Pathways to Pre-Clinical Development Success: Focus on Biologics and ATMPs

hosted by BioRN Network e.V.

Technology Park Conference Center

Start: Thursday, 15 Nov 2018 14:00

End: Thursday, 15 Nov 2018 17:30

  • Organisers

    About ERA Consulting:

    The ERA Consulting Group is one of the longest established and most experienced regulatory affairs and product development consulting groups serving the biopharmaceutical industry.
    ERA has experience with a wide range of products (over 500 products to date), including recombinant DNA and hybridoma technology, synthetic peptides, conventional and advanced vaccines, classical blood products, advanced therapy medicinal products comprising gene therapy, gene editing, somatic cell therapy and tissue-engineered products. ERA also works with innovative new chemical entities, particularly those indicated for neurological, oncological and immunological diseases. The specialised international team of more than 24 full-time professionals includes scientists with a research and development background, those with extensive industry experience and former regulators, offering both breadth and depth of expertise, from which clients can benefit. ERA currently has five office locations (Germany, the UK (2), the USA and Australia), with the in-house capability to prepare documents and complete submissions on behalf of clients, including a dedicated eCTD group.

    About BioRN – Life Science Cluster Rhine-Neckar (

    BioRN is a life science research and industry cluster dedicated to the development of cell-specific, molecular and personalised innovative treatments. The BioRN Cluster stands for the development, networking, representation and promotion of the life science region into one of the leading life science clusters in Europe. The cluster-members include renowned academic research institutions such as the Universities of Heidelberg, the German Cancer Research Center (DKFZ) and the European Molecular Biology Laboratory (EMBL) and global health care companies such as AbbVie, Boehringer Ingelheim, Johnson & Johnson, Merck, Roche, und Sanofi-Aventis, and about 80 small and medium-sized biotech enterprises. Beyond the members registered in the cluster, BioRN gives access to a wider network via partnerships and collaborations.

    In terms of the use of clusters for the internationalization of companies, BioRN has founded, together with Leuven (Belgium), Maastricht (Netherlands) and Copenhagen (Denmark), an alliance for the enforcement of biomedical innovation in Europe, called the Health Axis Europe





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