EBE at DIA EuroMeeting 2018: 17-19 April 2018, Basel, Switzerland
1) Tuesday 17 April from 12h30 to 13h45 – CAT Spotlight: What’s on the Horizon for ATMPs in the Near Future?
Moderator: Duane Schulthess, Managing Director, Vital Transformation, Belgium
– Martina Schüssler-Lenz, Chair CAT, Deputy Head, Section Advanced Therapy Medicinal Products, Paul-Ehrlich-Institute (PEI), Germany
– Barbara Freischem, Executive Director, European Biopharmaceutical Enterprises (EBE), Belgium
– Evert Jan van Lente, Director EU-Affairs, AOK Bundesverband (Federal Insurer), Germany
2) Wednesday 18 April from 10h30 to 12h00 – EBE-EFPIA Personalised Medicines Working Group Session on In Vitro Diagnostic Medical Device Regulation (IVDR)
The implementation of the new IVDR introduces new challenges for all stakeholders involved, whether it is Companion Diagnostics (CDx) and Personalised Medicines (PM) developers or the European Medical Agency, National Competent Authorities or Notified Bodies. This session will examine the impact of this new regulatory landscape for all stakeholders and highlight new possible opportunities and areas of collaboration to ensure that CDx and their paired PM products are successfully brought to market.
Chair: Claudia Dollins, Head Global Regulatory Affairs, Biomarkers and Diagnostics, Merck Group, Germany
–Anna Hallersten, Head Regulatory Policy Europe, Roche Diagnostics
–Sue Spencer, Global Service Line Director Regulatory at UL
–Stephen Lee, Medicines and Healthcare Products Regulatory Agency (MHRA)
3) Wednesday 18 April from 14h00 to 14h30: Enabling and Constraining Factors in Commercial ATMP Development: Learning from the Escher-ATMP Study
Renske M.T. ten Ham, Division of Pharmacoepidemiologye and Clinical Pharmacology, Utrecht University, Netherlands
4) Wednesday 18 April from 16h00 to 17h30 – EBE-EFPIA Personalised Medicines Working Group on Health Economics
Health systems throughout the world are faced with demands for additional services and rising costs. Healthcare decision makers need to identify efficient medical strategies and to choose the right interventions to maximise the achievable benefits for the patient within the available budgets. The concept of PM not only promises to enhance the life of patients and to increase the quality of clinical practice and targeted care pathways, but also to lower overall healthcare costs through early-detection, prevention, accurate risk assessments and efficiencies in care delivery. In this session, the view and impact of both the pharmaceutical industry and the healthcare insurance are introduced. In addition, current cases from an EBE-EFPIA study comparing different European countries will highlight the value of PM and the access for patients.
Chair: Annette Mollet, Head of Education and Training, ECPM Institute of Pharmaceutical Medicine, University of Basel
–Guido Papa, Head Global Pricing & Market Access Excellence, Roche
Health economic impact of genomic and genetic testing
–Eelko den Breejen, Vice-Chair EBE-EFPIA PMWG
The case for the value of PM – An European perspective
–Thomas Szucs, ECPM, University of Basel and Helsana Health Insurance
How can we afford PHC – The payer’s view