We are involved in various innovative trials covering a broad range of biologic drug products, including recombinant peptides, Vaccines and adenoviral vector delivery systems.
Our vast experience in the clinical development of biologics provides sponsors of biosimilars with the highest quality and most cost effective solutions for a successful, global clinical development of biosimilars.
Genelife’s experience and knowledge base in the regulation of such drugs makes a US FDA strategy for approval a reality, despite that the guidelines have not been finalized. In addition to in-depth knowledge of the existing regulatory guidance documents, drafts, and potential obstacles, our team is well-versed in the development issues surrounding biosimilars, from initial engineering of the cell line, through process development, cGMP manufacture, and clinical development. The infrastructure is in place for rapid site selection and patient accrual as well as the expert management of clinical PK/PD and optimized endpoints.