The Instand-NGS4P High-Level Seminar at the EU Parliament (Brussels, May 20, 2025, 14:00–18:00 CET) will gather policymakers, healthcare experts, and patient advocates to discuss the role of Next-Generation Sequencing (NGS) in cancer care, regulatory challenges, and health economics.
Join us to explore groundbreaking innovations in precision oncology!
Why should you attend this event?
The High Level Seminar will highlight the medical need for innovative NGS in cancer care, as well as discussing regulatory challenges and health economic aspects.
Patient advocates can learn about the importance of NGS for their cancer treatment, and the efforts being made to meet their needs, such as including insights from pharmacogenomics when determining therapeutic options.
Clinicians will hear about the benefits of NGS and its role in precision cancer care, as well as current innovations to improve the provision of integrated standardized information from NGS for supporting therapy decision making at the bedside. They are invited to participate in highlighting the challenges facing its prompt and widespread availability, and how these can and should be addressed.
Policymakers, regulators and industry will come together with health care providers to discuss the technical, financial and regulatory obstacles currently facing the provision of timely and affordable access to precision cancer care across Europe.
Background
Providing the best possible therapy in a timely and accurate way to cancer patients critically depends on precision diagnostics. The more specifically medicines are selected to act on cancer, the more detailed diagnostic characterization of individual cancer tumors has to be performed to select the right therapy for the right patients at the right time.
In this context, next generation sequencing (NGS) has become a key diagnostic technology that should be available to newly diagnosed cancer patients throughout Europe. The rapid progress in the development of NGS technology allows comprehensive genetic analysis of cancers at affordable costs and in reasonable time. However, there are several challenges and hurdles in making innovative diagnostic solutions available to patients in health care.
Programme
This high level event will present lessons learned from the Pre-commercial Procurement Project “Integrated and Standardized NGS Workflows for Personalised Therapy (Instand-NGS4P)” (www.instandngs4p.eu), which is cofunded by the European Commission, and will discuss possible solutions on how to bring innovation to patients. The event will focus on three main issues to be introduced by short lectures and elaborated further in panel discussions, involving key stakeholders including patients, health care professionals, representatives from industry, regulators and policy makers.
- Medical need for NGS and precision diagnostics in cancer care
- How can innovative technologies meet regulatory requirements for in vitro diagnostics and how European standards can help
- Health economic benefits of NGS as prerequisite for cancer diagnostics reimbursement schemes. Addressingdisparities in accesstoprecisiondiagnosticsacross Europe.
Preliminary agenda
| 4.00 | WelcomeProf. Kurt Zatloukal - Project Coordinator - Director - Diagnostic and Research Institute of Pathology - Medical University of Graz – Austria Alexandru Padurean – Project Officer – HaDEA – EU Commission |
| 14.10 | Addresses of MEPsVlad Voiculescu – Romania – RENEW Europe Dan Barna – Romania – RENEW Europe Aldo Patriciello – Italy – Patriots for Europe |
| 14.20 | Session 1 – Medical need of NGS and precision diagnostics in cancer careModerator Prof. Ruth Ladenstein - Senior Consultant in Paediatric Oncology - St. Anna Children’s Cancer Research Institute - Austria, Coordinator ERN PaedCan - Board Member SIOP Europe Speaker Prof. Giuseppe Curigliano - Department of Oncology and Hemato-Oncology - University of Milano La Statale - Clinical Director - Division of Early Drug Development - European Institute of Oncology, IRCCS - Milan - Italy Panel Discussion Dr. Giovanni Apolone - President & Chairperson OECI EU Affairs - Scientific Director Foundation IRCCS - Istituto Nazionale dei Tumori - Milan - Italy Dr. Marc van den Bulcke PhD - Head of Service – Sciensano - Belgium Prof. Paolo Casali - Director Medical Oncology Unit 2 - & Secretary of the Ethics Committee - Istituto Nazionale - Milan - Italy - Project Coordinator of Joint Action On Networks of Expertise on Cancer - Board Member ESMO Prof. Francesco de Lorenzo - President F.A.V.O. - Italian Federation of Volunteer Cancer Patient Organisations Prof. Klaus Pantel - Director of Institute of Tumor Biology - University Hospital Eppendorf (UKE) - University of Hamburg - Germany Open Floor and Wrap Up |
| 15.20 | Session 2: How can innovative technologies meet regulatory requirements for in vitro diagnostics and how European standards can helpModerator Prof. Kurt Zatloukal - Project Coordinator - Director - Diagnostic and Research Institute of Pathology - Medical University of Graz - Austria Speaker Innovative Workflow Technologies and European Standards meet Regulatory Requirements Dr. Uwe Oelmüller - Vice President, Head of the Molecular Diagnostics Technology Center for Sample Technologies - QIAGEN GmbH – Germany Panel Discussion Niklas Blomberg – Executive Director -IHI Innovative Health Initiative Francesca Fenizia – Executive Director IQNPath Flora Giorgio - Head of Unit Medical Devices D3 -DG Sante TBC Matthijs van Meerveld -EFPIA Oncology Platform Representative - Associate Vice President - Global Head of Access Policy & Patient Advocacy - Oncology Dept. – Menarini Jesus Rueda Rodriguez - Director-General of Strategies and Special Projects – MedTech Open Floor and Wrap Up |
| 16.20 | Coffee Break |
| 16:40 | Session 3: Health economic benefits of NGS as prerequisite for reimbursement schemes. How to overcome inequalities for patients in accessing precision diagnostics in EuropeModerator Prof. Wim van Harten - Research Group Leader - The Netherlands Cancer Institute, Amsterdam - Chair Working Group Health Economics, OECI - (em) Professor Quality Management and Health Care Technology Speaker Prof. Valesca Retèl - Endowed Professor - Health Technology Assessment - Erasmus School of Health Policy & Management
Panel Discussion Dr. Marc van den Bulcke PhD - Head of Service - Sciensano - Belgium Prof. Fortunato Ciardiello - Director - Division of Medical Oncology - Dean of the School of Medicine and Surgery - University of Campania Luigi Vanvitelli - Naples Francesco Florindi - Policy Officer - DG Research & Innovation - Unit D2 Health Innovations & Ecosystems - Brussels - Belgium Prof. Jose M. Martin-Moreno - Preventive Medicine and Public Health - University of Valencia - Spain Prof. Lotte Steuten - Deputy Chief Executive - Office of Health Economics Open Floor and Wrap Up |
ConclusionsProf. Marialuisa Lavitrano - School of Medicine and Surgery - University Milano-Bicocca - Italy | |
| 18.00 - 19.00 | Cocktail Reception |
Outcome
A White Paper based on the conclusions of the event will follow with concrete proposals for future activities.