Biopharmaceuticals (includes Biologics)
Advanced therapies, including cell and gene therapies, tissue engineered products, and cell and tissue products, are being developed throughout the biotechnology and pharmaceutical industry to treat serious and life-threatening diseases. The development of advanced therapies and nucleic acid drugs is challenging, but global health authorities have established regulatory designations and pathways to help expedite development. In this session, the speakers will provide an overview of the regulatory challenges and opportunities, and discuss their experiences developing a tissue engineered product and RNA-based therapeutics. The session will highlight some of the unique characteristics of developing mRNA and RNAi therapeutics, including discussion of indication selection and their fit within US and European regulatory frameworks.