DIA Europe 2019: Full Schedule

11:00 CET

#DMD1: European Regulatory Town Hall Meeting – Key Topics for the Future

Component Type: Session

• Status of telematic implementation • Timely access to medicine • Availability of medicinal products • First look at ideas for Strategy 2021 – 2025

Chair

Christa Wirthumer-Hoche, PhD

Speaker

Panel Discussion
Nicola Bedlington

Panel Discussion
Karl Broich, DrMed

Panel Discussion
Nathalie Moll

Panel Discussion
Guido Rasi, MD

Panel Discussion
Thomas Senderovitz, DrMed, MD

Speakers

Karl Broich

President, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Physician, MD (certifications in Neurology, Psychiatry, Behavioural Psychotherapy). BfArM in Bonn (Germany): 2000 to 2014 several executive functions, since 08/2014 head (President). Work in several EMA committees. Current research: clinical trials methodology CNS, biomarkers in drug... Read More →

Harald Enzmann

Chair, CHMP; Head of European and International Affairs, Federal Institute for Drugs and Medical Devices (BfArM)

Harald Enzmann is chairperson of EMA’s Committee for Medicinal Products for Human Use (CHMP). A physician by training, Harald held positions at the German Cancer Research Center (dkfz), at the Intitute of Pharmacology and Toxicology at the University of Erlangen, at R&D at Bayer... Read More →

Nathalie Moll

Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)

Guido Rasi

Executive Director, European Medicines Agency

Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →

Thomas Senderovitz

Chair of HMA Management Group; Director General, Danish Medicines Agency

Thomas Senderovitz took over as Director General of the Danish Medicines Agency on 1 April 2016. His career includes more than 20 years working with medicinal products and he has held several senior positions in international biopharmaceutical Companies. He previously worked at the... 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 →

Nicola Bedlington

Secretary General, European Patient's Forum

Nicola Bedlington was first Executive Director of the European Patients’ Forum (EUPATI), which she continues to serve as its Secretary General, and is co-founder of Patients Access Partnership (PACT). She previously provided leadership to the Swiss government’s Environment and... Read More →

Tuesday February 5, 2019 11:00 - 12:30 CET
Hall D Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Regulatory Science
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11:00 CET

#DMD6: Real World Data: How to Deliver its Potential to Support Innovation

Component Type: Session

Real World Data (RWD) has the potential to support getting products to patients with unmet needs. It is already supporting key decisions by regulators, HTA bodies, payers and industry but the opportunity for even better use of RWD is huge. This session draws on the expertise of some of the most experienced global experts and through TED-style talks and debate will look at how this opportunity can be realised in Europe.

Chair

Daniel Morales, MD, PhD, MRCP

Speaker

How Industry is Delivering Innovation through Real World Data
Ryan Dean Kilpatrick, PhD

Confidence in Real World Data
Sebastian Schneeweiss, DrSc, MD, MS, FISPE

How a Common Data Model Can Support Innovation
Peter Rijnbeek, PhD

Collaboration between Data Owners to Deliver Quality Data and Robust Analysis
Miriam Sturkenboom, PhD, MPharm, MSc, FISPE

Speakers

Ryan Kilpatrick

Global Head, Epidemiology, AbbVie

Ryan Kilpatrick is the head of epidemiology at AbbVie, Inc. Prior to this, he held roles in Amgen, GSK and Baxalta. His primary interest is in use of pharmacoepidemiology in drug safety and to support drug development across the product lifecycle.

Daniel Morales

Member PRAC, Pharmacovigilance and Epidemiology Department, University of Dundee

Daniel Morales is a General Practitioner and Epidemiologist at the University of Dundee and current member of the EMA Pharmacovigilance Risk Assessment Committee. His research interests include the use of real world data to support medicines regulation and safer prescribing, and has... Read More →

Peter Rijnbeek

Assistant Professor Medical Informatics, Erasmus Medical Center

Peter Rijnbeek is Assistant Professor at the Erasmus University Medical Center in Rotterdam where he is leading the Health Data Science group at the Department of Medical Informatics (www.healthdatascience.nl). He is co-leading the European Health Data and Evidence Network (EHDEN... Read More →

Sebastian Schneeweiss

Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology, Harvard Medical School and Brigham and Women's Hospital, United States

Dr. Schneeweiss's research focuses on assessing the effectiveness and safety of biopharmaceuticals in clinical practice. He has developed analytic methods to improve the accuracy of estimating causal treatment effects of new drugs using complex digital healthcare databases. His work... Read More →

Miriam Sturkenboom

Professor, Julius Global Health, University Medical Center Utrecht

Miriam Sturkenboom is a professor in Observational Data Analysis, a pharmacoepidemiologist, currently working at the Julius Global Health group of University Medical Center Utrecht in the Netherlands. She is a past president of ISPE. Her research focuses on knowledge discovery from... Read More →

Tuesday February 5, 2019 11:00 - 12:30 CET
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Clinical Development ,Pharmacovigilance,Data and Data Standards
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14:00 CET

#DMD3: Patient Engagement as a Strategic Imperative in Therapeutic Innovation

Component Type: Session

Patient engagement remains very much in vogue, but does it really make a difference? This session will look at why patient engagement matters to different stakeholders in the value chain of medicines. We will explore patient engagement strategies within various institutions, organisations and companies - and the kind of buy-in needed from different stakeholders (patient organisations, industry, regulators, policy makers, HCPs) involved in making patient engagement happen across the entire life cycle. We will look candidly at some of the challenges of patient engagement and if we are where we need to be as we move towards the next decade of the 21st century. • A Brief History – The roots of patient engagement • Key Pillars of the IMI Patient Engagement Strategy • Prioritising Patient Engagement at the EMA and Looking to the Future • Transforming a Major Pharma towards Patient Engagement

Chair

Nicola Bedlington

Speaker

Panel Discussion
Dimitrios Athanasiou, MBA

Panel Discussion
Pierre Meulien, PhD

Panel Discussion
Guido Rasi, MD

Speakers

Dimitrios Athanasiou

Patient Advocate, WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS

Dimitrios Athanasiou is a PDCO member representing EURORDIS. He holds a BA and an MBA in Financial Management He attended Eurordis Summer School and European Patient Academy (EUPATI) acquiring basic biotech and regulatory knowledge. As a full time patient advocate in DMD, he is a... Read More →

Nicola Bedlington

Secretary General, European Patient's Forum

Pierre Meulien

Executive Director, Innovative Medicines Initiative (IMI)

Pierre Meulien is executive director of the Innovative Medicines Initiative (IMI), a €5 billion public-private partnership between the European Union and the European pharmaceutical industry. At IMI, he is responsible for the overall management of the program, which works to improve... Read More →

Guido Rasi

Executive Director, European Medicines Agency

Tuesday February 5, 2019 14:00 - 15:15 CET
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Patient Engagement
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14:00 CET

#DMD4: EUnetHTA Town Hall: Impact of Health Technology Assessment when Evidence (Regulatory vs Relative), Costs and Patient Expectations are Challenging to Combine

Component Type: Session

Chair

Niklas Hedberg, MPharm

Speaker

Regulator Perspective
Marie Gardmark

Payer Perspective
Robert Sauermann

Industry Perspective
Adam Parnaby

Speakers

Marie Gardmark

Head of Licensing, Swedish Medicines Agency (MPA), Sweden

Niklas Hedberg

Chair EUnetHTA Executive Board; Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden

Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and... Read More →

Adam Parnaby

Senior Director Market Access Policy, Worldwide Markets, Celgene, France

Adam has 18 years of experience in the pharma industry and started his career as an academic health economist. Previously, he was Director of Pricing and Market Access for Celgene’s Oncology portfolio in the EMEA region. Prior to joining Celgene, he worked in Health Economics and... Read More →

Bettina Ryll

Chair ESMO Patient Advocates Working Group (PAWG), Melanoma Patients

Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered... Read More →

Robert Sauermann

Department Head, Association of Austrian Social Insurance

Tuesday February 5, 2019 14:00 - 15:15 CET
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Value and Access
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16:00 CET

#DMD5: The Convergence of Medicines, Medical Devices and Analytics

Component Type: Session

Is the new European legislation on medical devices sufficient enough to handle the new paradigm of convergence between advanced medicinal products / diagnostics / apps / algorithms et al? Are we ready as regulators?

Chair

Thomas Senderovitz, DrMed, MD

Speaker

Setting the Scene
Thomas Senderovitz, DrMed, MD

Panel discussion
Elena Bonfiglioli

Panel discussion
Karl Broich, DrMed

Panel discussion
Lindsay Edwards

Panel discussion
Jorgen Scholler

Speakers

Elena Bonfiglioli

Managing Director, Health and Life Sciences, Microsoft

Karl Broich

President, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Lindsay Edwards

GSK

Jorgen Scholler

Head of Division. Department of Health Technology, Techincal University Denmark

Thomas Senderovitz

Chair of HMA Management Group; Director General, Danish Medicines Agency

Tuesday February 5, 2019 16:00 - 17:30 CET
Hall D Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Regulatory Science
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09:15 CET

#DMD7: Digital Trials, Sensors, Bots, AI/Machine Learning, RWD– Will Product Approvals Be Accelerated By These New Technologies?

Component Type: Session

Digital trials or “smart” trials, AI, Bots are the new buzzwords in our industry. But what do we mean by digital trials and how will these new technologies accelerate product approvals? Drug development timelines and cost keep increasing while reimbursement is diminishing; a paradigm shift is needed in the way we develop drugs. Will this come from new technologies and digitisation? And how will these technologies impact drug development process? What are the implications for regulators and how will they approve usage of sensors, bots and ML algorithm. Do pharma and regulators need to adapt their process and organisations (e.g., introduce a Chief Digital Officer role). And finally, will the patients accept these new technologies with increasing patient adherence and preparing a natural continuum with mHealth?

Chair

Isabelle M de Zegher, DrMed, MD, MS, MSc

Speaker

Panel Discussion
Ulo Palm, MD, PhD, MBA

Panel Discussion
Thomas Senderovitz, DrMed, MD

Panel Discussion
Peter Shone

Panel Discussion
Meni Styliadou

Speakers

Ulo Palm

Senior Vice President, Head Global Drug Development Operations, Allergan

Thomas Senderovitz

Chair of HMA Management Group; Director General, Danish Medicines Agency

Peter Shone

Corporate Vice President, R&D Engineering, PAREXEL Informatics

Meni Styliadou

VP Government Affairs & Public Policy, Europe & Canada, Takeda

Isabelle de Zegher

Vice President, PAREXEL Informatics

Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →

Wednesday February 6, 2019 09:15 - 10:15 CET
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Data and Data Standards
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09:15 CET

#DMD8: EU Cooperation on HTA and beyond - Current Action and Future Developments

Component Type: Session

With the confirmed participation of the European Commission, NICE, a Ministry of Health advisor and the coordination of EUCOPE, this panel discussion will provide a deep overview of EU Cooperation on HTA, namely on the centralisation of HTA assessment and the different stakeholders involved.

Chair

Alexander Natz, JD

Speaker

Panelist
Ana-Eva Ampelas, LLM

Panelist
Zoe Garrett

Panelist
Diane Kleinermans

Speakers

Ana-Eva Ampelas

Head of Unit, Medical products: Quality, Safety, Innovation, European Commission

Anna-Eva Ampelas is Head of Unit for Medical Products: quality, safety, innovation in Unit B4 in DG SANTE, European Commission. In this capacity, she manages files on medicinal products (falsified medicines, clinical trials, shortages, GMP etc); Health Technology Assessments (HTA... Read More →

Alexander Natz

Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

Dr. Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org). From 2008-2013 he has been heading the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany... Read More →

Zoe Garrett

SeniorTechnical Adviser – EUnetHTA, National Institute for Health and Care Excellence (NICE)

Diane Kleinermans

Advisor, Ministry of Health and Social Affairs

Wednesday February 6, 2019 09:15 - 10:15 CET
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Value and Access
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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

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
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14:00 CET

#DMD10: Raising Europe’s Voice in Globalising Regulatory Science

Component Type: Session

In this session, we aim to take the long view of regulatory science and innovation in establishing the value of medicines and medical treatments, exploring the heritage of European contributions to this scholarship and practice. However, this is undertaken only in the service of the principal goal of this session: to map out the role that Europe could - and should - play in the global evolution of regulation.

Chair

Virginia Lee Acha, PhD, MSc

Speaker

Panel Discussion
Dimitrios Athanasiou, MBA

Panel Discussion
Marieke De Bruin, PharmD, PhD

Panel Discussion
Sini Eskola, MPharm, MSc

Panel Discussion
Ian Hudson

Panel Discussion
Anthony Humphreys, MPharm

Speakers

Virginia Acha

AVP, Global Regulatory Policy, Merck Sharp & Dohme LLC, United Kingdom

Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better... Read More →

Dimitrios Athanasiou

Patient Advocate, WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS

Marieke De Bruin

Director, Copenhagen Centre for Regulatory Science, Copenhagen University

Marieke De Bruin, PhD was trained as a pharmacist and epidemiologist. Her drug regulatory science research has focused on pharmacoepidemiology in the drug regulatory setting and pharmacovigilance. The main clinical areas are cardiovascular diseases and cancer. As of August 2016, she... Read More →

Sini Eskola

Director Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations (EFPIA)

Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014 and leads the team since 2018. She is responsible for various regulatory policy and advocacy activities in relation to regulatory science and regulatory strategy. She has previously worked... Read More →

Ian Hudson

Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Division... Read More →

Anthony Humphreys

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

Thursday February 7, 2019 14:00 - 15:00 CET
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

DIAmond Sessions, Session

Featured Topics Regulatory Science
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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

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.

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 →

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)

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 →

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
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