A mid-sized Japanese pharmaceutical company had made the strategic decision to expand their pipeline and geographical footprint by securing global development and commercialization rights to a clinical-stage gene therapy program. Our client had identified a lentiviral vector program of interest, which was being advanced in clinical trials in both US and Europe for a neurodevelopmental disorder by a European biotech company. The pharma company had little/no in-house expertise developing or commercializing gene therapies, so asked Alacrita to help them appraise the asset to identify and qualify any program risks remaining.
From our expert network, Alacrita created a multi-disciplinary technical due diligence team with the relevant gene therapy product development experience. This team included industry experts in gene therapy technology (i.e. vector design, plasmid constructs, transgene, promoters, delivery vehicle), preclinical and toxicology, CMC/Quality, Regulatory Affairs and Clinical. Using documents provided in a secure data room by the biotech company developing the asset, our team prepared a detailed report describing all aspects of the program and any issues which we felt the client should be aware of before making a licensing decision. For any significant risks, our experts predicted the length of potential delays to the program timeline and proposed possible mitigation strategies. The DD report was presented in detail, section-by-section, to the client in a series of workshop style meetings to ensure that client R&D personnel fully understood the observations and recommendations.
Alacrita's due diligence experts have conducted over 200 major assignments for large pharma, biotech, universities and investors, underpinned by our ability to ensure each due diligence exercise is supported by individuals with the precise expertise required for a complete, thorough and accurate assessment.