Employing over three decades of experience, we specialize in collaborating with small and emerging biopharma sponsors on research projects involving cell and gene therapy products and similar biologics, treating a variety of areas including oncology and infectious diseases, among others.
Our regulatory and clinical trial experience encompasses the use of autologous dendritic cells, stem cells, and gene therapy for the potential treatment of a variety of diseases, including oncology indications, infectious diseases, degenerative joint diseases, neurodegenerative diseases, and various immunodeficiency disorders. We’ve also provided scientific support for the development of gene transfer vectors and master cell banks.
Our ongoing, extensive interactions with the various regulatory groups provide us with the opportunity to maintain an awareness of current FDA and Health Canada Health Products and Food Branch (HPFB) regulations, guidelines, and positions regarding monoclonal antibody development programs. These interactions include the FDA’s division of the Center for Biologics Evaluation and Research (CBER), the Office of Cell and Gene Therapy, as well as the HPFB.
Approaching each cell and gene therapy study requires an understanding of the patient’s pathway, as well as the specific safety and logistical needs of your program. Critical to study startup, our teams will collaborate with investigators during the site selection and qualification process to ensure full understanding of both capabilities and training. Our experienced project management teams will consult closely with you on cellular handling and logistics planning and will apply systems and processes that address the safety and data profiling involved with the unique study monitoring needs for these study designs.