, Janssen Clinical Innovation (JCI), Janseen, Spain Rasmus Hogreffe, Head of Virtual Clinical Trials, Leo Innovation Lab, Denmark Adama Ibrahim, Associate Director, POC, Global Clinical Operations, Women in Innovation UK, Biogen, UKMatthew Bonam, Head of R&D Digital, AstraZeneca R&D, AstraZeneca R&D, UK

17:40 Christine Pierre Lifetime Achievement Award

17:50 Inspirational Talk: Keep Moving – Adventures with Parkinson’s diseaseBeing diagnosed with Parkinson’s disease at the age of 36, has had a profound and life changing effect on Alex. Overcoming adversity, dealing with diagnosis, travel adventure, danger and facing the future In a world of perpetual change. Alex Flynn, Adventurer, Speaker, Writer

18:30 Drinks and CTE Party



DAY THREE • Thursday 21st November 2019

08:50 Chairperson’s Opening RemarksPaul Bouten, Managing Director, PharmCMed, The Netherlands

Chairperson’s Opening RemarksAnca Copaescu, Chief Executive Officer, Strategikon Pharma, USA

Chairperson’s Opening RemarksJennifer Burgess, Senior Director, Vice President, Global Engagement & Communications, TransCelerate Biopharma Inc, USA

Chairperson’s Opening RemarksMaria Kuthning, Executive Global Clinical Operations, Former Johnson & Johnson Germany

Chairperson’s Opening RemarksJulianne Hull, CEO, WenStar Enterprizes, UK

Chairperson’s Opening Remarks

RISK MANAGEMENT OF PARTNERSHIP

RISK BASED MONITORING REAL WORLD EVIDENCE

SITE, INVESTIGATOR & CRA ENGAGEMENT

NEW TECHNOLOGIES IN CLINICAL TRIALS REAL WORLD EVIDENCE

09:00 CASE STUDY: Appropriate Upfront Risk Management to plan your study wellDr Nurcan Coskun, Global Risk Based Monitoring, Program and Technology Solutions Manager, Medtronic, Switzerland

CASE STUDY: Outsourcing RBM (Risk Based Monitoring). Requirements and expectationsSara Aguilar, Senior Specialist, Risk management and Central Monitoring, Janssen Pharmaceutical Companies of J&J, Belgium

KEYNOTE: FDA’s Real World Evidence Program – Looking Forward Jacqueline Corrigan-Curay, Director, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, USA

Role of the investigators and how do Pharma/CRO support investigators to maintain investigator engagement and decrease the burden?Dr Donna Graham, Honorary Consultant in Medical Oncology, Experimental Cancer Medicine Team (ECMT), The University of Manchester, UK

Digital technology in clinical trials: The paradigm of multiple sclerosisDr Marcello Moccia, Department of Neurosciences, Federico II University, Italy

KEYNOTE: FDA’s Real World Evidence Program – Looking ForwardJacqueline Corrigan-Curay, Director, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, USA

09:30 The impact of risk-based quality management on vendor oversight Keith Dorricott, Contractor for the Metrics Champion Consortium, Metrics Champion Consortium, UK

Challenges of data anonymisation and data transfer Michael Prinz, Deputy Head of IT4Science Department, Medical University of Vienna, Austria

How do we use real world evidence - How to turn Real World Data into Real World Evidence?Nicolle Gatto, Group Lead, Senior Director, Epidemiology, Worldwide Safety and Regulatory, Pfizer

CRA insights – Monitoring: how to make it pain-free (well, almost..)Isobel Hawley, Senior Clinical Research Associate, Centre For Drug Development, Cancer Research UK, UK

CASE STUDY: Adoption of eSource Jennifer Nielsen, Transcelerate eSource, NovoNordisk, Denmark

Real World Evidence (RWE) and AI to find new patient pools and patterns Mishal Patel, Head of Health Informatics, AstraZeneca, UK



10:00 Spotlight Presentation:Please contact [email protected],Tel +44 (0) 20 7017 6631 if you areinterested in participating as a speaker,panellist, moderator or hosting a webinar.

End-to-End workflow automation: From budget creation to payment executionKyle Cunningham, Chief Product Officer, Greenphire, USAElisa Toma, Chief Executive Officer, CTA Focus, Romania

The role of emerging technology in gathering new data to support Real World EvidenceDr Chris Watson, Director of Product Strategy, Digital Patient, ERT, UK

Spotlight Presentation:Please contact [email protected],Tel +44 (0) 20 7017 6631 if you areinterested in participating as a speaker,panellist, moderator or hosting a webinar.

Digital trials radically accelerate and power a new era of medicines and therapiesMichelle Longmire, CEO, Medable, USA

Spotlight Presentation:Please contact [email protected],Tel +44 (0) 20 7017 6631 if you areinterested in participating as a speaker,panellist, moderator or hosting a webinar.

10:30 Networking Refreshment Break in the Exhibit Hall

MANAGING PARTNERSHIPS

SITE MANAGEMENT & SELECTION REAL WORLD EVIDENCE

PATIENT ENGAGEMENT & TRUST

NEW TECHNOLOGIES IN CLINICAL TRIALS

AUTOMATION & CLINICAL EHR APPLICATIONS

11:20 CASE STUDY: Building Partnerships in a new therapeutic area (Autism Spectrum Disorder (ASD))Lisa Shafe, Clinical Programme Leader, Strategy, Portfolio & Clinical Operations, Pharma Research & Early Development, Roche, UK

CASE STUDY: Study and site feasibility – How to ensure feasibility will reflect the actual conduct of the trial? Dr Diderik Boot, Director – Global Clinical Development Operations, Neuroscience, Janssen Biologics B.V., The Netherlands

PANEL: Making Real World Research a realityModerator: Nicolle Gatto, Group Lead, Senior Director, Epidemiology, Worldwide Safety and Regulatory, PfizerJacqueline Corrigan-Curay, Director, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, USADr Marcello Moccia, Department of Neurosciences, Federico II University, Italy

Patient trust in clinical trial data- From Transparency to risk communicationProfessor Frederic Bouder, University of Stavanger, Norway

Mobile Health – Development and use of a system for the electronic assessment of Patient Reported Outcome (PRO) data Professor Bernhard Holzner, Department of Psychiatry, Psychotherapy and Psychosomatics, Innsbruck Medical University, Austria

Robot Scientists, the application of AI to science, and the automation of scienceRoss D. King, Machine learning and Optimisation, The University of Manchester, UK

11:50 How to manage your partnerships?Pasi Piitulainen, Former Head of Global Procurement, Actelion Pharmaceuticals Ltd (J&J), Switzerland

POST-BREXITHow do you build up Trust- do patients trust industry and does industry trust patients?Richard Stephens, National Cancer Research Institute Consumer Forum, UK

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

Federated EHR research platforms for supporting clinical research services: the case of AI tailored disease algorithms to support patient recruitmentMats Sundgren, Scientific Advisor, AstraZeneca, Sweden

Regulatory implications of Brexit on R&D in the EU and UKMaren von Fritschen, Director Regulatory Affairs, EUCOPE, Belgium



12:20 PANEL: Defining your sourcing strategy and addressing the factors that should be consideredModerator: Anna Matranga, Strategic Sourcing R&D, Senior Director, Global Scientific Affairs & Strategic Sourcing Consultant, France

Stephen Byrne, EU Managing Director, Integron, USA

Dr Estrella García, Director Global Clinical Operation, Almirall, Spain

Maksims Vlasenko, Head of International Trade/Strategic Comparator Sourcing, RP Clinical, Latvia

Dr Stephen Walker, Outsourcing Programme Director, Alliance Management, AstraZeneca, UK

Helene Buckley, Managing Director, Triacle, UK Sigrid Viergutz, Senior Manager, Global Clinical Program Resource Management, Amgen, Germany

Stephen Byrne, EU Managing Director, Integron, USA

PANEL: Complexities of managing multiple partners Moderator: Marco Salami, Head of Clinical Outsourcing Management, Chiesi Farmaceutici, Italy

Lisa Shafe, Clinical Programme Leader, Strategy, Portfolio & Clinical Operations, Pharma Research & Early Development, Roche, UK

Pasi Piitulainen, Senior Director, Business & Science Affairs, Actelion Pharmaceuticals, Switzerland

Christophe Depierreux, Director Quality, Head of Strategic Alliances & Third Party Quality oversight for Labs & Process Development, GSK, Belgium

Dr Frank Berger, Head of Analytics, Global Clinical Operations, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

PANEL: Will patient engagement give Industry a competitor advantage? Moderator: Nicholas Brooke, Executive Director, PFMD (Patient Focused Medicines Development, Belgium

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

Richard Stephens, National Cancer Research Institute Consumer Forum, UK

Alain Zogheib, President, Middle East Clinical Research Association, Lebanon

PANEL: Integrating the interface of eClinical (software and data capture) and MHealth (wearables) - Where Is the Internet of Medical Things (IoMT) taking clinical research?Moderator: Jeannett Dimsits, Formerly Senior Director, Trial Management Anchor, Novo Nordisk A/S, Denmark

Dr Nurcan Coskun, Global Risk Based Monitoring, Program and Technology Solutions Manager, Medtronic, Switzerland

Martin Popovic, Researcher, Medical University of Vienna, Austria

Natacha Udo-Beauvisage, Global Data Protection Officer, Compliance Department, Servier, France

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

Valdo Arnera, Scientific Advisor, ERT, Switzerland

Using clinical EHRs to assist the drug commercialization processRuby Saharan, Senior Medical Advisor - Melanoma, RWE, Novartis Oncology UK and Ireland, UK

13:00End of Conference


DAY ONE • Tuesday 19th November 2019

REGULATIONS14.00

Trial regulations 2020: anticipating the impact on early phase clinical developmentMassimiliano Sarra, Pre-clinical and Clinical Assessor, Italian Medicine Agency (AIFA) and Secretary, Clinical Trial Facilitation Group, Italy (subject to confirmation)

14.30FIH guideline update: regulators insightCamilla Svensson, Non-Clinical Assessor, Dept of Clinical Trials, The Swedish Medical Products Agency (MPA), Sweden

15.00 Regulator’s perspective on innovative protocol designs in early phase designs: basket, umbrella and platform designsKhadija Rantell, Statistical Assessor, Medicines and Health Care Products Regulatory Agency (MHRA), United Kingdom (subject to final confirmation)

15.30Improving regulator confidence for novel early phase clinical developmentOlivier Collignon, Statistical Leader, GSK, UK

16:10

Networking Break

16:45The changing regulatory landscape for cardiac safety assessments Boaz Mendzelevski, President, Cardiac Safety Consultants, United Kingdom

17.00Optimizing your hybrid trial: Avoiding the pitfallsCatherine Laing, Senior Clinical Scientist, Medical and Scientific Affairs, Covance, UK

17:30Concentration 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

Grand Opening of the CTE Exhibition Hall with Covance Networking Drinks Reception



INNOVATION AND SCIENCE08:50 Chairperson’s Opening Remarks

Chris Twelves, Professor of Clinical Cancer Pharmacology and Oncology, Leeds Institute of Cancer and Pathology and Head of Oncology Clinical Research, Leeds Cancer Reseach Centre, UK

09.00 Innovative Biomarker and Surrogate End Point Driven Early Clinical TrialsWojciech Smoron, Assoc. Global Trial Director, Novartis, Switzerland

9.30 Magnetic Resonance Imaging Biomarkers in Early Phase Clinical Development: From Patient Selection to Proof of Mechanism Geor Bakker, Senior Development Scientist, Sosei Heptares, United Kingdom

10.00 At-Home Data Collection in Early phase Clinical Development Peter Van Der Ark, Clinical Research Manager, Experimental Medicine Neuroscience, Janssen, Belgium

10.30Questions and Answer Session

10.40Networking Break

11.30 Inclusion of Sleep Assessments to Accelerate Early Clinical Development of CNS Active CompoundsDr John Connell, Chief Scientific Officer, MAC Clinical Research, United Kingdom

12:00 The Role of Statistical Analysis and Continuous Decision Making to Improve Flexibility and Efficiency in Early DevelopmentPhilip Overend, Director, Early Oncology Biometrics Team Leader, AstraZeneca, UK

12.30Networking Lunch

14.00 PK/PD Modelling to Support Early Clinical Development and Regulatory AssessmentBenjamin Ribba, Pharma Research and Early Development, F. Hoffmann-La Roche Ltd, Switzerland

14.30 Wearables and Biosensors in Early Phase Clinical DevelopmentChrister Gottfridsson, ECG Centre Cardiologist, Astrazeneca, Sweden

15.00 Harnessing Innovation to Accelerate Progress for Phase I to Phase IIa Clinical TrialsTav Ganguli, Medical Director, Medical & Scientific Affairs, Clinical Pharmacology Services, Covance, UK




16.00The application of AI in early phase clinical development Riccardo Belli, Director, Novartis Oncology, Switzerland

EARLY PHASE CLINICAL DEVELOPMENT ROUND TABLE SESSION

16.30Table 1: Is biomarker driven early clinical development achieving critical go/no go decisions faster?Pradeep Nathan, Vice President, CNS Clinical Development and Experimental Medicine, Sosei Heptares, United Kingdom

Table 2: How effective are translational models for predicting safety? Modelling pharmacology and other pre-clinical evidence to accelerate clinical trial designBenjamin Ribba, Pharma Research and Early Development, F. Hoffmann-La Roche Ltd, Switzerland

Table 3: Digital biomarkers and RWD: emerging applications in early phase clinical development. What impact will wearables have on early phase safety monitoring: how, and for how long should we continue to monitor patients in early phase trials?Christer Gottfridsson, ECG Centre Cardiologist, Astrazeneca, SwedenPeter Van Der Ark, Clinical Research Manager, Experimental Medicine Neuroscience, Janssen, Belgium

Table 4: The role of AI and big data: how is it impacting trial designs and drug development thinking?Riccardo Belli, Director, Novartis Oncology, Switzerland

17.00REPORT BACK SESSION: Where to focus your early phase strategy? Feedback and key themes emerging from the round table sessionChris Twelves, Professor of Clinical Cancer Pharmacology and Oncology, Leeds Institute of Cancer and Pathology and Head of Oncology Clinical Research, Leeds Cancer Research Centre, UK

17:30

Rejoin Plenary Session

PLENARY SESSION17.40

Christine Pierre Lifetime Achievement Award

17:50 Inspirational Talk: Keep Moving – Adventures with Parkinson’s diseaseBeing diagnosed with Parkinson’s disease at the age of 36, has had a profound and life changing effect on Alex. Overcoming adversity, dealing with diagnosis, travel adventure, danger and facing the future In a world of perpetual change. Alex Flynn, Adventurer, Speaker, Writer

18:30

Drinks and CTE Party



OPERATIONAL STRATEGIES08.55

Chairperson’s Opening RemarksNigel A Blackburn, Director of Drug Development, Centre for Drug Development, Cancer Research, United Kingdom

09.00Collaborative frameworks and new research infrastructuresKristy Draper, Global Trial Lead for the Proof of Concept Trial, European Prevention of Alzheimer's Dementia (EPAD), United Kingdom

09.30Multisite early phase studies in patients: the changing operational landscape of early clinical developmentStaffan Dahlgren, Unit Manager Phase-I, Karolinska Trial Alliance, Sweden

10.00 Early phase patient recruitment & retention strategiesPlease contact [email protected], Tel +44 (0) 20 7017 6631 if you are interested in participating as a speaker, panellist, moderator or hosting webinar.


11.20Outsourcing models for early clinical trialsTamzin Blagbrough, Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly, United KingdomAndrew Rubis, Clinical Functional Consultant, Eli Lilly, United Kingdom

12:00 Practically applying a patient centric approach to early phase studiesMarisol Montolio del Olmo, Scientific Director, Duchenne Parent Project, Spain

12.30 The power of patient engagement in turning around a failing studyNigel A Blackburn, Director of Drug Development, Centre for Drug Development, Cancer Research, United Kingdom

13.00Close of Conference

For Sponsorship and Exhibition opportunities, please contact Dylan Smith: [email protected] 16

Thank You to Our Sponsors and Exhibitors

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EXHIBITORS

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Documents

CLINICAL TRIALS: NAVIGATE THE PATH TO GROUNDBREAKING … · 2019-11-12 · Anca Copaescu, Chief Executive Officer, Strategikon Pharma, USA Professor Steven Carver, Senior Lecturer