EBE Working Groups’ Mission and Remit

  • Advanced Therapies (joint Working Group with EFPIA)

    The role of the Advanced Therapies WG is to support a consistent and harmonised regulatory framework for advanced therapies. The WG provides industry input on relevant regulatory issues and also acts as a point of contact for discussions with the EMA Committee of Advanced Therapies. The WG has recently developed a paper on hospital exemptions and will be providing input to the Commission review on the Advanced Therapy Regulation.

    Chair: Maria Pascual, TiGenix
    Vice Chair: Esther Choi, Bristol-Myers Squibb
    EBE Staff Liaison: Véronique Debaut
  • Innovation and Funding Models Working Group

    The role of the Innovation and Funding Models Working Group is to support the development of attractive entrepreneurial conditions for the biopharmaceutical industry, working together with the relevant EU institutions, as well as to develop programmes that support greater connectivity in the European Biotech-Pharma ecosystem. Its role is also to represent Biotech/SMEs perspective in EU’s public research and innovation funding schemes (eg Horizon 2020, IMI II) and to provide research partnering opportunities for EBE members
    Chair: Poul Sørensen, Stallergenes-Greer
    Vice Chair: Emil Pot
    EBE Staff Liaison: Barbara Freischem
  • Biosimilars Working Group

    The objectives of the Biosimilars Working Group are to contribute industry expertise to the development of new legislation for biological. It is a forum for industry expertise to provide active follow-up on relevant topics such as tendering, traceability, SmPC labeling for biosimilar products.
    Chair: Stephanie Lane, MSD
    Vice Chair: Fabio Bisordi, Roche
    EBE Staff Liaison: Véronique Debaut
  • Personalised Medicine (joint Working Group with EFPIA)

    The mission of the Personalised Medicine Working Group is to promote personalised medicine towards key stakeholders, and particularly politicians, to explain how it can improve patients’ health by delivering the right medicine to the right patient at the right time.

    The WG also aims to ensure a favorable legislative environment to allow innovative medicines to be developed. The group plays a leading role in the recast of the In Vitro Diagnostics - Medical Devices Regulation.

    Chair: Christine Mayer-Nicolai, Merck Group
    Vice Chair: Felipe Fernandez, Novartis
    EBE Staff Liaison: Audrey Wolf
  • BioManufacturing Working Group

    The objectives of the EBE Bio-Manufacturing Working Group are to: Raise the awareness of biotech manufacturing in the technical and quality arena. Ensure the protection of the patient and promote consistent application of requirements by industry and competent authorities. Provide a forum for the exchange of information and good practices between companies to develop and communicate technical positions externally.
    Chair: Markus Goese, Roche
    Vice Chair: Ronald Imhoff, J&J
    EBE Staff Liaison: Véronique Debaut
  • Public Affairs Network

    The Public Affairs network mission is to efficiently communicate EBE messages externally as biopharmaceutical industry representatives. The network needs to be aware of the positioning and key messages of all working groups to adapt the main messages and develop advocacy plans on issues that EBE is leading, e.g. In Vitro Diagnostics Regulation recast, or tendering for biosimilars. The group meets on an as needed basis, but at least once a year.

    Chair: Nathalie Stieger, Roche
    Vice Chair: Heike Galbraith, Pfizer / Mazen Elzaabi, LFB Biotechnologies
    EBE Staff Liaison: Audrey Wolf
  • Regulatory & Technical Affairs Network

    The objectives of the Regulatory & Technical Affairs network are to contribute industry expertise to the development of new regulatory frameworks, guidelines and standards of relevance to biopharmaceutical companies operating in Europe, promoting the exchange of good practices fostering the development of safe, efficacious and high-quality medicines, and providing a forum for expert information exchange between members and the establishment of Good Practices. The group convenes as needed, but at least once a year.

    Chair: Kate Beaujeux, MedImmune
    Vice Chair: Emma Dufour, AbbVie
    EBE Staff Liaison: Véronique Debaut
  • Allergen Immunotherapy Task Force

    The Allergen Immunotherapy Task Force unites experts from biopharmaceutical companies with a focus on allergen immunotherapy. It carries out a project investigating the burden of disease for allergic patients, and looks at the need for harmonisation of the regulatory framework for allergens in Europe.

    Lead on Access: Niels Serup-Hansen, ALK
    Lead on Regulatory:  Anne Luetzhoeft Aarbogh, ALK
    EBE Staff liaison: Audrey Wolf

     

  • Cancer Control Task Force

    The Cancer Control (CanCon) Task Force prepares and provides industry input into the EU Expert Group on Cancer Control, on which EBE represents the biopharmaceutical industry.

    LEAD: Thomas Buechele, Roche
    EBE STAFF LIAISON: Audrey Wolf