24th March 2020

08:30 – 09:00

Registration & Welcome Coffee

09:00

Setting the Policy Framework for Personalised Medicine

Chair: Denis Horgan, Executive Director, European Alliance for Personalised Medicine

Pascal Canfin, Member of the European Parliament; Chair, ENVI Committee

Tiemo Wölken, Member of the European Parliament

Benedikt Westphalen, Coordinator Molekulare Onkologie, Comprehensive Cancer Centre, University of Munich

Ivica Belina, President, Coalition of Healthcare Association

Benjamin Horbach, Health Systems Strategy Leader — Personalised Healthcare (PHC), Roche

Tuula Helander, Senior Advisor, Ministry of Social Affairs and Health, Permanent Secretary’s Cabinet; and Secretary General at Finnish Cancer Institute

Q&A

10:00 – 11:15

Session 1: Biomarkers and Molecular Diagnostics

This session aims to facilitate patient access to biomarkers and molecular diagnostic technologies, through the development of a policy framework with input from expert, multi-stakeholder viewpoints.

The session will examine the current and evolving landscape, variations in national processes and procedural requirements, and developments in regions outside the EU.

When it comes to the value of molecular diagnostics, for patients, this lies in safer and more effective therapies, as well as increased confidence and certainty in their treatment decisions.

Physicians, meanwhile, would be better informed to make the best possible individual treatment decision for their patients, and payers would see more cost-effective healthcare and better budget allocation.

Chair: Mark Lawler, Chair in Translational Cancer Genomics Centre for Cancer Research and Cell Biology, Queen’s University Belfast

Monika Benova, Member of the European Parliament

Sofie Persson, Research Director, Swedish Institute for Health Economics (IHE)

Paul Naish, Director, Oncology Advocacy and Government Affairs, AstraZeneca

Fabrizia Galli, Vice-President, aBRCAdaBRA

Beata Jagielska, Polish Alliance for Personalised Medicine

Falk Ehmann, Science and Innovation Support, European Medicines Agency (EMA) (TBC)

Q&A

11:15 – 12:30

Session 2: Prostate Cancer – Prevention and Early Diagnosis

The number of men being diagnosed with prostate cancer across Europe has increased over recent years. This is thought to be mainly down to men becoming more aware and having tests to detect very early prostate cancers as well, of course, as the ageing population that leaves us with more-older men in society.

The actual causes of prostate cancer are still unknown, but some factors such as age, as mentioned, and a family history of the disease increase the chances of developing it.

Today, some 3 million European men are living with prostate cancer. There are in the region of 105.5 new cases per 100,000 men across the European Union each year. But there are significant differences between Member States with, for example, as many as 123 cases per 100,000 in Ireland.

It is important to note that prostate cancers often have no early symptoms. Early diagnosis is therefore key. The problem of prostate cancer will only worsen, with projections suggesting that, by 2060, there will be an increase by around 32 million in the number of men aged over 65. We need to work hard to make policymakers aware of the situation.

Chair: James NDow, Guidelines Office chair, European Association of Urology 

Véronique Trillet-Lenoir, Member of the European Parliament, co-chair of the MEPs Against Cancer Interest Group

Jan-Willem van de Loo, Directorate E – Health Research, DG Research and Innovation, European Commission

Erik Briers, Europa Uomo

Hein Van Poppel, EAU Adjunct Secretary General – Education; University Hospitals of the KULeuven

Maria Ribal, Head of the Uro-Oncology Unit, Hospital Clinic, University of Barcelona 

Q&A

12:30 – 13:30

Networking Lunch

13:30 – 14:45

Session 3: Orphan Regulation and Personalised Medicine

Orphan drugs are, according to Orphanet (which is supported by the European Commission and formed to gather knowledge on rare diseases), are intended to treat diseases so rare that pharmaceutical companies are reluctant to develop them under usual marketing conditions.

The European definition of a rare disease is one that affects fewer than five people per 10,000 of the population (or, approximately 500 patients per million of population).

Ultra-rare diseases must also be part of any personalised medicine debate as, despite the very small number of patients they affect, it is clear that their impact on patients, their families, and society is very great, not least as many have high mortality rates.

As an overview, it is estimated that 5,000 to 8,000 distinct rare diseases exist in the EU. Therefore, development of orphan medicinal products (OMPS) is an important consideration for public health policymakers.

Throughout the last decade of the 20th century, a number of Member States adopted specific measures to improve knowledge of rare diseases in respect of their detection, diagnosis, prevention and treatment.

The EU’s Orphan Regulation of late 1999, now being reviewed, came into being chiefly to ensure that patients suffering from rare conditions have the same quality of treatment as any other patient in the EU. Equitable access to the best treatment available is also a pre-requisite demanded by those who espouse the concept of personalised medicine.

Chair: Ivana Cattaneo, Public Affairs Director Europe, Novartis

Maciej Gajewski, Head Intl Government Affairs & Policy, Alexion

Simone Boselli, Public Affair Director, EURORDIS

Andrzej Rys, Director, Health Systems, Medical Products and Innovation, DG SANTE, European Commission

Antoni Montserrat Moliner, Active Senior on Public Health for the European Commission

Tilly Metz, Member of the European Parliament

Q&A

14:45 – 16:00

Session 4: Realising the potential of Data: The Million EUropean Genome Declaration and the EU Digital Health Strategy

A Declaration of Cooperation “Towards access to at least 1 million sequenced genomes in the European Union by 2022” was signed in Brussels on 10 April 2018 during Digital Day.EAPM has now put in place MEGA+, which seeks to utilise all relevant medical data, not just genomes.

Clearly, coordination and support is needed to develop cross-border solutions for sharing expertise and linking genomic and other health data.

At the heart of genetics-based personalised medicine – aimed at giving the right treatment to the right patient at the right time – lies the collection, storage, use and sharing of data.

To make the most of all the massive amount of valuable information flowing into super computers and biobanks there needs to be a shared vocabulary and data-set standards, with agreed universal protocols for sending, receiving, and querying the information.

This could be achieved by:

  • Identifying relevant initiatives and projects
  • Discerning best practice emerging from clinical implementation
  • Engaging with relevant stakeholders

Meanwhile, it is critical to identify:

  • Common standards for data quality, security, interoperability, privacy, ethical guidelines
  • Governance models underpinning the establishment of sustainable cross-border digital infrastructures and networks for genomics and personalised medicine in Europe

Chair: Niklas Blomberg, Director, Elixir

Astrid Moura Vicente, PhD, Coordenadora do Departamento de Promoção da Saúde e Prevenção de Doenças Não Transmissíveis Investigadora Principal

Edina Toth, Member of the European Parliament

Toni Andreu, Scientific Director, EATRIS

Veli Stroetmann, Director, Empirica Communication & Technology Research

Andres Metspalu, Full professor of Biotechnology; Head of the Estonian Biobank, Institute of Genomics, University of Tartu

Marco Marsella, Head of Unit eHealth, Wellbeing & Ageing, European Commission

Merck speaker

Q&A

16:00 – 16:45

Closing Session: Bridging Forward

Denis Horgan, Executive Director, European Alliance for Personalised Medicine

Cristian Busoi, Member of the European Parliament

Frederique Ries, Member of European Parliament

Mario Romao, EMEA Global Public Policy team, Intel

18:00 – 21:30

Presidency Conference Cocktail & Dinner

18.00               Welcome

Sirpa Pietikainen, Member of the European Parliament

Sara Cerdas, Member of the European Parliament

Esther de Lange, Member of the European Parliament

Pre-Meeting Discussion: EAPM Annual Conference Launch

18.10 – 18:30            Key Note Address: 

Public Health and the Role of Personalised Health Care

Chair: Alastair Kent, Formerly Director of Genetic Alliance UK

Margaritis Schinas, European Commission Vice-President for Promoting our European Way of Life (TBC)

19.15              Presidency Dinner for EAPM Congress In the European Parliament

Early Diagnosis, Screening and Biomarkers

In this modern era, patients are demanding to become more-and-more involved in their own treatments. They know more than ever before and have a right to dialogue with their doctors, nurses and surgeons.

But in the age of personalised medicine it has become clear that neither the patients nor the healthcare professionals (HCPs) know quite enough. The same holds true for regulators and policymakers.

Understanding at every level will bring about greater awareness of stakeholder issues and will inevitably lead to better regulation and legislation from on high.

All HCPs in close contact with patients or their families need to possess a solid knowledge of the current aspects of personalised medicine and its latest breakthroughs, in order to better understand patients’ concerns. And weaned to find ways to give even more knowledge to the patient, through civil society, plus EU and Member State activities.

Chair: Denis Horgan, Executive Director, European Alliance for Personalised Medicine

Boris Brkljacic, President – European Society of Radiology

Frederique Penault-Llorca, Director, Centre de Lutte Contre le Cancer de Clermont-Ferrand.

Giulia Veronesi, Chief of the Robotic Surgery Unit at the Humanitas Hospital in Milan

Stefan Gijssels, Executive Director, Digestive Cancers Europe