DIA Europe 2019: Full Schedule

09:15 CET

#DMD9: Brexit and the European Network: 1,5 months to go! Where Do We Stand?

Component Type: Session

The session will discuss the challenges and solutions identified within the EU Regulatory Network on how to carry forward after the UK is no longer an official member of the European Union. It will discuss the tactical solutions put in place to continue operating without disturbance and also give advice to the industry on the expectations on them.

Chair

Christa Wirthumer-Hoche, PhD

Speaker

Panel Discussion
Kora H Doorduyn-van der Stoep, MSc, RPh

Panel Discussion
Anthony Humphreys, MPharm

Panel Discussion
Hugo Hurts

Panel Discussion
Nick Meade, MSc

Panel Discussion
Lorraine Nolan, PhD

Panel Discussion
Aimad Torqui, MSc

Speakers

Hugo Hurts

Chair HMA Task Force; Executive Director, Medicines Evaluation Board (MEB)

Nick Meade

Director of Policy, Genetic Alliance UK

Nick Meade leads the policy work of Genetic Alliance UK. The organisation works on behalf of more than 230 patient organisation member groups, aiming to improve outcomes for everyone affected by genetic, rare and undiagnosed conditions through evidence-based influencing and campaigning... Read More →

Christa Wirthumer-Hoche

Chair, EMA Management Board, Head, Austrian Medicines and Medical Devices Agency

Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices... Read More →

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA)

He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority , Ireland

Dr Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →

Kora Doorduyn-van der Stoep

Vice-Chairperson CMDh (NL) and CMDh Member/Senior Policy Adviser, Medicines Evaluation Board, Netherlands

Her current position (since 2009) is CMDh member (EU-representative)/Policy adviser of the department Policy, Governance and Regulatory Affairs. Since May 2009 she is acting as Member and official representative in the CMDh on behalf of the MEB. She is member of several working parties... Read More →

Aimad Torqui

Director Global Regulatory Policy, MSD

Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment includes Medicines Evaluation Board and Novartis Vaccines. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.

Wednesday February 6, 2019 09:15 - 10:15 CET
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Regulatory Science
Tags Session

10:45 CET

#S0901: Clinical Trials and GDPR

Component Type: Session

In recent guidance, both the European Commission and the Article 29 Committee overseeing the GDPR have suggested that consent should not be the preferred basis for processing data in clinical trials. This panel will explore why this view was reached and what its implications are for the conduct of research and relations with research participants. We will in particular look at how the ethical and legal safeguards that govern clinical research, viewed from the perspective of the privacy regulator, and how these relate to the principle of accountability under GDPR.

Chair

Brendan Barnes

Speaker

The View of the Privacy Regulator
Joao Soares da Silva, MA

Company Experience in Adapting to the New Requirements
Lee Parker, JD, LLM

What do Trial Participants and Patients Think?
Souzi Makri

Speakers

Brendan Barnes

Director, Multilateral Issues and Health Policy, EFPIA

Brendan Barnes

Director IP & Data Protection, EFPIA

Brendan Barnes joined EFPIA in 2002 to work on the alignment of national laws in new member states during the enlargement of 2004. Subsequently, he has been involved in EFPIA’s work on multilateral trade and intellectual property issues, including the EU’s legislation on product... Read More →

Souzi Makri

Vice-President, Cyprus League Against Rheumatism

Lee Parker

Director EU+ Privacy, Biogen International Gmbh

Lee Parker is Director Data Privacy Europe and Canada at Biogen. He also acts as EU Data Protection Officer. Lee is an experienced data privacy professional and English-qualified solicitor, with numerous years of pharmaceutical industry data protection experience. He is a member of... Read More →

Wednesday February 6, 2019 10:45 - 11:45 CET
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

Hot Topics/Stand Alone, Session

Featured Topics Clinical Development
Tags Session

12:00 CET

#S0402: Where Will Patients Come from in the Future? EHR and Biobanks

Component Type: Session

There is no clinical research without patients who are willing to participate in clinical trials. As long as this paradigm is valid, finding the right patients is a key to success in clinical development. Sometimes one has to apply sophisticated concepts to find eligible patients, but more straightforward access strategies may be available with Biobanks and Electronic Health Records (EHRs). Representatives of both tools will discuss their value and limitations.

Chair

Peter Schueler, DrMed, MD

Speaker

Biobanks – What and Where They Are
Berthold Huppertz, PhD

“Anonymized Identification” Technology and its Use in EHR Clinical Trial Patient Search and Identification
Ian Rentsch, JD

How a Data-Driven Approach Can Lead Difficult to find Pediatrics Sickle Cell Disease Patients into Clinical Trials
Martim Goncalves, MBA

Roundtable: EHR - A Breakthrough in Patient Recruitment? - The View from National Competent Authority
Janet Valentine, PhD

Roundtable: EHR - A Breakthrough in Patient Recruitment? - The Obstacles
Peter Gocke

Roundtable: EHR - A Breakthrough in Patient Recruitment? - The Solutions
Christine Mueller, PhD

Speakers

Peter Gocke

Chief Digital Officer, Charité Berlin

Martim Goncalves

Global Solutions Manager (R&D), IQVIA

Martim Gonçalves is leading cross-functional projects for the Analytics Center of Excellence in a collaboratively way to find novel, differentiating solutions to challenging and complex problems. In this role, I am passionate about innovation, and new data science solutions at a... Read More →

Berthold Huppertz

Chair, Division of Cell Biology, Histology and Embryology, Medical University of Graz

Berthold Huppertz is PhD and professor of cell biology. From 2011 to 2017 he has been director and CEO of Biobank Graz, the largest clinical biobank in Europe with more than 20 million samples. During this time, Biobank Graz was awarded “Research Biobank of the Year” in 2014... Read More →

Christine Mueller

Hospital Engagement Lead, Custodix NV

Christina Mueller holds a PhD in Biomedical Science from the University of Gent, Belgium as a continuation of her undergrad degree in Molecular Biology at the University of St. Andreas, Scotland. She has practical experiences in fundamental research for medication development, in... Read More →

Ian Rentsch

Chief Executive Officer, Clinerion

Ian Rentsch has over 23 years’ experience in Multinational Corporate Affairs, Outsourcing Management & Clinical Research Development working in large multinational companies including large biopharma and Contract Research Organizations Globally and in Emerging Markets. Most recent... Read More →

Peter Schueler

Senior Vice President, Drug Development Neurosciences, ICON plc (CRO)

Peter Schüeler, MD, serves as Senior Vice President, Drug Development Neurosciences, for ICON plc (Germany). He joined ICON as Vice President for Medical Affairs and Drug Safety for Europe, and has authored an eBook about drug development methodology. Dr. Schüeler is Head Lecturer... Read More →

Janet Valentine

Director of Clinical Practice Research Datalink (CPRD), MHRA

Janet Valentine PhD joined the Clinical Practice Research Datalink (CPRD) as Director in 2015. CPRD is the UK Government real world health data research service supporting retrospective and prospective public health and clinical studies. Previously Janet was Head of Population Health... Read More →

Wednesday February 6, 2019 12:00 - 13:15 CET
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

04 Modern Clinical Research, Session

Featured Topics Clinical Development
Tags Session

15:15 CET

#S0403: Change is Coming… Getting the Questions Right in Clinical Development

Component Type: Session

The need for greater clarity in the articulation of the scientific questions to be answered with randomised clinical trials has recently resulted in regulations that aim at the development of clear scientific questions as a prerequisite of adequate study design and analysis. The session will discuss challenges and opportunities for clinical development both for the evaluation of efficacy and safety as well as implications on benefit-risk evaluations and product labeling.

Chair

Jürgen Kübler, PhD

Speaker

Getting the Questions Right in Efficacy
Wolfgang Kothny, MD

Getting the Questions Right in Safety
Reinhard Fescharek, MD

Implications on Benefit-Risk and Labelling
Robert Hemmings, MS, MSc

Speakers

Reinhard Fescharek

Vice President, CSL Behring GbmH

Robert Hemmings

Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)

Rob has been with MHRA for 16 years and heads up the team of statisticians and pharmacokineticists. Much of Rob’s time is spent educating colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a co-opted member of the... Read More →

Wolfgang Kothny

Global Head Clinical Sciences, Novartis Pharma, Switzerland

Dr. Wolfgang Kothny is a physician who did his clinical training in the department of cardiology at the University Munich before joining the industry in 1999. Wolfgang joined Novartis in 2007 and currently is holds the Position of Global Head Clinical Sciences. Before that, he was... Read More →

Jürgen Kübler

Owner, QSciCon

Dr. Kübler has over 25 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from the... Read More →

Wednesday February 6, 2019 15:15 - 16:15 CET
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

04 Modern Clinical Research, Session

Featured Topics Clinical Development
Tags Session

16:45 CET

#S0404: Study Design and Innovative Statistics

Component Type: Session

Having “got the questions right” (Session 0403 Change is Coming… Getting the Questions Right in Clinical Development), trial designs and analytical approaches are needed that are able to give reliable answers to those questions while being efficient in terms of costs and burdens to patients and the healthcare system. This session will explore novel approaches that are working in practice.

Chair

Robert Hemmings, MS, MSc

Speaker

Innovation in Clinical Trial Design – Why Embracing Novel Approaches is Important and Where We Go from Here
Chrissie Fletcher, MSc

New Precision R&D Models in Oncology – Complex Clinical Trials to Investigate Histology-Independent Indications
Sacha Wissink, PhD

Adaptive Trial Designs: Delivering the Unicorn of Clinical Trials in the UK
Matt Cooper, PhD

Panel Discussion
Kirsty Wydenbach, DrMed, MSc

Speakers

Matt Cooper

Business Development and Marketing Director, NIHR Clinical Research Network

Matt has been Business Development & Marketing Director at the Clinical Research Network Coordinating Centre since 2014, having been part of the Network structure for a decade. In a previous roles he was a member of the leadership team of the National Cancer Research Network and before... Read More →

Chrissie Fletcher

Executive Director, Biostatistics in Global Biostatistical Science, Amgen Ltd

Chrissie is an Executive Director Biostatistics in Global Biostatistical Science at Amgen. She is the Global Biostatistics TA Head for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology disease areas, the EU Regional Head for Biostatistics and leads a Health... Read More →

Robert Hemmings

Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)

Sacha Wissink

Exec. Director Regulatory Affairs Europe, MSD

Dr. Wissink joined Regulatory Affairs Europe MSD in January 2014 to lead the company’s oncology efforts, including the registration of the PD-1 inhibitor, Keytruda® as well as its developmental activities. Prior to joining Regulatory Affairs Europe, Dr. Wissink was Director, Global... Read More →

Kirsty Wydenbach

Deputy Unit Manager, Clinical Trials Unit, MHRA

Joined MHRA in 2009, as the Senior Medical Assessor and Deputy Unit Manager in the Clinical Trials Unit. Involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including trials for chemical and biological products, Advanced Therapy... Read More →

Wednesday February 6, 2019 16:45 - 18:00 CET
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

04 Modern Clinical Research, Session

Featured Topics Clinical Development
Tags Session

09:15 CET

#S0405: Reducing Cost and Improving Quality of Clinical Trials

Component Type: Session

Discover three questions to ask before you innovate to reduce cost and improve quality of clinical trials from lessons learned.

Chair

Clara Heering, MS, MSc

Speaker

Evolution of RBM - Risk-Based Quality Management
Artem Andrianov, PhD, MBA

Implementing a Scalable Risk-Based Monitoring Strategy
Richard Davies

How to drive forward clinical development between Japan and EU?
Hideyuki Kondo, MBA

An Integrated Artificial Intelligence Platform for Clinical Study Management
Manfred Koehler, DrSc

Speakers

Artem Andrianov

CEO, Cyntegrity Germany GmbH

"Artem Andrianov graduated with degrees in software engineering, and MBA. After graduation, he defended a PhD with the focus on mathematical modeling. Artem started his career at CareFusion, and after three years shifted to the position of Development Manager with a focus on Data... Read More →

Richard Davies

Vice President, Solution Expert, CluePoints

Richard Davies joined CluePoints in September 2018 and is based in the UK. As VP, Solution Expert his role is to support organizations’ adopting CluePoints solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection... Read More →

Clara Heering

Enterprise JJCO lead for Capacity & Alliance Management, Johnson & Johnson

Clara Heering is lead for Capacity and Alliance management at Johnson & Johnson Clinical Operations. Clara began her career as Research Fellow at Harvard Medical School, then joined Pfizer in Clinical Research & Development, where she served in roles of increasing responsibility for... Read More →

Manfred Koehler

CEO, Koehler eClinical GmbH

CEO and Founder KOEHLER eClinical GmbH in Freiburg, Germany.

Hideyuki Kondo

Deputy Director, Office of International Program, Pharmaceuticals and Medical Devices Agency (PMDA)

Hideyuki Kondo experienced, for more than 10 years of carrier in Ministry of Health, Labour and Welfare, Japan, several positions in the field of pharmaceutical and medical device regulations, including those related to pre-market review policies, GMP/QMS inspections, post-market... Read More →

Thursday February 7, 2019 09:15 - 10:15 CET
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

04 Modern Clinical Research, Session

Featured Topics Clinical Development
Tags Session

10:45 CET

#S0406: Will Patient Involvement Improve Clinical Research?

Component Type: Session

Chair

Jan Geissler, MBA

Speaker

The EUPATI Patient Qualification Programme
Jan Geissler, MBA

Patient Preferences for Medical Decision Making - A Portfolio of Case Studies Using Patient Preference Methods in Different Patient Populations
Ardine De Wit

Speakers

Matt Cooper

Business Development and Marketing Director, NIHR Clinical Research Network

Jan Geissler

CEO, Patvocates

Founder and Managing Director of Patvocates. Former Director of the European Patients' Academy (EUPATI). Cancer survivor and co-founder of the CML Advocates Network, the Leukemia Patient Advocates Foundation, LeukaNET, Leukämie-Online and the European Cancer Patient Coalition.

Ardine De Wit

Associate Professor of HTA, University Medical Center Utrecht

Thursday February 7, 2019 10:45 - 11:45 CET
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

04 Modern Clinical Research, Session

Featured Topics Clinical Development
Tags Session

14:00 CET

#DMD11: Modern Clinical Research and Paradigm Shift – What Can We Take Home?

Component Type: Session

The panel will reflect on the previous days’ key messages about “Modern Clinical Research”, such as innovative study design and statistics, patient centricity, digital technologies. The audience will be involved through the voting system.

Chair

Peter Schueler, DrMed, MD

Speaker

Panel Discussion
Janet Valentine, PhD

Panel Discussion
Jan Geissler, MBA

Panel Discussion
Tomas Salmonson, PhD

Speakers

Jan Geissler

CEO, Patvocates

Robert Hemmings

Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)

Tomas Salmonson

Senior Scientific Advisor, Medical Products Agency (MPA)

Tomas Salmonson, M.Sc., PhD, brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency... Read More →

Peter Schueler

Senior Vice President, Drug Development Neurosciences, ICON plc (CRO)

Janet Valentine

Director of Clinical Practice Research Datalink (CPRD), MHRA

Thursday February 7, 2019 14:00 - 15:00 CET
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Clinical Development
Tags Session